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Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study.
在有效避免二次中风 (PRoFESS) 的预防方案中,阿司匹林加缓释药达莫与氯吡格雷和替米沙坦对缺血性中风患者复发后残疾和认知功能的影响试验: 一项双盲、主动和安慰剂对照的研究。

摘要

BACKGROUND:The treatment of ischaemic stroke with neuroprotective drugs has been unsuccessful, and whether these compounds can be used to reduce disability after recurrent stroke is unknown. The putative neuroprotective effects of antiplatelet compounds and the angiotensin II receptor antagonist telmisartan were investigated in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial.
METHODS:Patients who had had an ischaemic stroke were randomly assigned in a two by two factorial design to receive either 25 mg aspirin (ASA) and 200 mg extended-release dipyridamole (ER-DP) twice a day or 75 mg clopidogrel once a day, and either 80 mg telmisartan or placebo once per day. The predefined endpoints for this substudy were disability after a recurrent stroke, assessed with the modified Rankin scale (mRS) and Barthel index at 3 months, and cognitive function, assessed with the mini-mental state examination (MMSE) score at 4 weeks after randomisation and at the penultimate visit. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov, number NCT00153062.
FINDINGS:20,332 patients (mean age 66 years) were randomised and followed-up for a median of 2.4 years. Recurrent strokes occurred in 916 (9%) patients randomly assigned to ASA with ER-DP and 898 (9%) patients randomly assigned to clopidogrel; 880 (9%) patients randomly assigned to telmisartan and 934 (9%) patients given placebo had recurrent strokes. mRS scores were not statistically different in patients with recurrent stroke who were treated with ASA and ER-DP versus clopidogrel (p=0.38), or with telmisartan versus placebo (p=0.61). There was no significant difference in the proportion of patients with recurrent stroke with a good outcome, as measured with the Barthel index, across all treatment groups. Additionally, there was no significant difference in the median MMSE scores, the percentage of patients with an MMSE score of 24 points or less, the percentage of patients with a drop in MMSE score of 3 points or more between 1 month and the penultimate visit, and the number of patients with dementia among the treatment groups. There were no significant differences in the proportion of patients with cognitive impairment or dementia among the treatment groups.
INTERPRETATION:Disability due to recurrent stroke and cognitive decline in patients with ischaemic stroke were not different between the two antiplatelet regimens and were not affected by the preventive use of telmisartan.

译文

背景: 使用神经保护药物治疗缺血性中风已经不成功,并且这些化合物是否可以用于减少中风复发后的残疾是未知的。在预防方案中研究了抗血小板化合物和血管紧张素 II 受体拮抗剂替米沙坦的假定神经保护作用,以有效避免二次中风 (PRoFESS) 试验。
方法: 将缺血性中风患者按两因素设计随机分为两组,分别接受 25 毫克阿司匹林 (ASA) 和 200 毫克缓释药达莫 (ER-DP)。每天两次或每天一次 75 毫克氯吡格雷,每天一次 80 毫克替米沙坦或安慰剂。这个亚研究的预定终点是复发中风后的残疾,在 3 个月时用改良的 Rankin 量表 (mRS) 和 Barthel 指数进行评估,以及认知功能, 在随机分组后 4 周和倒数第二次随访时,用简易精神状态检查 (MMSE) 评分进行评估。分析是通过意向治疗。该研究在 ClinicalTrials.gov 注册,编号为 nct00153062。
结果: 20,332 名患者 (平均年龄 66 岁) 被随机分组并随访,中位时间为 2.4 年。反复发作的中风发生在 916 (9%) 被随机分配到 ER-DP 的 ASA 患者和 898 (9%) 被随机分配到氯吡格雷的患者; 880 (9%) 被随机分配到替米沙坦的患者和 934 (9%) 服用安慰剂的患者有反复中风。在接受 ASA 和 ER-DP 与氯吡格雷 (p = 0.38) 或替米沙坦与安慰剂 (p = 0.61) 治疗的复发性中风患者中,mRS 评分没有统计学差异。用 Barthel 指数测量,在所有治疗组中,结果良好的复发性中风患者比例没有显著差异。此外,MMSE 评分中位数、 MMSE 评分为 24 分或更低的患者百分比没有显著差异, 在 1 个月到倒数第二次访问期间 MMSE 评分下降 3 分或以上的患者百分比,以及治疗组中痴呆患者的数量。在治疗组中,认知障碍或痴呆患者的比例没有显著差异。
解释: 缺血性中风患者因复发性中风和认知功能下降而导致的残疾在两种抗血小板方案之间没有区别,也没有受到预防性使用替米沙坦的影响。

Dipyridamole

神经 扩张血管 治疗药物
概述  :  

主要的药理作用为抑制血小板凝集和扩张血管。本品能增加冠状动脉血流量,但不增加心肌耗氧量,并能减少血小板的凝聚性。临床用于冠状动脉供血不足或伴有心绞痛的患者,也可用于防治血栓形成。药动学本品口服后迅速吸收。本品的血药浓度波动较大,普通制剂难以维持较稳定的有效抑制血小板聚集的血药浓度。健康者每日口服200 mg,其血药浓度波动于1.8-5.6 μmo/L。少量药物可透过胎盘屏障,分布于乳汁。血浆蛋白结合率高达97%-99%。药物与在肝内与葡萄糖醛酸结合后排入胆汁,进人小肠后被再吸收入血,故作用较

dipyridamole    英 [,daɪpɪ'rɪdəməʊl] 美 [daɪ'pɪrɪdə,mol; daɪ'pə'rɪdə,mol] 

释    义   n. 双嘧达莫

例    句   To investigate the protective effect and mechanism of dipyridamole against ischemia-reperfusioninjury on rabbit liver. 探讨潘生丁对兔肝脏热缺血再灌注损伤的保护作用及其相关机制。

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