Osaka Rousai Hospital

Sakai, Japan

Osaka Rousai Hospital

Sakai, Japan
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Kurokawa M.,Osaka University | Hiramatsu N.,Osaka University | Oze T.,Osaka University | Yakushijin T.,Osaka University | And 25 more authors.
Journal of Gastroenterology | Year: 2012

Background Nucleotide analogues have recently been approved for the treatment of patients with hepatitis B virus (HBV) infection. However, it is still controversial whether the decrease of HBV-DNA amount induced by treatment with nucleotide analogues can reduce the risk of hepatocellular carcinoma (HCC) development in HBV patients. Methods A total of 293 HBV patients without HCC who were treated with lamivudine (LAM) were enrolled in a multicenter trial. The incidence of HCC was examined after the start of LAM therapy, and the risk factors for liver carcinogenesis were analyzed. The mean follow-up period was 67.6 ± 27.4 months. Results On multivariate analysis for HCC development in all patients, age ≥50 years, platelet count <14.0×10 4/mm3, cirrhosis, and median HBV-DNA levels of C4.0 log copies/ml during LAM treatment were significant risk factors. The cumulative carcinogenesis rate at 5 years was 3% in patients with chronic hepatitis and 30% in those with cirrhosis. For the chronic hepatitis patients, the log-rank test showed the significant risk factors related to HCC development to be age ≥50 years, platelet count <14.0×104/mm3, and hepatitis B e antigen negativity, but median HBV-DNA levels of <4.0 log copies/ml (maintained viral response, MVR) did not significantly suppress the development of HCC. In cirrhosis patients, however, the attainment of MVR during LAM treatment was revealed to reduce the risk of HCC development. Conclusions These results suggest that the incidence of HCC in HBV patients with cirrhosis can be reduced in those with an MVR induced by consecutive LAM treatment. © 2012 Springer.


Oze T.,Osaka University | Hiramatsu N.,Osaka University | Yakushijin T.,Osaka University | Mochizuki K.,Osaka University | And 25 more authors.
Journal of Gastroenterology | Year: 2011

Background: Which patients with hepatitis C virus (HCV) genotype 1 can benefit from extended treatment with pegylated interferon (Peg-IFN) plus ribavirin is unknown, although the overall sustained virologic response (SVR) rate has been shown to improve in patients with a late virologic response (LVR), defined as detectable serum HCV RNA at week 12 and undetectable at week 24. Methods: Among 1163 chronic hepatitis C patients with genotype 1 treated with Peg-IFN plus ribavirin combination therapy, 213 patients with an LVR were examined in this study. In addition, we selected 81 patients of matched sex and age from each of the 48- and 72-week treatment groups, using the propensity score, to compare the efficacy of the two treatment durations. Results: With 72-week treatment, the timing of HCV RNA disappearance and the hemoglobin level at baseline showed a strong correlation with the SVR on multivariate analysis. Earlier HCV RNA disappearance was associated with a better SVR rate, regardless of the ribavirin dose (HCV RNA disappearance at week 16, 74%; at week 20, 52%; and at week 24, 31%, p = 0.01). The SVR rate with 72-week treatment was higher than that with 48-week treatment, irrespective of age, sex, or the platelet value, and, especially in aged patients (≥65 years old), the SVR rate increased markedly with 72-week treatment (48 weeks, 25% vs. 72 weeks, 56%; p < 0.05). Conclusions: An earlier response predicts a higher SVR rate in patients with an LVR given 72-week treatment. Extended treatment with Peg-IFN plus ribavirin for patients with an LVR improved the treatment efficacy, even for aged patients. © 2011 Springer.


Oze T.,Osaka University | Hiramatsu N.,Osaka University | Yakushijin T.,Osaka University | Mochizuki K.,Osaka University | And 24 more authors.
Journal of Gastroenterology | Year: 2011

Background: It is still not known which patients with chronic hepatitis C who failed to respond to previous pegylated interferon (Peg-IFN) plus ribavirin therapy can benefit from re-treatment. Methods: Seventy-four patients (HCV genotype 1, n = 56, genotype 2, n = 18) were re-treated with Peg-IFN plus ribavirin. Results: On re-treatment, the sustained virologic response (SVR) rate was 41% for genotype 1 and 56% for genotype 2. With genotype 1, the factors associated with an SVR were previous treatment response and the serum hepatitis C virus (HCV) RNA level at the start of re-treatment. Patients with a <2-log decrease in HCV RNA at week 12 (partial early virologic response, p-EVR) in previous treatment had significantly higher SVR rates than those without these decreases (p < 0.001); no patient without a p-EVR in the previous treatment attained an SVR with re-treatment (0/16). All patients with <5 log 10 IU/ml of HCV RNA at the start of re-treatment attained an SVR (6/6), while only 33% (15/45) of those patients with <5 log10 IU/ml of HCV RNA attained an SVR (p < 0.01). Among the patients with relapse in the previous treatment, those who attained an SVR on re-treatment required a longer duration of re-treatment than the duration of the previous treatment (re-treatment, 63.8 ± 13.0 weeks vs. previous treatment, 53.9 ± 13.5 weeks, p = 0.01). Conclusions: Re-treatment of genotype 1 patients should be limited to patients with a p-EVR in the previous treatment and a low HCV RNA level at the start of re-treatment. In re-treatment with Peg-IFN plus ribavirin, longer treatment duration can contribute to increasing the anti-viral effect. © 2011 Springer.


Oze T.,Osaka University | Hiramatsu N.,Osaka University | Yakushijin T.,Osaka University | Miyazaki M.,Osaka University | And 18 more authors.
Journal of Gastroenterology | Year: 2014

Background: HCV kinetics during treatment demonstrated strong association with the antiviral outcome of patients treated with pegylated interferon (Peg-IFN) plus ribavirin. However, the relationship between HCV kinetics and pre-treatment factors remains unclear. Methods: Of 547 patients with HCV genotype 1 treated with Peg-IFN alfa-2b plus ribavirin, 401 completed the response-guided therapy and were assessed for per protocol analysis. Results: The sustained virologic response (SVR) rate was 53 % for all patients, 60 % for those with genotype TT, and 19 % for those with genotype TG/GG according to IL28B (rs8099917) single nucleotide polymorphisms. The SVR rates increased with HCV decrease at week 4; 4 % (2/56) with <1 log10 decrease, 13 % (7/56) with 1-2 log10 decrease, 51 % (44/87) with 2-3 log 10 decrease, 64 % (56/87) with 3-4 log10 decrease, 88 % (72/82) with more than 4 log10 decrease but with detectable HCV RNA and 100 % (33/33) with undetectable HCV RNA (p < 0.001). Similarly, SVR rates increased step-by-step in proportion to HCV decrease in both IL28B TT and TG/GG groups, showing almost the same SVR rates for the same conditions. In multivariate analysis, age (p = 0.005) and the magnitude of HCV decrease at week 4 (p < 0.001) but not IL28B were associated with SVR. Advanced liver fibrosis (p = 0.004) and the magnitude of HCV decrease at week 4 (p < 0.001) but not IL28B were associated with non-response. Conclusions: The magnitude of the HCV decrease at week 4 seems to be the most reliable marker for predicting antiviral outcome after starting Peg-IFN plus ribavirin therapy. © 2013 Springer.


Masuda N.,National Hospital Organization Osaka National Hospital | Higaki K.,Hiroshima City Hospital | Takano T.,Toranomon Hospital | Matsunami N.,Osaka Rousai Hospital | And 8 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2014

Purpose: Better treatments for triple-negative breast cancer (TNBC) are needed. To address this need, we studied the effects of preoperative metronomic paclitaxel/cyclophosphamide/capecitabine (mPCX) followed by 5-fluorouracil (FU)/epirubicin/cyclophosphamide (FEC) as preoperative chemotherapy in TNBC patients. Methods: Forty primary TNBC patients received four cycles of metronomic paclitaxel (80 mg/m2 on Days 1, 8, and 15), cyclophosphamide (50 mg/body daily), and capecitabine (1,200 mg/m2 daily), followed by four cycles of 5-FU (500 mg/m2), epirubicin (100 mg/m2), and cyclophosphamide (500 mg/m2) every 3 weeks. The primary end point was the pathological complete response (pCR) rate. Results: Forty patients formed the intent-to-treat population. The median dose intensities of paclitaxel, cyclophosphamide, and capecitabine were 89.7, 92.1, and 89.8 %, respectively. Five patients discontinued mPCX and two discontinued FEC, primarily because of adverse events, resulting in a per-protocol population (PPS) of 33 patients. The pCR (ypT0/Tis ypN0) rate was 47.5 % (19/40) in the intent-to-treat population and 54.5 % (18/33) in the PPS. The clinical response rates were 36/40 (90.0 %) and 31/33 (93.9 %) in the intent-to-treat and PPS, respectively. The breast conservation rate was 72.7 % (24/33), and 5/13 patients underwent partial resection instead of pre-planned total mastectomy. Grade 3-4 adverse events included neutropenia (35 %), leukopenia (25 %), and hand-foot syndrome (8 %). Conclusions: Metronomic PCX followed by FEC chemotherapy was associated with a high pCR rate and low toxicity in TNBC patients. Further studies of this regimen in larger numbers of patients are warranted. © 2014 Springer-Verlag.


Inoue Y.,Osaka University | Hiramatsu N.,Osaka University | Oze T.,Osaka University | Yakushijin T.,Osaka University | And 20 more authors.
Journal of Viral Hepatitis | Year: 2010

Reducing the dose of drug affects treatment efficacy in pegylated interferon (Peg-IFN) and ribavirin combination therapy for patients with hepatitis C virus (HCV) genotype 1. The aim of this study was to investigate the impact of drug exposure, as well as the baseline factors and the virological response on the treatment efficacy for genotype 2 patients. Two-hundred and fifty patients with genotype 2 HCV who were to undergo combination therapy for 24 weeks were included in the study, and 213 completed the treatment. Significantly more patients who achieved a rapid virological response (RVR), defined as HCV RNA negativity at week 4, achieved a sustained virological response (SVR) (92%, 122/133) compared with patients who failed to achieve RVR (48%, 38/80) (P < 0.0001). Multivariate logistic-regression analysis showed that only platelet counts [odds ratio (OR), 1.68; confidence interval (CI), 1.002-1.139] and RVR (OR, 11.251; CI, 5.184-24.419) were independently associated with SVR, with no correlation being found for the mean dose of Peg-IFN and ribavirin for RVR and SVR. Furthermore, in the stratification analysis of the timing of viral clearance, neither mean dose of Peg-IFN (P = 0.795) nor ribavirin (P = 0.649) affected SVR in each group. Among the patients with RVR, the lowest dose group of Peg-IFN (0.77 ± 0.10 μg/kg/week) and ribavirin (6.9 ± 0.90 mg/kg/day) showed 100% and 94% of SVR. Hence, RVR served as an important treatment predictor, and drug exposure had no impact on both SVR and RVR in combination therapy for genotype 2 patients. © 2009 Blackwell Publishing Ltd.


Okanoue T.,Saiseikai Suita Hospital | Shima T.,Saiseikai Suita Hospital | Hasebe C.,Red Cross | Karino Y.,Sapporo Kohseiren Hospital | And 18 more authors.
Hepatology Research | Year: 2016

Aim: We analyzed the 5-year post-treatment response to peginterferon α-2a (PEG IFN-α-2a) in hepatitis B e-antigen (HBeAg) positive and negative chronic hepatitis B patients. Methods: One hundred and thirty-seven chronic hepatitis B (CHB) patients receiving 90 μg or 180 μg of PEG IFN-α-2a for 24 or 48 weeks in phase II or III studies were enrolled in the study, including 100 HBeAg positive patients and 37 HBeAg negative patients; 121 patients (88.4%) had genotype C. Results: Of the 137 patients, 94 received additional antiviral therapy because of viral reactivation and 43 did not receive any additional antiviral treatment during follow up. Five years upon PEG IFN-α-2a treatment, 32 patients (23.4%) who did not receive any additional antiviral agent after PEG IFN-α-2a therapy achieved a good response (normal serum alanine aminotransferase, low-level hepatitis B virus [HBV] DNA, and HBeAg negativity). Female sex and low HBV DNA levels by the end of treatment were independently associated with favorable 5-year post-treatment responses. Forty-eight-week administration of PEG IFN-α-2a showed a better response (26.4%) than 24-week administration (18.0%). Six patients (4.3%), four males and two females, cleared hepatitis B surface antigen (HBsAg) during the 5-year follow-up period. Conclusion: The 48-week administration of PEG IFN-α-2a achieved better biochemical and virological responses than the 24-week administration, particularly in younger females. The 5-year post-treatment response rate was 23.4%; however, more than two-thirds of the patients received additional antiviral therapy because of viral reactivation after PEG IFN-α-2a treatment. HBsAg clearance was noted in six patients (4.3%). PEG IFN-α-2a is effective in young female patients. © 2016 The Japan Society of Hepatology


PubMed | National Hospital Organization Osaka National Hospital, Osaka General Medical Center, Osaka University, Kaizuka City Hospital and 9 more.
Type: Clinical Trial | Journal: Journal of gastroenterology | Year: 2016

Hyperbilirubinemia, mild or moderate, is a commonly observed laboratory abnormality in chronic hepatitis C patients treated with simeprevir with pegylated interferon (Peg-IFN) plus ribavirin. In this prospective, multicenter study, we aimed to investigate the clinical features and factors associated with bilirubin increases during the therapy.A total of 192 patients with chronic hepatitis C who were treated with simeprevir with Peg-IFN plus ribavirin were analyzed.The mean serum bilirubin level increased significantly during the initial 12 weeks of simeprevir administration and peaked at 2 weeks after the administration. Hyperbilirubinemia of more than 2 mg/dl developed in 18% of the patients; in 85% of those patients, the bilirubin levels peaked within 6 weeks and gradually decreased thereafter. A univariable analysis revealed that an increase in serum total bilirubin of 1.0 mg/dl or more from baseline was significantly associated with the sex, red blood cell count, serum hemoglobin level, serum alanine aminotransferase level, serum creatinine level and inosine triphosphate pyrophosphatase (ITPA) genotype. In the multivariable analysis, the ITPA genotype (CC odds ratio 4.990, p = 0.011) was found to be the only independent factor. Consistent with this result, there was a significant correlation between hyperbilirubinemia and the degree of hemolytic anemia.Hyperbilirubinemia develops at early time points after simeprevir administration in most cases and is dependent on the ITPA genotype. Careful attention should be paid to hyperbilirubinemia, which occurs at later time points or in patients with an ITPA non-CC genotype so that a diagnosis of liver damage with hyperbilirubinemia is not missed.


Kashii M.,Osaka University | Yamazaki R.,Osaka Rousai Hospital | Yamashita T.,Kansai Rousai Hospital | Okuda S.,Osaka Rousai Hospital | And 7 more authors.
European Spine Journal | Year: 2013

Purpose: In general, osteoporotic vertebral collapse (OVC) with neurological deficits requires sufficient decompression of neural tissues to restore function level in activities of daily living (ADL). However, it remains unclear as to which procedure provides better neurological recovery. The primary purpose of this study was to compare neurological recovery among three typical procedures for OVC with neurological deficits. Secondary purpose was to compare postoperative ADL function. Methods: We retrospectively reviewed data for 88 patients (29 men and 59 women) with OVC and neurological deficits who underwent surgery. Three typical kinds of surgical procedures with different decompression methods were used: (1) anterior direct neural decompression and reconstruction (AR group: 27 patients), (2) posterior spinal shorting osteotomy with direct neural decompression (PS group: 36 patients), and (3) posterior indirect neural decompression and short-segment spinal fusion combined with vertebroplasty (VP group: 25 patients). We examined clinical results regarding neurological deficits and function level in ADL and radiological results. Results: The mean improvement rates for neurological deficits and ADL function level were 60.1 and 55.0 %, respectively. There were no significant differences among three groups in improvement rates for neurological deficits or ADL function level. The VP group had a significantly lower estimated mean blood loss (338 mL) and mean duration of surgery (229 min) than both the AR and PS groups (p < 0.001). Conclusion: Direct neural decompression is not always necessary, and the majority of patients can be treated with a less-invasive procedure such as short-segment posterior spinal fusion with indirect decompression combined with vertebroplasty. The high-priority issue is careful evaluation of patients' general health and osteoporosis severity, so that the surgeon can choose the procedure best suited for each patient. © 2013 Springer-Verlag Berlin Heidelberg.


Kashii M.,Osaka University | Yamazaki R.,Osaka Rousai Hospital | Yamashita T.,Kansai Rousai Hospital | Okuda S.,Osaka Rousai Hospital | And 7 more authors.
Journal of Bone and Mineral Metabolism | Year: 2015

Surgical treatment of osteoporotic vertebral collapse (OVC) with neurological deficits presents significant clinical challenges because some patients have fragile bones and often have medical comorbidities, which affect the severity of osteoporosis. We hypothesized that clinical results of surgery in these patients depend on the extent of medical comorbidities that induce secondary osteoporosis. The aim of this study is to examine the effects of medical history and comorbidities on surgical outcomes for these patients, along with the factors that predict postoperative function in activities of daily living (ADL). We retrospectively reviewed data for 88 patients with OVC and neurological deficits who underwent surgery. We assessed clinical results regarding neurological deficits and function in ADL. The presence or absence of comorbidities responsible for secondary osteoporosis and treatments or medical events that affect bone metabolism were examined. We performed statistical analysis to examine prognostic factors for postoperative function in ADL. Of 88 patients, the distributions of comorbidities, treatment, and events in medical history were as follows: hypertension, 57 patients (64.8 %); chronic kidney disease (CKD) stage 3 or 4, 32 (36.4 %); diabetes mellitus, 16 (18.2 %); liver dysfunction, 11 (12.5 %); cardiovascular disease, 10 (11.4 %); rheumatoid arthritis, 9 (10.2 %); and glucocorticoid intake, 8 (9.1 %). Twenty-five patients (28.4 %) represented poor postoperative ADL (chair-bound or bed-bound), and 11 of 25 patients with poor postoperative ADL represented full neurological recovery. Multivariate analysis revealed decreased estimated glomerular filtration rate (odds ratio 0.96; 95 % confidence interval 0.93–0.99; p = 0.005) and a high serum alkaline phosphatase (ALP) level (odds ratio 1.01; 95 % CI 1.00–1.02; p = 0.01) were strong predictive factors for poor postoperative function in ADL. The majority of patients with poor postoperative function in ADL had advanced CKD with a disorder of bone metabolism as well as bone fragility. © 2014, The Japanese Society for Bone and Mineral Research and Springer Japan.

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