Atia Atia M, Mumina Ann, Tayler-Smith Katherine, Boulle Philippa, Alcoba Gabriel, Elhag Mousab Siddig, Alnour Mubarak, Shah Safieh, Chappuis François, van Griensven Johan, Zachariah Rony
Médecins Sans Frontières - Switzerland, Sudan mission, Gedaref, Sudan.
Médecins Sans Frontières-Brussels Operational Center, Brussels, Luxembourg.
Trop Med Int Health. 2015 Dec;20(12):1674-84. doi: 10.1111/tmi.12603. Epub 2015 Nov 11.
Among patients with primary and relapse visceral leishmaniasis (VL) in eastern Sudan, we determined the proportion eligible for treatment with sodium stibogluconate and paromomycin (SSG/PM) and, of these, their demographic and clinical characteristics; initial treatment outcomes including adverse side effects requiring treatment discontinuation; treatment outcomes by 6 months; and risk factors associated with initial (slow responders) and late treatment failure (relapses and post-kala-azar dermal leishmaniasis, PKDL).
A retrospective cohort study in Tabarak Allah Hospital, Gedaref Province, eastern Sudan, from July 2011 to January 2014.
Of 1252 individuals diagnosed with VL (1151 primary and 101 relapses), 65% were eligible for SSG/PM including 83% children, almost half of them malnourished and anaemic. About 4% of individuals discontinued treatment due to side effects; 0.7% died during treatment. Initial cure was achieved in 93% of 774 primary cases and 77% of 35 relapse cases (P < 0.001). Among the 809 patients eligible for SSG/PM, 218 (27%) were lost to follow-up. Outcomes by six months among the 591 patients with available follow-up data were: definitive cure (n = 506; 86%), relapse (n = 38; 6%), treatment discontinuation (n = 33; 6%), PKDL (n = 7; 1%) and death (n = 7; 1%). Among those completing a full course of SSG/PM, relapses and under-fives were at significantly higher risk of early and late treatment failure, respectively.
Whether SSG/PM as a first-line regimen is an undeniable progress compared to SSG monotherapy, it excluded a considerable proportion of VL patients due to drug safety concerns. We call for accelerated development of new drugs and treatment regimens to improve VL treatment in Sudan.
在苏丹东部原发性和复发性内脏利什曼病（VL）患者中，我们确定了符合使用葡萄糖酸锑钠和巴龙霉素（SSG/PM）治疗条件的患者比例，以及这些患者的人口统计学和临床特征；初始治疗结果，包括因不良反应需要停药的情况；6个月时的治疗结果；以及与初始（反应缓慢者）和晚期治疗失败（复发和黑热病后皮肤利什曼病，PKDL）相关的危险因素。
2011年7月至2014年1月在苏丹东部加达里夫省塔巴拉克·安拉医院进行的一项回顾性队列研究。
在1252例被诊断为VL的患者中（1151例原发性和101例复发性），65%符合使用SSG/PM的条件，其中83%为儿童，几乎一半营养不良和贫血。约4%的患者因副作用停药；0.7%在治疗期间死亡。774例原发性病例中的93%和35例复发病例中的77%实现了初始治愈（P<0.001）。在809例符合使用SSG/PM条件的患者中，218例（27%）失访。在591例有可用随访数据的患者中，6个月时的结果为：彻底治愈（n = 506；86%）、复发（n = 38；6%）、停药（n = 33；6%）、PKDL（n = 7；1%）和死亡（n = 7；1%）。在完成SSG/PM全疗程的患者中，复发患者和5岁以下儿童分别有更高的早期和晚期治疗失败风险。
与葡萄糖酸锑钠单药治疗相比，SSG/PM作为一线治疗方案无疑是一个进步，但由于药物安全性问题，它排除了相当一部分VL患者。我们呼吁加快新药和治疗方案的研发，以改善苏丹的VL治疗。
