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首页> 外文期刊>The Lancet >Efficacy of rectal artesunate compared with parenteral quinine in initial treatment of moderately severe malaria in African children and adults: a randomised study.
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Efficacy of rectal artesunate compared with parenteral quinine in initial treatment of moderately severe malaria in African children and adults: a randomised study.

机译：直肠青蒿琥酯与肠胃外奎宁相比在非洲儿童和成人中度重度疟疾的初始治疗中的疗效：一项随机研究。

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摘要

BACKGROUND: Many patients with malaria of increasing severity cannot take medicines orally, and delay in injectable treatment can be fatal. We aimed to assess the reliability of absorption, antimalarial efficacy, and tolerability of a single rectal dose of artesunate in the initial management of moderately severe falciparum malaria. METHODS: 109 children and 35 adults were randomly assigned to rectal artesunate (single dose of about 10 mg/kg) or parenteral quinine treatment (10 mg/kg at 0, 4, and 12 h). The primary endpoint was the proportion of patients with peripheral asexual parasitaemia of less than 60% of that at baseline after 12 h. Secondary endpoints were clinical response and concentrations of drug in plasma. Analysis was by intention-to-treat. FINDINGS: All artesunate-treated patients had pharmacodynamic or pharmacokinetic evidence of adequate drug absorption. 80 (92%) of 87 artesunate-treated children had a 12 h parasite density lower than 60% of baseline, compared with three of 22 (14%) receiving quinine (relative risk 0.09 [95% CI 0.04-0.19]; p<0.0001). In adults, parasitaemia at 12 h was lower than 60% of baseline in 26 (96%) of 27 receiving artesunate, compared with three (38%) of eight receiving quinine (relative risk 0.06 [0.01-0.44]; p=0.0009). These differences were greater at 24 h. Clinical response was equivalent with rectal artesunate and parenteral quinine. INTERPRETATION: A single rectal dose of artesunate is associated with rapid reduction in parasite density in adults and children with moderately severe malaria, within the initial 24 h of treatment. This option is useful for initiation of treatment in patients unable to take oral medication, particularly where parenteral treatment is unavailable.
机译：背景：许多疟疾病情日益严重的患者无法口服药物，而延迟注射治疗可能是致命的。我们旨在评估在中度严重恶性疟疾的初始治疗中单次直肠剂量青蒿琥酯的吸收可靠性，抗疟疾效力和耐受性。方法：将109名儿童和35名成人随机分配到直肠青蒿琥酯（单剂量约10 mg / kg）或肠胃外奎宁治疗（0、4和12 h分别为10 mg / kg）。主要终点是12小时后外周无性寄生虫血症的患者比例低于基线时的60％。次要终点是临床反应和血浆药物浓度。分析是按意向性进行的。结果：所有青蒿琥酯治疗的患者均具有足够药物吸收的药效学或药代动力学证据。在接受青蒿琥酯治疗的87名儿童中，有80名（92％）的12 h寄生虫密度低于基线的60％，而接受奎宁的22名中的3名（14％）则有3名（相对风险0.09 [95％CI 0.04-0.19]; p < 0.0001）。在成年人中，接受青蒿琥酯的27例中有26例（96％）的12小时寄生虫血症低于基线的60％，而接受奎宁的8例中有3例（38％）（相对风险0.06 [0.01-0.44]; p = 0.0009） 。这些差异在24小时时更大。临床反应与直肠青蒿琥酯和肠胃外奎宁相当。解释：青蒿琥酯的单次直肠剂量与在治疗的最初24小时内成人和患有中度严重疟疾的儿童的寄生虫密度快速降低有关。此选项对于无法服用口服药物的患者尤其是在无法进行肠胃外治疗的患者中开始治疗很有用。

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