Thakur C P, Sinha G P, Barat D, Singh R K
Patna Medical College and Hospital, India.
Ann Trop Med Parasitol. 1994 Aug;88(4):365-70. doi: 10.1080/00034983.1994.11812878.
One-hundred-and-twenty visceral leishmaniasis patients, all with demonstrable splenic amastigotes after treatment with sodium stibogluconate and pentamidine, were treated with amphotericin B. The patients were allocated into two equal groups matched by age and sex. Patients in one group received amphotericin B in the traditional incremental dose regimen, i.e. 0.05, 0.10, 0.25, 0.50 and 1.0 mg/kg body weight on days 1, 2, 3, 4, and > 4, respectively. Patients in the other group received amphotericin B at a constant 1 mg/kg bodyweight per day from day 1. Each of the 120 patients received a total dose of 20 mg/kg bodyweight. By the end of treatment the incidence of infusion-related toxicities, such as rigor and fever, and of renal toxicities, such as elevated serum creatinine and low serum potassium, was the same in both groups (P > 0.05). The two treatment regimens were also equally effective; every patient was cured and none relapsed within 6 months' follow-up. It is therefore recommended that amphotericin B be given as the full optimal dose (1 mg/kg) from day 1. There seems no advantage in the incremental regimen; not only does it 'waste' 4 days before the optimal dose is reached but it is more expensive and may encourage the development of drug resistance.
120例内脏利什曼病患者在用葡萄糖酸锑钠和喷他脒治疗后脾脏均有可检测到的无鞭毛体，对这些患者采用两性霉素B进行治疗。患者按年龄和性别匹配被分为两组。一组患者采用传统的递增剂量方案接受两性霉素B治疗，即分别在第1、2、3、4天及4天以后给予0.05、0.10、0.25、0.50和1.0mg/kg体重的药物。另一组患者从第1天起每天按1mg/kg体重的固定剂量接受两性霉素B治疗。120例患者每人接受的总剂量均为20mg/kg体重。治疗结束时，两组中输注相关毒性（如寒战和发热）以及肾毒性（如血清肌酐升高和血清钾降低）的发生率相同（P>0.05）。两种治疗方案同样有效；所有患者均治愈，在6个月的随访期内无一例复发。因此，建议从第1天起就给予两性霉素B最佳全剂量（1mg/kg）。递增方案似乎没有优势；它不仅在达到最佳剂量之前“浪费”了4天时间，而且成本更高，还可能促使耐药性的产生。
