Thakur C P, Kumar P, Kumar N, Singh G N, Singh A K, Narain S
Balaji Utthan Sansthan-Kala-Azar Research Centre, Fraser Road, Patna-800 001.
J Assoc Physicians India. 1998 Sep;46(9):779-83.
One hundred thirty parasitologically confirmed cases of kala-azar were randomly divided in two equal treatment groups. Patients in group A were treated by infusion with amphotericin B deoxycholate (ABD), 1 mg/kg day on days 1-20 and the infusion was given in two hours. Patients in group B were treated by an escalating dose of ABD 0.05 mg/kg, 0.1 mg/kg, 0.25 mg/kg, 0.5 mg/kg, 1 mg/kg on days 1-5, respectively and then in the same dosage on alternate days. The infusion was completed in 6 hours. Total dose of 20 mg/kg remaining the same in both the groups, the treatment was completed in 20 days in group A and 43 days in group B. Clinical cure (subsidence of fever, improvement in general well being and regression in the size of the spleen) and parasitological cure (absence of parasites in splenic aspirates at the end of treatment) occurred in all patients in both the groups. Sixty four (99%) patients in each group had not relapsed clinically and parasitologically within 6 months of follow up and were ultimately cured. The two relapsed patients, one in each group were treated with a 20-day course of ABD and were cured. Leukocyte count, haemoglobin, serum albumin increased (P < 0.05) and ESR, spleen and liver size decreased (P < 0.05) at the end of treatment and follow up. Adverse events were similar in both the groups. The minimum cost of treatment estimated was Rs. 14,500 in group B and Rs. 10,000 in Group A. Thus the newer mode of administration was more cost effective.
It was concluded that newer mode of administration of amphotericin B was as effective and tolerable as the classical mode of administration and was no more toxic. The newer mode of administration of amphotericin B is more cost effective and puts lesser burden on hospital staff and is recommended for use in kala-azar.
130例经寄生虫学确诊的黑热病患者被随机分为两个相等的治疗组。A组患者接受去氧胆酸两性霉素B（ABD）静脉输注治疗，第1 - 20天剂量为1mg/kg/天，输注时间为两小时。B组患者在第1 - 5天分别接受递增剂量的ABD治疗，剂量依次为0.05mg/kg、0.1mg/kg、0.25mg/kg、0.5mg/kg、1mg/kg，之后隔日给予相同剂量。输注在6小时内完成。两组总剂量均为20mg/kg，A组在20天内完成治疗，B组在43天内完成治疗。两组所有患者均实现临床治愈（发热消退、一般健康状况改善及脾脏大小回缩）和寄生虫学治愈（治疗结束时脾穿刺液中无寄生虫）。每组64例（99%）患者在随访6个月内未出现临床和寄生虫学复发，最终治愈。两组各有1例复发患者，均接受了为期20天的ABD治疗并治愈。治疗结束及随访时，白细胞计数、血红蛋白、血清白蛋白升高（P < 0.05），血沉、脾脏和肝脏大小减小（P < 0.05）。两组不良事件相似。估计B组最低治疗费用为14,500卢比，A组为10,000卢比。因此，新的给药方式更具成本效益。
得出结论，两性霉素B的新给药方式与经典给药方式一样有效且可耐受，毒性并不更大。两性霉素B的新给药方式更具成本效益，对医院工作人员负担较小，推荐用于黑热病治疗。
