54例中药不良反应/事件报告探讨中医药安全性

Discussion on the Safety of Traditional Chinese Medicine by 54 Cases of Adverse Reactions/Events of Traditional Chinese Medicine

目的:旨在通过分析54例中药不良反应/事件报告探讨中医药安全性。方法:收集我院中药不良反应报告共54例,分析患者性别、年龄、不良反应报告类型、涉及药物类型及组分类型。结果:全部不良反应报告中男性33例,占总数61.11%;女性患者21例,占总数38.89%;其中<18岁共1例,占总数1.85%;18~44岁共16例,占总数29.63%;45~49岁共20例,占总数37.04%;≥50岁共17例,占总数31.48%;属于新发现一般不良反应共33例,占总数61.11%,属于新发现一般不良反应共2例,占总数3.70%;属于一般不良反应共17例,占总数31.48%,属于严重不良反应共1例,占总数1.85%;属于中药针剂共53例,占总数98.15%,属于中药方剂仅1例,占总数1.85%;其中单一成分共18例,占总数33.33%,含有2至3种中成分共20例,占总数37.04%;含有4种成分共16例,占总数29.64%。结论:静脉注射类中成药和复方制剂可增加中药不良反应发生风险,故在临床药学管理中应加强监护。

Objective: To explore the safety of traditional Chinese medicine by analyzing the reports of 54 cases of adverse reactions/events of traditional Chinese medicine. Methods: A total of 54 cases of Chinese medicine adverse reactions were collected from our hospital from February 2015 to July 2018. Results: There were 33 males, accounting for 61.11%. There were 21 female patients, accounting for 38.89%of the total. Among them, 1 case was less than 18 years old, accounting for 1.85%of the total. There were 16 patients aged 18 ~ 44 years, accounting for 29.63%of the total. There were 20 cases(37.04%)between 45 and 49 years old. There were 17 patients ≥ 50 years old, accounting for 31.48%of the total. There were 33 cases of newly discovered general adverse reactions, accounting for 61.11%of the total, and 2 cases of newly discovered general adverse reactions, accounting for 3.70%of the total. There were 17 cases of general adverse reactions, accounting for 31.48%of the total, and 1 case of severe adverse reactions, accounting for 1.85%of the total. There were 53 cases of traditional Chinese medicine injections, accounting for 98.15%of the total number, and only 1 case of traditional Chinese medicine prescriptions, accounting for 1.85%of the total number. There were 18 cases with single component, accounting for 33.33%of the total number, and 20 cases with 2 ~ 3 components, accounting for 37.04%of the total number. There were 16 cases containing 4 components, accounting for 29.64%of the total. Conclusion: Intravenous injection of proprietary Chinese medicines and compound preparations can increase the risk of adverse reactions of traditional Chinese medicine.