Program for the Study and Control of Tropical Disease, University of Antioquia, Carrera 53 #61-30, Medellín, Colombia.
Trials. 2012 May 17;13:58. doi: 10.1186/1745-6215-13-58.
BACKGROUND: Pentavalent antimonials (Sb5) and miltefosine are the first-line drugs for treating cutaneous leishmaniasis in Colombia; however, toxicity and treatment duration negatively impact compliance and cost, justifying an active search for better therapeutic options. We compared the efficacy and safety of thermotherapy and meglumine antimoniate for the treatment of cutaneous leishmaniasis in Colombia. METHOD: An open randomized Phase III clinical trial was performed in five military health centres. located in northwestern, central and southern Colombia. Volunteers with parasitological positive diagnosis (Giemsa-stained smears) of cutaneous leishmaniasis were included. A single thermotherapy session involving the application of 50°C at the center and active edge of each lesion. Meglumine antimoniate was administered intramuscularly at a dose of 20 mg Sb5/kg weight/day for 20 days. RESULTS: Both groups were comparable. The efficacy of thermotherapy was 64% (86/134 patients) by protocol and 58% (86/149) by intention-to-treat. For the meglumine antimoniate group, efficacy by protocol was 85% (103/121 patients) and 72% (103/143) by intention-to-treat, The efficacy between the treatments was statistically significant (p 0.01 and < 0.001) for analysis by intention to treat and by protocol, respectively. There was no difference between the therapeutic response with either treatment regardless of the Leishmania species responsible for infection. The side effects of meglumine antimoniate included myalgia, arthralgia, headache and fever. Regarding thermotherapy, the only side effect was pain at the lesion area four days after the initiation of treatment. CONCLUSION: Although the efficacy rate of meglumine antimoniate was greater than that of thermotherapy for the treatment of cutaneous leishmaniasis, the side effects were also greater. Those factors, added to the increased costs, the treatment adherence problems and the progressive lack of therapeutic response, make us consider thermotherapy as a first line treatment for cutaneous leishmaniasis.
背景：五价锑（Sb5）和米替福新是治疗哥伦比亚皮肤利什曼病的一线药物；然而，毒性和治疗持续时间会对依从性和成本产生负面影响，这使得人们积极寻找更好的治疗选择。我们比较了热疗和米替福新治疗哥伦比亚皮肤利什曼病的疗效和安全性。
方法：在哥伦比亚西北部、中部和南部的五个军事医疗中心进行了一项开放、随机、III 期临床试验。纳入了寄生虫学阳性诊断（吉姆萨染色涂片）的皮肤利什曼病志愿者。对每个病变的中心和活动边缘进行单次热疗，温度为 50°C。米替福新肌肉注射，剂量为 20mg Sb5/kg 体重/天，共 20 天。
结果：两组具有可比性。根据方案，热疗的疗效为 64%（134 例患者中的 86 例），意向治疗为 58%（149 例患者中的 86 例）。米替福新组根据方案的疗效为 85%（121 例患者中的 103 例），意向治疗为 72%（143 例患者中的 103 例），两种治疗方法的疗效在意向治疗和方案分析中均具有统计学意义（p<0.01 和 <0.001）。无论感染的利什曼原虫种类如何，两种治疗方法的治疗反应均无差异。米替福新的副作用包括肌痛、关节痛、头痛和发热。关于热疗，唯一的副作用是治疗开始后四天病变部位疼痛。
结论：尽管米替福新治疗皮肤利什曼病的疗效高于热疗，但副作用也更大。这些因素，加上治疗费用增加、治疗依从性问题以及治疗反应逐渐下降，使得我们考虑将热疗作为皮肤利什曼病的一线治疗方法。
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