Rahman Atiya, Tahir Moizza, Naveed Tehseen, Abdullah Mohammad, Qayyum Nida, Malik Danish Hafeez, Amin Bushra
Department of Dermatology, PNS Shifa Hospital and Bahria University, Karachi, Pakistan.
Department of Dermatology, Combined Military Hospital, Peshawar, Pakistan.
J Coll Physicians Surg Pak. 2023 Dec;33(12):1367-1371. doi: 10.29271/jcpsp.2023.12.1367.
OBJECTIVE: To compare the efficacy and safety of meglumine antimoniate and miltefosine in the treatment of cutaneous leishmaniasis in Pakistan. STUDY DESIGN: Randomised-controlled trial. Place and Duration of the Study: Department of Dermatology, Combined Military Hospital, Lahore and Peshawar, from January to December 2021. METHODOLOGY: Smear positive and/or skin biopsy-confirmed cases of cutaneous leishmaniasis in adult males aged between 18-60 years were enrolled after receiving informed consent. Patients were randomly divided into Group A and Group B by lottery method. Group A received intramuscular meglumine antimoniate 15-20mg/kg/day, and Group B received oral miltefosine 50 mg thrice a day for a duration of 28 days. Data were analysed by SPSS 22. Effectiveness and safety of therapeutic agents were calculated by Independent t-test and p-value of 0.05 or less was taken as significant. RESULTS: Sixty-six patients, 33 in each group, participated in the study. Total number of cutaneous leishmaniasis lesions were 77 in Group A and 76 in Group B. The duration of lesions was 3.5 months in Group A and 3.2 months in Group B. Treatment response, in terms of complete or near complete resolution of lesions, was significantly higher in Group A as compared to Group B (p = 0.011). Both therapeutic agents had considerable side-effects with more patients withdrawn from Group A as compared to Group B (p = 0.010). CONCLUSION: Intra-muscular meglumine antimoniate was more effective in comparison to oral miltefosine in the treatment of cutaneous leishmaniasis. However, efficacy of meglumine antimoniate is mired by its side-effect profile. KEY WORDS: Cutaneous leishmaniasis, Meglumine antimoniate, Miltefosine, Efficacy, Side-effects, Adverse effects, Safety, Treatment, Old world cutaneous leishmaniasis.
目的:比较葡甲胺锑酸盐和米替福新治疗巴基斯坦皮肤利什曼病的疗效和安全性。 研究设计:随机对照试验。研究地点和时间:拉合尔和白沙瓦联合军事医院皮肤科,2021年1月至12月。 方法:在获得知情同意后,纳入年龄在18至60岁之间涂片阳性和/或皮肤活检确诊的成年男性皮肤利什曼病病例。通过抽签法将患者随机分为A组和B组。A组接受肌肉注射葡甲胺锑酸盐,剂量为15 - 20mg/kg/天,B组接受口服米替福新,剂量为50mg,每日三次,疗程为28天。数据采用SPSS 22进行分析。治疗药物的有效性和安全性通过独立t检验计算,p值小于或等于0.05被视为具有显著性。 结果:66例患者参与研究,每组33例。A组皮肤利什曼病病变总数为77个,B组为76个。A组病变持续时间为3.5个月,B组为3.2个月。就病变完全或接近完全消退而言,A组的治疗反应显著高于B组(p = 0.011)。两种治疗药物均有相当多的副作用,与B组相比,A组有更多患者退出研究(p = 0.010)。 结论:在治疗皮肤利什曼病方面,肌肉注射葡甲胺锑酸盐比口服米替福新更有效。然而,葡甲胺锑酸盐的疗效因其副作用而受到影响。 关键词:皮肤利什曼病;葡甲胺锑酸盐;米替福新;疗效;副作用;不良反应;安全性;治疗;旧世界皮肤利什曼病
J Coll Physicians Surg Pak. 2023-12
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J Ayub Med Coll Abbottabad. 2022
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