Karbwang J, Na-Bangchang K, Wattanakoon Y, Thanavibul A, Harinasuta T
Clinical Pharmacology Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Southeast Asian J Trop Med Public Health. 1994 Dec;25(4):702-6.
Twenty-eight male Thai patients with severe falciparum malaria were randomized to receive either artemether for a 5 (300 mg initial dose followed by 100 mg for another 4 days) or a 7 days regimen (160 mg initial dose, followed by 80 mg daily for another 6 days). Thirteen patients received a 5 day regimen and 15 received 7 day regimen. The follow-up period was 28 days. The patients in both groups were comparable in age, body weight, admission parasitemia, hematocrit and white cell count. There were 4 patients in each group who presented with cerebral malaria. The median values of parasite and fever clearance times (PCT and FCT) in the 5 and 7 days regimens were 52 vs 60 hours, and 85 vs 68 hours, respectively. There were 8 and 4 patients, respectively who had recrudescence during days 15 to 25. The cure rates were 38% (95% CI = 14-68%) and 73% (95% CI - 50-96%), respectively for 5 and 7 day regimens. None died in either group. No patients in either group had neurological sequelae after recovery of consciousness. Clinically adverse effects in either group were transient pain at the site of injection. No drug related biochemical or ECG changes were noted in either group. The duration of treatment is the determinant of the cure rate; however, the duration of even 7 days still resulted in high recrudescence rate. It may be necessary to combine artemether with other longer half-life antimalarials to improve the cure rate.
28名患有严重恶性疟原虫疟疾的泰国男性患者被随机分为两组,分别接受为期5天(初始剂量300毫克,随后4天每天100毫克)或7天(初始剂量160毫克,随后6天每天80毫克)的蒿甲醚治疗方案。13名患者接受5天治疗方案,15名患者接受7天治疗方案。随访期为28天。两组患者在年龄、体重、入院时的疟原虫血症、血细胞比容和白细胞计数方面具有可比性。每组各有4名患者出现脑型疟疾。5天和7天治疗方案中寄生虫清除时间(PCT)和发热清除时间(FCT)的中位数分别为52小时对60小时和85小时对68小时。在第15至25天分别有8名和4名患者复发。5天和7天治疗方案的治愈率分别为38%(95%CI = 14 - 68%)和73%(95%CI - 50 - 96%)。两组均无死亡病例。两组患者在意识恢复后均无神经后遗症。两组的临床不良反应均为注射部位短暂疼痛。两组均未观察到与药物相关的生化或心电图变化。治疗持续时间是治愈率的决定因素;然而,即使是7天的治疗持续时间仍导致高复发率。可能有必要将蒿甲醚与其他半衰期更长的抗疟药物联合使用以提高治愈率。