Details of a Researcher - Sato, Yasunori

Papers - Sato, Yasunori

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Modern management for brain metastasis patients using stereotactic radiosurgery: literature review and the authors' gamma knife treatment experiences

Higuchi, Y., Yamamoto, M., Serizawa, T., Aiyama, H., Sato, Y. and Barfod, B. E.

Cancer Manag Res (Cancer Management and Research) 10 1889 - 1899 2018.09

Research paper (scientific journal), Joint Work, ISSN 1179-1322

Historically, whole brain radiotherapy was administered to most patients with brain metastases. However, over the past three decades, stereotactic radiosurgery (SRS), targeted at individual cranial lesions, has been accepted widely. In this study, based on the authors' experiences along with published data, recent trends in SRS for brain metastases are discussed. This article focuses on the following issues: 1) How many tumors can or should be treated with SRS? 2) Two-/three-staged SRS for relatively large tumors, 3) post- or preoperative SRS, and 4) repeat SRS.

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Is ganglionated plexus ablation effective for treating atrial fibrillation?

Watanabe, Michiko, Kohno, Hiroki, Kondo, Yusuke, Ueda, Hideki, Ishida, Keiichi, Tamura, Yusaku, Abe, Shinichiro, Sato, Yasunori, Kobayashi, Yoshio, Matsumiya, Goro

SURGERY TODAY (Surgery Today) 48 ( 9 ) 875 - 882 2018.09

Research paper (scientific journal), Joint Work, ISSN 0941-1291

© 2018, Springer Nature Singapore Pte Ltd. Purpose: Very few studies have investigated the efficacy of ganglionated plexus ablation during the conventional maze procedure. In this study, we sought to evaluate its additive effect in reducing recurrent atrial fibrillation after concomitant maze surgery. Methods: A retrospective study was conducted of 79 patients who underwent Cox maze IV concomitantly with open-heart surgery with (GP group) or without (Maze group) ganglionated plexus mapping. All active ganglionated plexuses were ablated. The two groups were compared and their follow-up data were analyzed. Results: Active ganglionated plexuses were found in 81% of patients who underwent ganglionated plexus mapping. The rates of freedom from atrial fibrillation at 1 year in the GP and Maze groups were 77 and 75%, respectively. The cumulative freedom from atrial fibrillation at follow-up (27.7 ± 17.3 months) was comparable in the two groups (p = 0.427). A multivariate analysis revealed that persistent atrial fibrillation for more than 90 months was an independent predictor of recurrent atrial fibrillation. Conclusion: Ganglionated plexus ablation with Cox maze IV did not reduce the incidence of recurrent atrial fibrillation in comparison to Maze alone.

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Postsurgical Salvage Radiosurgery for Nonfunctioning Pituitary Adenomas Touching/Compressing the Optic Chiasm: Median 13-Year Postirradiation Imaging Follow-up Results

Yamamoto, M., Aiyama, H., Koiso, T., Watanabe, S., Kawabe, T., Sato, Y., Higuchi, Y., Barfod, B. E. and Kasuya, H.

Neurosurgery 2018.08

Research paper (scientific journal), Joint Work, ISSN 0148-396

BACKGROUND: There is little information on long-term outcomes after salvage treatment by either surgery or stereotactic radiosurgery (SRS) for patients with recurrent/residual nonfunctioning pituitary adenomas (NFPAs). OBJECTIVE: To reappraise the efficacy and safety of SRS for patients with NFPAs touching/compressing the optic apparatus (OA). METHODS: We studied 27 patients (14 females, 13 males; mean age: 61 [range, 19-85] yr) who underwent SRS between 1998 and 2008 for NFPAs with such condition. The median tumor volume was 4.9 (range, 1.8-50.8) cc. To avoid excess irradiation to the OA, the lower part of the tumor was covered with a 50% or a 60% isodose gradient, ie 49% to 98% (mean, 84%; median, 88%) of the entire tumor received the selected doses. Median doses at the tumor periphery/OA were 7.6/11.0 (interquartile range [IQR], 5.8-9.1/10.1-11.8) Gy. RESULTS: Seven patients (26%) were confirmed to be deceased due to unrelated diseases at a median post-SRS period of 149 (IQR, 83-158) mo. Follow-up magnetic resonance imaging (MRI) showed tumor growth in 2 patients (7%) at the 11th and 134th post-SRS month; the former underwent surgery and the other SRS. Excluding these 2 patients, the latest follow-up MRI examinations, performed 13 to 238 (median: 168, IQR: 120-180) mo after SRS, showed no size changes in 5 (19%) and shrinkage in 20 (74%) patients. Cumulative incidences of tumor growth control were 96.3% and 91.8% at the 120th and 180th post-SRS month. None of our patients developed subjective symptoms suggesting SRS-induced optic neuropathy or endocrinological impairment. CONCLUSION: In patients with NFPAs touching/compressing the OA, SRS achieves good long-term results.

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Comparison of meniscal extrusion and osteophyte formation at the intercondylar notch as a predictive biomarker for incidence of knee osteoarthritis-Data from the Osteoarthritis Initiative

Okada, K., Yamaguchi, S., Sato, Y., Enomoto, T., Ogawa, Y., Ohtori, S., Tahara, M. and Sasho, T.

J Orthop Sci (Journal of Orthopaedic Science) 24 ( 1 ) 121 - 127 2018.08

Research paper (scientific journal), Joint Work, ISSN 0949-2658

BACKGROUND: Medial meniscal extrusion (ME) is a biomarker to predict later development of knee osteoarthritis (KOA). On the other hand, we have reported osteophyte formation at the posterior condylar notch of the femur served as a biomarker for the same purpose. The purpose of this study is to compare capacity of the two biomarkers in predicting KOA development. METHODS: Two cohort of knees were established utilizing publicly available data from the Osteoarthritis Initiative (OAI). No OA group (NOA) consisted of knees that were grade 0 or 1 on Kellgren and Lawrence grade (K/L) both at baseline and 48 months later, and pre-radiographic-OA group (PROA) consisted of knees that were grade 0 or 1 at baseline but grade >/=2 48 months later. Baseline MR images were evaluated in terms of ME and osteophyte formation at the posterior condylar notch. ME was evaluated both by meniscus subluxation index (MSI) indicating the ratio of the extruded width of the medial meniscus to the width of medial meniscal body and by the medial radial displacement (MRD) indicating actual extruded width. The size of the osteophyte was assessed using a semi-quantitative whole-organ magnetic resonance imaging score (WORMS). The predictive accuracy of KOA was assessed by the area under the receiver operating characteristic curve (AUC) and optimal cutoff was determined for each parameter. RESULTS: The AUC for MSI was 0.654 (0.561-0.748: 95% CI) and the cutoff value was determined as 17%. That for MRD was 0.677 (0.584-0.770) and the cutoff value was 2.2 mm. The AUC for the WORMS score at the posterior condylar notch was 0.667 (0.579-0.756) and the cutoff value was 2. CONCLUSIONS: Similar predicting capacity of KOA development was found both in ME and osteophyte formation at the posterior condylar notch. Using these simple parameter, mas-screening for KOA development would be possible.

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Development of a self-efficacy questionnaire, "Insulin Therapy Self-efficacy Scale (ITSS)", for insulin users in Japanese: THE SELF-EFFICACY-Q study

Nakaue, J., Koizumi, M., Nakajima, H., Okada, S., Mohri, T., Akai, Y., Furuya, M., Hayashino, Y., Sato, Y. and Ishii, H.

J Diabetes Investig (Journal of Diabetes Investigation) 10 ( 2 ) 358 - 366 2018.08

Research paper (scientific journal), Joint Work, ISSN 2040-1116

AIMS/INTRODUCTION: Although patient self-efficacy is known to affect adherence to therapy, no available tool measures self-efficacy of insulin therapy administration while addressing the entire therapeutic process and management. In light of this, we developed the "Insulin Therapy Self-efficacy Scale (ITSS)". MATERIALS AND METHODS: Development of the ITSS involved three phases: 1) item generation and creation of a questionnaire draft; 2) testing and correcting the items through interviews with patients; and 3) a multicenter single arm study to validate the questionnaire. RESULTS: A factor analysis and Cronbach's alpha both confirmed good internal consistency in the subjects' confidence regarding the following four factors: the insulin injection procedure, insulin titration, glycemic control, and ability to cope with hypoglycemia. Reproducibility was confirmed using weighted kappa statistics and intra-class correlations. Good concurrent validity was confirmed with two other questionnaires. The ITSS score was also found to correlate with several patient characteristics and clinical parameters, as well as with a better adherence to injected insulin therapy 6 months later, suggesting the predictive validity of this scale. CONCLUSIONS: The ITSS is a reliable and valid tool for assessing and quantifying patients' self-efficacy. The ITSS estimation of self-efficacy can predict a patient's glycemic control and future adherence to insulin therapy. These characteristics will ensure the usefulness of the ITSS in ensuring a successful therapeutic process for patients and physicians. This article is protected by copyright. All rights reserved.

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The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF)

Kotooka N, Kitakaze M, Nagashima K, Asaka M, Kinugasa Y, Nochioka K, Mizuno A, Nagatomo D, Mine D, Yamada Y, Kuratomi A, Okada N, Fujimatsu D, Kuwahata S, Toyoda S, Hirotani SI, Komori T, Eguchi K, Kario K, Inomata T, Sugi K, Yamamoto K, Tsutsui H, Masuyama T, Shimokawa H, Momomura SI, Seino Y, Sato Y, Inoue T, Node K; HOMES-HF study investigators.

HEART AND VESSELS (Heart and Vessels) 33 ( 8 ) 866 - 876 2018.08

Research paper (scientific journal), Joint Work, Accepted, ISSN 0910-8327

© 2018, Springer Japan KK, part of Springer Nature. Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0–31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548–1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.

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Identifying improvable employment-related factors in schizophrenia patients

Hasegawa, Tadashi, Hashimoto, Tasuku, Kanahara, Nobuhisa, Yamanaka, Hiroshi, Ishige, Minoru, Sato, Yasunori, Iyo, Masaomi

PSYCHIATRY RESEARCH (Psychiatry Research) 266 199 - 205 2018.08

Research paper (scientific journal), Joint Work, ISSN 0165-1781

© 2018 Elsevier B.V. Although many studies report various factors related to future employment of schizophrenia patients, few identify the treatable or improvable ones. The responses to the first year of treatment and daily antipsychotic drug doses may be the treatable and improvable factors. We surveyed 235 schizophrenia outpatients in three facilities, of whom 129 and 106 were employed and unemployed, respectively. Through face-to-face interviews and medical record reviews, we investigated symptomatic and social functioning responses to the first year of treatment using the Global Assessment of Psychopathology Scale (GAPS) and the Social and Occupational Functioning Assessment Scale (SOFAS). We investigated daily antipsychotic drug doses and other clinical assessments at the interview time. Finally, we used multivariable logistic regression analysis. SOFAS-measured improvements in the period 6 to 12 months after beginning treatment and daily antipsychotic drug doses equivalent to less than 600 mg of chlorpromazine were identified as an employment-related factor, but GAPS-measure improvements were not. Social functioning improvements in the period 6 to 12 months after beginning treatment and low-to-moderate daily antipsychotic drug doses were detected as employment-related factors, suggesting that early efforts to improve social functioning and optimize antipsychotic drug doses could lead to future employment for schizophrenia patients.

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Avulsion fracture of the distal fibula is associated with recurrent sprain after ankle sprain in children

Yamaguchi, S., Akagi, R., Kimura, S., Sadamasu, A., Nakagawa, R., Sato, Y., Kamegaya, M., Sasho, T. and Ohtori, S.

Knee Surg Sports Traumatol Arthrosc (Knee Surgery, Sports Traumatology, Arthroscopy) 27 ( 9 ) 2774 - 2780 2018.07

Research paper (scientific journal), Joint Work, ISSN 0942-2056

PURPOSE: The purpose of this study was to clarify radiographic and clinical outcomes, as well as their association, of ankle sprain in children. METHODS: Patients who sustained a first-time ankle sprain were prospectively surveyed. Patients underwent radiography of the ankle in the mortise, lateral, anterior talofibular ligament (ATFL), and calcaneofibular ligament views at the first clinic visit to assess avulsion fractures of the distal fibula. Patients with avulsion fractures underwent radiography after 8 weeks to assess bone union. The treatment method was not standardized and was determined by the patient, their parents, and the treating physician. Recurrent sprain and quality of life were evaluated by using the Self-Administered Foot Evaluation Questionnaire and reviewing the medical records of patients. The association between avulsion fracture and recurrent sprain was assessed using univariate and multivariate analyses. RESULTS: A total of 143 patients with a median age of 9 (range 6-12) years were analyzed. Avulsion fractures were present in 89 (62%) patients. The sensitivity of the ATFL view for the diagnosis of avulsion fractures was 0.94, whereas that for the anteroposterior and lateral views was significantly lower at 0.46 (P < 0.001). Only 17% of fractures united at 8 weeks. Of 114 (follow-up rate, 80%) patients who were followed up for a median period of 24 months, recurrent sprain occurred in 41 (36%) patients. The incidence rate was significantly higher in patients with avulsion fractures than in patients without the fractures (44 vs. 23%, P = 0.027). In multivariate logistic regression analysis, avulsion fracture was independently associated with recurrent sprain (P = 0.027). CONCLUSION: More than one-third of patients experienced recurrent sprain. The presence of avulsion fracture was associated with an increased risk of recurrent sprain. Patients with avulsion fracture and their parents should be informed about the risk of recurrent sprain and subsequent ankle instability, and careful follow-up is needed for these patients. LEVEL OF EVIDENCE: III.

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Medical costs attributable to overweight and obesity in Japanese individuals

Fujita, M., Sato, Y., Nagashima, K., Takahashi, S. and Hata, A.

Obes Res Clin Pract (Obesity Research and Clinical Practice) 12 ( 5 ) 479 - 484 2018.06

Research paper (scientific journal), Joint Work, ISSN 1871-403X

OBJECTIVE: We aimed to reveal the association between body mass index (BMI) and medical costs in the current Japanese population, and to estimate the population attributable fraction (PAF) of medical costs due to overweight and obesity. METHODS: A generalized linear mixed model with log link function and gamma distribution was used to evaluate the association between BMI and medical costs in 34,537 beneficiaries of the National Health Insurance aged 40-69 years in Chiba City. Medical cost data were obtained from insurance claims submitted between April 2012 and March 2016. PAFs due to overweight (BMI >/=25.0 and <30.0kg/m(2)) and obesity (BMI >/=30.0kg/m(2)) were calculated. RESULTS: Overweight and obesity were significant predictors of excessive medical costs in all age and sex groups. PAF due to overweight and obesity was estimated to be 9.62% (95% confidence interval, 8.52-10.73%). Additionally, PAFs in 40-59-year-old individuals (12.76% in men and 11.63% in women) were greater than those in 60-69-year-old subjects (6.55% in men and 7.80% in women) for both sexes. CONCLUSIONS: In the Japanese population, overweight and obesity are an excessive financial burden with an estimated PAF of 9.62% of total medical costs.

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The effects of xanthine oxidase inhibitor in patients with chronic heart failure complicated with hyperuricemia: a prospective randomized controlled clinical trial of topiroxostat vs allopurinol-study protocol

Sakuma, M., Toyoda, S., Arikawa, T., Koyabu, Y., Kato, T., Adachi, T., Suwa, H., Narita, J. I., Anraku, K., Ishimura, K., Yamauchi, F., Sato, Y. and Inoue, T.

Clin Exp Nephrol (Clinical and Experimental Nephrology) 22 ( 6 ) 1379 - 1386 2018.06

Research paper (scientific journal), Joint Work, ISSN 1342-1751

BACKGROUND: Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia. We focus on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiography-based cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress. METHODS: The excited-UA is a prospective, randomized, open-label, blinded-endpoint clinical trial designed to prove our hypothesis that topiroxostat is more effective than allopurinol in patients with chronic heart failure and hyperuricemia. A total of 140 patients with chronic heart failure and hyperuricemia (plasma brain natriuretic peptide level >/= 40 pg/mL and serum uric acid level >/= 7.0 mg/dL) are randomly assigned (ratio 1:1) into either the topiroxostat group (40-160 mg/day) or allopurinol group (100-300 mg/day), to achieve the target uric acid level of 6.0 mg/dL. According to the protocol, all patients are followed up annually for 24 weeks. The primary endpoint is percent change in serum NT-proBNP level at 24 weeks from baseline. CONCLUSIONS: The Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.

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Safety and efficacy of eculizumab in Guillain-Barre syndrome: a multicentre, double-blind, randomised phase 2 trial

Misawa S, Kuwabara S, Sato Y, Yamaguchi N, Nagashima K, Katayama K, Sekiguchi Y, Iwai Y, Amino H, Suichi T, Yokota T, Nishida Y, Kanouchi T, Kohara N, Kawamoto M, Ishii J, Kuwahara M, Suzuki H, Hirata K, Kokubun N, Masuda R, Kaneko J, Yabe I, Sasaki H, Kaida KI, Takazaki H, Suzuki N, Suzuki S, Nodera H, Matsui N, Tsuji S, Koike H, Yamasaki R, Kusunoki S; Japanese Eculizumab Trial for GBS (JET-GBS) Study Group.

LANCET NEUROLOGY (The Lancet Neurology) 17 ( 6 ) 519 - 529 2018.06

Research paper (scientific journal), Joint Work, ISSN 1474-4422

© 2018 Elsevier Ltd Background: Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein C5, in patients with severe Guillain-Barré syndrome. Methods: This study was a 24 week, multicentre, double-blind, placebo-controlled, randomised phase 2 trial done at 13 hospitals in Japan. Eligible patients with Guillain-Barré syndrome were aged 18 years or older and could not walk independently (Guillain-Barré syndrome functional grade 3–5). Patients were randomly assigned (2:1) to receive 4 weeks of intravenous immunoglobulin plus either eculizumab (900 mg) or placebo; randomisation was done via a computer-generated process and web response system with minimisation for functional grade and age. The study had a parallel non-comparative single-arm outcome measure. The primary outcomes were efficacy (the proportion of patients with restored ability to walk independently [functional grade ≤2] at week 4) in the eculizumab group and safety in the full analysis set. For the efficacy endpoint, we predefined a response rate threshold of the lower 90% CI boundary exceeding 50%. This trial is registered with ClinicalTrials.gov, number, NCT02493725. Findings: Between Aug 10, 2015, and April 21, 2016, 34 patients were assigned to receive either eculizumab (n=23) or placebo (n=11). At week 4, the proportion of the patients able to walk independently (functional grade ≤2) was 61% (90% CI 42–78; n=14) in the eculizumab group, and 45% (20–73; n=5) in the placebo group. Adverse events occurred in all 34 patients. Three patients had serious adverse events: two in the eculizumab group (anaphylaxis in one patient and intracranial haemorrhage and abscess in another patient) and one in the placebo group (depression). The possibility that anaphylaxis and intracranial abscess were related to eculizumab could not be excluded. No deaths or meningococcal infections occurred. Interpretation: The primary outcome measure did not reach the predefined response rate. However, because this is a small study without statistical comparison with the placebo group, the efficacy and safety of eculizumab could be investigated in larger, randomised controlled trials. Funding: The Japan Agency for Medical Research and Development, Ministry of Health, Labor and Welfare, and Alexion Pharmaceuticals.

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Effectiveness of a cognitive behavioural therapy-based anxiety prevention programme at an elementary school in Japan: a quasi-experimental study

Urao, Yuko, Yoshida, Michiko, Koshiba, Takako, Sato, Yasunori, Ishikawa, Shin-ichi, Shimizu, Eiji

CHILD AND ADOLESCENT PSYCHIATRY AND MENTAL HEALTH (Child and Adolescent Psychiatry and Mental Health) 12 ( 1 ) 772 - 780 2018.06

Research paper (scientific journal), Joint Work, ISSN 1753-2000

© 2018 The Author(s). Background: The efficacy of cognitive behavioural therapy (CBT) for anxiety related problems in children is empirically supported. In addition, universal anxiety prevention programmes based on CBT have been demonstrated in recent years. The purpose of this study was to verify the effectiveness of a CBT based original programme 'Journey of the Brave,' aiming to prevent anxiety disorders and anxiety-related problems for Japanese children aged 10-12 years old. Methods: Intervention groups from two classes of 5th grade elementary students (n = 41) received ten 45-min programme sessions. The control group was drawn from one class of 5th grade children (n = 31) from a nearby school. All participants completed the Spence Children's Anxiety Scale (SCAS) at pre, post, and 3 months follow-up. Mixed-effects model for repeated measures analysis was conducted. Results: The mean anxiety score on the SCAS for the intervention group was significantly reduced at both post intervention and 3 months follow-up compared with the control group. The group differences on the SCAS from baseline to post-test were - 5.321 (95% CI - 10.12 to - 0.523, p = 0.030), and at the 3-month follow-up were - 7.104 (95% CI - 11.90 to - 2.306, p = 0.004). Conclusions: The effectiveness of the anxiety prevention programme 'Journey of the Brave' was verified though this study using a quasi-experimental design on a small sample. Trial registration: UMIN000009021

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【新生児外科-最近の話題】先天性横隔膜ヘルニアにおける栄養管理

照井慶太, 臼井規朗, 田附裕子, 永田公二, 伊藤美春, 奥山宏臣, 早川昌弘, 田口智章, 佐藤泰憲, 吉田英生

小児外科 ((株)東京医学社) 50 ( 6 ) 588 - 592 2018.06

ISSN 0385-6313

日本先天性横隔膜ヘルニア(CDH)スタディグループ内の5施設で実施された栄養に関する追跡調査のデータを元に、CDH管理における急性期栄養が乳幼児期の成長に及ぼす影響について報告した。その結果、CDH軽症例では、積極的な経腸栄養(EN)が乳児期の体重増加に寄与することが示唆された。重症例では急性期におけるENが困難な場合が多く、静脈栄養によるサポートが体重増加に寄与する可能性が示唆された。

SLCO1B1 Polymorphism Is a Drug Response Predictive Marker for Advanced Pancreatic Cancer Patients Treated With Gemcitabine, S-1, or Gemcitabine Plus S-1

Sato, Y., Ueno, H., Ioka, T., Ohkawa, S., Ikeda, M., Shimamura, T., Tsuji, A., Tsuchiya, Y., Furuse, J., Ishii, H., Furuya, K., Iguchi, H., Saito, Y., Kaniwa, N., Sawada, J. I., Sakamoto, H., Sekine, A., Okusaka, T. and Yoshida, T.

Pancreas (Pancreas) 47 ( 5 ) 637 - 642 2018.05

Research paper (scientific journal), Joint Work, ISSN 0885-3177

OBJECTIVES: The aim of this study was to evaluate the effects of single-nucleotide polymorphisms (SNPs) on advanced pancreatic cancer risk and overall survival (OS) in a candidate-gene approach. METHODS: Overall, 5438 SNPs in 219 candidate genes encoding several drug-metabolizing enzymes or transporters were analyzed. In the screening study, 3 SNPs were found associated with OS (P </= 0.0005). We validated these SNPs as part of the randomized phase 3 study (GEST study). The associations between OS and SNPs were investigated using log-rank test and Cox proportional hazards model. RESULTS: From the GEST study, the SNP rs4149086 in the 3' UTR of the solute carrier organic anion transporter family member 1B1 (SLCO1B1) gene showed significant interaction with treatment (P = 0.02). In the gemcitabine group, the SNP was associated with short OS (hazard ratio [HR], 3.75; 95% confidence interval [CI], 1.30-10.8; P = 0.008) even after multiple-comparisons adjustment. In contrast, the SNP was not associated with OS in S-1 (HR, 0.77; 95% CI, 0.33-1.81; P = 0.55) or gemcitabine plus S-1 groups (HR, 1.18; 95% CI, 0.46-3.00; P = 0.72). CONCLUSIONS: Patients with advanced pancreatic cancer with the rs4149086 AG or GG genotype may obtain good clinical results when treated with S-1-containing regimens.

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Adverse Event Reporting Patterns of Marketing Authorization Holders, Healthcare Professionals and Patients in Japan: Lessons Learnt From the Human Papilloma Virus Vaccine

Inokuma Y., Sato Y., Masuda S.

Pharmaceutical Medicine (Pharmaceutical Medicine) 32 ( 2 ) 123 - 129 2018.04

ISSN 11782595

© 2018, Springer International Publishing AG, part of Springer Nature. Background: A patient organization was founded in 2013 due to skepticism about the safety of human papilloma virus (HPV) vaccines. Objective: To evaluate the impact of “priming” patients with information on adverse events following immunization (AEFI) via mainstream media and its impact on reporting by marketing authorization holders (MAHs), healthcare professionals (HCPs), and patients, and to assess the contribution of a pilot patient reporting system for adverse events in Japan to pharmacovigilance. Methods: A summary list of reports of anaphylaxis, vagal reflex, and generalized pain-related AEFI, as presented to the Vaccine Adverse Reactions Review Committee (VARRC) between 2011 and 2016, was analyzed to gain information on MAH and HCP reports. Data on patient AEFI reporting were obtained from a pilot Pharmaceuticals and Medical Devices Agency (PMDA) database designed for this purpose. Data on vaccine shipment volumes were obtained from the VARRC. Results: The leading reporting source transitioned from MAHs (82% of the total AEFI reported in 2010) to HCPs (63% in 2011), and patients (43% in 2015). Sharp peaks were observed for both MAH and HCP reports in 2011. A second peak in pain-related AEFIs reported by HCPs was observed in 2013 when the Ministry of Health, Labour and Welfare suspended the active recommendation of HPV vaccines. Patient reports were continuous and accounted for 21.7% of the total AEFIs reported to the current patient reporting system. Conclusion: In Japan, the characteristics of AEFI reports differed by source for HPV vaccines. MAH and HCP reports identified the major trend in AEFI occurrence during the early post-marketing phase, whereas patient reports in cooperation with HCPs facilitated the detection of weak signals of possible AEFIs throughout the product lifecycle. Patient reporting systems should be encouraged, especially by promoting the communication between patients and local “home” pharmacies in cooperation with patient organizations.

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Development of new method to enrich human iPSC-derived renal progenitors using cell surface markers

Hoshina, Azusa, Kawamoto, Tatsuya, Sueta, Shin-Ichi, Mae, Shin-Ichi, Araoka, Toshikazu, Tanaka, Hiromi, Sato, Yasunori, Yamagishi, Yukiko, Osafune, Kenji

SCIENTIFIC REPORTS (Scientific Reports) 8 ( 1 ) 637 - 642 2018.04

Research paper (scientific journal), Joint Work, ISSN 2045-2322

© 2018 The Author(s). Cell therapy using renal progenitors differentiated from human embryonic stem cells (hESCs) or induced pluripotent stem cells (hiPSCs) has the potential to significantly reduce the number of patients receiving dialysis therapy. However, the differentiation cultures may contain undifferentiated or undesired cell types that cause unwanted side effects, such as neoplastic formation, when transplanted into a body. Moreover, the hESCs/iPSCs are often genetically modified in order to isolate the derived renal progenitors, hampering clinical applications. To establish an isolation method for renal progenitors induced from hESCs/iPSCs without genetic modifications, we screened antibodies against cell surface markers. We identified the combination of four markers, CD9-CD140a+CD140b+CD271+, which could enrich OSR1+SIX2+ renal progenitors. Furthermore, these isolated cells ameliorated renal injury in an acute kidney injury (AKI) mouse model when used for cell therapy. These cells could contribute to the development of hiPSC-based cell therapy and disease modeling against kidney diseases.

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Bronchoscopic assessment of bronchial anastomosis by visualizing local circulation status-index of hemoglobin (IHb) imaging

Yamamoto, Takayoshi, Yoshida, Shigetoshi, Nakajima, Takahiro, Fujiwara, Taiki, Suzuki, Hidemi, Iwata, Takekazu, Sato, Yasunori, Yoshino, Ichiro

JOURNAL OF THORACIC DISEASE (Journal of Thoracic Disease) 10 ( 4 ) 2196 - + 2018.04

Research paper (scientific journal), Joint Work, ISSN 2072-1439

© Journal of Thoracic Disease. Background: Healing of airway anastomosis is largely affected by local circulation. Index of hemoglobin (IHb) imaging is a color enhancement technique that clarifies local circulation in the gastrointestinal endoscopic field. In this study, we investigated the relationship between bronchoscopic assessment of bronchial anastomosis using IHb mode and occurrence of anastomosis-related complications. Methods: IHb was calculated by logarithmic transformation for each pixel of the electronic endoscopic images and expressed by colors of red, green, and blue. The distribution of each color area was automatically calculated by the summation of pixels. A preliminary experiment spraying vasodilator on swine was performed to confirm the relationship between bronchial mucosal circulation and the IHb image. Forty consecutive patients who underwent bronchoplasty were divided into retrospective training and prospective validation cohorts, and anastomosis-related complications and IHb images were analyzed. Results: The IHb images immediately and accurately reflected the mucosal changes in the animal experiment. Among 25 cases in the retrospective training cohort, 6 cases experienced complications, with significantly lower red and higher blue values in IHb observed (P=0.03 and P=0.01, respectively). A receiver operating characteristic (ROC) curve for IHb red and blue distributions revealed the thresholds to differentiate cases with complications as 89.2 and 109.0, respectively. An analysis of the prospective validation cohort revealed that IHb blue on POD 7 was a potentially reliable predictor of complications, with 60.0% sensitivity and 90.0% specificity. Conclusions: IHb mode of bronchoscopy may be useful for assessing the local circulatory condition of bronchoplasty, which can predict anastomosis-related morbidity.

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Prevalence and associated factors of foot and ankle pain among nurses at a university hospital in Japan: A cross-sectional study

Tojo, Maki, Yamaguchi, Satoshi, Amano, Naoko, Ito, Akemi, Futono, Machiko, Sato, Yasunori, Naka, Takako, Kimura, Seiji, Sadamasu, Aya, Akagi, Ryuichiro, Ohtori, Seiji

JOURNAL OF OCCUPATIONAL HEALTH (Journal of Occupational Health) 60 ( 2 ) 132 - 139 2018.03

Research paper (scientific journal), Joint Work, ISSN 1341-9145

© 2018 by the Japan Society for Occupational Health. Objectives: The purposes of this study were to clarify 1) the prevalence of foot and ankle pain and 2) the factors associated with foot and ankle pain among nurses. Methods: Nurses working at a university hospital in Japan were recruited to participate in this crosssectional, questionnaire-based study. The occurrence of foot and ankle pain in the previous month was assessed by using the Standardized Nordic Questionnaire and the Manchester Foot Pain and Disability Index. Subjects also answered questions on footwear-related factors, including using the visual analog scale for shoe comfort. In addition, information on personal factors and psychosocial factors was collected using the Job Content Questionnaire. The relationships between the presence of foot and ankle pain and the associated factors were examined using multiple logistic regression analysis. Results: Responses of 636 nurses (response rate, 67%) were included for analysis. The prevalence of foot and ankle pain was 23% and 51% when using the Standardized Nordic Questionnaire and the Manchester Foot Pain and Disability Index, respectively. The prevalence of pain that prevented the nurses from performing activities of daily living and work was 4% and 17%, respectively. A low level of shoe comfort, personal factors (age and body mass index), and psychosocial factors (low job control and high job strain) was independently associated with the presence of foot and ankle pain. Conclusions: Foot and ankle pain occurred frequently in nurses. Shoe comfort, personal factors, and psychosocial factors were associated with foot and ankle pain.

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Impact of initial aortic diameter and false-lumen area ratio on Type B aortic dissection prognosis

Matsushita, Akihito, Hattori, Takashi, Tsunoda, Yu, Sato, Yasunori, Mihara, Andwahei

INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY (Interactive Cardiovascular and Thoracic Surgery) 26 ( 2 ) 176 - 182 2018.02

Research paper (scientific journal), Joint Work, ISSN 1569-9293

© 2017 The Author. OBJECTIVES: Medical treatment is the gold standard for uncomplicated acute Type B aortic dissection (ATBAD). Although endovascular treatment could become an alternative therapy, it is unclear which ATBAD patients should undergo endovascular intervention. We aimed to evaluate the outcomes of patients with uncomplicated ATBAD and identify the risk factors for major adverse events. METHODS: We retrospectively reviewed 134 consecutive patients who underwent initial treatment for uncomplicated ATBAD between 2004 and 2015. Follow-up rate was 98.5%, and the median follow-up period was 47 months. We evaluated the incidence of major adverse events (aortic-related death, aortic surgery and dilated aorta >55 mm) and identified the predictors of major adverse events using multivariable analysis. RESULTS: In-hospital mortality rate was 0.7% (1/134). During follow-up, 46 patients had major adverse events. The 1-, 3-, and 5-year rates of freedom from major adverse events were 79.8%, 71.4%, and 63.6%, respectively. The independent risk factors for major adverse events were initial aortic diameter <40mm (hazard ratio 3.735, 95% confidence interval 1.888-7.390; P < 0.001) and false-lumen diameter < truelumen diameter (hazard ratio 3.411, 95% confidence interval 1.491-7.806; P = 0.004). CONCLUSIONS: Initial aortic diameter <40mm and false-lumen diameter < true-lumen diameter are predictors of major adverse events after uncomplicated ATBAD. Patients with these risk factors may benefit from early endovascular intervention. Clinical registration number: UMIN 000025388, https://upload.umin.ac.jp/cgi-open-bin/ctr-e/ctr-view.cgi?recptno=R000029229.

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Development of Adherence Questionnaire for Children and Adolescents with Asthma

Fujisawa, Takao, Nagao, Mizuho, Mizuno, Yumi, Shimojo, Naoki, Itoh-Nagato, Natoka, Ohya, Yukihiro, Imai, Takanori, Ebisawa, Motohiro, Habukawa, Chizu, Odajima, Hiroshi, Sato, Yasunori

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY 141 ( 2 ) AB222 - AB222 2018.02

Research paper (scientific journal), Joint Work, ISSN 0091-6749

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