Liu Wei, Qin Jun
1 Department of Psychiatry and Psychology, the First Affiliated Hospital of Harbin Medical University, Harbin, China.
2 Qingdao Mental Health Center, Qingdao, China.
Int J Psychiatry Med. 2016 Aug;51(6):534-543. doi: 10.1177/0091217417696740. Epub 2017 Mar 20.
Objective The aim is to comparatively study Shugan Jieyu capsule and sertraline for non-inferiority in the treatment of patients with acute myocardial infarction and depression (observing the curative effects and safety) by the randomized controlled experiment. Methods A total of 149 patients with acute myocardial infarction and depression were randomly divided into two groups, the Shugan Jieyu group (76 cases) and the sertraline group (73 cases), and received treatments for 24 weeks. Depression states were assessed by the rote diagnostic checklist, and effects were evaluated by the Hamilton depression scale. Drug safety for heart was assessed by left ventricular ejection fraction (reduced by 5%), blood pressure, heart rate, P-wave and R wave interval, Q-R-S complex wave, and corrected Q-T interval after 12 weeks of treatment. Results There were no significant differences in the effective rates of Shugan Jieyu and sertraline groups. Significantly lower adverse event rate was observed in the Shugan Jieyu group. Two groups had a similar cardiac safety. Conclusion Shugan Jieyu capsule has a reliable effect and high safety in patients with acute myocardial infarction and depression.
目的 通过随机对照试验，比较疏肝解郁胶囊与舍曲林治疗急性心肌梗死伴抑郁症患者的非劣效性（观察疗效和安全性）。方法 将149例急性心肌梗死伴抑郁症患者随机分为两组，疏肝解郁组（76例）和舍曲林组（73例），治疗24周。采用定式诊断检查表评估抑郁状态，用汉密尔顿抑郁量表评估疗效。治疗12周后，通过左心室射血分数（降低5%）、血压、心率、P波与R波间期、QRS复合波以及校正QT间期评估心脏药物安全性。结果 疏肝解郁组与舍曲林组的有效率无显著差异。疏肝解郁组不良事件发生率显著较低。两组心脏安全性相似。结论 疏肝解郁胶囊治疗急性心肌梗死伴抑郁症患者疗效可靠，安全性高。
