摘要
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。
Objectives To investigate the effects of blood pressure lowering treatment on stroke recurrence among Chinese patients with previous cerebrovascular diseases. Methods Patients were eligible if they had a history of stroke or transient ischaemic attack （TIA） within the previous 5 years. Participants had no definite indication or contraindication for study drugs. There were no blood pressure entry criteria. This study was a large-scale randomised, double-blind, placebo controlled clinical trial. After 4 weeks runin period, 1520 randomised patients received either ACE inhibitor-perindopril （ ＋ diuretic-indapamide） treatment or matching placebo for 4 years. The primary study outcome was stroke event. Secondary outcomes included cardiovascular death, myocardial infarction, all-cause death and blood pressure. Results Ssven hundred and sixty-two were assigned active treatment and 758 assigned placebo. The characteristics of randomised patients of active and control groups were similar. In active and control groups： 70. 8% and 70.5% were male, 93. 8% and 93.4% had a history of stroke （haemorrhagic or cerebral infarction）. Baseline mean blood pressure in the active and control groups were 145. 3 ± 20. 2/86. 8 ± 11.1 mm Hg and 145. 3 ± 20. 3/87. 2 ± 10. 8 mm Hg, and mean age were 63.9 ± 7. 5 and 63.8 ± 7. 7 years, respectively. Blood pressure in those assigned active treatment was reduced on average 14/6 mm Hg more than placebo at 4 years. During double-blind treatment, active treatment reduced stroke recurrence （8. 8% vs 19. 4% ） by 55% （P 〈0.001）, myocardial infarction （1.4% vs 2. 8%） by 48% （P = 0.070）, cardiovascular mortality （3.6% vs 6. 6. % ） by 45% （P = 0. 010）, and all-cause mortality （6. 3% vs 9. 8% ） by 36% （P = 0. 010）. These benefits were achieved similarly in all subgroups： male or female, middle-aged or elderly, with or without hypertensive, cerebral infarct or haemorrhagic stroke. Conclusion 4 years of blood pressure lowering treatment was beneficial
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2005年第7期613-617,共5页
Chinese Journal of Cardiology
