青蒿琥酯片治疗恶性疟的剂量再探索

A Further Verification of the Dosage of Artesunate in Treatment ofFalciparum Malaria

为探索青蒿琥酯治疗恶性疟的最佳剂量和疗程，本研究在中国海南岛抗性恶性疟流行地区，采用青蒿琥酯片５ｄ疗程总量６００ｍｇ和７ｄ疗程总量８００ｍｇ治疗无并发症恶性疟疾，进行开放性随机比较。每组治疗５０例，全部病例住院２８ｄ观察原虫复燃情况。结果：两组病例临床症状均被迅速控制。５ｄ疗程组和７ｄ疗程组退热时间分别为（２４．０±１３．６）ｈ和（２０．０±１０．１）ｈ，原虫转阴时间分别为（６１．７±２１．１）ｈ和（５５．８±１５．８）ｈ，两组无显著性差异。２８ｄ内原虫复燃率７ｄ组为４．２％（２／４８），５ｄ组为１９．１％（９／４７），治愈率分别为９５．８％和８０．９％。两组比较有非常显著性差异（χ２＝５．２１，Ｐ＜０．０１），表明７ｄ疗程可使复燃率明显下降。两组皆未见临床不良反应。提示青蒿琥酯７ｄ疗程总量８００ｍｇ是一个高治愈率的给药方案，可作为标准疗程剂量。

n open randomized comparative study of artesunate 600mg as a total dose for 5_day course and 800mg for 7_day course in treatment of uncomplicated falciparum malaria has been done in drug_resistant malaria epidemic area of Hainan island, China. Fifty patients were observed in each group and all patients were hospitalized for 28 days.The results showed that all patients were clinically cured.In 5_day and 7_day groups, the mean fever subsidence times(FST) were (24.0±13.6)and (20.0±10.0)hrs and the mean parasite clearance times(PCT) were(61.7±21.1) and (55.8±15.8) hrs respectively, the differences being not significant. In 28 days, the recrudecence rate and curative rate were 4.2%(2/48)and 95.8% in 7_day group, while 19.1%(9/47) and 80.9% in 5_day group respectively, the differences being significant (χ2=5.20,P<0.01).Patients in this area were mostly non_immune to malaria, this may explain the relatively high recrudescence rate in 5_day regimen and an obvious decrease in 7_day regimen. No clinical side effect was found in two groups.It is suggested that artesunate 800mg for 7_day course is a regimen with high curative rate and can be used as a standard dose and a criterion for monitoring sensitivity in vivo.