Ketoprofen,peginterferon 2a and ribavirin for genotype 1 chronic hepatitis C:A phaseⅡ study  

作　　者：Annagiulia Gramenzi Carmela Cursaro Marzia Margotti Clara Balsano Alessandra Spaziani Simona Anticoli Elisabetta Loggi Maddalena Salerno Silvia Galli Giuliano Furlini Mauro Bernardi Pietro Andreone 

机构地区：[1]Department of Clinical Medicine,University of Bologna,40138 Bologna, Italy [2]Molecular Virology and Oncology Laboratory,"A.Cesalpino" Foundation,University of Rome"La Sapienza",00161 Rome, Italy [3]Department of Internal Medicine,University of L'Aquila,67100 L'Aquila,Italy [4]Hepatology Outpatient Clinic,Hospital of Paola,87027 Paola(CS),Italy [5]Department of Hematology, Oncology and Laboratory Medicine,S.Orsola-Malpighi Hospital,40138 Bologna,Italy

出　　处：《World Journal of Gastroenterology》2009年第47期5946-5952,共7页世界胃肠病学杂志（英文版）

摘　　要：AIM:To evaluate the safety of adding ketoprofen to pegylated-interferon(PEG-IFN)with or without ribavirin and the effect on viral kinetics,STAT1 activity and expression of 2'-5'-oligoadenylate synthetase (2'-5'OAS)in genotype 1 chronic hepatitis C in a phaseⅡstudy. METHODS:Forty-five patients were studied:fifteen were randomized to PEG-IFN plus ribavirin(PR),16 to PEGIFN plus ketoprofen and 14 to PR and ketoprofen.Themolecular study of IFN-dependent signal transduction was conducted in 9 patients from each group. RESULTS:The combination of ketoprofen and PEG- IFN with or without ribavirin was safe and well tolerated.An early activation of STAT1 was observed in ke-toprofen-treated patients,but this activation was less sustained over time.Conversely,ketoprofen plus PEG- IFN and ribavirin induced an early and sustained increase of 2'-5'OAS transcription starting 24 h after the first dose until the 36th wk.These data are consistent with the clinical results,showing a better sustained virological response and a lower relapse rate in patients receiving ketoprofen plus PEG-IFN and ribavirin. CONCLUSION:The addition of ketoprofen to the standard therapy of chronic hepatitis C should be explored in larger randomized clinical studies.AIM：To evaluate the safety of adding ketoprofen to pegylated-interferon（PEG-IFN）with or without ribavirin and the effect on viral kinetics,STAT1 activity and expression of 2＇-5＇-oligoadenylate synthetase （2＇-5＇OAS）in genotype 1 chronic hepatitis C in a phaseⅡstudy. METHODS：Forty-five patients were studied：fifteen were randomized to PEG-IFN plus ribavirin（PR）,16 to PEGIFN plus ketoprofen and 14 to PR and ketoprofen.Themolecular study of IFN-dependent signal transduction was conducted in 9 patients from each group. RESULTS：The combination of ketoprofen and PEG- IFN with or without ribavirin was safe and well tolerated.An early activation of STAT1 was observed in ke-toprofen-treated patients,but this activation was less sustained over time.Conversely,ketoprofen plus PEG- IFN and ribavirin induced an early and sustained increase of 2＇-5＇OAS transcription starting 24 h after the first dose until the 36th wk.These data are consistent with the clinical results,showing a better sustained virological response and a lower relapse rate in patients receiving ketoprofen plus PEG-IFN and ribavirin. CONCLUSION：The addition of ketoprofen to the standard therapy of chronic hepatitis C should be explored in larger randomized clinical studies.

关 键 词：LIVER Viral hepatitis Chronic hepatitis C Clinical pharmacology Non-steroidal antiinflammatory drugs 

分 类 号：R512.63[医药卫生—内科学]