Thakur C P, Kumar M, Kumar P, Mishra B N, Pandey A K
Patna Medical College and Hospital, India.
Br Med J (Clin Res Ed). 1988 Jun 4;296(6636):1557-61. doi: 10.1136/bmj.296.6636.1557.
The efficacy and safety of six regimens of treatment for kala-azar (visceral leishmaniasis) with sodium stibogluconate were evaluated in a prospective randomised study to ascertain the optimal treatment for Indian patients. Altogether 371 patients with kala-azar were randomised to receive sodium stibogluconate intramuscularly at a dose of 10 mg/kg body weight/day for 20 or 40 days (groups A and A1, respectively), 15 mg/kg body weight/day for 20 or 40 days (groups B and B1, respectively), or 20 mg/kg body weight/day for 20 or 40 days (groups C and C1, respectively). Patients were examined blind before and at the end of treatment and every month for six months. The number of patients who were apparently cured--that is, those whose temperature had returned to normal at the end of their regimen of treatment--was 45 (78%) in group A, 53 (87%) in group A1, 50 (81%) in group B, 60 (95%) in group B1, 58 (92%) in group C, and 62 (97%) in group C1. At six months 62 patients (97%) in group C1, 51 (81%) in group C, 54 (86%) in group B1, 42 (68%) in group B, 45 (74%) in group A1, and 33 (57%) in group A had not relapsed and were cured as confirmed by a bone marrow aspirate free of parasites. The differences between groups C1 and C, B1 and B, and A1 and A were significant. Logistic regression of the proportion cured with the dose and length of treatment showed that both factors were significant in improving the rate of cure; the highest dose for the longer time (group C1) had the best rate of cure. One patient in group C1, 12 in group C, nine in group B1, 18 in group B, 15 in group A1, and 23 in group A were cured with extended courses of 20 mg sodium stibogluconate. One patient in each of groups C1, B, A1, and A became unresponsive to antimony and were cured with pentamidine. One patient in each of groups C1, B, and A became unresponsive to both antimony and pentamidine. The patients tolerated the longer duration of treatment safely, and side effects were minor. Sodium stibogluconate should be given intramuscularly in the dosage of 20 mg/kg for at least 40 days, when patients should be assessed for further treatment if necessary. Such a regimen should achieve the highest rate of cure with low toxicity and low rates of relapse and unresponsiveness.
在一项前瞻性随机研究中，对六种葡萄糖酸锑钠治疗黑热病（内脏利什曼病）方案的疗效和安全性进行了评估，以确定针对印度患者的最佳治疗方法。总共371例黑热病患者被随机分组，分别接受以下治疗：肌肉注射葡萄糖酸锑钠，剂量为10mg/kg体重/天，共20天或40天（分别为A组和A1组）；15mg/kg体重/天，共20天或40天（分别为B组和B1组）；或20mg/kg体重/天，共20天或40天（分别为C组和C1组）。在治疗前、治疗结束时以及之后的六个月内每月对患者进行盲法检查。明显治愈的患者数量——即那些在治疗方案结束时体温恢复正常的患者——A组为45例（78%），A1组为53例（87%），B组为50例（81%），B1组为60例（95%），C组为58例（92%），C1组为62例（97%）。在六个月时，C1组62例患者（97%）、C组51例（81%）、B1组54例（86%）、B组42例（68%）、A1组45例（74%）和A组33例（57%）未复发，经骨髓穿刺无寄生虫证实已治愈。C1组与C组、B1组与B组以及A1组与A组之间的差异具有统计学意义。对治愈比例与治疗剂量和疗程进行逻辑回归分析表明，这两个因素在提高治愈率方面均具有显著意义；较长时间的最高剂量（C1组）治愈率最高。C1组有1例患者、C组有12例患者、B1组有9例患者、B组有18例患者、A1组有15例患者和A组有23例患者通过延长使用20mg葡萄糖酸锑钠疗程而治愈。C1组、B组、A1组和A组各有1例患者对锑剂无反应，改用喷他脒后治愈。C1组、B组和A组各有1例患者对锑剂和喷他脒均无反应。患者能够安全耐受较长疗程的治疗，且副作用较小。葡萄糖酸锑钠应以20mg/kg的剂量肌肉注射，至少持续40天，必要时应对患者进行进一步治疗评估。这样的治疗方案应能实现最高治愈率，且毒性低、复发率和无反应率低。
