【评论】静脉注射利多卡因用于结肠手术中肠道功能恢复:一项随机临床试验  

[Comment] Intravenous lidocaine for gut function recovery in colonic surgery: a randomized clinical trial

作　　者：霍志魁 李建男[1] Huo Zhikui;Li Jiannan

机构地区：[1]吉林大学第二医院结直肠肛门外科,吉林长春130021

出　　处：《结直肠肛门外科》2025年第1期65-67,共3页Journal of Colorectal & Anal Surgery

摘　　要：重要性尽管微创手术术后恢复速度快,但结肠切除术后肠道功能恢复延迟是及时出院的常见障碍。目的评价围手术期静脉注射2%利多卡因对选择性微创结肠切除术后肠道功能恢复的影响。设计、设置和参与者ALLEGRO试验是一项在27家英国医院进行的随机、安慰剂对照、双盲试验。共有590例因良性或恶性疾病而计划进行选择性微创结肠切除术的成年人被1∶1随机分配至2%静脉利多卡因注射组(观察组)或生理盐水安慰剂注射组(对照组)。招募时间为2018年8月13日至2023年4月11日,2020年3月20日至2020年7月6日暂停招募,随访终止时间为2023年8月10日。干预观察组患者在麻醉诱导时接受2%利多卡因静脉注射,剂量为1.5 mg/kg,然后以1.5 mg/(kg·h)的速度给药6 h或12 h。对照组患者接受0.9%生理盐水给药6 h或12 h。主要结局和指标主要结局为术后72 h肠道功能恢复的患者比例,由GI-3耐受(连续三餐摄入食物和液体未出现明显恶心或呕吐)和排气或排便的复合终点定义。有11个次要结局,包括GI-3恢复时间、GI-2恢复(经口进食和排便耐受性)时间、术后肠梗阻、术后恶心和呕吐评分、镇痛总效益评分、术后阿片类药物消耗情况、恢复质量-15评分、欧洲五维健康量表评分、加强恢复方案依从性、达到医学定义的出院时间以及患者自我评估的出院时间。结果本试验初期纳入590例患者(观察组295例,对照组295例),在33例患者被随机化排除后,最终共纳入557名患者,其中观察组279例,对照组278例;女性患者249例(44.7%);平均年龄(66±10.9)岁;532例患者(96%)接受随机化治疗。观察组和对照组分别有160例(57.3%)和164例患者(59.0%)在72 h内实现了GI-3复合结局定义的肠道功能恢复(调整后的绝对差异为-1.9%,95%CI:-8.0%~4.2%);相对风险为0.97(95%CI:0.88~1.07)。在11个次要终点中,两组比较差异无统计学意义。结论和相关性在接受选Importance Despite the recovery advantages of minimally invasive surgical techniques,delayed return of gut function after colectomy is a common barrier to timely discharge from hospital.Objective To evaluate the effect of 2%perioperative intravenous lidocaine infusion on return of gut function after elective minimally invasive colon resection.Design,setting,and participants The ALLEGRO trial was a randomized,placebo-controlled,double-blind trial conducted in 27 UK hospitals.A total of 590 adults scheduled for elective minimally invasive colon resection for benign or malignant disease were randomized 1∶1 to 2%intravenous lidocaine or saline placebo.Enrollment occurred from August 13,2018,to April 11,2023,with a pause in recruitment from March 20,2020,through July 6,2020;final follow-up was on August 10,2023.Interventions The intervention patients received 2%intravenous lidocaine administered as 1.5-mg/kg bolus at induction of anesthesia followed by 1.5 mg/kg/h for 6 or 12 hours.Control patients received 0.9%saline placebo for 6 or 12 hours.Main outcomes and measures The primary outcome was the proportion of patients with return of gut function at 72 hours after surgery,defined by the GI-3 composite end point of tolerating diet(ingestion of food and drink without significant nausea or vomiting for 3 consecutive meals)and passage of flatus or stool.There were 11 secondary outcomes,including time to GI-3 recovery,time to GI-2 recovery(tolerance of oral diet and passage of stool),prolonged postoperative ileus,postoperative nausea and vomiting score,Overall Benefit of Analgesia Score,postoperative opioid consumption,Quality of Recovery-15,quality of life(EuroQol 5-Dimension 5-Level),enhanced recovery protocol adherence,time to meeting medically defined criteria for discharge,and time to patient self-assessed readiness for discharge.Results The trial enrolled 590 patients(295 intervention,295 control);after 33 postrandomization exclusions,557 patients were included(279 intervention,278 control;249 female patients[44.7

关 键 词：选择性微创结肠切除术 利多卡因 肠道功能 

分 类 号：R735.3[医药卫生—肿瘤]