中成药治疗复发性流产的临床研究概况性综述

doi:10.19803/j.1672-8629.20240057

摘要/Abstract

摘要： 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。

关键词: 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

Abstract: 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.

Key words: recurrent spontaneous abortion, habitual abortion, Zishenyutai pills, Gushenantai pills, Baotailing preparation, Chinese patent medicine, rational use of drugs

中图分类号:

R994.11
R984

余馨, 贡磊磊, 姚伟洁, 袁偲偲, 冯欣. 中成药治疗复发性流产的临床研究概况性综述[J]. 中国药物警戒, 2024, 21(4): 361-365.

YU Xin, GONG Leilei, YAO Weijie, YUAN Sisi, FENG Xin. Chinese patent medicines for recurrent spontaneous abortion: a scoping review of clinical evidence[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 361-365.

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