首页|中成药治疗复发性流产的临床研究概况性综述

中成药治疗复发性流产的临床研究概况性综述

Chinese patent medicines for recurrent spontaneous abortion:a scoping review of clinical evidence

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目的 系统梳理中成药治疗复发性流产(RSA)的药品信息和临床研究现状,为临床合理用药提供参考证据,为临床实践和医疗卫生决策提供依据.方法 检索中英文数据库中对中成药治疗RSA的临床文献进行系统回顾,利用相关软件进行文献管理,并对药品及研究的基本信息进行提取,以文字描述和图表的形式开展可视化对比分析.结果 共纳入95篇文献,包括系统评价和Meta分析 2 篇,临床研究 93篇;涉及11种中成药,包括1种中药注射剂.临床研究数量较多的药品是滋肾育胎丸、固肾安胎丸和保胎灵制剂;2005 年起相关研究数量整体呈升高趋势,已在全国24 个地区开展;样本量为51～100 例的研究最多,包括 67项(72.04%);研究数量最多的比较类型是中成药联合西药与西药比较,研究总量达75项(80.65%).目前临床无统一的治疗方案及疗效判断标准,部分研究(43.01%)记录了患者用药过程中不良反应发生情况.结论 临床上中成药治疗RSA具有较好的适宜性,其与西药联用的效果明确.但存在药品说明书内容缺乏、用药时机疗程和结局评价指标未标准化、用药安全的重视程度不够、中医特色体现度不足等问题有待未来改善.
Objective To systematically sort out the drug information and current status of clinical research on the treatment of Recurrent Spontaneous Abortion(RSA)with Chinese patent medicines,so as to provide reference evidence for the rational use of medicines in the clinic,and a basis for the decision-making in the clinical practice and healthcare.Methods We carried out Chinese and English database document retrieval to review the clinical studies on Chinese patent medicines for the treatment of RSA.Relevant software was used to manage the literature,extract the basic information of the drugs and studies,and carry out visual comparative analyses in the form of textual descriptions and charts.Results A total of 95 research articles on Chinese patent medicines were screened out,including 2 systematic reviews and 93 clinical studies.11 types of Chinese patent medicines were involved,including 1 Chinese medicine injection.The drugs with a higher number of clinical studies were Zishenyutai pills,Gushenantai pills,and Baotailing preparation.Since 2005,the number of related studies has been on an overall elevated trend,and has been carried out in 24 regions of China,the largest number of studies with sample sizes of 51～100 cases included 67(72.04%);the type of comparison with the largest number of studies was the comparison of Chinese patent medicines in combination with Western medicines versus Western medicines,with a total number of studies amounted to 75(80.65%).At present,there is no uniform clinical treatment protocol and efficacy judgement standard,and some studies(43.01%)recorded the occurrence of adverse reactions during drug administration in patients.Conclusion Chinese patent medicines have good suitability for the treatment of RSA,and their effectiveness in combination with western medicines is clear.However,there are problems such as lack of content in the drug instruction,timing and duration of medication and outcome evaluation indexes are not standardised,insufficient attention to medication safety,insufficient embodiment of Chinese medicine characteristics,which needs to be improved in the future.

recurrent spontaneous abortionhabitual abortionZishenyutai pillsGushenantai pillsBaotailing preparationChinese patent medicinerational use of drugs

余馨、贡磊磊、姚伟洁、袁偲偲、冯欣

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首都医科大学附属北京妇产医院,北京妇幼保健院药事部,北京 100026

复发性流产 习惯性流产 滋肾育胎丸 固肾安胎丸 保胎灵制剂 中成药 合理用药

国家自然科学基金北京市医院管理局临床医学专项北京市市属医院科研培育计划首都医科大学附属北京妇产医院北京妇幼保健院中青年学科骨干培养专项(2021)

82204783ZYLX202119PZ2023029FCYY202110

2024

10.19803/j.1672-8629.20240057

中国药物警戒
国家药品监督管理局药品评价中心（国家药品不良反应监测中心）

中国药物警戒

CSTPCD
影响因子：1.105
ISSN：1672-8629
年,卷(期)：2024.21(4)
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