Ji B, Perani E G, Petinom C, N'Deli L, Grosset J H
Faculté de Médecine Pitié-Salpêtrière, Paris, France.
Antimicrob Agents Chemother. 1994 Apr;38(4):662-7. doi: 10.1128/AAC.38.4.662.
Twenty-four patients with newly diagnosed lepromatous leprosy were allocated randomly to three groups and treated for 56 days with 400 mg of ofloxacin daily, 800 mg of ofloxacin daily, or 400 mg of ofloxacin, 100 mg of dapsone, and 50 mg of clofazimine daily plus 300 mg of clofazimine once every 28 days. The patients in all three groups demonstrated remarkable clinical improvements, accompanied by rapid decline of the morphological index in skin smears during treatment. More than 99, > 99.99, and > 99.99% of the viable Mycobacterium leprae organisms had been killed by 14, 28, and 56 days of treatment, respectively, as measured by inoculation into the footpads of immunocompetent and nude mice of organisms recovered from skin biopsy specimens obtained before and during treatment. Mild to moderate elevations of the serum glutamic pyruvic transaminase level were observed in four patients, all after 28 days of treatment, which returned to normal after the trial had been completed. Clinical improvement, bactericidal activity, and hepatotoxicity did not differ significantly among the three groups. Ofloxacin displayed powerful bactericidal activity against M. leprae in leprosy patients and may be an important component of new multidrug regimens for the treatment of leprosy. Its optimal dosage appears to be 400 mg daily, and combination with dapsone and clofazimine does not enhance its activity.
24例新诊断的瘤型麻风患者被随机分为三组，分别接受以下治疗，为期56天：每日服用400毫克氧氟沙星；每日服用800毫克氧氟沙星；每日服用400毫克氧氟沙星、100毫克氨苯砜和50毫克氯法齐明，外加每28天服用一次300毫克氯法齐明。所有三组患者的临床症状均有显著改善，治疗期间皮肤涂片的形态学指数迅速下降。通过将治疗前和治疗期间从皮肤活检标本中分离出的麻风分枝杆菌接种到免疫健全和裸鼠的脚垫上检测发现，治疗14天、28天和56天时，分别有超过99%、>99.99%和>99.99%的存活麻风分枝杆菌被杀死。4例患者出现血清谷丙转氨酶水平轻度至中度升高，均在治疗28天后出现，试验结束后恢复正常。三组之间的临床改善、杀菌活性和肝毒性无显著差异。氧氟沙星对麻风患者的麻风分枝杆菌显示出强大的杀菌活性，可能是治疗麻风的新联合用药方案的重要组成部分。其最佳剂量似乎为每日400毫克，与氨苯砜和氯法齐明联合使用并不会增强其活性。
