A PILOT-STUDY OF ANTITUBERCULOSIS COMBINATIONS COMPARING RIFABUTIN WITH RIFAMPICIN IN THE TREATMENT OF HIV-1 ASSOCIATED TUBERCULOSIS - A SINGLE-BLIND RANDOMIZED EVALUATION IN UGANDAN PATIENTS WITH HIV-1 INFECTION AND PULMONARY TUBERCULOSIS
A PILOT-STUDY OF ANTITUBERCULOSIS COMBINATIONS COMPARING RIFABUTIN WITH RIFAMPICIN IN THE TREATMENT OF HIV-1 ASSOCIATED TUBERCULOSIS - A SINGLE-BLIND RANDOMIZED EVALUATION IN UGANDAN PATIENTS WITH HIV-1 INFECTION AND PULMONARY TUBERCULOSIS
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DOI：
10.1016/s0962-8479(05)80007-3
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发表时间：
1995-06-01
期刊：
影响因子：
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通讯作者：
DIETRICH, M
中科院分区：
文献类型：
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作者：
SCHWANDER, S;RUSCHGERDES, S;DIETRICH, M
背景：这项试点研究是在乌干达坎帕拉的联合临床研究中心 (JCRC) 进行的，那里的结核病 (TB) 是一种因 HIV-1 大流行而加剧的流行性健康问题。目的：评估使用利福布丁替代利福平短期治疗肺结核的更大型 III 期试验的可行性。设计：在 50 名新发涂片和培养阳性肺结核患者中进行的单盲随机试验结核病和 HIV-1 感染。比较利福布丁与利福平以及异烟肼、乙胺丁醇和吡嗪酰胺的每日、间歇性监督的 6 个月治疗方案。结果：含利福布丁和利福平的方案具有相当的效率。然而，与利福平治疗的患者相比，利福布汀治疗的患者在 2 个月时（P < 0.05，Fisher 精确检验）和整个研究期间（P < 0.05，对数秩检验）从痰中清除抗酸杆菌的速度明显更快。对于接受任一方案治疗的患者来说，空洞疾病的存在与较长的痰转化时间相关。任一治疗组均未发现需要减少剂量或停止任何研究药物的重大不良事件。所有受试者的平均绝对外周血 CD4 T 淋巴细胞计数从第 0 周到第 12 周增加了 28%（分别为 334-427/μl）。一个意外的发现是从 49% 的痰培养物中分离出非洲分枝杆菌。这是第一份表明乌干达人类结核病中非洲分枝杆菌高患病率的报告。结论：含有利福布丁或利福平的短期抗结核治疗方案在治疗 HIV-1 相关结核病方面既安全又有效。含利福布丁的治疗方案与早期痰涂片和培养物转化有关。
Setting: 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.Objective: To evaluate the feasibility of a larger phase III trial utilizing rifabutin as a substitute for rifampicin in short-course therapy for pulmonary TB.Design: 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.Results: 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 sputun 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/mu l, 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.Conclusion: 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.