从司法判决分析降低β内酰胺类药物过敏所致纠纷的策略

Strategies of reducingβ-lactam allergy disputes by judgment

目的:分析与β内酰胺类过敏相关医疗损害责任纠纷的规律及特点,为临床合理用药提供参考。方法:检索"中国裁判文书网"从建库到2020年12月31日北京地区的与β内酰胺类过敏相关的医疗损害责任纠纷的裁判文书,建立数据库,汇总分析相关纠纷的原因并制定较为全面的防控策略。结果:共检索到判决书480例,纳入裁判文书14例,涉及男性患者6例,女性患者8例,年龄范围为1个月至87岁。判决结果中医方3例无责,11例有责。引发过敏的有责案例主要由头孢菌素类药物引起(72.73%),既往有过敏史者(63.63%),通过静脉滴注给药(72.73%),用药后发生速发型过敏反应(54.55%),过敏主要表现为过敏性休克(72.73%)。过敏反应最终导致4例死亡,2例成为植物人或瘫痪,4例延长治疗时间,1例恢复。判决结果认定错误用药原因分别为:未充分关注过敏史,说明书要求皮试未做皮试,超说明书用药及抢救不当。结论:医师应重视β内酰胺药物引起的过敏反应,切实询问过敏史,遵照说明书用药。医院或可利用相关辅助软件减少该不良反应对患者造成的生命安全威胁及相关用药纠纷。

OBJECTIVE To explore the regularity and characteristics of medical damage liability related toβ-lactam allergy and provide references for clinical rational dosing of drugs.METHODS The database of China Judgments Online was searched from its inception up until December 2020 in Beijing area.A registry was established for analyzing the causes and formulating a comprehensive prevention and control strategy.RESULTS Among a total of 480 judgments,14 judgments were included.There were 6 male patients and 8 female patients with an age range of 1 month to 87 years.In the verdict,3 cases were not responsible and 11 cases responsible.The cases of triggering disputes were caused by cephalosporins(72.73%),allergy history(63.63%),intravenous drip(72.73%)and immediate hypersensitivity(54.55%).And the most common allergy was anaphylactic shock(72.73%).The outcomes of allergic reaction were death(n=4),vegetation or paralysis(n=2),extended treatment time(n=4)and recovery(n=1).The reasons for medication errors were physicians failing to heed allergic history,compulsory skin test not performed,off-label dosing and improper rescue.CONCLUSION Physicians should watch for allergic reaction ofβ-lactam,inquire about the history of allergies and follow dosing instructions.Hospitals may develop a dedicated software to reduce adverse reaction,resolve medication disputes and even save life.