Schwander S, Rüsch-Gerdes S, Mateega A, Lutalo T, Tugume S, Kityo C, Rubaramira R, Mugyenyi P, Okwera A, Mugerwa R
Clinical Department Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.
Tuber Lung Dis. 1995 Jun;76(3):210-8. doi: 10.1016/s0962-8479(05)80007-3.
This pilot study was conducted at the Joint Clinical Research Centre (JCRC) in Kampala, Uganda, where tuberculosis (TB) is an epidemic health problem aggravated by the HIV-1 pandemic.
To evaluate the feasibility of a larger phase III trial utilizing rifabutin as a substitute for rifampicin in short-course therapy for pulmonary TB.
Single-blind randomized trial in 50 patients with new onset smear- and culture-positive pulmonary tuberculosis and HIV-1 infection. Comparison of daily, intermittently supervised 6-month treatment regimens of rifabutin versus rifampicin, together with isoniazid, ethambutol and pyrazinamide.
Rifabutin- and rifampicin-containing regimens had comparable efficiency. However, rifabutin-treated patients had significantly more rapid clearance of acid-fast bacilli from sputum at 2 months (P < 0.05, Fisher exact test) and over the entire study period (P < 0.05, logrank test) than rifampicin-treated patients. The presence of cavitary disease was associated with a longer sputum conversion time for patients treated with either regimen. No major adverse events requiring dosage reduction or withdrawal of any study medication were seen in either treatment group. Mean absolute peripheral blood CD4 T lymphocyte counts increased by 28% from week 0 to week 12 in all subjects (334-427/microliters, respectively). An unexpected finding was the isolation of Mycobacterium africanum from 49% of the sputum cultures. This is the first report indicating a high prevalence of M. africanum in human TB in Uganda.
Short-course antituberculosis regimens containing rifabutin or rifampicin are both safe and efficacious in the treatment of HIV-1 associated tuberculosis. Rifabutin-containing regimens were associated with earlier sputum smear and culture conversion.
本试点研究在乌干达坎帕拉的联合临床研究中心（JCRC）开展，在该地，结核病是一种因艾滋病毒-1大流行而加剧的流行性健康问题。
评估在肺结核短程治疗中使用利福布汀替代利福平进行更大规模III期试验的可行性。
对50例新诊断为涂片和培养阳性的肺结核且合并艾滋病毒-1感染的患者进行单盲随机试验。比较利福布汀与利福平每日、间歇督导的6个月治疗方案，同时使用异烟肼、乙胺丁醇和吡嗪酰胺。
含利福布汀和含利福平的治疗方案疗效相当。然而，与接受利福平治疗的患者相比，接受利福布汀治疗的患者在2个月时（P<0.05，Fisher精确检验）以及在整个研究期间（P<0.05，对数秩检验）痰中抗酸杆菌清除速度明显更快。空洞性病变的存在与两种治疗方案治疗的患者痰菌转阴时间较长有关。两个治疗组均未出现需要减少剂量或停用任何研究药物的重大不良事件。所有受试者外周血CD4 T淋巴细胞绝对计数从第0周至第12周平均增加了28%（分别为334/微升和427/微升）。一个意外发现是在49%的痰培养物中分离出非洲分枝杆菌。这是首次报告表明非洲分枝杆菌在乌干达人类结核病中患病率很高。
含利福布汀或利福平的短程抗结核治疗方案在治疗艾滋病毒-1相关结核病方面均安全有效。含利福布汀的治疗方案与痰涂片和培养转阴更早有关。
