Table of Content

Volume 25 Issue 5
26 May 2020

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Protective effects of Xiaochaihu Decoction on chemical hepatic fibrosis in mice

WU Furong, NING Lijuan, ZHOU Ran

2020, 25(5):  481-488.  doi:10.12092/j.issn.1009-2501.2020.05.001

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AIM: To observe the protective effects of Xiaochaihu Decoction (XCHD) on carbon tetrachloride (CCl4)-induced hepatic fibrosis (HF) in mice. METHODS: HF was induced in male mice by 20% CCl4 twice a week for 12 weeks. XCHD (3.90, 7.80, 15.60 g/kg) and Silybin (0.1 g/kg) were administrated via gavage once a day starting from the CCl4 treatment for subsequent 12 weeks. Then, the levels ALT and AST in serum were assayed, liver samples were taken to examine the degree of HF by HE, Masson, Sirius Red staining and Electron microscope. Moreover, the protein and mRNA expression levels of α-smooth muscle actin (α-SMA) and Collagen Ι were determined by RT-qPCR, immunofluorescence and Western blot. RESULTS: The data demonstrated that XCHD (7.80, 15.60 g/kg) effectively reduced histopathological changes, such as steatosis, collagen deposition; meanwhile the histopathological analysis suggested that XCHD obviously alleviated the degree of HF. Furthermore, XCHD significantly reduced the levels of ALT, AST (P<0.05), and attenuated the expressions of α-SMA, Collagen Ι both of protein and mRNA levels (P<0.05). CONCLUSION: XCHD has protective effect on chemical HF in mice.

miR-138-5p protects β cell function by regulating HIF-1α in gestational diabetes mellitus

HUANG Hao, XIAO Fang, JIA Hong, WANG Xiaoshuang, DUAN Yating

2020, 25(5):  489-497.  doi:10.12092/j.issn.1009-2501.2020.05.002

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AIM: To study the effect of miR-138-5p on the function of β cell in gestational diabetes mellitus (GDM) and its related mechanism. METHODS: The expression of miR-138-5p in peripheral blood of 15 GDM pregnant women and 15 normal pregnant women were compared by RT-qPCR. miR-138-5p mimic and inhibitor were transfected into INS-1 cells, respectively, and their expression level was over expressed or inhibited. RT-qPCR was used to verify the transfection efficiency.MTT proliferation experiment, Annexin V-FITC apoptosis experiment and insulin release experiment were used to detect the effects of miR-138-5p on INS-1 cell proliferation, apoptosis and insulin release ability. The target gene of miR-138-5p was screened by TargetScan, a miRNA target gene prediction software. The functional rescue experiment confirmed whether miR-138-5p could exert its influence on INS-1 cell proliferation, apoptosis and insulin release ability by targeting its target gene. Western blot was used to detect the molecular signaling pathway of miR-138-5p in INS-1 cells. RESULTS: The expression of miR-138-5p in peripheral blood of GDM pregnant women was significantly lower than that of normal pregnant women. RT-qPCR showed that miR-138-5p mimic and inhibitor could significantly promote or inhibit the expression of miR-138-5p in INS-1 cells. The results of MTT proliferation experiment, Annexin V-FITC apoptosis experiment and insulin release experiment indicated that over expression of miR-138-5p could significantly promote the proliferation of INS-1 cells, inhibit the apoptosis of cells and promote the insulin release ability of cells. However, down-regulating the expression of miR-138-5p could significantly inhibit the proliferation of INS-1 cells, promote apoptosis and inhibit insulin release. HIF-1α was selected as the target gene of miR-138-5p by TargetScan. The double luciferase gene report and Western blot showed that miR-138-5p could inhibit the expression of HIF-1α in INS-1 cells. The functional rescue experiment confirmed that miR-138-5p could affect the proliferation, apoptosis and insulin release of INS-1 cells by regulating the expression of HIF-1α. Western blot showed that miR-138-5p may play a role in INS-1 cells by affecting PI3K, Akt and p-PI3K, p-Akt protein after phosphorylation in PI3K/Akt signaling pathway. CONCLUSION: miR-138-5p may reguLate HIF-1α expression in a targeted manner, thereby affecting the PI3K/AKT signaling pathway, promoting the proliferation and inhibition of the parent cells' apoptosis, and promoting their insulin-releasing ability to protect the function of β cell in GDM.

Effects of pterostilbene on myocardial function, myocardial fibrosis and inflammatory response in rats with acute myocardial infarction and on Notch1/eIF3a signaling pathway

ZHAO Wei, WU Youyang, LIN Cong, HUANG Shiwei, CHEN Hao, JIANG Wenbing

2020, 25(5):  498-504.  doi:10.12092/j.issn.1009-2501.2020.05.003

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AIM: To analyze the effects of pterostilbene on myocardial function, myocardial fibrosis and inflammatory response in rats with acute myocardial infarction and on Notch1/eIF3a signaling pathway. METHODS: Seventy-five Wistar male rats of SPF grade were selected and divided into 5 groups. The low-, medium-, high-dose groups of pterostilbene were pretreated with pterostilbene solution before modeling. The dosage was 10, 20 and 40 mg/kg of the pterostilbene sputum solution, rats of the model group and the normal group were intragastrically administered with the same dose of normal saline; except for the normal group, other rats were prepared with AMI model. The left ventricular function, cardiac blood flow index, myocardial histopathology and fibrosis, myocardial inflammatory factor content, eIF3a and Notch1 protein and mRNA expression were observed. RESULTS: LVFS and LVEF were lower in the model group than in the normal group. LVEDd, LVESd, LVESV and LVEDV were higher than those in the normal group. The LVFS and LVEF in the low, medium and high dose groups of the pterostilbene were higher than those in the model group, LVEDd, LVESd, LVESV, and LVEDV were lower than the model group, and the difference was statistically significant (P<0.05).In the model group, the －dp/dtmax, +dp/dtmax, and LVSP were lower than the normal group, and the LVEDP was higher than the normal group. The －dp/dtmax, +dp/dtmax, and LVSP in the low, medium, and high dose groups of the pterostilbene were increased as compared with model group; while LVEDP was lower than the model group, and the difference was statistically significant (P<0.05).The contents of IL-6, IL-1β and TNF-α in the myocardial tissue of the model group were higher than those in the normal group. The contents of IL-6, IL-1β and TNF-α in the myocardial tissue of rats with low, medium and dose groups of the pterostilbene were decreased as compared with the model group, the difference was statistically significant (P<0.05). The expression of eIF3a and Notch1 protein and mRNA in the myocardial tissue of the model group was higher than that in the normal group. eIF3a, Notch1 protein and mRNA expression in the low-, medium-, and high-dose rat myocardial tissue were lower than the model group, and the difference was statistically significant (P<0.05). CONCLUSION: The development of myocardial inflammation and fibrosis in AMI rats may be associated with the increase of eIF3a expression in the downstream of Notch signaling pathway. Pretreatment of pterostilbene can significantly improve ventricular remodeling in AMI rats, and its mechanism may be related to the inhibition of eIF3a and Notch1 expression.

AHVAC-I inhibits the proliferation in human primary gastric cancer cells

TIAN Dahao, LU Linming, ZHI Hui, ZHOU Jue, WANG Xiaoqing, JIANG Yuhua

2020, 25(5):  505-511.  doi:10.12092/j.issn.1009-2501.2020.05.004

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AIM: To explore the effect of inhibiting proliferation and inducing apoptosis in human primary gastric tumor by the Agkis-trodon halys venom anti-tumor component Ⅰ (AHVAC-Ⅰ). METHODS: Human primary gastric cancer cells were isolated by trypsin digestion, serum-free culture, and purified by differential adherence method, and cells were identified by immunohistochemistry. Cell proliferation and toxicity assay (CCK-8) was used to detect the inhibition rate of AHVAC-Ⅰ in different concentrations of primary gastric cancer cells. Immunohistochemistry was used to verify the apoptosis of human primary gastric cancer cells induced by AHVAC-Ⅰ and the morphological changes were observed by Hematoxylin-Eosin staining (HE staining). AHVAC-Ⅰ-induced primary gastric cancer cell transformation rate was detected by flow cytometry Annexin V/PI double staining. RESULTS: Seven human primary gastric cancer cells were successfully isolated and purified, and 11 cases failed. Immunohistochemical identifications of carcinoembryonic antigen (CEA) and broad-spectrum keratin protein (AE1/AE3) were positive for both antibodies. AHVAC-Ⅰ inhibited the proliferation of human primary gastric cancer cells and showed a dose-dependent effect (P<0.01). Immunohistochemistry showed that the expression level of cysteine aspartic protease-3 (Caspase-3) up-regulated with the increase of AHVAC-Ⅰ concentration. HE staining showed that with the increase of AHVAC-Ⅰ concentration, the cell gap increased, nuclear pyknosis, and apoptosis cells increased. Flow cytometry showed that the apoptosis rate of human primary gastric cancer cells up-regulated with the increase of AHVAC-Ⅰ concentration (P<0.05). CONCLUSION: AHVAC-Ⅰ can inhibit the proliferation and induce apoptosis in human primary gastric cancer cells in a dose-dependent manner.

Yiqi Huoxue decoction inhibits malignant biological behavior of human lung cancer cells via the miR-21/PTEN signaling pathway

YANG Guoliang, HU Dandan, XU Yikai, LOU Liming

2020, 25(5):  512-518.  doi:10.12092/j.issn.1009-2501.2020.05.005

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AIM: To investigate the inhibitory effect of Yiqi Huoxue decoction on the malignant biological behavior of lung cancer cells and its mechanism. METHODS: Human lung cancer A549 cells were treated with different doses of Yiqi Huoxue Decoction serum (5%, 10%, 15%). CCK-8 assay, transwell chamber experiment, flow cytometry, Western blot and qRT-PCR method were used to study the effect of different doses of Yiqi Huoxue Decoction-containing serum to cell proliferation, cell migration and invasion, cell apoptosis, PTEN protein and miR-21 expression. RESULTS: Compared with the drug-free serum group, survival rate, migration and invasion ability of A549 cells decreased after treatment with different doses of drug-containing serum. The apoptosis rate of A549 cells increased, PTEN mRNA and the expression of its protein increased, the expression of miR-21 decreased, and the medium-dose (10%) drug-containing serum group had the best effect. After the transfection of miR-21 mimics, miR-21 expression was up-regulated, while PTEN protein expression was down-regulated in cells. PTEN protein expression was up-regulated after treatment with medium-dose (10%) drug-containing serum. CONCLUSION: Yiqi Huoxue Decoction can effectively inhibit the malignant cell biological behavior of human lung cancer A549 cells and may be related to the regulation of the miR-21/PTEN signaling pathway.

Lidocaine inhibits the malignant proliferation, invasion and regulates the mitochondrial respiration of osteosarcoma MG-63 cells

CHEN Yi, CAO Hua, CAI Lingfang, CHEN Ben, CHEN Mingkun

2020, 25(5):  519-526.  doi:10.12092/j.issn.1009-2501.2020.05.006

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AIM: To investigate the effects of lidocaine on malignant proliferation, invasion and mitochondrial respiration of osteosarcoma MG-63 cells. METHODS: MG-63 cells were treated with 25, 50 and 100 μmol/L of lidocaine and were randomly divided into four groups: lidocaine 0 μmol/L, lidocaine 25 μmol/L, lidocaine 50 μmol/L and lidocaine 100 μmol/L for subsequent experiments. BrdU staining was used to detect cell proliferation. Transwell for cell invasion. Protein expression levels of Ki67, Survivin, VEGF and Vimentin were detected by Western blot. Mitochondrial membrane potential was detected by flow separator. Activity of mitochondrial respiratory complex was detected by Clark oxygen electrode method. The kit detected the content of ATP, SOD and MDA. RESULTS: Results showed that compared with lidocaine 0 μmol/L group, BrdU positive cells in lidocaine 50, 100 μmol/L group was significantly reduced (P<0.05), invasive cells was significantly reduced (P<0.05), Ki67, Survivin, VEGF, Vimentin protein levels decreased significantly (P<0.05), mitochondrial membrane potential decreased significantly, compound I, II, IV activity decreased significantly (P<0.05), ATP, SOD content decreased significantly (P<0.05), MDA content was significantly increased (P<0.05). CONCLUSION: Lidocaine can inhibit the malignant proliferation, invasion and improve the mitochondrial function of osteosarcoma MG-63 cells.

miR-106a regulates the proliferation of ovarian granulosa cells by targeting TIMP-2

OU Jun, HOU Wenwen, TANG Jingwen, LI Jiaping, XU Qingyang

2020, 25(5):  527-532.  doi:10.12092/j.issn.1009-2501.2020.05.007

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AIM: To investigate the regulation function of miR-106a on the proliferation of human ovarian granulosa cells, and to explore its possible target. METHODS: The expression of miR-106a in granulosa cells was regulated by cell transfection, and its expression level was detected by RT-PCR. The MTT assay was used to detect the cell proliferation activities of cells. Bioinformatics methods were used to predicted the possible target genes of miR-106a, which were verified them by double-luciferase assay. The expression of target protein was detected by Western blot. RESULTS: The expression of miR-106a in KGN cells was significantly higher than that of normal ovarian epithelial cell (IOSE80), the difference was statistically significant (P<0.05). The proliferation activity of KGN cells was significantly decreased after inhibiting the expression of miR-106a (P<0.05). The results of dual luciferase assay showed that miR-106a could directly target TIMP-2 gene. Western blot results showed that the expression level of TIMP-2 protein was significantly decreased after overexpression of miR-106a (P<0.05). CONCLUSION: miR-106a can promote the proliferation of KGN cell; The mechanism is related to the targeted reduction of TIMP-2 expression level.

Lycium barbarum polysaccharide inhibits the proliferation and promots the apoptosis of osteosarcoma HOS cells by blocking Shh signaling pathway

YANG Wenteng, LIN Xiaojun, YE Weijian, YANG Lele

2020, 25(5):  533-539.  doi:10.12092/j.issn.1009-2501.2020.05.008

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AIM: To study the effects and mechanism of Lycium barbarum polysaccharide on the proliferation and apoptosis of osteosarcoma HOS cells. METHODS: Osteosarcoma HOS cells were divided into four groups: control group, LBP-I group, LBP-II group and LBP-III group. MTT was used to detect cell proliferation; PI single staining was used to detect cell cycle; Annexin V-FITC/PI double staining was used to detect apoptosis; Western blot was used to detect the expression of Cleaved Caspase-3, Cleaved PARP, cyclin-dependent kinase 4 (CDK4), cyclin D1, Shh and Gli1. Shh signal activator and Lycium barbarum polysaccharide treated osteosarcoma HOS cells together; the changes of cell proliferation, cell cycle and apoptosis were observed. RESULTS: Compared with the control group, the proliferation ability of LBP-I group, LBP-II group and LBP-III group decreased, the proportion of cells in G0/G1 phase increased[(51.2±4.1)% vs. (59.1±3.2)%, (66.8±2.0)%, (72.3±3.2)%, F=72.76, P<0.001], the level of apoptosis increased[(3.9±0.3)% vs. (13.2±1.2)%, (17.6±1.3)%, (24.8±2.1)%, F=364.50, P<0.001], the expression levels of Cleaved Caspase-3, Cleaved PARP protein increased, the expression levels of CDK4, cyclin D1, Shh and Gli1 decreased (P<0.05). Compared with cells not treated with Shh signal activator, the cells treated with Shh signal activator could reverse the effect of Lycium barbarum polysaccharide on the proliferation, cycle arrest and apoptosis of osteosarcoma HOS cells. CONCLUSION: Lycium barbarum polysaccharides blocked the cell cycle of osteosarcoma HOS cells, inhibited cell proliferation and promoted cell apoptosis by inhibiting Shh signaling pathway.

Missed and remedial dosage regimens of erlotinib by Monte Carlo simulation

XU Gaoqi, ZHANG Yiwen, ZHENG Xiaowei, LIU Yujia, LI Li, HUANG Ping

2020, 25(5):  540-545.  doi:10.12092/j.issn.1009-2501.2020.05.009

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AIM: To evaluate the missed and remedial dosage regimens in cancer patients using erlotinib population pharmacokinetics (PPK) model by Monte Carlo simulation (MCS). METHODS: According to erlotinib PPK model (150 mg po qd), 10 000 MCS were estimated for missed doses and remedial dosage regimens (6 h, 12 h, 18 h, and 24 h double doses) by NONMEM. The proportion of people outside the individual treatment window (ITW) and duration outside the ITW (>5%) under the missed and remedial regimens were calculated, and the rationality of the supplemental regimen in each scenario were analyzed. RESULTS: When missed taking erlotinib, the drug concentration continued to drop to the next medication time and affected the next day's concentration. The durations below the ITW were 25.1 h and 6.6 h, respectively. The proportion of people below ITW increased from 6.82% to 14.55%, and the duration time increased from 5.9 h to 23.6 h; the proportion of people above ITW increased from 5.99% to 10.74%, and the duration time increased from 3.7 h to 9.7 h. CONCLUSION: According to MCS results, patients should improve erlotinib medication compliance and avoid missed doses. In case of missed dose, remedial should be given as soon as possible, but it is not recommended to take remedial or double dosage near the next administration time to avoid increased adverse drug reactions.

Discussion on the format and content of new drug population pharmacokinetic study report

LI Jian, YANG Jinbo, WANG Yuzhu

2020, 25(5):  546-549.  doi:10.12092/j.issn.1009-2501.2020.05.010

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Population pharmacokinetics (PopPK) is an analytical method that can quantify the variability of drug concentration among individuals. It is widely used in various stages of new drug researches from non-clinic to clinic. With the rapid development of PopPK, more and more sponsors are keen to comprehensively analyze the in vivo processes of new drugs as well as its influencing factors using modeling and simulation methods. Several guidelines have been issued to recommend the use of PopPK in China. However, no explicit requirement of PopPK study report has been issued for regulatory application. This article conducts a preliminary discussion on new drug PopPK study and its reporting format and content, with reference to the requirements in relevant guidelines as well as previous review experiences, for the discussion or reference of industries and researchers.

Characteristic and development of standard operating procedure of electronic data management in traditional Chinese medicine clinical research

LI Qingna, HUANG Ke, LU Fang, ZHAO Yang, QIU Panbo, WANG Shuge, GAO Rui

2020, 25(5):  550-554.  doi:10.12092/j.issn.1009-2501.2020.05.011

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Electronic data management has the advantages of saving cost and research time and improving the data quality, which has gradually been the mainstream form of clinical data collection and management. It is important to improve the quality of Traditional Chinese Medicine (TCM) clinical researches. This paper introduces the function, general style, developing principles and processes, management and training of Standard Operating Procedure (SOP) for electronic clinical data management. The characteristics and difficulties of electronic data management of TCM clinical researches are discussed and suggested solutions are proposed in the end.

Design and practice of clinical trial management information system

ZENG Chan, XIANG Yuxia, LIU Chang, YANG Guoping, HUANG Zhijun

2020, 25(5):  555-558.  doi:10.12092/j.issn.1009-2501.2020.05.012

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AIM: To explore the information management of the whole process of clinical trials based on the laws and guidelines. METHODS: Taking the clinical trial management of our hospital as an example, we designed the clinical trial management information systems separately for researcher and sponsor to realize the whole process management of clinical trial in our hospital. RESULTS:The application of the clinical trial information management systems realized the real-time monitoring and information management of the whole process of project initiation, contract signing, ethical review, start-up, project selection/enrollment, subject management and conclusion. CONCLUSION: The separate design can ensure the information security of subjects, make effective statistics on the data generated, which can greatly improve the work efficiency of clinical trial management.

Effects of imipenem-cilastatin sodium combined with immunoglobulin on serum PCT, hs-CRP and TNF-α in children with baby sepsis complicated with disseminated intravascular coagulation

RU Caiwang, YUAN Tianming, YANG Bingfen, WU Fugen, LIN Yingrong, MO Miaojun

2020, 25(5):  559-565.  doi:10.12092/j.issn.1009-2501.2020.05.013

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AIM: To investigate the effects of imipenem-cilastatin sodium combined with immunoglobulin on serum PCT, hs-CRP and TNF-α in child with baby sepsis complicated with disseminated intravascular coagulation (DIC). METHODS: Ninty-two cases of patients with sepsis and DIC neonates admitted to our hospital from January 2013 to April 2019 were enrolled in this study. All the children were divided into observation group and control group according to random number table method, 46 cases in each group. The patients in the control group were treated with imipenem-cilastatin sodium, and the patients in the observation group were treated with imipenem-cilastatin sodium combined with immunoglobulin. The efficacy of the two groups, the time of DIC index returned to normal, bleeding stopped and ICU hospitalization time, coagulation parameters (FIB, PLT, D-D, TT), serum inflammatory factor levels and incidence of adverse reactions were compared. RESULTS: The total effective rate of treatment in the observation group was 93.48% (43/46), which was higher than that in the control group (78.26%, 36/46) (P<0.05). The DIC index of the observation group returned to normal time, bleeding stop time, ICU hospitalization time was shorter than those of the control group (P<0.05). After 5 days of treatment, the plasma levels of FIB, D-D and TT were decreased in the two groups, and the observation group was lower than those of the control group, the difference was statistically significant (P<0.05). After 5 days of treatment, the expressions of serum PCT, hs-CRP and TNF-α were decreased in the two groups, and the observation group was lower than the control group (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups [2.17% (1/46) vs. 6.52% (3/46)] (P>0.05). CONCLUSION: Imipenem-cilastatin combined with immunoglobulin is effective in the treatment of baby sepsis complicated with DIC. It can alleviate or eliminate bleeding and other symptoms, shorten ICU hospitalization time, improve coagulation function, and reduce serum PCT and hs-CRP, TNF-α expression, and the body's inflammatory response, combined with fewer adverse reactions, which has a higher clinical value.

Therapeutic drug monitoring and pharmacokinetics of new coronavirus pneumonia antiviral drugs

ZHANG Lu, LIN Liangmo, LIU Keke, HUANG Yamin, HUANG Xingxing, YANG Yongyu, XIAO Jian

2020, 25(5):  566-575.  doi:10.12092/j.issn.1009-2501.2020.05.014

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The recent outbreak of pneumonia caused by new coronavirus (SARS-CoV-2) infection has brought major challenges to public health and governance in various countries. At present, there is no clinically specific drug for SARS-CoV-2, and most of the antiviral drugs used are drugs for the treatment of severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS). This article aims to organize and analyze the antiviral drugs and their pharmacokinetic characteristics, and to discuss the characteristics and necessity of therapeutic drug monitoring (TDM), so as to provide a reference for the safety of anti-SARS-CoV-2 treatment.

Research progress in the mechanism of BRAF inhibitor resistance in melanoma

WANG Cheng, MA Pengcheng, SUN Jianfang, LI Hongyang

2020, 25(5):  576-583.  doi:10.12092/j.issn.1009-2501.2020.05.015

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Melanoma is a malignant tumor of melanocyte origin, and BRAF mutations occur in about 50% of melanoma patients clinically. BRAF inhibitors can target mutated BRAF sites, thus rapidly inhibiting the proliferation and promoting apoptosis of tumor cells. However, the subsequent rapid occurrence of drug resistance events seriously restricted the continuous use of such drugs, so it is of great importance to explore the mechanism of BRAF inhibitors resistance. This paper introduces the research progress of BRAF inhibitor resistance in melanoma in recent years, in order to provide some references for the follow-up research and clinical application.

Research Progress of Pirfenidone for connective tissue disease-associated interstitial lung diseases

WANG Xiao, YUE Hongmei, WANG Ruoli, SUN Jinying, LI Le, LIU Ruichao

2020, 25(5):  584-590.  doi:10.12092/j.issn.1009-2501.2020.05.016

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Pirfenidone is an anti-fibrotic drug that has been shown to reduce the decline of lung function in patients with idiopathic pulmonary fibrosis (IPF) in multiple clinical trials, and has become first-line drugs for the treatment of IPF. Similar to the pathogenesis of IPF , clinical incidence of connective tissue disease-associated interstitial lung diseases (CTD-ILD) is high, and the clinical performance is not obvious. ILD may be the only or the original manifestation. Thus the clinical heterogeneity and the misdiagnosis rate are relatively high. Also, CTD-ILD is one of the important reasons that resulted in the death of patients. Currently, the clinical diagnosis and treatment of CTD-ILD still lack effective guide or unified agreement. Studies have shown that anti fibrosis drug pirfenidone shows some potential in the treatment of CTD-ILD. Here we summarize the research advances of pirfenidone in the treatment of CTD-ILD.

Clinical trials during post-COVID pandemic: An interim review

HUANG Zhijun, YANG Guoping

2020, 25(5):  591-594.  doi:10.12092/j.issn.1009-2501.2020.05.017

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China has experienced an unprecedented pandemic of corona virus disease 2019 (COVID-19) in 2020. In the background of serious public health events, clinical trials in most Chinese regions have experienced a series of tough periods such as suspension of admission and protocol violation. With resumption of work and production around the country, China has entered the post-COVID pandemic period. This article analyzes how clinical trial institutions resume professional work, and advocates to continue to strengthen the countermeasures and experience during the outbreak, such as the design of subject-centered clinical trial, comprehensively promotion of information technology, construction of professional clinical research centers and clinical research support teams, respecting evidence-based evidence and real-world evidence, optimal ethical committee review modes, and standardization of agency disaster recovery plan. These experiences should be applied to future clinical researches.

Research progress on the mechanism and treatment of pelvic organ prolapse

ZHOU Yiwen, PING Yi

2020, 25(5):  595-600.  doi:10.12092/j.issn.1009-2501.2020.05.018

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Pelvic organ prolapse (POP) is caused by a variety of causes, such as weak pelvic floor support system, abnormal location of female reproductive system and adjacent organs, uterine prolapse, anterior and posterior vaginal wall prolapse and other clinical diseases. In this paper, the epidemiology, etiology and current treatment of the disease were summarized, and the basic pathogenesis and the application prospect of mesenchymal stem cells (MSCs) in the disease were described in detail.