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Tsuda, Yasuhiro,Ugai, Hiroyuki,Wunderlich, Glen,Shin, Jae-Gook Elsevier 2019 Clinical therapeutics Vol.41 No.5
<P><B>Abstract</B></P> <P><B>Purpose</B></P> <P>This study's primary goal was to evaluate the safety profile, tolerability, pharmacokinetics, and dose proportionality of BI 425809, a potent and selective inhibitor of glycine transporter 1, in healthy Chinese and Japanese subjects.</P> <P><B>Methods</B></P> <P>This single center, double-blind, single-rising dose study conducted in Korea randomly assigned (3:1) subjects within each ethnic subgroup (Chinese and Japanese) to receive a single dose of BI 425809 (10, 25, or 50 mg) or placebo. The primary end point was number (%) of subjects with drug-related adverse events (AEs). Secondary end points included AUC, C<SUB>max</SUB>, t<SUB>max</SUB>, and t<SUB>½</SUB> for BI 425809 in plasma. The CL/F and volume of distribution (V<SUB>z</SUB>/F) were also measured.</P> <P><B>Findings</B></P> <P>Of the 49 subjects enrolled into the study (24 Chinese, 25 Japanese), 36 were randomly assigned to receive BI 425809 (12 per dose group) and 13 to receive placebo. All subjects were analyzed for the primary end point and completed the study. Overall, 4 of 49 subjects (8.2%) reported ≥1 AE (placebo: n = 1, BI 425809: n = 3). One drug-related AE of moderate somnolence was reported by a Japanese subject who received placebo. In both subgroups, slightly lower than dose-proportional increases in exposure (AUC and C<SUB>max</SUB>) were observed with increasing dose. In addition, median t<SUB>max</SUB> was 3.5–4.0 h, with a geometric mean t<SUB>½</SUB> of 29.0–41.2 h. CL/F was similar between Chinese and Japanese subjects and increased with increasing dose (10–50 mg: 68.1–111 mL/min). V<SUB>z</SUB>/F was 209–315 L and similar between the subgroups.</P> <P><B>Implications</B></P> <P>BI 425809 was generally well tolerated in healthy Chinese and Japanese subjects with no significant findings for tolerability. No apparent difference in the pharmacokinetic variables of BI 425809 was observed between Chinese and Japanese subjects. The safety profile results and pharmacokinetic exposure levels are consistent with previous trials in Caucasian subjects. ClinicalTrials.gov identifier: NCT02383888.</P>
Lipocalin-2: A novel biomarker for lung hypoplasia in congenital diaphragmatic hernia fetus
( Yoshinori Moriyama ),( Hiroyuki Tsuda ),( Tomomi Kotani ),( Seiji Sumigama ),( Tomoko Nakano ),( Shima Hirako ),( Fumitaka Kikkawa ) 대한산부인과학회 2016 대한산부인과학회 학술대회 Vol.102 No.-
Objective: Congenital diaphragmatic hernia (CDH) results in pulmonary hypoplasia and pulmonary hypertension, which are often fatal. In order to improve clinical care and counseling, reliable prenatal parameters predicting outcome of CDH fetus are urgently needed. Some prenatal predictors of outcome of CDH fetus have been reported, but they are focused mainly on the assessment of fetal lung volume, and a gold-standard parameter has not yet been established. The aim of this study is to establish an accurate predictive marker for fetal lung hypoplasia in CDH cases. Methods: Neonatal lung tissue was collected at E21 from normal and nitrofen-induced CDH rats (administered 100 mg orally at E9), and microarray analysis and real-time polymerase chain reaction (RT-PCR) were performed. Sixty-three human amniotic fluid samples of isolated CDH cases (n = 33) and scheduled Cesarean section (CS) without any fetal complication (controls) (n = 30) were obtained with signed informed consent. All amniotic fluid samples were obtained at CS performed at 35th to 38th weeks of gestation from April 2007 to January 2016. Results: Genes which showed significantly decreased expression in nitrofen-induced CDH lung were lipocalin-2 (9-fold) and GATA-2 (3.3-fold). In lipocalin-2, this result was confirmed by RT-PCR. Next, the lipocalin-2 level in human amniotic fluid was examined using ELISA, and it was significantly lower in CDH cases than in controls (73.7 ng/mL vs 163.8 ng/mL; p < 0.05). A significant positive correlation was observed between amniotic lipocalin- 2 level and lung area to head circumference ratio (p < 0.001, r<sup>2</sup> = 0.453). Conclusion: Our results suggest that gene expression level of lipocalin-2 was significantly decreased in hypoplastic lung in rats, and that amniotic lipocalin-2 level was significantly lower in CDH cases in human. Amniotic lipocalin- 2 can be a useful marker to predict the prognosis of fetal CDH.
Activated Protein C Anticoagulant System Dysfunction and Thrombophilia in Asia
Naotaka Hamasaki,Hiroyuki Kuma,Hiroko Tsuda 대한진단검사의학회 2013 Annals of Laboratory Medicine Vol.33 No.1
Thrombophilia that is common among Caucasians is caused by genetic polymorphisms of coagulation factor V Leiden (R506Q) and prothrombin G20210A. Unlike that in Caucasians, thrombophilia that is common in the Japanese and Chinese involve dysfunction of the activated protein C (APC) anticoagulant system caused by abnormal protein S and protein C molecules. Approximately 50% of Japanese and Chinese individuals who develop venous thrombosis have reduced activities of protein S. The abnormal sites causing the protein S molecule abnormalities are distributed throughout the protein S gene, PROS1. One of the most common abnormalities is protein S Tokushima (K155E), which accounts for about 30% of the protein S molecule abnormalities in the Japanese. Whether APC dysfunction occurs in other Asian countries is an important aspect of mapping thrombophilia among Asians. International surveys using an accurate assay system are needed to determine this.
Review : Epithelial borderline ovarian tumor: Diagnosis and treatment strategy
( Kimio Ushijima ),( Kouichiro Kawano ),( Naotake Tsuda ),( Shin Nishio ),( Atsumu Terada ),( Hiroyuki Kato ),( Kazuto Tasaki ),( Ken Matsukuma ) 대한산부인과학회 2015 Obstetrics & Gynecology Science Vol.58 No.3
Epithelial borderline ovarian tumors (BOT) are distinctive from benign tumors and carcinoma. They occur in younger women more often than carcinoma, and there is some difficulty making correct diagnosis of BOT. Two subtypes of BOT, serous and mucinous borderline tumor have different characteristics and very different clinical behavior. Serous borderline tumor (SBT) with micropapillary pattern shows more incidence of extra ovarian disease and often coexists with invasive implant. SBT with micropapillary pattern in advanced stage has showed a worse prognosis than typical SBT. Huge mucinous borderline tumors have histologic heterogeneity, and the accuracy of frozen section diagnosis is relatively low. Extensive sampling is required to reach a correct pathological diagnosis. Mucinous adenoma (intestinal type) also runs the risk of recurrence after cystectomy, or intraoperative rupture of cyst. Laparoscopic procedure for BOT has not increased the risk of recurrence. Fertility preserving procedures are generally accepted, except in advanced stage SBT with invasive implants. Only cystectomy shows a significant risk of recurrence. Re-staging surgery and full staging surgery is not necessary for all BOT. We should not attempt to treat them uniformly, by the single diagnosis of “borderline tumor”. It depends on histologic type. Close communication with the pathologist is necessary to gain more detail and ask more pathological samples in order to make the optimal treatment strategy for each individual patients.
Highly transparent Zn1-xMgxO/ITO multilayer for window of thin film solar cells
강동원,Amartya Chowdhury,Porponth Sichanugrist,Yusuke Abe,Hirofumi Konishi,Yuki Tsuda,Tomohiro Shinagawa,Hidetada Tokioka,Hiroyuki Fuchigami,Makoto Konagai 한국물리학회 2015 Current Applied Physics Vol.15 No.9
Texture-etched Zn1-xMgxO films were fabricated and applied as front transparent electrodes for superstrate type thin film solar cells. The Zn0.65Mg0.35O film (x = 0.35) showed optical transparency better than commercially available Asahi VU and double-textured ZnO (WT-ZnO) substrates. To provide pertinent conductivity, ITO film was coated on the texture-etched Zn0.65Mg0.35O. By employing the Zn0.65Mg0.35O/ITO substrate instead of the SnO2, we demonstrated an enhancement of quantum efficiency for amorphous silicon thin film solar cell devices, resulted in efficiency improvement from 8.92 to 9.56%. We also examined effectiveness of the Zn0.65Mg0.35O/ITO substrate for the microcrystalline silicon solar cells which delivered an efficiency of 9.73% with proper anti-reflection coating. Our experimental results suggest that the Zn0.65Mg0.35O/ITO multilayer front contact can be beneficial for reinforcing performances of silicon-based thin film solar cell devices.
Numano, Takamasa,Xu, Jiegou,Futakuchi, Mitsuru,Fukamachi, Katsumi,Alexander, David B.,Furukawa, Fumio,Kanno, Jun,Hirose, Akihiko,Tsuda, Hiroyuki,Suzui, Masumi Asian Pacific Journal of Cancer Prevention 2014 Asian Pacific journal of cancer prevention Vol.15 No.2
Two types of nanosized titanium dioxide, anatase ($anTiO_2$) and rutile ($rnTiO_2$), are widely used in industry, commercial products and biosystems. $TiO_2$ has been evaluated as a Group 2B carcinogen. Previous reports indicated that $anTiO_2$ is less toxic than $rnTiO_2$, however, under ultraviolet irradiation $anTiO_2$ is more toxic than $rnTiO_2$ in vitro because of differences in their crystal structures. In the present study, we compared the in vivo and in vitro toxic effects induced by $anTiO_2$ and $rnTiO_2$. Female SD rats were treated with $500{\mu}g/ml$ of $anTiO_2$ or $rnTiO_2$ suspensions by intra-pulmonary spraying 8 times over a two week period. In the lung, treatment with $anTiO_2$ or $rnTiO_2$ increased alveolar macrophage numbers and levels of 8-hydroxydeoxyguanosine (8-OHdG); these increases tended to be lower in the $anTiO_2$ treated group compared to the $rnTiO_2$ treated group. Expression of $MIP1{\alpha}$ mRNA and protein in lung tissues treated with $anTiO_2$ and $rnTiO_2$ was also significantly up-regulated, with $MIP1{\alpha}$ mRNA and protein expression significantly lower in the $anTiO_2$ group than in the $rnTiO_2$ group. In cell culture of primary alveolar macrophages (PAM) treated with $anTiO_2$ and $rnTiO_2$, expression of $MIP1{\alpha}$ mRNA in the PAM and protein in the culture media was significantly higher than in control cultures. Similarly to the in vivo results, $MIP1{\alpha}$ mRNA and protein expression was significantly lower in the $anTiO_2$ treated cultures compared to the $rnTiO_2$ treated cultures. Furthermore, conditioned cell culture media from PAM cultures treated with $anTiO_2$ had less effect on A549 cell proliferation compared to conditioned media from cultures treated with $rnTiO_2$. However, no significant difference was found in the toxicological effects on cell viability of ultra violet irradiated $anTiO_2$ and $rnTiO_2$. In conclusion, our results indicate that $anTiO_2$ is less potent in induction of alveolar macrophage infiltration, 8-OHdG and $MIP1{\alpha}$ expression in the lung, and growth stimulation of A549 cells in vitro than $rnTiO_2$.