目的 系统评价程序性死亡蛋白-1（PD-1）抑制剂联合化疗对比单纯化疗治疗晚期食管鳞状细胞癌的有效性与安全性。方法 计算机检索截至2025年4月，PubMed、Web of Science、EMBASE、Cochrane图书馆、中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）中评估PD-1抑制剂联合化疗对比单纯化疗治疗晚期食管鳞状细胞癌的随机对照试验（RCTs）。采用RevMan和Stata软件计算总生存期（OS）、无进展生存期（PFS）的合并风险比（HR），以及客观缓解率（ORR）、疾病控制率（DCR）和≥3级不良事件的相对风险比（RR）。结果 共纳入15项RCTs。与单纯化疗相比，PD-1抑制剂联合化疗显著改善OS（HR＝0.70，95% CI： 0.65～0.75，P＜0.000 01）、PFS（HR＝0.63，95% CI： 0.58～0.67，P＜0.000 01）、ORR（RR＝1.48，95% CI： 1.33～1.65，P＜0.000 01）和DCR（RR＝1.10，95% CI： 1.07～1.13，P＜0.000 01）。但联合治疗的≥3级不良事件发生率更高（RR＝1.06，95% CI： 1.01～1.10，P＝0.01）。结论 在晚期食管鳞状细胞癌治疗中，PD-1抑制剂联合化疗较单纯化疗可显著提升生存获益和应答效果，但会增加严重不良事件。支持将PD-1抑制剂联合化疗方案作为一线选择，但需注意毒性风险的管理。

Objective To systematically evaluate the efficacy and safety of PD-1 inhibitor combination chemotherapy versus chemotherapy alone for advanced esophageal squamous cell carcinoma. Methods A computerized search was performed for randomized controlled trials evaluating PD-1 inhibitors in combination with chemotherapy versus chemotherapy alone for the treatment of advanced esophageal squamous cell carcinoma in PubMed, Web of Science, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang databases until April 2025. RevMan and Stata software were used to calculate the combined risk ratios (Hazard Ratio, HR) for overall survival, progression-free survival, and the relative risk ratios (RR) for objective remission rate, disease control rate, and grade ≥ 3 adverse events. Results A total of 15 randomized controlled trials were included. Compared with chemotherapy alone, PD-1 inhibitors combined with chemotherapy significantly improved OS (HR = 0.70, 95% CI: 0.65—0.75, P < 0.000 01), PFS (HR = 0.63, 95% CI: 0.58—0.67, P < 0.000 01), ORR (RR = 1.48, 95% CI: 1.33—1.65, P < 0.000 01), and DCR (RR = 1.10, 95% CI: 1.07—1.13, P < 0.000 01). However, the incidence of grade ≥ 3 AEs was higher with combination therapy (RR = 1.06, 95% CI: 1.01—1.10, P = 0.01). Conclusion In the treatment of advanced esophageal squamous cell carcinoma, the combination of PD-1 inhibitors with chemotherapy significantly enhances survival benefit and response outcome compared with chemotherapy alone, but increases serious adverse events. This study supports the use of PD-1 inhibitors in combination with chemotherapy regimens as a first-line option, but attention should be paid to the management of toxicity risks.

R979.1

国家自然科学青年科学基金项目（82003849）