multicenter study to evaluate the safety and efficacy of heberon [interferon alfa-2b] in combination with ribavirin for the treatment of chronic hepatitis C in Iran

interferon and ribavirin is the most effective treatment for chronic hepatitis C today. The aim of this study was to evaluate the efficacy and safety of thrice-weekly Heberon [interferon alfa-2b] in combination with ribavirin as first-line treatment of chronic hepatitis C.A total of 97 treatment-naive patients received Heberon three million units thrice-weekly subcutaneously in combination with ribavirin for 12 months. Serum HCV RNA levels were measured before and during therapy and 6 months after the end of therapy. End-of-treatment and sustained virological responses was defined as an undetectable HCV-RNA level at the end of treatment, and 6 months after treatment was completed [end of follow-up], respectively.In an intent-to-treat analysis, HCV-RNA was undetectable at the end of treatment in 49.5% of patients. At the end of follow-up, sustained virological response was 36.1%. Combination treatment was generally well tolerated. Six patients stopped therapy because of side effects: severe cytopenia [n=4], depression [n=1], and hyperthyroidism [n=1]. Common side effects of therapy include: Flu-like syndrome [85.6%], generalized alopecia [41.2%], injection site inflammation [37.1%], mood changes [36%], anorexia [34%] and weight loss [32%].Heberon as an IFN product in combination with ribavirin for treatment of patients with chronic hepatitis C is relatively safe, feasible, and potentially efficacious. It has comparable results in achieving end-of-treatment and sustained viro-logical responses in chronic hepatitis C

Efficacy and complications of endoscopic balloon dilation in treatment of benign gastric outlet obstruction

Gastric outlet obstruction [GOO] due to peptic stricture is one of three known complications of peptic ulcer disease and usually requires therapeutic intervention for symptoms relief. After Benjamin SB who primarily used balloon dilation for treatment of GOO in 1982, some series has been published investigating procedure efficacy with different results. The purpose of this study is to investigate efficacy of balloon dilation in some Iranian patients with GOO and also the probable role of some other factors on responsiveness. 23 patients were enrolled in a 10 month duration prospective case study and followed for mean of 30 weeks. some factors such as gender, age, cigarette smoking, Helicobacter pylori [H.p] infection, stenosis diameter, symptom duration, degree of weight loss, dilation sessions, response to therapy and time to response after procedure were registered for each patient. Mean age was 49.5 years and most patients were in the 5th decade of life. 2 and 23 of patients [8.7% and 91.3%] were female and male, respectively. the most common symptoms among patients were epigastric fullness and heart burn [each 87% of patients], nausea [82.6], vomiting [78.3%] and pain [69.6%]. 21 out of 23 patients were asymptomatic at end of study. 18 of 21 patients with response to therapy underwent only one session of dilation. There was not any statistically significant correlation between response to therapy and any one of factors as, gender, H.p infection, cigarette smoking, symptom duration and stenosis diameter. Time to response was shorter in males comparing to females [2.7 vs 8 weeks respectively] [p=0.002]. Trans the scope [TTS] balloon dilation of GOO in short term is effective and safe. if in long term, symptom recurrence rate proves to be acceptable, it will be recommended as first line treatment of benign GOO. Also it seems that use of fluoroscopy has not any additional advantage in increasing efficacy of the procedure

Safety and efficacy of interferon alfa for the treatment of chronic hepatitis C infected subjects with transfusion dependent thalassemia in Iran

Up to 30% of Iranian adult multi-transfused thalassemic patients are infected with hepatitis C virus [HCV] which can intensify the progression of liver disease caused by iron overload in this group of patients. Our aim was to assess the biochemical and virological response of interferon alfa [INF-alpha] and its safety in thalassemic patients with chronic HCV infection. This trial was a single center, open label, single treatment prospective study of INF-alpha[Heberon alfa R, 3 MU, every other day] for a period of 12 months. 29 subjects, 13 to 56 years old [mean +/- SD: 25.1 +/- 10.4 years], whose serum HCV-RNA was positive and mean AlT remained greater than 1.5 times upper limit of normal in the last 6 months before the study were enrolled. A percutaneous liver biopsy was performed before treatment and all patients underwent monthly assessment for adverse events and monitoring of serum ALT. Qualitative serum HCV -RNA was obtained in months 3 and 6 and at the end of therapy. Pretreatment liver biopsy showed mild fibrosis in 33.3%, moderate fibrosis in 56.7% and cirrhosis in 10% of patients. Siderosis was severe in 14 patients [46.7%]. Two nonsplenectomized patients discontinued INF because of mild cytopenia, which resolved in less than one week after interruption of therapy. The following were some of the important adverse events observed during the study period: Flu syndrome in 29[100%], chills or fever>39°C in 14[48%], local pain in 14[48%], transient gastrointestinal symptoms in 13[44%], weakness in 5[17%], local induration in 3[10%] and edema in 2[7%] of the patients. By the end of 12 months of therapy, 15 patients out of 27 [55.6%] had a normal ALT and negative HCV -RNA [complete end-treatment response], they were followed up for a mean duration of 10.5 months [range: 6 to 22 months] and in 8 of them [53.3%] the condition relapsed [abnormal ALT with positive PCR]. Viral clearance was a delayed event in our patients [29% by the end of month 3 and 63% by month 7] but ALT normalization occurred in 94% of responders by the end of month 3. Our experience indicates that the cure of HCV -related liver disease in thalassemic patients is not an unrealistic aim and may be achieved with a safe and inexpensive INF preparation [Heberon Alfa R] in a sizeable portion of cases. As opposed to non-thalassemic patients, in whom most viral responses happen in the first 3 months of therapy, in this group of thalassemic patients we found that maximum virologic response happened between 3 to 6 months of therapy. Although INF-alpha is an effective drug for initial treatment in thalassemic patients infected with HCV, its efficacy with the above dose and duration, for maintaining long term remission is under question

efficacy and safety of interferon alfa for treatment of chronic hepatitis B infected subjects in Iran

This preliminary study was designed to evaluate the effects of Heberon Alfa for the treatment of chronic hepatitis B infected subjects in Iran. A single center, open label, single treatment prospective study of Interferon Alfa [Heberon Alfa], 5 million units every other day for a period of 4 months, was performed between 1996 to 1998. A total number of 30 patients with histologically documented chronic hepatitis and positive serum HBsAg were included in the study. Serum ALT of all patients was greater than 1.5 times normal before start of therapy. Effect of therapy on aminotransferase activity and HBsAg, HBeAg seroconversion was monitored and all the patients underwent a second liver biopsy at the end of the study period. Mean age of patients was 35.5 +/- 12 [17 to 60 years old] and 73% of patients were mate. Most patients experienced adverse effects, but none warranted stopping the treatment. No serious or unexpected adverse event was reported during the study period. Thrombocytopenia was recorded in 2 patients. Liver biopsy showed a decrease in hepatic inflammation in 53.5% of patients, no change in 36.7% and increase in hepatic inflammation in 10% of patients after the treatment. Serum ALT returned to normal in 18 patients [60%], decreased in 7 patients [23.3%] and didn't change in 5 patients [16.7%]. There was a strong correlation between serum ALT normalization and histological improvement. HBsAg became negative in 5 patients [16.6%]. 10 patients had positive HBeAg prior to therapy, which became negative in 4 of them [40%] by the end of the study. The current study confirms the result of other clinical trials and indicates that Heberon Alfa is a safe and effective drug for the treatment of chronic hepatitis B infected subjects with histologically documented chronic hepatitis

Primary pancreatic lymphoma: a case report and literature review

Primary pancreatic lymphoma is a rare extranodal manifestation of any histopathologic subtype of B cell non-Hodgkin's lymphoma that predominantly involves the pancreas. It comprises less than 0.2% of pancreatic malignancies and less than 0.7% of non-Hodgkin's lymphomas. This lymphoma is almost never suspected clinically. It is usually diagnosed by surgical exploration for suspected adenocarcinoma because this kind of lymphoma resembles pancreatic adenocarcinoma, a much more common disease, in clinical presentation and radiologic appearance. Differentiation is, however, essential because of different clinical management and outcome. This report describes an interesting case of primary pancreatic lymphoma and review of the literature to elucidate features that suggest this entity