随机对照观察进口普罗帕酮治疗室性早搏的疗效和安全性(英文)  

Appraisal of efficacy and safety of imported propafenone in treatment of ventricular premature beats

作　　者：周达新[1] 李志善[1] 戚文航[2] 刘霞[2] 何汝敏[2] 蔡乃绳[1] 童步高[1] 

机构地区：[1]复旦大学附属中山医院心内科,上海200032 [2]上海第二医科大学附属瑞金医院心内科,上海200025

出　　处：《中国临床药学杂志》2003年第5期261-264,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的:评价进口普罗帕酮治疗室性早搏的疗效及安全性。方法:采用随机分组、美西律平行对照的方法,对其进行了研究;入选患者共107例,男性47例,女性60例,年龄为(45.8±12.4)a,进口普罗帕酮组71例,其中男性34例,女性37例,年龄为(45.3±13.5)a;美西律组36例,男性13例,女性23例,年龄为(46.8±10.0)a。结果:进口普罗帕酮组的有效率为54.9％;美西律组的有效率为66.2％;2组有效率经x^2检验P>0.05,无统计学意义;进口普罗帕酮组治疗前后P-R间期经t检验,延长有统计学意义P<0.05),对ECG的其他指标在治疗前后均无统计学意义(P>0.05);美西律组在治疗前后对ECG的各指标无统计学意义(P>0.05)。2组治疗前后ECG各指标的改变经t检验无统计学意义(P>0.05)。进口普罗帕酮组不良反应的发生率为14.1％,与心脏有关的不良反应6例,占不良反应的60％;美西律组有3例出现不良反应,发生率为8.3％,未观察到与心脏有关的不良反应;2组均无死亡及因心脏不良反应出现严重的事件;经x^2检验,2组不良反应发生率无统计学意义(P>0.05)。未发现肝、肾功能损害。结论:服用进口普罗帕酮600mg·d^(-1)(含600mg·d^(-1))以下治疗室性早搏,有效、安全,但由于病例较少,结果仅供参考。AIM: To appraise efficacy and safety of imported propafenone in treatment of vertricular premature beats(VPBs) . METHODS:Taking mexiletine as the control, 107 patients, aged (45.8 + 12.4) a, with VPBS was enrolled in this study and randomized to 2 treatment groups, propafenone and mexiletine groups. The ratio of numbers of imported propafenone group to that of mexiletine group was 2-1. RESULTS: The effective rates for VPBS in patients given imported propafenone and mexiletine were 54.9% and 66.6% , respectively. The effective rates of 2 groups were insignificant statistically (P > 0.05) . P-R interval before and after treatment with imported propafenone was significant (P<0.05), and electrocardiogram (ECG) indexes else between before treatment and after treatment of imported propafenone were insignificant statistically ( P > 0.05) . All ECG indexes between before treatment and after treatment of mexiletine were insignificant statistically ( P > 0.05) , and it was insignificant to compare the differences of ECG indexes between before treatment and after treatment of imported propafenone with those of mexiletine ( P > 0.05) . The occurrence rate of adverse drug reactions (ADRs) was 14.1 % in imported propafenone treatment group, in which cardiovascular ADRs accounted for 60% , and that in mexiletine treatment group was 8.3% , and no cardiovascular ADRs were observed in mexiletine treatment group. There wasn' t significant difference to be found in occurrence rate of ADRs between 2 groups. The function damage of liver and kidney wasn' t observed in 2 treatment groups. CONCX/USION: The imported propafenone is effective in treatment of VPBg, and it's dosage of not more than 600 mg'd'1 is relatively safe.

关 键 词：普罗帕酮 药物治疗 室性早搏 疗效 安全性 

分 类 号：R541.7[医药卫生—心血管疾病] R972[医药卫生—内科学]