caa a22 4500 605490392 CHVBK 20210128100504.0 cr unu---uuuuu 210128e20150201xx s 000 0 eng 10.1007/s10147-014-0678-2 doi (NATIONALLICENCE)springer-10.1007/s10147-014-0678-2 Effect of TU-100, a traditional Japanese medicine, administered after hepatic resection in patients with liver cancer: a multi-center, phase III trial (JFMC40-1001) [Elektronische Daten] [Mitsuo Shimada, Yuji Morine, Hiroaki Nagano, Etsuro Hatano, Takashi Kaiho, Masaru Miyazaki, Toru Kono, Toshiya Kamiyama, Satoshi Morita, Junichi Sakamoto, Mitsuo Kusano, Shigetoyo Saji, Takashi Kanematsu, Masaki Kitajima] Background: This multi-center, phase III trial assesses the efficacy of daikenchuto (TU-100) on gastrointestinal disorders after hepatic resection (UMIN Registration No. 000003103). Materials and methods: A total of 231 patients, who underwent hepatic resection at 26 Japanese centers, were enrolled. Patients were randomly assigned to receive either oral doses (15g/day, three times a day) of TU-100 or placebo control from preoperative day 3 to postoperative day 10, except on the day of surgery. Primary end points were the time from extubation until the first postoperative bowel movement (FBM-T), serum C-reactive protein (CRP) and ammonia levels. Results: Finally, 209 patients (TU-100: n=108, placebo: n=101) were included in the statistical analysis. The median FBM-T was 88.2h (95% CI 74.0-94.1) in the TU-100 group and 93.1h (95% CI 83.3-99.4) in the placebo group, demonstrating that TU-100 accelerated the time to first bowel movement significantly more than placebo control. Serum CRP levels did not differ significantly during the study period, although serum CRP levels in the TU-100 group tended to be lower than those in the placebo group in patients with grade B liver damage. Meanwhile, the two groups had similar serum ammonia levels. TU-100-related serious adverse events did not occur during the study. Conclusions: TU-100 appears to improve gastrointestinal dysmotility and reduce serum CRP levels in patients with grade B liver damage after hepatectomy. TU-100 is an effective treatment option after hepatic resection in patients with liver cancer. Japan Society of Clinical Oncology, 2014 Japanese medicine nationallicence Bowel movement nationallicence Inflammation nationallicence C-reactive protein nationallicence Liver damage nationallicence TU-100 : Daikenchuto nationallicence JFMC : Japanese Foundation for Multidisciplinary Treatment of Cancer nationallicence FBM-T : The time from extubation until the first postoperative bowel movement nationallicence CRP : C-reactive protein nationallicence COX-2 : Cyclooxygenase-2 nationallicence CGRP : Calcitonin gene-related peptide nationallicence VIP : Vasoactive intestinal polypeptide nationallicence AUC : Area under curve nationallicence SD : Standard deviation nationallicence CRLR : Calcitonin receptor like receptor nationallicence Ramp1 : Receptor activity modifying protein 1 nationallicence ADM : Adrenomedullin nationallicence Shimada Mitsuo Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan aut Morine Yuji Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan aut Nagano Hiroaki Department of Surgery, Osaka University, Osaka, Japan aut Hatano Etsuro Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan aut Kaiho Takashi Department of Surgery, Kimitsu Chuo Hospital, Chiba, Japan aut Miyazaki Masaru Department of General Surgery, Chiba University Graduate School of Medicine, Chiba, Japan aut Kono Toru Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan aut Kamiyama Toshiya Department of General Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, Japan aut Morita Satoshi Department of Biostatistics and Epidemiology, School of Medicine, Yokohama City University, Yokohama, Japan aut Sakamoto Junichi Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan aut Kusano Mitsuo Kushiro Rosai Hospital, Hokkaido, Japan aut Saji Shigetoyo Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan aut Kanematsu Takashi Nagasaki Municipal Hospital, Nagasaki, Japan aut Kitajima Masaki International University of Health and Welfare, Tokyo, Japan aut International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 95-104 1341-9625 20:1<95 2015 20 10147 https://doi.org/10.1007/s10147-014-0678-2 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0678-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Shimada Mitsuo Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan aut NATIONALLICENCE 700 1- Morine Yuji Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan aut NATIONALLICENCE 700 1- Nagano Hiroaki Department of Surgery, Osaka University, Osaka, Japan aut NATIONALLICENCE 700 1- Hatano Etsuro Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan aut NATIONALLICENCE 700 1- Kaiho Takashi Department of Surgery, Kimitsu Chuo Hospital, Chiba, Japan aut NATIONALLICENCE 700 1- Miyazaki Masaru Department of General Surgery, Chiba University Graduate School of Medicine, Chiba, Japan aut NATIONALLICENCE 700 1- Kono Toru Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan aut NATIONALLICENCE 700 1- Kamiyama Toshiya Department of General Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, Japan aut NATIONALLICENCE 700 1- Morita Satoshi Department of Biostatistics and Epidemiology, School of Medicine, Yokohama City University, Yokohama, Japan aut NATIONALLICENCE 700 1- Sakamoto Junichi Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan aut NATIONALLICENCE 700 1- Kusano Mitsuo Kushiro Rosai Hospital, Hokkaido, Japan aut NATIONALLICENCE 700 1- Saji Shigetoyo Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan aut NATIONALLICENCE 700 1- Kanematsu Takashi Nagasaki Municipal Hospital, Nagasaki, Japan aut NATIONALLICENCE 700 1- Kitajima Masaki International University of Health and Welfare, Tokyo, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 95-104 1341-9625 20:1<95 2015 20 10147