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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
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| 篇名： | 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 |
| TITLE： | Correlation analysis between the judgment of medical damage liability disputes related to off-label drug use and evidence-based evidence |
| 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。 |
| ABSTRACT： | OBJECTIVE To explore wheth er 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 off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn |
| 期刊： | 2022年第33卷第15期 |
| 作者： | 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 |
| AUTHORS： | BAO Qi， HU Lin，HU Huajie，HUANG Tao，FU Mengyuan，Haishaerjiang·Wushouer，GUAN Xiaodong，SHI Luwen |
| 关键字： | 超说明书用药；医疗损害责任纠纷；判决结果；循证证据 |
| KEYWORDS： | off-label drug use ；medical damage liability |
| 阅读数： | 149 次 |
| 本月下载数： | 9 次 |
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