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Development of a competitive enzyme-linked immunosorbent assay for therapeutic drug monitoring of afatinib

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Journal of Pharmaceutical Analysis 2019年第1期9卷 49-54页

作者： Rintaro Sogawa tetsuya saita Yuta Yamamoto Sakiko Kimura Yutaka Narisawa Shinya Kimura Masashi Shin Department of Pharmacy Saga University Hospital Applied Life Science Department Faculty of Biotechnology and Life Science Sojo University Division of Hematology Respiratory Medicine and Oncology Department of Internal Medicine Faculty of Medicine Saga University

Afatinib is an oral tyrosine kinase inhibitor(TKI) approved for treating advanced non-small cell lung cancer. It is necessary to develop a simple quantification method for TKIs in order to facilitate therapeutic drug monitoring(TDM) in clinical settings. This study sought to develop a simple and sensitive competitive enzyme-linked immunosorbent assay(ELISA) to quantify afatinib in plasma for routine pharmacokinetic applications. An anti-afatinib antibody was obtained using(S)-N-4-(3-chloro-4-fluorophenyl)-7-(tetrahydrofuran-3-yloxy)-quinazoline-4,6-diamine(CTQD), which has the same substructure as afatinib, as a hapten. Enzyme labeling of afatinib with horseradish peroxidase was similarly performed using CTQD. A simple competitive ELISA for afatinib was developed based on the principle of direct competition between afatinib and the enzyme marker for the anti-afatinib antibody, which had been immobilized on the plastic surface of a microtiter plate. Plasma afatinib concentrations below the limit of quantification of 30 pg/mL were reproducibly measurable. Also, the values of plasma afatinib levels measured from 20 patients were comparable with those measured by high-performance liquid chromatography, and there was a strong correlation between the values determined by both methods(Y=0.976 X – 0.207, r=0.975). As indicated by its specificity and sensitivity, this newly developed ELISA for afatinib is an important tool for TDM and studies of the pharmacokinetics of afatinib.

关键词： Afatinib Enzyme-linked immunosorbent assay Therapeutic drug monitoring Tyrosine-kinase inhibitor

Calibrating the Level of Capital： The Way We See It

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Journal of Mathematics and System Science 2011年第1期1卷 23-42页

作者： Ryo Kato Shun Kobayashi Yumi saita Bank of Japan Tokyo 103-8660 Japan Deloitte Touche Tohmatsu New York 10019-6754 USA

This paper aims to propose a framework for estimating the optimal levels of capital at banks, elaborating factors such as liquidity and macroeconomic conditions. Firstly, as a preamble, the authors attempt to reorganize the variety of policy proposals for enhancing financial sector regulation. In light of the broad perspective of the prudential policy framework, the authors discuss the role of bank capital in enhancing banking-sector resilience. Secondly, the authors lay out an early warning system （EWS） to predict a financial crisis where the role of capital and liquidity are explicitly captured. Then, the authors apply the EWS as a component of a cost-benefit analysis （CBA） to gauge the benefit from raising capital and liquidity requirements, as more stringent regulations are expected to reduce the probability of financial ,crisis. On the other hand, financial-sector regulations should come along with certain costs. To quantify the cost, the authors employ some existing macroeconomic models to estimate the cost of raising capital and liquidity requirements. Combining the EWS （for benefit calculation） with the macroeconomic models （for cost calculation）, the authors provide a full-fledged CBA framework that can detemaine the optimal levels of capital that strike the right balance between the costs and benefits of the financial-sector regulation. The main results indicate that the optimal level of bank capital would considerably vary depending on the level of liquidity indicators both on the asset and liability sides of banks＇ balance sheets as well as macroeconomic conditions, typically represented by housing market inflation. Finally, the CBA framework suggests that banks could stand in a better shape with a counter-cyclical capital buffer to be well-prepared for a prospective distress.

关键词： Capital ratio liquidity financial crisis probit model bank regulation.

Clinical Results of Arthroscopic Rotator Cuff Repair with a Tape-Attached Anchor

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Open Journal of Orthopedics 2018年第7期8卷 249-256页

作者： Noriaki Shimada Jun’ichi Inoue Katsuhiko Shiraki Kazuo saita Department of Orthopaedic Surgery Saitama Medical Center Saitama Medical University Kawagoe Japan Department of Orthopaedic Surgery Kamifukuoka General Hospital Fujimino Japan

Objective: The purpose of this study was to evaluate the clinical results of arthroscopic rotator cuff repair with a tape-attached anchor: The HEALICOILRG with ULTRATAPE. We hypothesised that performing arthroscopic rotator cuff repair with tape-attached anchors would result in better clinical outcomes and reduce the retear rate compared with conventional suture anchors. Methods: We included 83 patients treated by arthroscopic rotator cuff repair with a minimum 1-year follow-up. We divided them into two groups: Use of the HEALICOILRG with ULTRATAPE (group T: 41 shoulders;mean patient age, 64.3 years) and use of the conventional suture anchor (group S: 42 shoulders;mean patient age, 68.9 years). We compared the University of California Los Angeles scores, Japanese Orthopaedic Association scores, range of motion, and retear rate between the two groups. The Student t test and chi-square test were used in statistical analyses. Results: At the 1-year postoperative follow-up, both groups showed improvement in the average University of California Los Angeles score, Japanese Orthopaedic Association score, and range of motion, although no significant difference was found in the retear rate between the two groups. Conclusions: Results of arthroscopic rotator cuff repair with the HEALICOILRG with ULTRATAPE were generally good. However, our results could not demonstrate efficacy of the HEALICOILRG with ULTRATAPE. Further detailed studies are needed to determine its treatment result.

关键词： Arthroscopic Rotator Cuff Repair Transosseous-Equivalent Technique Suture Anchor Tape-Attached Anchor Retear

Chitosan Sub-micron Particles Prepared Using Sulfate Ion Salt as Bacteriostatic Materials in Neutral pH Condition

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Journal of Biomaterials and Nanobiotechnology 2011年第4期2卷 347-352页

作者： Kanako saita Shoji Nagaoka Maki Horikawa Tomohiro Shirosaki Shigeki Matsuda Hirotaka Ihara 不详

In this paper, the newly developed ion exchange phase separation method to create chitosan sub-micron particles is introduced: 1) chitosan was dissolved in a lactic acid aqueous solution. 2) the obtained chitosan solution was added stepwise in a sodium sulfate aqueous solution and cooled down to 5℃ to become slightly turbid through agglutination. 3) desalinating and deacidifying of the mixture was carried out by a dialyzing tube method. IR spectroscopy and elemental analysis indicated that the agglutination of chitosan was induced by crosslinking effect with an electrostatic interaction between sulfate anions and amino groups in the glucosamine unit although large excess of Na2SO4 caused undesirable further agglutination of the resultant chitosan particles. As a result, the proper amount of Na2SO4 was approximately 1.0 - 10.0 equivalent for the amino group to create the chitosan particles with a sub-micron size. In addition, we investigated an antibacterial activity test for Escherichia coli of the obtained chitosan particles. The significant antibacterial activity was observed in incubation even at neutral pH condition while the chitosan microbeads (size: ca 200 ∫m) prepared by the conventional method and chitosan granules (size: ca 600 ∫m) as starting materials showed almost no antibacterial activity in the same condition.

关键词： Chitosan Particle Crosslinking Microbeads E. coli

Risk Factors Associated with In-Hospital Post-Chemotherapy Mortality in Patients with Malignant Musculoskeletal Tumors

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Journal of Cancer Therapy 2016年第6期7卷 363-369页

作者： Toru Akiyama Kazuo saita Hirotaka Chikuda Hiromasa Horiguchi Kiyohide Fushimi Hideo Yasunaga Department of Orthopaedic Surgery Saitama Medical Center Jichi Medical University Saitama Japan Department of Orthopaedic Surgery Faculty of Medicine The University of Tokyo Tokyo Japan Department of Clinical Data Management and Research Clinical Research Center National Hospital Organization Headquarters Tokyo Japan Department of Health Policy and Informatics Tokyo Medical and Dental University Graduate School of Medicine Tokyo Japan Department of Clinical Epidemiology and Health Economics School of Public Health The University of Tokyo Tokyo Japan

Introduction: Reducing the in-hospital post-chemotherapy mortality rate in patients with malignant musculoskeletal tumors is important for improving treatment outcome. This study aimed to investigate the risk factors associated with in-hospital post-chemotherapy mortality in patients with primary malignant musculoskeletal tumors. Methods: Using a Japanese national inpatient database, we retrospectively identified 5039 patients (2920 men and 2131 women;mean age, 39 years) who underwent curative chemotherapy for malignant musculoskeletal tumors between 2007 and 2010. We extracted data on the patients’ characteristics, complications, chemotherapeutic agent use, comorbidities, and in-hospital death. Logistic regression analyses were performed to analyze factors affecting in-hospital post-chemotherapy death in these patients. Results: The overall in-hospital mortality rate was 1.1%. Higher in-hospital mortality rates were significantly associated with a greater volume of blood transfusion (>2500 mL) (odds ratio [OR], 49.71;95% confidence interval [CI], 22.24 - 111.12;p < 0.001), diabetes mellitus (OR, 3.05;95% CI: 1.21 - 7.70;p = 0.019), and older age (OR, 3.05;95% CI, 1.11 - 8.37;p = 0.031). Conclusions: Higher in-hospital post-chemotherapy mortality rates were associated with massive blood transfusion, which was associated with a 16-fold higher risk of in-hospital mortality compared with other risk factors. Blood transfusion volume should be considered an important indicator for deciding whether the next cycle of chemotherapy is administered continuously or not.

关键词： Chemotherapy Sarcoma In-Hospital Mortality Chemotherapy-Related Death Japanese Diagnosis Procedure Combination Database

Mortality and Morbidity Following Surgery for Primary Malignant Musculoskeletal Tumors in the Pelvis and Limbs: A Retrospective Analysis Using the Japanese Diagnosis Procedure Combination Database

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Journal of Cancer Therapy 2016年第4期7卷 303-310页

Introduction: Resection of malignant pelvic tumors has long been considered to be associated with higher postoperative mortality and morbidity than resection of malignant limb tumors. We compared the postoperative adverse events of pelvic tumor surgery and limb tumor surgery using a national inpatient database. Methods: We identified patients who underwent surgery for primary musculoskeletal malignant tumors of the pelvis or limbs between July and December in 2007- 2010 using the Japanese Diagnosis Procedure Combination inpatient database. We calculated the risk-adjusted odds ratio for the occurrence of postoperative complications following pelvic tumor surgery with reference to limb tumor surgery using a multivariable logistic regression analysis. Results: Of 3255 eligible patients, 3116 underwent limb tumor surgery and 139 underwent pelvic tumor surgery. In-hospital mortality was 0.6% and 0.7% and postoperative complication rates were 8.2% and 18.7%, respectively. The rate of blood transfusion and duration of anesthesia over 480 min were higher in the pelvic tumor group. Blood transfusion volume and duration of anesthesia were independently associated with worse outcomes, but there was no significant association between tumor location and occurrence of postoperative complications (odds ratio 1.18, 95% confidence interval 0.73 - 1.88, p = 0.502). Conclusions: Blood transfusion volume and duration of anesthesia were significant predictors of outcome. Our data demonstrate that the higher morbidity rate after pelvic tumor resection could result from the larger blood transfusion volume and longer anesthesia duration.

关键词： Musculoskeletal Tumor Resection Sarcoma Pelvic Tumor Postoperative Complication Japanese Diagnosis Procedure Combination Database

Chronological changes in Epstein-Barr virus genome and subsets of peripheral mononuclear cells in a case of HLH

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Open Journal of Pediatrics 2011年第3期1卷 30-33页

作者： Yukayo Ukeba-Terashita Yoshinori saita Yoshinori Ito Hirokazu Kanegane Hiroshi Kimura Ichiro Kobayashi 不详

Hemophagocytic lymphohistiocytosis (HLH) is a rare disorder characterized by high grade fever, heaptos-plenomegaly, lymphadenopathy and cytopenia in association with hypercytokinemia and macrophage activation. Epstein-Barr virus (EBV) is a common cause of HLH particularly in Asian countries. Although EBV usually infects B cells and causes infectious mononucleosis, it is detected predominantly in CD8+ T cells in EBV-associated HLH. In the present study we found the EBV genome in various lineages of the lymphoid cells including T, B, and natural killer cells in a 14-month-old boy with mild EBV-associated HLH. Furthermore, chronological changes in the copy number of EBV-DNA in each lineage are reported. Profound decrease in the number of peripheral natural killer cells at the early stage could be involved in the development of HLH.

关键词： Epstein-Barr Virus Hemophagocytic Lymphohistio Cytosis Natural Killer Cell

Huge Congenital Thymic Cyst with Microscopic Thymoma

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World Journal of Cardiovascular Surgery 2013年第3期3卷 111-113页

作者： Alberto Terminella Giacomo Cusumano Ignazio Vasta Rosalia Giarlotta Salvatore Bellofiore Carmelo Riscica Lizzio Salvatore saita Maria D’Arrigo Department of Histopathology “Vittorio Emanuele—Policlinico” Hospital Catania Italy Division of General Thoracic Surgery “Vittorio Emanuele—Policlinico” Hospital Catania Italy

The congenital thymic cysts are rare. They have a congenital origin and they are benign. The differential diagnosis of acquired cysts, cystic thymoma and thymic malignancies in cystic degeneration can be particularly difficult. Rarely, they assume clinical relevance for the appearance of symptoms of compression, more typical of malignant lesions, and the association with thymoma was reported in very few cases in literature. For all these features, treatment strategy remains controversial and in particular surgical approach. We report a case of a huge symptomatic congenital thymic cyst, surgically removed with histological finding of microscopic thymoma.

关键词： Thymic Cystis Thymoma Mediastinal Tumor Surgery

Effect of enpishin (press tack acupuncture needles) on autonomic function, WBC count and oxidative stress

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Health 2011年第7期3卷 437-443页

作者： Mitsunori Tsumaki Yoshitomo saita Hiroshi Ikeda Kazuo Kaneko Takehiko Yukishita Keiko Lee Sungdo Kim Shinichi Yokota Nobuhiro Suetake Hiroyuki Kobayashi 不详

Acupuncture as a vital component of traditional medical systems of the Far East has been used to restore and maintain health for over three millennia. However, the neurobiological correlates of this therapy remain largely unknown. The purpose of this study was therefore to determine the effect of enpishin acupuncture (press tack needles (PTN)) on autonomic function, WBC count, and oxidative stress between subjects that received either verum or placebo PTN treatment. Twenty men (mean(SD) age: 36.7(5.1) years) who provided oral consent were randomized to receive either verum PTN (n = 9) or placebo PTN (n = 11). Bi-Digital O-Ring Test (BDORT) was used to select the acupoints for each participant. Autonomic function and oxidative stress level were analyzed before and after the treatment via heart rate variability (HRV) and free radical analysis system (FRAS4), respectively. Pre- and post-treatment WBC count was also evaluated. Verum PTN group had a statistically significant increase (p = 0.008) in Ln TP, an index of overall autonomic activity. Subjects in this group also had a significantly greater (p = 0.006) variation in Ln TP than the placebo PTN group in response to the treatment. Similarly, Ln HF of subjects receiving verum PTN showed a marked increase (p = 0.0026) after the treatment. Moreover, a significantly greater (p < 0.001) variation in mean Ln HF before and after the treatment was noted in the verum group than the placebo group, reflecting a greater parasympathetic activation in the former. In contrast, sympathetic activity was not significantly influenced by verum PTN based on the lack of observed changes in LF/HF ratio. In addition, both groups failed to demonstrate significant variations in pre- and post-treatment mean Ln LF/HF ratio. Further, no significant intergroup difference was found with regard to mean variation in Ln LF/HF ratio. Verum PTN did not induce significant changes in WBC count and markers of oxidative stress, namely reactive oxygen spec

关键词： Heart Rate Variability Press Tack Needles Acupoints Bi-Digital O-Ring Test Oxidative Stress