Page 18 - 《中国药房》2022年5期

《医疗机构药品遴选指南》中临床有效性的评价体系构建 Δ

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韩 滨 ，吴佳瑶 ，谢 栋 ，禹 璐 ，仲威龙 ，段 蓉 ，李正翔 （1.天津医科大学总医院药剂科，天津
300052；2.天津医科大学总医院消化内科，天津 300052）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）05-0524-06
DOI 10.6039/j.issn.1001-0408.2022.05.03
摘 要 目的 构建《医疗机构药品遴选指南》中药品临床有效性的评价体系，为医疗机构药品遴选提供参考。方法 计算机检索中
国相关政府网站及 PubMed、Embase、中国生物医学文献数据库、中国期刊全文数据库等，检索时限均为建库起至 2021 年 9 月 14
日，分别提取“指南推荐级别和强度”“临床路径”“疗效证据及级别”3个二级指标中涉及临床有效性的相关内容，构建药品临床有
效性的评价体系。结果 针对“指南推荐等级和强度”“临床路径”“疗效证据及级别”指标分别纳入政策文件及文献5、4、17篇。药
品的“指南推荐级别和强度”可体现药品的临床有效性，评价内容指遴选药品适应证对应疾病的相关指南中对遴选药品的推荐级
别和强度；“临床路径”是药品有效性的体现，评价内容指遴选药品是否纳入适应证对应疾病的临床路径；化学药/生物制剂和中成
药的“疗效证据及级别”评价内容各有不同，化学药/生物制剂疗效研究的证据及质量级别参照GRADE体系，中成药疗效研究的证
据及质量级别参考经典著作或临床经验传承，因此该指标评价内容是遴选药品相关疗效研究的证据及质量级别。结论 从医疗机
构药品遴选角度构建的药品临床有效性的评价指标体系，可为《医疗机构药品遴选指南》的构建奠定评价体系基础，也可为针对有
效性的医疗机构药品遴选提供参考。
关键词 医疗机构；药品遴选；临床有效性；指南推荐级别；临床路径；证据分类

Construction of evaluation system for clinical effectiveness of Drug Selection Guideline for Medical
Institutions
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HAN Bin ，WU Jiayao ，XIE Dong ，YU Lu ，ZHONG Weilong ，DUAN Rong ，LI Zhengxiang（1. Dept. of
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Pharmacy， General Hospital of Tianjin Medical University， Tianjin 300052， China； 2. Dept. of
Gastroenterology，General Hospital of Tianjin Medical University，Tianjin 300052，China）
ABSTRACT OBJECTIVE To establish an evaluation system of clinical effectiveness of Drug Selection Guideline for Medical
Institutions，and to provide reference for drug selection in medical institution. METHODS Retrieved from relevant Chinese
government websites，PubMed，Embase，CBM and CNKI，etc.，from the inception to Sept. 14th 2021，related contents of clinical
effectiveness related to three secondary indicators，such as“recommended level and strength of guideline”“clinical pathway”and
“evidence and level of efficacy”were extracted respectively；evaluation system was construction for the clinical effectiveness.
RESULTS A total of 5，4 and 17 policy documents or literatures were included according to“recommended level and strength of
guideline”“clinical pathway”and“evidence and level of efficacy”，respectively.“The recommended level and strength of drug
guideline”could reflect the clinical effectiveness of drugs，and the evaluation content referred to the recommended level and
strength of the selected drugs in the guidelines for corresponding indications.“Clinical pathway”was the embodiment of drug
effectiveness, and the evaluation content referred to the clinical path of whether the selected drugs were included in the
corresponding indications. The evaluation contents of“evidence and level of efficacy”were different between chemical medicine/
biological agent and Chinese patent medicine；evidence and quality level of efficacy research for chemical medicine/biological agent
referred to GRADE system，while those for Chinese patent medicine referred to classic works or clinical experience inheritance.
Therefore，the evaluation contents of this index system were the evidence and quality level of the efficacy research related to
selected drugs. CONCLUSIONS The evaluation system of clinical effectiveness of drugs constructed from the perspective of drug
selection in medical institutions can lay the foundation of evaluation system for the construction of Drug Selection Guideline for
Medical Institutions，and also provide reference for drug selection in medical institutions.
KEYWORDS medical institution；drug selection；clinical
Δ 基金项目：天津市赵以成医学科学基金会资助项目
＊主管药师，硕士。研究方向：药理学、药事管理。电话：022- effectiveness； level of evidence recommendation； clinical
60362923。E-mail：hanbintj@163.com pathway；evidence classification
# 通信作者：主任药师。研究方向：药事管理、医院药学。电话：
022-60362161。E-mail：13820893896@163.com

·524 · China Pharmacy 2022 Vol. 33 No. 5 中国药房 2022年第33卷第5期