目的 明確養(yǎng)心氏片上市后大規(guī)模人群使用的安全性，識別其不良反應（ADR）的性質、特點、發(fā)生率和潛在的風險因素。方法 采用藥物源性、多中心、回顧性、非對照臨床試驗，監(jiān)測2012年9月1日－2013年8月31日9家臨床研究中心所有使用養(yǎng)心氏片、且符合倫理學要求的患者，記錄并分析所有ADR，以及ADR處理情況，統(tǒng)計Naranjo評分。結果 本次安全性評價共納入3 002例患者，其中5人發(fā)生不良事件（ADE），主要為胃腸道、心血管和神經(jīng)系統(tǒng)反應（包括口干、胃部燒灼、陣發(fā)性頭痛和心悸），ADE發(fā)生率為0.17%。根據(jù)Naranjo評分運算法則，發(fā)現(xiàn)的ADR包括2例口干、1例心悸、ADR發(fā)生率為0.1%。結論 養(yǎng)心氏片的ADR為偶見，臨床應用安全性較高。由于ADR的例數(shù)較少（3例），年齡、病程、西醫(yī)診斷等因素對ADR發(fā)生率的影響有待進一步研究。

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.

國家自然科學基金（81001596、81473514）；中國中醫(yī)科學院自主選題項目（Z0254）