基于Logistic回归分析的丹参酮ⅡA磺酸钠注射液致药品不良反应影响因素分析

Logistic Regression Analysis on Influential Factors of Adverse Drug Reactions Caused by Sulfotanshinone Sodium Injection

目的分析丹参酮ⅡA磺酸钠注射液所致药品不良反应(ADR)的影响因素。方法收集不同地区多家医院2014年1月至2019年12月上报的丹参酮ⅡA磺酸钠注射液相关ADR报告236份,对人群特征、ADR发生时间、用法用量等进行回归分析,总结影响ADR发生的危险因素。结果236例ADR患者中,51岁及以上患者居多(94.49%),用药后30min内ADR发生率最高(44.49%)。Logistic回归分析结果显示,丹参酮ⅡA磺酸钠注射液ADR的主要影响因素包括年龄、用药时段、单次用药剂量、溶剂量不符合药品说明书要求、联合用药、原患疾病。结论丹参酮ⅡA磺酸钠注射液所致ADR发生原因较多,临床应规范其应用,并加强ADR监测,减少ADR发生,确保临床用药的安全性和合理性。

Objective To analyze the influential factors of adverse drug reactions(ADR)caused by Sulfotanshinone Sodium Injection.Methods A total of 236 ADR reports related to Sulfotanshinone Sodium Injection were collected from many hospitals in different regions from January 2014 to July 2019.Regression analysis was used to analyze the population characteristics,the onset time of ADR,usage and dosage of medicines.The risk factors affecting the occurrence of ADR were summarized.Results Among the 236 patients with ADR,most of them were 51 years old or above(94.49%),and the occurrence of ADR was the highest within 30 min after administration(44.49%).Logistic regression analysis showed that the main influential factors of ADR caused by Sulfotanshinone Sodium Injection were as follows:age,period of medication,single dose of drug,the amount of solvent didn’t meet the requirements of drug instructions,drug combination and the primary disease.Conclusion There are many causes of the occurrence of ADR caused by Sulfotanshinone Sodium Injection.Clinicians should standardize the clinical application,strengthen the monitoring of ADR,reduce the occurrence of ADR,and ensure the safety and rationality of clinical medication.