强化心率控制指导药物治疗慢性心力衰竭的临床研究

Efficacy and safety of drug therapy for chronic heart failure guided by intensified control of heart rate

目的探讨强化心率控制指导药物治疗慢性心力衰竭的疗效及其安全性。方法确诊慢性心力衰竭患者156例,纽约心脏病协会(New York Heark Association,NYHA)分级为II^IV级,所有患者经最佳的药物治疗稳定后,按数字表法随机分为治疗组(78例)和对照组即常规治疗组(78例)。治疗组在常规治疗基础上,以患者清晨静息心率降至55~60次/min为目标心率指导药物治疗。控制心率采用的药物为酒石酸美托洛尔或琥珀酸美托洛尔,酒石酸美托洛尔起始剂量为6.25 mg,2次/d,或琥珀酸美托洛尔起始剂量为11.875 mg/d,根据病情逐渐增至目标剂量或最大耐受剂量。比较两组治疗前及治疗12个月后的NYHA分级、左心室心肌质量、左心室射血分数和左心室后壁收缩期增厚率(△T%)的变化,以及两组全因病死率和心力衰竭恶化住院率。结果治疗12个月后,治疗组患者的临床症状改善情况明显优于对照组(总体有效率:94.8%vs.73.1%,P<0.01);同时,治疗组左心室心肌质量的减少幅度,左心室射血分数和左心室后壁收缩期增厚率的升高幅度均明显高于对照组,且差异有统计学意义(9.39%vs.3.59%,P<0.05;18.34%vs.11.62%,P<0.01;20.43%vs.10.64%,P<0.05);两组均未发生死亡患者,而治疗组因心力衰竭恶化住院治疗的次数明显少于对照组,差异有统计学意义(13次vs.32次,P<0.01)。结论强化心率控制指导药物治疗慢性心力衰竭安全有效,可改善患者临床症状、提高心功能、改善心肌重构,减少因心力衰竭恶化住院治疗次数。

Objectives To investigate the efficacy and safety of drug therapy for chronic heart failure（CHF） based on intensified control of heart rate. Methods Totally 156 cases diagnosed as CHF with New York Heart Association（NYHA） class II-IV were randomized into treatment group（n=78） and control group（n=78）. All the patients were in stable situation after optimal drug treatment. Patients in treatment group underwent conventional treatment based on intensified control of heart rate with a downregulation of the resting morning heart rate to 55-60 bits / min. These patients were treated with metoprolol tartrate or metoprolol succinate. Metoprolol tartrate was given 6.25 mg twice per day at baseline, while metoprolol succinate was 11.875 mg once per day. The titration approach was applied until drugs reached the target dose or the maximum tolerated dose. The endpoints were the differences in clinical symptoms, NYHA functional class, left ventricular muscle volume（LVMV）, left ventricular ejection fraction（LVEF） and changes in systolic thickening ratio of left ventricular posterior wall（△T%） between the two groups before and after treatment. In addition, we also evaluated the all-cause mortality and the hospitalization rate caused by worsening heart failure between the two groups. Results（1） Improvement of clinical symptoms in treatment group was significantly better than that in control group（94.8% vs. 73.1%, P〈0.01）.（2） LVMV decreased more obviously in treatment group than in control group（9.39% vs. 3.59%, P〈0.05）. In addition, LVEF and △T% increased more significantly in treatment group than in control group（18.34% vs. 11.62%, P〈0.01; 20.43% vs. 10.64%, P〈0.05）. No death occurred in the two groups.However, compared with control group, the times of re-inhospital due to worsening heart failure were significantly lower in treatment group（13 vs. 13, P〈0.01）. Conclusions To strengthen the guidance of heart rate control drugs in treatment of CHF is effective and safe. This measure can significantly improve the clinical symptoms, heart function,myocardial remodeling, and reduce times of re-inhospital due to worsening heart failure.