Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial.
Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial.
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DOI：
10.1136/bmj.b2763
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发表时间：
2009-07-21
期刊：
影响因子：
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通讯作者：
Talisuna AO
中科院分区：
文献类型：
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作者：
Achan J;Tibenderana JK;Kyabayinze D;Wabwire Mangen F;Kamya MR;Dorsey G;D'Alessandro U;Rosenthal PJ;Talisuna AO
目的比较口服奎宁与蒿甲醚-氨苯曲明治疗儿童单纯性疟疾的疗效。设计随机、开放标签有效性研究。设置乌干达坎帕拉国家转诊医院门诊。参与者175名6至59个月的儿童，患有无并发症的疟疾。干预措施参与者被随机分配接受由护理人员在家给药的口服奎宁或蒿甲醚-氨苯曲明。主要结局指标主要结局是28天随访后的寄生虫治愈率，未调整和通过基因分型调整以区分复发和新感染。次要结果是对研究药物的依从性、配子体的存在、第28天血红蛋白浓度从基线恢复以及安全性。结果生存分析显示，未经基因分型调整的蒿甲醚-氨芳汀组治愈率为96%，奎宁组为64%（风险比为10.7,95%可信区间为3.3 ~ 35.5，P=0.001）。在奎宁组中，69%（18/26）的寄生虫学失败是由于复发，而蒿甲醚-氨芳啶组中没有。蒿甲醚-甲基芳啶的平均依从性为94.5%，奎宁的平均依从性为85.4% （P=0.0008）。依从性水平达到80%或以上与治疗失败风险降低相关（0.44,0.19至1.02，P=0.06）。两组之间的不良事件没有差异。结论奎宁7天疗程治疗乌干达儿童无并发症疟疾的有效性明显低于蒿甲醚-甲氧苄啶。这些发现对推荐奎宁治疗非洲无并发症疟疾的可取性提出了质疑。试验注册ClinicalTrials.gov NCT00540202。
Objective To compare the effectiveness of oral quinine with that of artemether-lumefantrine in treating uncomplicated malaria in children. Design Randomised, open label effectiveness study. Setting Outpatient clinic of Uganda’s national referral hospital in Kampala. Participants 175 children aged 6 to 59 months with uncomplicated malaria. Interventions Participants were randomised to receive oral quinine or artemether-lumefantrine administered by care givers at home. Main outcome measures Primary outcomes were parasitological cure rates after 28 days of follow-up unadjusted and adjusted by genotyping to distinguish recrudescence from new infections. Secondary outcomes were adherence to study drug, presence of gametocytes, recovery of haemoglobin concentration from baseline at day 28, and safety profiles. Results Using survival analysis the cure rate unadjusted by genotyping was 96% for the artemether-lumefantrine group compared with 64% for the quinine group (hazard ratio 10.7, 95% confidence interval 3.3 to 35.5, P=0.001). In the quinine group 69% (18/26) of parasitological failures were due to recrudescence compared with none in the artemether-lumefantrine group. The mean adherence to artemether-lumefantrine was 94.5% compared with 85.4% to quinine (P=0.0008). Having adherence levels of 80% or more was associated with a decreased risk of treatment failure (0.44, 0.19 to 1.02, P=0.06). Adverse events did not differ between the two groups. Conclusions The effectiveness of a seven day course of quinine for the treatment of uncomplicated malaria in Ugandan children was significantly lower than that of artemether-lumefantrine. These findings question the advisability of the recommendation for quinine therapy for uncomplicated malaria in Africa. Trial registration ClinicalTrials.gov NCT00540202.