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Efficacy and safety of a combined treatment of sodium stibogluconate at 20mg/kg/day with upper maximum daily dose limit of 850mg and Paromomycin 15mg/kg/day in HIV negative visceral leishmaniasis patients. A retrospective study, northwest Ethiopia.
PLOS Neglected Tropical Diseases ( IF 3.8 ) Pub Date : 2021-08-31 , DOI: 10.1371/journal.pntd.0009713
Aschalew Tamiru 1 , Rezika Mohammed 2 , Saba Atnafu 1 , Girmay Medhin 3 , Asrat Hailu 4
Affiliation  

BACKGROUND Visceral leishmaniasis (VL) is one of the most neglected tropical infectious diseases. It is fatal if left untreated. The objective of this study was to assess the efficacy and safety of 17-day injections of combined regimen of sodium stibogluconate and paromomycin (SSG/PM) in HIV-negative VL patients. METHODS A retrospective analysis of medical records of VL patients treated in the University of Gondar Hospital during period 2012-2019 was carried out. RESULTS A total of 2836 patients were treated for VL from 2012 to 2019. Of these 1233 were treated with SSG-PM, and 1000 of them were included in the study. Initial cure was achieved in 922 (92.2%) patients. The frequency of treatment failure, treatment interruptions, default and deaths respectively were 30 (3%), 20 (2%), 13 (1.3%) and 15 (1.5%). Among 280 patients who completed 6-month follow up, the final cure was 93.9% (263/280), 4 (1.4%) relapsed and 13 (4.6%) developed post-kala-azar dermal leishmaniasis (PKDL). The most common adverse events (AEs) were raised liver transaminases (35.1%; 351 patients), injection site pain (29.1%, 291 patients) and raised serum alpha-amylase (29.1%, 291 patients). Factors associated with poor treatment outcomes were sepsis, pneumonia, and adverse events. CONCLUSION A combination of SSG at 20mg/kg with upper daily maximum dose of 850mg and PM was effective for achieving initial cure at end of treatment and safe for treatment of HIV negative VL patients in northwestern Ethiopia. Our data are consistent with previous reports and confirms effectiveness of SSG/PM treatment regimen in the Eastern African countries. Efficacy at 6-months (93.9%) was estimated on data derived from patients who completed follow up and needs to be interrogated by future studies.

中文翻译:

葡萄糖酸钠 20 毫克/公斤/天(每日最大剂量上限为 850 毫克)和巴龙霉素 15 毫克/公斤/天联合治疗 HIV 阴性内脏利什曼病患者的疗效和安全性。一项回顾性研究,埃塞俄比亚西北部。

背景技术内脏利什曼病(VL)是最被忽视的热带传染病之一。如果不及时治疗,这是致命的。本研究的目的是评估 HIV 阴性 VL 患者注射葡萄糖酸钠和巴龙霉素联合方案 (SSG/PM) 17 天的有效性和安全性。方法对 2012 年至 2019 年期间在贡德尔大学医院治疗的 VL 患者的医疗记录进行回顾性分析。结果 2012年至2019年,共有2836名患者接受了VL治疗。其中1233名患者接受了SSG-PM治疗,其中1000名患者被纳入研究。922 名(92.2%)患者获得初步治愈。治疗失败、治疗中断、违约和死亡的频率分别为 30 例 (3%)、20 例 (2%)、13 例 (1.3%) 和 15 例 (1.5%)。在完成 6 个月随访的 280 名患者中,最终治愈率为 93.9% (263/280),其中 4 名 (1.4%) 复发,13 名 (4.6%) 发展为黑热病后皮肤利什曼病 (PKDL)。最常见的不良事件 (AE) 是肝转氨酶升高(35.1%;351 名患者)、注射部位疼痛(29.1%,291 名患者)和血清 α-淀粉酶升高(29.1%,291 名患者)。与不良治疗结果相关的因素包括败血症、肺炎和不良事件。结论 20mg/kg 的 SSG 与每日最大剂量 850mg 的上限和 PM 的组合对于在治疗结束时实现初步治愈是有效的,并且对于埃塞俄比亚西北部的 HIV 阴性 VL 患者的治疗是安全的。我们的数据与之前的报告一致,证实了 SSG/PM 治疗方案在东非国家的有效性。6 个月的疗效 (93.9%) 是根据完成随访的患者的数据估计的,需要通过未来的研究进行询问。
更新日期:2021-08-31
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