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首页> 外文期刊>International journal of infectious diseases : >Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis
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Insignificant difference in culture conversion between bedaquiline-containing and bedaquiline-free all-oral short regimens for multidrug-resistant tuberculosis

机译：含床尿苷与贝壳型无晶圆的无晶型全口腔短期治疗多药结核病的微不足道差异

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Background Multidrug-resistant tuberculosis (MDR-TB) patients have been suffering long, ineffective, and toxic treatment until short-course injectable-free regimens emerged. However, the new WHO-recommended regimens might be less feasible in the real-world setting. Here, we evaluated two optimized all-oral short-course regimens in China. Methods From April 2019 to August 2020, we conducted a prospective nonrandomized controlled trial and consecutively included 103 MDR-TB patients diagnosed with pulmonary MDR-TB in Shenzhen, China. A 4-5 drug regimen of 9-12 months was tailored to the strain's resistance patterns, patients' affordability, and tolerance to drugs. This was an interim analysis, focusing on the early treatment period. Results 53.4% (55/103) of patients were prescribed linezolid, fluoroquinolone (FQ), clofazimine, cycloserine, and pyrazinamide, followed by a regimen in which clofazimine was replaced by bedaquiline (35/103, 34.0%). The culture conversion rate was 83.1% and 94.4% at two and four months, respectively, with no significant difference between bedaquiline-free and bedaquiline-containing cases and between FQ-susceptible and FQ-resistant cases. Among 41 patients who completed treatment, 40 (97.6%) patients had a favorable outcome and no relapse was observed. Peripheral neuropathy and arthralgia/myalgia were the most frequent AEs (56.3%, 58/103). 18 AEs caused permanent discontinuation of drugs, mostly due to pyrazinamide and linezolid. Conclusion Optimized all-oral short-course regimens showed satisfactory efficacy and safety in early treatment stage. Further research is needed to confirm these results.
机译：背景多药耐药结核病（MDR-TB）病人已久的痛苦的，无效的，和有毒的治疗，直至注射，免费课程短期方案应运而生。然而，新的WHO推荐的方案可能是在真实环境不太可行。在这里，我们在中国的评价了两种优化了所有口服短疗程治疗方案。方法从四月2019至2020年8月，我们进行了一项前瞻性非随机对照试验，并连续列入103诊断为在中国深圳肺MDR-TB MDR-TB患者。 9-12个月，4-5个药物治疗方案是针对该菌株的耐药模式，患者的经济承受能力，以及对药物的耐受。这是一个中期分析，注重早期治疗时期。患者结果53.4％（55/103）被规定利奈唑胺，氟喹诺酮（FQ），氯法齐明，环丝氨酸，和吡嗪酰胺，随后在其中氯法齐明，通过bedaquiline（35/103，34.0％）代替的方案。将培养的转化率分别为83.1％和在两个四个月94.4％，与和含有bedaquiline - 自由bedaquiline-情况之间和FQ-敏感和FQ耐情况之间没有差别显著。其中41例谁完成治疗，40（97.6％）患者预后良好，并没有观察到复发。周围神经病变和关节痛/肌痛是最常见的不良事件（56.3％，58/103号决议）。 18个不良引起的药物永久终止，主要是由于吡嗪酰胺和利奈唑胺。结论优化了所有口服短池方案显示，早期治疗阶段满意的疗效和安全性。需要进一步的研究来证实这些结果。

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