A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria
A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria
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DOI：
10.1056/nejm199607113350202
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发表时间：
1996-07-11
影响因子：
158.5
通讯作者：
White, NJ
中科院分区：
文献类型：
--
作者：
Hien, TT;Day, NPJ;White, NJ
背景青蒿素(青蒿素)及其衍生物是从中国植物中提取的速效抗疟疾药物。初步研究表明，这些药物在治疗严重疟疾方面可能比奎宁更有效。我们在越南研究了蒿甲醚，那里的恶性疟原虫降低了对奎宁的敏感性。方法我们对560名患有严重恶性疟疾的成年人进行了随机双盲试验。276人肌肉注射奎宁(每公斤体重20毫克，然后每公斤8小时10毫克)，284人肌肉注射蒿甲醚(每公斤4毫克，每8小时每公斤2毫克)。结果蒿甲醚组死亡36例(13%)，奎宁组死亡47例(17%；P=0.16；服用蒿甲醚组的相对死亡风险为0.74；95%可信区间为0.5~1.11)。蒿甲醚组寄生虫清除较快(平均72小时对90小时，P<；0.001)，但发热消退较慢(127对90小时，P<；0.001)，昏迷恢复时间较长(66对48小时，P=0.003)，住院时间较长(288对240小时，P=0.005)。服用奎宁的患者发生低血糖的风险较高(相对危险度为2.7；95%可信区间为1.7~4.4；P<；0.001)，但两组患者均未见其他严重副作用。结论蒿甲醚是治疗成人重症疟疾的理想替代药物。(C)1996年，马萨诸塞州医学会。
Background Artemisinin (qinghaosu) and its derivatives are rapidly effective antimalarial drugs derived from a Chinese plant. Preliminary studies suggest that these drugs may be more effective than quinine in the treatment of severe malaria. We studied artemether in Vietnam, where Plasmodium falciparum has reduced sensitivity to quinine.Methods We conducted a randomized, double-blind trial in 560 adults with severe falciparum malaria. Two hundred seventy-six received intramuscular quinine dihydrochloride (20 mg per kilogram of body weight followed by 10 mg per kilogram every eight hours), and 284 received intramuscular artemether (4 mg per kilogram followed by 2 mg per kilogram every eight hours). Both drugs were given for a minimum of 72 hours.Results There were 36 deaths in the artemether group (13 percent) and 47 in the quinine group (17 percent; P = 0.16; relative risk of death in the patients given artemether, 0.74; 95 percent confidence interval, 0.5 to 1.11). The parasites were cleared more quickly from the blood in the artemether group (mean, 72 vs. 90 hours; P < 0.001); however, in this group fever resolved more slowly (127 vs. 90 hours, P < 0.001), the time to recovery from coma was longer (66 vs. 48 hours, P = 0.003), and the hospitalization was longer (288 vs. 240 hours, P = 0.005). Quinine treatment was associated with a higher risk of hypoglycemia (relative risk, 2.7; 95 percent confidence interval, 1.7 to 4.4; P < 0.001), but there were no other serious side effects in either group.Conclusions Artemether is a satisfactory alternative to-quinine for the treatment of severe malaria in adults. (C) 1996, Massachusetts Medical Society.