Berman J D, Badaro R, Thakur C P, Wasunna K M, Behbehani K, Davidson R, Kuzoe F, Pang L, Weerasuriya K, Bryceson A D
Biology Department, Walter Reed Army Institute of Research, Washington, DC, USA.
Bull World Health Organ. 1998;76(1):25-32.
Reported are the results of a study to determine the efficacy and safety of liposomal amphotericin B (AmBisome) for treating visceral leishmaniasis (kala-azar) in several developing countries where the disease is endemic (Brazil, India, and Kenya). At each study site, sequential cohorts of 10 patients each were treated with AmBisome at a dose of 2 mg.kg-1.day-1 (2 MKD). The first cohort received regimen 1:2 MKD on days 1-6 and day 10 (total dose: 14 mg/kg). If the efficacy with this regimen was satisfactory, a second cohort received regimen 2:2 MKD on days 1-4 and 10 (total dose: 10 mg/kg); and a third cohort received regimen 3:2 MKD on days 1, 5, and 10 (total dose: 6 mg/kg). In India, regimens 1, 2, and 3 (which were studied concurrently) each cured 100% of 10 patients. In Kenya, regimen 1 cured all 10 patients, regimen 2 cured 90% of 10 patients, but regimen 3 cured only 20% of 5 patients. In Brazil, regimen 1 was only partially curative: 5 of 13 patients (62%). Therefore, 15 patients were administered regimen 4 (2 MKD for 10 consecutive days; total dose, 20 mg/kg) and 13 patients were cured (83%). These results suggest that for the treatment of kala-azar the following doses of AmBisome should be administered: in India and Kenya, 2 mg/kg on days 1-4 and day 10; and in Brazil, 2 mg/kg on days 1-10.
报告了一项研究的结果，该研究旨在确定脂质体两性霉素B（安必素）在几个该疾病流行的发展中国家（巴西、印度和肯尼亚）治疗内脏利什曼病（黑热病）的疗效和安全性。在每个研究地点，每组10名患者按顺序接受剂量为2mg·kg⁻¹·天⁻¹（2MKD）的安必素治疗。第一组接受方案1：在第1 - 6天和第10天给予2MKD（总剂量：14mg/kg）。如果该方案的疗效令人满意，第二组接受方案2：在第1 - 4天和第10天给予2MKD（总剂量：10mg/kg）；第三组接受方案3：在第1、5和10天给予2MKD（总剂量：6mg/kg）。在印度，方案1、2和3（同时进行研究）分别治愈了每组10名患者中的100%。在肯尼亚，方案1治愈了所有10名患者，方案2治愈了10名患者中的90%，但方案3仅治愈了5名患者中的20%。在巴西，方案1仅部分治愈：13名患者中有5名（62%）。因此，15名患者接受了方案4（连续10天给予2MKD；总剂量，20mg/kg），13名患者治愈（83%）。这些结果表明，对于黑热病的治疗，应给予以下剂量的安必素：在印度和肯尼亚，在第1 - 4天和第10天给予2mg/kg；在巴西，在第1 - 10天给予2mg/kg。
