中国心功能不全患者对比索洛尔耐受剂量范围和安全性研究

The safety and tolerant dose-range of bisoprolol in Chinese patients with cardiac insufficiency

目的 确定我国心功能不全患者对比索洛尔的耐受剂量范围和安全性。方法 入选因冠心病、扩张型心肌病或高血压而导致的心功能不全患者 74 6例 ,在基础治疗外加用比索洛尔。比索洛尔初始剂量为 1 2 5mg ,每日一次 ,逐渐加量至 2 5 0、3 75、5 0 0、7 5 0、10 0 0mg等。每位患者均达到并维持所能耐受的最大剂量至试验结束 ,随访时间为 1年。结果 可供统计学分析的病例为730例 ,其中 81 1%的患者服用比索洛尔≥ 5 0 0mg。在试验过程中 ,因药物不良反应而退出研究的有 15例 (2 1% )。 8例死亡 ,经研究者判定可能与研究药物无关。结论 我国心功能不全患者对比索洛尔的耐受剂量与国外相似 ,基础治疗加 β 受体阻滞剂长期治疗能改善心力衰竭患者的心功能 ,提高左室射血分数。

Objective To investigate the safety and tolerant dose-range of bisoprolol in Chinese cardiac insufficiency patients. Methods Seven hundred and forty-six patients with chronic heart failure caused by coronary artery disease, dilated cardiomyopathy and hypertension were enrolled in the study. Before enrollment, all patients received angiotensin-converting enzyme inhibitor, diuretics and digitalis. All patients were started on bisoprolol 1.25 mg daily, and then successively increased to 2.50 mg, 3.75 mg, 5.00 mg, 7.50 mg, 10.00 mg, etc. according to their tolerance. The investigators must ensure that the patients had reached the tolerant dose and maintained to the end of the study. The follow-up period was 1 year. Results Among 746 patients enrolled 730 cases were qualified for analysis. 81.1% patients were used bisoprolol 5.00 mg and above. Fifteen patients(2.1%) withdrew the drug due to adverse drug reaction. Eight patients died, the cause of death was not related to bisoprolol according to the investigator′s judgement. Conclusion The study indicates that the Chinese patients with cardiac insufficiency can tolerant bisoprolol quite well, and the tolerant dose is similar with the abroad reported. The study also shows that baseline therapy plus β blocker can improve the cardiac function and increase left ventricular ejection fraction.