摘要
目的:系统评价康莱特注射液(KLT)联合GP化疗方案(吉西他滨+顺铂)治疗中晚期非小细胞肺癌(NSCLC)的临床作用。方法:计算机检索CNKI、WanFang Data、VIP、PubMed、Embase和Cochrane Library数据库,搜集KLT联合GP化疗方案治疗中晚期NSCLC患者的随机对照试验(RCT),检索时限均从建库至2022年2月10日,由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入14个RCT,共1 497例患者。Meta分析结果显示,对比单纯GP化疗方案,KLT联合GP化疗方案能提高总有效率[OR=1.77,95%CI(1.43,2.19),P<0.000 01]和Karnofsky功能状态(KPS)评分提高率[OR=2.46,95%CI(1.68,3.60),P<0.000 01];降低不良反应发生率:胃肠道反应[OR=0.54,95%CI(0.38,0.78),P=0.000 8]、白细胞减少[OR=0.30,95%CI(0.20,0.44),P<0.000 01]、血小板减少[OR=0.54,95%CI(0.36,0.79),P=0.002];提高免疫水平:CD4^(+)/CD8^(+)[MD=0.86,95%CI(0.36,1.36),P=0.000 8]、CD4^(+)[MD=6.59,95%CI(5.58,7.60),P<0.000 01]、CD3^(+)[MD=7.75,95%CI(5.45,10.05),P<0.000 01]。结论:当前证据显示,KLT联合GP化疗方案可提高中晚期NSCLC患者的总有效率、KPS评分提高率和免疫水平,能降低不良反应发生率,但由于受到所纳入文献数量以及研究方法学质量的限制,此结论尚需更多高质量研究予以验证。
Objective:To systematically evaluate the clinical effect of Kanglaite(KLT) injection combined with GP chemotherapy regimen(gemcitabine+cisplatin) in the treatment of intermediate and advanced non-small cell lung cancer(NSCLC).Methods:CNKI,WanFang Data,VIP,PubMed,Embase and Cochrane Library databases were electronically searched to collect randomized controlled trials(RCTs) of KLT injection combined with GP chemotherapy regimen in the treatment of patients with intermediate and advanced NSCLC from inception to February 10 th,2022.Two reviewers independently screened literature,extracted data,and assessed the risk of bias of included studies.Then,meta-analysis was performed using RevMan 5.3 software.Results:A total of 14 RCTs involving 1 497 patients were included.The results of meta-analysis showed that,compared with GP chemotherapy alone,KLT injection combined with GP chemotherapy could improve the total effective rate(OR=1.77,95%CI 1.43 to 2.19,P<0.000 01) and KPS score improvement rate(OR=2.46,95%CI 1.68 to 3.60,P<0.000 01);reduce the incidence of adverse reactions:gastrointestinal reactions(OR=0.54,95%CI 0.38 to 0.78,P=0.000 8),leucopenia(OR=0.30,95%CI 0.20 to 0.44,P<0.000 01),thrombocytopenia(OR=0.54,95%CI 0.36 to 0.79,P=0.002);improve the immune level:CD4^(+)/CD8^(+)(MD=0.86,95%CI 0.36 to 1.36,P=0.000 8),CD4^(+)(MD=6.59,95%CI 5.58 to 7.60,P<0.000 01),CD3^(+ )(MD=7.75,95%CI 5.45 to 10.05,P<0.000 01).Conclusion:Current evidence shows that KLT injection combined with GP chemotherapy can improve the total effective rate,KPS score improvement rate and immune level of patients with intermediate and advanced NSCLC,and reduce the incidence of adverse reactions,but due to the limitations of the number and methodology quality of the included literature,more high-quality studies are required to verify above conclusions.
作者
李慧
王俊彦
王萌萌
宗晓郁
郑征
王树月
陈明珠
张兴会
贾敏
沈智文
张灵健
宫建
Li Hui;Wang Junyan;Wang Mengmeng;Zong Xiaoyu;Zheng Zheng;Wang Shuyue;Cheng Mingzhu;Zhang Xinghui;Jia Min;Shen Zhiwen;Zhang Lingjian;Gong Jian(Research Group of Jian Gong on Pharmacoepidemiology and Clinical Drug Evaluation,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《药物流行病学杂志》
CAS
2022年第6期363-370,共8页
Chinese Journal of Pharmacoepidemiology
关键词
康莱特注射液
吉西他滨
顺铂
非小细胞癌
临床作用
META分析
Kanglaite injection
Gemcitabine
Cisplatin
Non-small cell lung cancer
Clinical effect
Meta-analysis
作者简介
通信作者:宫建,Tel:15840064816,E-mail:fanxing1230@163.com。
