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首页> 外文期刊>Medical Journal of Shree Birendra Hospital >BEDAQUILINE: A long but much fruitful wait since seventies
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BEDAQUILINE: A long but much fruitful wait since seventies

机译：BEDAQUILINE：自七十年代以来漫长而富有成果的等待

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Tuberculosis (TB) is a major health problem in developing countries one of the leading cause of deaths due to infectious disease in the world. Drug treatment had being successful with anti-tubercular drugs available, but Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) are serious forms of TB which have emerged as real concern. Bedaquiline (TMC-207 or R207910), is a new anti TB agent been approved as a part of drug regimen therapy in pulmonary MDR-TB. Bedaquiline acts on energy metabolism of the bacteria. It acts as a bactericidal drug. There are two important black box warnings for this drug, firstly prolongation of QT interval and secondly increased risk of death with bedaquiline as compared to placebo treatment. Fast track approval for bedaquiline was based on two phase 2 trials. The FDA has approved bedaquiline on Dec 2012, for the treatment of MDR-TB in adults (>18 years) as part of combination therapy under the fast track designation, priority review and orphan-product designation based on two Phase II trials. Careful use of this drug along with monitoring of the potential adverse effects and drug interactions becomes very important, as this new anti-tubercular drug has being approved after forty years, since last anti tubercular drug was approved.doi: http://dx.doi.org/10.3126/mjsbh.v13i1.13000
机译：结核病（TB）是发展中国家的主要健康问题，是世界上由于传染病导致死亡的主要原因之一。可用抗结核药治疗药物成功，但是耐多药结核病（MDR-TB）和广泛耐药结核病（XDR-TB）是严重的结核病形式，已引起人们的真正关注。 Bedaquiline（TMC-207或R207910）是一种新型抗结核病药物，已被批准作为肺部MDR-TB药物治疗方案的一部分。贝达喹啉作用于细菌的能量代谢。它起杀菌作用。该药物有两个重要的黑盒警告，首先是延长QT间隔，其次是与安慰剂相比，苯达喹啉的死亡风险增加。苯达喹啉的快速批准基于两项2期试验。 FDA于2012年12月批准了bedaquiline，根据两项II期临床试验，在快速通道指定，优先权审查和孤儿产品指定下，将bedaquiline用于成人（> 18岁）的耐多药结核病治疗，作为联合疗法的一部分。谨慎使用该药物以及监测潜在的不良反应和药物相互作用变得非常重要，因为自从最后一种抗结核药物获得批准以来，这种新的抗结核药物已在40年后获得批准。doi：http://dx.com。 doi.org/10.3126/mjsbh.v13i1.13000

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