Sharma Sadhana
Dept. of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai.
J Assoc Physicians India. 2018 Aug;66(8):85-86.
Delamanid is a nitro-dihydro-imidazooxazole compound which was developed by a Japanese company, Otsuka Holdings inc. and has shown in-vitro and in-vivo activity against drug resistant tuberculosis. The drug exerts its anti-mycobacterial activity by inhibition of mycolic acid biosynthesis, leading to defective cell wall formation ultimately leading to bacterial death. Following the promising results in Phase 2 trials, Delamanid received approval in European Union in 2014, following which it was also approved in Japan and Korea in the same year. It was approved in India recently in August, 2017. Though relatively well tolerated, there have been concerns due to QT prolongation associated with the use of Delamanid. WHO has currently recommended use of Delamanid in combination with optimized background regimen in patients with pulmonary TB (conditional recommendation). More data from clinical trials and observational studies is awaited regarding use of Delamanid in children, HIV co-infection, pregnant women and use in combination with Bedaquiline.
德拉马尼是一种硝基二氢咪唑并恶唑化合物，由日本大冢控股公司研发，已显示出对耐药结核病的体外和体内活性。该药物通过抑制分枝菌酸生物合成发挥其抗分枝杆菌活性，导致细胞壁形成缺陷，最终导致细菌死亡。在2期试验取得令人鼓舞的结果后，德拉马尼于2014年在欧盟获得批准，同年在日本和韩国也获得批准。它于2017年8月在印度获得批准。尽管耐受性相对较好，但由于使用德拉马尼会导致QT间期延长，人们对此表示担忧。世界卫生组织目前建议在肺结核患者中使用德拉马尼并结合优化的背景治疗方案（有条件推荐）。关于德拉马尼在儿童、合并感染艾滋病毒者、孕妇中的使用以及与贝达喹啉联合使用，还需要更多来自临床试验和观察性研究的数据。
