缬沙坦联合依那普利治疗老年慢性心力衰竭的临床疗效及安全性

Study on curative effect of valsartan combined with enalapril on elderly patients with congestive heart failure and its adverse reaction

目的探讨缬沙坦联合依那普利治疗老年慢性心力衰竭(CHF)的临床效果及其不良反应。方法 206例老年CHF患者按照半随机方法分为依那普利治疗组(对照组)和缬沙坦联合依那普利治疗组(试验组),每组103例。所有患者分别在治疗前及治疗后6、12个月行纽约心脏病协会(NYHA)心功能分级,测量心率,超声心动图测定左室射血分数(LVEF)、左室舒张末期内径(LVDD)、左室收缩末期内径(LVSD)、收缩末期左心房前后径(LA),在治疗后6、12个月记录和比较患者的不良反应发生情况。结果疗效方面:治疗后6、12个月,同组患者的心功能分级与治疗前比较差异均有统计学意义(P<0.05),较治疗前均明显改善;同组患者治疗后6、12个月的心功能分级比较差异无统计学意义(P>0.05);两组患者之间治疗后6个月与12个月的心功能分级比较差异无统计学意义(P>0.05)。治疗6、12个月后,同组患者的LVEF、LA、LVDD、LVSD和心率与治疗前比较差异均有统计学意义(P<0.05),治疗后6个月与12个月比较,对照组各项差异均有统计学意义(P<0.05),试验组心率,LA和LVEF差异有统计学意义(P<0.05),LVDD、LVSD无统计学差异(P>0.05)。治疗6个月后,两组患者随访指标比较差异无统计学意义P>(0.05);治疗12个月后,两组患者的LVSD比较差异有统计学意义(P<0.05)。安全性方面:治疗6、12个月后,两组咳嗽、头昏、胸闷、恶心、疲劳、味觉异常和血管性水肿的发生率比较差异均无统计学意义(P>0.05),同组患者治疗后6个月与12个月时咳嗽的发生率比较差异有统计学意义(P<0.05)。结论缬沙坦联合依那普利与依那普利单药治疗老年CHF的疗效比较无统计学差异(P>0.05),联合用药不增加患者不良反应的发生率。

Objective To study the curative effect of valsartan combined with enalapril on elderly patients with congestive heart failure （CHF） and its adverse reaction. Methods A total of 206 elderly patients with CHF were divided into two groups by admission sequencing, i.e. trial group （ n = 103 ） treated with enalapril plus valsartan and control group （n = 103） treated with enalapril. Clinical parameters, including heart function （ assessed by NYHA ） and heart rate, as well as left ventricular ejection fraction （LVEF） , left ventrieular end-diastolic diameter （LVDD） , left ventricular end-systolic diameter （LVSD） and left atrial end-systolic diameter （LA） measured by echocardiography, were recorded before therapy and after 6 and 12 months＇ therapy. Adverse events were also recorded after 6 and 12 months＇ treatment. Results There was significant difference in heart function in the same group between before treatment and after 6 or 12 months＇ treatment （ P 〈 0.05）. There was no statistical difference in heart function be- tween after 6 and 12 months＇ treatment in the same group or between the two groups （P 〉0.05 ）. Between before and after （6 or 12 months＇ ） treatment, there were significant differences in LVEF, LA, LVDD, LVSD and heart rate both in the two group （P 〈 0.05 ） ; in the control group there were significant differences in all the above parameters, and in the trial group there were signifi- cant differences in LA and LVEF （ P 〈 O. 05 ） but there were no significant differences in LVDD and LVSD （ P 〉 0.05 ）. There were no significant differences in the parameters after 6 months＇ treatment between the two groups （ P 〉 0.05 ） , but the significant difference in LVSD was found（ P 〈 0.05 ）. As for adverse reaction, there were no statistical differences in cough, dizzy, chest tight- ness, nausea, fatigue, dysgeusia and angioedema between the two group after 6 and 12 months＇ treatment （ P 〉 0.05 ）. However, in the same group the incidence of cough was statistically different between after 6 and 12 months＇ treatment （P 〈 0.05 ）. Conclusion There is no statistically difference in curative effect on elderly patients with CHF between valsartan combined with enalapril and sin- gle enalapril （P 〉 O. 05 ）. However, the combined therapy does not increase the adverse reaction.