国产与进口硝苯地平控释片治疗高血压病比较

作者:朱福，黄波，兰军文，唐志红，蒋庆渊，胡春燕，关雁，丁银林【摘要】目的评价国产硝苯地平控释片治疗高血压病（EH）的临床疗效和不良反应。方法采用随机对照研究高血压病病人120例， 60例给予国产硝苯地平控释片(试验组)，另外60例服用进口硝苯地平控释片（对照组），均30～60mg，qd×8周。治疗前后做人工血压测定、24h动态血压测定（ABPM）、血生化检验、血常规、尿常规及心电图。结果国产与进口硝苯地平控释片总有效率分别为95％和97％，显效率为78％和82％，2组比较差异无显著性（P＞0．05）；2组服药前、服药后8周的24h、白昼和夜间的平均收缩压、舒张压明显下降，差异有显著性（P<0.01），国产与进口硝苯地平控释片服药后8周各时点收缩压和舒张压均较服药前下降，差异有显著性（P<0.01）。2组不良反应均轻微。试验组和对照组的不良反应发生率分别为13.3％和11.7％，撤药率分别为 1.7%和3.3%（P＞0.05），组间比较无统计学差异。结论国产硝苯地平控释片与进口硝苯地平控释片一样治疗高血压病有效、安全，不良反应少，而且有良好的耐受性，是轻、中度高血压满意的降压药物。【关键词】硝苯地平控释片；高血压病；药物评价 Domestic vs imported nifedipine controlled release tablets in treatment of essential hypertention 【Abstract】 Objective To evaluate the clinical efficacy and adverse reactions of domestic nifedipine controlled release tablets in the treatment of essential hypertent5HZ〗Methods One hundred and twety patients with EH were included. A study randomized was conducted. Sixty patients were treated with domestic nifedipine controlled release tablets(Test group)， 30～60mg/d and another sixty patients were treated with imported nifedipine controlled release tablets(Control group) 30～60mg／d for 8wk. Blood pressure were taken before and after domestic vs imported nifedipine controlled release tablets treatment. 24 hour ambulance blood pressure， blood and urine routine， blood biochemics， ECG were examined before and after treatment.Results The total effective rate of domestic nifedipine controlled release tablets was 95%，remarkable effective rate of domestic nifedipine controlled release tablets was 78%； while those of imported nifedipine controlled relesse tablets were 97% and 82%， there was no significant difference(P ＞0.05). Blood and urine routine， blood biochemics were unchanged before and after treatment ； the adverse reactions were mild. At the end of the 8th week， the two group the mean SBP/DBP of 24h， day-time and night-time were obviously decreased and had significant difference before and after taken([!--empirenews.page--]P<0.01). SBP and DBP were decreased and had significant difference at every time point of 24h-ABPM in treatment(P<0.01). The adverse reaction rates in test and control groups were 13.3% and 11.7% ， respectively， and the withdrawal rates were 1.7% and 3.3% ， respectively. No statistical significant difference (P>0.05) between the patients in test and control groups were found. Conclusion Domestic nifedipine controlled relesse tablets as well as imported nifedipine controlled relesse tablets is effective， safe and well tolerated in mild to moderate hypertensive patients. 【Key words】 nifedipine controlled relesse tablets； hypertention； drug evaluation 硝苯地平（nifedipine）作为最早的1、4双氢吡啶类钙通道阻滞药，具有阻止钙离子进入细胞膜，直接舒张血管平滑肌细胞，而起到扩张血管、降血压的作用。与其他钙通道阻滞药相比，该药具有生物利用度高、降压疗效显著肯定的特点，但其半衰期短，达峰后持续时间较短［1］。自进口硝苯地平控释片（nifedipine controlled realease tablets）上市来，已在40余国家及地区使用，主要适应证为高血压、心绞痛，其克服了硝苯地平片的缺点，疗效较为满意，不良反应较少［2～4］。上海现代制药股份有限公司，在国内首先成功生产了国产