Health Insurance Hitoyoshi General Hospital

Kumamoto-shi, Japan

Health Insurance Hitoyoshi General Hospital

Kumamoto-shi, Japan
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Ishikawa Y.,Nippon Medical School | Kiyama T.,Nippon Medical School | Haga Y.,National Hospital Organization | Ishikawa M.,Red Cross | And 6 more authors.
Annals of Surgery | Year: 2010

Objective: To investigate whether maximal sterile barrier precautions (MSBPs) during central venous catheter (CVC) insertion are truly effective in preventing catheter-related bloodstream infections (CRBSIs) in patients in general surgical units. SUMMARY BACKGROUND DATA: The reported effectiveness of MSBPs was based on the Results: of a single-center randomized controlled trial by Raad et al and the majority of the patients (99%) in the study were chemotherapy outpatients. Methods: Between March 14, 2004 and December 28, 2006, the patients scheduled for CVC insertion in surgical units at 9 medical centers in Japan were randomly assigned to either an MSBP group (n = 211) or a standard sterile barrier precaution (SSBP) group (n = 213). This study was registered in the UMIN Clinical Trials Registry (registration ID number: UMIN000001400). Results: The median (range) duration of catheterization was 14 days (0-92 days) in the MSBP group and 14 days (0-112 days) in the SSBP group. There were 5 cases (2.4%) of CRBSI in the MSBP group and 6 cases (2.8%) in the SSBP group (relative risk, 0.84; 95% confidence interval, 0.26-2.7; P = 0.77). The rate of CRBSIs per 1000 catheter days was 1.5 in the MSBP group and 1.6 in the SSBP group. There were 8 cases (3.8%) of catheter-related infections in the MSBP group and 7 cases (3.3%) in the SSBP group (relative risk, 1.2; 95% confidence interval, 0.43-3.1; P = 0.78). The rate of catheter-related infection per 1000 catheter days was 2.4 in the MSBP group and 1.9 in the SSBP group. Conclusion This study is larger in sample size than the one performed by Raad et al and could not demonstrate better prevention of CRBSIs by MSBP compared with SSBP. A large randomized controlled trial or at least a meta-analysis of any other studies in the literature is necessary to reach to a Conclusion on this issue. Copyright © 2010 by Lippincott Williams & Wilkins.


Tsujita K.,Kumamoto University | Sugiyama S.,Jinnouchi Hospital | Sumida H.,Kumamoto Central Hospital | Shimomura H.,Fukuoka Tokushukai Medical Center | And 23 more authors.
Journal of the American College of Cardiology | Year: 2015

Background Despite standard statin therapy, a majority of patients retain a high "residual risk" of cardiovascular events. Objectives The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention (PCI). Methods This trial was a prospective, randomized, controlled, multicenter study. Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily. Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol (LDL-C) <70 mg/dl. Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients. Results The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy (63.2 ± 16.3 mg/dl vs. 73.3 ± 20.3 mg/dl; p < 0.001). For the absolute change in percent atheroma volume (PAV), the mean difference between the 2 groups (-1.538%; 95% confidence interval [CI]: -3.079% to 0.003%) did not exceed the pre-defined noninferiority margin of 3%, but the absolute change in PAV did show superiority for the dual lipid-lowering strategy (-1.4%; 95% CI: -3.4% to -0.1% vs. -0.3%; 95% CI: -1.9% to 0.9% with atorvastatin alone; p = 0.001). For PAV, a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression (78% vs. 58%; p = 0.004). Both strategies had acceptable side effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events. Conclusions Compared with standard statin monotherapy, the combination of statin plus ezetimibe showed greater coronary plaque regression, which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering. (Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [PRECISE-IVUS]; NCT01043380) © 2015 American College of Cardiology Foundation.


PubMed | National Hospital Organization Kumamoto Medical Center, Red Cross, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto University and 13 more.
Type: Journal Article | Journal: European journal of preventive cardiology | Year: 2016

The IMPROVE-IT trial showed that the clinical benefit of statin/ezetimibe combination appeared to be pronounced in patients with prior statin therapy. We hypothesized that the antiatherosclerotic effect of atorvastatin/ezetimibe combination was pronounced in patients with statin pretreatment.In the prospective, randomized, controlled, multicenter PRECISE-IVUS trial, 246 patients undergoing intravascular ultrasound-guided percutaneous coronary intervention were randomized to atorvastatin/ezetimibe combination or atorvastatin alone. The dosage of atorvastatin was uptitrated with a treatment goal of lowering low-density lipoprotein cholesterol to below 70mg/dl in both groups. Serial volumetric intravascular ultrasound was performed at baseline and 9-12 month follow-up to quantify the coronary plaque response in 202 patients. We compared the intravascular ultrasound endpoints in all subjects, stratified by the presence or absence of statin pretreatment.The baseline low-density lipoprotein cholesterol level (100.723.1mg/dl vs. 116.425.9mg/dl, p<0.001) and lathosterol (55 (38 to 87)) g/100mg total cholesterol vs. 97 (57 to 149) g/100mg total cholesterol, p<0.001) was significantly lower, and campesterol/lathosterol ratio (3.9 (2.4 to 7.4) vs. 2.6 (1.5 to 4.1), p<0.001) was significantly increased in patients with statin pretreatment. Contrary to the patients without statin pretreatment (-1.3 (-3.1 to -0.1)% vs. -0.9 (-2.3 to 0.9)%, p=0.12), the atorvastatin/ezetimibe combination showed a significantly stronger reduction in delta percent atheroma volume, compared with atorvastatin alone, in patients with statin pretreatment (-1.8 (-3.6 to -0.3)% vs. -0.1 (-1.6 to 0.8)%, p=0.002).Compensatory increase in cholesterol absorption observed in statin-treated patients might attenuate the inhibitory effects of statins on coronary plaque progression. A low-dose statin/ezetimibe combination might be a promising option in statin-hyporesponder.


PubMed | National Hospital Organization Kumamoto Medical Center, Red Cross, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto University and 13 more.
Type: | Journal: Atherosclerosis | Year: 2016

Although dual low-density lipoprotein cholesterol (LDL-C)-lowering therapy (DLLT) with statin-ezetimibe combination showed clinical benefit in patients with acute coronary syndrome (ACS) confirming the lower, the better, the underlying mechanisms of DLLT are still unknown.PRECISE-IVUS trial evaluated the effects of DLLT on IVUS-derived coronary atherosclerosis and lipid profile, compared with atorvastatin monotherapy, quantifying the coronary plaque response in 100 ACS patients. We explored the potential predictors of plaque regression.Lower total cholesterol, LDL-C, triglyceride, remnant-like particles cholesterol, and stronger reduction of small dense LDL-C and cholesterol absorption markers were observed in patients with plaque regression compared to those with progression. Multivariate analysis revealed that achieved LDL-C was the strongest predictor for coronary plaque regression (95% CI: 0.944-1.000, p=0.05), followed by age (95% CI: 0.994-1.096, p=0.09).Incremental LDL-C lowering by DLLT was associated with stronger coronary plaque regression, reconfirming that lowering LDL-C to levels below previous targets provided additional clinical benefit.


PubMed | National Hospital Organization Kumamoto Medical Center, Red Cross, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto University and 13 more.
Type: Journal Article | Journal: Journal of the American College of Cardiology | Year: 2015

Despite standard statin therapy, a majority of patients retain a high residual risk of cardiovascular events.The aim of this study was to evaluate the effects of ezetimibe plus atorvastatin versus atorvastatin monotherapy on the lipid profile and coronary atherosclerosis in Japanese patients who underwent percutaneous coronary intervention (PCI).This trial was a prospective, randomized, controlled, multicenter study. Eligible patients who underwent PCI were randomly assigned to atorvastatin alone or atorvastatin plus ezetimibe (10 mg) daily. Atorvastatin was uptitrated with a treatment goal of low-density lipoprotein cholesterol (LDL-C)<70 mg/dl. Serial volumetric intravascular ultrasound was performed at baseline and again at 9 to 12 months to quantify the coronary plaque response in 202 patients.The combination of atorvastatin/ezetimibe resulted in lower levels of LDL-C than atorvastatin monotherapy (63.2 16.3 mg/dl vs. 73.3 20.3 mg/dl; p< 0.001). For the absolute change in percent atheroma volume (PAV), themean difference between the 2 groups (-1.538%; 95% confidence interval [CI]: -3.079% to 0.003%) did not exceedthe pre-defined noninferiority margin of 3%, but the absolute change in PAV did show superiority for the dual lipid-lowering strategy (-1.4%; 95% CI: -3.4% to -0.1% vs. -0.3%; 95% CI: -1.9% to 0.9% with atorvastatin alone; p=0.001). For PAV, a significantly greater percentage of patients who received atorvastatin/ezetimibe showed coronary plaque regression (78% vs. 58%; p= 0.004). Both strategies had acceptable side effect profiles, with a low incidence oflaboratory abnormalities and cardiovascular events.Compared with standard statin monotherapy, the combination of statin plus ezetimibe showed greater coronary plaque regression, which might be attributed to cholesterol absorption inhibition-induced aggressive lipid lowering. (Plaque Regression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by Intravascular Ultrasound [PRECISE-IVUS]; NCT01043380).


Kato K.,National Cancer Center Hospital | Chin K.,Cancer Institute Hospital Tokyo | Yoshikawa T.,Kanagawa Cancer Center | Yamaguchi K.,Saitama Cancer Center | And 8 more authors.
Investigational New Drugs | Year: 2012

Purpose NK105 is a new drug delivery system formulation for paclitaxel (PTX) whose recommended dose (RD) is 150 mg PTX equivalent/m 2 administered every 3 weeks, as determined in a phase I trial. This study aimed to evaluate the efficacy and safety of NK105 in patients with advanced gastric cancer after failure of first-line chemotherapy. Experimental design Eligible patients had measurable disease and one chemotherapeutic regimen except taxane. NK105 (150 mg PTX equivalent/m 2) was administered by a 30-minute intravenous infusion every 3 weeks without antiallergic premedication until disease progression, unacceptable toxicity or patient refusal. The primary efficacy endpoint was best overall response rate (ORR) post baseline. The secondary endpoints were progression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS). All adverse events were reported using CTCAE v3.0. Results Between November 2007 and July 2009, 57 patients were enrolled and 56 were evaluable for efficacy. Two complete responses and 12 partial responses were observed for an ORR of 25%. The median PFS was 3.0 months, the median TTF was 2.8 months, and the median OS was 14.4 months. Drug related toxicity was mainly mild (grades 1-2) to severe (grades 3-4); other data: neutropenia (64.9%); leukopenia (17.5%); lymphopenia (8.8%); neuropathysensory (1.8%); fatigue (3.5%); and stomatitis (1.8%). There were no treatment-related deaths. Conclusions This study of NK105 (150 mg PTX equivalent/m 2) proves the concept for the modest activity and tolerability of a new drug delivery system formulation for PTX. A phase III trial will be evaluated to clarify survival benefit. © Springer Science+Business Media, LLC 2011.


Toyama K.,Kumamoto University | Toyama K.,Japan Society for the Promotion of Science | Toyama K.,Health Insurance Hitoyoshi General Hospital | Sugiyama S.,Kumamoto University | And 8 more authors.
PLoS ONE | Year: 2012

Objective: Statin- and exercise-therapy are both clinically beneficial by preventing cardiovascular events in patients with coronary artery disease (CAD). However, there is no information on the vascular effects of the combination of statins and exercise on arterial wall stiffness in CAD patients. Methods: The present study is a sub-analysis of PRESET study that determined the effects of 20-week treatment with statins (rosuvastatin, n = 14, atorvastatin, n = 14) combined with regular exercise on arterial wall stiffness assessed by measurement of brachial and ankle pulse wave velocity (baPWV) in CAD patients. Results: The combination of statins and regular exercise significantly improved exercise capacity, lipid profile, including low- and high-density lipoprotein cholesterol, and high-sensitivity C-reactive protein (hs-CRP), baPWV (baseline: 1747±355, at 20 weeks of treatment: 1627±271 cm/s, p = 0.008), and basophil count (baseline: 42±32, 20 weeks: 26±15 cells/μL, p = 0.007), but had no effect on blood pressure (baseline: 125±22, 20 weeks: 121±16 mmHg). Changes in baPWV correlated significantly with changes in basophil count (r = 0.488, p = 0.008), but not with age, lipids profile, exercise capacity, or hs-CRP. Conclusion: In CAD patients, the combination treatment with statins and exercise resulted in significant amelioration of arterial wall stiffness, at least in part, through reduction of circulating basophils. © 2012 Toyama et al.


Toyama K.,Kumamoto University | Sugiyama S.,Kumamoto University | Oka H.,Health Insurance Hitoyoshi General Hospital | Sumida H.,Kumamoto University | Ogawa H.,Kumamoto University
Journal of Cardiology | Year: 2010

Background: Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) are at high risk of cardiovascular mortality, thus therapies to improve renal function should be clinically investigated. Methods and results: We divided consecutive patients with CVD and CKD (n=19) into exercise (n=10) and non-exercise (n=9) therapy groups. Exercise therapy for 12 weeks significantly improved the anaerobic metabolic threshold (AT-. V̇O2) and high-density lipoprotein cholesterol (HDL-C) levels, and reduced triglyceride levels. Exercise therapy also improved estimated glomerular filtration rate (eGFR). Change in eGFR correlated significantly and positively with change in AT-. V̇O2 and HDL-C, and negatively with change in triglyceride levels. Conclusions: Exercise therapy correlates with improving renal function in CVD patients with CKD through modifying lipid metabolism. Exercise therapy could be an effective clinical strategy to improve renal function. © 2010 Japanese College of Cardiology.


Toyama K.,Kumamoto University | Toyama K.,Health Insurance Hitoyoshi General Hospital | Sugiyama S.,Kumamoto University | Oka H.,Health Insurance Hitoyoshi General Hospital | And 8 more authors.
Atherosclerosis | Year: 2011

Background: Coenzyme Q10 levels are low in patients with coronary artery disease (CAD), and increasing or preserving coenzyme Q10 could be a beneficial strategy. Exercise and statins improve high-density lipoprotein cholesterol (HDL-C) levels. However, statins inhibit coenzyme Q10 biosynthesis, and the combination of statins with coenzyme Q10 supplementation increases HDL-C compared to statins alone. We compared the effects of two statins (rosuvastatin and atorvastatin) combined with exercise on coenzyme Q10 and HDL-C levels in CAD patients. Methods: After randomizing 28 CAD patients to rosuvastatin (n= 14) and atorvastatin (n= 14) groups, patients performed weekly in-hospital aerobic exercise and daily home exercise for 20 weeks. We measured serum lipids, ubiquinol, and exercise capacity. Results: Both statins equally improved exercise capacity and lowered low-density lipoprotein cholesterol and triglyceride levels. Rosuvastatin significantly increased HDL-C (rosuvastatin, +12 ± 9 mg/dL [+30%], atorvastatin, +5 ± 5 mg/dL [+13%], p= 0.014) and apolipoprotein A1 (ApoA1) (rosuvastatin, +28.3 ± 20.7. mg/dL, atorvastatin, +13.4 ± 12.0. mg/dL, p= 0.030) compared to atorvastatin. Atorvastatin significantly decreased serum ubiquinol (731 ± 238 to 547 ± 219 nmol/L, p= 0.001), but rosuvastatin (680 ± 233 to 668 ± 299 nmol/L, p= 0.834) did not. There was a significant positive correlation between changes in ubiquinol and ApoA1 (r= 0.518, p= 0.005). Multivariate regression analysis showed that changes in ubiquinol correlated significantly with changes in ApoA1 after adjusting for age, sex, body mass index, and smoking (β= 0.502, p= 0.008). Conclusions: Compared to atorvastatin, rosuvastatin combined with exercise significantly preserved ubiquinol levels associated with an increase in HDL-C. Rosuvastatin with regular exercise could be beneficial for CAD patients. © 2011 Elsevier Ireland Ltd.

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