Qingshan Zheng

Shanghai University of Traditional Chinese Medicine

Author Statistics

Papers

Citation

H-Index

i-10 index

Research Trends

Author Order

Document Type

Co-Authors

Lujin Li

Shanghai University of Traditional Chinese Medicine

Jihan Huang

Shanghai University of Traditional Chinese Medicine

Yingchun He

Hunan University of Traditional Chinese Medicine

Yinghua Lv

Shanghai University of Traditional Chinese Medicine

Juan Yang

Shanghai University of Traditional Chinese Medicine

Hongxia Liu

Gannan Medical University

Kun Wang

Shanghai University

Ling Xu

Yueyang Hospital

F Yin

Duke Medical Center

Yi Fang

Shanghai Tenth People's Hospital

Cooperative Institutions

Chinese Academy of Medical Sciences & Peking Union Medical College

128

University of Florida

122

Columbus Oncology and Hematology Associates

117

Peking University

113

Shanghai University of Traditional Chinese Medicine

109

Capital Medical University

Clinical Trial Investigators

Emerald Coast Science Center

Shanghai Jiao Tong University

Chinese Academy of Sciences

Author Statistics

Papers

Citation

H-Index

i-10 index

Research Field

Effect of CYP2C19 genotypes on the pharmacokinetic/pharmacodynamic relationship of rabeprazole after a single oral dose in healthy Chinese volunteers

European Journal of Clinical Pharmacology (2010)

Yucheng Sheng Kun Wang Yingchun He Juan Yang Qingshan Zheng

Rabeprazole

Pharmacodynamics

10.1007/s00228-010-0892-4

Cite

Citations (7)

[In vitro pharmacodynamic interactions of antitumor effect of the combination of adriamycin and curcumin evaluated by the parameter method and the response surface].

PubMed (2010)

Yinghua Lu Juan Yang Jun-chao Chen Lujin Li Hongxia Liu

The paper aimed to find the optimal combination and evaluation of the interactions of antitumor effect of the curcumin (Cur) and adriamycin (ADM) in vitro. According to the factorial design and data characteristics, the parameter method combined with the response surface approach were used to analyze the pharmacodynamic interactions of in vitro antitumor effects of the combination of Cur and ADM at different dosages. The results showed that the dose-effect relationship of the combination with the ratio of ADM-Cur 1:3 showed significant differences in comparison with either used alone. The dose-effect curve was shift left in combination. The combination of adriamycin (ADM, 0.693-2.132 micromol L(-1)) and curcumin (Cur, 2.047-6.304 micromol L(-1)) with a fixed ratio (1:3) showed a synergism. With increasing doses of the combination, there is an additive effect. Computer simulation showed a trend of decreasing difference between the observed and expected effects with the dose increasing in Cur from 6.304 to 16.0 micromol L(-1) and ADM from 2.132 to 5.3 micromol L(-1). The response surface analysis showed the optimal combination to be Cur 18.50 micromol L(-1) and ADM 3.89 micromol L(-1) with a ratio of 5:1. This study suggests that the parameter method combined with the response surface analysis provides richer and more reasonable information, and is helpful for quantitative design of drug combination therapy and to describe the nature and degree of drug interaction.

Pharmacodynamics

Combination therapy

Dose

Interaction

Source

Cite

Citations (0)

Pharmacological interventions for the treatment of insomnia: quantitative comparison of drug efficacy

Sleep Medicine (2020)

Xijun Zheng Yingchun He F Yin Hongxia Liu Yunfei Li

Zolpidem

Sleep onset latency

Primary Insomnia

Temazepam

Bedtime

10.1016/j.sleep.2020.03.022

Cite

Citations (14)

Factors affecting the efficacy and safety of docetaxel combined with platinum in the treatment of advanced non-small cell lung cancer

Expert Review of Clinical Pharmacology (2021)

FengLi Wang Chenyang Zhao Xin Wen Qingshan Zheng Lujin Li

This study aimed to quantitatively evaluate factors influencing the efficacy and safety of the docetaxel-platinum regimen to provide reliable information for optimizing chemotherapy regimens.A parametric survival function model was used to describe the time course of overall survival (OS) of patients with advanced non-small cell lung cancer (NSCLC) receiving a docetaxel-platinum regimen. A random-effects model in a single-arm meta-analysis was used to analyze the objective response rate and grade 3-4 adverse event rates based on various docetaxel-platinum regimens.The model revealed that the risk of death in East Asians was approximately 1.5-fold higher than that in non-East Asians, with a median OS of 13.7 (95% confidence interval [CI]: 12.8-14.7) months and 9.3 (95% CI: 7.7-11.1) months, respectively. No significant impact of different administration regimens on OS was found. However, when drug exposure increased, the incidence of grade 3-4 anemia or neutropenia significantly increased.The docetaxel-platinum regimen has different efficacies in the treatment of advanced NSCLC between East Asian and non-East Asian populations. A better benefit-risk ratio can be obtained with a lower exposure regimen of docetaxel combined with platinum.

Regimen

10.1080/17512433.2021.1976638

Cite

Citations (5)

Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD

Therapeutic Advances in Respiratory Disease (2022)

Yiwen Gong Yinghua Lv Hongxia Liu Qingshan Zheng Lujin Li

This study aimed to quantitatively compare the efficacy and safety of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combinations (FDCs) for the treatment of stable chronic obstructive pulmonary disease (COPD), especially in terms of their loss of efficacy in lung function.

Lama

Indacaterol

Muscarinic antagonist

Formoterol Fumarate

Fixed-dose combination

10.1177/17534666211066068

Cite

Citations (13)

[Quality control of clinical data management based on EDC].

PubMed (2015)

Hongxia Liu Yinghua Lv Mao-sheng Zhou Qing-heng Meng Jun-chao Chen

With the wide application of electronic data management (EDC), the data management is shifting to a new mode. In order to recognize the advantages of EDC, we choose 20 representative registered clinical trials, which involve 5 404 subjects and 321 sites. We found that EDC has many beneficial impacts on the course of clinical trial data management, including the process of data collection, data cleaning, data quality control and clinical trial decision-making. The result also provides a reference for the adoption of EDC in clinical trials.

Electronic data capture

Source

Cite

Citations (0)

Comparative efficacy of nonhormonal drugs on menopausal hot flashes

European Journal of Clinical Pharmacology (2016)

Lujin Li Ling Xu Junyi Wu Lidan Dong Shuiyu Zhao

Pharmacodynamics

Hot flash

10.1007/s00228-016-2090-5

Cite

Citations (28)

A Review of Ginseng Clinical Trials Registered in the WHO International Clinical Trials Registry Platform

BioMed Research International (2018)

Yingchun He Juan Yang Yinghua Lv Junchao Chen F Yin

Although ginseng has long been broadly used in clinical settings around the world, few clinical trials on ginseng have been conducted. The objective of this study was to provide a comprehensive evaluation of the characteristics of ginseng clinical trials registered in the WHO International Clinical Trials Registry Platform (ICTRP) as of December 2017 regarding their frequency, design, type of ginseng, dosage, duration, condition, funding sources, and publication status. A total of 134 ginseng clinical studies were registered from 2002 to 2017, of which 60.4% were completed and 23.1% are actively recruiting participants. A large number of trials were associated with aspects of high-quality trial design. Overall, 94% of the trials employed randomized allocation to study arms, 78.4% were double-blind studies using placebo as one of the control groups, and 71% were published as completed trials. Trials whose sample size was restricted to fewer than 100 participants accounted for 74.7% of the total. Of the primary funding sources for ginseng studies, 67.2% were nonindustry organizations. The ginseng clinical trials were heterogeneous with respect to ginseng species and variety, indications, dose, duration, and participant characteristics. Clearly, stricter and methodologically suitable studies are needed to demonstrate the efficacy and safety of ginseng.

Clinical study design

10.1155/2018/1843142

Cite

Citations (33)

A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults

Expert Opinion on Investigational Drugs (2020)

Jiaxue Wang Suping Niu Wen‐Liang Dong Li Wei Lun Ou

Objectives Recombinant human HER2 monoclonal antibody for injection (AK-HER2) is a potential biosimilar of trastuzumab (Herceptin®). This phase Ⅰ study aimed to demonstrate the pharmacokinetic (PK) equivalence between AK-HER2 and trastuzumab in healthy volunteers. Besides, safety and immunogenicity were investigated.Research design and methods This was a randomized, double-blind phase Ⅰ trial in 96 healthy adults who received a single intravenous infusion of AK-HER2 or trastuzumab at 6 mg/kg. The primary PK endpoints were area under the serum concentration curve (AUC) from time 0 to the last time point (AUC0-t) and peak concentration in serum (Cmax). The PK bioequivalence was confirmed using the standard equivalence margins of 80%-125%.Results The PK profiles of AK-HER2 and trastuzumab displayed high similarity. The geometric mean ratios (90% confidence intervals) of primary PK endpoints were within 80%-125%. The C max and AUC 0-t of female subjects in the AK-HER2 group were greater than those of male subjects (P <0.05). No infusion-related reactions (IRRs) or anti-drug antibody-positivity was observed after dosing.Conclusions AK-HER2 was demonstrated to have highly similar PK to trastuzumab in healthy Chinese adults. Both drugs showed comparable safety and immunogenicity using dexamethasone as premedication to prevent IRRs..

Bioequivalence

Clinical endpoint

10.1080/13543784.2020.1770226

Cite

Citations (11)

Development and Application of the Placebo Response Model in Clinical Trials for Primary Sjögren’s Syndrome

Frontiers in Immunology (2021)

ZHI-Zhou Wang Qingshan Zheng Hongxia Liu Lujin Li

This study aimed to develop a placebo response model for pharmaceutical clinical trials of primary Sjogren’s syndrome,and to quantitatively analyze the distribution and related factors influencing the placebo response to further optimize the design of clinical trials and evaluate the results of single-arm clinical trials. Public databases, including PubMed, Embase, and Cochrane Library were searched for reports on randomized placebo-controlled trials for Sjögren’s syndrome which used the change from baseline in ESSDAI score as the primary outcome. The model-based meta-analysis method was used to evaluate the time course and the related influencing factors of the placebo response for ESSDAI in such clinical trials. A virtual placebo control group was constructed based on the final placebo response model to determine the treatment efficacy of belimumab and cyclosporine A for primary Sjögren’s syndrome in a single-arm study. A total of 12 studies involving 450 subjects were included in the analysis. The established model described the time-course characteristics of the changes in ESSDAI score from the baseline in the 48 weeks placebo group. We found that the onset time of placebo response was approximately 12 weeks, and its efficacy plateaued at 48 weeks. The baseline ESSDAI score had a significant effect on the maximum value of the placebo response; the maximum value of the placebo response decreased by 0.552 for every 1 score rise in the baseline ESSDAI score. The efficacy of belimumab and cyclosporine A in the single-arm trial was comparable to that of the placebo response at the same baseline; no significant therapeutic advantage was observed. The placebo response model established in this study could provide a basis for designing clinical trials for primary Sjogren’s syndrome in the future. It may also provide a reliable external efficacy control standard for single-arm clinical trials.

Belimumab

10.3389/fimmu.2021.783246

Cite

Citations (2)