Anh Le T N, M V Kumar Ajay, Ramaswamy Gomathi, Htun Thurain, Thanh Hoang Thi Thuy, Hoai Nguyen Giang, Quelapio Mamel, Gebhard Agnes, Nguyen Hoa Binh, Nguyen Nhung Viet
Vietnam Integrated Center for TB and Respirology Research, National Lung Hospital, Ha Noi 100000, Vietnam.
International Union Against Tuberculosis and Lung Disease, South East Asia Office, New Delhi 110016, India.
Trop Med Infect Dis. 2020 Mar 10;5(1):43. doi: 10.3390/tropicalmed5010043.
Vietnam has been using a levofloxacin-based shorter treatment regimen (STR) for rifampicin resistant/multidrug-resistant tuberculosis (RR/MDR-TB) patients since 2016 on a pilot basis. This regimen lasts for 9-11 months and is provided to RR/MDR-TB patients without second-line drug resistance. We report the treatment outcomes and factors associated with unsuccessful outcomes. We conducted a cohort study involving secondary analysis of data extracted from electronic patient records maintained by the national TB program (NTP). Of the 302 patients enrolled from April 2016 to June 2018, 259 (85.8%) patients were successfully treated (246 cured and 13 'treatment completed'). Unsuccessful outcomes included: treatment failure (16, 5.3%), loss to follow-up (14, 4.6%) and death (13, 4.3%). HIV-positive TB patients, those aged ≥65 years and patients culture-positive at baseline had a higher risk of unsuccessful outcomes. In a sub-group of patients enrolled in 2016 (n = 99) and assessed at 12 months after treatment completion, no cases of relapse were identified. These findings vindicate the decision of the Vietnam NTP to use a levofloxacin-based STR in RR/MDR-TB patients without second-line drug resistance. This regimen may be considered for nationwide scale-up after a detailed assessment of adverse drug events.
自2016年起，越南开始对利福平耐药/耐多药结核病（RR/MDR-TB）患者试行基于左氧氟沙星的短程治疗方案（STR）。该方案疗程为9至11个月，适用于无二线耐药的RR/MDR-TB患者。我们报告了治疗结果以及与治疗失败相关的因素。我们进行了一项队列研究，对从国家结核病规划（NTP）维护的电子患者记录中提取的数据进行了二次分析。在2016年4月至2018年6月登记的302例患者中，259例（85.8%）患者得到成功治疗（246例治愈，13例“完成治疗”）。治疗失败包括：治疗失败（16例，5.3%）、失访（14例，4.6%）和死亡（13例，4.3%）。HIV阳性的结核病患者、年龄≥65岁的患者以及基线时培养阳性的患者治疗失败风险较高。在2016年登记的一组患者（n = 99）中，在治疗完成后12个月进行评估，未发现复发病例。这些发现证明了越南国家结核病规划对无二线耐药的RR/MDR-TB患者使用基于左氧氟沙星的STR方案的决定是正确的。在对药物不良事件进行详细评估后，可考虑在全国范围内推广该方案。
