索他洛尔注射液对室性心律失常的疗效及安全性

Efficacy and safety of sotalol injection on ventricular arrhythmias: A prospective double-blind randomized control study

采用前瞻性双盲及随机试验，对安慰剂（ＰＬＡ）与盐酸索他洛尔注射液进行比较，评价其对室性心律失常患者的疗效及安全性。研究发现，索他洛尔治疗频发室性早搏和室速４０例，显效２１例，占５２５％，有效１２例，占３００％，总有效率３３例，占８２５％，无效１７５％。注射安慰剂总有效率２０％。室性心律失常病人使用索他洛尔的过程中和结束后，心率、血压均有一定程度下降（Ｐ＜００５），ＱＴｃ间期轻度延长（Ｐ＜００５）。１例（２５％）频发室早病人，用药后３ｍｉｎ出现一过性（持续２ｍｉｎ左右）的Ⅰ度房室传导阻滞，２例使用索他洛尔后出现头晕、疲倦，用药前后，胸透和血、尿常规，肝、肾功能、血钾等无显著变化，提示使用索他洛尔注射液安全且有效。

In this prospective, double-blind, randomized study, the comparison of efficacy and safetiness of sotalol (SOT) injection and placebo (PLA) had been done in patients with premature ventricular contracts (PVCs), the rate of excellent effect of SOT was 52 9%, the good was 30 3%, the overall effect was 82 5% and the ineffective rate was 17 5%. HR and BP decreased at some extend after or in the treatment of SOT ( P <0 05). The QTc interval prolonged slightly ( P <0 05). One patient of FPVCs occurred Io-AVB (lasted about 2 minutes) after 3 minutes in treatment. Two patients (5%) occurred dizzy and fatigue. There were no varieties of biological indices including BRt, URt, ALT, GCt, BUN, Cr and K + in study. Thus, in Chinese patients with PVCs, SOT was relatively effective and safe.