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目的明确养心氏片上市后大规模人群使用的安全性,识别其不良反应(ADR)的性质、特点、发生率和潜在的风险因素。方法采用药物源性、多中心、回顾性、非对照临床试验,监测2012年9月1日-2013年8月31日9家临床研究中心所有使用养心氏片、且符合伦理学要求的患者,记录并分析所有ADR,以及ADR处理情况,统计Naranjo评分。结果本次安全性评价共纳入3 002例患者,其中5人发生不良事件(ADE),主要为胃肠道、心血管和神经系统反应(包括口干、胃部烧灼、阵发性头痛和心悸),ADE发生率为0.17%。根据Naranjo评分运算法则,发现的ADR包括2例口干、1例心悸、ADR发生率为0.1%。结论养心氏片的ADR为偶见,临床应用安全性较高。由于ADR的例数较少(3例),年龄、病程、西医诊断等因素对ADR发生率的影响有待进一步研究。
Objective To determine the safety of large-scale use of nourishing heart tablets and to identify the nature, characteristics, incidence and potential risk factors of adverse reactions (ADR). METHODS: Drug-based, multicenter, retrospective, and uncontrolled clinical trials were conducted to monitor 9 clinical studies centers from September 1, 2012 to August 31, 2013. All patients who received Yang Xin tablets and met ethical requirements , Record and analyze all ADR, and ADR treatment, statistics Naranjo score. Results A total of 3 002 patients were enrolled in this safety assessment. Five of them developed adverse events (ADEs), mainly gastrointestinal, cardiovascular and neurological reactions (including dry mouth, gastric burning, paroxysmal headaches and palpitations ), The incidence of ADE was 0.17%. According to the Naranjo scoring algorithm, ADRs were found to include 2 cases of dry mouth and 1 case of palpitations with an incidence of ADR of 0.1%. Conclusion Yang Xin tablets ADR is rare, clinical application of higher safety. Due to the small number of ADR cases (3 cases), the influence of age, course of disease, western medicine diagnosis and other factors on the incidence of ADR remains to be further studied.