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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。
AIM: To evaluate the efficacy and safety of Swan-Ganz catheter in the hemodynamic monitoring of patients with acute decompensated heart failure (acute heart failure) treated with recombinant human brain natriuretic peptide (Nisinidine) Sex. Methods: Five Chinese cardiovascular clinical research centers were involved in this study. Forty patients with acute heart failure were enrolled. Patients before administration of Swan-Ganz catheter hemodynamic monitoring, the use of nesiritide first intravenous injection of 2μg / kg, followed by continuous intravenous infusion of 0.01μg / (kg · min) for 24 hours. Pulmonary capillary wedge pressure (PCWP), pulmonary artery pressure (PAP) and cardiac output index (CI) were measured before and 15 min, 1 h, 3 h and 24 h after treatment. At the same time, before and after treatment, the degree of dyspnea, other clinical symptoms and systemic clinical evaluation. Blood pressure, heart rate, respiration rate and related blood biochemical indexes were measured regularly during the course of medication and after medication, and all adverse events occurred during the medication were recorded for safety evaluation. Results: All 40 subjects in this trial completed 24-hour treatment. After administration of pulmonary capillary wedge pressure, pulmonary artery systolic pressure decreased significantly, cardiac index increased significantly. After treatment, the observation time points compared with before treatment, the differences were statistically significant (P <0.05 ~ 0.01). 24h dyspnea after treatment and clinical conditions have been significantly improved. In terms of tolerability and safety, none of the subjects discontinued the study early due to adverse events, and no deaths and serious adverse drug reactions associated with the trial occurred. CONCLUSION: Nesiritide can improve the hemodynamic parameters, degree of dyspnea and general clinical status in patients with acute heart failure, and the subjects can be well tolerated without obvious adverse reactions.