Fransen M, Anderson C, Chalmers J, Chapman N, Davis S, MacMahon S, Neal B, Sega R, Terent A, Tzourio C, Woodward M
Institute for International Health, University of Sydney, Sydney, Australia.
Stroke. 2003 Oct;34(10):2333-8. doi: 10.1161/01.STR.0000091397.81767.40. Epub 2003 Sep 4.
We sought to quantify the effects of blood pressure lowering on long-term disability and dependency among patients with cerebrovascular disease.
We performed a randomized, double-blind, placebo-controlled trial. A total of 6105 participants with a history of stroke or transient ischemic attack in the past 5 years were recruited from 172 hospital outpatient clinics in 10 countries. Subjects were randomly assigned to the following groups: active treatment (angiotensin-converting enzyme inhibitor perindopril [4 mg/d] for all patients, with the diuretic indapamide added at the discretion of treating physicians) or matching placebo(s). Measurements were disability (defined as a Barthel Index score < or =99/100) and dependency (a positive response to the following question: "In the last 2 weeks has the patient required regular help with everyday activities?").
The median duration of follow-up was 4 years. At the last available assessment, 19% of the active treatment group and 22% of the placebo group were disabled (adjusted odds ratio, 0.76; 95% CI, 0.65 to 0.89; P<0.001). Twelve percent of the active treatment group and 14% of the placebo group were dependent (adjusted odds ratio, 0.84; 95% CI, 0.71 to 0.99; P=0.04). The effects of treatment appeared to be mediated primarily through the prevention of disability and dependency associated with recurrent stroke. Four-year treatment with the study drug regimen would be expected to result in the avoidance of 1 case of long-term disability for every 30 (95% CI, 19 to 79) patients.
Among individuals with cerebrovascular disease, a perindopril-based blood pressure-lowering regimen not only reduced the risk of stroke and major vascular events but also substantially reduced the risks of associated long-term disability and dependency.
我们试图量化血压降低对脑血管疾病患者长期残疾和依赖的影响。
我们进行了一项随机、双盲、安慰剂对照试验。从10个国家的172家医院门诊招募了总共6105名在过去5年内有中风或短暂性脑缺血发作病史的参与者。受试者被随机分配到以下组:积极治疗组(所有患者使用血管紧张素转换酶抑制剂培哚普利[4毫克/天],治疗医生可酌情添加利尿剂吲达帕胺)或匹配的安慰剂组。测量指标为残疾(定义为巴氏指数评分≤99/100)和依赖(对以下问题的肯定回答:“在过去2周内,患者是否需要日常活动的定期帮助?”)。
随访的中位持续时间为4年。在最后一次可用评估时,积极治疗组19%的患者和安慰剂组22%的患者有残疾(调整后的优势比为0.76;95%置信区间为0.65至0.89;P<0.001)。积极治疗组12%的患者和安慰剂组14%的患者有依赖(调整后的优势比为0.84;95%置信区间为0.71至0.99;P = 0.04)。治疗效果似乎主要通过预防与复发性中风相关的残疾和依赖来介导。使用研究药物方案进行4年治疗预计每30名(95%置信区间为19至79)患者可避免1例长期残疾。
在脑血管疾病患者中,基于培哚普利的降压方案不仅降低了中风和主要血管事件的风险,还大幅降低了相关长期残疾和依赖的风险。