Efficacy of Artemisinin-Naphtoquine and Dihydroartemisinin-Piperaquine for uncomplicated malaria patient at primary health care

Abstract

AbstrakLatar belakang: Hasil uji klinik terdahulu terhadap artemisinin-naftokuin (ANT) dosis sekali minum pada pengobatan pasien dewasa dengan malaria tanpa komplikasi menunjukkan aman, dapat ditoleransi, dan sangat efektif. Data tambahan dibutuhkan untuk verifikasi keamanan dan efikasi dari kelompok umur lainnya sebelum obat baru ini dapat digunakan secara luas di Puskesmas di Indonesia. Metode: Pada penelitian ini, kami menggunakan modifikasi pedoman uji klinis WHO 2009. Studi kuasi- eksperimental ini membandingkan dua paralel grup, subjek dengan ANT di 5 puskesmas rawat inap, dan subjek dengan obat kontrol dihidroartemisinin-piperakuin (DHP) minum obatnya di 5 puskesmas rawat jalan. Hasil: Dari total 182 subjek yang direkrut, 168 kasus malaria yang dianalisis dalam uji klinik ini. Mereka adalah 71 kasus dalam ANT grup dan 97 kasus dalam DHP grup. Karakteristik subjek yang mendapat ANT dan DHP saat rekrutmen adalah Sama kecuali proporsi subjek dengan suhu aksila ≥37.50C, dan proporsi subjek dengan anemia (Hb <11 g/dl) di ANT grup lebih tinggi dibanding DHP grup (61.8% vs23.8%, and 83.1% vs 48.5%). Subjek ANT grup juga lebih rendah proporsi parasite asexualnya pada hari ke-3 dibanding DHP grup (1.4% vs 10.3%). Efikasi terapetik ANT dan DHP adalah 95.1% (95% CI: 88.8-99.1) dan 91.9% (95% CI:84.3-96.0) pada hari 42. Kedua obat memiliki kejadian sampingan ringan.Kesimpulan: Penggunaan ANT adalah aman dan memiliki efikasi yang sama dengan DHP untuk pengobatan pasien dewasa dan anak dengan malaria tanpa komplikasi di Puskesmas. (Health Science Indones 2014;2:100-5).Kata kunci: semua umur, malaria, artemisinin-naftokuin, dihidroartemisinin-piperakuin, puskesmas.AbstractBackground: Our previous study of single dose artemisinin-naphthoquine (ANT) in adult majority male patients showed it as a safe, tolerable, and very effective treatment for uncomplicated malaria. More data is required to verify safety and efficacy from other age groups before this new drug could be widely used in Primary Health Care (PHC)s in Indonesia.Methods: For this study, we modified the 2009 WHO guidelines for clinical trials. This quasi-experimental study compared two parallel groups, subjects given ANT at 5 PHCs with inpatient facilities, and subjects given the control drug dihydroartemisinin-piperaquine (DHP) administered to subjects at 5 PHCs without inpatient facilities. Results: Of a total 182 recruited subjects, 168 malaria cases could be analyzed. There were 71 cases in the ANT group and 97 cases in the DHP group. The characteristics of subjects receiving ANT and DHP at baseline were similar except the proportion of axillary temperature ≥37.50C, and proportion of anaemic subjects (Hb <11 g/dl) in the ANT group were higher than DHP group (61.8% vs 23.8%, and 83.1% vs 48.5%). Subjects in ANT group also had a lower proportion of asexual parasitemia on day-3 than DHP group (1.4% vs 10.3%). The therapeutic efficacy of ANT and DHP, were 95.1% [95% confidence interval (CI) = 88.8-99.1] and 91.9% (95% CI = 84.3-96.0) by day 42. Both drugs had mild adverse events. Conclusion: The use of ANT is safe and has similar efficacy to DHP for treatment of adults and children patient with uncomplicated malaria at Primary Health Care. (Health Science Indones 2014;2:100-5).Key words: malaria, artemisinin-naphthoquine, dihydroartemisinin-piperaquine, primary health care.

Keywords

• malaria, artemisinin-naphthoquine, dihydroartemisinin-piperaquine, primary health care.