Tesis

Efek Pemberian Ketoprofen Suppositoria Terhadap Pencegahan Pankreatitis Pasca ERCP : Uji Klinis Acak Tersamar Ganda = Effect of Rectal Ketoprofen to prevent Post ERCP Pancreatitis (PEP): a randomized controlled trial .

Latar Belakang : Pada studi invivo, seperti indometasin dan diklofenak,, ketoprofen menghambat aktifitas enzim fosfolipase A2 yang memainkan peran penting dalam patogenesis pankreatitis. Tujuan : Mengetahui efektifitas ketoprofen suppositoria terhadap pencegahan pankreatitis pasca ERCP Metode : Uji klinis acak tersamar ganda ini dilakukan di Pusat Endoskopi Saluran Cerna dan ruang rawat inap Rumah Sakit Pusat Nasional Dr Cipto Mangunkusumo pada bulan oktober 2016 sampai dengan Januari 2017 terhadap 74 pasien ikterus obstruktif dewasa atau dengan indikasi ERCP lainnya. Pasien yang memenuhi kriteria penerimaan diberikan ketoprofen suppositoria atau plasebo dosis tunggal sesaat sebelum tindakan ERCP dan dievaluasi tanda dan gejala pankreatitis akut serta evaluasi ulang amilase lipase 24 jam pasca tindakan untuk menentukan adanya pankreatitis pasca ERCP. Derajat pankreatitis akut dinilai berdasarkan kriteria imrie (modified glasgow) pada 48 jam pasca ERCP Hasil : 74 subjek yang memenuh kriteria penelitian dirandomisasi menjadi dua kelompok, masing-masing terdiri dari 37 pasien, terdapat 1 pasien dari setiap kelompok yang tidak dapat dikanulasi. Dilakukan analisis dengan prinsip intention to treat analysis, kedua kelompok sebanding dalam karakteristik demografis dan klinis termasuk faktor risiko terkait pasien dan prosedur. Insidens PPE pada kelompok ketoprofen sebanyak 13,5% (5) sedangkan pada kelompok plasebo sebanyak 21,6% (8), Absolute Risk Reduction (ARR)= 0,081, Relative Risk (RR) = 0,625, Relative risk reduction (RRR)= 0,375, Number Needed to Treat (NTT)=12 (95% IK=-9-25). Terdapat laporan adverse event berupa perforasi usus pada 1 subjek. Kesimpulan: ketoprofen suppositoria menurunkan insidens pankreatitis pasca ERCP
Kata Kunci : ketoprofen, insidens, pankreatitis pasca ERCP


Background: An invitro study showed ketoprofen as well as indomethacin and diclofenac inhibits the activity of phospholipase A2 that is supposed to play a major role in the pathogenesis of pancreatitis. Objectives : To determine the effect of rectal suppository ketoprofen to prevent post ERCP pancreatitis Methods : This randomized double blind controlled trial performed at Gastrointestinal Endoscopy Center and inpatient unit in Cipto Mangunkusumo National General Hospital during October 2016 to January 2017 among patients with obstructive jaundice and patients with other indications of ERCP. All subjects with inclusion criteria were treated with rectal ketoprofen or rectal placebo suppository single dose immediately before ERCP. Sign and symptoms of acute pancreatitis and serum amylase and lipase level observed in 24 hours after ERCP to determine post ERCP pancreatitis. Acute pancreatitis was graded according to the Imrie’s (modified Glasgow) severity criteria in 48 hours after ERCP. Result : In total, 74 subjects were randomized into two groups containing 37 subjects in each group. One patient in each group was failed for cannulation. We used intention to treat analysis, both groups were comparable regarding demographic and clinical factors. The incidence of PEP was 13,5% (5) in ketoprofen group and 21,6% (8) in placebo group, Absolute Risk Reduction (ARR)= 0,081, Relative Risk (RR) = 0,625, Relative risk reduction (RRR)= 0,375, and Number Needed to Treat (NTT)=12(95% CI=-9– 25). Reported adverse event was bowl perforation in 1 subject. Conclusion : Rectal ketoprofen reduced the incidence of post ERCP pancreatitis
Key Words : Ketoprofen, Incidence, Post ERCP pancreatitis