预康复联合ERAS对新辅助胃癌患者 围手术期结局及生活质量的影响： 一项随机对照研究

The Impact of Pre-Rehabilitation Combined with ERAS on Perioperative Outcomes and Quality of Life in Neoadjuvant Gastric Cancer Patients: A Randomized Controlled Study

摘要: 目的：探讨多模式预康复联合加速康复外科(ERAS)路径与单纯ERAS路径相比，对新辅助化疗(NACT)后局部进展期胃癌患者功能状态、术后并发症及近期康复结局的影响。胃癌新辅助化疗虽能改善长期生存，但其毒副作用常导致患者生理功能受损、营养不良及心理应激，形成治疗相关脆弱状态，可能增加手术风险并延缓术后康复。本研究旨在通过前瞻性随机对照试验，评估在ERAS路径中前置整合多模式预康复干预的临床价值与安全性。方法：本研究采用前瞻性随机对照设计，将83例接受NACT后拟行微创根治性胃切除术的局部进展期胃癌患者，随机分配至预康复联合ERAS组(预康复组，n = 51)或单纯ERAS组(对照组，n = 32)。预康复方案包含三大核心模块：(1) 个体化运动训练，结合有氧运动与抗阻训练；(2) 营养支持，包括高蛋白饮食(1.2~1.5 g/kg/d)及免疫营养制剂；(3) 心理调适，通过认知行为干预与放松训练缓解焦虑抑郁情绪。主要观察指标为术后30天内总体并发症发生率(Clavien-Dindo分级 ≥ II级)。次要指标涵盖术前功能状态(6分钟步行试验，6MWT)、医院焦虑抑郁量表(HADS)评分、EORTC QLQ-C30生活质量评分等。数据分析采用符合方案集(PP)分析。结果：预康复组患者依从性良好，均完成 > 70%的预定干预内容。预康复组患者干预后(术前) 6MWT距离显著优于对照组(中位数451米 vs 423米，P = 0.005)。预康复组总体并发症(≥II级)发生率显著低于对照组(13.7% vs 34.4%, P = 0.026)，相对风险降低60.2%。多因素逻辑回归分析确认接受预康复干预是降低术后并发症的独立保护因素(OR = 0.32, 95% CI: 0.12~0.87, P = 0.028)。预康复组在术前HADS焦虑评分(9.49 vs 13.53)及抑郁评分(8.02 vs 11.81)上均较对照组有显著改善(P < 0.05)。生活质量方面，预康复组在EORTC QLQ-C30的总体健康状况(80 vs 71)及功能量表(80.14 vs 53.5)评分上亦显著优于对照组(P < 0.05)。预康复组术前血清白蛋白水平显著高于对照组(39.24 g/L vs 30.44 g/L)。两组在手术时间、术中出血量及肿瘤退缩分级(TRG)等指标上均无显著差异。结论：多模式预康复联合ERAS路径是一种安全、可行且高效的围术期管理策略。对于接受NACT的局部进展期胃癌患者，该策略可显著逆转化疗造成的身心功能损害，有效降低以II级为主的术后并发症风险(对III级以上严重并发症的影响尚需大样本证实)，并在不影响肿瘤学结局及手术安全性的前提下，全面优化患者的近期康复结局与生活质量。

Abstract: Objective: This study aims to investigate the impact of multimodal pre-rehabilitation combined with Enhanced Recovery After Surgery (ERAS) pathway compared to ERAS pathway alone on functional status, postoperative complications, and short-term recovery outcomes in patients with locally advanced gastric cancer following neoadjuvant chemotherapy (NACT). While neoadjuvant chemotherapy for gastric cancer can improve long-term survival, its toxic side effects often lead to impaired physiological function, malnutrition, and psychological stress, creating treatment-related vulnerability that may increase surgical risks and delay postoperative recovery. This prospective randomized controlled trial aims to evaluate the clinical value and safety of integrating multimodal pre-rehabilitation interventions into the ERAS pathway. Methods: This study employed a prospective randomized controlled design, randomly assigning 83 patients with locally advanced gastric cancer who underwent NACT and were scheduled for minimally invasive radical gastrectomy to either the pre-rehabilitation combined with ERAS group (pre-rehabilitation group, n = 51) or the ERAS group alone (control group, n = 32). The pre-rehabilitation program comprised three core modules: (1) individualized exercise training, combining aerobic exercise with resistance training; (2) nutritional support, including a high-protein diet (1.2~1.5 g/kg/d) and immunonutritional preparations; and (3) psychological adjustment, alleviating anxiety and depression through cognitive behavioral intervention and relaxation training. The primary endpoint was the overall complication rate within 30 days post-operation (Clavien-Dindo grade ≥ II). Secondary endpoints included preoperative functional status (6-minute walk test, 6MWT), Hospital Anxiety and Depression Scale (HADS) score, and EORTC QLQ-C30 quality of life score. Data analysis was performed using procedural set (PP) analysis. Results: Patients in the pre-rehabilitation group showed good compliance, completing >70% of the planned intervention. The 6MWT distance in the pre-rehabilitation group was significantly better than that in the control group after intervention (preoperatively) (median 451 meters vs 423 meters, P = 0.005). The overall complication rate (≥Grade II) in the pre-rehabilitation group was significantly lower than that in the control group (13.7% vs 34.4%, P = 0.026), with a relative risk reduction of 60.2%. Multivariate logistic regression analysis confirmed that receiving pre-rehabilitation intervention was an independent protective factor against postoperative complications (OR = 0.32, 95% CI: 0.12~0.87, P = 0.028). The pre-rehabilitation group showed significant improvements in preoperative HADS anxiety scores (9.49 vs 13.53) and depression scores (8.02 vs 11.81) compared to the control group (P < 0.05). Regarding quality of life, the pre-rehabilitation group showed significantly better overall health status (80 vs 71) and functional scale (80.14 vs 53.5) scores on the EORTC QLQ-C30 than the control group (P < 0.05). The preoperative serum albumin level in the pre-rehabilitation group was significantly higher than that in the control group (39.24 g/L vs 30.44 g/L). There were no significant differences between the two groups in terms of operation time, intraoperative blood loss, and tumor regression grade (TRG). Conclusion: Multimodal pre-rehabilitation combined with the ERAS pathway is a safe, feasible, and efficient perioperative management strategy. For patients with locally advanced gastric cancer who have received NACT, this strategy can significantly reverse the physical and mental functional impairment caused by chemotherapy, effectively reduce the risk of postoperative complications, mainly grade II (the impact on serious complications of grade III and above still needs to be confirmed with a large sample size), and comprehensively optimize the patient’s short-term rehabilitation outcomes and quality of life without affecting oncological outcomes and surgical safety.