摘要目的:系统评价在可切除胰腺癌患者中新辅助治疗与直接手术治疗的临床效果。方法:本研究为荟萃分析。以pancreatic neoplasms、pancreas tumor、neoadjuvant therapy、randomized controlled trial及胰腺癌、新辅助治疗、随机对照试验为检索词，检索了PubMed、Embase、Cochrane Library、Web of Science、中国知网、维普数据库。检索时间为自建库至2025年5月19日。纳入比较新辅助治疗与直接手术治疗可切除胰腺癌患者的临床高质量随机对照试验（RCT）研究，由两名研究者独立筛选文献、提取数据和进行质量评价。总体生存（OS）时间的评价采用 HR及其95% CI表示，组间R0切除率、术后淋巴结阴性率、术后并发症发生率和术后90 d内病死率的评价采用 RR及其95% CI表示。采用 Q检验和 I 2值对纳入文献进行异质性检验，采用漏斗图和Egger检验分析文献发表偏倚，采用剪补法评估发表偏倚对结果的影响，采用逐一剔除法行敏感性分析确定合并效应值的可靠性。 结果:最终共纳入7项RCT研究（1 026例患者）。其中新辅助治疗组553例，直接手术组473例。荟萃分析结果显示，5篇研究报告了OS，其在新辅助治疗组与直接手术组的差异无统计学意义（ HR=0.85，95% CI：0.62~1.17， P=0.320），采用逐一剔除单篇文献的方法剔除异质性文献后，新辅助治疗组OS时间较直接手术组长（ HR=0.75，95% CI：0.62~0.90， P=0.003）；新辅助治疗组的手术R0切除率（ RR=1.28，95% CI：1.07~1.55， P=0.008）及术后淋巴结阴性率（ RR=2.12，95% CI：1.59~2.82， P<0.01）较高；两组术后并发症发生率和术后90 d内病死率的差异均无统计学意义（ RR=0.95，95% CI：0.81~1.13， P=0.590； RR=0.67，95% CI：0.24~1.87， P=0.450）。 结论:基于现有的最佳研究及实验数据，对于可切除胰腺癌，新辅助治疗可提高R0切除率和术后淋巴结阴性率；新辅助治疗较传统的直接手术治疗方式未增加术后并发症发生率和病死率。但以上结果仍需要更多高质量的RCT研究进行验证。

abstractsObjective:To systematically compare the clinical outcomes of neoadjuvant therapy (NAT) versus upfront surgery (US) in patients with resectable pancreatic cancer.Methods:This meta-analysis was conducted following established guidelines. Reaearch articles were searched in PubMed, Embase, Cochrane Library, Web of Science, CNKI, and VIP databases from their inception to May 19,2025, using search terms including “pancreatic neoplasms” “pancreas tumor” “neoadjuvant therapy” “randomized controlled trial” and their Chinese equivalents. High-quality randomized controlled trial (RCT) comparing NAT with US in resectable pancreatic cancer patients were included. Two researchers independently performed literature screening,data extraction,and quality assessment. Overall survival (OS) was evaluated using hazard ratios ( HR) with 95% CI,while R0 resection rate,pN0 rate,postoperative complication rate,and 90-day postoperative mortality were assessed using risk ratios ( RR) with 95% CI. Heterogeneity was assessed using the Q-test and I2 statistic. Publication bias was evaluated using funnel plots and Egger′s test,with the trim-and-fill method used to assess its impact on the results. Sensitivity analysis was conducted using the leave-one-out method to determine the robustness of the pooled effect estimates. Results:Seven RCTs involving 1 026 patients were included (NAT group: n=553;US group: n=473). The initial meta-analysis of five studies on OS showed no statistically significant difference between the NAT and US groups ( HR=0.85,95% CI: 0.62 to 1.17, P=0.320). However,sensitivity analysis performed by sequentially removing individual studies identified and excluded a source of heterogeneity. After this exclusion,the analysis revealed that NAT was associated with significantly longer OS time compared to US ( HR=0.75,95% CI: 0.62 to 0.90, P=0.003). Furthermore,NAT significantly improved the R0 resection rate ( RR=1.28,95% CI: 1.07 to 1.55, P=0.008) and the pN0 rate ( RR=2.12,95% CI: 1.59 to 2.82, P<0.01). No significant differences were found between the two groups in terms of postoperative complication rate ( RR=0.95,95% CI: 0.81 to 1.13, P=0.590) or 90-day postoperative mortality ( RR=0.67,95% CI: 0.24 to 1.87, P=0.450). Conclusions:Based on the current best available evidence from RCT,for resectable pancreatic cancer, neoadjuvant therapy improves the R0 resection rate and pN0 rate without increasing postoperative complications or mortality compared to the traditional approach of upfront surgery. However,these findings warrant further validation by more high-quality RCT.