Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study)
作者： Hidetoshi Katsuno , Koutarou Maeda , Masatoshi Ohya , Kazuhiko Yoshioka , Akira Tsunoda
DOI: 10.1007/S00535-015-1100-1
关键词: Clinical trial 、 Abdominal surgery 、 Surgery 、 Placebo-controlled study 、 Medicine 、 Gastroenterology 、 Placebo 、 Gastric emptying 、 Colectomy 、 Colorectal surgery 、 Gastrointestinal function 、 Internal medicine
摘要: This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer. Eighty-eight who underwent colectomy at one 11 clinical sites Japan from January 2009 June 2011 were registered study. Patients received either placebo (15.0 g/day, 5 g three times a day) postoperative day 2 day 8. The study end points included tract transit time evaluated with radiopaque markers and first flatus. safety profile also until day 8. Seventy-one (daikenchuto, n = 38; placebo, n = 33) statistically analyzed. Although number anal side small intestine 6 h significantly greater group than (15.19 vs 10.06, p = 0.008), total analysis results mean flatus did not differ between two groups. Daikenchuto has positive effect on resolution delayed gastric emptying, but limited paralytic ileus after may contribute early oral intake course.
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