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)
| LEADER | caa a22 4500 | ||
|---|---|---|---|
| 001 | 605490392 | ||
| 003 | CHVBK | ||
| 005 | 20210128100504.0 | ||
| 007 | cr unu---uuuuu | ||
| 008 | 210128e20150201xx s 000 0 eng | ||
| 024 | 7 | 0 | |a 10.1007/s10147-014-0678-2 |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s10147-014-0678-2 | ||
| 245 | 0 | 0 | |a 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) |h [Elektronische Daten] |c [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] |
| 520 | 3 | |a 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. | |
| 540 | |a Japan Society of Clinical Oncology, 2014 | ||
| 690 | 7 | |a Japanese medicine |2 nationallicence | |
| 690 | 7 | |a Bowel movement |2 nationallicence | |
| 690 | 7 | |a Inflammation |2 nationallicence | |
| 690 | 7 | |a C-reactive protein |2 nationallicence | |
| 690 | 7 | |a Liver damage |2 nationallicence | |
| 690 | 7 | |a TU-100 : Daikenchuto |2 nationallicence | |
| 690 | 7 | |a JFMC : Japanese Foundation for Multidisciplinary Treatment of Cancer |2 nationallicence | |
| 690 | 7 | |a FBM-T : The time from extubation until the first postoperative bowel movement |2 nationallicence | |
| 690 | 7 | |a CRP : C-reactive protein |2 nationallicence | |
| 690 | 7 | |a COX-2 : Cyclooxygenase-2 |2 nationallicence | |
| 690 | 7 | |a CGRP : Calcitonin gene-related peptide |2 nationallicence | |
| 690 | 7 | |a VIP : Vasoactive intestinal polypeptide |2 nationallicence | |
| 690 | 7 | |a AUC : Area under curve |2 nationallicence | |
| 690 | 7 | |a SD : Standard deviation |2 nationallicence | |
| 690 | 7 | |a CRLR : Calcitonin receptor like receptor |2 nationallicence | |
| 690 | 7 | |a Ramp1 : Receptor activity modifying protein 1 |2 nationallicence | |
| 690 | 7 | |a ADM : Adrenomedullin |2 nationallicence | |
| 700 | 1 | |a Shimada |D Mitsuo |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan |4 aut | |
| 700 | 1 | |a Morine |D Yuji |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan |4 aut | |
| 700 | 1 | |a Nagano |D Hiroaki |u Department of Surgery, Osaka University, Osaka, Japan |4 aut | |
| 700 | 1 | |a Hatano |D Etsuro |u Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan |4 aut | |
| 700 | 1 | |a Kaiho |D Takashi |u Department of Surgery, Kimitsu Chuo Hospital, Chiba, Japan |4 aut | |
| 700 | 1 | |a Miyazaki |D Masaru |u Department of General Surgery, Chiba University Graduate School of Medicine, Chiba, Japan |4 aut | |
| 700 | 1 | |a Kono |D Toru |u Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Kamiyama |D Toshiya |u Department of General Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Morita |D Satoshi |u Department of Biostatistics and Epidemiology, School of Medicine, Yokohama City University, Yokohama, Japan |4 aut | |
| 700 | 1 | |a Sakamoto |D Junichi |u Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Kusano |D Mitsuo |u Kushiro Rosai Hospital, Hokkaido, Japan |4 aut | |
| 700 | 1 | |a Saji |D Shigetoyo |u Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan |4 aut | |
| 700 | 1 | |a Kanematsu |D Takashi |u Nagasaki Municipal Hospital, Nagasaki, Japan |4 aut | |
| 700 | 1 | |a Kitajima |D Masaki |u International University of Health and Welfare, Tokyo, Japan |4 aut | |
| 773 | 0 | |t International Journal of Clinical Oncology |d Springer Japan |g 20/1(2015-02-01), 95-104 |x 1341-9625 |q 20:1<95 |1 2015 |2 20 |o 10147 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10147-014-0678-2 |q text/html |z Onlinezugriff via DOI |
| 898 | |a BK010053 |b XK010053 |c XK010000 | ||
| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
| 908 | |D 1 |a research-article |2 jats | ||
| 949 | |B NATIONALLICENCE |F NATIONALLICENCE |b NL-springer | ||
| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10147-014-0678-2 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Shimada |D Mitsuo |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Morine |D Yuji |u Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, 770-8503, Tokushima, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Nagano |D Hiroaki |u Department of Surgery, Osaka University, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Hatano |D Etsuro |u Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kaiho |D Takashi |u Department of Surgery, Kimitsu Chuo Hospital, Chiba, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Miyazaki |D Masaru |u Department of General Surgery, Chiba University Graduate School of Medicine, Chiba, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kono |D Toru |u Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kamiyama |D Toshiya |u Department of General Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Morita |D Satoshi |u Department of Biostatistics and Epidemiology, School of Medicine, Yokohama City University, Yokohama, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Sakamoto |D Junichi |u Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kusano |D Mitsuo |u Kushiro Rosai Hospital, Hokkaido, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Saji |D Shigetoyo |u Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kanematsu |D Takashi |u Nagasaki Municipal Hospital, Nagasaki, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kitajima |D Masaki |u International University of Health and Welfare, Tokyo, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t International Journal of Clinical Oncology |d Springer Japan |g 20/1(2015-02-01), 95-104 |x 1341-9625 |q 20:1<95 |1 2015 |2 20 |o 10147 | ||