Renal cell carcinoma (RCC) is characterized by insidious onset, lack of early typical clinical manifestations, metastasis or advanced stage at diagnosis in most patients and poor efficacy of radical nephrectomy. In recent years, with the broadly application of targeted therapies in tumors, the postoperative recurrence and mortality rates have been greatly reduced. However, there is a lack of evidence for the efficacy and safety of clinical treatment due to the existence of certain adverse effects and complications.

To systematically review the efficacy and safety of programmed death-1 (PD-1) /programmed death-1 ligand (PD-L1) inhibitors in the treatment of RCC.

CNKI, Wanfang Data, VIP, PubMed, Web of Science, Embase, Cochrane Library, Clinical Trials and other English databases were searched by computer and manually for the randomized controlled trials of PD-1/PD-L1 inhibitors for RCC from the inception to 2022-09-30. Two researchers independently extracted and collated the data, evaluated the quality of the included literature according to Cochrane 5.3 manual criteria, and performed meta-analysis using RevMan 5.4 software.

A total of 11 papers were finally included, involving 7 895 study subjects with 3 936 cases in the trial group and 3 959 cases in the control group. Meta-analysis results showed that the overall survival (OS) and progression-free survival (PFS) were better in the trial group than in the control group〔HR=0.87, 95%CI (0.84, 0.90), P<0.000 01; HR=0.85, 95%CI (0.78, 0.92), P<0.000 1〕; the objective response rate (ORR), partial response rate (PR), complete response rate (CR), and disease-control rate (DCR) were higher in the trial group than in the control group〔RR=1.72, 95%CI (1.39, 2.12), P<0.000 01; RR=1.56, 95%CI (1.20, 2.01), P=0.000 7; RR=3.05, 95%CI (2.39, 3.09), P<0.000 01; RR=1.12, 95%CI (1.05, 1.20), P=0.000 5〕; the rate of stable disease (SD) was lower in the trial group than in the control group〔RR=0.66, 95%CI (0.62, 0.72), P<0.000 01〕. The differences were not statistically significant when comparing the rate of PD, total rate of adverse events (AEs), rates of grade Ⅰ-Ⅱ adverse events and grade Ⅲ-Ⅴ adverse events between the trial and control groups〔RR=0.73, 95%CI (0.53, 0.99), P=0.05; RR=1.01, 95%CI (0.89, 1.04), P=0.60; RR=1.02, 95%CI (0.88, 1.17), P=0.82; RR=1.02, 95%CI (0.88, 1.19), P=0.80〕. Egger's tests resulted in P>0.05, indicating no significant publication bias among studies.

PD-1/PD-L1 inhibitors for RCC can significantly improve and enhance OS, PFS, ORR, CR, PR and DCR in patients without increasing the incidence of adverse effects in terms of safety, thus confirming the superiority of PD-1/PD-L1 inhibitors for RCC in terms of clinical efficacy and safety.

肾细胞癌因起病隐匿，缺乏早期典型的临床表现，多数患者确诊时已经发生转移或已到晚期，根治性肾细胞癌切除术疗效较差。近年来，随着靶向治疗在肿瘤治疗中广泛应用，很大程度上降低了术后复发率和死亡率，但由于存在一定的不良反应及并发症，因而临床治疗的有效性及安全性缺乏循证依据。

系统评价程序性死亡因子1（PD-1）/程序性死亡因子1配体（PD-L1）抑制剂治疗肾细胞癌的有效性及安全性。

计算机检索中国知网、万方数据知识服务平台、维普网及PubMed、Web of Science、Embase、Cochrane Library、Clinical Trials英文数据库和手动检索以收集PD-1/PD-L1抑制剂治疗肾细胞癌的随机对照试验，试验组为接受PD-1/PD-L1抑制剂治疗，对照组为接受常规治疗或安慰剂。检索时间为建库至2022-09-30。由2位研究员独立提取和整理资料，依据Cochrane 5.3手册标准对纳入文献的质量进行评价，应用RevMan 5.4软件进行Meta分析。

最终纳入11篇文献，研究对象7 895例，试验组3 936例，对照组3 959例。Meta分析结果显示，试验组总生存期（OS）、无进展生存期（PFS）优于对照组〔HR=0.87，95%CI（0.84，0.90），P<0.000 01；HR=0.85，95%CI（0.78，0.92），P<0.000 1〕；试验组客观缓解率（ORR）、部分缓解率（PR）、完全缓解率（CR）、基本控制率（DCR）高于对照组〔RR=1.72，95%CI（1.39，2.12），P<0.000 01；RR=1.56，95%CI（1.20，2.01），P=0.000 7；RR=3.05，95%CI（2.39，3.09），P<0.000 01；RR=1.12，95%CI（1.05，1.20），P=0.000 5〕；试验组疾病稳定率（SD）低于对照组〔RR=0.66，95%CI（0.62，0.72），P<0.000 01〕。试验组和对照组疾病进展率（PD）、总不良反应发生率（AEs）、Ⅰ~Ⅱ级不良反应发生率、Ⅲ~Ⅴ级不良反应发生率比较，差异无统计学意义〔RR=0.73，95%CI（0.53，0.99），P=0.05；RR=1.01，95%CI（0.89，1.04），P=0.60；RR=1.02，95%CI（0.88，1.17），P=0.82；RR=1.02，95%CI（0.88，1.19），P=0.80〕。Egger's检验结果均为P>0.05，表明各研究间发表偏倚不显著。

PD-1/PD-L1抑制剂治疗肾细胞癌可显著改善和提高患者的OS、PFS、ORR、PR、CR和DCR，其安全性较好，未增加患者的不良反应发生率，从而证实PD-1/PD-L1抑制剂治疗肾细胞癌在临床有效性及安全性方面有一定的优越性。