双氢青蒿素两个复方治疗恶性疟的临床对比研究

Randomized trial of Artekin and Artekin(T) for treatment of uncommplicated falciparum malaria patients

目的 比较双氢青蒿素的两个复方—Artekin与Artekin(T)治疗无并发症恶性疟的有效性和安全性。 方法 收治 60例无并发症恶性疟 ,随机分成两组 ,每组 3 0例 ,采用 2d4次给药 ,成人总量 8片的方案 ,观察治愈率、平均原虫转阴时间、退热时间和副作用。 结果 Artekin组的平均原虫转阴时间为 (5 6 7± 16 3 )h ,Artekin(T)组为 (5 8 4±18 6)h ;平均退热时间Artekin组为 (2 0 2± 1 3 )h ,Artekin(T)组为 (2 2 8± 1 1)h ;随访 2 8d ,两组均有 1例复燃 ,Artekin组和Artekin(T)组治愈率均为 96 7%。两组患者对两复方均有很好的耐受性 ,恶心、腹痛等症状均轻微。 结论 本试验初步显示双氢青蒿素复方高效、速效、低毒等优点。

Objective To compare the efficacy and safety of Artekin and Artekin(T),the two compounds dihydroartemisinin (DHA) for treatment of uncomplicated falciparum malaria patients Methods The 60 cases were randomly divided into 2 groups,each consisted of 30 cases and adult total dose of 8 tablets were given to the 2 groups 4 times in 2 days The cure rate,average parasite clearance time,average fever clearance time and side effects were also observed Results The average parasite clearance time in Artekin groups was (56 7±16 3)h and (58 4±18 6)h in Artekin(T) Group;the average fever clearance time in Artekin group was (20 2±1 3)h and (22 8±1 1)h in Artekin(T) group A recrudescence occurred in each group after a follow-up of 28 days The cure rate in Artekin group and Artekin(T) group was 96 7% The side effect nausea and stomach ache were mild in the two groups Conclusion Artekin and Artekin(T),the compound dihydroartimisinin are of high efficacy,rapid action and low toxicity for treatment of uncomplicated falciparum malaria patients and both of them can be used for treatment of patients in multi-drug resistant falciparum malaria endemic areas