不同剂量吉非替尼治疗晚期非小细胞肺癌的系统评价  

Different dose of Gefitinib in the treatment of advanced non-small cell lung cancer:a systematic review

作　　者：段惠洁[1] 雷钟[2] 刘春玲[1] 王秀丽[1] 

机构地区：[1]新疆医科大学附属肿瘤医院内二科,乌鲁木齐830011 [2]新疆医科大学附属肿瘤医院麻醉科,乌鲁木齐830011

出　　处：《新疆医科大学学报》2013年第1期95-103,共9页Journal of Xinjiang Medical University

摘　　要：目的系统评价口服不同剂量吉非替尼治疗晚期非小细胞肺癌的临床疗效与安全性。方法计算机检索MEDLINE(1966年-2012年2月)、EMBASE(1984年-2012年2月)、OVID(1980年-2012年2月)、Co-chrane图书馆(2012年第2期)、PubMed(1966年1月-2012年2月)、中国生物医学文献光盘数据库(1980年-2012年2月)、CNKI(1994年-2012年2月)、万方数据库。手工检索中文文献。收集口服吉非替尼500mg/d(试验组)对比250mg/d(对照组)治疗晚期非小细胞肺癌的随机对照和半随机对照试验,并评价纳入研究的方法学质量。结果共纳入临床随机对照试验(RCT)4篇,共1 848例患者。结果显示:与对照组相比,试验组未能延长中位生存时间和肿瘤进展时间。Meta分析表明,两组1年生存率差异无统计学意义[RR=0.93,95%CI(0.77,1.13),P=0.48],总体反应率差异无统计学意义[RR=0.98,95%CI(0.79,1.21),P=0.83]。与对照组相比,试验组治疗后皮肤和消化道不良反应明显增多,且差异有统计学意义。两组治疗后全身乏力、造血系统抑制和肺部不良事件的发生差异无统计学意义。结论应用吉非替尼治疗晚期非小细胞肺癌时加大剂量未能取得更好的临床疗效;皮肤和消化道等不良反应会随着药物剂量的增加而增加。选择大剂量吉非替尼治疗晚期非小细胞肺癌的有效性和安全性尚缺乏临床数据,还需大样本临床随机对照研究加以证实。Objective To evaluate clinical efficacy and safety of oral different dose of gefitinib for treatment of advanced non-small cell lung cancer systematically. Methods We searched MEDLINE （1966--2012.2）, EMBASE （1984--2012.2）, OVID database （1980--2012.2）, the Cochrane Library （issue 2012）, PubMed （1966.1--2012. 2）, Chinese Biomedical CD database of literature （1980--2012. 2）, the CNKI （1994-- 2012.2）, Wanfang data library. Hand searches of Chinese literature. Collecting oral gefitinib contrast oral gefitinib 500 mg/day versus 250 mg/day in the treatment of advanced non-small cell lung cancer, a ran domized and quasi-randomized controlled trials, and to evaluate the methodological quality of included studies. Statistical software provided by the Cochrane Collaboration Network RevMan 4.2.8. Results Total 4 articles into clinical randomized controlled trials, 1 848 patients were included. It showed that com pared with cintrol group, test group failed to extend median survival time and time to progression. Meta a nalysis showed that the comparison of two groups 1-year survival rate, the difference was not statistically significant ~RR 0.93,95 CI （0.77,1.13）, P =0. 481; the overall response rate, the difference was not sta- tistically significant [RR 0.98, 95 CI （0.79,1.21）, P =0.83]. Compared with control group, test group in the treatment of skin and gastrointestinal adverse reactions increased sharply, and statistically signifi cant differences. Two groups in malaise, hematopoietic system suppression after treatment and pulmonary adverse events occurrede that the differences has not statistical significance. Conclusion Use of gefitinib in the treatment of advanced non-small cell lung cancer can increase dose failed to obtain a better clinical curative effect; The skin and gastrointestinal adverse effects will increase as the dose increases. Selection of a large dose of gefitinib in the treatment of advanced non-small cell lung cancer is lack of clinical data of effectiveness and saf

关 键 词：非小细胞肺癌 吉非替尼 随机对照试验 系统评价 

分 类 号：R730.53[医药卫生—肿瘤]