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翻譯：馮玉蓉  編輯：馮玉蓉  審校：曹瑩

背景：已有試驗評估了氯吡格雷和阿司匹林在預(yù)防缺血性卒中或短暫性腦缺血發(fā)作(TIA)后的作用。曾有研究報道，替格瑞洛在預(yù)防卒中或TIA后的血管事件或死亡方面并不優(yōu)于阿司匹林。目前替格瑞洛聯(lián)合阿司匹林預(yù)防卒中的效果尚未得到充分研究。

方法：我們進(jìn)行了一項隨機、安慰劑對照、雙盲試驗，研究對象為美國國立衛(wèi)生研究院卒中量表（NIHSS）評分為5分或以下（范圍為0至42分，得分越高表示卒中越嚴(yán)重）的輕度至中度急性非心源性缺血性卒中患者，或TIA患者，以及未進(jìn)行溶栓治療或血栓切除術(shù)的患者?；颊咴诎Y狀出現(xiàn)后24小時內(nèi)，按照1:1的比例，接受30天的治療方案：替格瑞洛（180mg負(fù)荷劑量，然后90 mg每天兩次）+阿司匹林（第一天300~325mg，然后每天75~100mg）；或相對應(yīng)的安慰劑+阿司匹林。主要觀察指標(biāo)是30天內(nèi)卒中或死亡的綜合結(jié)果。次要觀察指標(biāo)是30天內(nèi)首次繼發(fā)缺血性卒中和殘疾發(fā)生率。主要安全指標(biāo)是嚴(yán)重出血。

結(jié)果：共有11016名患者參與了隨機分組（替格瑞洛-阿司匹林組為5523例，阿司匹林組為5493例）。替格瑞洛-阿司匹林組發(fā)生主要結(jié)局事件303例（5.5%），阿司匹林組發(fā)生362例（6.6%）（危險比0.83；95%CI 0.71～0.96；P=0.02）。替格瑞洛-阿司匹林組發(fā)生缺血性卒中276例（5.0%），阿司匹林組發(fā)生345例（6.3%）（危險比0.79；95%CI 0.68～0.93；P=0.004）。兩組間殘疾發(fā)生率無顯著差異。替格瑞洛-阿司匹林組發(fā)生嚴(yán)重出血28例（0.5%），阿司匹林組發(fā)生7例（0.1%）（P=0.001）。

結(jié)論：未接受靜脈或血管內(nèi)溶栓治療的輕度至中度急性非心源性缺血性卒中（NIHSS評分≤5）或TIA的患者，替格瑞洛-阿司匹林組30天內(nèi)卒中或死亡的綜合風(fēng)險低于單獨使用阿司匹林組，但兩組間殘疾發(fā)生率無顯著差異。使用替格瑞洛更容易出現(xiàn)嚴(yán)重出血。

原始文獻(xiàn)來源：Johnston SC, Amarenco P, Denison H, et al. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA[J]. N. Engl. J. Med. 2020 07 16;383(3).

Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA

Abstract

BACKGROUND  Trials have evaluated the use of clopidogrel and aspirin to prevent stroke after an ischemic stroke or transient ischemic attack (TIA). In a previous trial, ticagrelor was not better than aspirin in preventing vascular events or death after stroke or TIA. The effect of the combination of ticagrelor and aspirin on prevention of stroke has not been well studied.

METHODS  We conducted a randomized, placebo-controlled, double-blind trial involving patients who had had a mild-to-moderate acute noncardioembolic ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 5 or less (range, 0 to 42, with higher scores indicating more severe stroke), or TIA and who were not undergoing thrombolysis or thrombectomy. The patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive a 30-day regimen of either ticagrelor (180-mg loading dose followed by 90 mg twice daily) plus aspirin (300 to 325 mg on the first day followed by 75 to 100 mg daily) or matching placebo plus aspirin. The primary outcome was a composite of stroke or death within 30 days. Secondary outcomes were first subsequent ischemic stroke and the incidence of disability within 30 days. The primary safety outcome was severe bleeding.

RESULTS  A total of 11,016 patients underwent randomization (5523 in the ticagrelor–aspirin group and 5493 in the aspirin group). A primary-outcome event occurred in 303 patients (5.5%) in the ticagrelor–aspirin group and in 362 patients (6.6%) in the aspirin group (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.02). Ischemic stroke occurred in 276 patients (5.0%) in the ticagrelor–aspirin group and in 345 patients (6.3%) in the aspirin group (hazard ratio, 0.79; 95% CI, 0.68 to 0.93; P=0.004). The incidence of disability did not differ significantly between the two groups. Severe bleeding occurred in 28 patients (0.5%) in the ticagrelor–aspirin group and in 7 patients (0.1%) in the aspirin group (P=0.001).

CONCLUSIONS  Among patients with a mild-to-moderate acute noncardioembolic ischemic stroke (NIHSS score ≤5) or TIA who were not undergoing intravenous or endovascular thrombolysis, the risk of the composite of stroke or death within 30 days was lower with ticagrelor–aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups. Severe bleeding was more frequent with ticagrelor.