摘要
目的:利用快速卫生技术评估(RHTA)的方法对四磨汤口服液、六味安消胶囊、保和丸、健胃消食口服液治疗功能性消化不良(FD)的安全性、有效性、经济性进行评价,以期为临床决策提供证据支持。方法:检索自建库以来至2022年3月中国知网(CNKI)、万方数据知识服务平台(WanFang)、维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Embase、Cochrane Library、Web of Science数据库。进行文献筛选、数据提取和证据质量评价后,结合可视化图表对结果进行描述性分析。该研究最终纳入19篇研究,其中随机对照试验(RCT)18篇,Meta分析1篇,未检索到经济学研究和卫生技术评估(HTA)报告。结果:四磨汤口服液、六味安消胶囊、保和丸、健胃消食口服液治疗FD安全有效,但经济学研究有所欠缺。其中,四磨汤口服液可用于婴幼儿FD患者以及气滞食积、肝脾不和、肝脾气滞所导致的FD患者,六味安消胶囊可用于饮食积滞所导致的成人FD患者,保和丸可用于老年FD患者,健胃消食口服液可用于小儿脾胃虚弱所导致的FD。结论:4种口服中成药对于FD特定亚人群各有其治疗优势,其中四磨汤口服液临床普适性更高。但目前临床证据质量普遍较低,药物剂型之间缺乏对比分析。未来在对中成药的临床综合疗效进行更规范、科学的循证证据来论证的同时,完善、应用和推广以快速证据产出为目的RHTA是很有必要的。
Objective:To evaluate the safety,efficacy,and economy of the four Chinese patent medicines(CPMs),including Simotang oral liquid,Liuwei Anxiao capsule,Baohe pill,and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia(FD)by a rapid health technology assessment(RHTA),thus providing evidence support for clinical decision making.Method:China National Knowledge Infrastructure(CNKI),WanFang Database,VIP Chinese Technology Periodical Database(VIP),China Biology Medicine disc(CBMdisc),PubMed,EMBASE,Cochrane Library,and Web of Science were searched by computer from inception to March 2022.After literature screening,data extraction,and quality evaluation,the descriptive analysis of the results combined with visual charts was performed.Nineteen studies were included,involving 18randomized controlled trials(RCTs)and 1 Meta-analysis.Neither economic studies nor health technology assessment(HTA)reports were retrieved.Result:The four CPMs were safe and effective in the treatment of FD,but economic research was lacking.Among them,Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation,liver and spleen disharmony,and liver and spleen stagnation.Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation.Baohe pill could be used for the elderly with FD.Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness.Conclusion:The four CPMs have their advantages in the treatment of FD.Among them,the clinical universality of Simotang oral liquid is higher.However,the quality of clinical evidence is generally low,and comparative analysis among drug dosage forms is lacking.In the future,it is necessary to improve,apply,and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidencebased demonstration of the comprehensive clinical efficacy of CPMs.
作者
李苗苗
赵晖
戴泽琦
吴雪
徐思敏
唐旭东
廖星
LI Miaomiao;ZHAO Hui;DAI Zeqi;WU Xue;XU Simin;TANG Xudong;LIAO Xing(Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China Center for Evidence-based Traditional Chinese Medicine,Beijing 100700,China;China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第20期161-169,共9页
Chinese Journal of Experimental Traditional Medical Formulae
基金
中国中医科学院科技创新工程项目(CI2021A05503,CI2021A00701-3)
中国中医科学院基本科研业务·优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075)
中国中医科学院第十四批基本科研业务课题(Z0724,Z0718,Z0754)
国家自然科学基金项目(82174239)
中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2)。
关键词
功能性消化不良
中成药
临床综合评价
快速卫生技术评估
四磨汤口服液
functional dyspepsia
Chinese patent medicines
comprehensive clinical evaluation
rapid health technology assessment
Simotang oral liquid
