双氢青蒿素-磷酸哌喹和蒿甲醚-本芴醇两种复方对海南岛无并发症恶性疟的疗效观察

Efficacy of Dihydroartemisinin-piperaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Falciparum Malaria in Hainan, China

目的观察双氢青蒿素-磷酸哌喹和蒿甲醚-本芴醇两种复方抗疟药对海南岛无并发症恶性疟的治疗效果。方法2005-2006年在海南省5县(市)恶性疟流行区,选择1～60岁无并发症单纯恶性疟病例107例(原虫无性体密度为1000～200000个/μl),病例随机分为2组,A组55例,口服双氢青蒿素-磷酸哌喹治疗(成人总剂量8片,1次/d,疗程为3d,首日4片),B组52例,口服蒿甲醚-本芴醇治疗(成人总剂量24片,2次/d,早晚各服4片,疗程为3d)。按照WHO体内法观察标准进行治疗、观察和随访。结果A组55例,全部完成治疗、观察和28d随访,平均退热时间为(22.35±13.26)h,平均原虫转阴时间为(34.99±12.28)h;B组52例中有51例完成治疗、观察和28d随访,平均退热时间为(20.99±11.38)h,平均原虫转阴时间为(36.45±12.60)h,两组间差异均无统计学意义(P>0.05)。28d随访两组病例均未出现复燃。个别病例在服药后出现中枢神经系统及胃肠道反应,如头痛、恶心、呕吐等,症状较轻,停药后即自行消失。未出现严重的不良反应。结论双氢青蒿素-磷酸哌喹和蒿甲醚-本芴醇两复方治疗海南岛无并发症恶性疟效果好,控制症状快,治愈率高。

Objective To assess the therapeutic efficacy of the combinations dihydroartemisinin-piperaquine and artemether-lumefantrine in treating uncomplicated falciparum malaria cases in an area with high level resistance of Plasmodium falciparum to chloroquine in Hainan Province. Methods Patients aged 1 to 60 with uncomplicated P. falciparum infection and parasite density 1 000 to 200 000 parasites/μl were enrolled following an informed consent. Eligible patients were randomly assigned to 2 groups for receiving either a 3-day course of dihydroartemisinin-piperaquine （40/320 mg, DP, group A） or 6-dose course of artemether/lumefantrine （20/120 mg tablets, AL, group B） over three days. They were followed up with clinical and laboratory examinations until day 28 using standard WHO in vivo antimalarial drug test protocol. Results Altogether 107 eligible patients were enrolled but 106 completed the study. Adequate clinical and parasitological response （ACPR） was observed in 51 （100%） and 55 （100%） cases in groups A and B respectively. The mean time of fever clearance and mean time of asexual parasite clearance were （20.99±11.38） h and （36.45±12.60） h in AL and （22.35±13.26）h and （34.99±12.28）h in DP, respectively. There was no statistical difference on the mean time of fever clearance and asexual parasite clearance between AL and DP（P〉0.05）. None of the participants showed recrudescence and serious adverse effect. Conclusion Both combinations artemether-lumenfantrine and dihydroartemisinin-piperaquine show a high cure rate and proper tolerability among the patients with uncomplicated falciparum malaria in Hainan.