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目的:评价短期静脉应用不同剂量的重组人心钠肽治疗急性心力衰竭(心衰)患者的血流动力学效应及安全性。方法:本试验为随机、平行对照、多中心临床研究。顺序入选中国2家心血管临床中心的48例急性心衰患者,用药前应用Swan-Ganz导管进行血流动力学监测,将接受急性心衰常规治疗的设为对照组(n=12),急性心衰常规治疗的同时给予静脉泵入重组人心钠肽1h的患者,按用药速率分为0.05μg/(kg.min)组(小剂量组,n=12)、0.1μg/(kg.min)组(中剂量组,n=12)、0.2μg/(kg.min)组(大剂量组,n=12)。分别在用药前、给药后30 min、1 h、3 h、12 h测量并记录血流动力学参数,同时记录治疗前、后呼吸困难、其他临床症状以及全身临床情况。定期测量血压、心率、呼吸频率以及相关的血液生化指标,并对试验过程中出现的所有不良事件进行记录,进行安全性评估。结果:中剂量组的肺毛细血管楔压、肺动脉压在用药后30 min、1 h、3 h较用药前均下降,而心脏指数(CI)用药后30 min、1 h较用药前升高,差异有统计学意义(P<0.05或0.01)。中剂量组的肺动脉压用药后30 min、1 h与对照组比较降低,差异有统计学意义(P<0.05)。大剂量组用药后30 min、3 h、12 h及24 h与用药前比较呼吸频率均减慢,差异有统计学意义(P均<0.05)。在耐受性和安全性方面,心率及血生化检查用药后24h无明显变化。大剂量组发生2例与试验药物相关的低血压。48例患者未出现与试验药物相关的严重不良事件,无受试者因不良事件中途退出研究。结论:重组人心钠肽改善急性心衰患者的血流动力学效果明显,且能改善呼吸困难等临床症状,使用中剂量重组人心钠肽不但疗效较好,且不良事件较少,适宜临床应用。
Objective: To evaluate the hemodynamic effects and safety of short-term intravenous administration of different doses of recombinant human atrial natriuretic peptide in patients with acute heart failure (HF). Methods: This randomized, parallel controlled, multicenter clinical study. Forty-eight patients with acute heart failure were enrolled in two cardiovascular clinical centers of China. Swan-Ganz catheter was used for hemodynamic monitoring before treatment. The routine treatment of acute heart failure was used as control group (n = 12), acute Patients with venous parenteral administration of recombinant human atrial natriuretic peptide for 1h were divided into 0.05μg / (kg · min) group (low dose group, n = 12), 0.1μg / (kg · min) Group (middle dose group, n = 12), 0.2μg / (kg.min) group (high dose group, n = 12). The hemodynamic parameters were measured and recorded before treatment, 30 min, 1 h, 3 h, 12 h after administration, and the dyspnea before and after treatment, other clinical symptoms and systemic clinical conditions were recorded. Blood pressure, heart rate, respiratory rate, and related blood biochemical parameters were regularly measured. All adverse events occurred during the test were recorded for safety assessment. Results: The pulmonary capillary wedge pressure and pulmonary arterial pressure in middle dose group decreased at 30 min, 1 h and 3 h after administration, and increased at 30 min and 1 h after administration of cardiac index (CI) The difference was statistically significant (P <0.05 or 0.01). Pulmonary arterial pressure in the middle-dose group decreased at 30 min and 1 h compared with the control group, the difference was statistically significant (P <0.05). The respiratory rate of high-dose group at 30 min, 3 h, 12 h and 24 h after treatment was slower than that before treatment, the difference was statistically significant (P all <0.05). In tolerance and safety, heart rate and blood biochemical tests 24h after no significant change. Two patients in the high-dose group developed hypotension associated with the test drug. 48 patients did not appear serious drug-related adverse events, no subjects were withdrawn from the study due to adverse events. Conclusion: The recombinant human atrial natriuretic peptide can improve hemodynamics in patients with acute heart failure and improve clinical symptoms such as dyspnea. The moderate dose of recombinant human atrial natriuretic peptide not only has good curative effect but also has fewer adverse events, which is suitable for clinical application.