Background

Cutaneous Leishmaniasis (CL) is the most common form of leishmaniasis. CL can be divided into two major groups: acute CL (ACL) and chronic CL (CCL). The aim of this study is to compare the efficacy of miltefosin and pentavalent antimony compounds in vivo with the CCL patient samples.

Materials

Three study groups were formed, each consisting of five male Mus musculus (Balb/C) mice. In this model, promastigotes from the culture of a CCL patient were utilized. 100 μL L. tropica promastigote suspension with a density of 10⁸ promastigotes/ml were injected into the hint-right footpad of each experimental animal intradermally. Footpads of the mice were measured every two weeks until 24th week. From the 13th week, miltefosin 50 mg/kg/day was administered orally using gavage for 21 days, Meglumin antimoniate (MA) was administered by intramuscular (IM) injection daily for 21 days at 50 mg/kg/day and saline was administered IM for 21 days for the miltefosine, MA and control group, respectively.

Results

The footpad measurements of the miltefosine group were lower than the control group statistically. Between the MA group and the miltefosine group and MA group and the control group, there was no statistically significant difference. Giemsa stained slides revealed amastigotes in one, two and all of the slides for the miltefosine, MA and control group, respectively. Molecular tests were performed with the Rotor-Gene device and L. tropica consistent peaks were obtained in one of the miltefosine group, four in the MA group and all mice in the control group.

Conclusions

Demonstration of both clinical and laboratory improvement in four of the five experimental animals provides strong evidence that miltefosine is an effective drug in the treatment of CCL. In the literature, no clinical or laboratory studies using miltefosine have been performed with CCL patients only.

中文翻译：

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克服挑战；米替福新对慢性皮肤利什曼病的体内疗效

背景

皮肤利什曼病 (CL) 是最常见的利什曼病形式。CL 可分为两大类：急性 CL (ACL) 和慢性 CL (CCL)。本研究的目的是比较米替福新和五价锑化合物与 CCL 患者样本的体内疗效。

材料

形成了三个研究组，每个组由五只雄性小家鼠 (Balb/C) 小鼠组成。在该模型中，使用了来自 CCL 患者培养物的前鞭毛体。将密度为10 ⁸前鞭毛体/ml的100μL热带原鞭毛体悬浮液皮内注射到每只实验动物的右脚垫中。每两周测量一次小鼠的足垫直到第 24 周。从第 13 周开始，使用管饲法口服米替福新 50 毫克/公斤/天，连续 21 天，通过肌内 (IM) 注射每天 50 毫克/公斤/天的方式每天肌内 (IM) 注射 Meglumin 锑酸盐 (MA)，持续 21 天，并肌肉注射生理盐水米替福新、MA 和对照组分别为 21 天。

结果

米替福新组的足垫测量值在统计学上低于对照组。MA组与米替福新组、MA组与对照组之间，差异无统计学意义。Giemsa 染色的载玻片分别在米替福新、MA 和对照组的一张、两张和所有载玻片中显示无鞭毛体。使用 Rotor-Gene 装置进行分子测试，在米替福新组中的一只、MA 组中的四只和对照组中的所有小鼠中都获得了L.tropica一致的峰。

结论

五只实验动物中有四只的临床和实验室改善证明提供了强有力的证据，证明米替福新是治疗 CCL 的有效药物。在文献中，没有仅对 CCL 患者进行过使用米替福新的临床或实验室研究。