坎地沙坦加氢氯噻嗪对轻中度高血压的疗效和安全性  

Efficacy and Safety of the Compound of Candesartan Cilexetial and Hydrochlorothiazide in Patients with Essential Hypertension

作　　者：贾友宏[1] 明广华[1] 王杨[2] 何青[3] 扬新春[4] 华琦[5] 陈君柱[6] 边文彦[1] 胡颖[1] 康健[1] 张阴凤[1] 刘红[1] 方丽[1] 刘蔚[3] 汪芳[3] 高明明[4] 李静[5] 姚雪艳[6] 李一石[1] 

机构地区：[1]中国医学科学院,阜外心血管病医院,卫生部心血管药物临床研究重点实验室组织牵头,北京100037 [2]中国医学科学院,阜外心血管病医院生物统计部,北京100037 [3]北京医院,北京100730 [4]首都医科大学附属朝阳医院,北京100020 [5]首都医科大学附属宣武医院,北京100053 [6]浙江大学医学院附属第一医院,浙江杭州310002

出　　处：《中华高血压杂志》2008年第2期120-123,共4页Chinese Journal of Hypertension

基　　金："十一五"国家科技支撑计划课题(2006BAI14B07)

摘　　要：目的评价坎地沙坦加氢氯噻嗪(复方坎地沙坦酯片)对原发性高血压的降压疗效和安全性。方法对原发性高血压患者经过2周清洗期后,进入坎地沙坦酯片8 mg单药治疗期,对4周后血压未达标者(达标血压为<140/90 mm Hg),以随机、双盲双模拟、平行对照、多中心试验方法,分别服复方坎地沙坦酯片(坎地沙坦酯16.0 mg/氢氯噻嗪12.5 mg)或坎地沙坦酯片16 mg单药治疗8周。结果经过2周清洗期,共有392例进入单药治疗期,坎地沙坦酯8 mg单药治疗(n=353)2周后,血压下降值(10.2±0.6)/(6.5±5.7)mm Hg;4周的下降值为(10.8±10.9)/(6.6±6.1)mm Hg,4周血压达标率为15.3%(54/353例),组内比较,差异有非常显著意义(P<0.01)。在以后8周随机双盲对照期,复方坎地沙坦酯组(134例)与坎地沙坦酯单药组(142例)4周时的血压分别下降为(9.3±11.7)/(8.7±6.2)和(5.4±10.8)/(5.4±6.1)mm Hg;8周时为(11.1±11.2)/(10.7±6.6)和(7.8±11.1)/(7.8±6.3)mm Hg(组内及组间比较P<0.01)。随机期4周时联合治疗组血压达标率分别为64.9%(87/ 134),单药组为39.4%(56/142),8周时分别为79.9%(107/134)和51.4%(73/142)(组间比较P<0.01)。不良反应事件,在单药治疗期为6.2%(22/353),复方坎地沙坦组为2.9%(4/134),坎地沙坦酯组2.8%(4/142),组间比较差异无统计学意义(P>0.05)。结论复方坎地沙坦酯片较之单用坎地沙坦对原发性高血压患者有较好的降压效果和耐受性。Objective To evaluate the efficacy and safety of combination of candesartan cilexetial and hydrochlorothiazide （16.0 mg/12. 5 mg） in patients with mild and moderate hypertension. Methods A 8 weeks, multicenter, double-blind, randomized, parallel-group study was carried out. After 2 weeks wash-out phase, treatment started with once-daily 8 mg candesartan cilexetil in the 392 patients for 4 weeks （phase 1 study） ; if target sitting diastolic BP （SeDBP〈90 mm Hg） was not achieved, the dose were titrated to candesartan 16 mg alone or candesartan 16.0 mg/hydrochlorothiazide 12.5 mg pill once daily for 8 weeks（phase 2 study）. Results The reduction of BP were 10.2±10.6/6.5±5.7 mm Hg after 4 weeks treatment of 8 mg candesartan cilexetial alone（ n= 353）, only 54 （15.3%） patients achieved the target DBP. During the consequential 8 weeks treatment, the antihypertensive effect of combined treatment（n=134） was much greater than that by candesartan alone（n=142） （11.1±11.2/10.7±6.6 mm Hg vs 7.8±11.1/7.8±6.3 mm Hg, P〈0.01）. The number of patients who achieved the target DBP were 73/142（51.4%） by monotherapy vs 107/134 （79. 9%） by combined treatment （P〈0. 01）. Patients were well tolerated in both groups with no difference in drug-related adverse events. Conlusion The combined candesartan cilexetiain and hydrochlorothiazide treatment is more effective and well tolerated in patients with mild and molderate hypertension than that by candesartan monotherapy.

关 键 词：复方坎地沙坦酯片 高血压 降压疗效 安全性 

分 类 号：R544.1[医药卫生—心血管疾病] R978.1[医药卫生—内科学]