重组人脑钠肽注射液治疗急性失代偿性心力衰竭患者的疗效和安全性

Efficacy and Safety Evaluation of Nesiritide for Treating the Patients With Acute Decompensated Heart Failure

目的:应用Swan-Ganz导管进行血流动力学监测,评价重组人脑钠肽注射液(商品名:奈西立肽)药物治疗急性失代偿性心力衰竭(急性心衰)患者的疗效和安全性。方法:本研究有中国5家心血管临床研究中心参加,入选40例急性心衰患者。患者用药前应用Swan-Ganz导管进行血流动力学监测,使用奈西立肽先静脉注射2μg/kg,之后,持续静脉泵入0.01μg/(kg·min)24小时。分别在用药前、用药后15min、1h、3h、24h测量并记录肺毛细血管楔压(PCWP)、肺动脉压(PAP)和心脏排血指数(CI)。同时记录治疗前、后的呼吸困难程度、其他临床症状以及全身临床情况的评估。用药过程中及用药后定期测量血压、心率、呼吸频率以及相关的血液生化指标,并对用药过程中出现所有不良事件进行记录,进行安全性评估。结果:本试验40名受试者都完成了24小时治疗。用药后肺毛细血管楔压、肺动脉收缩压显著性下降、心脏排血指数显著性增高。用药后各观察时间点与用药前比较,差异均有统计学意义(P<0.05～0.01)。用药后24h呼吸困难和临床状况得到明显改善。在耐受性与安全性方面,无受试者因不良事件提前终止研究,试验中未发生死亡病例和与试验相关的严重不良反应。结论:奈西立肽能改善急性心衰患者的血流动力学指标、呼吸困难程度及全身临床状况,并且受试者可以较好的耐受,未出现明显不良反应。

Objective ： To evaluate the efficacy and safety of intravenous （ IV ） infusion of nesiritide for treating acute decompensated heart failure by monitoring the hemodynamic parameters with Swan-Ganz Catheter. Methods ： An open-label, one-arm clinical study was carried out by five cardiovascular researeh centers in China and 40 patients diagnosed for acute decompensated heart failure were enrolled. The hemodynamic parameters were monitored by Swan-Ganz Catheter. Pulmonary capillary wedge pressure （PCWP） , pulmonary arterial pressure （PAP） and cardiac index （CI） were measured in all patients at different time points as immediately before drug administration,and 15 rain,1 h,3 h and 24 h after drug administration. All patients received nesiritide at an IV bolus of 2 ug/kg （approximately 60 seconds）, followed by IV infusion at the flow rate of 0. 01 ug/kg/min for 24 hours. Clinical index and adverse events were recorded. Results： PCWP（33.0 ±9.1, 26. 8 ± 11.1, 25.9 ± 11.7, 25.1 ± 8.5 and 24. 8 ± 10.6 mmHg） and PAP（ 55.5 ± 18.9, 49. 2 ±21.6, 47.8 ±22. 1, 46. 9 ±20. 0 and 45.2 ±21.8 mmHg） were significantly descended at different time points （base line,15 min,1 h,3 h,24 h after the administration）. CI（1.97 ±0.62, 2.32 ±0.75, 2.26 ±0.67, 2.23 ±0.61 and 2.2 ± 0. 53 L/min/m2） were significantly increased. After using nesiritide, the blood pressure, heart rate and respiratory rate at each time point were decreased, clinical symptom was improved. No patient was withdrawal and no death during the experimental course. Conclusion： Nesiritide could significantly improve the hemodynamic parameters and clinical symptoms in patients with acute heart failure.