摘要
目的系统评价康莱特注射液(KLT)联合NP方案(长春瑞滨+顺铂)治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法计算机检索Pub Med、EMbase、CENTRAL、CNKI、VIP和万方数据库,查找所有关于康莱特注射液联合NP方案治疗晚期NSCLC的随机对照试验,检索时限均为建库至2016年12月。同时手工检索纳入相关文献,独立进行文献筛选、提取资料及质量评价,采用Ren Man 5.3软件进行Meta分析,GRADE系统进行证据质量评价。结果共纳入12项研究,1 143名受试者,试验组采用KLT联合NP方案治疗573例,对照组采用单纯化疗570例。Meta分析结果显示:(1)有效性,与单纯化疗相比,KLT液联合NP方案可显著提高NSCLC患者的近期疗效(RR=1.37,95%CI 1.20~1.57,P<0.000 01)、提高卡氏评分(RR=1.94,95%CI 1.64~2.29,P<0.000 01)。(2)安全性,发生白细胞、血小板下降及胃肠道不良反应风险分别降低(RR=1.37,95%CI 1.07~1.76,P=0.01;RR=1.28,95%CI 1.05~1.57,P=0.02;RR=1.26,95%CI 1.13~1.40,P<0.000 01))。基于GRADE系统分级标准,当前结局指标为2个"关键"和3个"重要",证据水平有3个结局指标为"中等",其他为"低级",推荐强度为弱推荐。结论 KLT联合NP方案与单纯化疗相比,可显著提高患者的近期疗效,改善生命质量,并降低不良反应发生风险。
Objective To evaluate the efficacy and safety of Kanglaite injection（ KLT） combined with NP（ vinorelbine ＋ cisplatin） chemotherapy for non-small cell lung carcinoma（ NSCLC）. Methods Pub Med,Embase,CENTRAL,CNKI,VIP,Wangfang databases were searched from their establishment to December 2016 for collecting eligible randomized controlled trials about KLT injection combined with NP chemotherapy for advanced NSCLC. Other relevant articles were searched by hand. Rev Man 5. 3 software was used to perform meta-analyses after the study selection,extraction and assessment of its quality,GRADE system was performed to assess the level of evidence. Results A total of 12 studies of 1 143 subjects were included. 573 patients were treated with KLT combined with NP regimen,570 patients with chemotherapy alone. Meta-analyses showed that：（1）efficacy indicator,short term effect was improved（ RR = 1. 37,95% CI 1. 20-1. 57,P 0. 000 01）; the quality of life（ KPS improvement） was much higher（ RR = 1. 94,95% CI 1. 64-2. 29,P 0. 000 01）.（2）safety indicator,decreased risk of the reducing of white blood cell（ RR = 1. 37,95% CI 1. 07-1. 76,P = 0. 01）,platelet（ RR = 1. 28,95% CI 1. 05-1. 57,P = 0. 02） and the risk of gastrointestinal adverse reaction（ RR = 1. 26,95% CI 1. 13-1. 40,P 0. 000 01））. Based on GRADE system,three evidences were at level B and others were at level C,the importance of current outcomes was 2 ＂ critical ＂ and 3 ＂ important ＂. Thus,they were of weak recommendation（ 2C）.Conclusion Compared with chemotherapy alone,KLT combined with NP chemotherapy con significantly improve the short-term effect,life quality of NSCLC patients,and decrease the risk of adverse reactions.
出处
《医学综述》
2017年第19期3931-3937,共7页
Medical Recapitulate
