基于功效的中药妊娠期风险评估与分析OA
Risk Assessment and Analysis of Traditional Chinese Medicine During Pregnancy Based on Efficacy Evaluation
目的:基于《中华人民共和国药典(一部)》(2025 年版,以下简称"《中国药典》")中妊娠期禁忌的中药,分析中药的妊娠期风险相关功效,评估中药的妊娠期风险.方法:基于《中国药典》记载的中药数据,拆分并形成每味中药对应的基础功效,结合妊娠期禁忌中药,采用统计学方法分析与妊娠禁忌显著相关的"风险功效",进而评估中药的妊娠期风险.结果:《中国药典》记载的 616 种中药中,共梳理出 353 种基础功效,其中 17 种功效与妊娠期风险显著相关(P<0.05).除《中国药典》已明确的 38 种妊娠期禁忌中药外,基于妊娠期风险功效评估具有妊娠期风险的中药 113 个,具有安胎功效的中药 13 个.结论:基于妊娠期风险功效能够有效评估中药的妊娠期风险,为进一步构建中药及中成药妊娠期安全性评估体系提供借鉴及参考.
OBJECTIVE:To analyze the efficacy of traditional Chinese medicine related to pregnancy risks,and evaluate the pregnancy risks of traditional Chinese medicine based on contraindicated traditional Chinese medicine during pregnancy listed in Part Ⅰ of Pharmacopoeia of the People's Republic of China(2025 edition,hereinafter referred to as"Chinese Pharmacopoeia").METHODS:Based on the data of traditional Chinese medicine recorded in Chinese Pharmacopoeia,the basic efficacy of each traditional Chinese medicine was separated and formed,combined with the contraindications of traditional Chinese medicine in pregnancy,the risk and efficacy of traditional Chinese medicine in pregnancy were analyzed by statistical methods.RESULTS:Among the 616 kinds of traditional Chinese medicine recorded in Chinese Pharmacopoeia,353 kinds of basic efficacy were sorted out,of which 17 kinds of efficacy were significantly correlated with pregnancy risk(P<0.05).In addition to 38 kinds of contraindicated traditional Chinese medicines in Chinese Pharmacopoeia,113 kinds of traditional Chinese medicines with pregnancy risks and 13 kinds of traditional Chinese medicines with anti-abortion effect were evaluated based on the risk and efficacy of pregnancy.CONCLUSIONS:Based on efficacy evaluation of pregnancy risk,the pregnancy risk of traditional Chinese medicine can be effectively evaluated,which can provide reference for the further construction of the safety evaluation system of traditional Chinese medicine and Chinese patent medicine during pregnancy.
杜博冉;史湘君;张雪艳;王建东;冯欣
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首都医科大学附属北京天坛医院,国家神经系统疾病临床医学研究中心,北京 100070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
医药卫生
中药功效中成药妊娠期风险评估
Traditional Chinese medicineEfficacyChinese patent medicinePregnancyRisk evaluation
《中国医院用药评价与分析》 2026 (3)
266-269,4
国家自然科学基金青年项目(No.72204170)首都卫生发展专项(No.首发2024-2-2115)中国药学会医院药学专业委员会医院药学科研专项资助项目(No.CPA-Z05-ZC-2022-002)中华医学会临床药学分会2023年度临床药学青年项目(No.Z-2021-46-2101-2023)
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