桥本甲状腺炎随机对照试验结局指标应用情况研究  

Study on Application of Outcome Indicators in RandomizedControlled Trial of Hashimoto′s Thyroiditis

作　　者：乔雪 李静蔚[2] 屈佳乐 陈翰翰[2] 陈宏志[1] QIAO Xue;LI Jingwei;QU Jiale;CHEN Hanhan;CHEN Hongzhi(Shandong University of Traditional Chinese Medicine,Jinan Shandong China 250355;The Affiliated Hospital Shandong University of Traditional Chinese Medicine,Jinan Shandong China 250014)

机构地区：[1]山东中医药大学,山东济南250355 [2]山东中医药大学附属医院,山东济南250014

出　　处：《中医学报》2024年第4期893-900,共8页Acta Chinese Medicine

基　　金：山东省医药卫生科技发展计划项目(202016001022);山东省中医药高层次人才培育项目{鲁卫函[2022]148号};齐鲁卫生与健康领军人才项目{鲁卫人字[2020]3号};齐鲁医派中医药特色技术整理推广项目{鲁卫函[2022]93号}。

摘　　要：目的:分析桥本甲状腺炎(Hashimoto′s thyroiditis,HT)随机对照试验结局指标,为HT临床研究结局指标的合理选择提供参考。方法:检索12个中英文数据库及2个临床试验注册中心,筛选诊断明确的随机对照试验,时间限定为各数据库建库至2022年3月。筛选文献,提取数据,定性分析结局指标。结果:158篇文献合计纳入患者15220例,应用结局指标165种,频次1379次,分属6个指标域:中医症状/证候48次(3.48%),症状/体征128次(9.28%),安全性事件142次(10.30%),远期预后6次(0.44%),理化检测1054次(76.43%),生活质量1次(0.07%)。结论:临床治疗HT理化检测指标应用频次较高,对HT共性问题较为重视,关注HT发病机制及预后的合理性。尚且存在结局指标差异大、命名相对不规范、卫生经济学评价不足、诊断及疗效参考标准不一致的局限性。建议构建HT核心指标集,合理选择相关结局指标,进一步推动HT临床研究的高质量发展。Objective:The outcome index of the randomized controlled trial of Hashimoto′s thyroiditis(HT)was analyzed,which provided a reference for the reasonable selection of outcome indicators for the clinical study of Hashimoto′s thyroiditis.Methods:Searched 12 Chinese and English databases and 2 clinical trial registries,to screen randomized controlled trials with clear diagnosis.The time limit is for each database to be created until March 2022.Literature was screened,data were extracted,and outcome measures were qualitatively analyzed.Results:A total of 15220 patients were included in 158 articles,and 165 outcome indicators were applied,with a frequency of 1379 times,which belonged to 6 index domains:48 TCM symptoms/symptoms(3.48%),128 signs/signs(9.28%),142 safety events(10.30%),6 long-term prognosis(0.44%),1054 physical and chemical tests(76.43%),and 1 quality of life(0.07%).Conclusions:In the clinical treatment of Hashimoto thyroid,the application frequency of physical and chemical testing indicators is high,the common problems of Hashimoto′s thyroiditis are paid more attention,the pathogenesis and prognosis of Hashimoto′s thyroiditis are reasonable,and there are still limitations such as large differences in outcome indicators,relatively irregular naming,inconsistent diagnostic and efficacy reference standards,and insufficient evaluation of health economic outcome indicators.It is recommended to construct a core index set of Hashimoto′s thyroiditis to reasonably select relevant outcome indicators,and further promote the high-quality development of Hashimoto′s thyroiditis clinical research.

关 键 词：桥本甲状腺炎 随机对照试验 结局指标 核心指标集 文献研究 

分 类 号：R259.814[医药卫生—中西医结合]