Division of Clinical Infectious Diseases, Research Center Boreal, Boreal, Germany; German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Hostelries-Rimes, Borstel, Germany; Respiratory Medicine and International Health, University of Lübeck, Lübeck, Germany.
Division of Clinical Infectious Diseases, Research Center Boreal, Boreal, Germany; German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Hostelries-Rimes, Borstel, Germany; Respiratory Medicine and International Health, University of Lübeck, Lübeck, Germany; Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Republic of Moldova.
Clin Microbiol Infect. 2023 Jun;29(6):751-757. doi: 10.1016/j.cmi.2023.02.013. Epub 2023 Feb 25.
To describe long-term treatment outcomes in patients with multi-drug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) and validate established outcome definitions for MDR/RR-TB treatment.
Among patients with MDR/RR-TB admitted to a German MDR/RR-TB referral centre from 1 September 2002 to 29 February 2020, we compared long-term treatment outcomes derived from individual patient follow-up with treatment outcomes defined by WHO-2013, WHO-2021 and the Tuberculosis Network European Trials Group-2016.
In a total of 163 patients (mean age, 35 years; standard deviation, 13 years; 14/163 [8.6%] living with HIV; 109/163 [66.9%] men, 149/163 [91.4%] migrating to Germany within 5 years), the treatment of culture-confirmed MDR/RR-TB was initiated. Additional drug resistance to a fluoroquinolone or a second-line injectable agent was present in 15 of the 163 (9.2%) Mycobacterium tuberculosis strains; resistance against both the drug classes was present in 29 of the 163 (17.8%) strains. The median duration of MDR/RR-TB treatment was 20 months (interquartile range, 19.3-21.6 months), with a medium of five active drugs included. The median follow-up time was 4 years (47.7 months; interquartile range, 21.7-65.8 months). Among the 163 patients, cure was achieved in 25 (15.3%), 82 (50.3%) and 95 (58.3%) patients according to the outcome definitions of WHO-2013, WHO-2021, and the Tuberculosis Network European Trials Group-2016, respectively. The lost to follow-up rate was 17 of 163 (10.4%). Death was more likely in patients living with HIV (hazard ratio, 4.28; 95% confidence interval, 1.26-12.86) and older patients (hazard ratio, 1.08; 95% confidence interval, 1.05-1.12; increment of 1 year). Overall, 101/163 (62.0%) patients experienced long-term, relapse-free cure; of those, 101/122 (82.8%) patients with a known status (not lost to-follow-up or transferred out) at follow-up.
Under optimal management conditions leveraging individualized treatment regimens, long-term, relapse-free cure from MDR/RR-TB is substantially higher than cure rates defined by current treatment outcome definitions.
描述耐多药/利福平耐药结核病(MDR/RR-TB)患者的长期治疗结局,并验证 MDR/RR-TB 治疗的既定结局定义。
在 2002 年 9 月 1 日至 2020 年 2 月 29 日期间,纳入德国 MDR/RR-TB 转诊中心收治的 MDR/RR-TB 患者,我们比较了来自患者个体随访的长期治疗结局与世界卫生组织(WHO)2013 年、WHO2021 年和欧洲结核网络临床试验组(TBNET)2016 年的治疗结局定义。
共纳入 163 例(平均年龄 35 岁,标准差 13 岁;14/163 [8.6%] 合并 HIV 感染;109/163 [66.9%] 男性,149/163 [91.4%] 在发病前 5 年内移居德国),对培养确诊的 MDR/RR-TB 进行了治疗。163 株分枝杆菌结核菌株中,有 15 株(9.2%)对氟喹诺酮或二线注射剂有额外耐药性;163 株中,有 29 株(17.8%)对这两类药物均有耐药性。MDR/RR-TB 治疗的中位持续时间为 20 个月(四分位间距,19.3-21.6 个月),平均使用 5 种活性药物。中位随访时间为 4 年(47.7 个月;四分位间距,21.7-65.8 个月)。根据 WHO 2013 年、WHO 2021 年和 TBNET 2016 年的结局定义,163 例患者中,治愈分别为 25 例(15.3%)、82 例(50.3%)和 95 例(58.3%)。失访率为 163 例中的 17 例(10.4%)。HIV 感染者(危险比,4.28;95%置信区间,1.26-12.86)和年龄较大的患者(危险比,1.08;95%置信区间,1.05-1.12;每增加 1 岁)死亡的可能性更高。总体而言,101/163(62.0%)例患者获得长期、无复发的治愈;其中,101/122(82.8%)例已知结局(无失访或转归)的患者在随访中未复发。
在充分利用个体化治疗方案的最佳管理条件下,MDR/RR-TB 的长期、无复发治愈率远高于现行治疗结局定义的治愈率。