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Updated: May 30, 2025

Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
Published on: April 9, 2012
利法抗性,诺基诺隆敏感性结核病的口服治疗方案
Lorenzo Guglielmetti1, Uzma Khan1, Gustavo E Velásquez1
1From Médecins Sans Frontières (L.G., F.V.), Sorbonne Université, INSERM Unité 1135, Centre d'Immunologie et des Maladies Infectieuses (L.G.), Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Universitaire Sorbonne Université, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux (L.G.), and Epicentre (M.G., E. Baudin), Paris, and Translational Research on HIV and Endemic and Emerging Infectious Diseases, Montpellier Université de Montpellier, Montpellier, Institut de Recherche pour le Développement, Montpellier, INSERM, Montpellier (M.B.) - all in France; Interactive Development and Research, Singapore (U.K.); McGill University, Epidemiology, Biostatistics, and Occupational Health, Montreal (U.K.); UCSF Center for Tuberculosis (G.E.V., P.N., P.P.J.P.) and the Division of HIV, Infectious Diseases, and Global Medicine (G.E.V.), University of California at San Francisco, San Francisco; the National Scientific Center of Phthisiopulmonology (A.A., E. Berikova) and the Center of Phthisiopulmonology of Almaty Health Department (A.K.), Almaty, and the City Center of Phthisiopulmonology, Astana (Z.D.) - all in Kazakhstan; Médecins Sans Frontières (C.B., I.M.), the Medical Research Council Clinical Trials Unit at University College London (I.M.), and St. George's University of London Institute for Infection and Immunity (S.W.) - all in London; MedStar Health Research Institute, Washington, DC (M.C.); Médecins Sans Frontières, Mumbai (V. Chavan), the Indian Council of Medical Research Headquarters-New Delhi, New Delhi (S. Panda), and the Indian Council of Medical Research-National AIDS Research Institute, Pune (S. Patil) - all in India; the Centre for Infectious Disease Epidemiology and Research (V. Cox) and the Department of Medicine (H. McIlleron), University of Cape Town, and the Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (S.W.) - both in Cape Town, South Africa; the Institute of Tropical Medicine, Antwerp, Belgium (B. C. J.); Médecins Sans Frontières, Geneva (G.F., N.L.); Médecins Sans Frontières, Yerevan, Armenia (O.K.); the National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia (N.K.); Partners In Health (M.K.) and Jhpiego Lesotho (L.O.) - both in Maseru; Socios En Salud Sucursal Peru (L.L., S.M.-T., J.R., E.S.-G., D.E.V.-V.), Hospital Nacional Sergio E. Bernales, Centro de Investigacion en Enfermedades Neumologicas (E.S.-G.), Hospital Nacional Dos de Mayo (E.T.), Universidad Nacional Mayor de San Marcos (E.T.), and Hospital Nacional Hipólito Unanue (D.E.V.-V.) - all in Lima; Global Health and Social Medicine, Harvard Medical School (L.L., K.J.S., M.L.R., C.D.M.), Partners In Health (L.L., K.J.S., M.L.R., C.D.M.), the Division of Global Health Equity, Brigham and Women's Hospital (K.J.S., M.L.R., C.D.M.), the Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, (L.T.), and Harvard T.H. Chan School of Public Health (L.T.) - all in Boston; and the Indus Hospital and Health Network, Karachi, Pakistan (H. Mushtaque, N.S.).
新的全口服疗法在治疗抗利芬结核病方面表现出非劣质的疗效. 这些缩短的治疗选择提供了与标准治疗相似的结果,具有类似的安全性.
科学领域:
- 传染性疾病 传染性疾病
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 从历史上看,对抗利法抗性结核病 (TB) 的治疗受到了有限的选择和证据不足的困扰.
- 结核病药物开发的进步和增加的资金使新治疗策略的严格试验成为可能.
研究的目的:
- 为了评估五种新的9个月全口服疗程的非劣势性,与对诺基诺隆敏感,耐利胺耐药结核病的标准治疗相比.
- 评估缩短,全口服治疗方案的疗效和安全性.
主要方法:
- 进行了第三阶段,多国,开放标签,随机控制的非劣质性试验.
- 参与者接受了标准治疗或五种口服疗法之一,其中包括贝达基林,德拉曼尼德,线索利德,勒沃素/莫西素,克洛法齐明和皮拉津胺.
- 使用贝叶斯响应适应性随机化,以第73周的良好结果作为主要终点.
主要成果:
- 在修改后的治疗意图分析中,接受标准治疗的80.7%的患者取得了良好的结果.
- 与标准治疗相比,三个新疗法 (BCLLfxZ,BLMZ,BDLLfxZ) 显示出非劣质的疗效.
- 不良事件的发生率在不同疗法中是相似的,在所有参与者的11.7%中观察到显著的肝毒性.
结论:
- 分析中一致的发现支持了三种全口服,缩短的治疗方案对抗利法耐药结核病的非劣质疗效.
- 这些发现为改善这种具有挑战性的结核病患者治疗选择铺平了道路.
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