Perioperative Administration of Daikenchuto (TJ-100) Reduces the Postoperative Paralytic Ileus in Patients with Pancreaticoduodenectomy
Perioperative Administration of Daikenchuto (TJ-100) Reduces the Postoperative Paralytic Ileus in Patients with Pancreaticoduodenectomy
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DOI：
10.5754/hge14897
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发表时间：
2015-03-01
影响因子：
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通讯作者：
Yamaue, Hiroki
中科院分区：
文献类型：
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作者：
Okada, Ken-ichi;Kawai, Manabu;Yamaue, Hiroki
背景/目的：没有研究报道围手术期给予Daikenchuto（TJ-100）是否减少胰腺切除术（PD）后的麻痹性肠梗阻。方法学：2010年8月至2011年8月期间计划在和歌山医科大学医院接受PD的45例连续患者入组本研究，包括第一个队列（n=15）作为对照组，后续队列（n=30）作为TJ-100组。本试验在UMIN-CTR ID# 000005056注册。结果如下：对照组术后麻痹性肠梗阻的发生率更高（对照组为73.3%，TJ-100组为20.0%; p=0.001）。与对照组相比，TJ-100组的第一次排气明显改善更早（p=0.014）。引流液和血清的多种细胞因子测定显示，TJ-100组引流液中的IL-9和IL-10在术后第1天显著升高。术前未发生与TJ-100给药相关的并发症，两组术后1 -2级腹泻（CTCAE4.0）发生率无显著差异。结论：TJ-100在PD患者围手术期应用是可行的，可降低麻痹性肠梗阻的发生率，需进一步开展随机对照试验。
Background/Aims: No study has reported whether perioperative administration of Daikenchuto (TJ-100) reduced paralytic ileus after pancreaticoduodenectomy (PD). Methodology: Forty-five consecutive patients that were scheduled to undergo PD at Wakayama Medical University Hospital between August 2010 and August 2011 were enrolled in this study including the first cohort (n=15) as the control group and the subsequent cohort (n=30) as the TJ-100 group. This trial was registered at UMIN-CTR ID# 000005056. Results: Postoperative paralytic ileus occurred more frequently in the control group (73.3% of the control group and 20.0% of the TJ-100 group; p=0.001). The first passages of flatus significantly improved earlier in the TJ-100 group than in the control group (p=0.014). A multiple cytokine assay of the drainage and serum showed that IL-9 and IL-10 in the drainage was significantly higher on postoperative day 1 in the TJ-100 group. There were no complications associated with the preoperative administration of TJ-100 before surgery, and no significant differences were Observed between the two groups in the incidence of postoperative Grade1-2 diarrhea (CTCAE4.0). Conclusions: Perioperative administration of TJ-100 was feasible and reduced the incidence of paralytic ileus in PD, and further randomized controlled trials should be conducted.