Oral pentoxifylline combined with pentavalent antimony: A randomized trial for mucosal leishmaniasis
Oral pentoxifylline combined with pentavalent antimony: A randomized trial for mucosal leishmaniasis
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DOI：
10.1086/511643
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发表时间：
2007-03-15
影响因子：
11.8
通讯作者：
Carvalho, Edgar M.
中科院分区：
文献类型：
--
作者：
Machado, Paulo R. L.;Lessa, Helio;Carvalho, Edgar M.
背景资料。粘膜利什曼病与严重的组织损伤和高肿瘤坏死因子a的产生有关。治疗失败的病例高达42%；经历治疗失败的患者将需要五价锑(SB-V)疗程或替代药物才能治愈。我们先前的研究表明，肿瘤坏死因子-α的抑制剂(己酮可可碱)联合SB-v可治愈90%的单用SB-v治疗无效的患者。一项涉及23名黏膜利什曼病患者的双盲安慰剂对照试验评估了己酮可可碱与SB-V联合治疗与单独SBV治疗的疗效。11例患者随机接受SB-V加口服己酮可可碱治疗30天，12例患者接受SB-V加口服安慰剂治疗。治愈的标准是皮损完全愈合。己酮可可碱组的所有患者都经历了1个疗程的SB-v治愈，而安慰剂组12名患者中有5名(41.6%)需要第二个疗程的SB-v(P=0.037)。己酮可可碱组愈合时间的标准差为83+/-36天，而安慰剂组为145+/-99天(P=0.049)。在两年的随访中，两组患者均无复发记录。在黏膜利什曼病的SB-V中加入己酮可可碱可显著缩短愈合时间，并防止SB-V进一步病程的需要。
Background. Mucosal leishmaniasis is associated with intense tissue damage and high tumor necrosis factor a production. Therapeutic failure occurs in up to 42% of cases; patients who experience treatment failure will require > 1 pentavalent antimony (Sb-v) course or alternative drugs to achieve a cure. We previously showed that an inhibitor of tumor necrosis factor-alpha (pentoxifylline) combined with Sb-v cured 90% patients refractory to monotherapy with Sb-v.Methods. A double-blind, placebo-controlled trial involving 23 patients with mucosal leishmaniasis evaluated the efficacy of pentoxifylline when administered in association with Sb-v, compared with Sbv treatment alone. Eleven patients were randomized to receive Sb-v plus oral pentoxifylline for 30 days, and 12 patients received Sb-v plus oral placebo. The criterion for cure was a complete healing of lesions.Results. All patients in the pentoxifylline group experienced a cure with 1 course of Sb-v, whereas 5 (41.6%) of 12 patients in the placebo group required a second course of Sb-v (P = .037). The healing time +/- standard deviation in the pentoxifylline group was 83 +/- 36 days, compared with 145 +/- 99 days in the placebo group (P = .049). No relapses were documented in either group at the 2-year follow-up visit.Conclusions. The addition of pentoxifylline to Sb-v in mucosal leishmaniasis reduces the healing time significantly and prevents the need for further courses of Sb-v.