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在埃塞俄比亚阿姆哈拉邦 Boru Meda 综合医院,局部皮肤利什曼病采用博来霉素治疗的疗效:实用临床试验。

Effectiveness of intralesional sodium stibogluconate for the treatment of localized cutaneous leishmaniasis at Boru Meda general hospital, Amhara, Ethiopia: Pragmatic trial.

机构信息

Boru Meda general hospital, Dermatology clinic, Dessie, Ethiopia.

Wollo University, Department of Public health, Dessie, Ethiopia.

出版信息

PLoS Negl Trop Dis. 2022 Sep 9;16(9):e0010578. doi: 10.1371/journal.pntd.0010578. eCollection 2022 Sep.


DOI:10.1371/journal.pntd.0010578
PMID:36084153
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9491591/
Abstract

BACKGROUND: Cutaneous leishmaniasis (CL) is generally caused by Leishmania aethiopica in Ethiopia, and is relatively hard to treat. Sodium stibogluconate (SSG) is the only routinely and widely available antileishmanial treatment, and can be used systemically for severe lesions and locally for smaller lesions. There is limited data on the effectiveness of intralesional (IL) SSG for localized CL in Ethiopia and therefore good data is necessary to improve our understanding of the effectiveness of the treatment. METHODOLOGY/PRINCIPAL FINDINGS: A pragmatic (before and after Quazi experimental) study was done to assess the effectiveness of intralesional SSG among localized CL patients at Boru Meda general hospital, Northeast Ethiopia. Patients who were assigned to intralesional SSG by the treating physician were eligible for this study. Study subjects were recruited between January and August 2021. Infiltration of intralesional SSG was given weekly to a maximum of six doses. However, when a patient's lesions were already cured before getting 6 doses, treatment was not conintued, and patient were only asked to come for lesion assessment. Skin slit smears (SSS) were taken each week until they became negative. Outcomes were assessed at day 90, with patients who had 100% reepithelization (for ulcerative lesions) and/or flattening (for indurated lesions) defined as cured. Multi-level logistic regression was done to assess factors associated with cure. A total of 83 patients were enrolled, and final outcomes were available for 72 (86.75%). From these 72, 43 (59.7%, 95% confidence interval 0.44-0.69) were cured at day 90. Adverse effects were common with 69/72 patients (95.8%) reporting injection site pain. Factors associated with cure were age (OR 1.07 95% CI: 1.07-1.27), being male (OR 1.79, 95% CI: 1.10-2.25), size of the lesion (OR 0.79, 95% CI: 0.078-0.94) and skin slit smear (SSS) result +1 grading (OR 1.53, 95% CI: 1.24-1.73) and +2 grading (OR 1.51, 95% CI: 1.41-3.89) compared to the SSS grade +6. CONCLUSION: Our findings revealed that intralesional sodium stibogluconate resulted in a cure rate of around 60%, with almost all patients experiencing injection site pain. This emphasizes the need for local treatment options which are more patient-friendly and have better cure rates.

摘要

背景:在埃塞俄比亚,皮肤利什曼病(CL)通常由利什曼原虫引起,治疗较为困难。葡萄糖酸锑钠(SSG)是唯一常规和广泛使用的抗利什曼原虫治疗药物,可用于严重病变的全身治疗和较小病变的局部治疗。关于SSG 在埃塞俄比亚局部 CL 中的疗效的信息有限,因此需要良好的数据来提高我们对该治疗方法有效性的理解。

方法/主要发现:在埃塞俄比亚东北博鲁梅达综合医院,进行了一项实用(前后准实验)研究,以评估局部 CL 患者使用局部 SSG 的疗效。接受治疗医生分配接受局部 SSG 的患者有资格参加这项研究。研究对象于 2021 年 1 月至 8 月期间招募。每周向病变内注射 SSG,最多可注射 6 剂。然而,当患者的病变在接受 6 剂之前已经治愈时,治疗将不再继续,并且仅要求患者前来进行病变评估。每周进行皮肤划痕涂片(SSS)检查,直到 SSS 转为阴性。在第 90 天评估结果,溃疡病变的 100%上皮再生(for ulcerative lesions)和/或硬结病变的平坦(for indurated lesions)定义为治愈。采用多水平逻辑回归评估与治愈相关的因素。共纳入 83 例患者,72 例(86.75%)患者最终结局可用。在这 72 例患者中,有 43 例(59.7%,95%置信区间 0.44-0.69)在第 90 天治愈。不良事件常见,72 例患者中有 69 例(95.8%)报告注射部位疼痛。与治愈相关的因素包括年龄(OR 1.07,95%CI:1.07-1.27)、男性(OR 1.79,95%CI:1.10-2.25)、病变大小(OR 0.79,95%CI:0.078-0.94)和皮肤划痕涂片(SSS)结果为+1 级(OR 1.53,95%CI:1.24-1.73)和+2 级(OR 1.51,95%CI:1.41-3.89)与 SSS 等级+6 相比。

结论:我们的研究结果表明,局部葡萄糖酸锑钠的治愈率约为 60%,几乎所有患者都经历了注射部位疼痛。这强调了需要更适合患者的局部治疗选择,这些治疗选择具有更好的治愈率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29c6/9491591/3bc8729663fe/pntd.0010578.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29c6/9491591/3bc8729663fe/pntd.0010578.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29c6/9491591/3bc8729663fe/pntd.0010578.g001.jpg

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本文引用的文献

[1]
Miltefosine for the treatment of cutaneous leishmaniasis-A pilot study from Ethiopia.

PLoS Negl Trop Dis. 2021-5

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