程序性死亡因子1/程序性死亡因子1配体抑制剂治疗肾细胞癌有效性及安全性的Meta分析

• 作者： 张懂理 ¹ 沈冲 ¹ 张卫川 ² 陈海滨 ² 赵建军 ²
• 作者单位：
  1.  056002 河北省邯郸市，河北工程大学临床医学院

  2.  056002 河北省邯郸市，河北工程大学附属医院泌尿外二科
• 提交时间：2023-06-08

摘要: 背景　肾细胞癌因起病隐匿，缺乏早期典型的临床表现，多数患者确诊已经发生转移或晚期，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。目的　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。方法　计算机检索中国知网、万方数据知识服务平台、维普网及PubMed、WebofScience、Embase、CochraneLibrary、ClinicalTrials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Cochrane5.3手册标准对纳入文献的质量进行评价，应用RevMan5.4软件进行Meta分析。结果　最终纳入11篇文献，研究对象7895例，试验组3936例，对照组3959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），P0.05，表明各研究间发表偏倚不显著。结论　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，而在安全性方面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。

Abstract: Background 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. Objective 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. Methods CNKI，Wanfang Data Knowledge Service Platform，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. Results 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），P0.05，indicating no significant publication bias among studies. Conclusion 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.

• 分类： 医学、药学 >> 预防医学与公共卫生学
• 引用： ChinaXiv:202306.00073 (或此版本 ChinaXiv:202306.00073V1)
  DOI:10.12114/j.issn.1007-9572.2023.0180
  CSTR:32003.36.ChinaXiv.202306.00073.V1
• 推荐引用方式： 张懂理,沈冲,张卫川,陈海滨,赵建军.(2023).程序性死亡因子1/程序性死亡因子1配体抑制剂治疗肾细胞癌有效性及安全性的Meta分析.中国全科医学.doi:10.12114/j.issn.1007-9572.2023.0180 (点此复制)