基层医院应用国产重组人脑利钠肽治疗急性左心衰临床疗效和安全性研究

The study of curative effect and safety to apply lyophilize recombinant human brain natriuretic peptide in acute heart failure patients in the basic hospital

目的观察国产冻干重组人脑利钠肽(新活素)在基层医院治疗急性心力衰竭的疗效和安全性。方法 60例急性心力衰竭患者分为治疗组30例和对照组30例。两组在心力衰竭标准基础治疗上,对照组静脉泵入硝酸甘油,起始剂量为5～10μg/min,根据血压及临床表现每5～10min递增5～10μg/min,最大剂量100～200μg/min;治疗组静脉泵入新活素,首次负荷剂量为1.5μg/kg,静脉注射3～5min,继以0.01μg/(kg.min)持续静脉泵入,连续用药72h。观察患者治疗前及治疗后72h的临床症状和体征、N-末端脑钠肽前体(NT-proBNP)的浓度等情况和不良事件。结果治疗72h后,治疗组疗效显效率,总有效率较对照组明显增高(60.0%与20.0%,P<0.01;93.3%与73.3%,P<0.05);治疗组无效率较对照组明显降低(6.7%与26.7%,P<0.05);治疗组有效率较对照组无显著性差异(33.3%与53.3%,P>0.05)。治疗72h后NT-proBNP浓度下降,治疗组较对照组有显著性差异([2894.3±2354.8)μg/L与(4835.2±2673.4)μg/L,P<0.01]。在治疗72h内,低血压、恶心、呕吐、头痛及肝肾功能损害等与用药相关的不良事件无统计学意义(P>0.05)。结论在基层医院国产重组人脑利钠肽新活素可以显著改善急性心力衰竭患者的临床症状、体征和心功能,降低血浆中NT-proBNP的浓度,且安全。

Observe domestic lyophilized recombinant human brain natriuretic peptide （Xinhuosu）, the efficacy and safety of the treatment of acute heart failure in primary hospitals. [Methods] 30 cases of 60 cases of a- cute heart failure （AHF） patients were divided into treatment group and control group （n =30）. Two sets of standards- based treatment on heart failure, intravenous infusion of the control group into the nitroglycerin starting dose 5-10μg/min, based on blood pressure and clinical manifestations of 5-10 rain increments 5-101μg/min, the maximum dose 100-200μg/min; intravenous infusion treatment group into the new active element, the initial loading dose of 1.5μg/kg, intravenous injection of 3-5 rain following continuous intravenous infusion of 0.01 IXg/（kg＇min）, continu- ous medication 72 h. Observation of patients before treatment and 72 h after the clinical signs and symptoms, the N- terminal pro-brain natriuretic peptide precursor （NT-proBNP） concentrations and adverse events. [ Results ] 72 h af- ter treatment, the treatment group significantly the efficiency, there is always more efficient than the control group was significantly higher （60.0% and 20.0%, P 〈0.01; 93.3% and 73.3%, P 〈0.05）; the treatment group compared with the control group was significantly lower （6.7% and 26.7%, P 〈0.05）; treatment group was more efficient than the control group, no significant difference （33.3% and 53.3%, P 〉0.05）. NT-proBNP concentrations decreased 72hours after treatment, a significant difference between treatment group than the control group [（2894.3±2354.8）μg/L, and （4835.2±2673.4）μg/L, P 〈0.01]. Treatment within 72 hours, hypotension, nausea, vomiting, headache and liver and kidney function damage and drug-related adverse events was statistically signifieant （P 〉0.05）. [ Conclusion ] In the primary hospital recombinant human brain natriuretie peptide is a new live elements can significantly improve the clinical symptoms of acute heart failure, signs and cardiac function, reduce the plasma concentration of NT- proBNP, and secure.