Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial.
Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial.
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DOI：
10.1371/journal.pctr.0020020
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发表时间：
2007-05-18
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影响因子：
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通讯作者：
Dorsey, Grant
中科院分区：
文献类型：
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作者：
Kamya, Moses R;Yeka, Adoke;Dorsey, Grant
目的：比较蒿甲醚-苯芴醇（AL）和双氢青蒿素-哌喹（DP）治疗乌干达单纯恶性疟疾的有效性和安全性。设计：随机单盲临床试验。地点：乌干达的Apac，一个疟疾传播强度非常高的地区。参与者：患有单纯恶性疟疾的6个月至10岁的儿童。干预：用AL或DP治疗疟疾，每种都遵循标准的3-d给药方案.OUTCOME MEASURES：28和42 d时复发性寄生虫血症的风险，未调整和通过基因分型调整以区分复发和新感染。在421名入组受试者中，417名（99%）完成了随访。随访28 d（11% vs 29%;风险差异[RD] 18%，95%置信区间[CI] 11%-26%）和42 d（43% vs 53%; RD 9.6%，95% CI 0%-19%）后，DP治疗受试者复发恶性疟原虫血症的未校正风险显著低于AL治疗受试者。同样，在28 d（1.9% vs 8.9%; RD 7.0%，95% CI 2.5%-12%）和42 d（6.9% vs 16%; RD 9.5%，95% CI 2.8%-16%）后，DP治疗受试者因可能复发（经基因分型调整）而导致的复发性寄生虫血症风险显著低于AL治疗受试者。DP治疗的患者有一个较低的风险复发寄生虫血症由于非恶性疟原虫物种，配子体血症的发展，和更高的平均增加血红蛋白相比，AL治疗的患者。这两种药物耐受性良好，严重的不良事件是罕见的，无关的研究drugs.CONCLUSION：DP是上级AL减少复发寄生虫血症和配子体血症的风险，并提供改善血红蛋白恢复。因此，DP似乎是一个很好的替代AL作为一线治疗无并发症的疟疾在乌干达。为了最大限度地发挥青蒿素类复方疗法在非洲的效益，治疗应与降低疟疾传播强度的积极战略相结合。
OBJECTIVES: To compare the efficacy and safety of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treating uncomplicated falciparum malaria in Uganda.DESIGN: Randomized single-blinded clinical trial.SETTING: Apac, Uganda, an area of very high malaria transmission intensity.PARTICIPANTS: Children aged 6 mo to 10 y with uncomplicated falciparum malaria.INTERVENTION: Treatment of malaria with AL or DP, each following standard 3-d dosing regimens.OUTCOME MEASURES: Risks of recurrent parasitemia at 28 and 42 d, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections.RESULTS: Of 421 enrolled participants, 417 (99%) completed follow-up. The unadjusted risk of recurrent falciparum parasitemia was significantly lower for participants treated with DP than for those treated with AL after 28 d (11% versus 29%; risk difference [RD] 18%, 95% confidence interval [CI] 11%-26%) and 42 d (43% versus 53%; RD 9.6%, 95% CI 0%-19%) of follow-up. Similarly, the risk of recurrent parasitemia due to possible recrudescence (adjusted by genotyping) was significantly lower for participants treated with DP than for those treated with AL after 28 d (1.9% versus 8.9%; RD 7.0%, 95% CI 2.5%-12%) and 42 d (6.9% versus 16%; RD 9.5%, 95% CI 2.8%-16%). Patients treated with DP had a lower risk of recurrent parasitemia due to non-falciparum species, development of gametocytemia, and higher mean increase in hemoglobin compared to patients treated with AL. Both drugs were well tolerated; serious adverse events were uncommon and unrelated to study drugs.CONCLUSION: DP was superior to AL for reducing the risk of recurrent parasitemia and gametocytemia, and provided improved hemoglobin recovery. DP thus appears to be a good alternative to AL as first-line treatment of uncomplicated malaria in Uganda. To maximize the benefit of artemisinin-based combination therapy in Africa, treatment should be integrated with aggressive strategies to reduce malaria transmission intensity.