目的：系统评价基于PD-1/PD-L1抑制剂的免疫联合治疗（以下称“免疫联合治疗”）对比舒尼替尼治疗晚期肾细胞癌（RCC）的安全性和有效性。方法：检索PubMed、Embase、Cochrane Library 及中国知网（CNKI）数据库，收集国内外公开发表的免疫联合治疗对比舒尼替尼应用于晚期RCC的随机对照试验（RCT），检索时间均为自建库时间至2022 年10 月。由两名研究者独立评价纳入研究的质量、提取资料并交叉核对，采用StataMP16.0软件进行Meta 分析。结果：共纳入6项RCT，Meta 分析结果显示，（1）有效性：与舒尼替尼相比，免疫联合治疗显著提高了晚期RCC患者的总生存期[OS，HR=0.74，95% CI（0.67，0.80），P<0.01]和无进展生存期[PFS，HR=0.66，95% CI（0.51，0.81），P<0.01]（；2）安全性：两治疗组均有较高的不良反应（AE）发生率，差异无统计学意义。但免疫联合治疗组发生皮肤及内分泌系统AE显著高于舒尼替尼治疗组，而血液系统相关AE则明显低于舒尼替尼治疗组（；3）以1%为临界点，免疫联合治疗组的RCC患者，无论是PD-L1阳性或阴性的，其OS和PFS均高于舒尼替尼组。结论：免疫联合治疗可显著延长晚期RCC患者的OS和PFS，但不同系统发生AE有差异，且RCC患者PD-L1表达状态（1%为临界点）并不影响免疫联合治疗的获益。

Objective: To systematically evaluate the safety and efficacy of PD-1/PD-L1 inhibitor-based immunotherapy (hereinafter referred to as "combination immunotherapy") compared with sunitinib in the treatment of advanced renal cell carcinoma (RCC). Methods: Databases such as PubMed, Embase, Cochrane Library, and CNKI were searched from the date of their establishment to October 2022 to collect the randomized controlled trials (RCTs) of combination immunotherapy versus sunitinib for the treatment of advanced renal cell carcinoma (RCC).Two reviewers independently evaluated the quality of included studies, extracted data, and cross-checked the information. Meta-analysis was performed using StataMP16.0 software. Results: A total of 6 RCTs were included. The results of the Meta-analysis showed that: (1)Effectiveness. Compared to sunitinib, combination immunotherapy significantly improved overall survival (HR=0.74, 95% CI [0.67, 0.80], P<0.01) and progression-free survival (HR=0.66, 95% CI [0.51, 0.81], P<0.01) in patients with advanced RCC. (2) Safety. Both groups had comparatively high incidences of adverse events (AEs) but the difference was not significant between the two arms. However, the AEs of the skin and endocrine system in the combination immunotherapy arm were significantly higher than those of the sunitinib arm, while the AEs of the blood system were significantly lower than those of the sunitinib arm. (3) No matter the expression of PD-L1 in RCC patients was negative or positive (1% as the Cut-off value), the OS and PFS of patients treated with combination immunotherapy were higher than those treated with sunitinib. Conclusion: Combined immunotherapy can significantly prolong the OS and PFS of patients with advanced RCC, but the incidence of AEs in different systems is different, and the expression of PD-L1 in RCC patients (with 1% as the Cut-off value) does not affect the benefit of combination immunotherapy.

福州市科技计划项目（No. 2021-S-171）；福建医科大学启航基金课题（No. 2020QH1259）