基于巢式设计的热毒宁注射液不良反应特征及影响因素分析

Analysis on Characteristics and Influential Factors of Adverse Reactions of Reduning Injection(热毒宁注射液) Based on Nested Design

目的观察热毒宁注射液不良反应的特征及影响因素。方法收集全国5家医院使用热毒宁注射液患者的临床信息,以不良反应为结局指标,进行巢式病例对照设计,采用单因素及多因素条件Logistic回归模型,分析热毒宁注射液不良反应发生的可能影响因素。结果 3000例热毒宁注射液患者中16例发生不良反应,以儿童居多,平均年龄10.12岁,男性11例,女性5例;以消化系统胃肠道症状(如腹痛、腹泻、胃脘痛)发生较多,占87.5%。以年龄、性别、用药季节、药品批次相同为匹配条件,按照1∶4比例匹配未发生不良反应的患者64例,多因素条件Logistic结果显示,滴速是不良反应发生的影响因素(P=0.043),注射前是否冲管是不良反应发生的重要因素(P=0.027)。结论热毒宁注射液不良反应以儿童居多,注射前未冲管及滴速过快是不良发应发生的重要影响因素。

ABSTRACT Objective To observe the characteristics and influential factors of adverse reactions （ADRs） of Reduning Injection （热毒宁注射液）. Methods The application information of Reduning Injection （热毒宁注射液） was collected in 5 hospitals. The nested case-control design was conducted by taking ADRs as the outcome indicators and univariate and multivariate Logistic regression model was used to analyze the possible influential factors of ADRs of Reduning Injection （热毒宁注射液）- Results The ADRs occurred in 16 patients （11 males and 5 females） among 3 000 patients, mostly children and with an average age of 10. 12 years old. The ADRs mainly manifested by gastrointestinal symptoms such as abdominal pain, diarrhea and stomachache, accounting for 87.5%. Sixty-four patients without ADRs were matched at a ratio of 1 to 4 by taking the same age and sex as a matching condition. A multivariate Logistic regression analysis showed that drip rate inge cleaning was an important factor of ADRs （P = 0. 027 ） commonly occur in children and the important factors was an influential factor of ADRs （ P = 0. 043 ） and syr Conclusion The ADRs of Reduning Injection （热毒宁注射液） are unwashed syringe before the injection and rapid drip.