基于关联规则的中药注射剂及其成分的不良反应发生规律研究

Study on Occurrence Rules of Adverse Drug Reactions of Traditional Chinese Medicine Injections and Their Components Based on Association Rules

目的 :分析中药注射剂及其成分不良反应发生的相关因素,为探索中药注射剂不良反应发生机理提供数据支撑。方法:选取苏州市2016—2018年药物不良反应管理平台中,中药注射剂不良反应报告629份,采用Apriori关联规则分析中药注射剂及其成分与不良反应表现类型、不良反应发生时间、过敏史、性别和年龄之间的关联。结果 :总体而言,中药注射剂的不良反应大多发生在首次用药的0~30 min内,不良反应症状以皮肤居多(56.3%)。其中以热毒宁注射液的不良反应发生率最高(32.4%),且热毒宁注射液与0~19岁男性,皮肤不良反应以及0~30 min时间段都呈现强关联。在中药材成分中,以青蒿与皮肤、0~30min和0~19岁关联度最高,以黄芩与无过敏史关联度最高,以麦冬和红参与女性关联度最高,聚山梨酯虽然出现频次最多,但关联度均较低,指导意义小。结论 :中药注射剂及其成分的不良反应呈现一定的分布特征,分析得到部分关联规则值得进一步探究和确认,可用于提升临床用药安全。

Objective:To analyze the related factors of adverse drug reactions(ADR)of traditional Chinese medicine injections and their components to provide data support for exploring the mechanism of ADR of traditional Chinese medicine injections.Methods:A total of 629 ADR reports of traditional Chinese medicine injections were selected from the platform of ADR management platform of Suzhou City from 2016 to 2018.Apriori association rules were used to analyze the relationship between traditional Chinese medicine injections and their components and the types and the occurrence time of ADR,allergic history,gender and age.Results:In general,most of ADR of traditional Chinese medicine injections occurred within 0~30 minutes of the first drug use,and most of ADR symptoms occurred in skin(56.3%).Among them,the incidence of ADR of reduning injections was the highest(32.4%),and reduning injections were strongly correlated with males aged 0~19 years,skin ADR and 0~30 min intervals.Among the components of Chinese medicinal materials,the correlation between artemisia annua and skin,0~30 min and 0~19 years old was the highest.The correlation between scutellaria baicalensis and no allergy history was the highest.The correlation between ophiopogon japonicus and radix ginseng Rubra was the highest.Polysorbide has the highest frequency,but the correlation is low and the guiding significance is small.Conclusion:The adverse drug reactions of traditional Chinese medicine injections and their components have certain distribution characteristics.Some association rules obtained from the analysis are worthy of further investigation and confirmation,which can be used to improve the safety of clinical drug use.