van den Broek Ingrid, Amsalu Ribka, Balasegaram Manica, Hepple Pamela, Alemu Engudaye, Hussein El Badri, Al-Faith Muhammed, Montgomery Jacqui, Checchi Francesco
Manson's Unit, MSF -UK, 67-74 Saffron Hill, London EC1N, UK.
Malar J. 2005 Feb 24;4:14. doi: 10.1186/1475-2875-4-14.
The treatment for Plasmodium falciparum malaria in Sudan has been in process of change since 2003. Preceding the change, this study aimed to determine which artemisinin-based combination therapies is more effective to treat uncomplicated malaria in Malakal, Upper Nile, Sudan.
Clinical trial to assess the efficacy of 2 antimalarial therapies to treat P. falciparum infections in children aged 6-59 months, in a period of 42 days after treatment.
A total of 269 children were followed up to 42 days. Artesunate plus Sulfadoxine/Pyrimethamine (AS+SP) and Artesunate plus Amodiaquine (AS+AQ) were both found to be efficacious in curing malaria infections by rapid elimination of parasites and clearance of fever, in preventing recrudescence and suppressing gametocytaemia. The combination of AS+SP appeared slightly more efficacious than AS+AQ, with 4.4% (4/116) versus 15% (17/113) of patients returning with malaria during the 6-week period after treatment (RR = 0.9, 95% CI 0.81-0.96). PCR analysis identified only one recrudescence which, together with one other early treatment failure, gave efficacy rates of 99.0% for AS+AQ (96/97) and 99.1% for AS+SP (112/113). However, PCR results were incomplete and assuming part of the indeterminate samples were recrudescent infections leads to an estimated efficacy ranging 97-98% for AS+SP and 88-95% for AS+AQ.
These results lead to the recommendation of ACT, and specifically AS+SP, for the treatment of uncomplicated falciparum malaria in this area of Sudan. When implemented, ACT efficacy should be monitored in sentinel sites representing different areas of the country.
自2003年以来,苏丹恶性疟原虫疟疾的治疗方法一直在变化。在这一变化之前,本研究旨在确定哪种以青蒿素为基础的联合疗法在苏丹上尼罗州马拉卡勒治疗非复杂性疟疾更有效。
进行一项临床试验,以评估两种抗疟疗法在治疗6至59个月大儿童恶性疟原虫感染后的42天内的疗效。
共有269名儿童接受了42天的随访。发现青蒿琥酯加磺胺多辛/乙胺嘧啶(AS+SP)和青蒿琥酯加阿莫地喹(AS+AQ)在通过快速清除寄生虫和退热来治愈疟疾感染、预防复发以及抑制配子体血症方面均有效。AS+SP组合似乎比AS+AQ稍有效,治疗后6周内疟疾复发的患者比例分别为4.4%(4/116)和15%(17/113)(RR = 0.9,95% CI 0.81 - 0.96)。PCR分析仅确定了一例复发,连同另一例早期治疗失败,AS+AQ的有效率为99.0%(96/97),AS+SP的有效率为99.1%(112/113)。然而,PCR结果不完整,假设部分不确定样本为复发感染,则估计AS+SP的有效率为97 - 98%,AS+AQ的有效率为88 - 95%。
这些结果导致推荐使用青蒿素联合疗法,特别是AS+SP,用于治疗苏丹该地区的非复杂性恶性疟。实施后,应在代表该国不同地区的哨点监测青蒿素联合疗法的疗效。