天津中医药大学学报2024，Vol.43Issue(4)：325-332,8.DOI:10.11656/j.issn.1673-9043.2024.04.07
中医药治疗胃癌前病变近20年疗效评价指标分析
Analysis of the evaluation indexes of the efficacy of traditional Chinese medicine in gastric precancerous lesions in recent 20 years
摘要
Abstract
[Objective]To systematically analyze the efficacy evaluation indexes of randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)in the treatment of gastric precancerous lesions.[Methods]RCTs of TCM for gastric precancerous lesions were searched in the databases of China Journal Full Text Database,Wanfang Data,Wipo Database,PubMed and Embase,etc.,and the timeframe of the search was from 2001 to 2022.Referring to the Cochrane Handbook of Evaluation Criteria for Interventional Trial Studies combined with expert opinions to determine the study inclusion criteria,we extracted the methods of efficacy evaluation,established the database,and performed statistical analysis.[Results]A total of 887 RCTs were included,involving 7 index domains:gastroscopic mucosal manifestation,pathology,symptoms,evidence,serology,quality of survival,and safety,in which the indexes in the categories of pathology(71.36%)and gastroscopic mucosal manifestation(37.54%)were more frequently applied.Containing 20 kinds of integral methods,which belonged to the four parts of gastroscopy,pathology,symptom,and evidence,the higher-used integral methods were,in order,effective rate(43.63%),total integral(11.99%),and single-symptom integral(25.86%),and some of the studies[46 articles of gastroscopy(5.19%),135 articles of pathology(15.22%),105 articles of symptom(11.84%)]only pointed out the use of integral methods without specifying them.indicated the use of a scoring method without specifying how the scoring was performed.[Conclusion]At present,the evaluation indexes of gastric precancerous lesion efficacy have the problems of insufficient attention to gastroscopic and pathological indexes,lack of rigor in the selection of single indexes,lack of standardization in the application of composite indexes,lack of uniformity in the integration method of indexes,insufficient safety indexes,and lack of applicability in the quality of life indexes.In the future,when designing the efficacy evaluation scheme for gastric precancerous lesions,we should consider various aspects and establish a comprehensive evaluation system that combines gastroscopic indicators,patient symptoms,quality of life and other indicators,so as to normalize and standardize the design of clinical efficacy trials and improve the authenticity and reliability of research results.关键词
胃癌前病变/中医药/疗效评价指标/随机对照试验/核心指标集Key words
gastric precancerous lesions/traditional Chinese medicine/evaluation index of curative effect/randomized controlled trial/core outcome set分类
医药卫生引用本文复制引用
张晴晴,吴迪,王奕晨,郭凤赟,杨胜男,王萍..中医药治疗胃癌前病变近20年疗效评价指标分析[J].天津中医药大学学报,2024,43(4):325-332,8.基金项目
国家重点研发计划项目(2017YFC1700601) （2017YFC1700601）
中国中医科学院中央级公益性科研院所基本科研业务费项目(2020YJSZX-5) （2020YJSZX-5）
北京市卫健委研究型病房建设项目(BCRW202108). （BCRW202108）
