RESUMEN
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 (> or = 250 asexual parasite x microl(-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 DO, 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.