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.
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.
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以20mg/kg/day的综合治疗对hiv阴性内脏利什曼病患者的效应和安全性，以20mg/kg/day的最大每日剂量极限为850mg/kg/day，每天15mg/kg/day的疗效和安全性。埃塞俄比亚西北的回顾性研究。
DOI：
10.1371/journal.pntd.0009713
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发表时间：
2021-08
影响因子：
3.8
通讯作者：
Hailu A
中科院分区：
文献类型：
--
作者：
Tamiru A;Mohammed R;Atnafu S;Medhin G;Hailu A
内脏利什曼病（VL）是最被忽视的热带传染病之一。如果不治疗是致命的。本研究的目的是评估葡萄糖酸锑钠和巴龙霉素（SSG/PM）联合方案注射17天治疗HIV阴性VL患者的疗效和安全性。对2012 - 2019年期间在贡达尔大学医院接受治疗的VL患者的病历进行了回顾性分析。2012年至2019年，共有2836例患者接受了VL治疗。其中1233人接受SSG-PM治疗，其中1000人被纳入研究。922例（92.2%）患者达到初始治愈。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例患者中，最终治愈率为93.9%（263/280），4例（1.4%）复发，13例（4.6%）出现黑热病后皮肤利什曼病（PKDL）。最常见的不良事件（AE）为肝转氨酶升高（35.1%，351例患者）、注射部位疼痛（29.1%，291例患者）和血清α-淀粉酶升高（29.1%，291例患者）。与不良治疗结果相关的因素是败血症、肺炎和不良事件。在埃塞俄比亚西北部，SSG 20 mg/kg（每日最大剂量上限为850 mg）和PM联合治疗可有效实现治疗结束时的初步治愈，并且对治疗HIV阴性VL患者是安全的。我们的数据与以前的报告一致，证实了SSG/PM治疗方案在东非国家的有效性。根据来自完成随访且需要在未来研究中询问的患者的数据估计6个月时的疗效（93.9%）。内脏利什曼病是由利什曼属寄生虫引起的最被忽视的热带疾病之一。我们评估了一个17天的联合治疗方案，即葡萄糖酸锑钠20 mg/kg/天，每日最大剂量上限为850 mg，巴龙霉素15 mg/kg/天注射治疗HIV阴性内脏利什曼病患者的疗效和安全性。我们还确定了与SSG/PM治疗的HIV阴性VL患者的治疗结果不佳相关的因素。72%的研究参与者在初始治疗过程中发生了至少一起AE，但大多数AE是可逆的。总体初始疗效为92.2%，与东非既往研究结果相当。在完成6个月随访的患者中，疗效为93.9%，由于6个月随访时评价的患者比例较小（29%），因此似乎存在偏倚。结果证实，葡萄糖酸锑钠（20 mg/kg B. wt）和巴龙霉素（15 mg/kg B. wt）联合给药17天在东非VL流行国家仍然有效。该数据适用于HIV阴性且未出现严重体征/症状的VL患者。
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. A retrospective analysis of medical records of VL patients treated in the University of Gondar Hospital during period 2012–2019 was carried out. 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. 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. Visceral leishmaniasis is one of the most neglected tropical diseases caused by the parasite of the genus leishmania. We assessed the efficacy and safety of a 17-day combined regimen of sodium stibogluconate 20mg/kg /day with daily upper maximum dose limit of 850mg and paromomycin 15mg/kg/day injections in HIV negative visceral leishmaniasis patients. We also identified factors associated with poor treatment outcomes in HIV negative VL patients treated with SSG/PM. Seventy two percent of the study participants developed at least one AE during the initial treatment course but most AEs were reversible. The overall initial efficacy was 92.2% which is comparable with previous study results in East Africa. Among patients who completed six-month follow-up, the efficacy was 93.9%, which appears to be biased due to the small proportion of patients (29%) evaluated at 6-month follow-up. The results affirm that the combination of sodium stibogluconate (20mg/kg b.wt) and paromomycin (15mg/kg b.wt) given for 17 days is still effective in Eastern Africa VL endemic countries. This data applies to VL patients who are HIV negative and not presenting with severe signs/symptoms.
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影响因子：
3.7
作者：
Ostyn B;Hasker E;Dorlo TP;Rijal S;Sundar S;Dujardin JC;Boelaert M
通讯作者：
Boelaert M
影响因子：
3.8
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通讯作者：
Leishmaniasis East Africa Platform (LEAP) group
影响因子：
3.8
作者：
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影响因子：
3.3
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3.8
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