Objective : Post-marketing surveillance was conducted for the purpose of demonstrating the relationship between the therapeutic effect of natural IFN-β preparation on chronic active hepatitis C and HCV subtype or viral load as well as various predictors of its efficacy.
Design : Cohort studies.
Methods : Questionnaires were sent to all medical institutions at which IFN-β ('IFNβMochida') was administered to patients with chronic active hepatitis C once daily for at least 8 weeks and its therapeutic effect was judged based on the rate of virological sustained response (VSR) and the rate of biochemical (ALT) sustained response (BSR).
Results : Questionnaires for 2, 076 patients were collected from 244 medical institutions all over the country. Of these questionnaires, those for 1, 503 patients, 930 men (61.9%) and 573 women (38.1%), collected from 229 institutions could be evaluated regarding the therapeutic effect of IFNβ Mochida. The patients' mean age was 50.2 years. The average VSR were 31% for all of the patients (1, 503 patients), 61% for those with a low viral load (HCV-RNA level before IFN treatment ; <106 copies/ml) and 14% for those with a high viral load (≥106 copies/ml) ; with the subtypes 1 b, 2 a and 2 b accounting for 18, 55 and 29% respectively. BSR were 45, 69 and 32%, respectively ; with the subtypes 1 b, 2 a and 2 b accounting for 32, 66 and 56%. As for the therapeutic effect in patients with the same level of viral load but different viral subtype, at each level of viral load VSR was the highest in subtype 2 a, followed by 2 b and 1 b, showing a significant difference between 2 a and 1 b or 2 b, depending on the level of viral load. BSR of 2 a and 2 b were similarly high, showing a significant difference between 2 a or 2 b and 1 b, depending on the level of viral load. In patients with subtype 1 a or 1 b, patients who were administered IFN-β≥339 MU obtained a higher VSR than those who were administered IFN-β ≤336MU. Adverse drug reactions were observed in 89% of the total 2, 076 patients, however, these symptoms disappeared immediately after the completion of the treatment. Univariate and multivariate logistic regression analyses conducted to detect the predictors on the therapeutic effect (VSR) of IFN-β revealed that the subtype, viral load and age were significant factors for all the patients and that the viral load and NS5A mutation were significant factors for the patients with subtype 1 b. However, the NS5A mutant type viral load was significantly less than that of the other types, showing no difference in the therapeutic effect in the comparison at the same level of viral load.
Conclusion : It was confirmed that the therapeutic effect of the natural IFN-β preparation on chronic active hepatitis C varied widely depending on the viral load and viral subtype. This information will play an important role in the development of therapy for chronic hepatitis C in the future.

Purpose: This study was performed to evaluate the prognostic value of preoperative C-reactive protein to albumin ratio (CAR) in older patients with colorectal cancer (CRC) undergoing curative resection. Methods: We retrospectively analyzed 244 older patients (aged 75 years or higher) with pathological stage II or III CRC who underwent curative surgery between 2008 and 2016. The optimal value of CAR was calculated and its correlation with the clinicopathological factors and prognosis was examined. Results: The optimal cutoff value of the CAR was 0.085. High preoperative CAR was significantly associated with high carcinoembryonic antigen levels (P=0.001), larger tumor size (P<0.001), and pT factor (P=0.001). On multivariate analysis, high CAR was independent prognostic factor for relapse-free survival (P=0.042) and overall survival (P=0.001). Conclusion Preoperative elevated CAR could be considered as an adverse predictor of both relapse-free survival and overall survival in older patients with CRC undergoing curative surgery.

Background/Aims: The aim of this study was to evaluate the safety of sedation with propofol as an alternative to benzodiazepine drugs in outpatient endoscopy. Methods: In this prospective study, examinees who underwent outpatient endoscopy under propofol sedation and submitted a nextday questionnaire with providing informed consent were evaluated. Periprocedural acute responses, late adverse events within 24 hours, and examinee satisfaction were evaluated. Results: Among the 4,122 patients who received propofol in the 17,978 outpatient-based endoscopic examinations performed between November 2016 and March 2018, 2,305 eligible examinees (esophagogastroduodenoscopy for 1,340, endoscopic ultrasonography for 945, and total colonoscopy for 20) were enrolled, and their responses to a questionnaire were analyzed. The mean propofol dose was 69.6±24.4 mg (range, 20–200 mg). Diazepam, midazolam, and/or pentazocine in combination with propofol was administered to 146 examinees. Mild oxygen desaturation was observed in 59 examinees (2.6%); and mild bradycardia, in 2 (0.09%). Other severe reactions or late events did not occur. After eliminating 181 invalid responses, 97.7% (2,065/2,124) of the patients desired propofol sedation in future examinations. Conclusions Propofol sedation was found to be safe—without severe adverse events or accidents—for outpatient endoscopy on the basis of the patients’ next-day self-evaluation. Given the high satisfaction level, propofol sedation might be an ideal tool for painless endoscopic screening.

Background/Aims: The aim of this study was to evaluate the safety of sedation with propofol as an alternative to benzodiazepine drugs in outpatient endoscopy. Methods: In this prospective study, examinees who underwent outpatient endoscopy under propofol sedation and submitted a nextday questionnaire with providing informed consent were evaluated. Periprocedural acute responses, late adverse events within 24 hours, and examinee satisfaction were evaluated. Results: Among the 4,122 patients who received propofol in the 17,978 outpatient-based endoscopic examinations performed between November 2016 and March 2018, 2,305 eligible examinees (esophagogastroduodenoscopy for 1,340, endoscopic ultrasonography for 945, and total colonoscopy for 20) were enrolled, and their responses to a questionnaire were analyzed. The mean propofol dose was 69.6±24.4 mg (range, 20–200 mg). Diazepam, midazolam, and/or pentazocine in combination with propofol was administered to 146 examinees. Mild oxygen desaturation was observed in 59 examinees (2.6%); and mild bradycardia, in 2 (0.09%). Other severe reactions or late events did not occur. After eliminating 181 invalid responses, 97.7% (2,065/2,124) of the patients desired propofol sedation in future examinations. Conclusions Propofol sedation was found to be safe—without severe adverse events or accidents—for outpatient endoscopy on the basis of the patients’ next-day self-evaluation. Given the high satisfaction level, propofol sedation might be an ideal tool for painless endoscopic screening.