糖皮质激素类药物用药错误相关医疗纠纷的案件分析

Analysis of Medical Disputes Caused by Medication Errors Related to Glucocorticoid Drugs

目的:整理分析2010—2021年中国裁判文书网所公布的糖皮质激素类药物相关医疗损害案件的纠纷原因,为临床合理使用糖皮质激素类药物、减少糖皮质激素类药物引起的医疗纠纷提供参考。方法:以“激素”及激素类药物的具体名称为关键词在中国裁判文书网进行检索,对用药纠纷案件基本信息进行整理并进行统计分析。结果:共检索到795例案件,纳入分析100例。案件发生时间在2012—2015年的糖皮质激素类药物用药错误的案件数量达到第一个高峰,2016年有所减少,之后案件发生数量再次升高。东部地区三级医疗机构骨科、眼科、神经内科纠纷案件数量占比较大。纠纷原因主要是因为糖皮质激素类药物使用过程中发生的药物不良事件,有72例案件(占比72%),医疗机构赔偿的主要判决理由是未提供必要的信息,涉及31例案件(占比31%)。多重逐步线性回归发现,与赔偿金额呈正向相关的因素包括年龄<20岁,儿科、妇产科、肿瘤科、泌尿外科、ICU、用药错误分类为治疗效果不佳,用药错误原因中用药时间过长及无适应证用药和有适应证但未及时应用。结论:医疗机构应建立完善的糖皮质激素类药物使用监管制度,注意糖皮质激素类药物使用前患者告知流程的规范性和使用过程中疗效及不良反应的监测,全流程规范糖皮质激素类药物的临床使用,在减少糖皮质激素类药物引起患者不良结局发生的同时降低糖皮质激素类药物相关的纠纷发生率。

Objective:To sort out and analyze the causes of medical damage liability dispute cases related to glucocorticoid drugs Published on China Judgements Online from 2010 to 2021,so as to provide references for rational use of glucocorticoids and reduce medical disputes related to glucocorticoid drugs in clinical practice.Methods:Hormone and specific drug names of Glucocorticoids were used as the key words to search on China Judgements Online,Excel 2019 was used to sort out the basic information of the cases and SPSS 21.0 was used to analyse results.Results:A total of 795 cases were retrieved and 100 cases were included in the analysis.The number of glucocorticoid-related disputes peaked from 2012 to 2015,and decreased in 2016 temporarily,after that,number of the cases increased again.Orthopedics,ophthalmology and neurology in tertiary medical institutions in eastern China accounted for a large proportion in the disputes.The main cause of the disputes was the adverse events during of the use of glucocorticoid drugs,including 72 cases(72%).The main reason for medical institution compensation was failure to provide necessary information,including 31cases(31%).According to the multiple linear regression,factors positively correlated with the amount of compensation were:age younger than 20 years old,patients in pediatrics,obstetrics,oncology,urinary surgery,ICU,poor treatment effect,long treatment course and irrational use related with indication.Conclusion:Medical institutions should establish a more perfect regulatory system on the use of glucocorticoid drugs.Process of information telling before glucocorticoid drugs use and monitor of efficacy and adverse effects during glucocorticoid drugs use should be paid more attention,aiming at reducing the occurrence of adverse events and reducing glucocorticoid drugs related disputes at the same time.