加速康复外科在胃癌根治术中临床价值的前瞻性研究

Clinical efficacy of enhanced recovery after surgery in the radical gastrectomy for gastric cancer： a prospective study

目的探讨加速康复外科（ERAS）在胃癌根治术中的临床价值。方法选取2011年4月至2013年6月青岛大学附属医院行胃癌根治术的140例患者进行前瞻性研究，采用随机、双盲对照法，通过随机数字表法将入组患者分为ERAS组（围术期采用ERAS处理方案）和对照组（围术期采用传统处理方案）。观察患者炎症指标、营养状况指标变化以及术后恢复情况。ERAS组患者于出院后24h内进行第1次电话随访，出院2周进行门诊随访，直至术后30d结束。对照组出院后3周门诊常规复查。正态分布的计量资料采用露±S表示，组间比较采用独立样本t检验；各指标趋势比较采用重复测量方差分析。计数资料采用，检验或Fisher确切概率法。结果筛选出符合研究条件的患者80例，ERAS组和对照组各40例。两组患者血清TP、Alb、前白蛋白、TNF-α、IL-6、C反应蛋白、静息能量消耗、血糖、胰岛素、胰岛素抵抗指数术后1、3、5d在一定趋势内变化，ERAS组术后ld分别为（61±5）g/L、（34±3）g/L、（160±18）g/L、（12．3±2．3）mmoL／L、（101±34）ng／L、（43±11）g／L、（1336±105）kaL／d、（7．6±0．8）mmol/L、（16．8±3．5）mU／L、5．7±1．3；对照组分别为（58±4）g/L、（31±4）g／L、（147±18）g/L、（15．3±2．2）mmol/L、（122±37）ng／L、（56±27）g／L、（1450±164）kal／d、（9．3±1．4）mmol/L、（30．5±6．8）mU／L、12．5±3．2，两组比较，差异有统计学意义（F=31．63，8．03，67．36，147．04，9．63，6．84，16．10，54．85，104．51，139．47，P〈0．05）。ERAS组患者术后发热时间、肛门排气时间、住院时间和住院费用、疼痛评分、生命质量评分分别为（2．9±0．9）d、（2．9±0．6）d、（7．6±2．1）d、（28495±4722）元、（1．4±1．0）分、（15．4±0．9）分；对照组分别为（3．8±0．6）d、（3．5±0．7）d、（8．9±2．6）d、（35318±7610）元、（2．4±1．1）分、（14．4±1．2）分，两组比较，差异有统计学意义（t=-0．91，-3．66，-2．85，-4．82，-4．20，3．92。P〈0．05）。ERAS组患者发生呼吸道相关并发症2例，再手术患者1例，术后30d再入院1例；对照组则分别为3例、1例、2例，两组比较，差异无统计学意义（P〉0．05）。结论ERAS应用于胃癌根治术患者的围术期安全可行。它能减轻手术应激，缩短住院时间，改善患者生命质量，且不增加术后并发症，这可能与减少患者胰岛素抵抗、降低静息能量代谢有关。临床试验注册在中国临床试验注册中心注册，注册号为ChiCTR-TRC-10001611。

Objective To investigate the clinical-efficacy of enhanced recovery after surgery （ERAS） in the radical gastrectomy for gastric cancer. Methods The clinical data of 140 patients undergoing radical gastrec- tomy for gastric cancer at the Affiliated Hospital of Qingdao University from April 2011 to June 2013 were prospec- tively analyzed. A double-blind, randomized, controlled study was performed in the 140 patients, and all of them were divided into the ERAS group （patients undergoing perioperative management according to enhanced recovery rehabilitation program） and the control group （patients undergoing perioperative management） based on a random numble table. The inflammatory markers, nutritional index and postoperative recovery of patients were observed. Patients of the ERAS group were followed up by telephone interview within the first 24 hours after discharge, and by outpatient examination since the second week after discharge. The follow-up was ended at postoperative day 30. Patients of the control group were reexamined at the third week after discharge. The measurement data with normal distribution was presented as x± s. The comparison between groups was evaluated with an independent samplet test. The trend analyses for variables were done using repeated measures ANOVA. The count data were analyzed using the ehi-square test or Fisher exact probability. Results Eighty patients were screened for eligibility, and were allocated into the ERAS group （40 patients） and the control group （40 patients）. The total protein in serum （TP）, albumin （Alb）, prealbumin, TNF-α, IL-6, c-reactive protein, resting energy expenditure （REE）, gly- cemic index, insulin index and Insulin resistance index in the 2 groups showed a range of variations at postopera- tive day 1,3, and 5, and these were （61 ± 5） g/L, （34±3 ） g/L, （ 160±18） g/L, （ 12.3 ± 2.3 ） mmol/L, （ 101 ± 34） ng/L, （43±11 ） g/L, （ 1 336 ± 105 ） kal/d, （7.6 ± 0.8 ） retool/L, （ 16.8 ± 3.5） mU/L and 5.7 ± 1.3 in the ERAS group at postoperative day 1, and （58 ± 4）g/L, （31 ± 4）g/L, （147± 18）g/L, （15.3 ±2.2 ）mmol/L, （ 122 ± 37 ） ng/L, （ 56 ± 27 ） g/L, （ 1 450 ± 164 ） kal/d, （ 9.3 ± 1.4 ） mmol./L, （ 30. 5 ± 6.8 ） mUlL and 12.5 ± 3.2 in the control group, respectively, showing a significant difference between the 2 groups （F = 31.63, 8.03, 67.36, 147.04, 9. 63, 6. 84, 16. 10, 54. 85, 104. 51, 139. 47, P 〈0.05）. The duration of fever, time to flatus, duration of hospital stay, hospital expenses, numeric rating scale and quality of life （QOL） were （2.9 ± 0.9 ） days, （2.9±0.6 ） days, （7.6 ± 2.1 ） days, （28 495 ± 4 722） yuan, 1.4 ±1.0 and 15.4 ± 0.9 in the ERAS group after operation, and （3.8 ± 0.6） days, （ 3.5 ± 0.7） days, （8.9 ± 2.6） days, （35 318 ± 7 610） yuan, 2.4 ± 1.1 and 14.4 ± 1.2 in the control group, respectively, with a significant difference between the 2 groups （ t = - 0.91, - 3.66, - 2. 85, - 4. 82, - 4.20, 3.92, P 〈 0. 05）. Two patients were complicated with respiratory diseases, 1 patient received reoperation and 1 was readmitted to the hospital at postoperative day 30 in the ERAS group. Three patients had respiratory diseases, 1 received reoperation and 2 were readmitted to the hospital at postoperative day 30 in the control group, with no significant difference between the 2 groups （ P 〉 0.05 ）. Conclusions ERAS is safe and feasible for the perioperative treatment of patients with gastric cancer, meanwhile it could reduce the surgical stress, shorten the duration of hospital stay and improve QOL and postoperative compli- cations, ERAS might take effects by reducing insulin resistance and decreasing REE. Registry This study was registered with the Chinese Clinical Trial Registry with the registry number of ChiCTR-TRC-10001611.