Morganroth J, Pratt C M, Kennedy H L, Singh S N, Platt M L, Baker B J, Mason D T
Likoff Cardiovascular Institute, Hahnemann University Hospital, Philadelphia, Pennsylvania 19102.
Am J Cardiol. 1987 Oct 16;60(11):48F-51F. doi: 10.1016/0002-9149(87)90721-1.
To investigate the tolerance and efficacy of moricizine HCl, single-blind placebo-controlled trials were conducted. The early protocols involved patients hospitalized for 14 days, and daily Holter monitoring was used to document efficacy and the degree of spontaneous variability of ventricular premature complexes (VPCs). Moricizine HCl was given orally from 2.9 to 15.3 mg/kg 3 times daily. Patients with lethal ventricular arrhythmias were excluded. Additional outpatient trials were conducted to define long-term efficacy and safety. A dose-response relation between moricizine HCl and the percentage of reduction in frequency of benign or potentially lethal ventricular arrhythmias was documented. Eighty-five percent of patients achieved a reduction in VPCs greater than 75% with daily dosages ranging from 10.1 to 15 mg/kg. This corresponded to a 95% decrease in mean frequency of VPCs. Long-term studies demonstrated no evidence of compromise in left ventricular function, and the proarrhythmic rate was only 2%. Symptomatic side effects were mild and usually well tolerated. Nausea, the most common, occurred in 11% of patients and dizziness in 9%. These results indicate that moricizine HCl is an effective and well-tolerated antiarrhythmic agent.
为研究盐酸莫雷西嗪的耐受性和疗效，进行了单盲安慰剂对照试验。早期方案纳入住院14天的患者，每日使用动态心电图监测记录疗效及室性早搏（VPC）的自发变异程度。盐酸莫雷西嗪按2.9至15.3毫克/千克口服，每日3次。排除有致命性室性心律失常的患者。还进行了额外的门诊试验以确定长期疗效和安全性。记录了盐酸莫雷西嗪与良性或潜在致命性室性心律失常频率降低百分比之间的剂量反应关系。85%的患者每日剂量在10.1至15毫克/千克时，室性早搏减少超过75%。这相当于室性早搏平均频率降低95%。长期研究表明，没有证据显示左心室功能受损，促心律失常发生率仅为2%。有症状的副作用较轻，通常耐受性良好。最常见的恶心发生在11%的患者中，头晕发生在9%的患者中。这些结果表明，盐酸莫雷西嗪是一种有效且耐受性良好的抗心律失常药物。
