【摘要】 目的:系统评价PD-1/PD-L1抑制剂联合化疗对比化疗一线治疗晚期非小细胞肺癌(non-small lung cancer,NSCLC)的疗效及安全性。方法:检索PubMed、Cochrane Library、EMbase、EBSCO循证医学数据库、中国生物医学文献数据库(Chinese Biomedical Literature Database,CBM)、中国知网(Chinese Journal Full-text Database,CNKI)、中文科技期刊全文数据库(VIP)中收录的PD-1/PD-L1抑制剂联合化疗对比化疗一线治疗晚期NSCLC的随机对照试验(randomized controlled trials,RCTs),采用RevMan 5.2软件进行Meta分析。结果:纳入6个临床RCTs共3 238例晚期NSCLC。Meta分析结果显示,PD-1/PD-L1抑制剂联合化疗与化疗相比可显著延长OS(HR=0.86,95%CI=0.79～0.94,P=0.0006)和PFS(HR=0.81,95%CI=0.78～0.84,P<0.00001);1～5级血小板计数减少、呕吐、腹泻、甲状腺功能减低或亢进、皮疹、肺炎、结肠炎、肝炎、味觉障碍,3～5级肝炎的不良反应发生率较化疗组高,差异具有统计学意义(P<0.01或P<0.05)。结论:PD-1/PD-L1抑制剂联合化疗较单独化疗一线治疗晚期NSCLC可显著延长患者OS和PFS,但不良反应发生率较化疗高。更多还原

【Abstract】 Objective: To systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitor combined with chemotherapy as comparing with chemotherapy alone for the first-line treatment of advanced NSCLC(non-small lung cancer). Methods: RCTs(randomized controlled trials) on PD-1/PD-L1 inhibitor combined with chemotherapy compared with chemotherapy alone for the first-line treatment of advanced NSCLC were searched in the PubMed, Cochrane Library, EMbase, EBSCO, Chinese Biomedical Literature Database(CBM), Chinese Journal Full-text Database(CNKI), and Chinese Scientific Journal Full-text Database(VIP). RevMan 5.2 software was used for the Meta-analysis. Results: Six RCTs with 3 238 advanced NSCLC patients were included in this study. Meta-analysis showed that the combination therapy group was more effective than the chemotherapy alone group in OS(HR=0.86, 95%CI=0.79～0.94, P=0.0006) and PFS(HR=0.81, 95%CI=0.78～0.84, P<0.00001). The incidence of adverse reactions, such as thrombocytopenia of grade 1-5, vomiting, diarrhea, hypothyroidism, hyperthyroidism, rash, pneumonitis, colitis, hepatitis, dysgeusia, hepatitis of grade 3-5 and colitis, in combined treatment group were all higher than those in chemotherapy alone group, the differences were statistically significant(P<0.01 or P<0.05). Conclusions: Compared with chemotherapy alone, PD-1/PD-L1 inhibitor combined with chemotherapy can significantly improve the OS and PFS of patients with advanced NSCLC in the first-line treatment, while the overall incidence of adverse reactions is higher than chemotherapy.更多还原