青蒿素哌喹片治疗无并发症恶性疟的剂量探索试验

Dosage exploring of artemisinin-piperaquine in treatment of uncomplicated falciparum malaria

目的探索青蒿素哌喹片治疗无并发症恶性疟的安全有效的适宜剂量。方法收治7～65岁男性和女性病人共100例,按区组随机化方案分成2组,成人总量1400 mg组年龄(22±s12)岁,1750 mg组年龄(21±12)岁。分别于0h和24h给药一次,比较2组的平均原虫转阴和退热时间、28d治愈率及原虫复燃率。结果2组的平均原虫转阴时间分别是(61±19)h和(57±21)h,平均退热时间为(20±15)h和(18±10)h,P>0.05;28 d治愈率是80%和96%,原虫复燃率为20%和4%,总量1750 mg组显著优于1400 mg组(P<0.05)。2组耐受性均良好,未发现明显的不良反应。结论推荐青蒿素哌喹片的临床治疗剂量为总量1750 mg,每日1次,分2d服完为1个疗程。

AIM To explore the effective and safe dosage of artemisinin-piperaquine for uncomplicated falciparum malaria. METHODS One hundred uncomplicated falciparum malaria male and female patients aged from 7 to 65 years old were enrolled in the trial according to randomized block design; equally distributed into 2 dosage groups, the adult total dose 1 400 mg group （mean age （22 ± s 12） years） and the 1 750 mg group （mean age （21 ± 12） years）. Once-daily administration respectively at 0 h and 24 h, comparison were made including the mean parasite clearance time, mean fever clearance time, 28-day cure rates, and parasite recrudescence rates in two groups. RESULTS The mean parasite clearance time were （61 ± 19） h and （57 ±21） h, the mean fever clearance time were （20 ± 15） h and （18 ± 10） h, P〉 0.05; 28-day cure rates were 80 % and 96 %, and parasite recrudescence rates were 20 % and 4 %, respectively. The efficacy of total dose 1 750 mg group is superior to that of the 1 400 mg group （P 〈 0.05）. Patients in both groups showed good tolerance and no obvious adverse reactions. CONCLUSION The recommended total clinical therapeutic dose of artemisinin-piperaquine is 1 750 mg, once daily, taking all together 2 d, as a course.