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两种不同口服青蒿琥酯方案治疗恶性疟的双盲随机临床试验。

Double blind randomised clinical trial of two different regimens of oral artesunate in falciparum malaria.

作者信息

Bunnag D, Viravan C, Looareesuwan S, Karbwang J, Harinasuta T

机构信息

Department of Clinical Tropical Medicine, Mahidol University, Bangkok, Thailand.

出版信息

Southeast Asian J Trop Med Public Health. 1991 Dec;22(4):534-8.

PMID:1820640
Abstract

A double blind randomized comparative trial of the efficacy of 7-day and 5-day courses of oral artesunate at 600 mg was studied in 89 Thai patients with uncomplicated falciparum malaria. Eighty patients completed the 28-day follow-up period. Artesunate was found to be well tolerated in either regimen. There was an increase of 7% in the cure rate obtained from a 7-day regimen. In 43 patients with a 7-day regimen, the cure rate was 92.5% and 15 patients showed P. vivax in their peripheral blood between days 12 and 34. The mean fever and parasite clearance times were 20 and 40 hours, respectively. In 46 patients with a 5-day regimen, the cure rate was 85% and 8 patients showed P. vivax during days 13 and 24. The mean fever and parasite clearance times were 29 and 40 hours, respectively. Although the cure rates of oral artesunate were high in both regimens, the efficacy was considered unsatisfactory since the aim of the treatment is to achieve 100% cure rate. We suggest however that the extension of the duration of treatment to 7 days together with the increase in total dose may improve therapeutic efficacy of artesunate in falciparum malaria.

摘要

对89例非复杂性恶性疟泰国患者开展了一项双盲随机对照试验,研究600毫克口服青蒿琥酯7天疗程和5天疗程的疗效。80例患者完成了28天的随访期。两种治疗方案中,青蒿琥酯耐受性均良好。7天疗程的治愈率提高了7%。43例接受7天疗程的患者中,治愈率为92.5%,15例患者在第12天至34天期间外周血中出现间日疟原虫。平均退热时间和原虫清除时间分别为20小时和40小时。46例接受5天疗程的患者中,治愈率为85%,8例患者在第13天至24天期间出现间日疟原虫。平均退热时间和原虫清除时间分别为29小时和40小时。尽管两种方案中口服青蒿琥酯的治愈率都很高,但由于治疗目标是达到100%治愈率,所以疗效仍被认为不理想。不过,我们建议将治疗时长延长至7天并增加总剂量,可能会提高青蒿琥酯治疗恶性疟的疗效。

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