Llanos-Cuentas A, Echevarría J, Cruz M, La Rosa A, Campos P, Campos M, Franke E, Berman J, Modabber F, Marr J
Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, and the U.S. Naval Medical Research Institute Detachment, Lima, Peru.
Clin Infect Dis. 1997 Sep;25(3):677-84. doi: 10.1086/513776.
A randomized, open, controlled clinical trial was designed to evaluate the efficacy, tolerance, and safety of sodium stibogluconate plus allopurinol and sodium stibogluconate alone as treatment of patients with mucocutaneous leishmaniasis. In phase 1 of the study, all 22 patients with severe disease had improvement of their lesions, but only two had clinical cure (both of these patients received sodium stibogluconate alone). In phase 2, which included 59 patients with moderate disease, the cure rate among sodium stibogluconate recipients was 75% (21 of 28) compared with 63.6% (14 of 22) among the sodium stibogluconate plus allopurinol recipients. The rates of clinical adverse events were similar among both groups. Thrombocytopenia was more frequent in the sodium stibogluconate plus allopurinol recipients, but the difference was not statistically significant. Eight patients (two sodium stibogluconate recipients and six sodium stibogluconate plus allopurinol recipients) withdrew from the study because of severe thrombocytopenia. In this study, the addition of allopurinol to sodium stibogluconate provided no clinical benefit as treatment of mucocutaneous leishmaniasis.
一项随机、开放、对照临床试验旨在评估葡萄糖酸锑钠加别嘌呤醇以及单独使用葡萄糖酸锑钠治疗皮肤黏膜利什曼病患者的疗效、耐受性和安全性。在研究的第一阶段，所有22例重症患者的病灶均有改善，但只有2例临床治愈（这2例患者均仅接受了葡萄糖酸锑钠治疗）。在第二阶段，纳入了59例中度疾病患者，接受葡萄糖酸锑钠治疗的患者治愈率为75%（28例中的21例），而接受葡萄糖酸锑钠加别嘌呤醇治疗的患者治愈率为63.6%（22例中的14例）。两组的临床不良事件发生率相似。血小板减少症在接受葡萄糖酸锑钠加别嘌呤醇治疗的患者中更为常见，但差异无统计学意义。8例患者（2例接受葡萄糖酸锑钠治疗的患者和6例接受葡萄糖酸锑钠加别嘌呤醇治疗的患者）因严重血小板减少症退出研究。在本研究中，葡萄糖酸锑钠加用别嘌呤醇作为皮肤黏膜利什曼病的治疗方法未显示出临床益处。
