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目的:评价对常规治疗效果不佳的重度失代偿性心力衰竭患者静脉注射桂哌齐特的有效性及安全性。方法:采用多中心、随机、平行、阳性药物对照临床研究,入选230例重度失代偿性心力衰竭患者,其中5例在试验开始前退出,其余225例随机分为试验组(120例)和对照组(105例)。试验组用桂哌齐特注射液以4μg.kg-1.min-1静脉滴注,持续23 h;对照组用多巴酚丁胺2μg.kg-1.min-1初始静脉滴注,1 h后增加到4μg.kg-1.min-1并持续23 h,综合评价药物的疗效和安全性。结果:试验组和对照组的临床有效率分别为31.67%(38/120)和18.10%(19/105)(P<0.01);治疗24 h后,试验组和对照组的左室射血分数均值上升分别为6.4%和4.5%(P>0.05),每搏心输出量均值上升分别为10.6 ml和2.5 ml(P<0.05);与对照组比较,试验组患者呼吸困难和全身临床状况有显著改善(23.33%:10.48%;6.67%:2.86%,均P<0.05)。试验组治疗前后平均血浆脑钠肽水平[(1 997±865)pg/ml:(384±114)pg/ml]和对照组治疗前后平均血浆脑钠肽水平[(1 879±202)pg/ml:(1 025±48)pg/ml]均差异有统计学意义(均P<0.01);治疗后,试验组与对照组平均血浆脑钠肽水平比较差异有统计学意义[(384±114)pg/ml:(1 025±48)pg/ml,P<0.01]。2组均未发生严重不良事件,试验组不良反应发生率显著低于对照组(13.33%:22.86%,P<0.05);试验组常见的不良反应为低血钾、低血压以及室性期前收缩等。结论:与多巴酚丁胺比较,桂哌齐特注射液治疗重度失代偿性心力衰竭疗效确切,安全性及耐受性良好。
OBJECTIVE: To evaluate the efficacy and safety of intravenous cinepazide in patients with severe decompensated heart failure who have poor response to conventional therapy. METHODS: A multicenter, randomized, parallel, positive-drug controlled clinical study was enrolled in 230 patients with severe decompensated heart failure, 5 of whom were exited before the start of the trial and the remaining 225 were randomly assigned to a trial group of 120 Control group (105 cases). The experimental group with cinepazide injection 4μg.kg-1.min-1 intravenous infusion for 23 h; control group with dobutamine 2μg.kg-1.min-1 initial intravenous infusion, 1 h after the increase to 4μg.kg-1.min-1 and lasted 23 h, a comprehensive evaluation of the efficacy and safety of the drug. Results: The clinical efficacies of the experimental group and the control group were 31.67% (38/120) and 18.10% (19/105) respectively (P <0.01). After 24 hours of treatment, the left ventricular ejection fraction The average value of cardiac output increased by 6.4% and 4.5% respectively (P> 0.05), and cardiac output of cardiac stroke increased by 10.6 ml and 2.5 ml respectively (P <0.05). Compared with the control group, dyspnea and systemic clinical status Significant improvement (23.33%: 10.48%; 6.67%: 2.86%, both P <0.05). The average level of plasma BNP in the experimental group before and after treatment [(1 997 ± 865) pg / ml: (384 ± 114) pg / ml] and the mean plasma BNP levels before and after treatment in the control group [(1 879 ± 202) pg / ml: (1 025 ± 48) pg / ml] (all P <0.01). After treatment, the mean plasma BNP levels of the experimental group and the control group were statistically significant (384 ± 114 ) pg / ml: (1 025 ± 48) pg / ml, P <0.01]. The incidence of adverse reactions in the experimental group was significantly lower than that in the control group (13.33% vs 22.86%, P <0.05). The common adverse reactions in the experimental group were hypokalemia, hypotension and ventricular preeclampsia Shrink and so on. Conclusion: Compared with dobutamine, cinepazide injection in the treatment of severe decompensated heart failure is effective, safe and well tolerated.