中医药治疗消化性溃疡随机对照试验结局指标现状研究 后印本

Краткое изложение: Background　Peptic ulcer（PUD） is a common disease of the digestive system. Traditional Chinese medicine（TCM） treatment is an effective treatment for PUD. However，in the randomized controlled trials（RCTs） of TCM treatment of this disease，there are great limitations in the selection of methodological quality and outcome indicators，which brings some challenges to efficacy evaluation and data integration analysis. Objective　This paper systematically reviews the application status and experimental design points of RCTs outcome indicators of traditional Chinese medicine intervention in PUD in the past 15 years，aiming to provide reference for the construction of core indicator set of traditional Chinese medicine treatment of PUD and the optimization of clinical trial design. Methods　Computerized searches were conducted in Chinese databases: China National Knowledge Infrastructure (CNKI)， Wanfang Data Knowledge Service Platform， VIP Chinese Journal Database，and China Biomedical Literature Service System， as well as international authoritative databases: PubMed， Embase， Cochrane Library， and Web of Science for RCTs on the treatment of PUD with traditional Chinese medicine. The search time frame was set from 2010 to 2024. Cochrane bias risk assessment was performed on the included literature，and relevant outcome indicators were counted，summarized and analyzed. Results　A total of 323 RCTs with 34 933 patients were included. The maximum sample size of single study was 498 cases，the minimum was 40 cases，and the average sample size was 108 cases. Among the 171 reports of TCM syndromes，the highest frequency of use was spleen and stomach deficiency cold（31 articles，18.13%）；47 articles were treated with pure traditional Chinese medicine，and 276 articles were treated with integrated traditional Chinese and Western medicine. The course of treatment was mostly 4 weeks（119 times，36.84%）；the outcome indicators were divided into 6 categories according to functional attributes. A total of 170 outcome indicators were reported，with a total frequency of 1 962 times. The outcome indicators with higher frequency of use were total clinical effective rate（233 times，11.88%），HP eradication rate（165 times，8.41%），and adverse reactions（155 times，7.9%）. The risk assessment of bias in the included literature is not clear. Conclusion　The RCTs of PUD treated with traditional Chinese medicine still exist in the following aspects：the dialectical classification and disease staging of traditional Chinese medicine are not standardized，the methodological design （blind method，distribution concealment） needs to be improved，the primary and secondary outcome indicators are not clearly distinguished，the clinical efficacy standards are not unified，the measurement time gap of outcome indicators is large，the scoring criteria of TCM syndromes/symptoms are diversified，the ethical registration needs to be paid attention to，and the report of safety indicators is not standardized. It is suggested to actively carry out the research on the core index set of TCM treatment of PUD，optimize and improve the methodological quality，and provide high scientific，reliable and practical evidence for the clinical practice of TCM treatment of PUD.