摘要
目的 探索芪蛭通络胶囊上市后在真实世界中的临床安全性.方法 通过药物源性前瞻性集中监测及巢式病例对照研究方法,对6个省份的19家机构2020 年11月24日至 2022年11月25日内所有使用芪蛭通络胶囊患者进行安全性评价.结果 共纳入 3 010 例患者,其中不良反应发生21例,包括胃肠系统疾病15例,各类神经系统疾病2例、精神病类2例、各种肌肉骨骼和结缔组织疾病2例,主要表现为腹部不适、腹泻、口腔溃疡、头痛及失眠等,无严重不良反应发生.多因素分析结果显示不良反应发生与芪蛭通络胶囊的服药频率有关,超出说明书建议的服药频率用药会增加不良反应发生率.结论 芪蛭通络胶囊不良反应发生率为0.70%,多集中于胃肠系统疾病.
Abstract
Objective To explore the clinical safety of Qizhitongluo capsule in the real world after its launch.Methods The safety of Qizhitongluo capsule was evaluated in all patients using the capsules from November 24,2020 to November 25,2022 at 19 institutions in 6 provinces(Henan,Shanxi,Guangxi,Liaoning,Shandong,and Heilongjiang)by means of drug-derived prospective centralised surveillance and nested case-control methods.Results A total of 3010 patients were included,and 21 cases of adverse reactions occurred,accounting for 0.7%,including 15 cases of gastrointestinal diseases,2 cases of various neurological disorders,2 cases of psychiatric disorders,and 2 cases of various musculoskeletal and connective tissue disorders,which were mainly manifested as abdominal discomfort,diarrhoea,oral ulcers,headache,and insomnia,etc.,and no serious adverse reactions occurred.The results of multifactorial analysis showed that the occurrence of adverse reactions was related to the dosage frequency of Qizhitongluo capsules,and the frequency of dosage exceeding the dosage frequency recommended by the instruction manual would increase the incidence of adverse reactions.Conclusion The incidence of adverse reactions of Qizhitongluo capsules was 0.70%,mostly in gastrointestinal diseases,and also in psychiatric diseases and musculoskeletal and connective tissue disease.
基金项目
国家自然科学基金资助项目(82074584)
中国中医科学院科技创新工程项目(CI2021A04702)
维普
万方数据