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一项评估蒿甲醚治疗重症恶性疟疗效的开放性研究。

An open study to evaluate the efficacy of artemether in severe falciparum malaria.

作者信息

Sharma P, Swarup D, Saxena G N, Bhandari S, Sharma U B, Tuteja R

机构信息

Upgraded Department of Medicine, SMS Medical College and Hospital, Jaipur.

出版信息

J Assoc Physicians India. 1999 Sep;47(9):883-5.

Abstract

An open clinical trial was conducted in 30 patients of severe falciparum malaria with heavy parasitaemia (parasitized erythrocytes above 5%). Artemether (methyl ether of dihydroartemisinin-active principle isolated from Chinese plant Qinghaosu) was administered as 80 mg intramuscular injection twice on first day and then single dose of 80 mg intramuscular on 2nd to 5th day. The trial could be completed in 28 patients and two patients expired. In our observation falciparum malaria affected the young adults in their most productive period of life i.e. 25-44 yrs. All patients became afebrile by the 4th day with fever clearance time approximately 31.92 +/- 15.30 hr. Twenty-five patients (83.33%) became parasite free by 5th day with mean parasite clearance time approximately 47.04 +/- 19.95 hr. Deranged liver function and renal profile was observed in 63% and 50% patients respectively. Two patients, who died had very high degree of parasitaemia (50% and 16%) with cerebral malaria. One died due to multiorgan failure and other due to massive hematemesis and shock. The type of response achieved by artemether therapy was analysed as per WHO criteria suggested for chloroquine resistance. S response was observed in 25 patients (cure rate 83.33%). Two patients (6.66%) patients showed R II response, one patient (3.33%) showed R III response and R I response was not observed in any patient. No significant side effects were noted. This pilot study demonstrated that intramuscular artemether is a useful addition to antimalarial drugs in this era of multidrug resistant P. falciparum malaria showing high clinical potency with virtually no side effect.

摘要

对30例重度恶性疟且寄生虫血症严重(寄生红细胞高于5%)的患者进行了一项开放性临床试验。蒿甲醚(从中国植物青蒿中分离出的双氢青蒿素的甲基醚——活性成分)在第1天给予80毫克肌肉注射,每日2次,然后在第2至5天给予80毫克肌肉注射的单剂量。该试验在28例患者中完成,2例患者死亡。在我们的观察中,恶性疟影响了处于生命中最具生产力时期的年轻人,即25 - 44岁。所有患者在第4天时退热,发热清除时间约为31.92 +/- 15.30小时。25例患者(83.33%)在第5天时疟原虫清除,平均疟原虫清除时间约为47.04 +/- 19.95小时。分别在63%和50%的患者中观察到肝功能和肾功能紊乱。两名死亡患者患有脑型疟,寄生虫血症程度非常高(分别为50%和16%)。一名患者死于多器官功能衰竭,另一名死于大量呕血和休克。根据世界卫生组织针对氯喹耐药性建议的标准,分析了蒿甲醚治疗所取得的反应类型。25例患者出现S反应(治愈率83.33%)。2例患者(6.66%)表现为R II反应,1例患者(3.33%)表现为R III反应,未观察到任何患者出现R I反应。未观察到明显副作用。这项初步研究表明,在耐多药恶性疟的这个时代,肌肉注射蒿甲醚是抗疟药物的一种有用补充,显示出高临床效力且几乎无副作用。

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