Table of Content

Volume 25 Issue 2
26 February 2020

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Statistical consideration in the design of COVID-19 clinical trials in emergency

LUO Yi, JIANG Zhiwei

2020, 25(2):  121-125.  doi:10.12092/j.issn.1009-2501.2020.02.001

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The outbreak of coronavirus disease 2019 (COVID-19) led to the first-level response to major public health emergencies in China. To explore the therapy of COVID-19, hundreds of clinical studies were conducted. For major public health emergencies, it is important to find out the effective drug and therapeutic regimen as soon as possible for the control of disease, which raises the claim of timeliness to the trials conducted in emergency, especially to the registered clinical trials. This paper discusses the choice of clinical endpoint and related questions in the design of clinical trials in emergency from the statistical perspective. 

New use of old drugs in the treatment of SARS-CoV-2 infection

LAN Qiaoshuai, XIA Shuai, ZHOU Jie, WANG Qian, LU Lu

2020, 25(2):  126-134.  doi:10.12092/j.issn.1009-2501.2020.02.002

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Recently, pneumonia caused by 2019 new coronavirus (SARS-CoV-2) outbroke in Wuhan, China, which has threatened people's health and lives and enormously influenced the people's daily life in China. However, there are currently no specific anti-SARS-CoV-2 drugs with explicit therapeutic efficacy. Some clinical drugs, which have been shown certain inhibitory activities for SARS-CoV-2 in vitro or have previously been reported to inhibit coronavirus infection, have been applied for clinical trials or tentative treatment of SARS-CoV-2 infected patients. From the perspective of exploring the new use of old drugs, this review mainly introduces characteristics, including mechanisms of action, in vitro antiviral effects and side effects, and research progress of these drugs, hoping to provide referential ideas for the treatment of SARS-CoV-2 infected patients.

Analysis of clinical trial registration information of COVID-19 in China

XIANG Yuxia, ZENG Chan, HUANG Zhijun, WANG Xiaomin, ZHANG Zeyu, YANG Guoping

2020, 25(2):  135-140.  doi:10.12092/j.issn.1009-2501.2020.02.003

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AIM: To provide advice for the clinical trials during the outbreak by analyzing the clinical trial registration information of COVID-19 in China. METHODS: Clinical protocols of COVID-19 registered at the Chinese Clinical Trials Registry and clinicaltrials.gov before February 17, 2020 were collected and the type, distribution, design and interventions of the studies were analyzed.RESULTS:A total of 172 trials were retrieved, mainly distributed in Hubei, Zhejiang, Guangdong and Beijing. Among the 120 interventional studies, chemical drugs and biological products accounted for 45%, traditional Chinese medicine or integrative medicine therapy accounted for 40%, cell therapy accounted for 7%, and plasma therapy accounted for 2%. There were only 13 randomized, blinded and placebo controlled studies, accounting for 11%. Blank control reached 46% (control group with clinical routine treatment without placebo，test group with clinical routine treatment as the basic). HIV and antimalarial drugs were the most frequently used. CONCLUSION: Chinese clinical research capacity and awareness have been greatly improved, but it is somewhat disordered. It is necessary to pay attention to the necessity, scientific nature, ethics and quality management of clinical research. It is recommended to initiate clinical trials coordinated and unified demonstration and to collect the national case information for big data analysis by the state during an emergency outbreak.

New coronavirus pneumonia: Question and confusion

HU Ke

2020, 25(2):  141-143.  doi:10.12092/j.issn.1009-2501.2020.02.004

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The outbreak of new coronavirus pneumonia (COVID-19) in Wuhan and surrounding areas has brought huge challenges to China. As a new infectious disease, there are questions and confusion about its epidemiological characteristics and clinical treatment. Therefore, it is urgent  to figure out how to achieve effective prevention, higher success rate of treatment and scientific management.

PROfound: A new hope for precise treatment of prostate cancer

HUANG Houbao

2020, 25(2):  144-150.  doi:10.12092/j.issn.1009-2501.2020.02.005

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Metastatic castrate-resistant prostate cancer (mCRPC) is the last stage of prostate cancer. Although new hormonal agents and taxane-based chemotherapies occurred for mCRPC treatment, the overall survival of mCRPC patients is limited. Olaparib is an inhibitor of poly ADP-ribose polymerase (PARP), which has a key role in DNA damage response. It has been approved for ovarian cancer and breast cancer treatment.  PROfound, a phase III clinical trial of olaparib in mCRPC treatment, has been reported in 2019 ESMO and 2020 ASCO-GU. In this paper, we will bring the results and updates of PROfound.

Effect of JiSuiKang on the microglia infiltration and neuron survival in the spinal cord injury area of rats

PAN Yalan, YUAN Wenchao, MA Yong, GUO Yang, ZHENG Suyang, XU Guihua, LIU Jiahuan

2020, 25(2):  151-158.  doi:10.12092/j.issn.1009-2501.2020.02.006

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AIM: To observe the effect of Chinese medicine compound JiSuiKang on the microglia infiltration and neuron survival at the spinal cord injury area of rats. METHODS: Sixty SD rats were randomly divided into sham operation group (Sham), model group (Ctrl), JSK low (JSK-L), JSK medium (JSK-M) and JSK high (JSK-H) dose group, prednisone group. The model of rat spinal cord injury (SCI) was established by improved Allen's method. After the operation, each group was intervened in different ways, and then we assessed the double hind limb motor function score in rats (BBB score). The heart perfusion was done and the spinal cord tissues from the injury area were taken. ELISA tests were used to detect the expression of inflammatory factors. The spinal cord tissue was sliced into sections and then immunofluorescence stained of CD11b/c and beta 3-Tubulin to observe the infiltration of microglia and the growth of neurons under the inverted fluorescence microscope. RESULTS:The BBB score of Sham, JSK-L, JSK-M, JSK-H and prednisone group were higher than Ctrl（P＜0.05）. For the expression of inflammation, the expressions of IL-1 in group Sham, JSK-L, JSK-M, JSK-H and prednisone were lower than that of Ctrl (P＜0.05). For the percentage of microglia infiltration, JSK-L, JSK-M, JSK-H and prednisone were all lower than that of Ctrl (P＜0.05), and there was no significant difference between JSK-H and prednisone(P＞0.05). For the growth state of the neuron, the JSK-L, JSK-M, JSK-H, prednisone group were better than Ctrl (P＜0.01), and JSK-H was better than JSK-L and JSK-M (P＜0.05). CONCLUSION: The Chinese medicine compound JSK inhibits the migration and invasion of microglia in SCI, promotes the recovery of damaged neurons and motor function in SCI rats.

Endoplasmic reticulum stress-induced apoptosis up-regulation of DR5 via a CHOP-dependent mechanism in HSC-T6 cells

XIE Jiali, LI Jun

2020, 25(2):  159-166.  doi:10.12092/j.issn.1009-2501.2020.02.007

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AIM: To investigate the inhibitory effects of endoplasmic reticulum stress(ERS) and TRAIL on hepatic stellate cells in vitro and how their interaction affect the apoptosis of hepatic stellate cells. METHODS: Take thapsigargin (TG) as the endoplasmic reticulum stress-inducing agents, ursodeoxycholic acid (UDCA) for the endoplasmic reticulum stress inhibitors, SP600125 as a c-Jun N-terminal kinase(JNK) inhibitor, HSC-T6 cells were divided into normal control group, DMSO group, TRAIL group, TG group, UDCA group, siCHOP group and SP600125 group. The apoptosis rate of HSC-T6 cell was detected by flow cytometry. Small interference RNA was applied to silence C/EBP homologous protein(CHOP) gene. The protein expression levels of Caspase-8 were detected by immunohistochemistry method. The ERS marker protein CHOP and TRAIL receptor DR5 expression levels were determined by RT-PCR and Western blot. RESULTS:TG (1 μmol/L, 2 μmol/L, 4 μmol/L, 8 μmol/L, 16 μmol/L) increased cell apoptosis rate of HSC-T6. RT-PCR and Western blot showed that the endoplasmic reticulum stress protein marker CHOP could induce the upregulation of TRAIL receptor DR5 and Caspase-8. Moreover, siCHOP and the JNK inhibitor SP600125 could reduce the expression of DR5 and Caspase-8 in HSC cells. CONCLUSION: These results indicated that CHOP and JNK may be a potential factor regulating DR5 expression, and play an important role in the process of apoptosis of hepatic stellate cells.

Role and mechanism of platelet-derived growth factor/AKT pathway in pressure overload-induced ventricular remodeling

ZHENG Sanfu, GUO Weixi, LUO Jinzhong, QIN Shuiqing

2020, 25(2):  167-173.  doi:10.12092/j.issn.1009-2501.2020.02.008

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AIM: To analyze the role and mechanism of PDGF/AKT pathway in pressure overload-induced ventricular remodeling. METHODS: A total of 55 C57BL/6 female mice were selected to establish aortic arch narrowing model. Forty-five models were successfully modeled. The randomized digital table method was used to divide the models into sham operation group, DMSO group and experimental group. The sham operation group was opened after chest operation. The suture was performed without aortic coarctation (TAC). After 24 hours of thoracotomy, 200 μL of PBS solution and 50 μL of DMSO were administered. The DMSO group was given 200 μL of PBS solution and 50 μL of DMSO 24 h after operation. The experimental group was given PBS solution 200 μL plus AG1296 50 μL 24 h after TAC to observe the heart function and myocardial histopathology of mice. Lentiviral infection was established to identify and culture HUVEC cells with different expression of PDGF gene. According to different treatments, the cells were divided into control group, PDGF group, shRNA group and PDGF+IMA group to detect the expression of p-AKT and t-AKT protein in HUVEC cells. RESULTS:LVESV, LVEDV, LVESD and LVEDD were increased in DMSO group as compared with sham operation group, while EF and FS of DMSO group were lower than those in sham operation group. LVESV, LVEDV, LVESD and LVEDD were lower in experimental group than those in DMSO group, while EF and FS in experimental group were higher than those in DMSO group. The difference was statistically significant (P<0.05). The sham operation group had neatly arranged myocardial tissue and normal interstitial; the DMSO group had irregular morphology, inflammatory cell infiltration, cell gap was enlarged, and the nucleus was deeply stained. The number of expanded or necrotic cells in experimental group decreased, the gap became smaller, and the inflammatory infiltration decreased. The cross-sectional area of myocardial cells in DMSO group was higher than that in sham operation group. The cross-sectional area of the myocardial cells in experimental group was lower than that in DMSO group (P<0.05). The expression of p-AKT and t-AKT protein in PDGF+IMA group was significantly higher than that in PDGF group and shRNA group, the difference was statistically significant (P<0.05). CONCLUSION:PDGF can accelerate ventricular remodeling induced by pressure overload and promote the formation of myocardial fibrosis, while inhibiting PDGF/AKT pathway can improve myocardial cell hypertrophy.

Resveratrol inhibits the proliferation of retinoblastoma cells via miR-937/FOXQ1 pathway

SONG Hui, WANG Yinghao

2020, 25(2):  174-181.  doi:10.12092/j.issn.1009-2501.2020.02.009

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AIM: To study the impact of resveratrol (RES) on the proliferation of retinoblastoma in vitro, and to explore its possible mechanism.  METHODS:CCK-8 assay and flow cytometry assay were used to measure cell viability and apoptosis. The relationship between miR-937 and forkhead box Q1 (FOXQ1) was predicted and confirmed by TargetScan and dual-luciferase reporter assay. In addition, gene and protein expression was detected using reverse transcription-quantitative polymerase chain reaction (RT-PCR) and Western blot, respectively.  RESULTS:RES inhibited the proliferation and induced the apoptosis of Y79 cells with time- and concentration-dependent manner. miR-937 was found to be down-regulated in retinoblastoma cell lines; treatment with RES increased the expression of miR-937 in Y79 cells. FOXQ1 was identified as a direct target of miR-937, and its expression was negatively associated with that of miR-937. Additionally, FOXQ1 was up-regulated in retinoblastoma cell lines; treatment with RES decreased the expression of FOXQ1 in Y79 cells. Furthermore, compared with treatment with RES alone, the combination of transfection with miR-937 inhibitor and RES treatment significantly decreased the expression of miR-937, increased FOXQ1 expression, promoted Y79 cell proliferation and reduced the apoptosis of cells in vitro. CONCLUSION: RES reduced the proliferation and induced the apoptosis of retinoblastoma cells by decreasing FOXQ1 expression via the up-regulation of miR-937, suggesting that the miR-937/FOXQ1 signaling pathway may be a novel therapeutic target in the treatment of retinoblastoma.

CNR1 genetic variation influences the clinical outcomes of early stage type 2 diabetes mellitus treated with liraglutide

ZHAO Qian, YANG Guang, CAO Lihua, YU Chenbao

2020, 25(2):  182-188.  doi:10.12092/j.issn.1009-2501.2020.02.010

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AIM: Recent studies have shown that the cannabinoid receptor 1 (CNR1) gene played an important role in diabetes and its complications development. And liraglutide was of positive therapeutic significance in patients with type 2 diabetes mellitus. This study was to investigate the influence of CNR1 genetic variation on the clinical outcomes of early stage type 2 diabetes mellitus treated with liraglutide. METHODS: From March 2016 to December 2018, a total of 230 patients with early stage type 2 diabetes mellitus were included as the research object in this study. The patients were treated with liraglutide, and the clinical outcomes were evaluated 16 weeks later. Additionally, peripheral blood and part of the patients with fresh peripheral blood specimens of the patients were collected for the genotyping of the genetic variation and CNR1 gene mRNA expression, respectively. The correlation between genetic polymorphism and other baseline characteristics was analyzed by chi square test and non-parametric test. The mRNA expression of CNR1 in different genotypes was analyzed by non-parametric test. RESULTS:All of the 230 diabetes mellitus patients were of available for efficacy evaluation. BMI, FPG, 2H PG and HbA1c of all patients decreased significantly after 16 weeks of treatment, and the difference was statistically significant compared with that before treatment (P<0.05). In terms of the CNR1 gene polymorphism analysis, only rs1049353 was found to be of clinical significance. The prevalence of rs1049353 among the 230 patients were as follows: GG genotype 188 cases (81.74%), GA genotype 39 cases (16.96%), AA genotype 3 cases (1.30%), the minor allele frequency is 0.10, The distribution of three genotypes were in accordance with Hardy-Weinberg Equilibrium (P=0.551). GA genotype and AA genotype patients were merged in the following analysis. The clinical outcomes analysis indicated that BMI index of GA/AA genotype patients decreased (3.4±0.9) kg/m2 on average, FPG index decreased (5.1±0.9) mmol/l on average, HbA1c decreased (2.7±0.5)%. And the BMI index of GG genotype patients decreased (3.0±1.5) kg/m2 on average, FPG index decreased (4.7±1.3) mmol/l on average, HbA1c decreased (2.6±0.5)%, respectively. There were statistically significant differences between the two genotypes. Additionally, of the 125 available specimens for CNR1 gene mRNA analysis, the results showed that the mRNA expression of CNR1 in the patients with GG genotypes were significantly higher than those of the GA/AA genotype patients［(4.2±1.3) vs. (2.8±1.2), P<0.001)］. In terms of adverse reactions, the incidence of adverse reactions during treatment was relatively low, and gradually disappeared after drug withdrawal, and there was no significant correlation with CNR1 gene rs1049353 polymorphism. CONCLUSION:It is safe and effective in early stage type 2 diabetes patients received liraglutide treatment. And the clinical outcomes of the patients received liraglutide treatment may be influenced by CNR1 rs1049353 through mediating the mRNA expression of CNR1.

Efficacy and safety of etoposide combined with carboplatin in children with recurrent medulloblastoma

PAN Luping, SHI Wujie, SHEN Zhipeng

2020, 25(2):  189-195.  doi:10.12092/j.issn.1009-2501.2020.02.011

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AIM: To evaluate the efficacy and safety of etoposide combined with carboplatin in the treatment of recurrent medulloblastoma in children. METHODS: From January 2011 to June 2014, 72 children (aged 3-15 years) with recurrent medulloblastoma were selected from Childrens Hospital Affiliated to Medical College of Zhejiang University. According to the random number table method, they were divided into the CE group and control group, with 36 cases each. The CE group received etoposide + carboplatin for chemotherapy. The control group received classical irinotecan + temozolomide + vincristine chemotherapy. Clinical efficacy, KPS score, PedsQLTM4.0 score, total survival (OS) and event-free survival (EFS) of children in the two groups were compared, and the occurrence of adverse drug reactions during treatment was recorded. RESULTS:After treatment, CR of CE group and control group was 41.67% (15 cases/36 cases) and 27.78% (10 cases/36 cases), OR of CE group and control group was 94.44% (34 cases/36 cases) and 77.78% (28 cases/36 cases), and there were statistically significant different in these indicators between the groups. There was no significant difference in KPS scores and PedsQLTM4.0 scores between the two groups before treatment (P＞0.05). After treatment, KPS scores of the CE group and the control group were (80±8) and (75±10) points, and PedsQLTM4.0 scores were (89±11) and (84±11) points, and there were statistically significant different in these indicators between the groups (both P<0.05). By the time of the last follow-up, the overall survival rates of the CE group and the control group were 78.8% (26 cases/33 cases) and 55.9% (19 cases/34 cases), respectively, with statistically significant differences (P<0.05), and the EFS rates were 72.7% (24 cases/33 cases) and 52.9% (18 cases/34 cases), respectively, with no statistically significant differences (P＞0.05). A total of 10 cases with severe adverse reactions occurred during chemotherapy in the CE group, with an incidence of 27.78% (10 cases/36 cases), and 9 cases of that occurred during chemotherapy in the control group, with an incidence of 25.00% (9 cases/36 cases), with no statistical significance (P＞0.05). CONCLUSION: Etoposide combined with carboplatin regimen can significantly improve the clinical remission rate and improve the overall survival of children without increasing adverse reactions to chemotherapy, but the effect on event-free survival was not obvious.

Qilin pills prevent ovarian hyperstimulation syndrome of patients after IVF-ET by regulating plasma-related indicators

LIU Hongdan, YIN Yihong

2020, 25(2):  196-202.  doi:10.12092/j.issn.1009-2501.2020.02.012

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AIM: To study the preventive effect of Qilin pill on ovarian hyperstimulation syndrome (OHSS) after in vitro fertilization and embryo transfer (IVF-ET) and its effects on vascular endothelial growth factor (VEGF), tissue factor (TF) and tissue factor pathway inhibitor (TFPI) in plasma.  METHODS:  Sixty-four patients undergoing IVF-ET treated in our hospital from January 2016 to January 2019 were selected. On the day of ovulation induction injection of human chorionic gonadotropin (HCG), 32 patients with high risk factors of OHSS were randomly divided into two groups. The control group received western medicine therapy, while the observation group received extra Qilin pill. The incidence of mild to moderate OHSS, fresh cycle transplant cancellation rate, plasma VEGF, TF, TFPI levels, and clinical outcomes of patients undergoing IVF-ET (HCG positive rate, biochemical pregnancy rate, clinical pregnancy rate) were compared between the two groups.RESULTS:There was no severe OHSS occurred in the two groups, the incidence of OHSS in the observation group (12.50%) and the cancellation rate of fresh cycle transplantation (15.63%) were lower than those in the control group (50.00%, 43.75%)（χ2=6.063,P=0.014）;The levels of VEGF and TF in the observation group on the day of egg retrieval and embryo transfer were ［(368±103) pg/mL, (392±91) pg/mL］,［(24±4)pg/ mL,(29±4) pg/mL］, which were lower than the control group ［(436±117) pg/mL, (448±108) pg/mL］,［(26±4) pg/mL, (31±4) pg/mL］ (t=2.450,2.237,4.093,5.204,P=0.017,0.029,＜0.001,＜0.001);The plasma TFPI levels in the observation group on the day of egg retrieval and embryo transfer were ［(73±18) ng/mL,(66±12) ng/mL］, higher than the control group ［(62±16）ng/mL, (58±10) ng/mL］(t=2.550,3.032,P=0.014,0.004);The biochemical pregnancy rate in the observation group (8.70%) was lower than that in the control group (42.86%) (χ2=4.147, P=0.042),the clinical pregnancy rate (91.30%) was higher than that of the control group (57.14%) (χ2=4.147,P=0.042).CONCLUSION:Qilin pill can prevent the occurrence of severe OHSS after IVF-ET, reduce the occurrence of mild to moderate OHSS, decrease the cancellation rate of fresh cycle transplantation and improve the pregnancy outcome after IVF-ET; Its mechanism may be related to the regulation of the expression of VEGF, TF and TFPI.

Distribution and drug resistance of bacterial pathogens in the infecting inpatients of department of nephrology

YANG Yanlang, LI Yan, WANG Lin

2020, 25(2):  203-208.  doi:10.12092/j.issn.1009-2501.2020.02.013

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AIM:To investigate the etiological distribution and drug resistance of bacterial infection in inpatients of nephrology department and to provide evidence for the selection of antibiotics for clinical treatment of bacterial infection. METHODS:The data of positive pathogenic bacteria were collected from the samples of inpatients of the department of nephrology of Yijishan Hospital of Wannan Medical College from January 2016 to June 2019. RESULTS:A Total of 286 strains of bacteria were cultured, which were mainly from the respiratory tract infection and the urinary tract infection. Gram-negative bacteria accounted for 89.51% and gram positive bacteria accounted for 10.49%. Among Gram-negative bacteria, Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae were the top three bacteria detected in Enterobacteriaceae, while Pseudomonas aeruginosa and Acinetobacter baumannii were the top two bacteria detected in non-fermentative negative bacilli; The detection rate of extended-spectrum β-lactamase-producing bacteria (ESBLs) was 32.87%, which were mainly Escherichia coli and Klebsiella pneumoniae. The resistant rates of Escherichia coli and Klebsiella pneumoniae in ESBLs to aztreonam and ceftriaxone were 83.8% and 100% respectively; The resistance rate of Carbapenem resistance strains was 6.29%. Among Gram-positive bacteria, Staphylococcus aureus was the most common, and the resistance rate of methicillin-resistant Staphylococcus aureus (MRSA) was 4.89%. CONCLUSION:ESBLs-producing Escherichia coli and Klebsiella pneumoniae had high detection rates among isolated bacterial pathogens in the department of nephrology.

Clinical characteristics of insulin autoimmune syndrome caused by methimazole in Chinese population

WANG Chunjiang，SUN Wei，SUN Linli

2020, 25(2):  209-213.  doi:10.12092/j.issn.1009-2501.2020.02.014

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AIM: To explore the clinical features of insulin autoimmune syndrome (IAS) induced by methimazole in Chinese population. METHODS: The literature on IAS cases caused by methimazole in the Chinese population published before and after June 30, 2019 was collected for retrospective analysis.RESULTS:The age of onset of men was earlier than that of women, and the sex ratio was 1∶2.31 in 95 patients.After taking methimazole 30 mg/d, IAS occurred most from one month to three months,characterized by neuropathic hypoglycemia as the first symptoms at night and early in the morning,blood sugar below 2 mmol/L,insulin concentration≥100 mU/L, IAA positive and no obvious abnormalities in pancreas imaging.The symptoms gradually relieved after symptomatic treatment and stopped taking methimazole. There was no significant difference in the time of hypoglycemia disappearance between the 54 patients who received hormone therapy and non-hormone therapy.CONCLUSION:Methimazole-induced IAS is a clinically rare autoimmune disease. It should be treated promptly occuring hypoglycemia or hyperglycemia during medication.The prognosis of IAS is generally good after proper treatment.

Regulation of REM sleep: Basic mechanisms and clinical drugs

SUN Xiao, YANG Surong, LI Shanqun, WANG Yiqun

2020, 25(2):  214-220.  doi:10.12092/j.issn.1009-2501.2020.02.015

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To explore the mechanism of rapid eye movement (REM) sleep regulation and the drugs that affect it. This article summarizes the relevant nucleuses regulating REM sleep in the pontine, medulla, and hypothalamus starting from the neural circuit that regulates REM sleep. Drugs that affect REM sleep, such as selective norepinephrine reuptake inhibitors and selective 5-hydroxytryptamine (5-HT) reuptake inhibitors, etc. The mechanism of action can be summarized as reducing the degradation of norepinephrine and 5-HT of synaptic sites, prolonging the action time of neurotransmitters, reducing the reuptake of presynaptic membrane, prolonging the action time of transmitters in the synaptic space, and relatively increasing norepinephrine and 5-HT neurons excitement.

Advances of the clinical pharmacology of hydroxychloroquine sulfate

CUI Cheng, YAO Xueting, TU Siqi, XIE Jieen, LI Haiyan, LIU Dongyang

2020, 25(2):  221-226.  doi:10.12092/j.issn.1009-2501.2020.02.016

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As the number of novel coronavirus disease (COVID-19) continues to increase, the medical situation is still critical, and potential therapeutic drugs, vaccines and stem cell replacement approaches are emerging. Chloroquine has shown better clinical antiviral efficacy than lopinavir/litonavir (clazidine) in clinical trials of small sample size. Since pharmacological action mechanism of hydroxychloroquine is similar with chloroquine and hydroxychloroquine is safer than chloroquine in the treatment of malaria and immunological diseases, the clinical pharmacology characteristics of hydroxychloroquine was reviewed, hoping to provide theoretical support for clinical effect verification of hydroxychloroquine from the perspective of clinical pharmacology and quantitative pharmacology.

A surey of bioanalysis methods for antibody drugs

ZHENG Fengjia, JIA Zhijun, XIE Xinyao, HAN Min, DONG Lihou

2020, 25(2):  227-232.  doi:10.12092/j.issn.1009-2501.2020.02.017

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Antibody drugs have become the first choice for clinical treatment of many diseases due to their advantages of targeting, high specificity and low toxicity. However, the disposal mechanism in vivo has its particularity and complexity, which greatly increases the difficulty of biological detection. Therefore, to establish the sensitive, accurate and repeatable methods is urgent. This paper mainly focuses on the bioanalytical methods of this kind of drugs, introduces the characteristics and application of enzyme-linked immunosorbent assay, electrochemiluminescence, liquid chromatography-mass spectrometry, flow cytometry and some new techniques, in hope of providing a reference for the study of related drugs.

Research progress in pharmacological effects and clinical applications of ebselen

ZHOU Jingxuan，WANG Peng，YUAN Chunling，WANG Jun，ZOU Lili

2020, 25(2):  233-240.  doi:10.12092/j.issn.1009-2501.2020.02.018

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Ebselen (EbSe) is a synthetic lipo-soluble selenium-containing organic small molecule compound with a wide range of physiological and pharmacological activities. EbSe is one of the most well-studied selenium-containing compounds. Early studies have shown that EbSe possess various bio-activities by eliminating intracellular oxygen free radicals and inhibiting lipid peroxidation. Recent studies have demonstrated that the multifarious biological activities of EbSe based on its selenium effect on the cysteine residues of substrates. Its potential clinical application range keeps expanding, which has a prospect application in the treatment of multiple system diseases in the human body. In addition, the latest study confirmed that EbSe has outstanding antibacterial activity against multidrug-resistant bacteria infections. Based on this, this article briefly reviews the research progress of pharmacological activities and related clinical applications of EbSe, providing some references for scientific research and clinical workers.