在艾滋病毒阳性成年人结核性脑膜炎的辅助德克萨米他
Joseph Donovan1, Nguyen D Bang1, Darma Imran1
1From the Oxford University Clinical Research Unit (J.D., D.T.T.H., N.T.T.H., L.H.B.N., D.V.T., N.T.T., D.D.A.T., N.T.M.N., R.B.G., N.T.T.T., E.K., N.H.P., G.E.T.), Pham Ngoc Thach Hospital for Tuberculosis and Lung Disease (N.D.B., L.T.D., D.C.G., D.T.M.H., N.H.L.), the Hospital for Tropical Diseases (H.D.T.N., N.T.T., N.H.H.H., P.K.N.O., N.V.V.C.), Pham Ngoc Thach University of Medicine (H.D.T.N.), and the School of Medicine, Vietnam National University of Ho Chi Minh City (N.H.H.H., N.H.P.) - all in Ho Chi Minh City, Vietnam; the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford (J.D., R.B.G., N.T.T.T., E.K., R.L.H., N.H.P., G.E.T.), and London School of Hygiene and Tropical Medicine, London (J.D.) - both in the United Kingdom; and Dr. Cipto Mangunkusumo National Reference Hospital (D.I., K.M., C.P.G., R.E., A.K.), Persahabatan National Respiratory Referral Hospital (E.B.), and Oxford University Clinical Research Unit Indonesia (A.L.S.W., R.L.H.), Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
补充德克萨米他并没有改善结核性脑膜炎的HIV阳性成年人的生存率. 这项研究发现,与安慰剂相比,这种脆弱人群中没有显著的益处或危害.
科学领域:
- 传染性疾病 传染性疾病
- 神经学 神经学
- 临床试验 临床试验
背景情况:
- 艾滋病毒阳性个体的结核性脑膜炎 (TBM) 是一个重大的全球卫生挑战.
- 辅助性皮质糖类药物,如甲,尽管对益处和潜在风险的证据有限,但通常使用.
- 在这个特定的患者群体中,有必要评估辅助治疗的疗效和安全性.
研究的目的:
- 为了确定HIV阳性成年人结核性脑膜炎的辅助德萨的疗效和安全性.
- 评估德克萨米他对这一群体的生存率和二次终点的影响.
- 为管理与艾滋病毒相关的TBM提供基于证据的指导.
主要方法:
- 一个双盲,随机,安慰剂对照试验在越南和印度尼西亚进行.
- 艾滋病毒阳性成年人与TBM接受了德克萨或安慰剂6-8周,与12个月的抗结核化疗一起.
- 主要终点是随机化后12个月内全因死亡率.
主要成果:
- 520名参与者被随机分配;德克萨梅他组的44.1%和安慰剂组的49.0%在12个月内死亡 (HR 0.85;95% CI 0.66-1.10;P=0.22).
- 没有任何子组分析表明德克萨米他具有明显的益处.
- 二次终点和严重不良事件的发生率在甲和安慰剂组之间是相似的.
结论:
- 与安慰剂相比,辅助德克萨米他在患有结核性脑膜炎的HIV阳性成年人中没有改善生存率或次要结果.
- 这些发现表明,德克萨米他可能没有益处,并且不会改变这个患者群体的安全性.
- 可能需要进一步的研究来探索与艾滋病毒相关的TBM的替代或优化治疗策略.
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