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Abstrak :

Latar belakang: Penggunaan aminofilin intravena masih merupakan terapi pilihan untuk mengatasi apnea of prematurity (AOP) pada bayi prematur di Indonesia karena obat tersebut lebih mudah diperoleh dan harganya lebih murah walaupun mempunyai jendela terapi yang sempit. Pemeriksaan kadar teofilin serum perlu dilakukan untuk menilai efektifitas dan keamanan obat tersebut. Faktor-faktor yang memengaruhi efektifitas dan keamanan penggunaan aminofilin intravena pada bayi prematur dalam pengobatan apnea of prematurity di unit Neonatologi belum jelas. 

Tujuan: Mengetahui efektifitas dan keamanan penggunaan aminofilin sebagai terapi apnea of prematurity dan faktor-faktor yang memengaruhinya.

Metode: Penelitian ini merupakan penelitian analitik dengan desain cohort prospektif. Subjek penelitian adalah 40 bayi prematur dengan usia gestasi kurang atau sama dengan 30 minggu di Unit Neonatologi Rumah Sakit Cipto Mangunkusumo (RSCM) di Jakarta pada bulan April 2019 hingga Oktober 2019. Bayi tersebut mendapat terapi aminofilin intravena dosis rumatan sebanyak lima kali dan dilakukan pemeriksaan kadar teofilin serum dengan menggunakan metode reversed phase high performance liquid chromatography diode array detector (RP-HPLC-DAD). Selanjutkan dilakukan pemantauan efektifitas dan efek samping yang terjadi selama pemberian aminofilin intravena. Analisis data dengan uji Kai kuadrat dan regresi logistik, hasil signifikan bila nilai p < 0,05.

Hasil: Pemberian aminofilin intravena 67,5% efektif sebagai terapi AOP pada bayi usia gestasi kurang dari 30 minggu. Faktor-faktor yang memengaruhi efektifitas penggunaan aminofilin intravena sebagai terapi AOP adalah berat lahir dan kadar teofilin serum dengan nilai p = 0,006 dan 0,022. Efek samping yang ditemukan pada pemberian aminofilin intravena adalah takikardi (37,5%) dan peningkatan diuresis (27,5%) pada kadar teofilin serum lebih dari 12 mg/mL. Faktor yang memengaruhi keamanan penggunaan terapi aminofilin intravena pada bayi prematur adalah kadar teofilin serum dengan nilai p < 0,001. 

Simpulan: Pemberian aminofilin intravena sebagai terapi AOP pada bayi prematur dengan usia kurang dari 30 minggu efektif dan aman. Namun perlu dilakukan pemantauan kadar teofilin serum mengingat pemberian aminofilin intravena sering menimbulkan efek samping.

 

Keywords: apnea of prematurity, aminofilin, efektifitas dan keamanan

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Background: Intravenous aminophylline still plays the role as the therapy of choice for apnea of prematurity (AOP) in Indonesia because the drug is easier
to obtain and the price is cheaper despite having a narrow window of therapy. An examination of serum theophylline levels needs to be performed to assess the effectiveness and safety of the drug. Factors that influence the effectiveness and safety in the treatment of apnea of prematurity in the Neonatology Unit remain unclear.

Aim: To determine the effectiveness and safety of using aminophylline as apnea of prematurity therapy and their influencing factors.

Methods: This research is an analytical study with a prospective cohort design. Subjects were 40 premature infants with gestational age less than or equal to 30 weeks in the Neonatology Unit of Cipto Mangunkusumo Hospital (RSCM) in Jakarta from April 2019 to Oktober 2019. The infants received intravenous 
aminophylline maintenance dosages five times and the levels of serum theophylline were examined using the reversed phase high performance liquid chromatography diode array detector (RP-HPLC-DAD) method. The follow up was set to monitor the effectiveness and side effects that occur during intravenous aminophylline administration. Data were analyzed using the Chi-square test and logistic regression. The results were considered significant if the p-value < 0,05.

Results: The administration of intravenous aminophylline 67.5% was effective as AOP therapy in infants of less than 30 weeks gestation. Factors that 
influence the effective use of intravenous aminophylline as AOP therapy are birth weight and serum theophylline levels with p = 0,006 and 0,022. Side effects that occurred were tachycardia (37.5%) and increased diuresis (27.5%) in serum theophylline levels of more than 12 mcg/mL. Factors that influence the safety of the use of intravenous aminophylline therapy in preterm infants are serum theophylline levels with p < 0,001.

Conclusion: Administration of intravenous aminophylline as AOP therapy in premature infants less than 30 weeks of age is effective and safe. However, it is necessary to monitor serum theophylline levels due to its frequent side 
effects occurence.

 

Keywords: apnea of prematurity, aminophylline, effectiveness and safety

Abstrak :
Pendahuluan: Penggunaan kafein lebih direkomendasikan dalam tatalaksana apnoe of prematurity (AOP) karena selain memberikan efektivitas yang tidak berbeda, namun juga memiliki keuntungan terapeutik lain dibandingkan teofilin atau aminofilin. Dalam kondisi ketersediaan kafein yang masih terbatas di Indonesia, RSAB Harapan Kita mengupayakan penggunaan sediaan kafein oral terhadap pasien bayi prematur yang dirawat di unit perawatan intensif neonatologi. Penelitian ini bertujuan untuk mengetahui capaian kadar kafein dalam plasma neonatus prematur yang mendapatkan kafein oral tersebut. Metode: Penelitian potong lintang ini mengumpulkan data rekam medis serta mengambil sampel darah untuk mengukur kadar kafein dalam darah neonatus prematur selama periode Maret – Agustus 2022 di RSAB Harapan Kita Jakarta dengan kriteria insklusi neonatus dengan usia gestasi 35 minggu atau kurang yang mendapat terapi kafein. Jenis kafein yang digunakan adalah caffeine base oral dengan dosis inisial 10mg/kgBB dan dilanjutkan dengan dosis rumatan 2,5 mg/kgBB/hari. Pengukuran kadar kafein dalam darah dilakukan setelah hari terapi kelima dengan menggunakan metode GCMS/MS. Hasil: Terdapat 33 subjek neonatus prematur yang diobservasi secara klinis serta dilakukan pemeriksaan kadar kafein dalam darah, dengan median usia gestasi 32 minggu (kisaran 25 – 34 minggu) dan rerata berat badan lahir 1296,8 (±307,8) gram. Sebanyak 97% subjek mencapai kisaran kadar terapeutik kafein pada keadaan steady state (4,49 – 20,63 mg/L). Subjek yang mengalami gejala AOP di hari terapi kafein ketujuh sebanyak 30,3%, mayoritas (27,2%) merupakan apnea tipe campuran. Efek samping yang paling banyak ditemui pada subjek penelitian ini adalah peningkatan diuresis. Kesimpulan: Mayoritas neonatus prematur yang mendapat caffeine base oral mencapai target kadar kafein darah 5 – 25 mg/L disertai penurunan kejadian AOP. Efek samping yang tersering adalah peningkatan diuresis namun tidak disertai kemaknaan klinis. ......Introduction: The use of caffeine is more recommended for the management of apnea of ​​prematurity (AOP) because, in addition to providing no difference in effectiveness, it also has other therapeutic advantages over theophylline or aminophylline. Because of the limited availability of caffeine in Indonesia, Harapan Kita National Women and Children Health Center seeks to use oral caffeine preparations for premature infants treated in the neonatology intensive care unit. This study aims to determine the achievement of caffeine levels in the plasma of premature neonates who received oral caffeine. Methods: This cross sectional study collected medical records and took blood samples to measure blood caffeine levels of preterm infants born in the period March – August 2022 at RSAB Harapan Kita Jakarta who fulfilled the inclusion criteria of neonates with a gestational age of 35 weeks or less and received caffeine therapy. The type of caffeine used was an oral caffeine base with an initial dose of 10mg/kg and continued with a maintenance dose of 2.5 mg/kg/day. Measurement of caffeine levels in the blood was carried out after the fifth day of therapy using the GCMS/MS method. Results: There were 33 preterm infants who were clinically observed and tested for caffeine levels in the blood, with a median gestational age of 32 weeks (range 25-34 weeks) and a mean birth weight of 1296.8 (±307.8) grams. A total of 97% of subjects reached the therapeutic range of caffeine levels at a steady state (4.49 – 20.63 mg/L). Subjects who experienced AOP symptoms on the seventh day of caffeine therapy were 30,3%, the majority (27,2%) were mixed type apnoe. The most common side effect found in the subjects of this study was an increase in diuresis. Conclusion: Most of the preterm infants who received oral caffeine base achieved targeted blood caffeine levels of 5 – 25 mg/L with reduced incidence of AOP. The most common side effect was increased diuresis but there was no clinical significance.