Okada Ken-Ichi, Kawai Manabu, Hirono Seiko, Miyazawa Motoki, Shimizu Atsushi, Kitahata Yuji, Yamaue Hiroki
Hepatogastroenterology. 2015 Mar-Apr;62(138):466-71.
BACKGROUND/AIMS: No study has reported whether perioperative administration of Daikenchuto (TJ-100) reduced paralytic ileus after pancreaticoduodenectomy (PD).
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.
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 Gradel-2 diarrhea (CTCAE4.0).
Perioperative administration of TJ-100 was feasible and reduced the incidence of paralytic ileus in PD, and further randomized controlled trials should be conducted.
背景/目的：尚无研究报道围手术期给予大建中汤（TJ - 100）能否减少胰十二指肠切除术（PD）后发生的麻痹性肠梗阻。
选取2010年8月至2011年8月期间在和歌山县医科大学医院计划接受PD的45例连续患者纳入本研究，其中第一组（n = 15）作为对照组，后续组（n = 30）作为TJ - 100组。本试验在UMIN - CTR注册号为000005056。
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）。TJ - 100组首次排气明显早于对照组（p = 0.014）。对引流液和血清进行的多种细胞因子检测显示，TJ - 100组术后第1天引流液中的IL - 9和IL - 10显著更高。术前给予TJ - 100未出现与手术相关的并发症，两组术后2级腹泻（CTCAE4.0）的发生率无显著差异。
围手术期给予TJ - 100是可行的，且可降低PD后麻痹性肠梗阻的发生率，应进一步开展随机对照试验。
