依普利酮片治疗轻中度高血压的疗效和安全性  

Efficacy and Safety of Eplerenone for the Treatment of Mild to Moderate Hypertension

作　　者：王敏[1] 谭茗月[1] 赵水平[1] 

机构地区：[1]中南大学湘雅二医院心血管内科,湖南长沙410011

出　　处：《医学临床研究》2013年第12期2333-2335,2339,共4页Journal of Clinical Research

摘　　要：【目的】评估依普利酮片治疗轻、中度原发性高血压的临床疗效和安全性。[方法]本研究为随机、双盲、平行对照的多中心II期临床试验，235例轻、中度高血压患者，随机分为两组：（1）氯沙坦组（n=118），（2）依普利酮组（n=117）。分别接受氯沙坦和依普利酮治疗，治疗4周后，若血压未达标，药物剂量加倍后继续治疗4周；若血压达标，维持原剂量继续治疗4周。观察两组疗效及不良反应。【结果】治疗8周后：①依普利酮组平均坐位舒张压下降（14．09±7．84）mmHg，收缩压下降（19．77±10．89）mmHg，氯沙坦组分别下降（12．87±8．04）mmHg，（18．63±9．66）mmHg，两组间差异无统计学意义（P均〉0．05）；依普利酮组及氯沙坦组平均坐位血压达标率分别为77．6％和73．50％，降压显效率分别为65．5％和56．6％，总有效率分别为87．9％和82．3％，两组间均无统计学意义（P〉0．05）。②两组的不良事件及不良反应发生率均无显著性差异（P〉0．05）。【结论】依普利酮能有效降压，疗效与氯沙坦相当，且其安全性良好。~Objective] To evaluate the efficacy and safety of eplerenone for the treatment of mild to mod- erate essential hypertension. [Methods]This study was randomized, double blind, equal-control, multi-centre and phase II clinical trial. A total of 235 patients with mild to moderate essential hypertension were randomly assigned to losartan group（ n = 118） and eplerenone group（ n = 117）. Two groups were treated with losartan or eplerenone, respectively. After 4 weeks of treatment, the dose was doubled for next 4 weeks if blood pres- sure did not reach the standard. Otherwise, the original dose remained unchanged for 4 weeks. II^esults] After 8 weeks of treatment, the average sitting diastolic blood pressure decreased by 14.09 ± 7.84mmHg and systolic pressure decreased by 12.87±8.04mmHg in eplerenone group, and those in losartan group decreased by 19.77±10.89mmHg and 18. 63±9.66mmHg respectively, but there was no significant difference between two group（all P 〉0.05）. The rate of average sitting blood pressure up to the standard in eplerenone group and losartan group was 77.6% and 73.50% respectively, and the excellence rate was 65.5% and 56.6% respectively, and the total effective rate was 87.9% and 82.3% respectively, but there was no significant difference between two groups（ P 〉0.05）. There was no significant difference in safety indexes between two groups（ P 〉0.05）. [Conclusion]Eplerenone can reduce blood pressure with good safety, and its efficacy is equal to losartan.

关 键 词：高血压 药物疗法 

分 类 号：R544.1[医药卫生—心血管疾病]