评价萘哌地尔治疗轻中度高血压的临床疗效  

Evaluation of therapeutic effect of naftopidil in patients with mild to moderate hypertension

作　　者：戚玮琳[1] 范维琥[1] 戚文航[2] 李勇[1] 邱慧丽[2] 范明昌[2] 

机构地区：[1]复旦大学附属华山医院心内科,上海200040 [2]交通大学附属瑞金医院心内科,上海200025

出　　处：《复旦学报（医学版）》2006年第4期487-490,共4页Fudan University Journal of Medical Sciences

摘　　要：目的评价新药萘哌地尔治疗轻中度高血压病的临床疗效和安全性。方法随机、双盲、安慰剂对照试验。67例轻中度高血压病患者停用原先服用的抗高血压药物,经过1-2周的单盲安慰剂导入期,进入为期6周的双盲治疗期,起始剂量为每日2次每次25mg萘哌地尔或者安慰剂,每周随访血压,若谷值坐位舒张压≥90mmHg,则剂量依次递增至每次37.5mg和50mg。结果经过6周的双盲治疗后,萘哌地尔能明显降低患者的血压。与安慰剂相比,坐位舒张压的下降幅度较大[(7.9±7.4)mmHg,P<0.05];萘哌地尔的降压总有效率为57.1%,显著高于安慰剂(22.6%,P=0.022),平均有效剂量为(47.66±5.04)mg每日2次。萘哌地尔常见的不良反应如头痛或头晕等的发生率与安慰剂相似。结论在中国轻中度高血压病患者中,每日2次,每次37.5mg-50mg萘哌地尔可达到满意的降压疗效,且安全、具有良好的耐受性。Purpose To evaluate the clinical efficacy and safety of naftopidil in patients with mild to moderate hypertension. Methods After withdrawing all previous antihypertensive drugs, 67 patients entered a single-blind placebo run-in period of 1 - 2 weeks, and then entered a 6 week, double-blind and placebo-controlled study period, where patients were randomized to receive the starting dose of 25 mg of naftopidil twice a day or placebo, 37.5 mg and 50 mg twice a day were available for titration to achieve a trough sitting diastolic blood pressure below 90 mmHg. Results After 6 weeks of double-blind therapy, naftopidil had significantly reduced trough sitting systolic and diastolic blood pressure relative to the baseline. The mean reduction in sitting diastolic blood pressure with naftopidil （7.9 ± 7.4） mmHg was significantly greater than with placebo （P〈0. 05）. The response rate in naftopidil group（57. 1%） was significantly higher than in placebo group（22.6% ,P= 0. 022）, the mean effective dose was （47.66 ± 5.04） mg twice a day. The incidence of common adverse events of naftopidil such as headache or dizziness was similar to that of placebo. Conclusions twice a day, 37.5 - 50 mg naftopidil is an clinically effective and safe regimen for Chinese patients with mild to moderate hypertension.

关 键 词：高血压病 萘哌地尔 疗效 

分 类 号：R972.4[医药卫生—药品]