111例山豆根及其制剂致不良反应文献分析

Literature Analysis of 111 Cases of Adverse Drug Reactions Induced by Sophora Tonkinensis and Related Preparations

目的探讨山豆根及其制剂引起不良反应发生的一般规律,为临床合理用药提供参考。方法通过检索现代医学期刊数据库和中国中医药数据库,对收集到的111例山豆根及其相关制剂致不良反应的文献报道进行统计分析。结果口服山豆根日剂量超过5 g或肌内注射肝炎灵注射液4 m L即出现不良反应,其不良反应以消化系统和神经系统的损害为主,分别占山豆根引起不良反应的32.21%和31.46%。结论山豆根作为临床治疗咽喉肿痛的常用药物,临床医师/药师应严格控制用药剂量,加强合理用药,避免或减少其不良反应的发生。

Objective To investigate relevant factors of the adverse drug reaction（ADR） induced by Sophora Tonkinensis and related preparations, and provide the scientific reference for the safe and rational use in clinic. Methods With retrospective case study, 111 cases of ADR induced by Sophora Tonkinensis and related preparations were analyzed, which were collected from medical journal database and traditional Chinese medicine database. Results Adverse reaction will occur when orally taken daily dose more than 5 g or intramuscularly injected 4 mL. The damage to digestive and nervous system was the most common, which accounted for 32.21%and 31.46%of total adverse reactions respectively. Conclusion Sophora Tonkinensis as a common traditional Chinese medicine is used for clinical treatment of sore throat and physicians/pharmacists should control the dosage strictly to avoid or reduce the incidence of ADR.