Rectal versus intravenous quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: A randomized, double-blind clinical trial
Rectal versus intravenous quinine for the treatment of childhood cerebral malaria in Kampala, Uganda: A randomized, double-blind clinical trial
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DOI：
10.1086/522972
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发表时间：
2007-12-01
影响因子：
11.8
通讯作者：
Tumwine, James K.
中科院分区：
文献类型：
--
作者：
Achan, Jane;Byarugaba, Justus;Tumwine, James K.
背景资料。尽管青蒿素衍生物有望用于治疗严重的恶性疟疾，但静脉注射奎宁仍然是最负担得起的治疗方法。然而，在非洲农村地区，由于缺乏简单的设备或训练有素的工作人员，静脉注射奎宁往往是不可行的。我们比较了直肠内奎宁和静脉奎宁治疗儿童脑型疟疾的疗效和安全性。方法：研究方法。在乌干达国家转诊医院穆拉戈医院(乌干达坎帕拉)进行的一项随机双盲临床试验中，我们研究了110名患有脑型疟疾的6个月至5岁儿童。患者随机接受直肠内或静脉注射奎宁。主要观察指标包括寄生虫清除时间、发热消失时间、昏迷恢复时间、无支撑坐位时间、开始口服奎宁时间、口服奎宁耐受性时间和死亡率。总体而言，两组的临床和寄生虫学结果没有差异(数据是偏差，直肠内奎宁组和静脉奎宁组)：昏迷恢复时间，h对平均+/-标准19.4+/-18.1 h；发热消失时间，h对h；寄生虫清除时间，h对17.0+/-12.1 h；发热清除26.7+/-16.1 h对29.9+/-18.1 h；寄生虫清除43.2+/-14.2h。两组死亡率相似；直肠内注射奎宁组56例死亡4例，静脉注射奎宁组54例死亡5例(优势比1.3，95%可信区间0.3-5.2)。直肠内注射奎宁耐受性良好，近期未发生重大不良反应。直肠内注射奎宁是有效的，可以作为治疗儿童脑型疟疾的替代方案，特别是在静脉治疗不可行的情况下。
Background. Although artemesinin derivatives are promising for the treatment of severe Plasmodium falciparum malaria, intravenous quinine remains the most affordable treatment. However, administration of intravenous quinine is often not feasible in rural areas in Africa because of the lack of simple equipment or trained staff. We compared the efficacy and safety of intrarectal quinine with those of intravenous quinine in the treatment of childhood cerebral malaria. Methods. In a randomized, double-blind clinical trial at Mulago Hospital (Kampala, Uganda), Uganda's national referral hospital, we studied 110 children aged 6 months to 5 years who had cerebral malaria. Patients were randomized to receive either intrarectal or intravenous quinine. Main outcome measures included parasite clearance time, fever clearance time, coma recovery time, time to sit unsupported, time to begin oral intake, time until oral quinine was tolerated, and death.Results. Overall, there was no difference in the clinical and parasitological outcomes between the 2 groups (data are deviation, intrarectal quinine group vs. intravenous quinine group): coma recovery time, h versus mean +/- standard 19.4 +/- 18.1 h; fever clearance time, h versus h; and parasite clearance time, h versus 17.0 +/- 12.1 h; fever clearance 26.7 +/- 16.1 h versus 29.9 +/- 18.1 h; and parasite clearance 43.2 +/- 14.2 h. Mortality was similar in both groups; 4 of 56 patients in the intrarectal quinine group died, and 5 of 54 patients 41.9 +/- 15.2 in the intravenous quinine group died (odds ratio, 1.3; 95% confidence interval, 0.3-5.2). Intrarectal quinine was well tolerated, and no major immediate adverse events occurred.Conclusions. Intrarectal quinine is efficacious and could be used as an alternative in the treatment of childhood cerebral malaria, especially in situations in which intravenous therapy is not feasible.