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" ABSTRAKLatar belakang. Sepsis masih menjadi masalah di bidang neonatalogi sampai saat ini karenadapat meningkatkan mortalitas dan morbiditas. Kolestasis merupakan salah satu morbiditasyang terjadi selama sepsis. Angka kematian dan lama perawatan di rumah sakit akanmeningkat pada sepsis neonatorum yang disertai kolestasis. Asam ursodeoksikolat (AUDK)dilaporkan dapat memperbaiki luaran kolestasis pada dewasa dan anak. Penelitian mengenaimanfaat AUDK pada neonatus masih terbatas, sampai saat ini belum ada penelitian tentangmanfaat AUDK pada kolestasis terkait sepsis (KTS).Tujuan. Mengetahui pengaruh AUDK terhadap penurunan parameter fungsi hati (bilirubintotal/direk/indirek, AST, ALT, GGT), angka kematian, dan lama rawat neonatus denganKTS.Metode. Penelitian ini merupakan uji klinis acak tersamar ganda yang dilakukan di DivisiNeonatologi Departemen IKA FKUI-RSCM dari Januari - Oktober 2012. Neonatus yangmemenuhi kriteria inklusi dibagi secara random menjadi 2 kelompok (AUDK atau plasebo).Asam ursodeoksikolat diberikan 30 mg/kgBB/hari dibagi 3 dosis selama 7 hari. Parameterfungsi hati di evaluasi setelah 7 hari pengobatan. Luaran utama adalah penurunan nilaibilirubin total/direk/indirek, AST, ALT, dan GGT. Luaran tambahan adalah angka kematiandan lama rawat. Analisis statistik untuk luaran utama dan lama rawat dilakukan dengan ujit/uji Mann-Whitney. Perbedaan kematian di analisis dengan uji x2 dan perbedaan survivaldengan metode Kaplan Meier.Hasil : Penelitian dilakukan pada 37 subjek, 19 subjek pada kelompok AUDK dan 18 subjekpada kelompok plasebo. Perbedaan perubahan parameter fungsi hati antara kelompok AUDKdan kelompok plasebo tidak bermakna [bilirubin total (2,2 ± 2,9 vs 1,7 ± 4,6; p= 0,080),bilirubin direk (1,1 ± 2,3 vs 0,6 ± 3,6; p= 0,080), bilirubin indirek [0,4 (0,1-5,6) vs 0,9 (0,1-4,1); p= 0,358], ALT (0,5 [(-80,0) – (21,0)] vs -2,0 [(-167,0) – (85,0)]; p= 0,730), AST (43,0(14,0-297,0) vs 150,0 (24,0-840,0); p= 0,081), and GGT (125,0 (48,0-481,0) vs 235,0 (56,0-456,0); p= 0,108)], tetapi perubahan nilai bilirubin total, bilirubin direk, dan AST cenderunglebih baik pada kelompok AUDK. Penurunan nilai bilirubin total terjadi pada 85,7% subjekkelompok AUDK dan 64,3% pada kelompok plasebo. Nilai bilirubin direk menurun pada78,6% subjek kelompok AUDK dan 64,3% subjek kelompok plasebo. Penurunan nilai ASTterdapat pada 57% subjek kelompok AUDK dengan penurunan terbesar 72 U/L, sedangkanpada kelompok plasebo 57% subjek mengalami peningkatan nilai AST dengan peningkatantertinggi 473 U/L. Kematian terjadi pada 10,5% subjek di kelompok AUDK dan 27,7% dikelompok plasebo (p=0,232). Dari analisis kesintasan tidak terdapat perbedaan survivalantara kedua kelompok. Tidak terdapat perbedaan rentang waktu lama rawat antarakelompok AUDK (15-70) hari dan kelompok plasebo (10-88) hari (p=0,148).Simpulan : Pemberian AUDK 30 mg/kg/hari selama 7 hari cenderung menurunkan nilaibilirubin total, bilirubin direk, AST, serta angka kematian meskipun secara statistik tidakterbukti bermakna. Hal ini masih mungkin disebabkan oleh power yang kurang padapenelitian ini. Penelitian ulang perlu dilakukan dengan jumlah sampel yang lebih besar dandurasi pemberian AUDK yang lebih panjang.

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<ABSTRACTBackground. Sepsis is still an important issue in Neonatology field since it is related withhigh mortality and morbidity. Cholestasis is one of the morbidities that related with sepsis.Mortality and length of hospital stay will be increased in neonatal sepsis that associated withcholestasis. Efficacy of ursodeoxycholic acid (UDCA) in cholestasis has been reported fromadult and pediatric population, however there is no publication regarding the efficacy of thisdrug in neonates with sepsis associated cholestasis.Objectives. To investigate the role of UDCA in liver function parameter (total, direct,indirect bilirubin, AST, ALT, GGT), mortality, and length of hospital stay in neonates withsepsis associated cholestasis.Methods. A randomized controlled trial were done in Neonatology Division, PediatricDepartment, Cipto Mangunkusumo Hospital from January to October 2012. Neonates thatfulfilled the inclusion criteria, randomized into UDCA group and placebo group. We gaveursodeoxycholic acid 30 mg/kg BW/day which divided into 3 doses for 7 days. Liverfunction test were done after 7 days treatment. Primary outcome are an improvement of liverfunction parameter and the secondary outcome are mortality rate and length of hospital stay.Statistical analysis with t test/ Mann-Whitney test was done for primary outcome and lengthof hospital stay, x2 test for differences of mortality, and Kaplan Meier method for survivalanalysis.Result. There were 37 subject, 19 subject in UDCA group and 18 in placebo group. Therewere no significant differences of liver function parameter between UDCA group andplacebo [total bilirubin (2.2 ± 2.9 vs 1.7 ± 4.6; p= 0.080), direct bilirubin (1.1 ± 2.3 vs 0.6 ±.6; p= 0.080), indirect bilirubin [0.4 (0.1-5.6) vs 0.9 (0.1-4.1); p= 0.358], ALT (0.5 [(-80.0) –(21.0)] vs -2.0 [(-167.0) – (85.0)]; p= 0.730), AST (43.0 (14.0-297.0) vs 150.0 (24.0-840.0);p= 0.081), and GGT (125.0 (48.0-481.0) vs 235,0 (56.0-456.0); p= 0.108)]. Although that,there were a better improvement of total bilirubin, direct bilirubin, and AST in UDCA group.Decrease of total bilirubin and direct bilirubin level occurred in 85.7% and 78.6% in UDCAgroup vs 64.3% and 64.3% in placebo group. For the AST level, there was an improvementin 57% subject UDCA with the profound declining 72 U/L; conversely, deteriorationoccurred in 57% subject placebo, with the maximal increment 473 U/L. Mortality occurredin 10.5% subject in UDCA group and 27.7% placebo group (p=0.232). There were nodifferences of survival from both groups. Length of hospital stay in UDCA and placebogroup were 15-70 days and 10-88 days (p=0.148).Conclusion: UDCA treatment 30 mg/kgBW/day for 7 days tends to decrease the totalbilirubin, direct bilirubin, AST level, and mortality, although not statistically significant.This could be happened due to the limitation of power in this study. Future studies withlarger subject and longer duration of UDCA treatment will be needed."

"Latar Belakang: Neonatus kurang bulan berisiko mengalami hiperbilirubinemia 12,5 kali lipat lebih besar dibandingkan neonatus cukup bulan, 54% membutuhkan fototerapi. Hiperbilirubinemia dapat menyebabkan neurotoksisitas hingga kematian, sedangkan fototerapi dapat menyebabkan beberapa komplikasi. Terapi ajuvan seperti asam ursodeoksikolat diperlukan untuk meningkatkan klirens bilirubin sehingga mengurangi durasi fototerapi. Saat ini belum ada data yang tersedia mengenai pengaruh penambahan asam ursodeoksikolat terhadap durasi fototerapi pada neonatus kurang bulan dengan hiperbilirubinemia.Tujuan: Penelitian ini bertujuan untuk menentukan durasi fototerapi dan penurunan kadar bilirubin pada neonatus kurang bulan yang mendapat fototerapi dan tambahan asam ursodeoksikolat.Metode: Penelitian ini merupakan uji klinis, terandomisasi, tersamar ganda, dengan kontrol plasebo, mencakup neonatus usia gestasi <37 minggu, mengalami hiperbilirubinemia yang terindikasi fototerapi, dirawat di unit perinatologi Rumah Sakit Dr. Cipto Mangunkusumo sejak bulan Februari-Mei 2024, sudah mendapat minum per oral sebanyak ≥10 mL/kgBB/hari. Grafik American Academy of Pediatrics (AAP) tahun 2022 dan The Royal Women’s Hospital (RWH) tahun 2020 digunakan untuk menentukan batas fototerapi. Total 40 subjek yang dibagi menjadi 2 kelompok. Kelompok intervensi (n=20) mendapat asam ursodeoksikolat 10 mg/kgBB/hari (puyer) dibagi 2 dosis sebagai terapi tambahan fototerapi, sedangkan kelompok kontrol (n=20) hanya mendapat fototerapi. Kadar bilirubin total diukur setiap 24 jam dengan serum dan/atau Bilistick. Hasil: Rerata durasi fototerapi adalah 24 jam pada kelompok intervensi, 36 jam pada kelompok kontrol (p=0,289). Di kelompok intervensi, penurunan kadar bilirubin setelah 24 jam fototerapi 4,15 ± 5,50 mg/dL (p=0,758), setelah 48 jam fototerapi 4,99 ± 7,66 mg/dL (p=0,664). Kadar bilirubin setelah 48 jam fototerapi lebih rendah bermakna pada neonatus yang mendapat asam ursodeoksikolat (p=0,020).Kesimpulan: Penambahan asam ursodeoksikolat tidak mengurangi durasi fototerapi maupun mempercepat penurunan kadar bilirubin pada neonatus kurang bulan dengan hiperbilirubinemia yang mendapat fototerapi setelah 24 jam dan 48 jam. Penelitian lanjutan perlu dilakukan sampai jumlah sampel terpenuhi.

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Background: Preterm neonates have a 12.5 times higher risk of developing hyperbilirubinemia compared to full-term neonates, with 54% requiring phototherapy. Hyperbilirubinemia can lead to neurotoxicity and even death, while phototherapy can cause several complications. Adjuvant therapy, such as ursodeoxycholic acid, is needed to increase bilirubin clearance and reduce the duration of phototherapy. Currently, there is no available data on the effect of adding ursodeoxycholic acid on the duration of phototherapy in preterm neonates with hyperbilirubinemia.

Objective: This study aims to determine the duration of phototherapy and the reduction of bilirubin levels in preterm neonates who receive phototherapy and additional ursodeoxycholic acid.

Method: This study is a randomized, double-blind, placebo-controlled clinical trial, involving neonates with a gestational age of less than 37 weeks who have hyperbilirubinemia requiring phototherapy, treated in the perinatology unit of Dr. Cipto Mangunkusumo Hospital from February to May 2024, and who have been fed orally at least 10 mL/kgBW/day. The 2022 American Academy of Pediatrics (AAP) and 2020 The Royal Women’s Hospital (RWH) charts were used to determine the phototherapy threshold. A total of 40 subjects were divided into 2 groups. The intervention group (n=20) received 10 mg/kgBW/day of ursodeoxycholic acid (powder) divided into 2 doses as an additional phototherapy treatment, while the control group (n=20) received only phototherapy. Total bilirubin levels were measured every 24 hours using serum and/or Bilistick.

Results: The average duration of phototherapy was 24 hours in the intervention group and 36 hours in the control group (p=0.289). In the intervention group, the reduction in bilirubin levels after 24 hours of phototherapy was 4.15 ± 5.50 mg/dL (p=0.758), and after 48 hours of phototherapy was 4.99 ± 7.66 mg/dL (p=0.664). Bilirubin levels were significantly lower after 48 hours of phototherapy in neonates who received ursodeoxycholic acid (p=0.020).

Conclusion: The addition of ursodeoxycholic acid did not reduce the duration of phototherapy nor accelerate the decrease of bilirubin levels in preterm neonates with hyperbilirubinemia who received phototherapy after 24 and 48 hours. Further research needs to be conducted until the sample size is sufficient."