中国老年收缩期高血压临床试验总结报告  

Systolic hypertension in the elderly: Chinese Trial(Syst China)——Final Report

作　　者：毕敏明 陈学奎 顾统元[1,2] 黄振华 牛文宣[1,2] 谢以勤 党爱民 董成华 简明[3] 刘力生 刘国仗[3] 王继光[3] 杨凯[3] 袁定华 张宇清 葛洪[4] 钱方毅[4] 王焕文 张良纯 王淑玉[6] 于学海 张树和[6] 周娟 李静 张娟 周象豪[7] 王葛英[8] 杨超元 张培兰[8] 胡锡衷[9] 俞玲[9] 黄平[10] 李培雄[10] 王定胜[11] 姚淙[11] 张德银[11] 张美祥[11] 郭忠莹 张鸿修[12] 

机构地区：[1]中国老年收缩期高血压临床试验协作组 [2]安徽省省立医院 [3]中国医学科学院心血管病研究所阜外心血管病医院 [4]北京国防科工委总医院 [5]北京酒仙桥医院 [6]北京首都钢铁公司医院心血管病防治所 [7]北京安贞医院 [8]卫生部北京老年医学研究所 [9]福建省心血管病研究所 [10]广东省老年医学研究所 [11]贵阳医学院附院内科 [12]河北省医学科学院 [13]镇江医学院附属医院 [14]河南省中医药研究院 [15]唐山开滦矿物局医院 [16]吉林医学院心血管病研究室 [17]上海市心血管病研究所 [18]白求恩医科大学第三临床学院 [19]成都市第一人民医院 [20]上海市高血压研究所 [21]辽宁大石桥镁矿耐火材料总厂职工医院 [22]江西医学院第二附院 [23]南京医科大学第一附属医院 [24]山东省医学科学院心血管病研究室 [25]河南医科大学附属第一医院 [26]大连医科大学附二院 [27]湖南医科大学湘雅医院 [28]大庆石油管理局职工医院 [29]辽宁省鞍山钢铁公司铁西医院 [30]抚顺钢厂职工医院 [31]苏州医学院附属第一医院

出　　处：《中华心血管病杂志》1998年第5期329-333,共5页Chinese Journal of Cardiology

摘　　要：目的研究降压治疗能否降低老年收缩期高血压患者的脑卒中和其它心血管并发症的发生和死亡率。方法采用随机、安慰剂对照的研究方法。入选病例总数为２３９４例。１２５３例患者分入尼群地平组，尼群地平的用量为１０～４０ｍｇ／ｄ，必要时加用卡托普利１２．５～５０ｍｇ／ｄ和（或）双氢克尿噻１２．５～５０ｍｇ／ｄ。１１４１例患者分入对照组，给予相应的安慰剂治疗。结果入选时坐位血压的平均值为１７０．５／８６．０ｍｍＨｇ（１ｍｍＨｇ＝０．１３３ｋＰａ），平均年龄６６．５岁，总胆固醇５．１ｍｍｏｌ／ｌ，经过４年的随访，治疗组和对照组血压均明显下降，两组间坐位收缩压和舒张压差异分别为８．０ｍｍＨｇ和３．２ｍｍＨｇ。经过降压治疗脑卒中降低了３８％（Ｐ＝０．０１），全病因死亡率降低了３９％（Ｐ＝０．００３），心血管病死亡率降低了３９％（Ｐ＝０．０３），致死性脑卒中降低了５８％（Ｐ＝０．０２），所有的致死和非致死性心血管事件降低了３７％（Ｐ＝０．００４）。结论每治疗１０００例老年收缩期高血压患者５年可减少５５例死亡，３９例脑卒中或５９例主要的心血管事件的发生。Objective Isolated systolic hypertension occurs in around 8% of Chinese people aged 60 years and olders. In 1988, the Systolic Hypertension in China (Syst China)Collaborative Group started to investigate whether active treatment could reduce the incidence of stroke and other cardiovascular complications in older patients with isolated systolic hypertension. Methods This study was a randomized, placebo controlled clinical trial. 2 394 patients were enrolled. All patients were initially started on masked placebo. After stratification for center, sex and previous cardiovascular complications alternate patients ( n =1 253) were assigned nitrendipine 10 40 mg daily with the possible addition of captopril 12.5 50.0 mg daily or hydrochlorothizide 12.5 50.0 mg daily, or both drugs. In the remaining 1 141 control patients,matching placebos were employed similarly. Results At entry sitting blood pressure averaged 170.5mmHg systolic and 86.0mmHg diastolic, aged averaged 66.5 years and total serum cholesterol was 5.1mmol/L. After 4 years of follow up, the blood pressures in both groups were significantly lowered. The difference between the two groups was 8.0mmHg systolic and 3.2 mmHg diastolic, respectively. Active treatment reduced total stroke by 38% from 20.8 to 13.0 endpoints per 1 000 patient years ( P =0.01), all cause mortality by 39% ( P =0.003), cardiovascular mortality by 39% ( P = 0.03) , stroke mortality by 58%( P =0.02), and all fatal and non fatal cardiovascular endpoints by 37%( P = 0.004). Conclusion Antihypertensive treatment prevents stroke and other cardiovascular complications in older Chinese patients with isolated systolic hypertension. Treatment of 1000 Chinese patients for 5 years could prevent 55 deaths, 39 strokes or 59 major cardiovascular complications.

关 键 词：高血压 尼群地平 临床试验 老年人 药物疗法 

分 类 号：R544.105[医药卫生—心血管疾病]