重组人脑利钠肽治疗失代偿性心力衰竭有效性及安全性的研究

The research on the efficacy and safety of recombinant human brain natriuretic peptide treating patients with de- compensated acute heart failure.

目的比较重组人脑利钠肤和硝普纳治疗失代偿性心力衰竭(心衰)的治疗效果、安全性,探讨重组人脑利钠钛对心脏细胞外基质的影响。为重组人脑利钠肤应用于心衰治疗提供依据。方法试验对入选的44例失代偿性心衰患者的临床资料采用随机、开放、平行对照方法进行采集和统计分析。入选患者随机分配为重组人脑利钠肤组和硝普纳组,分别在给药的0、15、30 min 和1、2、4、6、9、12、24 h 结束时测量记录治疗前后的收缩压、舒张压,心率,呼吸困难程度及临床状况。在用药前、用药后24 h、用药后1周行心彩超检查测定射血分数。试验组使用重组人脑利钠肽首先以1.5μg/kg 静脉冲击后,以0.0075μg/(kg·min)连续静脉滴注;对照组静脉持续滴注硝普纳。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。结果试验组于各时间点改善呼吸困难作用均好于对照组;试验组在用药过程中对血压的影响小于对照组;试验组的用药过程中24 h 液体入量少于对照组(P<0.05),试验组用药过程中24 h 液体出量大于对照组(P<0.05)。两组在改善用药后1周左室射血分数方面无显著差异。试验组与对照组不良反应发生率差异无显著性意义(P=0.38)。用药后7 d 病死率,30 d 病死率两组差异无显著性意义,用药后30 d 再住院率试验组显著低于对照组。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,可提高患者左室射血分数。静脉应用重组人脑利钠肽低血压等不良事件的发生率至少不高于硝普纳,可改善心衰患者预后。

Objective To compare the efficacy and safety of intravenous infusion of recombinant human brain natriuretic peptide(rhBNP)versus Sodium Nitroprusside on treating patients with decompensated acute heart failure.Discuss rhBNP 's effect on connective tissue of heart.Methods A total of 44 patients characterized of decompensated acute heart failure were enrolled in this study.The patients were randomLy allocated to rhBNP group who receive rhBNP(1.5μg/kg bolus intravenous injection followed by 0.0075μg/(kg·min)for 24 hours,n=23)and Sodium Nitroprusside group(10 μg/ rain for 24 hours,n=21 ).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 Dyspnea and symptom im- provements were much more significant in rhBNP group compared to Sodium Nitroprusside group(P<0.05).Fluctuation of blood pressure in rhBNP groop were much more stable than Sodium Nitroprusside groop.Urine output was much more significantly increased after rhBNP treatments than Sodium Nitrprusside(P<0.05).There is no significant difference on LVEF(Iefi ventricle ejection fraction)(P=0.38).The rates of adverse events were resemble.There were less patient who were in hospital again after treatment for one month.There is no significant difference on death rate after treatment for one week or one month.Conclusion rhBNP can significantly improve the hemodynamie,dyspnea and clinical situation. Adverse events rate of rhBNP is no more than sodium Nitroprusside at least,rhBNP can improve the prognosis of heart failure patient.