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中成药治疗先兆流产的临床研究进展的文献分析

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目的:通过文献分析,对治疗先兆流产有关中成药的药品信息及临床研究进展进行整合分析,为未来中成药治疗先兆流产的研究主题及临床应用提供有力依据。方法:通过全面检索药智数据库和"三大目录"[《中华人民共和国药典:一部》(2020 年版)、《中国基本药物目录 2018 版》和《2020 年版国家基本医疗保险、工伤保险和生育保险药品目录》],查找相关书籍中可用于保胎的中成药,以药品说明书为筛选标准,纳入明确提及具有安胎作用、用于治疗先兆流产的中成药。在四大中文数据库(中国知网、维普数据库、万方数据库和中国生物医学文献服务系统)和四大英文数据库(PubMed、Embase、the Cochrane Library和Web of Science)中检索相关中成药的文献,提取符合纳入标准的文献信息,统计分析后用文字描述和可视化图表的形式展示。结果:共纳入 17 种中成药,相关文献 289 篇,研究文献量最多的药品为固肾安胎丸(79 篇),其次为孕康制剂(64 篇)和滋肾育胎丸(63 篇);自 1998 年起,相关研究数量整体呈升高趋势,已在全国 26 个省(自治区、直辖市)开展。纳入分析的 285 项临床研究中,样本量为 51~100 例的研究最多,共153 项(占53。68%);研究数量最多的为加载试验,达255 篇(占89。47%);目前临床无统一的疗效评定标准,有 113 项研究(占 39。65%)涉及药物安全性问题。结论:临床上中成药治疗先兆流产具有较好的适宜性,研究成果越来越多。然而仍缺乏相关高质量的临床研究,希望今后能够增加这方面的投资,以期为中成药在治疗先兆流产的临床应用中提供科学、可靠的依据。
Literature Analysis of Clinical Research Progress of Chinese Patent Medicine in the Treatment of Threatened Abortion
OBJECTIVE:To integrate and analyze the information and clinical research progress of Chinese patent medicine in the treatment of threatened abortion based on literature analysis,so as to provide a strong basis for the future research theme and clinical application of Chinese patent medicine in the treatment of threatened abortion.METHODS:Through a comprehensive search of the DRUGDATAEXPY and"Three Major Catalogs"such as Pharmacopoeia of the People's Republic of China(Volume 1,2020 Edition),National Essential Medicine List(2018 Edition),and National Basic Medical Insurance,Occupational Injury Insurance and Maternity Insurance Catalogue(2020 Edition),Chinese patent medicine in the treatment of threatened abortion were retrieved.Drug instructions were used as the screening criterion to include Chinese patent medicine mentioned to have a tranquilizing effect and used in the treatment of threatened abortion.Literature related to Chinese patent medicine was searched in four Chinese databases(CNKI,VIP,Wanfang Data and SinoMed)and four English databases(PubMed,Embase,the Cochrane Library and Web of Science).Literature information meeting the inclusion criteria was extracted,and then displayed in the form of text description and visual charts after statistical analysis.RESULTS:Totally 17 kinds of Chinese patent medicines were enrolled,including 289 articles.Gushenantai pills gained the highest attention(79 articles),followed by Yunkang preparation(64 articles),and Zishenyutai pills(63 articles).Since 1998,the overall attention of threatened abortion research was on the rise,clinical studies conducted in 26 provinces(autonomous regions and municipalities)in China.Of the 285 clinical studies,a total of 153 studies(53.68%)had a sample size of 51 to 100 cases,with the most being load tests,constituting a total of 255 studies(89.47%).Currently,there is no unified standard for clinical efficacy assessment,and 113 studies(39.65%)involve drug safety issues.CONCLUSIONS:The clinical appropriateness of Chinese patent medicine in the treatment of threatened abortion is well established,and research results are increasing.However,there is still a lack of relevant high-quality clinical studies,and it is hoped that investment in this area can be increased in the future,with a view to providing a scientific and reliable basis for the clinical application of Chinese patent medicine in the treatment of threatened abortion.

Threatened abortionChinese patent medicineClinical researchLiterature analysis

余馨、贡磊磊、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

先兆流产 中成药 临床研究 文献分析

北京市医院管理局临床医学专项经费资助

ZYLX202119

2024

中国医院用药评价与分析
中国医药生物技术协会,中国药房杂志社

中国医院用药评价与分析

CSTPCD
影响因子:1.142
ISSN:1672-2124
年,卷(期):2024.24(9)