基于文献分析及融变时限考察国产黄体酮软胶囊阴道给药处方合理性审核的研究  

Study on the rationality of vaginal administration of domestic progesterone soft capsules based on literature analysis and melting time investigation

作　　者：禹洁[1] 彭绪玲 任耘[1] 杨妙[1] 杨晨[1] 李蒙[1] 蓝高爽[1] 李正翔[1] 袁恒杰[1] YU Jie;PENG Xu-ling;REN Yun;YANG Miao;YANG Chen;LI Meng;LAN Gao-shuang;LI Zheng-xiang;YUAN Heng-jie(Pharmacy Department,General Hospital of Tianjin Medical University,Tianjin 300052,China;School of Chinese Materia Medica,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]天津医科大学总医院药剂科,天津300052 [2]天津中医药大学中药学院,天津301617

出　　处：《中国医院药学杂志》2023年第9期1013-1019,共7页Chinese Journal of Hospital Pharmacy

基　　金：天津市卫生健康委员会科技人才培育项目(编号:KJ20159)。

摘　　要：目的:评价某国产黄体酮软胶囊阴道给药的循证证据,并进行融变时限考察,为其是否通过处方审核提供依据和参考。方法:系统检索指南数据库、中英文文献数据库及国内外药品管理政府网站,对符合纳入标准的文献,根据《超说明书用药循证评价规范》进行相应文献质量评价;采用《中国药典》(2020年版)标准,考察国产黄体酮软胶囊的融变时限。结果:共纳入29篇文献,其中5篇指南/专家共识,经AGREEⅡ工具评价,高质量等级(A)2篇、低质量等级(C)3篇;6篇系统评价/Meta分析,经ASMTAR工具评价,高、中、低质量文献分别为2,3,1篇;16篇临床研究文献经Jadad或NOS量表评价后,高质量文献10篇、低质量6篇,所有文献均肯定了黄体酮阴道用药的有效性及安全性;检索获得的原研药品说明书包含阴道给药的用法用量;国产黄体酮软胶囊融变时限符合《中国药典》的规定。结论:该国产黄体酮软胶囊阴道给药通过循证医学证据考察,融变时限符合《中国药典》的规定,应通过处方审核。OBJECTIVE To evaluate the evidence of domestic progesterone soft capsules for vaginal administration and investigate the melting time,so as to provide basis and reference for prescription review.METHODS The guideline database,Chinese and English literature database and drug administration government websites were systematically searched,and the corresponding literature quality was evaluated according to the Evidence-based Evaluation Specification of Off-label Medication Use.According to the standard of Chinese Pharmacopoeia(2020 Edition),the melting time of domestic progesterone soft capsules was investigated.RESULTS Twenty-nine articles were included in this study.There were 5 guidelines/expert consensus,of which 2 were with high quality(A)and 3 were with low quality(C)assessed by AGREEⅡ.There were 6 systematic reviews/Meta-analysis,of which 2 were high-quality,3 were medium-quality and 1 was low-quality literature evaluated by ASMTAR.The 16 clinical research literature were evaluated by Jadad or NOS scale,of which 10 were high-quality and 6 were low-quality.All the literature confirmed the effectiveness and safety of progesterone vaginal administration.The imported drug description contained the usage and dosage of vaginal administration.The melting time of domestic drug was in accord with the demands of Chinese Pharmacopoeia.CONCLUSION The vaginal administration of domestic progesterone soft capsules has passed the evidence-based medical evidence investigation,and the melting time conforms to the provisions of Chinese Pharmacopoeia.The vaginal administration of domestic progesterone soft capsules should be approved by prescription review.

关 键 词：黄体酮软胶囊 融变时限 阴道用药 处方审核 

分 类 号：R984[医药卫生—药品]