Factors Influencing the Quality of Drug Clinical Trials for Non-alcoholic Steatohepatitis

ZHAO Di; JI Jia; XU Jing; LI Shuang

doi:10.3969/j.issn.1004-437X.2025.24.005

Abstract：Objective To analyze the risk factors affecting the quality of clinical trials of drugs for non-alcoholic steatohepatitis.Methods By retrospective analysis,347 patients with non-alcoholic steatohepatitis treated and treated in the Zhengzhou Sixth People's Hospital from January 2022 to June 2023 were selected as research objects,and grouped according to whether quality problems occurred in combination with the quality control of drug clinical trial projects.The patients with non-alcoholic steatohepatitis who did not have quality problems in drug clinical trials were set into the control group(258 cases),and the patients with non-alcoholic steatohepatitis who had quality problems in drug clinical trials were set into the observation group(89 cases).Clinical data of two groups of patients were analyzed to summarize the risk factors of drug clinical trial quality problems in patients with non-alcoholic steatohepatitis.Results Among 347 patients with non-alcoholic steatohepatitis,89 patients had quality problems in drug clinical trials,and the incidence of quality problems in drug clinical trials was 25.65％.Univariate analysis and logistic multivariate regression analysis showed that liver function impairment,smoking,drinking,poor compliance and drug combination were not only related risk factors but also independent risk factors for drug clinical trial quality problems in patients with non-alcoholic steatohepatitis(P＜0.05).Conclusion The quality of drug clinical trials for non-alcoholic steatohepatitis is closely related to liver function impairment,smoking,drinking,poor compliance and drug combination.In view of the above risk factors,strict clinical control and corresponding intervention measures should be given to avoid or reduce the occurrence of drug clinical trial quality problems.