关键词: 肝纤维化, 临床研究, 临床试验注册, 现状分析

Abstract: Objective This paper reviews the registration status of hepatic fibrosis (HF) clinical research in the Chinese clinical trial Registry(ChiCTR), summarizes the current research results and analyzes the existing problems, so as to provide reference for the design and implementation of clinical trials in the future. Methods All HF-related clinical studies in the ChiCTR from 2005 to 2024-12-31 were searched with "hepatic fibrosis" as the search term. The relevant information of HF registration in ChiCTR was analyzed, including but not limited to registration time, registration status, study type, program design, sample size and whether there was financial support. Results A total of 83 clinical studies on hepatic fibrosis were included, covering 19 provincial-level administrative regions across the country, with a total sample size of 29 572 cases. At present, there are some problems in HF-related clinical trials, such as small number of registrations, concentrated research results, uneven geographical distribution, large proportion of financial support, and diverse innovative non-invasive diagnostic tests, but the accuracy and staging criteria need to be unified. Conclusion Relevant researchers should enhance their professionalism in clinical trials, optimize trial design, complete registration information, and standardize the application of blinding methods. It is necessary to establish a cross-regional and multi-institutional collaborative mechanism to conduct high-quality clinical trials and innovate research protocols tailored to the characteristics of traditional Chinese medicine. Meanwhile, it is essential to improve the diagnostic efficacy of non-invasive hepatic fibrosis, carry out evidence-based studies, and explore new randomized controlled trial models for traditional Chinese medicine to boost its modernization.

Key words: Hepatic fibrosis, Clinical research, Clinical trial registration, Analysis of current situation