Dautzenberg B, Olliaro P, Ruf B, Esposito R, Opravil M, Hoy J F, Rozenbaum W, Carosi G P, Micoud M, L'Age M, Pirotta N, Sassella D
Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
Clin Infect Dis. 1996 Apr;22(4):705-8. doi: 10.1093/clinids/22.4.705.
The aim of this double-blind, randomized, placebo-controlled, 12-week study was to assess the efficacy of rifabutin (450 or 600 mg/d) in the treatment of disseminated nontuberculous mycobacterial infection in patients with AIDS. Companion drugs in both arms of the study were ethambutol, clofazimine, and isoniazid. Because of low accrual, the study was prematurely terminated when a total of 382 patients had been enrolled, of which 200 were eligible (i.e., their specimens were culture-positive for Mycobacterium avium complex [MAC] or Mycobacterium xenopi at baseline) and 102 were evaluable (i.e., they were eligible, were treated for a minimum of 6 weeks, and had at least one culture assessment after baseline). The original protocol called for a total of 220 evaluable patients. At week 12, rifabutin treatment was associated with higher, although nonsignificant, rates of bacteriologic conversion than was the placebo arm, with regard to both the eligible patients (25% vs. 18%) and the evaluable patients (45% vs. 38%). Corresponding median times to culture conversion were 42 vs. 63 days (eligible patients) and 43 vs. 69 days (evaluable patients). No significant difference was observed in clinical improvement, mortality, or toxicity between the two treatment arms. The addition of rifabutin to a triple-drug regimen may contribute to the clearance of disseminated MAC infection in patients with AIDS, without causing additional toxicity.
这项双盲、随机、安慰剂对照的12周研究旨在评估利福布汀（450或600毫克/天）治疗艾滋病患者播散性非结核分枝杆菌感染的疗效。研究两组的辅助药物均为乙胺丁醇、氯法齐明和异烟肼。由于入组率低，在共纳入382例患者后该研究提前终止，其中200例符合条件（即其标本在基线时鸟分枝杆菌复合群[MAC]或偶发分枝杆菌培养阳性），102例可评估（即他们符合条件，接受了至少6周的治疗，且在基线后至少有一次培养评估）。原方案要求共有220例可评估患者。在第12周时，就符合条件的患者（25%对18%）和可评估的患者（45%对38%）而言，表示利福布汀治疗组的细菌学转阴率高于安慰剂组，尽管差异无统计学意义。相应的培养转阴中位时间分别为42天对63天（符合条件的患者）和43天对69天（可评估的患者）。在两个治疗组之间，未观察到临床改善、死亡率或毒性方面的显著差异。在三联药物治疗方案中加用利福布汀可能有助于清除艾滋病患者播散性MAC感染，且不会引起额外毒性。
