利福布汀治疗耐多药肺结核临床观察

Clinic assessment of rifabutin in the treatment of multidrug-resistant pulmonary tuberculosis

目的评价利福布汀治疗耐多药肺结核的临床有效性和安全性。方法采用为期18个月的随机、开放、对照临床试验。试验组:3BPaVEThAk/6BPaVETh/9BPaVE;对照组:3L2PaVEThAk/6L2PaVETh/9L2PaVE。结果试验组在各阶段的病灶显吸率与空洞闭合率均高于平行对照组,且临床症状与体征的改善也优于对照组。其中试验组在3个月时病灶有效率达100.0%(9/9),在6个月时痰结核菌阴转率达100.0%,与对照组同期经χ2检验比较,差异有显著性(P<0.05)。利福布汀不良反应为抗结核药物中常见的副反应。结论利福布汀治疗耐多药肺结核的疗效优于利福喷丁,且具有较好的安全性,对治疗耐多药肺结核具有很大的潜力。

Objective To assess the efficacy and safety of rifabutin in the treatment of multidrug-resistant pulmonary tuberculosis. Methods An 18-month randomized, open and controlled study was conducted. In rifabutin group, rifabutin, pasiniazid, levofloxacin, ethambutol, protionamide and amikacin were administrated in the initial 3-month phase. In the following 6-month phase, rifabutin, pasiniazid, levofloxacin, ethambutol and protionamide were used. And then in the 9 months continuation phase, patients received rifabutin, pasiniazid, levotloxacin and ethambutol. Drug administration in control group was similar to rifabutin group, the only excepticn was that rifabutin was replaced by rifapentine. Results Compared with the control group, the rifabutin group showed potential for radiologically evident improvement, cavity closure and clinical improvement in all phases. The rate of radiologically evident improvement in 3-month phase and the rate of bacteriologic conversion in 6-month phase were 100%. Besides, adverse events of rifabutin were similar to other regimens of treating TB. Conclusion In the treatment of multidrug-resistant pulmonary tuberculosis, the efficacy and safety of rifabutin was superior to rifapentine, which indicated that rifabutin was a prospective drug to treat muhidrug-resistant pulmonary tuberculosis.