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

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

摘要:

[目的] 系统分析中医药治疗胃癌前病变相关随机对照试验（RCT）的疗效评价指标。[方法] 检索中医药治疗胃癌前病变相关的RCT，检索数据库包括中国知网、万方数据知识服务平台、维普数据库、PubMed及Embase数据库，检索时限为2001—2022年。参考Cochrane手册的干预性试验研究评价标准，结合专家意见确定研究的入选标准，提取疗效评价方法，建立数据库，并进行统计分析。[结果] 共纳入887项RCT，涉及胃镜下黏膜表现、病理、症状、证候、血清学、生存质量、安全性7个指标域，其中病理（71.36%）和胃镜下黏膜表现（37.54%）类指标应用较多。包含20种积分方法，分属于胃镜、病理、症状、证候4个部分，使用较高的积分方法依次为有效率（43.63%）、总积分（11.99%）、单一症状积分（25.86%）。部分研究（胃镜46篇，5.19%；病理135篇，15.22%；症状105篇，11.84%）在积分时仅指出使用的积分方法，却未具体说明如何进行积分。[结论] 目前，胃癌前病变疗效的评价指标存在对胃镜及病理指标重视程度不足、单一指标选择缺乏严谨性、复合指标应用缺乏规范化、指标积分方法不统一、安全性指标不足、生活质量指标缺乏适用性等问题。今后在设计胃癌前病变的疗效评价方案时，应多个方面综合考虑，建立以病理组织学指标为核心，结合胃镜指标、患者症状、生活质量等指标的综合评价体系，使临床疗效的试验设计更加规范化和标准化，提高研究结果的真实性和可靠性。

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.