Arevalo Iracema, Tulliano Gianfranco, Quispe Ana, Spaeth Gerald, Matlashewski Greg, Llanos-Cuentas Alejandro, Pollack Henry
Division of Pediatric Infectious Diseases, New York University School of Medicine, New York, NY 10016, USA.
Clin Infect Dis. 2007 Jun 15;44(12):1549-54. doi: 10.1086/518172. Epub 2007 May 2.
Cutaneous leishmaniasis is a serious public health problem in the developing world. The main therapeutic agent--pentavalent antimony, developed >50 years ago--is expensive, often accompanied by severe adverse effects, and complicated by the emergence of drug resistance. Better therapies are urgently needed. In the present pilot study, we compared the use of imiquimod, an immunomodulatory molecule, to the use of meglumine antimoniate alone and in combination for the initial treatment of cutaneous leishmaniasis.
Patients with newly diagnosed cutaneous leishmaniasis were enrolled from a single referral center in Lima, Peru, from August 2005 through October 2005. Patients were randomly assigned to 1 of 3 treatment groups and received either imiquimod 7.5% cream administered topically every other day for 20 days, intravenous meglumine antimoniate administered at a dosage of 20 mg/kg per day every day for 20 days, or combination therapy with both intravenous meglumine antimoniate and imiquimod 7.5% cream. Patients were evaluated weekly and at 1 and 3 months after treatment. Patients who had healed lesions at 3 months were considered to be clinically cured.
Although several patients showed initial resolution of symptoms with imiquimod treatment alone, all of these patients experienced relapse after treatment discontinuation. Four (57%) of 7 patients treated with meglumine antimoniate alone and 7 (100%) of 7 patients treated with combination therapy were cured. Combination therapy was not only more effective than the other 2 treatments (P<.05) but also led to faster healing and better cosmetic results.
Combination therapy with imiquimod and meglumine antimoniate is a promising regimen for the initial treatment of cutaneous leishmaniasis that warrants additional larger studies.
皮肤利什曼病是发展中世界的一个严重公共卫生问题。主要治疗药物——50多年前研发的五价锑——价格昂贵，常伴有严重不良反应，且出现了耐药性问题。迫切需要更好的治疗方法。在本初步研究中，我们比较了免疫调节分子咪喹莫特与葡甲胺锑酸盐单独使用及联合使用对皮肤利什曼病进行初始治疗的效果。
2005年8月至2005年10月，从秘鲁利马的一个单一转诊中心招募新诊断的皮肤利什曼病患者。患者被随机分配到3个治疗组中的1组，分别接受以下治疗：每2天外用一次7.5%咪喹莫特乳膏，持续20天；每天静脉注射葡甲胺锑酸盐，剂量为20mg/kg，持续20天；或静脉注射葡甲胺锑酸盐与7.5%咪喹莫特乳膏联合治疗。每周以及治疗后1个月和3个月对患者进行评估。治疗3个月后病变愈合的患者被视为临床治愈。
虽然部分患者单独使用咪喹莫特治疗后症状最初有所缓解，但所有这些患者在停药后均复发。单独使用葡甲胺锑酸盐治疗的7例患者中有4例（57%）治愈，联合治疗的7例患者中有7例（100%）治愈。联合治疗不仅比其他两种治疗更有效（P<0.05），而且愈合更快，美容效果更好。
咪喹莫特与葡甲胺锑酸盐联合治疗是皮肤利什曼病初始治疗的一种有前景的方案，值得进一步开展更大规模的研究。
