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目的:探讨中药注射剂不良反应发生的相关影响因素,为临床安全用药提供参考。方法:本研究采用回顾性队列研究,进行1:2病例-对照研究,所得资料进行单因素和多因素条件Logistic回归分析,分析中药注射剂ADRs发生的高危因素。结果:中药注射剂不良反应的相关危险因素多因素条件Logistic回归分析结果表明:是否辨证论治、是否有药物过敏史或过敏体质、注射剂配液后放置时间、给药剂量大于推荐剂量、超疗程和每小时输入量大于250mL这6个因素的回归系数均为正值,校正混杂作用后各因素OR值均大于1,并都有统计学意义,为中药注射剂ADRs发病关系密切的独立危险因素。结论:中药注射剂ADRs的发生是多种因素综合作用的结果。
Objective: To explore the related factors of adverse reactions of traditional Chinese medicine injections, and to provide references for the clinical use of drugs. Methods: A retrospective cohort study was conducted in a 1: 2 case-control study. The data were analyzed by conditional and multivariate logistic regression analysis to analyze the risk factors for ADRs in Chinese medicine injection. Results: Logistic regression analysis showed that whether syndrome differentiation, history of drug allergy or allergy constitution, injection time after dosing with injection, dosage greater than the recommended dose, overdose and hourly The regression coefficients of the 6 factors with the input more than 250 mL were all positive, and the OR of all the factors after the mixed effect was more than 1, all of which were statistically significant, which was an independent risk factor closely related to the pathogenesis of ADRs. Conclusion: The occurrence of ADRs in Chinese medicine injection is the result of the combination of many factors.