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        Anti-Allergic Effects of the Subcritical Water Extract Powder of Citrus unshiu in Mouse and Guinea Pig Models

        Hisae Oku,Fumika Kitagawa,Yoshihisa Kato,Tomoya Miyashita,Masaomi Hara,Toshitaka Minetoki,Shizuo Yamada 한국식품영양과학회 2021 Journal of medicinal food Vol.24 No.5

        We evaluated the effects of unripe mandarin orange (Citrus unshiu) extract powder (unripe mandarin extract powder [UMEP]) treated with subcritical water on allergic diseases by using animal models. High performance liquid chromatography (HPLC) analysis revealed that subcritical water is a more effective solvent than alcohol and hot water, as it quickly extracted approximately 90% of the functional compounds narirutin (1) and hesperidin (2) from whole fruits. Repeated oral administration of UMEP significantly reversed the peripheral blood flow decline observed during the promotion of allergies after sensitization with the antigen, hen egg-white lysozyme (HEL). UMEP also significantly inhibited compound 48/80-induced scratching behavior in HEL-sensitized mice, which are more sensitive to itching stimuli than are normal mice, without suppressing locomotor activity. In addition, repeated oral administration of UMEP in ovalbumin-challenged guinea pigs significantly suppressed the late phase of nasal airway resistance. This study provides evidence that the subcritical water extract powder of unripe C. unshiu fruit is an effective anti-allergic functional food.

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        Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice

        Tomoo Nakagawa,Taku Kobayashi,Kiyohiro Nishikawa,Fumika Yamada,Satoshi Asai,Yukinori Sameshima,Yasuo Suzuki,Mamoru Watanabe,Toshifumi Hibi 대한장연구학회 2019 Intestinal Research Vol.17 No.4

        Background/Aims: An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease. Methods: Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018. Results: Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group. Conclusions: In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

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