Xu Liang-Liang, Zhou Xiao-Qin, Yi Peng-Sheng, Zhang Ming, Li Jing, Xu Ming-Qing
Department of Liver Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China.
Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China.
J Surg Res. 2016 Jun 1;203(1):211-21. doi: 10.1016/j.jss.2016.01.027. Epub 2016 Feb 23.
To assess the efficacy and safety of alvimopan in conjunction with enhanced recovery strategy, compared with this strategy alone, in management of postoperative ileus in patients undergoing open abdominal surgery.
Electronic databases were comprehensively searched for relevant randomized controlled trials. We were interested in doses of 6 and 12 mg. The efficacy end points included the time to recovery of full gastrointestinal (GI) function (a composite end point measured by the time to first toleration of solid food [SF] and the time to first passage of stool, GI-2), the recovery of upper (SF) or the lower (the time to first bowel movement, BM) GI function, and the length of hospital stay (the time to discharge order written). Safety end points included GI-related, non-GI-related, and serious adverse events. These parameters were all analyzed by RevMan 5.3 software.
Nine randomized controlled trials involving 4075 patients were enrolled in this study. The pooled results showed that alvimopan significantly decreased the time to GI-2 recovery (6 mg, hazard ratio [HR] = 1.45, P < 0.00001; 12 mg, HR = 1.59, P < 0.00001), BM (6 mg, HR = 1.54, P < 0.00001; 12 mg, HR = 1.74, P = 0.0002), and the time to discharge order written (6 mg, HR = 1.37, P < 0.00001; 12 mg, HR = 1.34, P < 0.00001) compared with the placebo group. However, SF was significantly reduced in 6 mg group (HR = 1.23, P = 0.008) rather than 12 mg group (HR = 1.14, 95% confidence interval 1.00, 1.30, P = 0.04). The incidence of some GI-related and serious adverse events were significantly lower in the alvimopan group than the placebo group, and the dose of 12 mg was superior to 6 mg in this regard.
Alvimopan can accelerate recovery of GI function (especially for the lower GI tract), shorten the length of hospital stay, and reduce postoperative ileus-related morbidity without compromising opioid analgesia in an enhanced recovery setting.
评估与单纯强化康复策略相比，阿维莫潘联合强化康复策略在开放性腹部手术患者术后肠梗阻管理中的疗效和安全性。
全面检索电子数据库以查找相关随机对照试验。我们关注6毫克和12毫克的剂量。疗效终点包括全胃肠（GI）功能恢复时间（一个综合终点，通过固体食物首次耐受时间[SF]和首次排便时间测量，GI - 2）、上消化道（SF）或下消化道（首次排便时间，BM）GI功能恢复情况以及住院时间（下达出院医嘱时间）。安全终点包括胃肠道相关、非胃肠道相关及严重不良事件。这些参数均采用RevMan 5.3软件进行分析。
本研究纳入了9项涉及4075例患者的随机对照试验。汇总结果显示，与安慰剂组相比，阿维莫潘显著缩短了GI - 2恢复时间（6毫克，风险比[HR]=1.45，P<0.00001；12毫克，HR=1.59，P<0.00001）、BM时间（6毫克，HR=1.54，P<0.00001；12毫克，HR=1.74，P=0.0002）以及下达出院医嘱时间（6毫克，HR=1.37，P<0.00001；12毫克，HR=1.34，P<0.00001）。然而，6毫克组的SF显著缩短（HR=1.23，P=0.008），而12毫克组未显著缩短（HR=1.14，95%置信区间1.00，1.30，P=0.04）。阿维莫潘组一些胃肠道相关和严重不良事件的发生率显著低于安慰剂组，在这方面12毫克剂量优于6毫克剂量。
在强化康复环境中，阿维莫潘可加速胃肠功能恢复（尤其是下消化道），缩短住院时间，降低术后肠梗阻相关发病率，且不影响阿片类药物镇痛效果。
