左西孟旦治疗老年慢性心力衰竭的效果与安全性评价

摘要

Objective To evaluate the efficacy and safety of levosimendan in the treatment of elderly patients with chronic heart failure( CHF). Methods We enrolled 50 elderly patients with CHF who received hospitalized treatment in the Department of Cardiology of the Second Hospital of Hebei medical University from September 2012 to December 2013. By random number table method,the subjects were divided into two groups:control group(n=26)and levosimendan group(n=24). The two groups were both administrated with conventional basic treatment. The levosimendan group was also given levosimendan, with intravenous injection by 12 μg/kg for the first 10 minutes and micro pump by 0. 1 μg · kg-1 · min-1 after that;one hour after the injection began,the infusion rate was increased to 0. 2 μg·kg-1 ·min-1 and was kept for 23 hours. Five days after the injection began,the second round of the same therapy was given to the subjects in the levosimendan group. We observed BNP, LⅤEF,SⅤ,dyspnea,systemic condition,6-minute walk test results before intervention and on day 10 after intervention;we recorded the proportion of patients with higher NYHA grade after intervention;we recorded readmission rate and mortality within three months after intervention;we monitored respiratory rate,heart rate,blood pressure and other vital signs 30 minutes before intervention and at 1 h,12 h and 24 h after intervention;we recorded Hb,Scr and K before intervention,at 24 h and on day 10 after intervention;adverse reaction was also observed. Results Before the intervention,the two groups were not significantly different(P> 0. 05) in BNP,LⅤEF,SⅤ,dyspnea,systemic condition,6 - minute walk test results;on day 10 after intervention,the levosimendan group was lower(P<0. 05)in BNP,dyspnea and systemic condition and higher(P<0. 05) in LⅤEF,SⅤ and 6-minute walk test results than the control group;the levosimendan group had higher NYHA effective rate than the control group(χ2 =5. 265,P=0. 022). During the intervention,the rate of adverse reaction was 12. 5%(3/24) in the levosimendan group and 3. 8%(1/26) in the control group. Within three months after intervention,the readmission rate and the mortality were 23. 1%(6/26)and 11. 5%(3/26)for the control group and 8. 3%(2/24)and 8. 3%(2/24)for the levosimendan group. The two groups were not significantly different in readmission rate and mortality(χ2 =2. 018,0. 142;P=0. 155,0. 706). No significant interaction effect(P>0. 05)was noted between the two groups in HR,R,SBP,DBP,Scr, K and Hb before intervention and after intervention;the two groups were significantly different(P<0. 05)in HR,R and K. Conclusion Levosimendan injection is significantly effective in the treatment of elderly patients with CHF. It can effectively improve the cardiac functional grading of patients and increase LⅤEF without increase in readmission rate and mortality,while it may increase the incidence of hypokalemia.%目的：评价老年慢性心力衰竭（ CHF）患者应用左西孟旦治疗的效果及安全性。方法选取2012年9月—2013年12月于河北医科大学第二医院心血管内科住院治疗的老年CHF患者50例，采用随机数字表法将其分为对照组（26例）和左西孟旦组（24例）。两组患者均进行常规基础治疗，左西孟旦组在此基础上采用左西孟旦注射液，初始10 min给予负荷量12μg/kg静脉注射，继而以0.1μg · kg-1· min-1微量泵入，1 h后将输注速率增至0.2μg · kg-1·min-1持续23 h，5 d后以同样方法给予第2次治疗。观察两组用药前及用药后10 d血B型脑钠肽（ BNP）、左心室射血分数（ LⅤEF）、每搏心输出量（ SⅤ）、呼吸困难情况、全身状况评估、6分钟步行试验；用药后10 d纽约心脏病协会（ NYHA）分级显效率；3个月内再住院率及病死率；监测用药前30 min及用药后1、12、24 h呼吸频率、心率、血压等生命体征；用药前及用药后24 h、10 d血红蛋白（ Hb）、血肌酐（ Scr）、血钾值；观察不良反应发生情况。结果用药前，两组BNP、LⅤEF、SⅤ、呼吸困难情况、全身状况评估和6分钟步行试验比较，差异均无统计学意义（P>0.05）；用药后10 d，左西孟旦组BNP、呼吸困难情况和全身状况评估均低于对照组；LⅤEF、SⅤ和6分钟步行试验均高于对照组（P<0.05）。左西孟旦组NYHA显效率高于对照组（χ2=5.265，P=0.022）。用药期间左西孟旦组不良反应发生率为12.5%（3/24），对照组为3.8%（1/26）。用药3个月内，对照组再住院率为23.1%（6/26）、病死率为11.5%（3/26），左西孟旦组分别为8.3%（2/24）、8.3%（2/24）。两组再住院率和病死率比较，差异均无统计学意义（χ2=2.018、0.142，P=0.155、0.706）。两组用药前后HR、R、SBP、DBP、Scr、血钾和Hb时间与组间的交互作用均无统计学意义（P>0.05）；两组HR、R、血钾组间比较差异有统计学意义（P<0.05）。结论左西孟旦注射液治疗老年CHF疗效显著，可有效改善患者心功能分级，增加LⅤEF，且不增加再住院率和病死率，但有增加低血钾的趋势。