摘要
目的:分析中药治疗再生障碍性贫血随机对照试验(RCTs)结局指标的使用现状,为构建中药治疗再生障碍性贫血的核心指标集研究提供参考.方法:检索中国知网(CNKI)、万方(Wanfang Data)、PubMed、Cochrane Library和Embase数据库,同时检索中国临床试验注册中心(ChiCTR)和Clinical Trials.gov收录的中药治疗再生障碍性贫血的研究,根据纳入标准筛选文献,评价纳入研究的偏倚风险,统计各结局指标的使用情况.结果:共纳入326项RCTs,样本量5～1 222例,共报告198个结局指标,应用总频数为2020.结局指标按照功能属性可归到7个指标域中,包括中医病证、症状体征、理化检测、生活质量、远期预后、经济学评估和安全性事件,其中有效率、中医证候积分作为高频结局指标(分别报告了 302次和52次),是中药治疗再生障碍性贫血核心结局指标的首要选择,其次应重点考虑的是中医证候有效率、不良反应、生活质量评分、生存质量.结论:中药治疗再生障碍性贫血RCTs在结局指标的使用方面存在着中医证型的诊断标准欠规范、临床疗效的评价标准不统一、指标种类多、指标数量及应用频数差异大、中医特色指标不足等诸多问题,尽快构建中药治疗再生障碍性贫血的核心指标集对推动中药治疗再生障碍性贫血临床研究具有深远的影响.
Abstract
Objective:To analyze the current status of the use of outcome measures in randomized controlled trials(RCTs)of TCM for aplastic anemia(AA),providing a reference for the construction of a core outcome set(COS)for TCM treatment of AA.Methods:A comprehensive literature search was conducted in databases including China National Knowledge Infrastructure(CNKI),WanFang Data,PubMed,Cochrane Library,and Embase databases.Additionally,relevant studies were identified through the Chinese Clinical Trial Registry(ChiCTR)and ClinicalTrials.gov.Studies were screened according to inclusion criteria,the risk of bias was assessed,and the usage of various outcome measures was statistically analyzed.Results:A total of 326 RCTs were included,with sample sizes ranging from 5 to 1 222 cases,reporting a total of 198 outcome measures with a cumulative application frequency of 2 020 times.Outcome measures were categorized into seven domains based on functional attributes:TCM syndromes,symptoms and signs,laboratory tests,quality of life,long-term prognosis,economic evaluation,and safety events.Efficacy rate and TCM syndrome scores were identified as high-frequency outcome measures(reported 302 and 52 times,respectively),which are primary choices for core outcome measures in TCM treatment of AA.Secondly,considerations should include TCM syndrome efficacy rate,adverse reactions,quality of life scores,and survival quality.Conclusion:RCTs of TCM treatment for AA exhibit issues such as non-standardized diagnostic criteria for TCM syndromes,inconsistent clinical efficacy evaluation standards,a plethora of outcome measures with significant variations in their frequency and application,and a deficiency of TCM's characteristic outcome measures.Establishing a COS for TCM treatment of AA is crucial for advancing TCM clinical research and will have a profound impact on the field.
基金项目
浙江省科技厅"尖兵""领雁"研发攻关计划项目(2024C03190)
国家中医药管理局科技司-浙江省中医药局共建科技计划项目(GZY-ZJ-KJ-24013)
浙江中医药大学附属医院科研专项基金(2023FSYYZZ03)
浙江省中医药科技计划项目(2020ZB095)
维普
万方数据