Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.
Universidad Icesi, Cali, Colombia.
PLoS Negl Trop Dis. 2023 Jan 23;17(1):e0011029. doi: 10.1371/journal.pntd.0011029. eCollection 2023 Jan.
BACKGROUND: Treatment guidance for children and older adult patients affected by cutaneous leishmaniasis (CL) is unclear due to limited representation of these groups in clinical trials. METHODS: We conducted a collaborative retrospective study to describe the effectiveness and safety of antileishmanial treatments in children ≤ 10 and adults ≥ 60 years of age, treated between 2014 and 2018 in ten CL referral centers in Latin America. RESULTS: 2,037 clinical records were assessed for eligibility. Of them, the main reason for non-inclusion was lack of data on treatment follow-up and therapeutic response (182/242, 75% of children and 179/468, 38% of adults). Data on 1,325 eligible CL patients (736 children and 589 older adults) were analyzed. In both age groups, disease presentation was mild, with a median number of lesions of one (IQR: 1-2) and median lesion diameter of less than 3 cm. Less than 50% of the patients had data for two or more follow-up visits post-treatment (being only 28% in pediatric patients). Systemic antimonials were the most common monotherapy regimen in both age groups (590/736, 80.2% of children and 308/589, 52.3% of older adults) with overall cure rates of 54.6% (95% CI: 50.5-58.6%) and 68.2% (95% CI: 62.6-73.4%), respectively. Other treatments used include miltefosine, amphotericin B, intralesional antimonials, and pentamidine. Adverse reactions related to the main treatment were experienced in 11.9% (86/722) of children versus 38.4% (206/537) of older adults. Most adverse reactions were of mild intensity. CONCLUSION: Our findings support the need for greater availability and use of alternatives to systemic antimonials, particularly local therapies, and development of strategies to improve patient follow-up across the region, with special attention to pediatric populations.
背景:由于临床试验中儿童和老年患者的代表性有限,因此针对皮肤利什曼病(CL)的儿童和老年患者的治疗指导尚不明确。
方法:我们进行了一项合作的回顾性研究,以描述 2014 年至 2018 年期间在拉丁美洲十个 CL 转诊中心接受治疗的≤10 岁儿童和≥60 岁成人的抗利什曼病治疗的有效性和安全性。
结果:对 2037 份临床记录进行了评估,以确定其是否符合入选标准。其中,未纳入的主要原因是缺乏治疗随访和治疗反应的数据(242 例中的 182 例,儿童为 75%;468 例中的 179 例,成人占 38%)。对 1325 例符合条件的 CL 患者(736 例儿童和 589 例老年人)的数据进行了分析。在两个年龄组中,疾病表现均较轻,中位数皮损数为 1 个(IQR:1-2),皮损直径中位数小于 3cm。不到 50%的患者有两次或更多次治疗后随访的数据(儿科患者仅为 28%)。在两个年龄组中,全身性锑剂均为最常见的单一疗法(736 例中的 590 例,儿童占 80.2%;589 例中的 308 例,成人占 52.3%),总治愈率分别为 54.6%(95%CI:50.5-58.6%)和 68.2%(95%CI:62.6-73.4%)。其他治疗方法包括米替福新、两性霉素 B、皮损内锑剂和喷他脒。11.9%(86/722)的儿童和 38.4%(206/537)的老年人发生了与主要治疗相关的不良反应。大多数不良反应为轻度。
结论:我们的研究结果支持在该地区更广泛地使用替代全身性锑剂的治疗方法,特别是局部治疗方法,并制定改善患者随访的策略,特别要关注儿科人群。
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