Jiao X, Liu G Y, Shan C O, Zhao X, Li X W, Gathmann I, Royce C
Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences (AMMS), Beijing, People's Republic of China.
Southeast Asian J Trop Med Public Health. 1997 Sep;28(3):476-81.
One hundred and two Chinese out-patients with naturally acquired, previously untreated, falciparum malaria were selected to evaluate the efficacy of a new combination anti-malaria therapy, CGP 56697 (artemether plus benflumetol). In this open non-comparative trial each patient received a combination of 80 mg artemether and 480 mg benflumetol given orally at 0, 8, 24 and 48 hours (total: 320 mg artemether, 1,920 mg benflumetol). Patients were kept for 28 days in a transmission-free hospital in an area with chloroquine resistant falciparum malaria to prevent reinfection and to aid diagnosis of recrudescence. Progress and possible adverse effects were monitored by blood film parasitology, blood biochemistry assays, urinalysis, ECG and X-ray. Ninety-eight of the 102 patients were shown to be free of infection at 28 days, a 96.1% cure rate. Parasite reduction at 24 hours was 99.4%. Time to effect complete parasite clearance ranged from 24 to 54 hours (median 30 hours). Time for fever clearance ranged from 6 to 78 hours (median 18 hours). Recrudescence was low (3.9%). No significant adverse side-effects were encountered. It is concluded that CGP 56697, a combination anti-malaria therapy of artemether with benflumetol, offered a rapid and highly effective treatment for acute uncomplicated falciparum malaria in an area of chloroquine-resistant malaria in China.
选取102例自然感染、未经治疗的恶性疟中国门诊患者，以评估新型抗疟联合疗法CGP 56697（蒿甲醚加本芴醇）的疗效。在这项开放性非对照试验中，每位患者在0、8、24和48小时口服80毫克蒿甲醚和480毫克本芴醇的组合（总计：320毫克蒿甲醚，1920毫克本芴醇）。患者在一个存在对氯喹耐药恶性疟的地区的无疟疾传播医院中留观28天，以预防再次感染并协助诊断复发情况。通过血片寄生虫学检查、血液生化检测、尿液分析、心电图和X光检查来监测病情进展和可能出现的不良反应。102例患者中有98例在28天时显示无感染，治愈率为96.1%。24小时时的寄生虫减少率为99.4%。完全清除寄生虫的时间为24至54小时（中位数为30小时）。退热时间为6至78小时（中位数为18小时）。复发率较低（3.9%）。未出现明显的不良副作用。结论是，蒿甲醚与本芴醇的抗疟联合疗法CGP 56697为中国氯喹耐药疟疾地区的急性非复杂性恶性疟提供了快速且高效的治疗方法。
