养心氏片上市后多中心安全性评价

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。

A multi-center clinical trial:Post-marketing drug evaluation on Yangxinshi Tablets

Objective To determine the safety of post-marketing drug Yangxinshi Tablets in a large population, and identify the nature, character, incidence, and potential risk factors of the adverse drug reaction (ADR). Methods The study was conducted from September 1st 2012 to August 31th 2013, using a design of drug-oriented, multicentre, retrospective, and non-controlled hospital clinical trials, and the patients treated with Yangxinshi Tablets and accorded with the ethics were monitored in nine hospitals. The adverse reactions and treatment of adverse reactions of all patients were recorded and analyzed, and Naranjo score was counted. Results There were 3 002 patients enrolled, with five cases of adverse events (ADE), mainly for gastrointestinal, cardiovascular, and nervous system response including dry mouth, stomach burning, paroxysmal headache, and palpitation, the incidence of ADE was 0.17%, and three cases had ADR related to the drug, two cases showed dry mouth and 1 case showed palpitation, the incidence of ADR was 0.1%. Conclusion The ADR of Yangxinshi Tablets is occasional, and the application of Yangxinshi Tablets in clinical therapy was safe. Because cases of ADRs were less (three cases), the influence of age, course of disease and Western medicine diagnostic criteria for the incidence of ADR remained unproved.