A value less than 0.05 was considered statistically significant. RESULTS The clinical characteristics of both groups are presented in Table 1. and liver function were compared between the two groups. Results Twenty-five patients (18 females and 7 males) were enrolled in the study group. The control group included 44 patients (26 females and 18 males). After 1 year, the least square mean values for the LSSs were significantly decreased by 3.910.98 kPa (values for multiple comparisons were modified with post-hoc analysis using Bonferroni’s correction. A value less than 0.05 was considered statistically significant. RESULTS The clinical characteristics of both organizations are offered in Table 1. Twenty-five individuals were enrolled in the study group (18 females and 7 males) with an average age at Ctsd enrollment of 6.13.0 years. The control group included 44 individuals (26 females and 18 males) with an average age at enrollment of 5.53.2 years. The mean age at the time of Kasai portoenterostomy for BA was not significantly different between the two organizations (66.336.6 days in the study group vs. 58.025.3 days in the control group; valuevalue /th /thead LSS (kPa)?6-month time point-2.361.22-0.390.920.203?1-yr time point-3.910.98-0.290.700.004TB (mg/dL)?6-month time point-0.180.15-0.130.060.756?1-yr time point-0.340.170.020.080.071AST (IU/L)?6-month time point-0.428.86-15.446.700.181?1-yr time point-13.418.40-21.376.240.450ALT (IU/L)?6-month time BIIL-260 hydrochloride point-2.3311.38-15.428.580.362?1-yr time point-10.1010.18-22.757.460.320 Open in a separate window LSS, liver stiffness scores; TB, serum total bilirubin; kPa, kilopascals; AST, aspartate aminotransferase; ALT, alanine aminotransferase. During the study period, the imply serum drug level in the BIIL-260 hydrochloride study group was 0.270.17 g/mL. Considering the possible side effects of COX-2i, we performed serum analysis including a blood cell count, hepatic and renal function checks, urinalysis, abdominal ultrasonography, and stool occult blood test every 3 months. LSS was measured 6 months after the start of medication. If the LSS was elevated by more than 10% in the 6-month time point compared to baseline, or if an irregular finding showed up in the follow-up checks every 3 months, we excluded the patient from the study group to prevent the possible event of hepatic toxicity or additional adverse BIIL-260 hydrochloride effect of the drug. Three individuals in the study group (two in the high-dose group and one in the low-dose group) were excluded in the 6-month time point, because their LSS were elevated by more than 10% compared to baseline. However, the median ideals of their LSSs were not significantly different with 12.60 (7.75C27.90) kPa at baseline LSS and 13.50 (9.50C45.00) kPa in the 6-month time point ( em p /em =0.109). Moreover, serum total bilirubin and liver enzymes were unchanged in the 6-month time point ( em p /em =0.102 for serum total bilirubin, em p /em =0.102 for AST, and em p /em =0.109 for ALT). Their elevated LSSs and the additional data obtained in the 6-month time point were included in the data analysis as the study group without the data in the 12-month time point. Moreover, no adverse effects due to COX-2i were mentioned with this study. The results of the serum analysis and the urinalysis indicated that hematologic, hepatic, and renal function ideals were not affected by the use of COX-2i during the study. The occult blood test result was bad for each and every stool test. When they were asked during follow-up appointments, none of the individuals complained of nausea, vomiting, diarrhea, bloody stool, indigestion, abdominal pain, heartburn, chest discomfort or tightness, mood change, panic, change in hunger, pores and skin rash, irritability, irregular sensation, changes in vision, misunderstandings, or loss of consciousness. DISCUSSION Despite the overall success of the Kasai procedure for BA,19,20 many children with BA encounter liver damage after the process.2 This liver damage, which includes fibrosis and cholangitis, can lead to chronic liver disease with portal hypertension, cirrhosis, and even HCC and the need for any liver transplant.2,3,4,5,21,22 Although approximately 80C90% of individuals who undergo the Kasai process or even liver transplantation survive to adolescence and beyond,2,3,20 these individuals encounter substantial morbidity. Liver fibrosis and cirrhosis begin early in babies with BA. 2 Corticosteroids may help limit inflammatory damage and increase bile circulation, but their effectiveness remains unclear.2,3 Therefore, additional pharmacological treatments are required to improve liver function in these individuals. Overexpression of COX-2 in the liver has been observed in individuals with chronic hepatitis, cirrhosis, and HCC,7,8,9,15,16 and COX-2 may mediate or get worse these conditions.6,7,9,15 Liver fibrosis is caused by cholestasis and collagen accumulation, and BIIL-260 hydrochloride COX-2 is upregulated with these conditions.13 COX-2 manifestation also correlates with the stage of fibrosis.9 Mohammed, et al.7 analyzed COX-2 manifestation in cirrhotic livers after hepatitis B and C illness and found that COX-2 was absent.