不同剂量沙库巴曲缬沙坦对慢性心力衰竭疗效及安全性的影响

Effects of different doses of sacubitril valsartan on the efficacy and safety of chronic heart failure

目的探究不同剂量沙库巴曲缬沙坦对慢性心力衰竭患者疗效及安全性的影响。方法根据入选及排除标准,选取2018年5月至2019年5月在沈阳市第四人民医院心血管内科病房住院慢性心力衰竭患者152例,常规治疗基础上,给予沙库巴曲缬沙坦起始剂量50 mg,2次/d,根据每2周剂量翻倍的原则,按照预定目标剂量随机分成3组:50 mg组(A组,51例),100 mg组(B组,51例),200 mg组(C组,50例),均2次/d。观察4周和12周随访氨基末端脑钠肽前体(NT-proBNP)、左心室射血分数(LVEF)、左心室舒张末期内径(LVEDD)、6 min步行试验(6-MWT)、明尼苏达州心功能不全生活质量量表评分以及不良反应发生情况。结果4周随访时,3组患者NT-proBNP、LVEDD水平均较治疗前改善,差异具有统计学意义(P<0.05),C组与A、B 2组比较差异具有统计学意义(P<0.05),但A组与B组比较差异无统计学意义(P>0.05);与治疗前相比,3组LVEDD水平差异无统计学意义(P>0.05)。12周随访时,NT-proBNP、LVEF、LVEDD 3个指标比较,C组与A、B组差异具有统计学意义(P<0.05),且A组与B组相比差异具有统计学意义(P<0.05)。3组患者入院1周症状改善后行6-MWT检查,12周随访时行6-MWT检查,C组与A、B组比较差异具有统计学意义(P<0.05),且A组与B组比较差异具有统计学意义(P<0.05)。12周随访时,3组患者的明尼苏达州心功能不全生活质量量表评分与治疗前比较,差异有统计学意义(P<0.05),C组与A、B组相比差异具有统计学意义(P<0.05),且A组与B组相比差异具有统计学意义(P<0.05)。3组治疗期间未发生重大不良反应事件,但C组的低血压发生率较A、B组高,差异具有统计学意义(P<0.05)。结论沙库巴曲缬沙坦200 mg组治疗慢性心力衰竭疗效优于50 mg及100 mg组。在药物安全性方面,200 mg组低血压发生率较高,提示临床医生用药时予以关注。

Objective To explore the effect and safety of different doses of sacubitril valsartan on the patients with chronic heart failure.Methods According to the inclusion and exclusion criteria,152 patients with chronic heart failure were selected from May 2018 to May 2019 in the Cardiovascular Department of Shenyang Fourth People′s Hospital.On the basis of conventional treatment,were given an initial dose of 50 mg,twice a day,according to the principle of doubling the dose every two weeks.According to the predetermined target dose,they were randomly divided into three groups:50 mg group(group A,n=51),100 mg group(Group B,n=51),200 mg group(Group C,n=50),twice a day.NT-proBNP,LVEF,LVEDD,6-MWT,Minnesota Heart Failure Quality of life scale score were followed up for 4 and 12 weeks,and adverse reactions were observed at 4 and 12 weeks.Results At the 4-week follow-up,the levels of NT-proBNP and LVEDD in the three groups were improved compared with those before treatment,and the difference was statistically significant(P<0.05),the difference between group C and group A and B was statistically significant(P>0.05),but there was no statistically significant difference between group A and Group B(P>0.05);Compared with before treatment,there was no statistically significant difference in LVEDD levels among the three groups(P>0.05).During the 12-week follow-up,comparison of NT-proBNP,LVEF and LVEDD showed that the difference between group C and group A and B was statistically significant(P<0.05),and the difference between group A and Group B was statistically significant(P<0.05).Patients in the three groups received 6-MWT after 1 week of admission and 6-MWT at 12 weeks of follow-up.The difference between group C and group A and B was statistically significant(P<0.05),and the difference between group A and Group B was statistically significant(P<0.05).At 12 weeks of fol-low-up,Minnesota cardiac insufficiency quality of life scale scores were statistically significant(P<0.05),the difference between group C and group A and B was statistically significant(P<0.05),and the difference between group A and Group B was statistically significant(P<0.05).There were no serious adverse reactions in the three groups during the treatment,but the incidence of hypotension in group C is higher than those in groups A and B,and the difference is statistically evident(P<0.05).Conclusions In terms of therapeutic effect,sacubitril valsartan 200 mg group is superior to the 50 mg and 100 mg groups.In terms of drug safety,sacubitril valsartan 200 mg group makes it a relatively high incidence of hypotension,which suggests that clinicians should pay attention to it.