咪达普利与福辛普利治疗原发性高血压患者咳嗽发生率及降压疗效的对照研究  

Comparative Study on Cough Occurrence and Antihypertensive Efficacy of Imidapril versus Fosinopril in Patients with Essential Hypertension

作　　者：咪达普利临床试验协作组 刘金来[1] 陈璘[1] 彭朝权[1] 赵长林[1] 陈鲁原[2] 蒋祖勋[2] 孟素荣[3] 侯玉清[3] 熊龙根[4] 

机构地区：[1]中山大学附属第三医院心内科,广州510630 [2]广东省人民医院心内科,广州510080 [3]南方医科大学附属南方医院心内科,广州510515 [4]广州医学院第二附属医院心内科,广州510260

出　　处：《循证医学》2005年第6期350-353,共4页The Journal of Evidence-Based Medicine

摘　　要：目的比较高血压患者应用咪达普利或福辛普利的咳嗽发生率以及降压疗效。方法采用前瞻性开放、随机交叉对照、多中心研究。原发性高血压患者符合入选标准者,随机分为二组,分别给予咪达普利或福辛普利,观察8周。然后,二组交叉,咪达普利组改服福辛普利,福辛普利组改服咪达普利,继续治疗8周。观察二组的咳嗽发生率和降压疗效。结果试验Ⅰ期(交叉前)咪达普利组咳嗽发生率为10.9%,福辛普利组为17.0%;试验Ⅱ期(交叉后)咪达普利组咳嗽发生率为15.3%,福辛普利组为18.8%,试验Ⅰ期、试验Ⅱ期二组差异无统计学意义(P>0.05);试验Ⅰ期、试验Ⅱ期合并后咪达普利组咳嗽发生率为13%,福辛普利组为17.8%,二组比较差异无统计学意义(P>0.05)。试验Ⅰ期和试验Ⅱ期咪达普利组和福辛普利组血压均显著性降低,治疗前后差异均有统计学意义(P<0.01)。在4周时咪达普利组降收缩压和舒张压均优于福辛普利组(P<0.01);在8周时咪达普利组在降收缩压上优于福辛普利组(P<0.01),但在降舒张压上两组之间差异无统计学意义(P>0.05)。结论高血压患者应用咪达普利或福辛普利降压治疗后,咳嗽发生率二组相似,但在4～8周时的降压效果咪达普利优于福辛普利。Objective To compare the cough occurrence and the antihypertensive efficacy of Imidapril versus Fosinopril in patients with essential hypertension. Methods A multicentre randomized crossover controlled prosperctive open-label trial was performed. Patients with essential hypertension were randomly divided into two groups. They were administered Imidapril 5-10 mg once daily or Fosinopril 10-20 mg once daily for 8 weeks. Then Imidapril group and Fosinopril group were crossed over, and continued to administer Imidapril or Fosinopril for another 8 weeks. The cough occurrence and the antihypertensive efficacy were observed during whole trial period. Results The cough occurrence in Imidapril and Fosinopril groups was 10.9% and 17.0% at stage Ⅰ （before crossing-over）, respectively（P〉 0.05）. The cough occurrence in both groups was 15.3% and 18.8% at stage Ⅱ , respectively（P〉 0.05）. No significant difference in the cough occurrence was found between both groups in stage Ⅰ and Ⅱ （P 〉 0.05）. Blood pressure decreased significantly in both groups at stage Ⅰ and Ⅱ （P 〈 0.01）. The antihypertensive efficacy of Imidapril was better than that of Fosinopril at the fourth week and eighth week （P 〈 0.01 ）. Conclusions The cough occurrence in Imidapril group and Fosinopril group in patients with essential hypertension is similar, however the antihypertensive efficacy of Imidapril is better than that of Fosinopril at the fourth week and eighth week.

关 键 词：高血压 血管紧张素转化酶抑制剂 咳嗽 

分 类 号：R544.1[医药卫生—心血管疾病]