陈芝强,李泽云,黄睿澜.晚期非小细胞肺癌患者PD-1使用的系统评价再评价[J].中国肿瘤,2021,30(6):465-480.
晚期非小细胞肺癌患者PD-1使用的系统评价再评价
Re-evaluation of Systematic Reviews and Meta Analyses of PD-1/PD-L1 Related Therapy for Advanced Non-small Cell Lung Cancer
中文关键词  修订日期:2020-07-01
DOI:10.11735/j.issn.1004-0242.2021.06.A010
中文关键词:  PD-1  PD-L1  非小细胞肺癌  系统评价  Meta 分析  再评价
英文关键词:PD-1  PD-L1  non-small cell lung cancer  systematic review  Meta analysis  re-evaluation
基金项目:2019国家中医药管理局中医药循证能力建设项目(2019XZZX-ZL001);
作者单位
陈芝强 广州中医药大学第一临床医学院 
李泽云 广州中医药大学第一临床医学院 
黄睿澜 广州中医药大学第一临床医学院 
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中文摘要:
      摘 要:[目的] 对目前公开发表的PD-1/PD-L1治疗晚期非小细胞肺癌的系统评价(systematic review,SR)/Meta分析进行再评价,评估其报告质量、方法学质量及证据质量。[方法] 计算机检索PubMed,EMBASE,the Cochrane Library,Clinical Trials,CNKI,VIP和万方数据库,搜集PD-1/PD-L1治疗晚期非小细胞肺癌的SR/Meta分析,检索年限均为建库至2020年7月。采用PRISMA声明、AMSTAR 2工具和GRADE方法分别评价所纳入SR/Meta分析的报告质量、方法学质量和证据质量。[结果] 最终纳入25个SR/Meta分析,包含36个结局指标。PRISMA声明评价结果显示纳入研究多数存在一定的报告缺陷。AMSTAR 2工具评价结果显示25个SR/Meta分析的质量等级均为极低,存在问题最多的3个关键条目是条目2“是否有预先发表的方案,研究与方案是否有明显偏倚”、条目4“是否使用全面的文献检索策略”、条目7“是否提供排除文献的清单,并说明了排除理由”。GRADE分级结果显示SR/Meta分析结局指标(包含亚组)的等级以低质量和中质量为主,导致降级的最主要因素为发表偏倚,其次为局限性以及不一致性。[结论] 当前证据显示PD-1/PD-L1或联合化疗治疗晚期非小细胞肺癌的循证医学证据多为低质量,相关SR/Meta分析的方法学质量及证据质量较差,规范性仍有待提高。
英文摘要:
      Abstract:[Purpose] To re-evaluate the quality of published systematic reviews and Meta analyses of PD-1/PD-L1 related therapy for advanced non-small cell lung cancer. [Methods] Systematic reviews and Meta analyses of PD-1/PD-L1 related therapy for advanced non-small cell lung cancer published before July 2020 were collected from PubMed,EMBASE,the Cochrane Library,Clinical Trials,CNKI,VIP and Wanfang databases. The quality of reporting items,methodologies and evidence of included systematic reviews and Meta analyses were assessed by PRISMA,AMSTAR 2 and GRADE,respectively. [Results] A total of 25 systematic reviews and Meta analyses included 36 outcomes were obtained. The evaluation of PRISMA showed that most of the included studies were insufficient on reporting items. The quality levels of included studies were very low according to AMSTAR 2. Most of the studies had deficiencies on Item 2 (Did the report of the review contain an explicit statement that the review methods were established prior to the conduct of the review and did the report justify any significant deviations from the protocol ?),Item 4 (Did the review authors use a comprehensive literature search strategy ?) and Item 7 (Did the review authors provide a list of excluded studies and justify the exclusions ?). Rated by the GRADE,the quality of outcomes (including outcomes of subgroups) was low or medium. The most important factors for downgrading were publication bias,followed by limitations and inconsistency. [Conclusion] This study suggests that the quality of published systematic reviews and Meta analyses of PD-1/PD-L1 related therapy or combined chemotherapy for advanced non-small cell lung cancer is unsatisfactory. The poor quality of methodology and evidence of included studies indicates that the standard of systematic reviews and Meta analyses of PD-1/PD-L1 related therapy for advanced non-small cell lung cancer should be improved.
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