摘要
目的分析针刺治疗良性前列腺增生(BPH)随机对照试验(RCTs)结局及其测量工具的报告情况,为今后临床试验和核心结局指标集的构建提供可靠的依据。方法检索中文和英文数据库,包括CNKI、CMIA、万方、PubMed、EMbase、Web of Science、clinicaltrials.gov和ChiCTR,检索日期为2014年7月1日—2024年7月1日,通过文献筛选和资料提取汇总结局指标及其测量工具并进行整理和分析。结果共纳入了47项研究,其中包括46项RCTs和1项进行中的试验注册方案。涵盖30项结局标;结局指标选用的测量工具种类多,但主要结局指标的选择趋于一致。采用的诊断标准存在差异大的问题。结论针刺治疗BPH的RCTs结局及其测量工具现状较为明晰,可以对其进行部分试验结果的汇总和比较。建议在未来的研究中采用统一的诊断标准,并加大对远期预后及经济学评估的关注。
Objective To analyze the reporting status of randomized controlled trials(RCTs)on acupuncture for treating benign prostatic hyperplasia(BPH),and provide reliable evidence for the design of future clinical trials and construction of core outcome sets.Methods Chinese and English databases,including CNKI,CMIA,Wanfang,PubMed,EMbase,Web of Science,clinicaltrials.gov,and ChiCTR,were searched for literature published between September 1,2013 and October 1,2023.The literature was screened and data extraction was conducted to summarize the primary outcome measures and their measurement tools for further analysis.Results A total of 47 studies were included,including 46 RCTs and 1 ongoing trial registration.The studies covered 30 outcome measures,which could be classified into 6 domains based on their functional attributes:clinical presentation,physical examination,quality of life,traditional Chinese medicine symptoms/syndromes,long-term prognosis,and safety evaluation.Economics assessment was not reported in these studies.The primary outcome measures and their corresponding measurement tools showed high heterogeneity,with some convergence for certain primary outcomes.The diagnostic criteria used in the included studies showed significant heterogeneity.Conclusion The status of acupuncture for treating BPH in RCTs is relatively clear,allowing for the aggregation and comparison of some trial results.Future research should use consistent diagnostic criteria,increase attention to long-term prognosis and economic evaluation,and further improve the standardization and quality of clinical trial design.
作者
苟德胜
莫倩
GOU De-sheng;MO Qian(College of acupuncture and moxibustion and Massage,Guizhou University of Traditional Chinese Medicine,Guiyang Guizhou 550000,China)
出处
《中华养生保健》
2024年第24期18-22,共5页
CHINESE HEALTH CARE
基金
国家自然科学基金资助项目(82260972)。
关键词
针刺
良性前列腺增生
结局指标
acupuncture
benign prostatic hyperplasia
outcome measures
作者简介
苟德胜(1998-),男,仡佬族,籍贯:贵州省贵阳市,硕士研究生在读,研究方向:针灸治疗盆底疾病;通讯作者:莫倩,E-mail:duoduo425@126.com。
