Sundar Shyam, Mehta Himanshu, Suresh A V, Singh Shri P, Rai Madhukar, Murray Henry W
Kala-Azar Medical Research Center, Department of Medicine, Banaras Hindu University, Institute of Medical Sciences, Varanasi, India.
Clin Infect Dis. 2004 Feb 1;38(3):377-83. doi: 10.1086/380971. Epub 2004 Jan 13.
In Bihar, India, where visceral leishmaniasis is hyperendemic, amphotericin B deoxycholate is now first-line parenteral treatment. To test the efficacy of amphotericin B deoxycholate versus that of its lipid formulations, Indian patients were randomized to receive treatment with amphotericin B deoxycholate (1 mg/kg on alternate days for 30 days; n=51), liposomal amphotericin B (2 mg/kg per day for 5 days; n=51), or amphotericin B lipid complex (2 mg/kg per day for 5 days; n=51). Infusion-associated reactions were frequent and persistent in subjects treated with amphotericin B deoxycholate. The illness of 3 patients failed to respond to treatment, and 5 patients experienced relapse. Final cure rates were similar. Estimated total treatment costs for a 25-kg patient-417 dollars for amphotericin B deoxycholate, 872 dollars for liposomal amphotericin B, and 947 dollars for amphotericin B lipid complex-differed as a result of drug cost. Substantial reductions (approximately 60%) in the price of liposomal amphotericin B and amphotericin B lipid complex would make treatment costs comparable to that of amphotericin B deoxycholate, permitting administration of short-course regimens in India.
在印度比哈尔邦,内脏利什曼病高度流行,目前两性霉素B脱氧胆酸盐是一线肠外治疗药物。为了测试两性霉素B脱氧胆酸盐与其脂质制剂的疗效,印度患者被随机分为三组,分别接受两性霉素B脱氧胆酸盐治疗(隔日1mg/kg,共30天;n = 51)、脂质体两性霉素B治疗(每日2mg/kg,共5天;n = 51)或两性霉素B脂质复合物治疗(每日2mg/kg,共5天;n = 51)。接受两性霉素B脱氧胆酸盐治疗的患者中,与输液相关的反应频繁且持续存在。3例患者的病情对治疗无反应,5例患者出现复发。最终治愈率相似。一名25公斤患者的估计总治疗成本——两性霉素B脱氧胆酸盐为417美元,脂质体两性霉素B为872美元,两性霉素B脂质复合物为947美元——因药物成本而有所不同。脂质体两性霉素B和两性霉素B脂质复合物价格大幅降低(约60%)将使治疗成本与两性霉素B脱氧胆酸盐相当,从而可以在印度采用短疗程治疗方案。