Page 24 - 《中国药房》2022年15期

超说明书用药医疗损害责任纠纷判决与循证证据的相关性分析 Δ

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保 琦 ，胡 琳 ，胡华杰 ，黄 涛 ，傅孟元 ，海沙尔江·吾守尔 ，管晓东 ，史录文 （1.北京大学药学院药
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事管理与临床药学系，北京 100191；2.北京大学医药管理国际研究中心，北京 100191）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）15-1810-05
DOI 10.6039/j.issn.1001-0408.2022.15.04
摘 要 目的 探究超说明书用药医疗损害责任纠纷判决结果是否与循证证据有关。方法 在“北大法宝”搜索截至2021年的超说
明书用药医疗损害责任纠纷案例，提取文书记录中的客观因素、主观因素及判决结果，根据广东省药学会《超说明书用药目录》和
《超说明书用药循证评价规范》判断有无循证证据，采用单因素分析评价判决结果与循证证据的相关性。结果 共纳入案例57例。
案例主要发生在我国东部地区（63.2％），涉事医院以三级医院（64.9％）为主，主要鉴定机构为鉴定中心或鉴定所（61.4％），最常见
的超说明书用药类型是超剂量用药（45.6％）。判决结果中，23例（40.4％）超说明书用药与医疗损害有因果关系，医方承担次要责
任的案例居多（28.1％），实际赔偿金额少于10万元的居多（54.4％）。所纳入案例中有25例（43.9％）有循证证据。单因素分析结
果显示，超说明书用药中有循证证据的案例索赔金额显著高于无循证证据的案例（P＝0.040），与案例实际赔偿金额（P＝0.741）、
因果关系判定（P＝0.256）、责任类型（P＝0.598）、鉴定机构（P≥0.260）均无显著相关性。结论 超说明书用药医疗损害责任纠纷判
决结果与循证证据无显著相关性，说明司法审判与医学科学间可能存在一定分歧。应通过建立完善的超说明书用药管理制度，规
范超说明书用药的知情同意程序来规范超说明书用药行为。
关键词 超说明书用药；医疗损害责任纠纷；判决结果；循证证据

Correlation analysis between the judgment of medical damage liability disputes related to off-label drug
use and evidence-based evidence
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BAO Qi ，HU Lin ，HU Huajie ，HUANG Tao ，FU Mengyuan ，Haishaerjiang·Wushouer ，GUAN Xiaodong ，
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SHI Luwen （1. Dept. of Pharmacy Administration and Clinical Pharmacy，School of Pharmaceutical Sciences，
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Peking University，Beijing 100191，China；2. International Research Center for Medicinal Administration，
Peking University，Beijing 100191，China）
ABSTRACT OBJECTIVE To explore whether there is a relationship between the judgment results of medical damage liability
disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes
related to off-label drug use up to 2021 on pkulaw.cn，documents were extracted to record objective factors，subjective factors and
judgment results；whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based
Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association；univariate analysis was adopted to test the
relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly
occurred in the eastern China（63.2％） and tertiary hospitals （64.9％），the main appraisal agency was the appraisal center or
institute（61.4％），and the most common type of off-label drug use was overdose drug use（45.6％）. Among the judgment results，
23 cases（40.4％）of off-label drug use had a causal relationship with medical damage，most of the responsibility of doctors was
secondary responsibility（28.1％），and the actual compensation amount of the most cases were less than 100，000 yuan（54.4％）.
There were 25 cases（43.9％）with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount
of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence （P＝
0.040），and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case
（P＝0.741），causality determination （P＝0.256），liability type （P＝0.598） or appraisal agency（P≥0.260）. CONCLUSIONS
There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use
and evidence-based evidence，indicating that there may be certain differences between judicial trials and medical science. The
off-label drug use should be regulated by establishing a complete
Δ 基金项目 国家自然科学基金资助项目（No.72074007）
off-label drug use management system and standardizing
＊ 第 一 作 者 硕 士 研 究 生 。 研 究 方 向 ：药 事 管 理 。 E-mail：
informed consent procedure for off-label drug use.
1610307322@pku.edu.cn
KEYWORDS off-label drug use；medical damage liability
# 通信作者 副教授，博士生导师，博士。研究方向：药品公平可及
disputes；judgment results；evidence-based evidence
与合理使用。电话：010-82805019。E-mail：guanxiaodong@pku.edu.cn
·1810 · China Pharmacy 2022 Vol. 33 No. 15 中国药房 2022年第33卷第15期