Lee C N, Lin T P, Chang M F, Jimenez M V, Dolfi L, Olliaro P
Taiwan Provincial Chronic Disease Control Bureau, Taipei.
J Chemother. 1996 Apr;8(2):137-43. doi: 10.1179/joc.1996.8.2.137.
This study was aimed at assessing the efficacy and tolerability of rifabutin for the re-treatment of cases of chronic, multidrug-resistant pulmonary tuberculosis. The study design was self-controlled, single center. Rifabutin was administered as part of an individual-tailored multidrug regimen. In-patients suffering from pulmonary tuberculosis, infected with Mycobacterium tuberculosis bacilli resistant to isoniazid, rifampicin and other drugs with progressive disease unresponsive to prior courses with standard anti-tuberculosis medications were treated. Overall, 43 patients were enrolled and treated with rifabutin at 300 or 450mg/day according to body weight in conjunction with available anti-tuberculous drugs for a mean time of 353 days (range 42-678). Of these, 36 met all eligibility criteria (i.e. positive baseline culture of sputum with bacilli resistant to rifampicin at least) and were retained for the analysis of efficacy. Seventeen patients (47%) achieved a sustained conversion to a negative culture of sputum in a mean time of 47.7 days with a range of 14-120 days. Treatment prevented deterioration in most patients and resulted in clinical and radiological cure or marked improvement in more than half of cases. No correlation was found between treatment outcome and use of medication concomitant to rifabutin or susceptibility of bacilli to the drugs used. Four deaths occurred due to disease progression, in no case being related to study drugs. Ten patients reported a total of 18 adverse events that led to treatment discontinuation in 5 cases. Rifabutin should be considered for inclusion in regimens for cases of pulmonary multidrug-resistant tuberculosis which fail to respond to previous therapy.
本研究旨在评估利福布汀用于慢性多药耐药性肺结核病例再治疗的疗效和耐受性。研究设计为单中心自身对照。利福布汀作为个体化多药方案的一部分给药。对患有肺结核、感染对异烟肼、利福平和其他药物耐药的结核分枝杆菌且对先前标准抗结核药物疗程无反应的进展性疾病患者进行治疗。总体而言，43例患者入组并根据体重以300或450mg/天的剂量服用利福布汀，同时联合使用现有的抗结核药物，平均治疗时间为353天（范围42 - 678天）。其中，36例符合所有入选标准（即基线痰培养阳性且至少对利福平耐药），并被保留用于疗效分析。17例患者（47%）在平均47.7天（范围14 - 120天）内痰培养持续转阴。治疗防止了大多数患者病情恶化，超过半数病例实现了临床和影像学治愈或显著改善。未发现治疗结果与利福布汀联用药物或菌株对所用药物的敏感性之间存在相关性。4例患者因疾病进展死亡，无一例与研究药物相关。10例患者报告了总共18起不良事件，其中5例导致治疗中断。对于先前治疗无反应的肺部多药耐药性肺结核病例，应考虑将利福布汀纳入治疗方案。
