作者：宋庆志1，2，颜畅2，李粤2，马亚辉1，2，李冠2，敖胜2，吕国庆1，2

单位：1.安徽医科大学北京大学深圳医院临床学院， 广东 深圳 518036；2.北京大学深圳医院 胃肠外科，广东 深圳 518036

Authors: Song Qingzhi1，2, Yan Chang2, Li Yue2, Ma Yahui1，2, Li Guan2, Ao Sheng2, Lyu Guoqing1，2

Unit: 1.Peking University Shenzhen Hospital, Clinical College of Anhui Medical University, Shenzhen 518036,Guangdong,China；2.Department of Gastrointestinal Surgery, Peking University Shenzhen Hospital, Shenzhen 518036,Guang[1]dong,China

摘要：

目的 比较进展期胃癌患者在术前接受新辅助化疗后对术后近期并发症的影响。方法 回顾性分析了北京大学深圳医院胃肠外科在2015-2020年接受胃癌根治术的进展期胃癌患者222例,根据患者接受治疗方式的不同分为直接手术组(159例),新辅助化疗患者为新辅助化疗组(63例)。手术组采用倾向评分匹配及多元回归模型方法控制混杂因素,匹配后比较两组的手术安全性,主要观察结果是术后近期并发症的发生率,包括术后并发症的Clavien-Dindo分级和分类;次要观察结果是手术时间、术中出血量、拔出引流管时间、排气时间、进食时间、排便时间、术后住院时间及总花费等。结果 经过倾向评分匹配后,新辅助化疗组和直接手术组各60例患者纳入最终的数据分析。与直接手术组相比,新辅助化疗组的术后近期并发症的发生率显著降低(13.33%比36.67%,P=0.003),且明显减少Ⅲ～Ⅳ级术后近期并发症(1.67%比11.67%,P=0.028)。在单因素分析中,pT分期中的T4a期患者与T3期患者相比、临床病理分期中的ⅢC期患者与ⅡA期患者相比,都增加了术后并发症的风险(OR=1.38,95%CI 1.19～3.24,P=0.041和OR=1.61,95%CI 1.14～2.64,P=0.035)。在多因素分析中,不纳入任何协变量,纳入pN、纳入全部协变量后,患者术前予以新辅助化疗与术后发生近期并发症的风险分别为0.27 (0.11～0.66, P=0.004)、0.25 (0.10～0.65,P=0.004)、0.18 (0.06～0.60,P=0.005)。在次要观察结果中,与直接手术组相比,新辅助化疗组患者在术后住院时间[(11.15±3.51)d比(13.78±6.57)d,P=0.007]、排气时间[(3.12±0.76)d比(3.60±0.74)d,P <0.001]、进食时间[(5.13±1.58)d比(6.10±2.22)d,P=0.007]、排便时间[(5.18±1.40)d比(6.80±2.75)d,P <0.001]、拔出引流管时间[(7.48±1.67)d比(9.63±5.98)d,P=0.008]明显缩短,在术中出血量[(199.67±134.44)ml比(335.50±291.61)ml,P=0.001]和总花费[(81 449.00±18471.07)元比(100 207.68±29 682.41)元,P <0.001]明显减少,且差异有统计学意义。结论 与直接手术组患者相比,接受新辅助化疗后显著减少进展期胃癌术后近期并发症的发生率,可明显降低术后Ⅲ～Ⅳ级近期并发症的风险;且具有术中出血量少、术后恢复快、住院费用低、进食及排便时间快等短期疗效优势。

关键词：进展期胃癌；新辅助化疗；近期并发症；倾向评分匹配

Abstract：

Objective The purpose of this study was to compare the effect of preoperative neoadjuvant chemotherapy on postoperative near -term complications in patients with advanced gastric cancer. Method A retrospective analysis was performed on 222 patients with advanced gastric cancer who received radical gastrectomy from January 2015 to December 2020 in the Department of Gastrointestinal Surgery of Peking University Shenzhen Hospital. Patients undergoing direct surgery were selected as the control group, and the confounding was controlled by the method of propensity score matching and multiple regression model. After matching, the surgical safety of the two groups was compared. The main observation indicator was the incidence of short-term postoperative complications in the two groups, including the Clavien-Dindo grade and classification of postoperative complications. Secondary observation results were operation time, intraoperative blood loss, postoperative drainage tube removal time, exhaust time, feeding time, defecation time, postoperative hospital stay and total cost, etc. Result A total of 222 patients were enrolled in this study, including 159 patients in the direct surgery group and 63 patients in the neoadjuvant chemotherapy group. After propensity score matching, 60 patients in the neoadjuvant chemotherapy group and 60 in the direct surgery group were included in the final data analysis. Compared with the direct surgery group, the incidence of short -term postoperative complications was significantly reduced in the neoadjuvant chemotherapy group （13.33% vs 36.67%, P=0.003）, and the incidence of grade Ⅲ-Ⅳ postoperative complications was significantly reduced（1.67% vs 11.67%, P=0.028）. In univariate analysis, T4a patients in pT stage compared with T3 patients and IIIC patients in clinicopathological stage compared with IIA patients had an increased risk of postoperative complications, with odds ratios （OR） （95% CI） of 1.38 （1.19-3.24，P=0.041） and 1.61 （1.14 -2.64，P=0.035）, respectively. In the multi -factor analysis, without including any covariable, including pN, including all covariables, The odds ratio （95% CI） between preoperative neoadjuvant chemotherapy and postoperative

recent complications were 0.27 （0.11-0.66，P=0.004），0.25 （0.10～0.65，P=0.004） , 0.18（0.06-0.60，P=0.005）, respectively. Among the secondary observations, patients in the neoadjuvant chemotherapy group had longer postoperative hospital stay ［（11.15±3.51）d vs （13.78 ± 6.57）d, P=0.007］ and exhaust time ［（3.12± 0.76 ）d vs（3.60±0.74）d, P<0.001］, feeding time ［ （5.13±1.58）d vs （6.10 ±2.22 ）d, P = 0. 007 ］ , defecation time［ （5.18±1.40）d vs（6.80±2.75）d, P<0.001］, drainage tube removal time/day ［ （7.48±1.67 ）d vs （9.63±5.98）d, P=0.008］, intraoperative blood loss ［ （199.67±134.44）ml vs （335.50±291.61）ml, P=0.001］ and total cost ［（81 449.00±18 471.07）yuan vs （100 207.68±29 682.41）, P<0.001］yuan, and the difference was statistically significant. Conclusion Compared with the direct surgery group, neoadjuvant chemotherapy significantly reduced the incidence of postoperative near-term complications of advanced gastric cancer, and significantly reduced the risk of postoperative near -term complications of grade Ⅲ-Ⅳ. Moreover, it has the advantages of short term efficacy, such as less intraoperative blood loss, fast postoperative recovery, low hospitalization cost, fast feeding and defecation time.

Key Words: Advanced gastric cancer; Neoadjuvant chemotherapy; Near -term complications; Propensity score matching