[1]刘思雪,黄健,周云乔,等.中药复方辅助治疗骨质疏松性骨折随机对照试验结局指标的现状分析[J].中医正骨,2025,37(07):49-53，59.
　LIU Sixue,HUANG Jian,ZHOU Yunqiao,et al.Current status of outcome measures in RCTs on Chinese herbal compounds for adjuvant treatment of osteoporotic fractures[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2025,37(07):49-53，59.
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中药复方辅助治疗骨质疏松性骨折随机对照试验结局指标的现状分析()

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第37卷
期数:
2025年07期
页码:
49-53，59
栏目:
文献研究
出版日期:
2025-07-20

文章信息/Info

Title:
Current status of outcome measures in RCTs on Chinese herbal compounds for adjuvant treatment of osteoporotic fractures
作者:
刘思雪; 黄健; 周云乔; 王康宁; 王钰泉; 房碧轩; 张帆; 李晋玉
北京中医药大学东直门医院,北京 100700
Author(s):
LIU Sixue; HUANG Jian; ZHOU Yunqiao; WANG Kangning; WANG Yuquan; FANG Bixuan; ZHANG Fan; LI Jinyu
Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China
关键词:
骨质疏松性骨折;  复方(中药);  随机对照试验专题;  结局指标
Keywords:
osteoporotic fractures;  compounds(TCD);  randomized controlled trials as topic;  outcome measure
摘要:
目的:分析中药复方辅助治疗骨质疏松性骨折随机对照试验结局指标的使用现状。方法:应用计算机检索中国知网、维普网、万方数据库、中国生物医学文献服务系统、PubMed、Embase和Cochrane Library中关于中药复方辅助治疗骨质疏松性骨折的随机对照试验研究,检索时限均为2005年1月至2024年12月。对照组采用手术联合西药常规治疗,试验组在对照组的基础上增加中药复方辅助治疗。2名研究人员分别独立进行文献筛选、数据提取和纳入研究的质量评价。采用Excel2016软件统计分析结局指标的种类与频次、指标域划分情况、综合疗效评价标准的使用情况、结局指标的测量时间点。结果:共检索到6810篇文献,最终纳入102篇文献,涉及10 317例患者。①结局指标分析一般结果。102项研究报告结局指标83种,总频次653,单项研究的结局指标2～18种,中位数7种。4项研究区分了主次要结局指标,但均使用了3种及以上结局指标作为主要结局指标。②结局指标的指标域划分情况。根据中医临床研究指标域分类,归属中医病证的结局指标2种,累计出现9次; 归属症状/体征的结局指标10种,累计出现132次; 归属生活质量的结局指标5种,累计出现14次; 归属理化检测的结局指标57种,累计出现267次; 归属远期预后的结局指标5种,累计出现185次; 归属资源利用的结局指标2种,累计出现4次; 归属安全性事件的结局指标2种,累计出现42次。③临床综合疗效评价标准的使用情况。28项研究报告了临床综合疗效评价标准,其中12项研究参照《中医病证诊断疗效标准》、8项研究参照《中药新药临床研究指导原则(试行)》、3项研究参照《骨科常见诊断分类方法和功能结果评定标准》、2项研究参照《中医病证诊疗标准与方剂选用》,各有1项研究参照《中国人骨质疏松症建议诊断标准(第二稿)》《中国骨质疏松性骨折诊疗指南(骨质疏松性骨折诊断及治疗原则)》《原发性骨质疏松症干预的疗效监测与评估专家意见》。④结局指标的测量时间点。102项研究均报告了在治疗前和治疗结束时测量结局指标。44项研究还报告了治疗结束后测量结局指标,其中18项研究为治疗结束后6个月、16项研究为治疗结束后12个月、9项研究为治疗结束后3个月、1项研究为治疗结束后24个月。结论:中药复方辅助治疗骨质疏松性骨折的随机对照试验,存在结局指标选择不规范、主次要结局指标未明确区分、普遍使用替代指标及临床综合疗效评价标准和结局指标测量时间点不统一等问题。
Abstract:
Objective:To analyze the current utilization of outcome measures in randomized controlled trials(RCTs)on Chinese herbal compounds(CHCs)for adjuvant treatment of osteoporotic fractures.Methods:All the RCTs about CHCs for adjuvant treatment of osteoporo-tic fractures included from January 2005 to December 2024 were retrieved from the China National Knowledge Infrastructure,Vip Database,Wanfang Database,Chinese Biomedical Literature Service System,PubMed,Embase,and Cochrane Library through computer.All patients were treated with surgery intervention and conventional western medicine therapy,while the ones in experimental group were further treated with CHCs as an adjunctive therapy.The pertinent articles were screened,the information was extracted and the methodological quality of the included RCTs was evaluated independently by two researchers.After that,a statistical analysis was performed using Microsoft Excel 2016 software to examine the types and frequencies of outcome measures,domain-specific classification of outcome measures,utilization of composite efficacy criteria,and measurement time points of outcome measures.Results:Six thousand eight hundred and ten articles were searched out.After screening,102 ones were included in the final analysis,involving 10 317 patients.①General results of analysis on outcome measures.Eighty-three distinct outcome measures were reported in the 102 studies,with a cumulative frequency of 653.The individual studies encompassed 2-18 outcome measures,with a median of 7.Four studies distinguished between the primary and secondary outcome measures,all which employing three or more co-primary outcomes as the primary endpoints.②Domain-specific classification of outcome measures.Based on the outcome domain taxonomy for TCM clinical research,the 86 outcome measures were taxonomized into 7 categories,with 2,10,5,57,5,2 and 2 unique outcome measures into TCM syndrome patterns,symptoms & signs,quality of life,physicochemical detection,long-term prognosis,resource utilization,and safety events,respectively,which were reported in 9,132,14,267,185,4,42 instances,respectively,across the 102 studies.③Utilization of composite efficacy criteria in clinical studies.The composite efficacy criteria for clinical evaluation was reported in 28 studies,among which,12,8,3,and 2 studies referred to the Standard for Diagnosis and Therapeutic Effectiveness Evaluation of Traditional Chinese Medicine Syndromes,Guiding Principles of Clinical Research on New Chinese Medicine(try out),Common Diagnostic Classification Methods and Functional Outcome Assessment Criteria for Orthopedics,and Diagnostic and Therapeutic Criteria for TCM Diseases and Syndrome and Selection of Prescriptions,respectively.In addition,one study each referenced the Recommended Diagnostic Criteria for Osteoporosis in Chinese Population(Second Draft),Guidelines for the Diagnosis and Treatment of Osteoporotic Fractures in China(Diagnostic and Treatment Principles for Osteoporotic Fractures),and Expert Opinions on Monitoring and Evaluation of the Intervention Efficacy for Primary Osteoporosis.④Measurement time points of outcome measures.Outcome measures were assessed before the treatment and at the end of treatment in all 102 studies.Furthermore,the post-treatment outcome measure assessments were reported in 44 studies,with measurements taken at 6-month post-treatment in 18 studies,12-month post-treatment in 16 studies,3-month post-treatment in 9 studies,and 24-month post-treatment in 1 study.Conclusion:Current RCTs on CHCs as an adjuvant therapy for osteoporotic fractures exhibit critical methodological limitations such as non-standardized outcome measure selection,failure to distinguish primary outcome measure from secondary outcome measure,prevalent use of surrogate outcome measure,and diverse clinical composite efficacy criteria and time points for outcome assessment.

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备注/Memo

备注/Memo:
基金项目:国家自然科学基金项目(82222076); 北京中医药大学东直门医院领军人才培养计划项目(DZMG-LJRC0013)
通讯作者:李晋玉 E-mail:leery_5566@163.com
更新日期/Last Update: 1900-01-01