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| 2019—2021年中医药治疗绝经过渡期随机对照试验结局指标文献分析 |
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艾艳珂1, 李杨2, 赵天易1, 孙海舒3, 葛志闪1, 曹雪1, 虞雪云1, 张艳宏4, 吴东宁5, 刘保延6, 何丽云1, 刘佳1
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1.中国中医科学院中医临床基础医学研究所, 北京 100700;2.北京丰台右安门医院, 北京 100054;3.中国中医科学院中医药信息研究所, 北京 100070;4.中国中医科学院针灸研究所, 北京 100070;5.中国中医科学院广安门医院西单门诊部, 北京 100032;6.中国中医科学院中医药数据中心, 北京 100070
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| 摘要: |
| [目的] 评价目前中医药治疗绝经过渡期随机对照试验结局指标的现状，为未来核心指标集研究提供依据和基础。[方法] 检索2019年1月—2021年12月中国知网（CNKI）、万方数据库（WanFang）、维普数据库（VIP）、PubMed、Embase和Cochranelibrary数据库，收集中医药治疗绝经过渡期的随机对照试验。按照预先设定的纳入排除标准由2名评价员独立筛选文献和进行资料提取，描述纳入的随机对照试验结局指标的使用情况。[结果] 最终纳入47篇随机对照试验，共使用了38个疗效指标，排在前5位的分别是临床疗效30篇（64%）、雌激素水平26篇（55%）、改良Kupperman指数评分18篇（38%）、中医症状评分15篇（32%）、匹兹堡睡眠质量指数14篇（30%）。35篇研究采用全局疗效评价指标，68%的研究评价时间点为治疗前后两次，85%的研究随访时间在3个月之内。[结论] 中医药治疗绝经过渡期的随机对照试验在结局指标的选择、测量和报告方面存在较大异质性，应该进行核心指标集的研究，并建立健全符合中医药特色的患者报告和医生报告疗效指标评价体系。 |
| 关键词: 中医药 绝经过渡期 随机对照试验 结局指标 |
| DOI：10.11656/j.issn.1672-1519.2022.11.10 |
| 分类号:R271.116 |
| 基金项目:中国中医科学院育苗基金培育专项（ZZ11-112）；艾滋病和病毒性肝炎等重大传染病防治（2017ZX10106001）；中国中医科学院第十四批自主选题（Z0733）；“三名工程”中国中医科学院刘保延首席研究员中医针灸临床评价方法创新团队（SZSM201612001）。 |
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| Analysis of the outcome indicators of randomized clinical trials in treatment of menopausal transition on traditional Chinese medicine in 2019-2021 |
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AI Yanke1, LI Yang2, ZHAO Tianyi1, SUN Haishu3, GE Zhishan1, CAO Xue1, YU Xueyun1, ZHANG Yanhong4, WU Dongning5, LIU Baoyan6, HE Liyun1, LIU Jia1
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1.Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;2.Beijing Fengtai You'anmen Hospital, Beijing 100054, China;3.Institute of Chinese Medicine Information, China Academy of Chinese Medical Sciences, Beijing 100700, China;4.Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China;5.Xidan Clinic of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100032, China;6.Traditional Chinese Medicine Data Center, China Academy of Chinese Medical Sciences, Beijing 100070, China
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| Abstract: |
| [Objective] To evaluate the outcome indicators in the randomized controlled trial of traditional Chinese medicine(TCM) for menopausal transition and to provide the references for the future researches of core outcome set.[Methods] Randomized controlled trials (RCTs) of TCM in the treatment of menopausal transition were collected in the database of CNKI,WanFang,VIP,PubMed,Embase and Cochrane library from January 2019 to December 2021.According to the inclusion and exclusion criteria,two evaluators independently screened the literature,extracted the data and described the use of outcome indicators of the included RCTs.[Results] The 47 RCTs were included and a total of 38 efficacy outcomes were used and the top five efficacy outcomes were the clinical curative effect of treatment with frequency of 30 times(64%),hormone level with frequency of 26 times (55%),the modified Kupperman index with frequency of 18 times(38%),TCM symptom score with frequency of 15 times (32%) and PSQI scale with frequency of 14 times (30%). The 35 RCTs used global efficacy evaluation outcomes,68%of the included RCTs were evaluated at two time points (before and after of the treatment) and 85% of studies were followed within 3 months.[Conclusion] Considerable heterogeneity existed in the selection,measurement and reporting of outcomes indicators in RCTs of TCM for menopausal transition and it is necessary to conduct research on core outcome set and establish the evaluation system of efficacy indicators for patient reports and doctor reports in accordance with the characteristics of TCM. |
| Key words: traditional Chinese medicine menopausal transition randomized controlled trial outcome indicator |
