2014~2024年中成药治疗肺癌的随机对照试验证据图分析OA
Evidence Map Analysis of Randomized Controlled Trials of Chinese Patent Medicines for Lung Cancer from 2014 to 2024
目的:采用证据图的方法,检索与梳理 2014~2024年中成药治疗肺癌的随机对照试验(RCTs),了解相关研究的证据分布和临床价值.方法:检索 2014~2024年收录于中国知网、万方、维普、中国生物医学文献服务系统、PubMed、Cochrane Library、EMbase 中关于中成药治疗肺癌的 RCTs 研究证据,对中成药的分类、样本量、干预措施、疗程、疗效评价指标进行可视化展示,依据 Cochrane 偏倚风险评估工具进行质量评价.结果:筛选出 596 篇 RCTs,共涉及 55 种中成药(中药注射剂18种、口服中成药 37 种),样本量以 61~100例居多,干预周期集中在 6~12 周,多以联合用药的基础上同步治疗和序贯用药的形式参与肺癌的综合治疗,以结局指标的功能属性为依据进行归类与合并,涉及近期疗效、远期预后、生活质量等11类.结论:中成药在肺癌不同阶段均有干预优势,更契合肺癌慢病管理的模式,但整体证据质量不高,缺乏设计严谨的高质量RCTs,对中医证候的诊断标准、客观评价和远期结局等关注不足,仍需进行上市后的补充研究和再评价.
Objective:To retrieve and sort out randomized controlled trials(RCTs)of Chinese patent medicines in the treatment of lung cancer from 2014 to 2024 by evidence mapping,so as to understand the evidence distribution and clinical value of relevant studies.Methods:RCTs on Chinese patent medicines for lung cancer published from 2014 to 2024 in CNKI,WanFang,VIP,SinoMed,PubMed,Cochrane Library and EMbase were retrieved.The classification,sample size,intervention measures,course of treatment and efficacy evaluation indexes of Chinese patent medicines were visualized.Quality evaluation was carried out according to the Cochrane risk of bias assessment tool.Results:A total of 596 RCTs were screened out,involving 55 kinds of Chinese patent medicines(18 traditional Chinese medicine injections and 37 oral Chinese patent medicines).Most sample sizes were 61-100 cases,and intervention courses were mainly 6-12 weeks.Chinese patent medicines were mostly used in comprehensive treatment of lung cancer in the forms of concurrent treatment on the basis of combined medication and sequential medication.Outcome indexes were classified and merged according to their functional attributes,involving 11 categories such as short-term efficacy,long-term prognosis and quality of life.Conclusion:Chinese patent medicines have intervention advantages at different stages of lung cancer and are more suitable for the chronic disease management model of lung cancer.However,the overall quality of evidence is low,lacking high-quality RCTs with rigorous design.Insufficient attention has been paid to the diagnostic criteria,objective evaluation of traditional Chinese medicine syndromes and long-term outcomes.Further post-marketing supplementary studies and re-evaluations are still needed.
李宁;崔璨;杨建雅;范雪茹;付芳芳
河南中医药大学第一附属医院国家区域中医(肺病)诊疗中心,郑州 450003河南中医药大学药学院,郑州 450046河南中医药大学第一附属医院国家区域中医(肺病)诊疗中心,郑州 450003河南中医药大学第一临床医学院,郑州 450003河南中医药大学第一附属医院国家区域中医(肺病)诊疗中心,郑州 450003
医药卫生
中成药肺癌随机对照试验证据图证据评价
Chinese patent medicinelung cancerrandomized controlled trialevidence mapevidence evaluation
《中国合理用药探索》 2026 (5)
63-72,10
河南中医药大学"双一流"创建工程中医学学科项目(HSRP-DFCTCM-2023-3-09)
评论