复方替米沙坦对单药控制不良高血压患者的有效性和安全性  

A randomized, double-blind, double-dummy study comparing a fixed dose combination of telmisartan 80 mg plus hydrochlothiazide 12. 5 mg to telruisartan 80 mg in Chinese hypertensive patients who failed to respond adequately to telmisartan 80 mg

作　　者：陈绍行[1] 张瑾[1] 陈绍良[2] 陈君柱[3] 严晓伟[4] 柯元南[5] 杜凤和[6] 张承宗[7] 秦永文[8] 蒲奎 朱鼎良[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院高血压科上海市高血压研究所,200025 [2]南京医科大学附属南京市第一医院心内科 [3]浙江大学医学院附属第一医院心内科 [4]中国医学科学院北京协和医学院北京协和医院心内科 [5]卫生部中日友好医院心内科 [6]首都医科大学附属北京天坛医院心内科 [7]天津医科大学第二医院心内科 [8]上海第二军医大学附属长海医院心内科 [9]解放军第二五四医院心内科

出　　处：《中华心血管病杂志》2008年第4期300-304,共5页Chinese Journal of Cardiology

摘　　要：目的评价复方替米沙坦在替米沙坦单药治疗无充分反应时中国高血压患者中的有效性和安全性。方法多中心、随机、双盲、双模拟临床试验。经1周安慰剂筛选期，699例符合入选标准的轻、中度高血压患者进入80mg替米沙坦单药开放治疗期。345例对替米沙坦单药开放治疗8周无充分反应[平均坐位舒张压≥90mmHg（1mmHg=0．133kPa）]的患者进入为期8周的随机双盲治疗期。175例患者进入复方替米沙坦治疗组（80mg替米沙坦加12．5mg氢氯噻嗪），170例进入80mg替米沙坦单药治疗组。每次随访测量坐位和立位的收缩压和舒张压谷值，记录不良事件。筛选期以及开放和随机双盲治疗期结束时进行实验室和心电图检查。结果（1）与开放治疗期结束（基线）比较，随机双盲治疗8周后，复方替米沙坦组坐位舒张压谷值平均下降10．1mmHg，替米沙坦单药组平均下降7．7mmHg，两组间比较P=0．0017。复方替米沙坦组坐位收缩压谷值平均下降14．2mmHg，替米沙坦单药组平均下降7．4mmHg，两组间比较P〈0．0001。（2）与基线比较，随机双盲治疗8周后，复方替米沙坦组立位舒张压和收缩压谷值平均下降幅度大于替米沙坦单药组，两组间比较P=0．0350和P〈0．0001。（3）按照平均坐位舒张压谷值〈90mmHg和（或）与基线值相比降低≥10mmHg评价，随机双盲治疗8周后，复方替米沙坦组有效率为74．6％（129．例患者），替米沙坦单药组为59．2％（100例患者），两组间比较P=0．0016。（4）在随机双盲期，两组与试验药物有关的不良事件发生率分别为3．5％和3．6％，两组间比较P〉0．05。结论替米沙坦单药治疗无充分反应的中国高血压患者，复方替米沙坦每日口服一次能够进一步降低血压，且安全性良好。Objective To evaluate the efficacy and safety of a fixed dose combination of telmisartan 80 mg plus hydrochlothiazide（HCTZ） 12. 5 mg （TH） to telmisartan 80 mg （T） in Chinese patients who failed to respond adequately to treatment with T. Method This is a multi-center, randomized, doubleblind, double-dummy clinical study. A total of 699 eligible hypertensive patients entered a one-week screening phase prior to the eight-week open-label T period. At the end of eight weeks, 345 patients who failed to respond to T （DBP≥90 mm Hg,1 mm Hg =0. 133 kPa） were randomized to receive either TH （175 patients） or T （170 patients） for another eight weeks. Sitting and standing BP were taken 24 hours post-dose and adverse events were documented at visit with 4 weeks interval. Laboratory, ECG and physical examination were performed at screening, at baseline and at the final visit. Results After 8 weeks treatment, （1） The mean trough reduction in sitting diastolic blood pressure （SiDBP） from baseline in TH group was greater than that in T group （ 10. 1 mm Hg vs 7.7 mm Hg, P = 0. 0017 ）. The mean trough reduction in sitting systolic blood pressure （SiSBP） from baseline was 14. 2 mm Hg in TH group and 7.4 mm Hg in T group （P 〈0. 0001 ）. （2） The mean trough reduction in standing DBP and standing SBP from baseline were significantly greater in TH group （8.7 mm Hg and 12, 9 mm Hg） compared those in T group （7.3 mm Hg and 7.0 mmHg, P = 0. 0350, P 〈 0. 0001 ）. （3） The number and percentage of responders in TH group （129,74. 6% ） were significantly higher than in T group （100, 59. 2%, P =0. 0016）. （d） The incidence of the study drug-related adverse events was similar between TH and T group （3. 5% vs. 3. 6 %, P 〉 0. 05）. Conclusion TH was more effective than T in patients not responded adequately to T in Chinese hypertensive patients.

关 键 词：高血压 血管紧张素Ⅱ1型受体拮抗剂 氢氯噻嗪 复方合剂 治疗结果 

分 类 号：R686[医药卫生—骨科学]