Studi Adverse Drug Reactions Penggunaan Obat Antiepilepsi Monoterapi Pada Anak di Rumah Sakit - Studi Farmakovigilans
DOI:
https://doi.org/10.31764/lf.v3i2.8384Keywords:
Adverse drug reactions, Antiepileptic, Pediatric.Abstract
ABSTRAK
Pengobatan epilepsi membutuhkan waktu yang lama, penghentian terapi dilakukan secara bertahap apabila dicapai bebas kejang selama dua tahun. Pengobatan yang bersifat jangka panjang dikaitkan dengan peningkatan efek samping dan membutuhkan monitoring pengobatan. Pasien anak sering mengalami efek samping obat yang sama dengan pasien dewasa, namun reaksi obat yang tidak dikehendaki pada pasien anak lebih sulit karena perbedaan karakteristik antara pasien anak dan pasien dewasa juga mempengaruhi efikasi dan efek samping obat. Tujuan penelitian ini untuk menghitung angka kejadian ADRs dan Klasifikasi Jenis ADRs pada penggunaan obat antiepilepsi Monoterapi. Metode yang digunakan yaitu penelitian cross sectional dengan pengambilan data secara prospektif, penilaian kausalitas ADRs menggunakan algoritma naranjo, selama periode penelitian didapatkan 56 pasien yang mendapatkan terapi monoterapi dari total 86 pasien. jenis-jenis ADRs yang terjadi pada pasien yaitu gangguan gastrointestinal 32,35%, reaksi kulit gatal dan kemerahan terjadi 7,35%, gangguan metabolik sebanyak 10,29%, dan gangguan CNS (Central nervous system) sebanyak 10,29%.
Â
Kata kunci : Adverse drug reactions; Antiepilepsi; Anak-anak.
ABSTRACT
Epilepsy treatment takes a long time, discontinuation of therapy is carried out gradually if achieved without seizures for two years. Treatment is long-term treatment with increased side effects and requires medication monitoring. Pediatric patients often experience the same side effects of drugs as adults, but adverse drug reactions in pediatric patients are more difficult because differences in characteristics between patients and adult patients also affect the efficacy and side effects of drugs. The purpose of this study was to calculate the incidence of ADR and Classification of Types of ADR in the use of monotherapy antiepileptic drugs. The method used is a cross sectional study with prospective data collection, ADR Causality Assessment using the Naranjo Algorithm, during the study period 56 patients received monotherapy therapy from a total of 86 patients. The types of ADR that occur in patients are gastrointestinal disorders 32.35%, itching and skin reactions that occur 7.35%, metabolic disorders as much as 10.29%, and CNS (Central Nervous System) disorders as much as 10.29%.
Keywords : Adverse drug reactions; Antiepileptic; Pediatric.
References
Akanksha Suman, D. D. G.. (2017). Study of Adverse Drug Effects of Antiepileptic Drugs used in Pediatric Patients in a Tertiary care rural Hospital-a Pharmacovigilance study. Journal of Young Pharmacists, 9(3).
Anderson, M., Egunsola, O., Cherrill, J., Millward, C., Fakis, A., & Choonara, I. (2015). A prospective study of adverse drug reactions to antiepileptic drugs in children. BMJ Open, 5(6).
Appleton, R. E., & Cross, J. H. (2017). Drug treatment of paediatric epilepsy. Elsevier, 8(2).
Camfield, P., & Camfield, C. (2015). Seminar in Epileptology Incidence , prevalence and aetiology of seizures and epilepsy in children, 17(2).
Jahromi, S. R., Togha, M., Fesharaki, S. H., Najafi, M., Moghadam, N. B., Kheradmand, J. A., … Gorji, (2011). A. Gastrointestinal adverse effects of antiepileptic drugs in intractable epileptic patients. Seizure, 20(4).
Jayalekshmi, K., Palanisamy, K., Ramanathan, S., & Akela, S. (2016). A Study on the Adverse Drug Reactions Induced by Anti Epileptic Drugs in the Epileptic Patients, 6(5).
Le, J., Nguyen, T., Law, A. V, & Hodding, J. (2006). Adverse Drug Reactions Among Children Over a 10- Year Period, 118(2).
Morita, D. A., Glauser, T. A., & Modi, A. C. . (2012). Development and validation of the pediatric epilepsy side effects questionnaire. Neurology, 79(12)
Nanau, R. M., & Neuman, M. G. (2013). Adverse drug reactions induced by valproic acid. Clinical Biochemistry, 46(15).
Tang, L., Ge, L., Wu, W., Yang, X., Rui, P., Wu, Y., … Wang, X. (2017). Lamotrigine versus valproic acid monotherapy for generalised epilepsy: A meta-analysis of comparative studies. Seizure, 51(12).
