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    Research progress on immunotherapy for triple-negative breast cancer
    HE Lihua, ZHU Xiuzhi, JIANG Yizhou
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (8): 842-853.   DOI: 10.12092/j.issn.1009-2501.2023.08.001
    Abstract777)      PDF (754KB)(647)       Save
    Triple-negative breast cancer (TNBC) is a subtype of breast cancer characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). It is highly aggressive, easy to relapse, and chemotherapy remains its mainstay treatment due to the lack of therapeutic targets. In recent years, many advances have been made in the development of immunotherapy for TNBC. This review summarizes the primary modalities of immunotherapy for TNBC, including immune checkpoint inhibitors, adoptive immune cell therapy, tumor vaccines and oncolytic virus. We present the latest research progress on each treatment from the perspective of clinical study and fundamental research, while introducing the potential predictive biomarkers and resistance mechanisms of immunotherapy for TNBC.
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    Advances in targeted therapy for HER2-positive breast cancer
    LUO Shiping, ZHANG Jie, YU Yushuai, SONG Chuangui
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (8): 876-886.   DOI: 10.12092/j.issn.1009-2501.2023.08.004
    Abstract708)      PDF (761KB)(492)       Save
    Since the beginning of the 21st century, with the continuous development of anti-HER2-targeted drugs, more treatment options have been provided for patients with HER2-positive breast cancer and the survival prognosis has been significantly improved. At present, anti-HER2 targeted drugs mainly include monoclonal antibody drugs such as trastuzumab and pertuzumab, small molecule tyrosine kinase inhibitors such as lapatinib and neratinib, and antibody-drug conjugates such as T-DM1 and T-DXd, which play an extremely important role in different disease processes. The treatment of HER2-positive breast cancer is based on targeted therapy with trastuzumab. Early-stage patients with high risk factors can be treated with intensive targeted therapy to further improve the prognosis, while advanced patients need a reasonable arrangement of targeted therapy to overcome drug resistance and prolong survival. This article will review the current status, the latest research progress and the future prospects of anti-HER2 targeted therapy in different stages of the disease.
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    PDE4 inhibitors serve as therapeutic targets for pulmonary fibrosis 
    LIU Nanyu, YUE Hongmei, SONG Peipei, WEI Jifang, WEI Yaqian, XIE Yingying, WANG Jiaqi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 355-360.   DOI: 10.12092/j.issn.1009-2501.2023.03.015
    Abstract545)      PDF (665KB)(677)       Save
    Idiopathic pulmonary fibrosis (IPF) is a progressive and ultimately fatal chronic interstitial lung disease characterized by a progressive decline in lung function, and current treatment options are limited. cAMP is one of the most important second messengers and plays a key role in relaxing airway smooth muscle cells and reducing inflammation. Phosphodiesterase (PDE) is a superfamily of enzymes, and PDE4 enzymes dominate 11 PDE super-family enzymes, available in four isoforms-PDE4A, PDE4B, PDE4C and PDE4D, which selectively decompose cAMP, while PDE4 inhibitors increase cAMP levels by preventing cAMP from breaking down, thereby exerting anti-inflammatory, anti-remodeling effects and providing an attractive drug target for the treatment of IPF. This review summarizes knowledge about the association of pulmonary fibrosis with PKE4, as well as emerging preclin-ical studies and clinical trials regarding PDE4 inhibitors.
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    Bioequivalence study of cinacalcet hydrochloride tablets in healthy Chinese volunteers
    YAN Qiangyong, XIANG Daxiong, ZHU Ronghua, YANG Lingfeng, YANG Xiding, LI Jingjing, FAN Xiao, LIU Sai, XIONG Shoujun, FANG Pingfei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 171-177.   DOI: 10.12092/j.issn.1009-2501.2023.02.007
    Abstract538)      PDF (1053KB)(228)       Save
    AIM: To evaluate the bioequivalence of cinacalcet hydrochloride tablets in healthy Chinese volunteers. METHODS: A randomized, open, double-period and crossover trial was conducted, 48 healthy volunteers were administered a single dose of cinacalcet test tablets or reference tablets orally under each fasting and fed condition. The concentration of cinacalcet was determined by validated LC-MS/MS method. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 to study its bioequivalence. RESULTS: The main pharmacokinetic parameters of test tablets and reference tablets under fasting condition were as follows: Cmax (5.96±4.15) and (6.11±4.08) ng/mL, AUC0-72h (45.82±30.20) and (46.11±29.50) ng·h·mL-1, AUC0-∞  (49.65±33.64) and (49.63±32.01) ng·h·mL-1, Tmax (4.5[1.0, 6.0]) and (4.5[1.0, 6.0]) h, t1/2 (23.15±9.23) and (22.43±8.81) h, respectively. Under fed condition, the main pharmacokinetic parameters of test tablets and reference tablets were as follows: Cmax (11.14±5.24) and  (10.24±5.39) ng/mL, AUC0-72h (76.70±39.34) and (75.18±34.36) ng·h·mL-1, AUC0-∞ (83.28±43.00) and (81.38±38.03) ng·h·mL-1, Tmax (3.0[1.5,5.0]) and (4.3[1.5,7.0]) h, t1/2 (28.07±6.37) and (27.46±5.44) h, respectively. The 90%confidence intervals of the geometric average ratios of Cmax, AUC0-72h and AUC0-∞ were all within the equivalent interval of 80.00%-125.00%. CONCLUSION: Two formulations of cinacalcet tablets are bioequivalent and safe.
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    Research progress of lactate dehydrogenase A in digestive system tumors and related drugs
    WANG Siyu, LI Jiawei, LI Chenghao, LI Ling, GUO Qingyang, QIU Lu, ZHOU Shiqin, LIU Yongqi
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (4): 445-454.   DOI: 10.12092/j.issn.1009-2501.2023.04.012
    Abstract537)      PDF (1441KB)(765)       Save
    Malignant tumors of digestive system are highly prevalent malignant tumors that seriously threaten human health around the world. At present, the curative efficacy and prognosis of traditional treatment methods cannot reach the expectation, so it is urgent to find new targets for cancer treatment and realize targeted therapy for tumors. Abnormal energy metabolism in tumor  cells is regarded as a hallmark of cancer, and malignant tumor cells absorb glucose through aerobic glycolysis pathway, and obtain a small amount of energy and produce lactate under the catalysis of a series of enzymes. Lactate dehydrogenase A (Lactate dehydrogenase A, LDHA), as a key enzyme in the aerobic glycolysis pathway of tumor cells, plays an important role in the metabolic changes of tumor cells. Studies have demonstrated that LDHA has high expression characteristics in a variety of tumor cells,and its high expression in clinic is often related to the poor prognosis and high metastasis rate of tumors, which is expected to be a new target for cancer therapy. This article reviews the role of LDHA in the development of digestive system tu- mors and the research progress of related drugs.
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    Research progress in population pharmacokinetics of rituximab
    LI Mengxue, HE Jie, YU Xiaxia, HU Linlin, SHAO Hua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (4): 468-474.   DOI: 10.12092/j.issn.1009-2501.2023.04.015
    Abstract513)      PDF (638KB)(613)       Save
    Rituximab, a chimeric human-mouse monoclonal antibody, has been used as a first-line treatment for CD20+ B-cell non-Hodgkin lymphoma in combination with chemotherapy. It is also used for autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus and immunemediated nephropathy. The clinical therapeutic effect of rituximab is significant. However, individual pharmacokinetics vary greatly, which bring some uncertainties to the efficacy and safety of clinical application, individualized treatment is needed to improve the rationality of its medication. Currently, studies on the optimization of rituximab administration regimen using population pharmacokinetics have been reported. Our paper reviewed the research progress in population pharmacokinetics of rituximab, aiming to provide reference to formulate an individualized dosing scheme of rituximab and realize precise administration for domestic patients.
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    Research progress in the treatment of early Alzheimer's disease with lecanemab
    JIN Panpan, LIU Yang, QIU Bo, WU Huizhen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (2): 207-214.   DOI: 10.12092/j.issn.1009-2501.2024.02.011
    Abstract512)      PDF (672KB)(1139)       Save
    Lecanemab is a new drug used to treat early Alzheimer's disease (AD) with mild cognitive impairment or mild dementia. It is a human anti-Aβ fibril monoclonal IgG1 antibody, which is injected intravenously into the patient, through the blood-brain barrier into the brain, clearing amyloid plaque, thereby slowing the rate of cognitive decline in patients and delaying disease progression. This article reviews the pharmacological studies, clinical studies, safety and limitations of lecanemab, in order to help clinical understand the current research status and existing achievements of this drug.
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    A comparative investigation of the impact of oral midazolam solution and dexmedetomidine nasal spray on preoperative anxiety in pediatric patients
    WU Xiongzhi, WANG Xuan, XU Siqi, JU Xia, WANG Shengbin, CHEN Yongquan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (6): 666-670.   DOI: 10.12092/j.issn.1009-2501.2023.06.009
    Abstract506)      PDF (630KB)(186)       Save
    AIM: To investigate the impact of oral midazolam solution and dexmedetomidine nasal spray on preoperative anxiety in pediatric patients.  METHODS: A total of 90 children who planned to receive elective surgery in our hospital from June to December 2022 were selected and divided into midazolam oral solution group, dexmedetomidine nasal spray group and normal saline nasal drops group by random number table method. Thirty minutes before anesthesia, midazolam oral solution 0.5 mg/kg was administered to midazolam oral solution group. Dexmedetomidine nasal spray group received 2 μg/kg dexmedetomidine nasal spray and normal saline nasal drops group received 2 mL normal saline nasal drip. Drug acceptance was recorded in the three groups. modified Yale preoperative anxiety scale-short form (m-YPAS-SF) score of the three groups of children were analyzed before administration (T1), while separated from their parents (T2), while during anesthesia induction (T3), while 24 hours after surgery (T4). The scores of induction Cooperation Scale (ICC) in induction of anesthesia were recorded in the three groups. The recovery time and PACU residence time of the three groups were recorded. RESULTS: Compared with dexmedetomidine nasal spray group and normal saline nasal drops group, midazolam oral solution group exhibited a lower drug acceptance score (P<0.05), as well as lower m-YPAS-SF scores at T2, T3, and T4 (P<0.05). Additionally, midazolam oral solution group had a lower ICC score (P<0.05) and longer recovery time (P<0.05), but no significant difference in the length of PACU stay was observed (P>0.05). CONCLUSION: Oral midazolam solution is more readily accepted by pediatric patients compared to dexmedetomidine nasal spray, and it exhibits superior efficacy in alleviating preoperative anxiety, however, its recovery time is prolonged. 
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    Research progress of pharmacologic therapy in obstructive sleep apnea
    WU Xingdong, YUE Hongmei, ZHU Haobin, LIU Miaomiao, LI Yating, XU Jinhui
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (2): 215-229.   DOI: 10.12092/j.issn.1009-2501.2024.02.012
    Abstract474)      PDF (1349KB)(312)       Save
    Obstructive sleep apnea (OSA) is a common sleep disordered breathing disorder. As a major global public health problem, untreated OSA can lead to a variety of adverse health outcomes, including various cardiovascular and cerebrovascular diseases, metabolic disorders, and psychiatric disorders such as anxiety and depression. Traditional OSA therapies such as positive airway pressure (PAP), weight loss, oral?appliance, upper airway surgery, and postural therapy focus on the anatomical factors of OSA. However, the pathogenesis of OSA is heterogeneous, and non-anatomical factors also play an important role in most patients. Although there is no drug with exact efficacy for the treatment of OSA, with the deepening understanding of the pathophysiological mechanism of OSA, more and more clinical studies are devoted to the study of drug treatment of OSA and its complications, and a series of results have been achieved. The following is a review of the relevant studies on drug treatment of OSA in recent years, hoping to provide literature support and theoretical basis for future research on drug treatment of OSA.
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    State of clinical application of meloxicam
    LI Xinyu, HUANG Xin
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 189-197.   DOI: 10.12092/j.issn.1009-2501.2023.02.010
    Abstract456)      PDF (603KB)(476)       Save
    Meloxicam is a long-acting non-steroidal anti-inflammatory drug, which is mainly used in the treatment of chronic osteoarthritis and postoperative analgesia. Recent studies have found that the drug has great therapeutic potential in anti-tumor, improving cognitive impairment in Alzheimer's disease, mobilizing hematopoietic stem cells and so on. This paper reviewed the pharmacological mechanism of meloxicam, the adverse reactions in gastrointestinal tract, kidney, liver and cardiovascular aspects, summarized various forms of clinical application from the perspective of preparation, and summarized the current clinical treatment strategy of combining with Western medicine and Chinese medicine respectively.
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    Comparison of calculation results of five population pharmacokinetic analysis tools
    HUANG Zhiwei, LI Yi, XU Xiaoyong, ZHANG Lei, SHEN Yifeng, LI Huafang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (5): 525-535.   DOI: 10.12092/j.issn.1009-2501.2023.05.006
    Abstract441)      PDF (22940KB)(237)       Save
    AIM: To compare the results calculated by population pharmacokinetic analysis tools Phoenix NLME, Monolix, R nlmixr package and CPhaMAS cloud platform with the gold standard sofeware NONMEM. METHODS: Fifty sparse sampling data sets based on a one-compartment model and fifty dense sampling data sets based on a two-compartment model were simulated, and the above five analysis tools were used to calculate the population typical value, individual variability and individual pharmacokinetic parameters. RESULTS: The population typical value and individual variability calculated by CPhaMAS and Phoenix NLME had the highest matching degree with NONMEM, followed by nlmixr. Monolix had the lowest matching degree, but Monolix and nlmixr might be more robust. The correspondence between clearance and distribution volume was better than the absorption rate constant. Except the absorption rate constant calculated by Monolix and intercompartmental clearance calculated by nlmixr, the correlation coefficients of individual pharmacokinetic parameters calculated by all analytical tools were greater than 0.99. CONCLUSION: The results calculated by the above four population pharmacokinetic analysis tools are highly correlated with that of NONMEM.
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    Helicobacter pylori infection influences the efficacy of immunotherapies for gastric cancer#br#
    WANG Dan, YAN Xiaoli, ZHANG Yuan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 228-234.   DOI: 10.12092/j.issn.1009-2501.2023.02.015
    Abstract440)      PDF (396KB)(226)       Save
    Gastric cancer is a common malignant tumor of digestive tract, and its incidence rate and mortality are very high in China. In recent years, immunotherapy represented by immunocheckpoint inhibitors has brought new therapeutic hope for patients with inoperable advanced gastric cancer. Helicobacter pylori infection is closely related to the occurrence and development of gastric cancer. In this review, we summarized the current status of immunotherapy for gastric cancer, the latest research progress on the impact of Helicobacter pylori infection on gastric mucosal immunity and tumor immunotherapy, and summarized the current challenges and future research directions, with a view to providing new ideas for clinical therapy and scientific research.
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    Research progress in vaccine for breast cancer 
    LI Mengxi, ZHANG Kejing, XIA Fan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (8): 918-925.   DOI: 10.12092/j.issn.1009-2501.2023.08.008
    Abstract431)      PDF (704KB)(200)       Save
    Breast cancer was the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%) in 2020. Breast cancer ranks first among malignant tumors in the world, seriously threatening women's health. Due to continuously enrichment of treatment methods for breast cancer, patients' prognosis have been greatly improved. The emergence of vaccines is an important treatment method to promote the development of human health. For cancer therapy, preventive vaccines have been popularized for kinds of tumor with specific incentives, such as cervical cancer caused by HPV infection. At present, the causative factors of breast cancer are still unclear, and it is still difficult to develop preventive vaccines against breast cancer. In recent years, a variety of therapeutic vaccines have emerged in the field of breast cancer treatment. When patient completed comprehensive treatment, vaccine is used to stimulate body immune system to recognize tumor cell-specific antigens, thereby reducing the recurrence rate as much as possible. Most of these vaccines are currently aimed at more malignant triple-negative breast cancer and HER2-positive breast cancer. This article will focus on the research progress of several therappeutic vaccines.
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    Progress in clinical research on remazolam
    XIN Yuqi, CAO Ya, WANG Yulong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (10): 1195-1200.   DOI: 10.12092/j.issn.1009-2501.2023.10.014
    Abstract405)      PDF (624KB)(857)       Save
    Benzodiazepines are among the most commonly used drugs in the field of anesthesia. Remazolam is a newly developed ultra-short-acting benzodiazepine, which has the characteristics of rapid onset, rapid recovery, high safety, and less side effects such as hypotension and respiratory depression. The aim of this review is to summarize the progress of pharmacokinetics, clinical pharmacology mechanism of action and clinical application of remazolam.
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    Intervention of quercetin in glycolysis of renal interstitial fibroblasts against interstitial fibrosis mechanism
    MA Yue, MA Wangbo, ZHOU Zhihua, CHANG Jingwen, FAN Fangtian
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 121-129.   DOI: 10.12092/j.issn.1009-2501.2023.02.001
    Abstract403)      PDF (7590KB)(148)       Save
    AIM: To investigate the function and mechanism of quercetin (Que) in anti-fibrosis in vitro and in vivo from the perspective of interfering with the glycolysis of renal interstitial fibroblasts.  METHODS: In vivo experiments, mice were administered in groups, kidneys were dissected, weighed and examined histopathologically and biochemically; In vitro experiments, rat normal renal fibroblasts (NRK-49F cells) were treated with different reagents, proteins were extracted, and NRK-49F cell activation indicators such as α-smooth muscle actin (α-SMA) were detected by protein immunoblotting (Western Blot). The expression of the proteins, such as proliferating cell nuclear antigen (PCNA), was examined by protein immunoblotting (Western Blot), and the effect of Que on glucose uptake in NRK-49F cells induced by transforming growth factor-β (TGF-β1) and epidermal growth factor (EGF) was examined by fluorescence assay; the lactate content of cells in different experimental groups was examined by lactate assay kit; the effect of Que on glucose uptake in NRK-49F cells induced by TGF-β1 and EGF was examined by fluorescence quantitative PCR. EGF-induced mRNA of hexokinase (HK2), phosphofructokinase 1 (PFK1) and muscle pyruvate kinase isozyme 2 (PKM2), key enzymes of glycolysis in NRK-49F cells. RESULTS: Compared with the UUO group, the morphological structures of kidney tissues in the Que administration group were all alleviated to different degrees, which were related to the inhibition of glycolysis, and the serum levels of urea nitrogen (BUN) and blood creatinine (Scr) in mice showed a significant downward trend; lactate production and glucose uptake in NRK-49F cells were gradually reduced, and Que affected TGF-β1 and EGF-induced RIF of mRNA levels of key enzymes of glycolysis gradually decreased and were associated with PKM2. CONCLUSION: Que inhibits PKM2 enzyme activity and glycolysis in NRK-49F cells and reduces TGF-β1-induced myofibroblast activation.
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    Platelet-endothelial aggregation receptor 1 and its mediated signalling pathway Advances in the study of the role of platelets and endothelial cells
    LI Ruoning, GUO Zhanli, WANG Yuan, SUN Jianjun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (4): 438-444.   DOI: 10.12092/j.issn.1009-2501.2023.04.011
    Abstract401)      PDF (1248KB)(525)       Save
    Platelet-aggregation  receptor 1 (PEAR1) is a transmembrane receptor identified in 2005 and expressed mainly on platelets and endothelial cells. PEAR1 is a receptor protein that contacts platelets with each other and plays an important role in platelet activation and aggregation. Endothelial cells play an important role in maintaining vascular tone and vascular repair, and PEAR1 regulates the process of tumourigenesis and development by affecting their proliferation and associated neovascularisation. In recent years, PEAR1 has gradually been recognized as a potential target for anti-thrombotic drugs. This review focuses on elucidating the mechanisms of platelet endothelial aggregation receptor 1 and related signaling pathways in platelets and endothelial cells, and provides new ideas for the study of drug therapy for tumour-associated thrombosis.
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    Progress on the pathological mechanism and treatment of frostbite 
    ZHANG Li, LIN Xingyao, SHANG Yun, WANG Qiang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 347-354.   DOI: 10.12092/j.issn.1009-2501.2023.03.014
    Abstract400)      PDF (808KB)(1436)       Save
    Frostbite is a tissue injury that occurs when the body is exposed to extreme cold. Its path-ological mechanism is complex and has not been ful-ly elucidated. In high cold and high altitude areas, outdoor sports people have a high risk of injury, and severe frostbite has high disability and mortality. Ex-ploring the pathological mechanism of frostbite is helpful to determine the treatment methods and timing. At present, the clinical treatment of frostbite is mainly symptomatic treatment, such as drug treatment and surgical treatment, but the curative effect can not meet the clinical needs. Therefore, it is of great significance to seek more efficient drugs or treatment methods. This article reviews the rele-vant research progress in pathophysiological mecha-nism, clinical treatment, cellular and molecular path-ways of frostbite in recent years, in order to provide new ideas for future research and clinical treatment. 
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    Progress and prospect of inhaled biological agents in asthma
    LI Guanghui, HUANG Jing, ZHU Min, ZHAO Rui, WAN Yakun, CHEN Zhihong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (4): 406-414.   DOI: 10.12092/j.issn.1009-2501.2024.04.007
    Abstract390)      PDF (904KB)(508)       Save
    More than 300 million people worldwide suffer from asthma, and the incidence is increasing year by year. As one of the most common chronic diseases, asthma is an immune-mediated inflammatory disease with complex triggering mechanisms and strong heterogeneity. With the in-depth study of physiological and pathological mechanisms, therapeutic small molecule and hormone drugs have been introduced to control and treat most patients, but about 5%-10% of patients still suffer from various subtypes of difficult to control and treat asthma, that is, severe asthma. In the past decade, with the rapid development of biopharmaceutical research, protein and antibody have become the key drugs for the treatment of severe asthma with high efficacy, high specificity and high safety. However, biological drugs are usually administered by injection, they cannot be noninvasive and directly delivered into the lung to quickly absorb and take effect. Therefore, there is an urgent need for the introduction of inhaled biologics with quick effectiveness, convenience, economy and safety in clinical. The review summarizes the existing small molecule, hormone and biological therapy drugs, and summarizes the development of inhalable biological agents of asthma, and analyzes the future prospects of the inhalable biological drugs, which is designed to deepen the perception of the direction of the inhalable biological drugs research, and update the information of the field, in order to provide reference for the development of more inhalable biologics.
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    Recent progress of targeting Nrf2-ferroptosis to treat brain injury after ischemic stroke
    LI Mei, LI Qiang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (2): 188-197.   DOI: 10.12092/j.issn.1009-2501.2024.02.009
    Abstract382)      PDF (973KB)(380)       Save
    Emerging evidences suggest that ferroptosis plays a vital role in the pathophysiological process of brain injury after Ischemic stroke. Accumulating evidence supports  pharmacological inhibition of ferroptosis as a therapeutic target for brain injury after Ischemic stroke through activating nuclear factor erythroid 2-related factor 2 (Nrf2), which transcriptionally controls many key components of the ferroptosis pathway. In this review, briefly describe ferroptosis processes and the roles they play in contributing to brain injury after ischemic stroke in the brain. We then provide a critical overview of the relationship between Nrf2 signalling and ferroptosis. With a focus on discuss how therapeutic modulation of the Nrf2 pathway is a viable strategy to explore in the treatment of ferroptosis-driven brain injury after Ischemic stroke.
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    Comparison of clinical effectiveness and safety between generic and branded dienogest tablets in the treatment of endometriosis
    LIU Qian, ZHANG Jianing, ZHANG Shuang, LIU Qinglan, ZHANG Baoyin, SUN Nan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (5): 527-534.   DOI: 10.12092/j.issn.1009-2501.2024.05.007
    Abstract380)      PDF (1781KB)(92)       Save
    AIM: To evaluate the clinical effectiveness and safety of generic and branded dienogest in the treatment of endometriosis. so as to provide the basis for clinical use of dienogest. MEHTODS: The data of patients admitted to Third Affiliated Hospital of Zhengzhou University from August 2022 to August 2023 who received dienogest (2 mg/d, orally, for 6 months) for treatment of endometriosis were collected. The clinical efficacy and adverse reactions of generic drugs and original drugs in the treatment of endometriosis-related pain were compared through follow-up surveys of the two groups of patients at 3 months and 6 months respectively. RESULTS: There was highly significant reduction in pelvic pain in both groups with mean of similar in generic group (34.0±3.0) mm and branded group (34.5±3.9) mm. The most frequent drug-related adverse effects in generic dienogest was vaginal bleeding (93%) which was no statistical difference with branded dienogest (90%). CONCLUSION: The generic and branded dienogest have the same clinical effectiveness and similar safety.
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    Research on the molecular mechanism of Zuo Jin Wan combined with cetuximab inducing ferroptosis in KRAS mutant colorectal cancer cells
    WEI Zhenzhen, SUI Hua, JIANG Yulang, SUN Mingyu, YAN Huaru, WANG Ziyuan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 130-137.   DOI: 10.12092/j.issn.1009-2501.2023.02.002
    Abstract375)      PDF (3684KB)(171)       Save
    AIM: To investigate the mechanism and reversal effect of Zuo Jin Wan (ZJW) on cetuximab (CET) resistance in KRAS mutant colorectal cancer cell.  METHODS: The mutation status of KRAS gene in SW620, Lovo, HCT116, HT29 and Caco2 cells were detected by Sanger sequencing. CCK-8 assay was used to detect the effects of ZJW, CET, ZJW combined with CET and CET, ZJW in combination with other cell death inhibitors on the survival rate of the above cells, and to observe the reversal effects of ZJW on CET-treated KRAS mutant cells (SW620, Lovo and HCT116). Flow cytometry, colorimetric method, and Fe2+ ions fluorescent probe FerroOrange were used to detect the effects of ZJW, CET and their combination on ROS, GSH and Fe2+ levels in KRAS mutant cells. Western blot and real-time PCR were used to detect the regulatory effects of ZJW combined with CET on proteins and mRNA of ferroptosis-related pathway. RESULTS: KRAS mutant cells include HCT116 (KRASG13D), Lovo (KRASG13D) and SW620 (KRASG12V), while HT29 and Caco2 were KRAS wild-type cells. Compared with 125 μg/mL CET-treated KRAS mutant cells, CET at same concentration significantly reduced cell viabilities of KRAS wild-type cells (Caco2 and HT29 cells) by 34.03%and 40.68%, respectively (P<0.01). ZJW (50 μg/mL) combined with CET (125 μg/mL) markedly reduced cell viability of HCT116, Lovo and SW620 cells, which were 59.97%, 59.47%and 52.58%, respectively (P<0.05), compared with the controls. ZJW could enhance ROS and Fe2+ levels, and decrease GSH levels in KRAS mutant cells. When ZJW combined with CET, the effects were more significant (P<0.05,P<0.01). ZJW combined with CET inhibited protein and mRNA expressions of SLC7A11, GPX4, Nrf2 and MDM2 in SW620 cells, and increased the expression of p53 protein. However, the combined treatment did not affect the level of p53 mRNA. CONCLUSION: ZJW could regulate Nrf2 and p53 pathways in KRAS mutant cells, thereby inhibiting SLC7A11 and GPX4 expressions and promoting ferroptosis, which may be the mechanism of reversing CET resisgtance.
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    Research progress in plasma concentration monitoring of rivaroxaban
    YU Qiaoling, ZHAI Weiwei, LIU Ping, QIU Bo, WU Huizhen
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (7): 809-817.   DOI: 10.12092/j.issn.1009-2501.2023.07.012
    Abstract375)      PDF (654KB)(646)       Save
    Rivaroxaban, a novel oral anticoagulant drug, is widely prescribed in clinical practice. Rivaroxaban offers predictable pharmacokinetic and pharmacodynamic properties, a lowprobability of drug-drug and food-drug interactions. Compared with warfarin, rivaroxaban does not require continuous therapeutic monitoring and can be administered in fixed doses.However,in certain emergency clinical situations, such as bleeding, acute stroke, acute kidney injury, prior to urgent surgery and in the suspected accumulation of durg, plasma concentration monitoring of rivaroxaban is necessary and important for patients. Existing studies proved that there were significant individual variability and wide range in the plasma rivaroxaban concentration, which increased the risk of clinical use. Therefore, Data in the degree of rivaroxaban concentration may provide recommendations for the clinical application to promote medication safety and individuality in the future. This article collected the latest literatures and case reports related to research progress of rivaroxaban plasma concentration monitoring, and Summarized influencing factors, monitoring methods, so as to provide a basis for further study on rational use of rivaroxaban in clinical.
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    Research progress of the classical TCM formula Huaihua powder 
    CHEN Cheng, DENG Yu, GONG Youlan, ZHANG Zhenming, DUAN Wulei, QING Jun, ZHANG Bo
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (6): 697-704.   DOI: 10.12092/j.issn.1009-2501.2023.06.013
    Abstract373)      PDF (734KB)(789)       Save
    Huaihua powder, a classical TCM formula, was initially recorded in Pu Ji Ben Shi Fang by the prestigious physician Xu Shuwei. It is a classical prescription for treating "chang-feng-zang-du"(chang-feng-xia-xue). Modern research shows that the main components of Huaihua powder are flavonoids, volatile oil, saponins and so on, which have anti-inflammatory, antioxidant, hemostatic, antibacterial, anti-tumor and other pharmacological effects.The clinical application is mostly used for the treatment of ulcerative colitis, radioactive enteritis, hemorrhoid postoperative bleeding and other skin diseases. Its modern clinical application is slightly better than the ancient clinical application. This paper summarized and summarized the chemical composition and analysis method, process research and quality control, modern pharmacology and clinical application, and discussed the material basis and research direction of its efficacy. Based on the research results, combined with the modern pharmacology and clinical application of Huaihua powder, it is recommended to develop the entire pharmacological active ingredients of this classic formula, as well as the main effective ingredients, anti-inflammatory targets, and mechanism of action for the treatment of radiation induced enteritis, allergic purpura, and other skin diseases.
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    Research progress of uterine endometrial epithelial cell organoids in the field of reproduction
    CAO Zhiwen, YAN Guijun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (5): 576-582.   DOI: 10.12092/j.issn.1009-2501.2024.05.013
    Abstract368)      PDF (829KB)(697)       Save
    In recent years, significant progress has been made in the study of endometrial epithelial organoids in the field of reproduction. Traditional two-dimensional cell culture models and animal experiments fail to accurately replicate the three-dimensional structure and physiological functions of the endometrium, limiting the in-depth exploration of its normal physiological mechanisms and related disease mechanisms. Emerging organoid technologies have provided new avenues for research. These organoids, formed by self-organization of stem cells or progenitor cells in a three-dimensional culture system, faithfully recapitulate the characteristics of endometrial glands in situ. Not only can these organoid models mimic the changes in the endometrium at different stages of the menstrual cycle, but they can also simulate the interaction between the fertilized embryo and the endometrium. Moreover, organoid systems have become essential tools for fundamental research in the field of reproduction and for disease research, including studies related to reproductive biology, drug screening and development, disease mechanism exploration, drug action mechanisms, drug combination therapies, and targeted therapies. These studies have provided novel insights and methods for a deeper understanding of the biological properties of the endometrium, its disease mechanisms, and the development of therapeutic strategies for related disorders.
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    Progress in clinical application of topical anesthesia
    TAO Yijia, YANG Chun, LIU Cunming
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (5): 594-600.   DOI: 10.12092/j.issn.1009-2501.2023.05.015
    Abstract348)      PDF (614KB)(2836)       Save
    Topical anesthesia are being widely used in clinical diagnostic or therapeutic fields such as ophthalmology, ENT, dermatology, urology. It is defined as superficial loss of sensation in mucous membranes or skin, produced by direct application of penetrating local anesthetics. Topical anesthesia has the advantages of simple performance, high safety, quick recovery, which can effectively improve patient's satisfaction. In recent years, more and more attention has been paid to the concept of comfortable diagnosis and treatment. The new drugs and application methods of topical anesthesia are emerging constantly, special attention must be paid to their pharmacological characteristics and possible adverse reactions when using them. This article reviews the research progress of topical anesthesia in clinical application in order to provide reference for clinical practice.
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    Application of quantitative pharmacology in vaccine research and de-velopment: overview and prospect 
    MA Guangli, ZHANG Jing
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 315-322.   DOI: 10.12092/j.issn.1009-2501.2023.03.010
    Abstract344)      PDF (1748KB)(595)       Save
    This article introduces the mechanism including antigen presentation, adjuvant, lymphatic system and the characteristics of vaccine, and then summarizes the key applications of core pharmaco-metrics approaches including QSP, PK/PD, dose re-sponse analysis, MBMA, in dose-response, preclini-cal and clinical translation, and correlation be-tween biomarkers and efficacy of vaccines. It is ex-pected that the successful application of model in-formed drug development can promote model in-formed vaccine development so that pharmaco-metrics makes its due contributions to the develop-ment of safer, more effective and more controlla-ble vaccine products.
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    Research progress on pathogenesis and potential therapeutic target of sarcopenia obesity 
    GUO Yixun, GUAN Xiaoyin, WANG Bo, WEI Yingda, ZHANG Yan, LIN Jianhua
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 341-346.   DOI: 10.12092/j.issn.1009-2501.2023.03.013
    Abstract343)      PDF (631KB)(548)       Save
    Sarcopenia obesity (SO), a specific dis-ease with co-occurrence of obesity and sarcopenia, is shown clinically as abnormal accumulation of fat, decreased mass and strength of muscle, and in-creased risk of incidence and mortality of other chronic diseases. Currently, there exist various defi-nitions and diagnoses about SO in the various re-gions of the world. Its prevalence in populations el-evates in an age-dependent manner. This article summarized the possible pathogenesis of SO from the view of chronic inflammation, oxidative stress, insulin resistance, and Hippo pathway, subsequent-ly listed and analyzed potential pharmacological targets (fibroblast growth factor, CD44, adiponec-tin, etc) involved in treating SO, in order to provide new ideas for clinical diagnosis, treatment of SO pa-tients and research and development of innovative drugs.
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    Comparison of common parameter estimation methods in NONMEM 7.5.1.: A case study of ibuprofen injection in Chinese healthy adult population 
    LUO Mingjie, LIU Runhan, ZHOU Jie, WANG Zhenlei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 290-298.   DOI: 10.12092/j.issn.1009-2501.2023.03.007
    Abstract340)      PDF (3390KB)(364)       Save
    NONMEM. is a software widely used in the field of population pharmacokinetics and pharmacodynamics, mainly for related data analy-sis. In theory, it mainly establishes a parameterized model, combines the obtained data, and uses dif-ferent parameter estimation methods to estimate the parameters in the model, and then analyzes the data according to the model. This paper briefly introduces the representation of parameterized models in NONMEM., and from statistical theory, summarizes three commonly used parameter esti-mation methods under the condition that the ran-domization effect parameters η and .do not inter-act. For nonlinear mixed effects models, the rela-tionships among three parameter estimation meth-ods are given under special cases of addictive intra-individual models and proportional intra-individual models. In addition, through numerical experi-ments on data of four pharmaceutical companies on the change of ibuprofen drug concentration with time, the rationality of theory is further veri-fied in terms of calculation time and model predic-tion residuals. 
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    Mechanism of neuroprotective effect of ginsenoside Rg1 regulating Epac1/Rap1 signaling pathway in rats with ischemic stroke
    WANG Kun, XU Peipei, ZHOU Lanlan, LU Sheng
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (7): 721-727.   DOI: 10.12092/j.issn.1009-2501.2023.07.001
    Abstract338)      PDF (1891KB)(203)       Save
    AIM: To investigate the neuroprotective effect of ginsenoside Rg1 on rats with ischemic stroke and to investigate its mechanism of action. METHODS: Eighty-four SPF-grade SD male rats at about 13 weeks of age were randomly divided into 7 groups (n=12): sham-operated group, model group, Rg1 low-dose group, Rg1 medium-dose group, Rg1 high-dose group, Epac1 agonist group, and Epac1 inhibitor group. The model group, Rg1 low, medium and high dose groups, Epac1 agonist group and Epac1 inhibitor group were all used to establish a permanent focal cerebral ischemia rat model. Rats in the Rg1 low, medium and high dose groups were treated with 60, 120 and 240 μmol/L Rg1 administered by gavage at a fixed time every morning. The rats in the Epac1 agonist and Epac1 inhibitor groups were administered intraperitoneally at a fixed time each morning with a concentration of 1.0×104 μmol/L for the Epac1 agonist 8-CPT and 1.0×105 μmol/L for the inhibitor ESI-09. After two weeks of continuous administration, the rats in each group were decapitated. The brain infarct volume, number of intact neurons, oxidative damage index, apoptosis, and protein expression levels of NOX2, Epac1, Rap1, and caspase3 in each group of rats were detected by TTC staining, Nissler staining, TUNEL staining, microenzyme labeling, and Western blotting method, respectively. RESULTS: Compared with the sham-operated group, the brain infarct volume of rats in the model group and Epac1 agonist group was significantly larger, the number of intact neurons in brain tissue was significantly reduced, the oxidative damage of neurons in brain tissue was significantly aggravated, the apoptosis rate of neuronal cells was significantly higher, and the expression of NOX2, Epac1, Rap1, and caspase3 was significantly higher, with statistically significant differences (P<0.05); compared with the model group, the brain infarct volume was significantly reduced in the Rg1 low, medium and high dose groups and Epac1 inhibitor group, the number of intact neurons in brain tissue was significantly increased, the apoptosis rate of neuronal cells was significantly reduced, and the expression of NOX2, Epac1, Rap1 and Caspase3 was significantly reduced, and the differences were statistically significant (P<0.05). CONCLUSION: Ginsenoside Rg1 can regulate the Epac1/Rap1 signaling pathway after ischemic stroke and attenuate the oxidative stress of brain neurons, thus reducing neurological impairment and exerting a protective effect on neuronal cells.
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    Research progress of metformin in the pathogenesis of pulmonary fibrosis
    WANG Jie, LI Long, CHEN Feng, LIU Shengfei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (2): 235-240.   DOI: 10.12092/j.issn.1009-2501.2023.02.016
    Abstract334)      PDF (378KB)(253)       Save
    Pulmonary fibrosis is a chronic, progressive and irreversible respiratory disease characterized by hyperposition of extracellular matrix leading to inflammation and extensive lung remodeling. There is currently no effective treatment. Multiple studies have shown that metformin is a classic antiglycemic drug with antifibrotic potential. However, at present, there is no consensus on the specific mechanism of metformin's anti-fibrosis effect, and this paper reviews the research progress of metformin in the field of pulmonary fibrosis in recent years, mainly from IGF-1/IGF-1R/PI3K signaling, AMPK/mTOR signaling, TGF-β/Smad signaling pathway, and intervening in myofibroblast proliferation and apoptosis, improving oxidative stress, inhibiting epithelial interstitial transformation and transglutaminase. In order to be able to more deeply and comprehensively understand the antifibrosis mechanism and clinical application scope of metformin in the future, and provide new ideas for the treatment of pulmonary fibrosis.
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    Practice of model-informed drug development in pharmaceutical industry in China
    LI Jian, WANG Yuzhu, WANG Jun
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (5): 596-600.   DOI: 10.12092/j.issn.1009-2501.2024.05.016
    Abstract320)      PDF (932KB)(215)       Save
    Guideline of model-informed drug development was published by National Medical Products Administration in 2020, which provided technical guidance for the application of modeling and simulation in the process of new drug development. In July 2022, Center of Drug Evaluation conducted a questionnaire survey on the practical ability of pharmaceutical industry to apply model-informed drug development (MIDD) in the process of new drug development, in order to investigate the practice of MIDD in China. Based on the feedback data collected from enterprises, this paper analyzes the practice of MIDD in domestic pharmaceutical industry, and briefly discusses several problems that still exist at present.
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    Pharmacological  and clinical evaluation of Dorzagliatin in the treatment of type 2 diabetes
    DU Xiaoyu, LI Yumeng, WU Huizhen, QIU Bo
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (10): 1177-1183.   DOI: 10.12092/j.issn.1009-2501.2023.10.012
    Abstract319)      PDF (639KB)(486)       Save
    Dorzagliatin is a new dual action allosteric systemic glucokinase agonist (GKA), which can simultaneously activate the glucokinase (GK) in the pancreas and liver, promote insulin secretion and liver glycogen conversion in patients with type 2 diabetes, and improve pancreatic islets β-Cell function and insulin resistance simultaneously stimulate intestinal GK to regulate the secretion of Glucagon-like peptide-1 to play multiple hypoglycemic effects. As the first marketed GKA drug, it provides a new therapeutic approach for patients with type 2 diabetes. This article reviews the mechanism of action, pharmacokinetics, Drug interaction, clinical research and safety of Dorzagliatin.
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    Study on bioequivalence evaluation of dexamethasone acetate tablets in Chinese healthy volunteers
    XIAO Lei, XU Yuanyuan, HUANG Xiaoqing, ZHANG Wen, CAO Yang, XIE Jing, ZHOU Huan, HUANG Shunwang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (12): 1365-1371.   DOI: 10.12092/j.issn.1009-2501.2023.12.006
    Abstract319)      PDF (1059KB)(181)       Save
    AIM: To assess the bioequivalence of oral dexamethasone acetate tablets between the test and reference formulations in healthy adult Chinese subjects on an empty stomach and after meals. METHODS: A randomized, open, single-dose, two-cycle double crossover bioequivalence study was followed. Twenty-four healthy subjects were included in the fasting group, and 32 healthy subjects were included in the postprandial group, taking 2 tablets (0.75 mg/tablet) of the test formulation (T) or 3 tablets (0.50 mg/tablet) of the reference formulation (R) per cycle for two cycles. The concentrations of dexamethasone acetate in human plasma were determined using liquid chromatography-mass spectrometry, and the pharmacokinetic parameters were calculated according to the non-atrial model using WinNonlin 8.0 software.The bioequivalence of both the test formulation and the reference formulation was evaluated. RESULTS: The pharmacokinetic parameters after oral administration of dexamethasone acetate tablets in a fasted state in subjects with the reference formulation are as follows: Tmax 1.13 (0.50, 4.00) and 1.00 (0.50,5.00) h, AUC0-t (72.25±21.55) and (69.23±17.76) ng·mL-1·h, Cmax (14.53±4.51) and (14.52±3.68) ng/mL, AUC0-∞ (74.63±23.01) and (71.32±19.12) ng·mL-1·h. The pharmacokinetic parameters after oral administration of dexamethasone acetate tablets in the postprandial state in subjects were as follows: Tmax 2.00 (1.00,4.50) and 1.50 (1.00, 4.50)h, AUC0-t (81.57±21.28) and (76.06±13.63) ng·mL-1·h, Cmax (12.14±3.21) and (11.93±2.78) ng/mL, and AUC0-∞ (85.12±23.92) and (78.95±14.99) ng·mL-1·h. The 90% confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters of the test formulation of dexamethasone acetate to the reference formulation ranged from 80.00% to 125.00% under both fasting and postprandial conditions. CONCLUSION: Under fasting and postprandial conditions, the test formulation of dexamethasone acetate tablets was bioequivalent to the reference formulation of dexamethasone acetate tablets.
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    Research progress on drug treatment and drug resistance mechanism of gastrointestinal stromal tumors
    ZHAO Quanming, YANG Mandou, HU Yibo, SU Youtong, PU Li, ZHANG Yu, LI Wenliang
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (1): 82-89.   DOI: 10.12092/j.issn.1009-2501.2024.01.009
    Abstract316)      PDF (835KB)(537)       Save
    Gastrointestinal stromal tumors (GIST) are the most common mesenchymal-derived tumors of the gastrointestinal tract. Tyrosine kinase inhibitors (TKIs) are the cornerstone of GIST therapy, but mutations in resistance genes pose many problems for treatment, especially the heterogeneity of KIT resistance mutations. In recent years, with the release of a number of GIST related drug research and experimental results, the great potential of targeted therapy, immunotherapy and combination therapy to treat GIST in different directions has been revealed, providing more therapeutic directions for GIST. This article will review the experimental research and future direction in recent years.
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    Mechanism of action and research progress of vaccine adjuvants
    ZHANG Li, LU Chang, AN Minghui, WANG Mengmeng, ZONG Xiaoyu, YU Lin, RAN Zhuo-ling, SONG Jing, LI Huijie, GONG Jian
    Chinese Journal of Clinical Pharmacology and Therapeutics    2024, 29 (7): 785-791.   DOI: 10.12092/j.issn.1009-2501.2024.07.008
    Abstract316)      PDF (831KB)(563)       Save
    Vaccines are among the most effective measures for preventing infectious diseases and play a crucial role in controlling the spread of these diseases. Adjuvants, serving as auxiliary components in vaccines, are indispensable in the vaccine development process. Ideal adjuvants not only enhance the immune response, enabling the body to achieve optimal protective immunity but also play important roles in reducing the dosage of immunogens and lowering vaccine production costs. To meet the demands of novel vaccines, many new types of adjuvants have been developed. However, there is still a lack of adjuvants that are safe, effective, easy to prepare, highly pure, and suitable for a variety of vaccines in clinical settings. This article categorizes adjuvants and summarizes their mechanisms of action and characteristics, focusing on traditional aluminum salt adjuvants and more modern lipid-based and nucleic acid-based adjuvants. The summary is based on a computer search of databases including PubMed, Embase, The Cochrane Library, CNKI (China National Knowledge Infrastructure), VIP Database, and Wanfang Database, using English search keywords such as Adjuvants, Vaccine, Vaccine Adjuvant, aluminum salts, MF59, AS03, Toll-like receptor agonist, etc., and corresponding Chinese search terms. The aim is to provide references for the development and application of adjuvants.
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    Research progress on mechanisms and therapeutic drugs of peroxisome proliferator-activated receptor in treatment of cholestatic liver disease
    WANG Anjing, WANG Yaya, LIANG Xuan, YAN Yajie, SU Jing, LI Caidong
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (7): 796-808.   DOI: 10.12092/j.issn.1009-2501.2023.07.011
    Abstract312)      PDF (851KB)(734)       Save
    Cholestatic liver disease is a common disease that causes bile flow dysfunction due to various reasons. The etiology of cholestatic liver disease is complexed, and therapeutic drugs are extremely limited. To date, ursodeoxycholic acid is the only FDA-approved drug for treating primary biliary cirrhosis, whereas its efficacy is limited to early stage of the disease, therefore novel drugs are urgently needed. Nuclear receptors become therapeutic hotspot target in cholestasis since these receptors play a key role in regulating bile acid homeostasis. Peroxisome proliferator-activated receptor (PPAR) is an important nuclear receptor involved in regulating multiple mechanisms of cholestasis in vivo. It can improve intrahepatic cholestasis by inhibiting bile acid synthesis, reducing bile acid toxicity, affecting the expression of bile acid metabolic enzymes and transporters, and can play an anti-inflammatory, anti-oxidation and anti-fibrosis role. A number of studies have shown that PPAR agonists represented by fibrates alone or in combination can improve liver function indexes, inflammatory factors and fibrosis markers in patients with cholestasis. This review analyzes and summarizes the lastest advances in the molecular mechanism of PPAR as a therapeutic target for cholestasis and drug treatment in development or have been used in clinical.
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    Research progress on the treatment of autism spectrum disorders based on gut microbiota intervention
    ZHANG Qiang, ZHENG Huajun, LI Quan
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (4): 475-480.   DOI: 10.12092/j.issn.1009-2501.2023.04.016
    Abstract309)      PDF (626KB)(398)       Save
    Autism spectrum disorder is a set of neurodevelopmental disorders with unclear etiology and pathogenesis and no cure. Studies have found that the gut microbiota plays a vital role in the occurrence and development of autism spectrum disorder. By supplementing with probiotics, diet management or fecal microbial transplantation, the balance of gut microbiota can be adjusted to improve the behaviors and symptoms of patients with autism spectrum disorder. This article reviews from the perspective of regulating the bal- ance of gut microbiota to treat autism spectrum disorder, and aims to provide assistance for the re- search and treatment of autism spectrum disorder.
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    New progress in research on novel control strategies for methicillin-resistant staphylococcus aureus infection
    QIAO Hongliang, DING Ning, DENG Kaihong, LIU Binbin, DONG Chuanjiang, CHEN Xiaobo, ZOU Lili
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (6): 676-687.   DOI: 10.12092/j.issn.1009-2501.2023.06.011
    Abstract307)      PDF (1017KB)(353)       Save
    Methicillin-resistant staphylococcus aureus (MRSA) is one of the most common multi-drug resistant bacteria in clinical practice and is known as a "superbug". With the evolution of MRSA resistance mechanisms, it is increasingly difficult to treat MRSA infections with conventional antibiotics. In recent years, novel control strategies for MRSA infections have been developed at various levels. The unique structure of nanomaterials has antimicrobial activity and can also be used as an efficient transport carrier. Photodynamic therapy promotes cellular oxidative stress by light-activated photosensitizer (PS) interacting with molecular oxygen or substrates to generate reactive oxygen species (ROS). The antimicrobial properties of herbal medicines by multiple mechanisms have been widely demonstrated. Immunotherapy has made breakthroughs in the use of immune escape mechanisms, polyvalent vaccines, and mixed antibodies against MRSA. Gene targets represented by the mecA gene are being explored. Novel candidate antibacterial compounds targeting TDRS, especially the Trx system, will be a promising force in the future. In this paper, novel control strategies for MRSA are reviewed and prospected.
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    Pharmacologic effects and clinical evaluation of Tenapanor, a new drug for hyperphosphatemia
    HOU Wenping, XU Lei, SU Changhai
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (12): 1429-1435.   DOI: 10.12092/j.issn.1009-2501.2023.12.014
    Abstract307)      PDF (700KB)(313)       Save
    Tenapanor is a novel phosphorus-lowering drug, which mainly inhibits sodium/hydrogen exchange protein 3 (NHE3), and also reduces intestinal phosphorus absorption by down-regulating the expression of sodium phosphate co-transporter protein (NAPI).Tenapanor is mainly used for the treatment of hyperphosphatemia in patients with end-stage renal disease-hemodialysis (ESRD-HD). Diarrhea is the most common adverse reaction to this product. This article reviews Tenapanor by performing a literature search on its pharmacological effects, pharmacokinetic properties, clinical evaluation, safety, drug interactions and dosage.
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    Silybin ameliorates lipid metabolism disorders in mice with non-alco-holic steatohepatitis
    CAI Zuhuan, DENG Taomei, WEI Naijie, ZHU Dan, QIAN Fei, WANG Guangji, ZHANG Jingwei
    Chinese Journal of Clinical Pharmacology and Therapeutics    2023, 28 (3): 241-248.   DOI: 10.12092/j.issn.1009-2501.2023.03.001
    Abstract304)      PDF (2718KB)(221)       Save
    AIM: To investigate the regulatory ef-fects of silybin on hepatic lipid metabolism in mice with non-alcoholic steatohepatitis (NASH) induced by high -fat and high-cholesterol (HFHD) diet. METHODS: Mice were fed a HFHD diet to construct a NASH model, and serum levels of triacylglycerol (TAG), total cholesterol (T-CHO), low-density lipo-protein cholesterol (LDL-C) and high-density lipo-protein cholesterol (HDL-C) were measured using biochemical kits. H&E staining and oil red O stain-ing were used to detect histopathological changes in the liver. Lipidomics was used to detect the alter-ations of hepatic lipid metabolism in NASH mice. 
    RESULTS: Silybin significantly inhibited the increase of body weight, liver weight and abdominal fat, de-creased serum T-CHO,TAG and LDL-C levels, im-proved hepatic lipid droplet accumulation and bal-looning degeneration, and back-regulated hepatic palmitoleic acid (C16:1) and polyunsaturated long-chain fatty acids (PUFAs) in NASH mice. CONCLU-SION: Silybin possibly reduced hepatic lipid accu-mulation and lipotoxicity by modulating abnormal hepatic lipid metabolism in mice induced by HFHC diet. 
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