双氢青蒿素哌喹片治疗缅甸拉咱市恶性疟的疗效和安全性评价

Therapeutic Efficacy and Safety of Compound Dihydroartemisinin/piperaquine for Uncomplicated Plasmodium falciparum Infection in Laiza City of Myanmar Bordering on China

目的评价双氢青蒿素哌喹片治疗中缅边境地区缅甸拉咱市恶性疟的疗效和安全性。方法 2008年9～12月,在缅甸拉咱市及隶属于该市的4个自然村开展临床试验,选择2～60岁、原虫密度≥250个/μl血、单纯恶性疟现症病例,用双氢青蒿素哌喹片(每片含双氢青蒿素40 mg,磷酸哌喹320 mg)2天4次疗法治疗,总剂量因体重而异,如50 kg体重患者总剂量8片均分4次口服,每次2片,每次间隔8～10 h,按体重剂量表给药。于服药当天、服药后的第1、2、3、7、14、21和28天随访观察患者症状、原虫密度、体温和药物不良反应。用WHO抗疟药治疗效果分类、退热时间、无性体原虫转阴时间和配子体转阴率评价其疗效。结果共64例完成全程随访,100%完全临床原虫治疗成功,平均退热时间为(22.5±8.2)h,无性体原虫转阴时间中位数为30.0 h[(17.1～168.2)h];服药后第3天和第7天无性体原虫转阴率和退热率分别为(93.8%、100%)和(100%、100%),服药后第28天配子体转阴率为75.0%;仅7例出现轻度不良反应,不良反应率为9.9%(7/71)。结论双氢青蒿素哌喹片治疗缅甸拉咱市恶性疟安全有效。

Objective To assess the efficacy and safety of compound dihydroartemisinin/piperaquine（DHAPIP） for treating uncomplicated falciparum malaria in Laiza city of Myanmar at the China-Myanmar border area.Methods A clinical trial was conducted in Laiza City and its four suburban natural villages bordering with China from September to December in 2008.Patients（aged 2-60 years）infected by Plasmodium falciparum without clinical complications（≥250 asexual parasite·μl-1 of whole blood）were recruited for the assessment.The cases were given a 2-day course with DHAPIP tablets each containing 40 mg of dihydroartemisinin and 320 mg of piperaquine phosphate,and the total dosage varied with the body weight.For example,a patient with 50 kg body weight was given 8 tablets divided into 4 times at an interval of 8-10 h.The cases were then followed-up at D0,D1,D2,D3,D7,D14,D21 and D28 for observing their symptoms,the density of parasite,body temperature and side reaction.The therapeutic efficacy was assessed by using WHO classification of therapeutic response to the treatment of antimalarial drugs,including the time of fever subsidence,the clearance time of asexual parasites and the clearance rate of gametocytes.Results Among the 74 cases enrolled,64 completed 28-day follow-up.The therapeutic efficacy reached 100% with adequate clinical and parasitological responses.The mean fever subsidence time was（22.5±8.2）h.The median of clearance time of asexual parasites in blood was 30.0 h[（17.1～168.2） h].The rate of eliminating asexual parasites and fever subsidence in D3 and D7 was（93.8% and 100%）and（100% and 100%）,respectively.The clearance rate of gametocytes in day-28 was 75.0%.It showed 9.9% of side reaction with 7 cases suffering from mild adverse responses among 71 of full-course medication.Conclusion DHAPIP is efficacious and safe for the treatment of uncomplicated falciparum malaria in Laiza city of Myanmar in the border area.