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中医药治疗功能性消化不良随机对照试验结局指标现状分析

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目的 分析中医药治疗功能性消化不良(Functional dyspepsia,FD)的随机对照试验(Randomized controlled trial,RCT)结局指标研究现状,为中医药治疗功能性消化不良核心指标集的构建奠定基础.方法 计算机检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、EMbase、PubMed、Cochrane Library数据库收录的中医药治疗FD的RCT,检索时限为2017年1月1日—2022年1月1日,2名研究者根据纳入、排除标准独立进行文献筛选与资料提取.结果 共纳入了 285项RCTs,28 061例患者,涉及117个结局指标及28种中医证型,单项RCT指标数最多12个,最少1个,平均5个.各指标共计使用1275次,结局指标使用频次排列前5位的指标为临床总有效率(81.40%),中医症候积分(54.04%),不良反应(47.02%)、胃动素(MTL)(30.18%),症状积分(23.1%).根据结局指标的功能属性将其分为6大指标域,其中,症状/体征(38.51%)及理化检测(28.94%)类指标应用较多.结论 目前中医药治疗FD的RCT中结局指标存在指标选择差异过大、结局指标主次不分、中医疗效评价指标不一致、总有效率指标缺乏规范、指标测量时点差异大、缺乏远期预后指标、指标测量工具种类偏多且适用性差、未纳入经济学评价指标及安全性事件报告简单化等问题,亟须构建规范、标准的中医药治疗功能性消化不良核心指标集研究,解决结局指标存在的诸多问题.
Current Status of Outcome Indexes in Randomized Controlled Trials of Traditional Chinese Medicine for Functional Dyspepsia
Objective To analyze the research status of outcome indexes in randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)treatment of functional dyspepsia(FD),to facilitate the construction of core index set for TCM treatment of FD.Methods The RCTs of TCM treatment of FD were retrieved from China National Knowledge In-frastructure(CN KI),Wanfang Data,VIP Chinese Science and Technology Periodicals Database(VIP),SinoMed,EMbase,PubMed and Cochrane Library.The retrieval time was from January 01,2017 to January 01,2022.Two researchers inde-pendently screened the literature and extracted the data according to the inclusion and exclusion criteria.Results A total of 285 RCTs were included,involving 28 061 patients,117 outcome indexes and 28 TCM syndromes.The maximum and minimum numbers of single RCT indexes was 12 and 1,respectively,with an average of 5.The indexes were used for 1 275 times in total.The top five indexes by frequency of use were total clinical effective rate(81.40%),TCM syndrome score(54.04%),adverse reaction(47.02%),motilin(MTL,30.18%),and symptom score(23.1%).According to the func-tional attributes of the outcome indexes,they were divided into six major domains.Among them,symptoms/signs(38.51%)and physical and chemical tests(28.94%)were more widely used.Conclusion At present,there are some problems in the RCTs of TCM treatment of FD,such as large difference in selecting outcome indexes,regardless of primary and second-ary outcome indexes,inconsistent evaluation indexes of TCM efficacy,lack of standardization in total effective rate indexes,large difference in index measurement time points,lack of long-term prognosis indexes,various index measurement tools and poor applicability,failing to include economic evaluation index and simple safety event reports.Therefore,it is urgent to standardize the core index set in TCM treatment of FD and solve the existing problems.

Traditional Chinese medicineFunctional dyspepsiaCore outcome setOutcome indexRandomized controlled trial

陈欢、吕金枝、王嘉琪、朱建珺、张洁、李彩玲、宁博、杜晓泉

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陕西中医药大学,陕西咸阳 712046

陕西中医药大学附属医院,陕西咸阳 712000

中医药 功能性消化不良 核心指标集 结局指标 随机对照试验

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ZYYCXTD-C-2020102019XZZX-XH0112019021

2024

世界中西医结合杂志
中华中医药学会

世界中西医结合杂志

CSTPCD
影响因子:1.053
ISSN:1673-6613
年,卷(期):2024.19(1)
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