摘要
目的比较重组人脑利钠肽和硝酸甘油治疗急性失代偿性心力衰竭(心衰)的治疗效果和安全性。方法试验对入选的209例急性失代偿性心衰患者的临床资料采用随机、开放、平行对照、多中心方法进行采集和统计分析。入选患者随机分配为导管组和非导管组,导管组应用Swan-Ganz导管进行血流动力学监测,分别在给药的0、15、30min和1、2、4、8、12、24h结束时测量记录治疗前后的肺毛细血管楔压(PCWP)、肺动脉压(PAP),分别于给药的1、4、8、24h测量右房压(RAP)、心排量(CO)和心排指数(CI)。导管组与非导管组均记录治疗前后的呼吸困难程度、出入量以及全身临床情况评估。分组后患者再随机分入试验组(重组人脑利钠肽)和对照组(硝酸甘油),试验组使用重组人脑利钠肽首先以0·15μg/kg静脉冲击后,以0·0075μg·kg-1·min-1连续静脉滴注;对照组静脉持续滴注硝酸甘油。安全性评估采用用药过程中及用药后定期测量血压、心率,并对过程中所有不良事件进行记录。结果试验资料显示,两组治疗期间的液体出量均显著增加;试验组的呼吸困难和临床状况好转率显著优于对照组;试验组的PCWP、PAP比对照组有显著下降,而两组RAP和CI差异无统计学意义。在与药物相关的不良事件方面,两组差异无统计学意义。结论重组人脑利钠肽能明显改善急性失代偿性心衰患者的血流动力学、呼吸困难程度及全身临床状况,在有效降低PCWP方面优于硝酸甘油,其安全性与硝酸甘油类似。
Objective To compare the efficacy and safety of intravenous infusion recombinant human brain natriuretie peptide（rhBNP） versus nitroglycerin （NIT） in treating patients with decompensated acute heart failure. Methods A total of 209 patients characterized of decompensated acute heart failure were enrolled in this multieenter, randomized, open-label, parallel-design study. The patients were randomly allocated to catheter group and non-catheter group （depending on the use of Swan-Ganz）. Each group was then randomly assigned to receive rhBNP （ O. 15 p,g/kg bolus intravenous injection followed by 0. 0075μg · kg^-1 · min^-1 for 24 hours, n = 105） or NIT （starting at 10μg/min and increasing 5 p,g/min each time till clinical effective dose for24 hours, a =104）. Blood pressure, heart rate, dyspnea grade, 24 hours fluid in- and output and improvement in patient symptoms and signs were evaluated and adverse events were documented. Results Urine output was significantly increased after both rhBNP and NIT treatments. Dyspnea and symptom improvements were more significant in rhBNP group compared to NIT group. PCWP and PAP were both decreased after rhBNP and NIT therapies and there was more significant reduction in PCWP and PAP between 30 rain and 2 hours in rhBNP group compared to NIT group. However, RAP and CI were similar between the two groups at various time points. The total adverse events were comparable between the two groups （20.0% vs. 19. 2%, P〉0. 05） and 7 patients withdrawed the study due to adverse events （4 in rhBNP and 3 in NIT group）. Condusions rhBNP is superior to nitroglycerin in improving dyspnea and symptoms and decreasing PCWP and PAP in patients with decompensated acute heart failure patients. The safety of rhBNP was comparable to nitroglycerin in treating patients with decompensated acute heart failure.
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2006年第3期222-226,共5页
Chinese Journal of Cardiology
关键词
心力衰竭
充血性
重组人脑利钠肽
血液动力学
Heart failure, congestive
Recombinant human brain natriuretic peptide
Hemodynamics
