Artemisinin-napthoquine versus dihydroartemisinin-piperaquine in adult subjects with Plasmodium vivax infection

Abstract

AbstrakLatar belakang: Penelitian ini untuk membandingkan efikasi dan keamanan Artemisinin-Napthoquine(AN) dengan dosis tunggal dan obat pilihan ACT lain, dengan Dihydroartemisinin-Piperaquine (DHP)pada pengobatan P.vivax.Metode: Penelitian ini adalah studi randomisasi terbuka dengan subyek direkrut mulai tahun 2007 – 2008dari RS St Gabriel, Maumere dan RS Polisi, RS Angkatan Darat dan RS Angkatan Laut di Jayapura.Penelitian ini merupakan bagian dari penelitian utama yang sudah dipublikasi sebelumnya. Efikasidinyatakan dengan ketiadaan klinis dan parasit malaria sampai dengan hari ke 42, disebut AdequateClinical and Parasitological Response (ACPR). Keamanan dinyatakan sebagai kejadian sampingan yangditemukan pada setiap kunjungan ulang yang tidak dilaporkan sebelumnya pada hari rekrutmen (h0).Hasil: Total 158 subyek dianalisis. Sejumlah 80 subyek direkrut pada kelompok AN dan 78 dengan DHP.Median Parasite Clearance Estimator (PCE) yaitu 2,32 (kisaran: 1,42 – 7,78; IQR: 1,99 – 2,82) jam padaAN dan 2,05 (kisaran: 1,30 – 8,30; IQR: 1,82 – 2,46) jam pada DHP. Parasite clearance sudah terjadi dalam64 jam. Adequate clinical parasitological response (ACPR) at day 42 was 100% (95% CI: 95,2-100) padaAN, dan 100% (95% CI: 94,9-100) pada DHP. Kejadian Sampingan ditemukan ringan dan dapat ditoleransi.Kesimpulan: Kedua obat memiliki efikasi dan keamanan yang sebanding untuk pengobatan malaria vivaksdewasa. Walaupun pembersihan parasit AN lebih lama dibandingkan DHP, 100% pembersihan terjadipada kedua kelompok pengobatan dalam 64 jam. (Health Science Journal of Indonesia 2015;6:92-8)Kata kunci: malaria, Artemisinin, napthoquine ,dihydroartemisinin, vivax AbstractBackground: This study was to compare the efficacy and safety between Artemisinin-Napthoquine (AN)as a single dose as well as an alternative drug, and Dihydroartemisinin-Piperaquine (DHP) as a three-daystandard regimen on P. vivax infection.Methods: This was an open randomized study performed during the period of April 2007- March 2008 inthree Armed Forces Hospitals in Jayapura, Papua Province, and one private hospital in Maumere, East NusaTenggara Province. This study was a part from previously published study for any malaria infection. Efficacywas the absence of clinical and parasitological malaria until day 42, performed as Adequate Clinical andParasitological Response (ACPR). Safety was performed based on adverse event in any day of follow upwhich never reported at day recruitment (d0).Results: This study analyses 158 P. vivax cases. A total 80 subjects were treated with AN and 78 with DHP.The median Parasite Clearance Estimator (PCE) was 2.32 (range: 1.42 – 7.78; Interquartile Range (IQR): 1.99– 2.82) hours in AN and 2.05 (range: 1.30 – 8.30; IQR: 1.82 – 2.46) hours in DHP group. The parasite clearancewas complete by 64 hours. The ACPR was 100% (95% Confidance Interval (CI): 95.2-100) in the AN, and100% (95% CI: 94.9-100) in the DHP group. Both drugs have similar mild and tolerated adverse events.Conclusions: Both drugs have similar efficacy and safety for the treatment of P. vivax in adults. AlthoughAN has took longer PCE compared to DHP, 100% clearance was achieved in both groups in 64 hours.(Health Science Journal of Indonesia 2015;6:92-8)Key word: malaria, Artemisinin, napthoquine ,dihydroartemisinin, vivax