Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients
Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients
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DOI：
10.5588/ijtld.14.0100
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发表时间：
2014-10-01
影响因子：
4
通讯作者：
Rieder, H. L.
中科院分区：
文献类型：
--
作者：
Aung, K. J. M.;Van Deun, A.;Rieder, H. L.
单位：结核病项目，达米安基金会项目，孟加拉国。目的：总结使用至少9个月的标准化方案首次治疗耐多药结核病的结果及其决定因素。设计：这是一项基于加替沙星（GFX）直接观察方案的前瞻性观察性研究，主要是首次住院治疗。4个月的强化期延长至痰涂片转换。患者在治疗完成后使用培养进行长达2年的监测。结果：在2005年至2011年连续入组的515例符合研究纳入标准的患者中，84.4%的患者具有细菌学上的有利结果。由于疾病广泛且痰转化延迟，只有一半的患者在9个月内完成治疗；然而，95%的患者能够在12个月内完成治疗。11名患者治疗失败或复发，435名成功治疗的患者中有93.1%完成了治疗后至少12个月的随访。细菌学上不利结果的最强危险因素是高水平的氟喹诺酮（FQ）耐药性，特别是当初始吡嗪酰胺（PZA）耐药性复合时。低水平FQ耐药对治疗结果无不利影响。耐药性扩增只发生一次，在最初只对卡那霉素和氯法齐明敏感的患者菌株中。结论：孟加拉方案的良好疗效在很大程度上得以维持。细菌治疗失败和复发是罕见的，除了高水平的GFX耐药患者，特别是在PZA耐药的存在。
SETTING: Tuberculosis (TB) program, Damien Foundation Projects, Bangladesh.OBJECTIVE: To summarize the outcome and its determinants of the first treatment for multidrug-resistant TB using a standardized regimen consisting of a minimum 9 months.DESIGN: This was a prospective, observational study of a gatifloxacin (GFX) based directly observed regimen, mainly with initial hospitalization. The 4-month intensive phase was extended until sputum smear conversion. Patients were monitored using culture for up to 2 years after treatment completion.RESULTS: Of the 515 patients who met the study inclusion criteria and were successively enrolled from 2005 to 2011, 84.4% had a bacteriologically favorable outcome. Due to extensive disease with delayed sputum conversion, only half of the patients completed treatment within 9 months; however, 95% were able to complete treatment within 12 months. Eleven patients failed or relapsed, and 93.1% of the 435 patients who were successfully treated completed at least 12 months post-treatment follow-up. The strongest risk factor for a bacteriologically unfavorable outcome was high-level fluoroquinolone (FQ) resistance, particularly when compounded by initial pyrazinamide (PZA) resistance. Low-level FQ resistance had no unfavorable effect on treatment outcome. Amplification of drug resistance occurred only once, in a patient strain that was initially only susceptible to kanamycin and clofazimine.CONCLUSION: The excellent outcome of the Bangladesh regimen was largely maintained. Bacteriological treatment failures and relapses were rare, except among patients with high-level GFX resistance, notably in the presence of PZA resistance.