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International Journal of Clinical Oncology

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01.02.2015 | Original Article

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)

verfasst von: 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

Erschienen in: International Journal of Clinical Oncology | Ausgabe 1/2015

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Abstract

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 (15 g/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 88.2 h (95 % CI 74.0–94.1) in the TU-100 group and 93.1 h (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.

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Titel: 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)
verfasst von: 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
Publikationsdatum: 01.02.2015
Verlag: Springer Japan
Erschienen in: International Journal of Clinical Oncology / Ausgabe 1/2015
Print ISSN: 1341-9625
Elektronische ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-014-0678-2

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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)