人重组B型利钠肽治疗高龄急性失代偿性心力衰竭患者的疗效和安全性

Efficacy and safety of recombinant human B-type natriuretic peptide in patients with advanced age and acute decompensated heart failure

目的:探讨人重组B型利钠肽(rhBNP)治疗高龄急性失代偿性心力衰竭患者的疗效和安全性。方法:试验设计为随机对照试验,对象为2008年1月至2010年12月解放军总医院连续收住的高龄急性失代偿性心力衰竭患者80例,以抽签的方式随机分配到常规心力衰竭治疗组(常规组)和常规+rhBNP治疗组(rhBNP组),每组40例。2组患者均接受抗心力衰竭规范治疗,rhBNP组每天再给予rhBNP 0.5～1.0 mg(溶于50 ml生理盐水),以0.007 5～0.015 0μg.kg-1.min-1速度经泵持续静脉输入10～15 h。疗程均为13 d。比较2组患者治疗前和治疗第4、8、14天的呼吸困难评分、水肿评分、净水分丢失情况、心率、血压和血肌酐水平。结果:常规组男性37例,女性3例,平均年龄(88±4)岁;rhBNP组男性38例,女性2例,平均年龄(86±5)岁。2组患者治疗前的基本临床特征和抗心力衰竭药物使用情况差异均无统计学意义。rhBNP组患者治疗第4天呼吸困难评分与常规组比较差异无统计学意义(P>0.05),第8和14天均明显低于常规组(均P<0.05)。rhBNP组患者水肿评分第4、8和14天均明显低于常规组(均P<0.05)。净水分丢失量第4、8和14天均明显多于常规组[中位数(最小值,最大值):263.5(-793,2184)ml比-129.0(-1249,3636)ml,239.5(-754,1370)ml比-29.5(-1364,2242)ml,386.5(-564,1490)ml比71.0(-2274,1660)ml,均P<0.05]。心率第4、8天均明显低于常规组[(73±13)次/min比(81±17)次/min,(70±10)次/min比(79±16)次/min,均P<0.05]。2组治疗后不同时点血压和血肌酐差异均无统计学意义。结论:常规治疗加用rhBNP对高龄急性失代偿性心力衰竭患者具有较佳疗效和安全性。

Objective：To explore the efficacy and safety of recombinant human brain natriuretic peptide（rhBNP） in patients with advanced age and acute decompensated heart failure.Methods：A randomized controlled trials was performed.From January 2008 to December 2010,80 hospitalized patients with advanced age and acute decompensated heart failure in Chinese PLA General Hospital were enrolled in this study.They were randomly divided into the conventional treatment group（conventional group） and the conventional treatment plus rhBNP group（rhBNP group） by using ballot method.There were 40 patients in each group.The patients in the conventional group received the conventional treatment for acute decompensated heart failure,and patients in the rhBNP group received the conventional treatment plus a continuous IV infusion of rhBNP 0.5-1.0 mg in 50 ml of normal saline via a pump at a rate of 0.007 5-0.015 0 μg·kg-1·min-1 for 10-15 hours once daily.The course of treatment was 13 days.The scores of dyspnea and edema,net water loss volume,heart rate,blood pressure,and serum creatinine level in the two groups before and after treatment（on days 4,8,and 14） were compared.Results： The conventional group comprised 37 males and 3 females with mean age of（88±4）years;The rhBNP group comprised 38 males and 2 females with mean age of（86±5） years.There was no statistically significant differences in the baseline clinical characteristics and the drugs used for the treatment of heart failure between the two groups before treatment.On day 4,there was no statistically significant difference in the scores of dyspnea between the two groups（P〈0.05）.On days 4 and 8,the scores of dyspnea in the rhBNP group were significantly lower than those in the conventional group（all P〉0.05）.On days 4,8 and 14,the scores of edema in the rhBNP group were significantly lower than those in the conventional group（all P〈0.05）.On days 4,8 and 14,the net water lose volume in the rhBNP group was significantly greater than those in the conventional group [263.5（-793,2184）ml vs-129.0（-1249,3636） ml,239.5（-754,1370）ml vs-29.5（-1364,2242） ml,and 386.5（-564,1490）ml vs 71.0（-2274,1660） ml,respectively;all P〈0.05].On days 4,8 and 14,there were no statistically significant differences in blood pressure and serum creatinine level between the two groups（all P〉0.05）.On days 4 and 8,the heart rates in the rhBNP group were significantly lower than those in the conventional group [（73±13）beats/min vs（81±17）beats/min and（70±10）beats/min vs（79±16）beats/min,respectively;all P〈0.05].Conclusion： The conventional treatment plus rhBNP has better efficacy and safety in treating patients with advanced age and acute decompensated heart failure.