Randomized Phase II Study of the Anti-inflammatory Effect of Ghrelin During the Postoperative Period of Esophagectomy
Randomized Phase II Study of the Anti-inflammatory Effect of Ghrelin During the Postoperative Period of Esophagectomy
复制标题
食管切除术术后胃泌素抗炎作用的随机 II 期研究
DOI：
10.1097/sla.0000000000000986
复制
发表时间：
2015-08-01
影响因子：
9
通讯作者：
Doki, Yuichiro
中科院分区：
文献类型：
--
作者：
Takata, Akihiro;Takiguchi, Shuji;Doki, Yuichiro
目的：采用前瞻性随机II期试验评价Ghrelin治疗食管癌术后全身炎症反应综合征(SIRS)的疗效。背景：食管癌切除具有高侵袭性，可导致SIRS持续时间延长和术后并发症的发生。方法：40例食道手术患者随机分为Ghrelin组(n=20)和安慰剂组(n=20)，Ghrelin组给予Ghrelin 0.5g/kg/h持续滴注5d，安慰剂组给予单纯生理盐水5d。主要终点是全身炎症反应综合征持续时间。次要终点为术后并发症发生率、负氮平衡时间、体重和成分变化以及炎症标志物，包括C-反应蛋白(CRP)和白介素6(IL-6)水平。结果：Ghrelin组SIRS持续时间短，CRP和IL-6水平低于安慰剂组。Ghrelin组的肺部并发症发生率低于安慰剂组，而其他并发症在两组之间没有差异。尽管Ghrelin组氮负平衡时间短于安慰剂组，但总体重和瘦体重的变化无明显差异。结论：食道癌术后应用Ghrelin能有效抑制炎症介质，改善术后临床病程。
Objective: A prospective randomized phase II trial was conducted to evaluate the efficacy of ghrelin administration in reducing systemic inflammatory response syndrome (SIRS) duration after esophagectomy.Background: Esophagectomy for esophageal cancer is highly invasive and leads to prolonged SIRS duration and postoperative complications. Ghrelin has multiple effects, including anti-inflammatory effects.Methods: Forty patients undergoing esophagectomy were randomly assigned to either the ghrelin group (n = 20), which received continuous infusion of ghrelin (0.5 g/kg/h) for 5 days, or the placebo group (n = 20), which received pure saline for 5 days. The primary endpoint was SIRS duration. The secondary endpoints were the incidence of postoperative complications, time of a negative nitrogen balance, changes in body weight and composition, and levels of inflammatory markers, including C-reactive protein (CRP) and interleukin-6 (IL-6).Results: The ghrelin group had a shorter SIRS duration and lower CRP and IL-6 levels than did the placebo group. The incidence of pulmonary complications was lower in the ghrelin group than in the placebo group, whereas other complications did not differ between the groups. Although time of the negative nitrogen balance was shorter in the ghrelin group than in the placebo group, changes in total body weight and lean body weight did not differ significantly.Conclusions: Postoperative ghrelin administration was effective for inhibiting inflammatory mediators and improving the postoperative clinical course of patients with esophageal cancer.