目的:系统评价康莱特注射液联合放疗用于非小细胞肺癌(NSCLC)的疗效和安全性,以为临床提供循证参考。方法:计算机检索PubMed、Cochrane图书馆、EMBase、中文科技期刊数据库、中国期刊全文数据库、万方数据库和中国生物医学文献数据库,收集康莱特注射液联合放疗用于NSCLC疗效和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并采用改良后的Jadad量表进行质量评价,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入9项RCT,合计561例患者。Meta分析结果显示,康莱特注射液联合放疗能显著提高有效率[OR=2.99,95%CI(2.07,4.31),P<0.001]、生存质量改善率[OR=3.74,95%CI(2.36,5.92),P<0.001]和降低放射性肺炎发生率[OR=0.23,95%CI(0.12,0.47),P<0.001]、放射性食管炎发生率[OR=0.10,95%CI(0.05,0.21),P<0.001],与单纯放疗比较差异均有统计学意义。结论:康莱特注射液联合放疗用于NSCLC的疗效和安全性均优于单纯放疗。
Abstract
OBJECTIVE: To systematically review the efficacy and safety of Kanglaite injection combined with radiothreapy in the treatment of the non-small cell lung cancer (NSCLC), and provide evidence-based reference for clinical treatment. METHODS: Retrieved from PubMed, Cochrane Library, EMBase, VIP, CJFD,Wanfang database and CBM, randomized controlled trials (RCT) about the efficacy and safety of Kanglaite injection combined with radiothreapy in the treatment of NSCLC were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extraction and quality evaluation with modified Jadad scale. RESULTS: Totally 9 RCTs were included, involving 561 patients. Results of Meta-analysis showed, Kanglaite injection combined with radiothreapy can significantly improve the effective rate [OR=2.99,95%CI(2.07,4.31),P<0.001] and improvement rate of life quality [OR=3.74,95%CI(2.36,5.92),P<0.001], and reduce the incidence of radiation pneumonitis [OR=0.23,95%CI(0.12,0.47),P<0.001] and radiation esophagitis [OR=0.10,95%CI(0.05,0.21),P<0.001] of NSCLC patients, the differences were statistically significant. CONCLUSIONS: Both the efficacy and safety of Kanglaite injection combined with radiothreapy in the treatment of NSCLC are superior to radiothreapy alone.