Efektivitas terapi artemeter dan primakuin versus klorokuin dan primakuin pada anak-anak penderita malaria tanpa komplikasi di wilayah Puskesmas Kokap, Samigaluh, Girimulyo Kabupaten Kulon Progo

YULIANI, Margareta, Prof.dr. Tony Sadjimin, MPH.,MSc.,Ph.D.,Sp.A.(K)

2004 | Tesis | PPDS I Ilmu Kesehatan Anak

Intisari : Latar Belakang. Malaria merupakan salah satu penyakit menular yang mempengaruhi angka kematian bayi, anak, dan ibu melahirkan, serta dapat menurunkan produktivitas kerja. Salah satu kendala dalam penanggulangan malaria adalah pengobatan. Klorokuin merupakan obat antimalaria standar atau obat antimalaria lini pertama, baik untuk terapi maupun untuk komoprofilaksis malaria yang masih sensitif di Indonesia. Adanya peningkatan resistensi terhadap obat-obatan standar merupakan salah satu penyulit dalam pemberantasan penyakit malaria khususnya di daerah endemis. Untuk mengatasi masalah tersebut, sejumlah obat anti malaria baru antara lain artemeter telah dan sedang diuji . Tujuan Penelitian. Membandingkan efektifitas terapi obat anti malaria artemeter dan primakuin versus klorokuin dan primakuin pada anak-anak penderita malaria tanpa komplikasi. Desain Penelitian. Uji klinis acak buta ganda Metode. Enam puluh tiga subyek penelitian yang didapat dari Active Case Detection (ACD) dan Passive Case Detection (PCD), mulai bulan April 2004 sampai Juli 2004 di wilayah Puskesmas Kokap, Samigaluh, Girimulyo, Kabupaten Kulon Progo yang memenuhi kriteria inklusi malaria tanpa komplikasi, serta bersedia diteliti selama 28 hari dengan menandatangani informed consent, diikutsertakan dalam penelitian ini. Subyek dibagi secara random ke dalam 2 kelompok pengobatan. Pengamatan gejala klinis dan parasitologis dilaksanakan pada Ho, H1, H2, H3, H7, H14, H21, H28. Efektifitas terapi dinilai menggunakan kriteria respon terapi menurut WHO, 2003. Hasil pengobatan yang sesuai (RKPaM) dibandingkan dengan yang gagal terapi (KPD+ KPK), dan dilakukan analisis statistik dengan uji pearson x2. Hasil. Dilakukan evaluasi terhadap 63 subyek penelitian yang terbagi dalam 2 kelompok. Tidak ada yang drop out. Hasil akhir penelitian didapatkan bahwa kelompok artemeter dan primakuin ACPR 30/32 (93,8%), gagal terapi (KPD+ KPK) 2/32 (6,3%). Pada kelompok klorokuin dan primakuin RKPaM 22/31 (71%), gagal terapi (KPD+ KPK) 9/31 (92%). Nilai tersebut secara statistik berbeda bermakna (p< 0,05). Angka rata-rata waktu bebas panas dan waktu bebas parasit pada kelompok artemeter dan primakuin 24,63 ± 8,65 jam dan 32,61 ± 13,15 jam. Sedangkan kelompok klorokuin dan primakuin 42,32 ± 18,9 jam dan 68,48 ± 6,69 jam. Efek samping yang muncul pada kelompok terapi artemeter dan primakuin berupa mual dan nyeri perut masing-masing 18,8% dan diare 6,3% yang sembuh tanpa pengobatan. Pada kelompok klorokuin dan primakuin didapatkan mual dan muntah masing-masing 22,6%, nyeri perut 12,9%, sakit kepala 32,2%, pandangan kabur 6,5%dan gatal-gatal dikulit 3,2%. Simpulan. Obat anti malaria artemeter dan primakuin mempunyai efektifitas terapi yang lebih baik (93,8%) dibanding klorokuin dan primakuin (71%) pada anak-anak malaria tanpa komplikasi.

Background. Malaria has been one of infectious diseases influencing mortality of newborns, infants, and delivering mothers. In addition, it also reduces working productivity. One of obstacles in malaria prevention involves medication. Chloroquine is a standard anti-malaria or fist-line anti malaria drug for treatment and chemoprophylaxis of susceptible uncomplicated malaria in Indonesia. Improved resistance toward standard medications turns out to be one of difficulties in malaria prevention, specifically among endemic areas. To solve the problem, a new anti malaria drugs i.e. arthemeter has been and is being examined. Objective. The objective of this study is to investigate the effectivity of arthemeter and primaquine therapy compared chloroquine and primaquine therapy for children with uncomplicated malaria. Design. A randomized double-blind clinical trial. Methods. Sixty-three subjects were recruited through Active Case Detection (ACD) and Passive Case Detection (PCD) from April to July 2004 at areas of Kokap, Samigaluh, Girimulyo Primary Health Care, Kulon Progo; they fulfilled inclusion criteria of uncomplicated malaria, and were willing to participate in 28 days-study by signing informed consent forms, were included in this study. Subjects were randomly divided into two groups of treatments. Clinical and parasitological observation were performed at D0, D1, D2, D3, D7, D14, D21, D28. WHO (2003) therapeutic responses criteria is used to evaluated the therapeutic effectivity. The results of Adequate Clinical and Parasitology Response (ACPR) compared to treatment failure (Early Treatment Failure/ETF and Late Treatment Failure/LTF); were statistically analysis was performed using Pearson X2. Results. Evaluation was performed on 63 subjects divided into two groups. No subjects were drop out. Final results obtained indicated that artemeter and primaquine group showed ACPR and failed therapy (ETF + LTF) of 30/32 (93.8%) and 2/32 (6.3%), respectively. The chloroquine and primaquine groups showed ACPR and treatment failures (ETF+LTF) of 22/31 (71%) and 9/31 (92%), respectively. This value was statistically significant (p< 0,05). Average rate of Fever Clearance Time (FCT) and Parasite Clearance Time (PCT) in artemeter and primaquine group were 24.63 ± 8.65 hours and 32.61 ± 13.1 hours, while chloroquine and primaquine group were 42.32 ±18.9 hours. In addition, side effects perceived among artemeter and primaquine group involved both nausea and abdominal pain among 18.8% subjects, individually, and diarrhea among 6.3% subjects and they recovered with no treatment. In chloroquine and primaquine group, both nausea or vomiting were found among individually 22.6% subjects, while abdominal pain, headache, blurred acuity and itching among 12.9%, 32.3%, 6.5%, and 3.2% subjects, respectively. Conclusion. Artemeter and primaquine anti-malaria drugs provided better therapeutic effectiveness (93,8%) compared to chloroquine and primaquine (71%) among uncomplicated children with malaria.

Kata Kunci : Malaria Tanpa Komplikasi,Terapi Artemeter,Klorokuin, Therapeutic effectivity – therapeutic response – chloroquine resistant – arthemeter – uncomplicated malaria