在印度孟买，接受抗逆转录病毒和二线抗结核治疗的 HIV/MDR-TB 合并感染患者的不良事件。
Adverse events among HIV/MDR-TB co-infected patients receiving antiretroviral and second line anti-TB treatment in Mumbai, India.
机构信息
Médecins Sans Frontières, Mumbai, India.
出版信息
PLoS One. 2012;7(7):e40781. doi: 10.1371/journal.pone.0040781. Epub 2012 Jul 11.
BACKGROUND
Significant adverse events (AE) have been reported in patients receiving medications for multidrug- and extensively-drug-resistant tuberculosis (MDR-TB & XDR-TB). However, there is little prospective data on AE in MDR- or XDR-TB/HIV co-infected patients on antituberculosis and antiretroviral therapy (ART) in programmatic settings.
METHODS
Médecins Sans Frontières (MSF) is supporting a community-based treatment program for drug-resistant tuberculosis in HIV-infected patients in a slum setting in Mumbai, India since 2007. Patients are being treated for both diseases and the management of AE is done on an outpatient basis whenever possible. Prospective data were analysed to determine the occurrence and nature of AE.
RESULTS
Between May 2007 and September 2011, 67 HIV/MDR-TB co-infected patients were being treated with anti-TB treatment and ART; 43.3% were female, median age was 35.5 years (Interquartile Range: 30.5-42) and the median duration of anti-TB treatment was 10 months (range 0.5-30). Overall, AE were common in this cohort: 71%, 63% and 40% of patients experienced one or more mild, moderate or severe AE, respectively. However, they were rarely life-threatening or debilitating. AE occurring most frequently included gastrointestinal symptoms (45% of patients), peripheral neuropathy (38%), hypothyroidism (32%), psychiatric symptoms (29%) and hypokalaemia (23%). Eleven patients were hospitalized for AE and one or more suspect drugs had to be permanently discontinued in 27 (40%). No AE led to indefinite suspension of an entire MDR-TB or ART regimen.
CONCLUSIONS
AE occurred frequently in this Mumbai HIV/MDR-TB cohort but not more frequently than in non-HIV patients on similar anti-TB treatment. Most AE can be successfully managed on an outpatient basis through a community-based treatment program, even in a resource-limited setting. Concerns about severe AE in the management of co-infected patients are justified, however, they should not cause delays in the urgently needed rapid scale-up of antiretroviral therapy and second-line anti-TB treatment.
背景
在接受多药耐药和广泛耐药结核病（MDR-TB 和 XDR-TB）治疗的患者中，已经报告了重大不良事件（AE）。然而，在规划环境中，针对 MDR 或 XDR-TB/HIV 合并感染患者接受抗结核和抗逆转录病毒治疗（ART）时的 AE，前瞻性数据很少。
方法
无国界医生组织（MSF）自 2007 年以来一直在印度孟买的一个贫民窟为感染 HIV 的耐药结核病患者提供社区为基础的治疗方案。这些患者同时接受两种疾病的治疗，并且尽可能在门诊基础上管理 AE。对前瞻性数据进行了分析，以确定 AE 的发生和性质。
结果
2007 年 5 月至 2011 年 9 月期间，67 名 HIV/MDR-TB 合并感染患者正在接受抗结核治疗和 ART 治疗；43.3%为女性，中位年龄为 35.5 岁（四分位间距：30.5-42），抗结核治疗的中位时间为 10 个月（范围 0.5-30）。总的来说，该队列中 AE 很常见：分别有 71%、63%和 40%的患者经历了一次或多次轻度、中度或重度 AE。然而，它们很少危及生命或致残。最常发生的 AE 包括胃肠道症状（45%的患者）、周围神经病（38%）、甲状腺功能减退（32%）、精神症状（29%）和低钾血症（23%）。11 名患者因 AE 住院，27 名（40%）患者中必须永久停用一种或多种可疑药物。没有 AE 导致整个 MDR-TB 或 ART 方案无限期暂停。
结论
在孟买 HIV/MDR-TB 队列中，AE 发生频繁，但与接受类似抗结核治疗的非 HIV 患者相比，AE 并不更频繁。大多数 AE 可以通过社区为基础的治疗方案在门诊基础上成功管理，即使在资源有限的环境中也是如此。对合并感染患者管理中严重 AE 的担忧是合理的，但是，它们不应导致急需快速扩大抗逆转录病毒治疗和二线抗结核治疗的延误。
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