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目的评估降压治疗对脑血管病患者脑卒中再发的影响。方法入选近5年内有脑卒中或短暂性脑缺血发作病史的患者,且无研究药物适应证或禁忌证,无血压入选标准。研究为大样本、随机、双盲、安慰剂对照临床试验。导入期4周后,1520例患者被随机分为培哚普利(或加吲哒帕胺)治疗组或安慰剂对照组,随访治疗4年。主要终点是脑卒中事件,次要终点包括心血管死亡,心肌梗死,全因死亡等。结果762例被分为治疗组,758例为对照组。治疗组与对照组两组患者基础临床特征相似。治疗组与对照组的男性分别为70·8%和70·5%;脑卒中史占93·8%和93·4%;基础血压为(145·3±20·2)/(86·8±11·1)mmHg(1mmHg=0·133kPa)和(145·3±20·3)/(87·2±10·8)mmHg;平均年龄为(63·9±7·5)岁和(63·8±7·7)岁。随访4年,治疗组较对照组血压平均下降14/6mmHg,治疗组脑卒中再发率(8·8%)较对照组(19·4%)明显减少,相对危险下降55%(P<0·001);心肌梗死发生(1·4%比2·8%)危险下降48%(P=0·070);心血管死亡(3·6%比6·6%)危险减少45%(P=0·010);总死亡(6·3%比9·8%)危险减少36%(P=0·010)。降压治疗对男性或女性、中年或老年、有或无高血压史、脑梗死史或脑出血史患者均有益。结论降压治疗对脑血管病患者的脑卒中再发的预防是有益的。
Objective To evaluate the effect of antihypertensive therapy on recurrent stroke in patients with cerebrovascular disease. Methods Patients with a history of stroke or transient ischemic attack during the last 5 years were enrolled in this study. There was no study drug indication or contraindication and no blood pressure inclusion criteria. The study was a large randomized, double-blind, placebo-controlled clinical trial. Four weeks after the induction period, 1520 patients were randomized into perindopril (or plus indapamide) or placebo control, followed up for 4 years. The primary endpoint was stroke, with secondary end points including cardiovascular death, myocardial infarction, all-cause death and more. Results 762 cases were divided into treatment group and 758 cases as control group. The basic clinical features of the two groups in the treatment group and the control group were similar. The treatment group and the control group were 70.8% and 70.5% respectively; the stroke history was 93.8% and 93.4%; the basal blood pressure was (145.3 ± 20.2) / (86.8) ± 11.1 mmHg (1 mmHg = 0.133 kPa) and (145.3 ± 20.3) / (87.2 ± 10.8) mmHg, mean age was (63.9 ± 7.5) years and ( 63 · 8 ± 7 · 7) years old. After 4 years of follow-up, the average blood pressure of the treatment group was 14 / 6mmHg lower than that of the control group. The incidence of recurrent stroke in the treatment group was significantly lower than that of the control group (19.4% vs 8.8%, P <0 (P = 0 · 070); cardiovascular death (3.6% vs. 6.6%) was associated with a 45% (P = 0.010). The total death (6.3% vs 9.8%) was 36% less dangerous (P = 0.010). Antihypertensive treatment of male or female, middle-aged or elderly, with or without history of hypertension, cerebral infarction or history of cerebral hemorrhage in patients with a history of benefit. Conclusions Antihypertensive therapy is beneficial for the prevention of recurrent stroke in patients with cerebrovascular disease.