初始低剂量氨氯地平加替米沙坦或复方阿米洛利联合治疗对高血压患者血压控制率影响的阶段报告  

Effects of amlodipine plus telmisartan or amlodipine pins amiroride regimen on blood pressure control in hypertensive patients： preliminary report of Chinese Hypertension Intervention Efficacy （CHIEF） trial

作　　者：王文[1] 马丽媛[1] 刘明波[1] 邓卿[1] 张宇清[1] 李卫[1] 朱鼎良[2] 林曙光[3] 黄峻[4] 刘力生[1] 

机构地区：[1]中国医学科学院北京协和医学院阜外心血管病医院卫生部心血管病防治研究中心,100037 [2]上海交通大学瑞金医院 [3]广东省人民医院 [4]江苏省人民医院

出　　处：《中华心血管病杂志》2009年第8期701-707,共7页Chinese Journal of Cardiology

基　　金：国家“十一五”科技支撑计划课题（2006BAI01A03）WHO临床试验注册号：ChiCTR-TRC-000087;志谢苏州东瑞制药有限公司免费供应了全部研究药品

摘　　要：目的探讨以氨氯地平为基础的联合治疗方案，对高血压患者血压达标及对心血管事件的影响。方法2007年10月至2008年10月，在全国180家医疗机构，入选50—79岁伴心血管病危险因素的高血压患者13542例。采用多中心随机开放对照盲终点评估的临床试验方法，患者随机分为低剂量氨氯地平（商品名：安内真2．5mg/d，苏州东瑞制药有限公司产品）＋复方阿米洛利（商品名：安利亚半片／d，苏州东瑞制药有限公司产品）组或氨氯地平＋替米沙坦（商品名：安内强40mg／d，苏州东瑞制药有限公司产品）组，计划治疗随访4年。主要研究终点是心血管病复合事件。结果氨氯地平＋复方阿米洛利组（n=6776）和氨氯地平＋替米沙坦组（n=6766）患者基线临床特征相似：平均年龄均为（61．5±7．7）岁，脑血管病史占19％、冠心病病史占12％，糖尿病占18％，血脂异常占42％，平均血压水平为157／93mmHg（1mmHg=0．133kPa）。治疗第8周氨氯地平＋复方阿米洛利组与氨氯地平＋替米沙坦组血压分别降至（133．0±11．0）／（81．0±7．6）mmHg与（132．9±11．6）／（80．6±7．9）mmHg；血压控制率分别达72．1％和72．6％。结论早期资料分析提示本研究患者多为高危人群，随机分配良好；以氨氯地平为基础的联合降压治疗血压控制率较高。Objective To evaluate the effects of amlodipine-based antihypertensive combination regimen on blood pressure control and impact on cardiovascular events. Methods From Oct. 2007 to Oct. 2008, a total of 13 542 hypertensive patients from 180 centers in China were included in this multi-centre randomized, controlled, blind-endpoint assessment clinical trial. Inclusion criteria were： essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and signed consent forms. Patients were randomly assigned to receive low-dose amlodipine ＋ diuretics （group A ） or low-dose amlodipine ＋ telmisartan （ group T）. The primary endpoints are composite of non-fatal stroke/myocardial infarction and cardiovascular death. All patients will be followed-up for 4 years. Results The characteristics of patients between the two groups were similar： mean age （61.5 ± 7.7 ）Yrs with 19% history of cerebrovaseular diseases, 12% coronary diseases, 18% diabetes,42% dyslipidemia, mean initial blood pressure 157/93 mm Hg. After 8-week treatment, mean blood pressure in group A and B were reduced to （ 133.0 ± 11.0） / （ 81.0 ± 7.6 ） mm Hg, （ 132. 9 ± 11.6 ） / （ 80. 6 ± 7.9 ）mm Hg respectively. Blood pressure control rates reached 72. 1% and 72. 6% in group A and T, respectively. Conclusion Amlodipine-based antihypertensive combination regimens achieved satisfactory blood pressure control rate in patients with essential hypertension in this patient cohort.

关 键 词：高血压 药物疗法 联合 随机对照试验 

分 类 号：R686[医药卫生—骨科学]