Thakur C P, Sinha G P, Sharma V, Pandey A K, Kumar M, Verma B B
Department of Medicine, Medical College, Patna.
Indian J Med Res. 1993 Jul;97:170-5.
A total of 150 patients of kala-azar matched for age and sex and parasitologically proved were randomly allocated to two equal treatment groups. Patients in one group received amphotericin B(AMB) in a dose of 1 mg/kg body weight (BW) on alternate days starting with 0.05 mg/kg/bw on first day with daily increments, till a total dose of 20 mg/kg/bw was given; the patients in the second group received sodium stibogluconate (SAG) in the dose of 20 mg/kg/bw, im daily for 30 days. The efficacy, safety and cost-effectiveness of the two drugs were compared. Apparent cure (afebrile at the end of therapy) in 75 (100%) and 69 (92%) patients and ultimate cure (no relapse in six months of follow up) in 75 (100%) and 60 (80%) patients occurred in the AMB and SAG groups respectively. The difference between the ultimate cure in the two groups was significant (P < 0.001). Six (8%) and 9(12%) patients of SAG group showed primary (with no response to SAG during treatment) and secondary unresponsiveness (with no response to SAG after relapse) respectively and they were cured with amphotericin B.(ABSTRACT TRUNCATED AT 250 WORDS)
总共150例年龄和性别匹配且经寄生虫学证实的黑热病患者被随机分为两个相等的治疗组。一组患者接受两性霉素B（AMB），起始剂量为0.05mg/kg体重（BW），首日开始隔天给药，每日递增，直至总剂量达到20mg/kg体重；第二组患者接受葡萄糖酸锑钠（SAG），剂量为20mg/kg体重，每日一次，共30天。比较了两种药物的疗效、安全性和成本效益。AMB组和SAG组分别有75例（100%）和69例（92%）患者达到显效（治疗结束时无发热），75例（100%）和60例（80%）患者达到根治（随访6个月无复发）。两组根治率差异有统计学意义（P<0.001）。SAG组分别有6例（8%）和9例（12%）患者出现原发性无反应（治疗期间对SAG无反应）和继发性无反应（复发后对SAG无反应），他们均用两性霉素B治愈。（摘要截选至250字）
