目的 通过研究热毒宁注射液不良反应（ADR）与其可能影响因素之间的关联性，总结热毒宁注射液ADR发生特点，为减少热毒宁注射液ADR特别是严重ADR的发生提供有益信息。方法 对2017年1月—2022年12月河南省不良反应监测中心收集的热毒宁注射液相关ADR进行回顾性分析，采用描述性统计方法分析ADR风险增加的可能影响因素，包括年龄、性别和原患疾病等。使用Apriori算法评价ADR与影响因素之间的关联。结果 共纳入有效ADR报告1 028例。近2/3的ADR发生于14岁及14岁以下患者中。主要累及器官为皮肤及其附件损害（55.54%），其次有全身性损害（15.18%）、胃肠系统损害（11.77%）和神经系统损害（5.25%）。关联规则分析中，根据支持度和置信度的值挖掘了多个强关联规则。其中，规则“是否伴随用药＝是and年龄段＝2～6岁”与“ADR分类＝皮肤及其附件损害”的置信度最高其支持度、置信度和提升度分别为6.42%、81.82%和1.47。结论 热毒宁注射液的不良反应主要发生在14岁以下人群；2～6岁且伴随用药的儿童尤其需要密切监测皮肤及附件损害类ADR。

Objective To investigate adverse drug reactions (ADRs)induced by Reduning Injection by analyzing the associations between these ADRs and potential risk factors, and therefore provide useful information for reducing the incidence of ADRs induced by Reduning Injection, especially serious ADRs. Methods A retrospective analysis was performed on ADRs induced by Reduning Injection reported to the Center for ADR Monitoring of Henan during the period January 2017— December 2021. Descriptive statistic was used to analyze possible risk factors associated with increased risk of ADRs, including gender, age, pre-existing diseases, et al. Then the Apriori algorithm was used to evaluate the associations between ADRs and these risk factors. Results A total of 1 028 effective ADR reports were included in the study. Almost two-third (64.90%) of the ADRs occurred in patients under 14 years old (inclusive). Skin and appendages disorders (55.54%) were the most commonly involved organ systems, followed by body as a whole-general disorders (15.18%), gastrointestinal disorders (11.77%) and nervous system disorders (5.25%). Several strong association rules were mined based on support value and confidence value in associations rule analysis. The rule between concomitant medication = yes and age group = 2 — 6 and ADR category = skin and appendages disorders had the highest confidence, with a 6.42% support, 81.82% confidence and 1.47 lift values. Conclusion The ADRs induced by Reduning Injection occur mainly in the population under 14 years old, children aged 2 to 6 years with concomitant drugs are especially required to be closely monitored for ADRs of skin and appendages disorders.

R978.7

河南省医学科技攻关计划联合共建项目（LHGJ20200944）；河南省市场监督管理局科技计划项目（2022sj59）