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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 investigate the efficacy and safety of recombinant human B-type natriuretic peptide (rhBNP) in the treatment of elderly patients with acute decompensated heart failure. Methods: The trial was designed as a randomized controlled trial of 80 consecutive elderly patients with acute decompensated heart failure admitted to PLA General Hospital from January 2008 to December 2010 and randomized to regular heart failure treatment by lottery Group (conventional group) and conventional + rhBNP group (rhBNP group), 40 cases in each group. The patients in the rhBNP group were treated with rhBNP 0.5 ~ 1.0 mg (dissolved in 50 ml of normal saline) every day for continuous treatment with 0.007 5 ~ 0.015 0 μg.kg-1.min-1 by continuous intravenous infusion 10 ~ 15 h. The course of treatment was 13 days. Dyspnea score, edema score, net water loss, heart rate, blood pressure and serum creatinine were compared between the two groups before treatment and on the 4th, 8th, and 14th day of treatment. Results: The routine group of 37 males and 3 females, mean age (88 ± 4) years; rhBNP group of 38 males and 2 females, mean age (86 ± 5) years. There was no significant difference between the two groups in the basic clinical features before treatment and in the use of anti-heart failure drugs. There was no significant difference in dyspnea score between the rhBNP group and the conventional group on the fourth day after treatment (P> 0.05). The levels of dyspnea in the rhBNP group were significantly lower than those of the conventional group on the 8th and 14th days (all P <0.05). The scores of edema in rhBNP group were significantly lower than those in the conventional group on the 4th, 8th and 14th days (all P <0.05). Net water loss was significantly greater on days 4, 8 and 14 than in the conventional group [median (minimum, maximum): 263.5 (-793,2184) ml vs -129.0 (-1249,3636) ml, 239.5 (-754,1370) ml-29.5 (-1364,2242) ml, 386.5 (-564,1490) ml -71.0 (-2274,1660) ml, all P <0.05]. The heart rate on the 4th and 8th day were significantly lower than that of the control group [(73 ± 13) / min (81 ± 17) / min, (70 ± 10) / min vs (79 ± 16) P <0.05]. There were no significant differences in blood pressure and serum creatinine between the two groups at different time points after treatment. Conclusion: The conventional treatment plus rhBNP has better curative effect and safety in elderly patients with acute decompensated heart failure.