1.Post-Marketing Surveillance of Natural IFN-β Preparation for Chronic Hepatitis C
Masaaki SOMA ; Minoru SASAKI ; Michio SAKAMAKI ; Shinsuke TANAKA ; Hagemu SHIMIZU ; Yasuyuki KUNIHIRO
Japanese Journal of Pharmacoepidemiology 2001;6(1):5-28
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.
2.Methods for teaching the pathology of organ systems
Kouki INAI ; Taizo SHIRAISHI ; Michio SHIMIZU ; Kohsuke SASAKI ; Koichi TAMURA ; Yutaka TSUTSUMI
Medical Education 2008;39(5):313-316
I) In most medical schools, the diseases of organ systems are divided within an integrated curriculum and are not taught in order, however, this situation will improve if several conditions are fulfilled.
2) The conditions that should be fulfilled are maintaining sufficient time for teaching general pathology and for bedside learning in the hospital's department of pathology.
3) Examples of training methods in the pathology of organ systems devised at various medical schools include the use of a virtual slide system, the presentation of surgically resected material, and practical training at a hospital's department of pathology.
3.Stone Attenuation Value and Cross-Sectional Area on Computed Tomography Predict the Success of Shock Wave Lithotripsy.
Michio TANAKA ; Eisuke YOKOTA ; Yoichiro TOYONAGA ; Fumitaka SHIMIZU ; Yoshiyuki ISHII ; Makoto FUJIME ; Shigeo HORIE
Korean Journal of Urology 2013;54(7):454-459
PURPOSE: To identify the parameters on noncontrast computed tomography (NCCT) that best predict the success of shock wave lithotripsy (SWL). MATERIALS AND METHODS: We reviewed the records of 75 patients who underwent SWL for urinary calculi measuring 5 to 20 mm. Using NCCT images, we estimated the largest stone cross-sectional area and contoured the inner edge of the stone. Clinical outcome was classified as successful (stone-free or <4 mm in diameter) or failed (stone fragments, > or =4 mm). The impact of preoperative parameters was evaluated by univariate and multivariate analysis. RESULTS: The overall success rate was 73.3%. Average stone attenuation value, stone length, and stone cross-sectional area in the success and failure groups were 627.4+/-166.5 HU (Hounsfield unit) vs. 788.1+/-233.9 HU (p=0.002), 11.7+/-3.8 mm vs. 14.2+/-3.6 mm (p=0.015), and 0.31+/-0.17 cm2 vs. 0.57+/-0.41 cm2 (p<0.001), respectively. In the multivariate analysis, stone attenuation value was the only independent predictor of SWL success (p=0.023), although stone cross-sectional area had a tendency to be associated with SWL success (p=0.053). Patients were then classified into four groups by using cutoff values of 780 HU for stone attenuation value and 0.4 cm2 for cross-sectional area. By use of these cutoff values, the group with a low stone attenuation value and a low cross-sectional area was more than 11.6 times as likely to have a successful result on SWL as were all other groups (odds ratio, 11.6; 95% confidence interval, 3.9 to 54.7; p<0.001). CONCLUSIONS: Stone attenuation value and stone cross-sectional area are good predictors of extracorporeal SWL outcome.
Humans
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Lithotripsy
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Multivariate Analysis
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Shock
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Treatment Outcome
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Urinary Calculi