Role of aspirin in tuberculous meningitis: A randomized open label placebo controlled trial
Role of aspirin in tuberculous meningitis: A randomized open label placebo controlled trial
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DOI：
10.1016/j.jns.2010.03.025
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发表时间：
2010-06-15
影响因子：
4.4
通讯作者：
Nair, P. P.
中科院分区：
文献类型：
--
作者：
Misra, U. K.;Kalita, J.;Nair, P. P.
目的：评价阿司匹林预防结核性脑膜炎（TBM）卒中和死亡的有效性和安全性。方法：根据临床、MRI和脑脊液（CSF）标准诊断的TBM患者随机分为每天服用150 mg的阿司匹林或安慰剂。所有患者均接受四种药物抗结核治疗——RHZE（利福平、异烟肼、吡嗪酰胺和乙胺丁醇），联合或不联合皮质类固醇。主要终点是 3 个月时 MRI 证实的中风，次要终点是 3 个月时通过 Barthel 指数评分评估的死亡率和功能结果。还分析了药物不良反应。结果：118例TOM患者被随机分为阿司匹林组和安慰剂组。两组之间的基线人口统计学、临床（脑膜炎严重程度、MRI 和脑脊液变化）没有显着差异。 19 名（16.1%）患者失访。随机分组后，21 名患者（33.3%）发生卒中，与安慰剂组（43.3%；OR 0.42，95%CI 0.12-1.39）相比，阿司匹林组（24.2%）的卒中发生率无显着减少。与安慰剂相比，阿司匹林使中风绝对风险降低 19.1%，死亡率显着降低（21.7% vs 43.4%，P=0.02）。二元Logistic回归分析显示，年龄（OR 1.09，CI 1.03-1.14，P=0.001）是卒中的唯一独立危险因素，阿司匹林与生存显着相关（OR 3.17，95% CI 1.21-8.31）。阿司匹林的耐受性良好，没有任何患者因副作用而停药。解释：阿司匹林可显着减少 TBM 患者的中风，并显着降低 3 个月死亡率。 (C) 2010 Elsevier B.V. 保留所有权利。
Objective: To evaluate the efficacy and safety of aspirin in preventing stroke and mortality in tuberculous meningitis (TBM).Methods: Patients with TBM diagnosed on the basis of clinical, MRI and cerebrospinal fluid (CSF) criteria were randomized into aspirin 150 mg daily or placebo. All the patients received four drug antitubercular treatment- RHZE (rifampicin, isoniazide, pyrazinamide and ethambutol) with or without corticosteroid. The primary endpoint was MRI proven stroke at 3 months and secondary end points were mortality and functional outcome assessed by Barthel Index score at 3 months. The adverse drug reactions were also analyzed.Results: 118 TOM patients were randomized into aspirin and placebo groups. The baseline demographic, clinical (severity of meningitis. MRI and CSF changes) were not significantly different between the two groups. 19 (16.1%) patients lost from follow up. 21(33.3%) patients developed stroke after randomization which was insignificantly lesser in aspirin (24.2%) compared to the placebo group (43.3%; OR 0.42, 95%CI 0.12-1.39). Aspirin resulted in absolute risk reduction of stroke in 19.1% and significant reduction in mortality compared to placebo (21.7% Vs 43.4%, P=0.02). On binary logistic regression analysis, the age (OR 1.09, CI 1.03-1.14, P=0.001) was the only independent risk factor of stroke and aspirin was significantly related to survival (OR 3.17, 95% CI 1.21-8.31). Aspirin was well tolerated and was not withdrawn in any patient because of side effects.Interpretation: Aspirin resulted in insignificantly lesser strokes and significantly reduced 3 month mortality in patients with TBM. (C) 2010 Elsevier B.V. All rights reserved.