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目的 采用随机、对照、开放性多中心临床试验对比研究经静脉注射腺苷与维拉帕米在终止室上性心动过速 (PSVT)发作的疗效及安全性。方法 符合入选条件的PSVT病人随机分为腺苷组 (6 0例 )和维拉帕米组 (6 2例 ) ,分别经静脉腺苷和维拉帕米推注。记录给药前后和给药期间临床和心电图状况。结果 两组病人临床及电生理特性差异无显著性。腺苷组转复成功率为 86 0 % ,与维拉帕米组 (87 1% )相比差异无显著性。腺苷组从用药到PSVT终止的时间 (34 2± 19 5 )s显著短于维拉帕米组 [(4 14 4± 191 2 )s,P <0 0 0 0 1]。腺苷组共发生不良事件 11例 ,18例次 ;维拉帕米组为 16例2 2例次 ,两组比较差异无显著性。腺苷组发生与心脏相关的不良事件 9例 ,维拉帕米组发生与心脏相关的不良事件 17例 ,差异无显著性。整个试验未发生严重不良事件。结论国产腺苷注射液是治疗PSVT的有效、安全药物。
Objective To compare the efficacy and safety of intravenous adenosine and verapamil in the termination of supraventricular tachycardia (PSVT) in a randomized, controlled, open-label multicenter clinical trial. Methods The PSVT patients who met the selection criteria were randomly divided into adenosine group (60 cases) and verapamil group (62 cases), which were injected with intravenous adenosine and verapamil respectively. Record clinical and electrocardiographic status before and after and during dosing. Results There was no significant difference in clinical and electrophysiological characteristics between the two groups. The success rate of adenosine transfection was 86 0%, which was not significantly different from that of verapamil (87 1%). Adenosine group was significantly shorter than the verapamil group [(4444 ± 191 2) s, P <0 0 0 01] at 342 ± 19 5 s from the end of treatment to PSVT. Adverse events occurred in 11 cases of adenosine group, 18 cases; verapamil group of 16 cases of 22 cases, no significant difference between the two groups. There were 9 heart-related adverse events in adenosine group and 17 heart-related adverse events in verapamil group, with no significant difference. The entire trial did not have serious adverse events. Conclusion Domestic adenosine injection is an effective and safe drug for the treatment of PSVT.