摘要
目的系统评价复方苦参注射液联合程序性死亡受体1(programmed death receptor 1,PD-1)/程序性死亡配体1(programmed death ligand 1,PD-L1)抑制剂治疗非小细胞肺癌的临床疗效及安全性。方法文献检索限定时间为从建库至2025年6月23日,在计算机检索PubMed、Embase、Cochrane library、知网、维普、万方和中国生物医学文献数据库关于复方苦参注射液联合PD-1/PD-L1抑制剂治疗非小细胞肺癌的随机对照试验。根据纳排标准筛选文献后,采用Cochrane偏倚风险评估工具进行质量评价,使用Revman 5.4进行统计学分析。结果共纳入6篇文献,包含患者520例。Meta分析结果显示:在临床疗效方面,相比于PD-1/PD-L1抑制剂治疗方案组,复方苦参注射液联合PD-1/PD-L1抑制剂治疗方案组能有效改善客观缓解率(RR=1.66,95%CI:1.36~2.03,P<0.001)、疾病控制率(RR=1.24,95%CI:1.08~1.42,P=0.002)和卡氏功能状态评分(MD=5.66,95%CI:2.22~9.09,P=0.001),对总生存期、中位无进展生存期、无病生存期、两年生存率也有一定的改善作用。在安全性方面,联合治疗能显著降低非小细胞肺癌患者总体不良反应发生率、消化道反应发生率(RR=0.83,95%CI:0.70~0.98,P=0.03)和骨髓抑制发生率(RR=0.64,95%CI:0.53~0.77,P<0.001)。结论复方苦参注射液联合PD-1/PD-L1抑制剂治疗能提高非小细胞肺癌的临床疗效,且安全性良好。
Objective To systematically evaluate the efficacy and safety of compound Kushen injection combined with programmed death receptor 1(PD-1)/programmed death ligand 1(PD-L1)inhibitors for non-small cell lung cancer.Methods Randomized controlled trials of compound Kushen injection combined with PD-1/PD-L1 inhibitors for the treatment of non-small cell lung cancer were searched from PubMed,Embase,Cochrane Library,CNKI,VIP,Wanfang,and SinoMed from the establishment of databases to June 23,2025.According to the inclusion and exclusion criteria,the Cochrane bias risk assessment tool was used for quality evaluation,and Revman 5.4 was used for statistical analysis.Results A total of 6 articles were included,including 520 patients.The Meta-analysis results showed that compared with PD-1/PDL1 inhibitor treatment group,compound Kushen injection combined with PD-1/PD-L1 inhibitor treatment group could effectively improve the objective response rate(RR=1.66,95%CI:1.36~2.03,P<0.001),disease control rate(RR=1.24,95%CI:1.08~1.42,P=0.002),and KPS(MD=5.66,95%CI:2.22~9.09,P=0.001).The combination therapy also showed some improvement in overall survival,progression-free survival,disease-free survival,and two-year survival rate.In terms of safety,the combination therapy significantly reduced the overall incidence of adverse reactions,the incidence of gastrointestinal reactions(RR=0.83,95%CI:0.70~0.98,P=0.03),and the incidence of bone marrow suppression(RR=0.64,95%CI:0.53~0.77,P<0.001)in patients with NSCLC.Conclusion Compound Kushen injection combined with PD-1/PD-L1 inhibitors can improve the efficacy of non-small cell lung cancer and has good safety.
作者
曹康迪
李铮
王家伟
王学谦
侯炜
CAO Kangdi;LI Zheng;WANG Jiawei;WANG Xueqian;HOU Wei(Graduate School,Beijing University of Chinese Medicine,Beijing 100029,China;Department of Oncology,Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China)
出处
《中医肿瘤学杂志》
2025年第5期113-122,共10页
Journal of Oncology in Chinese Medicine
基金
国家重点研发计划“中医药现代化”重点专项(编号:2023YFC3503300,2023YFC3503301)
中央高水平中医医院临床科研业务费项目(编号:HLCMHPP2023034,HLCMHPP2023085)
中国中医科学院广安门医院护航工程-骨干人才培育项目(编号:GAMHH9324016)。
