Sundar S, Chakravarty J, Agarwal D, Shah A, Agrawal N, Rai M
Kala-azar Medical Research Center, Institute of Medical Sciences, Banaras Hindu University, Varanasi, and Muzaffarpur, India.
Trop Med Int Health. 2008 Sep;13(9):1208-12. doi: 10.1111/j.1365-3156.2008.02128.x. Epub 2008 Jul 28.
Amphotericin B (AB) deoxycholate is highly effective in antimony refractory cases for the treatment of visceral leishmaniasis (VL) in Bihar. But the need for prolonged hospitalisation and frequent, occasionally serious, adverse events are its major drawbacks. Lipid formulations of AB are devoid of these problems, but very expensive. We evaluated the safety and efficacy of a commercial standardised amphotericin B emulsion, a product of AB formulated in lipid emulsion vehicle (ABLE) in the treatment of Indian VL. In this open label, non-comparative study, 15 patients in each group were given three daily intravenous infusions each of 3, 4 or 5 mg/kg. All 45 patients (15 in each group) completed the treatment. The drug was tolerated well. Infusion reactions occurred in 5 (11%) patients and vomiting in 2 (4.4%). No nephrotoxicity or other organ toxicity was observed. At the end of treatment all patients of every group were clinically and parasitologically cured. However, during 6 months follow up, three patients from the 5 mg/kg group and one from the 4 mg/kg group tested positive for splenic aspirate. Thus 41 (91.1%; 95% CI 78-97) of 45 patients were cured with a total dose ranging between 9 and 15 mg/kg. There was no dose response linear correlation. In this preliminary study, AB formulated in a lipid emulsion vehicle was safe and effective for the treatment of VL in India.
两性霉素B（AB）脱氧胆酸盐在比哈尔邦治疗内脏利什曼病（VL）的锑难治性病例中非常有效。但需要长期住院以及频繁出现、偶尔严重的不良事件是其主要缺点。AB的脂质制剂没有这些问题，但非常昂贵。我们评估了一种商业标准化两性霉素B乳剂（一种以脂质乳剂载体配制的AB产品，即ABLE）治疗印度VL的安全性和有效性。在这项开放标签、非对照研究中，每组15名患者每天静脉输注3次，剂量分别为3、4或5mg/kg。所有45名患者（每组15名）均完成了治疗。该药物耐受性良好。5名（11%）患者出现输液反应，2名（4.4%）患者出现呕吐。未观察到肾毒性或其他器官毒性。治疗结束时，每组所有患者在临床和寄生虫学上均治愈。然而，在6个月的随访期间，5mg/kg组的3名患者和4mg/kg组的1名患者脾穿刺检查呈阳性。因此，45名患者中有41名（91.1%；95%可信区间78 - 97）治愈，总剂量在9至15mg/kg之间。不存在剂量反应线性相关性。在这项初步研究中，以脂质乳剂载体配制的AB在治疗印度VL方面安全有效。
