Abstract

Drug resistance is one of the global problems, particularly in communicable diseases control including Indonesian malaria elimination program. Since 2004, Artesunate-Amodiaquine (AS+AQ), an Artemisinin based Combination Therapy (ACT), has been used in Indonesia as recommended by the WHO for treatment of acute uncomplicated malaria, replacing of chloroquine resistant antimalarial. Since then, implementation of AS+AQ has never been evaluated. It was reported that AS+AQ coverage was 33,7% because the patients did not comply due to adverse events, and the combination therapy was not a single formulation (fixed-dose). Therefore, there is a need to assess and evaluate the compliance of AS+AQ on subjects malaria treated with AS+AQ at Health Center (Puskesmas) sentinel sites in Kalimantan and Sulawesi.  This was a cross-sectional and non intervention observational study. There were 99 malaria subjects participated in this study.  All subjects were treated with 3 days regimen AS+AQ as the national malaria treatment guideline, and they were followed-up on days 3, 7 and 28. Indepth interview was done in several subjects  as informants and staff of puskesmas for knowledge, attitude, practice (KAP) of AS+AQ used. Of the 99 malaria subjects evaluated, there were 34 P. falciparum, 36 P. vivax, and 29 mixed infection malaria subjects. Almost all the study subjects (92,9%)  completed the therapy. There were 2 subjects withdrawn due to serious adverse event (SAE), 4 subjects were withdrawn because of having severe untolerable adverse events and 1 subject because of lost to follow up. About 84% subjects experienced clinical complaints after AS+AQ administered. Most of the complaints were mild to moderate and tolerable. Overall, the compliance of the 3-day AS+AQ regimen was moderately satisfied. AbstrakResistensi obat merupakan salah satu masalah kesehatan di dunia, khususnya  dalam pengendalian penyakit menular termasuk program pemberantasan malaria di Indonesia. Sejak tahun 2004, Program Pemberantasan Malaria menggunakan Artemisinin-based Combination Therapy (ACT) yaitu kombinasi Artesunat dan Amodiakuin (AS+AQ) untuk pengobatan malaria falciparum dan vivax tanpa komplikasi sebagai pengganti obat malaria klorokuin yang telah resisten. Sejak itu implementasi AS+AQ belum pernah dievaluasi. Telah dilaporkan bahwa cakupan AS+AQ adalah 33,7% kemungkinan karena ketidakpatuhan pasien  akibat keluhan yang ditimbulkan dan formula obat yang tidak tunggal (fixed dose). Penelitian ini bertujuan untuk menilai dan mengevaluasi keluhan dan kepatuhan subyek yang mendapatkan pengobatan AS+AQ pada penderita malaria falciparum, vivax dan campuran falciparum-vivax di puskesmas sentinel di Kalimantan dan Sulawesi. Desain penelitian adalah potong lintang  melibatkan 99 subyek malaria dewasa (usia ≥15 tahun) yang diobati dengan AS+AQ (Artesunat-Amodiakuin) selama 3 hari sesuai dengan pedoman. Upaya tindak lanjut (follow up) kepada subyek dilakukan pada hari ke 3 (H3), hari ke 7 (H7) dan hari ke 28 (H28) setelah minum AS+AQ. Di samping itu, dilakukan wawancara mendalam (kualitatif) pada sejumlah subyek dan tenaga kesehatan untuk menilai Pengetahuan Sikap dan Perilaku (PSP) terhadap kepatuhan pengobatan AS+AQ.Hasil penelitian : Sebagian besar subyek (92,9 %) menyelesaikan terapi dan 7,1% drop out dari penelitian;  dua subyek diantaranya mengalami Serious Adverse Events (SAE), empat subyek mengalami keluhan yang tidak dapat ditolerir dan dua subyek tidak datang pada kunjungan ulang yang telah ditetapkan jadwalnya. Meskipun 84,1% mengalami keluhan setelah minum AS+AQ, namun keluhan bersifat ringan-sedang, masih dapat ditolerir dan jauh berkurang setelah 1 minggu pengobatan. Kesimpulan : pengobatan AS+AQ selama 3 hari relatif masih dapat ditoleransi dan kepatuhan subyek minum obat  masih cukup baik.