Perbandingan Efektivitas dan Efek Samping Antipsikotik Berbasis Aripiprazole pada Pasien Skizofrenia

Karina Nurlitasari, Dr. apt. Woro Harjaningsih, Sp.FRS; Prof. Dr. apt. Agung Endro Nugroho, M.Si; Dr. dr. Bambang Hasta Yoga L.B., Sp.KJ; Prof. Dr. apt. Zullies Ikawati

2024 | Tesis | S2 Mag.Farmasi Klinik

Regimen terapi yang bervariasi pada terapi skizofrenia memberikan permasalahan terkait efek samping yang muncul. Aripiprazole dinilai efektif untuk mengurangi gejala skizofrenia, serta menimbulkan efek ekstrapiramidal dan perburukan gangguan metabolik yang lebih rendah dibanding antipsikotik lain. Pada penggunaannya, aripiprazole sering dikombinasikan dengan antipsikotik tipikal atau atipikal. Penelitian ini bertujuan untuk mengetahui perbandingan efektivitas dan efek samping berupa kejadian Sindrom Ekstrapiramidal (EPS), peningkatan Indeks Massa Tubuh (IMT) dan Tekanan Darah (TD), antara dua regimen antipsikotik berbasis aripiprazole, yaitu aripiprazole-antipsikotik tipikal dan aripiprazole-antipsikotik atipikal, pada pasien skizofrenia di RSJD Klaten.

Penelitian ini menggunakan desain observasional cohort retrospektif, dengan pengambilan data berdasarkan rekam medis pasien skizofrenia rawat inap di RSJD Dr. RM Soedjarwadi pada periode Januari-September 2024. Subjek yang diperoleh dalam penelitian sebanyak 80 orang, terbagi menjadi dua kelompok yaitu 31 orang (aripiprazole-antipsikotik tipikal) dan 49 orang (aripiprazole-antipsikotik atipikal). Efektivitas dilihat berdasarkan selisih skor PANSS-EC dengan interval 5-10 hari, serta perbaikan kondisi klinis berdasarkan skor PANSS-EC akhir ?15. Efek samping regimen antipsikotik dilihat dari kejadian EPS berdasarkan manifestasi klinis pada saat dirawat, serta peningkatan IMT dan TD. Analisis statistik yang digunakan adalah Chi-square test, Fisher's exact test, Mann-whitney test, Wilcoxon test, dan binary logistic regression.

Hasil penelitian menunjukkan rata-rata penurunan skor PANSS-EC pada  kelompok aripiprazol-antipsikotik tipikal sebesar 4±4,07 dan kelompok aripiprazol-antipsikotik atipikal sebesar 3±3,98. Tidak ada perbedaan signifikan diantara kedua kelompok, baik pada selisih skor PANSS-EC (p=0,954) maupun perbaikan klinis (p=0,689). Perbedaan efek samping pada kejadian EPS (p=0,011) dan peningkatan TD (p=0,039) menunjukkan hasil yang signifikan. Proporsi kejadian EPS lebih besar pada kelompok aripiprazol-antipsikotik tipikal (25,8%), sementara proporsi peningkatan TD lebih besar pada kelompok aripiprazol-antipsikotik atipikal. Selain itu, tidak terdapat perbedaan signifikan pada peningkatan IMT (p=0,474) antara kedua kelompok regimen. Penelitian ini menyimpulkan bahwa kedua kelompok tidak berbeda signifikan dalam hal efektivitasnya, namun kombinasi aripiprazol-antipsikotik atipikal menunjukkan hasil yang lebih aman pada kejadian EPS.

Various antipsychotic regimens present challenges related to the occurrence of side effects. Aripiprazole is considered effective in reducing symptoms of schizophrenia, and causes lower extrapyramidal effects and worsening metabolic disturbances compared to other antipsychotics. In practice, aripiprazole is often combined with either typical or atypical antipsychotics. This study aims to compare the effectiveness and side effects, including extrapyramidal symptoms (EPS), increases in body mass index (BMI) and blood pressure (BP), between two aripiprazole-based antipsychotic regimens, namely aripiprazole-typical antipsychotics and aripiprazole-atypical antipsychotics, among schizophrenia patients Psychiatric Hospital Klaten.

The study design used is an observational cohort retrospective, with data collected from the medical records of inpatient schizophrenia patients at Dr. RM Soedjarwadi Psychiatric Hospital from January-September 2024. The study included 80 subjects, divided into two groups: 31 patients in the aripiprazole-typical antipsychotic group and 49 patients in the aripiprazole-atypical antipsychotic group. Effectiveness was assessed based on the reduction in PANSS-EC scores over a 5–10 day interval and clinical improvement defined by a final PANSS-EC score of ?15. Side effects of the antipsychotic regimens were evaluated based on the occurrence of extrapyramidal syndrome based on clinical manifestations during hospitalization, as well as an increases in BMI and blood pressure. Statistical analyses used include the Chi-square test, Fisher's exact test, Mann-Whitney test, Wilcoxon test, and binary logistic regression.

The results showed an average reduction in PANSS-EC scores of 4±4.07 in the aripiprazole-typical antipsychotic group and 3±3.98 in the aripiprazole-atypical antipsychotic group. There was no significant difference between the two groups in terms of PANSS-EC score reduction (p=0.954) or clinical improvement (p=0.689). However, significant differences were found in side effects, specifically in the occurrence of EPS (p=0.011) and increases in BP (p=0.039). The proportion of EPS cases was higher in the aripiprazole-typical antipsychotic group (25.8%), while the proportion of BP increases was higher in the aripiprazole-atypical antipsychotic group. Additionally, there was no significant difference in BMI increases (p=0.474) between the two regimens. This study concludes that the two groups do not differ significantly in terms of effectiveness. However, the combination of aripiprazole and atypical antipsychotics demonstrated a safer profile regarding the occurrence of EPS.

Kata Kunci : Skizofrenia, Kombinasi aripiprazol, Efektivitas terapi, Efek samping