Purpose

The Korea Centers for Disease Control & Prevention has implemented a review process for the approval of new drugs used to treat patients with multidrug-resistant tuberculosis (MDR-TB) since September 2016. Therefore, this study aimed to evaluate the efficacy and safety of these new drugs bedaquiline (Bdq) and delamanid (Dlm).

Methods

A total of 318 patients with MDR-TB were reviewed by the committee from September 2016 to February 2018; 282 (88.7%) of them were treated with the new drugs (Bdq, 107 patients; Dlm, 108 patients; and both concurrently or sequentially, 67 patients) and retrospectively evaluated. Culture conversion rates, interim treatment outcomes at 12 months, and predictors of unfavorable outcomes were analyzed. Treatment efficacy was also compared between Bdq and Dlm.

Results

The mean age of the patients was 49.3 years, and 197 (69.9%) were male. Three patients were HIV seropositive and 151 (53.5%) were quinolone resistant. The culture conversion rates at 2 and 6 months were 57.4% (81/141) and 89.4% (126/141), respectively. A favorable outcome at 12 months was achieved in 84.8% of patients (239/282). Differences in the culture conversion rate or interim treatment outcomes were not statistically significant among the drug susceptibility test patterns or new drugs used. Multivariable analysis showed that age >60 years and body mass index of <18.5 kg/m² were significant risk factors for unfavorable outcomes at 12 months.

Conclusions

The use of new drugs resulted in satisfactory interim treatment results, without significant differences between them.

中文翻译：

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在韩国使用苯达喹啉和/或德拉曼尼德对多药耐药结核病的中期治疗结果。

目的

自2016年9月起，韩国疾病控制与预防中心已实施审查程序，批准用于治疗耐多药结核病（MDR-TB）患者的新药。因此，本研究旨在评估这些药物的疗效和安全性。新药bedaquiline（Bdq）和delamanid（Dlm）。

方法

从2016年9月至2018年2月，委员会共审查了318例耐多药结核病患者；其中282例（88.7％）接受了新药治疗（Bdq，107例患者； Dlm，108例；同时或相继治疗，67例），并进行了回顾性评估。分析了文化转化率，12个月的临时治疗结局以及不良结局的预测因素。还比较了Bdq和Dlm之间的治疗效果。

结果

患者的平均年龄为49.3岁，其中男性为197位（69.9％）。3例患者HIV血清阳性，其中151例（53.5％）对喹诺酮耐药。2和6个月时的培养转化率分别为57.4％（81/141）和89.4％（126/141）。84.8％的患者在12个月时获得了良好的结局（239/282）。在药物敏感性测试模式或使用的新药物中，培养转化率或临时治疗结果的差异在统计学上无统计学意义。多变量分析表明，年龄大于60岁且体重指数小于18.5 kg / m ²是导致12个月不良结局的重要危险因素。

结论

新药的使用产生了令人满意的中期治疗效果，两者之间没有显着差异。