阿米福汀在局部晚期非小细胞肺癌放疗中作用的meta分析

Effect of Amifostine on Locally Advanced Non-small Cell Lung Cancer Patients Treated with Radiotherapy: A Meta-analysis of Randomized Controlled Trials

背景与目的阿米福汀(Amifostine)是否影响非小细胞肺癌(non-small cell lungcancer NSCLC)放疗疗效并降低放疗相关副反应一直存在较大争议,本研究旨在探讨阿米福汀在局部晚期NSCLC放疗近期疗效及预防放疗副反应中的作用。方法检索Medline、CENTRAL(the Cochrane central register of controlled trials)、EM-BASE、中国生物医学文献数据库系统(CBM)、中国期刊全文数据库(CNKI)、万方数据库、美国临床肿瘤学会(ASCO)、欧洲肿瘤协会(EMSO)官方网等,检索公开发表的有关局部晚期NSCLC放疗期间应用阿米福汀的随机临床对照研究。应用Stata11.0统计软件分析阿米福汀对放疗近期疗效及副反应发生率的影响。结果最终纳入9项研究,阿米福汀组患者381例,对照组388例。涉及近期疗效的研究8项,阿米福汀组患者328例,对照组333例。结果显示放疗期间接受阿米福汀治疗的患者完全缓解(completeresponse,CR)、部分缓解(partialresponse,PR)和客观缓解(objectiveresponse,OR)的相对危险度(relativerisk,RR)分别为1.16(95%CI:0.90-1.50,Z=1.07,P=0.29)、1.02(95%CI:0.87-1.19,Z=0.21,P=0.83)和1.06(95%CI:0.97-1.17,Z=1.31,P=0.20)。涉及放疗副反应研究7项,阿米福汀组患者367例,对照组371例,放疗期间接受阿米福汀治疗的患者3级-4级放射性食管炎和放射性肺炎发生的RR分别为0.51(95%CI:0.37-0.72,Z=3.88,P<0.001)和0.51(95%CI:0.26-0.99,Z=1.98,P=0.04)。结论阿米福汀可以降低NSCLC放疗中放射性食管炎和放射性肺炎的发生率,但不降低放疗的近期疗效。

Controversy exists on whether amifostine can reduce the efficacy and decrease the side effects of non-small cell lung cancer （NSCLC） treated by radiotherapy. The aim of this meta-analysis is to evaluate the efficacy and side effects of amifostine in NSCLC patients treated with radiotherapy. Methods Open published randomized controlled trials on the efficacy and side effects of amifostine in NSCLC patients treated with radio- therapy were collected from Medline, Cochrane Central Register of Controlled Trials, EMBSE, CBM, CNKI, WANFANG, American Society of Clinical Oncology, and European Society of Medical Oncology databases. The pooled efficacy and side effects of amifostine in these patients were calculated using the statistics software Stata 11.0. Results Nine trials that included 769 （381 and 388 in each arm） patients were analyzed. he pooled relative risk of complete, partial, and objective responses were 1.16 （95%CI： 0.90-1.50, Z=1.07, P=0.29）, 1.02 （95%CI： 0.87-1.19, Z=0.21, P=0.83） and 1.06 （9S%CI： 0.9%1.17, Z=1.31, P=0.20）, respectively. The side effects in seven trials including 738 （367 and 371 in each arm） patients were analyzed. The pooled relative risk of developing grades 3 to 4 esophagitis and pneumonitis were 0.51 （95%CI： 0.37-0.72, Z=3.88, P〈0.001） and 0.51 （9S%CI： 0.26-0.99, Z=1.98, P=O.04）, respectively. Conclusion Amifostine can significantly decrease the risk of developing serious esophagitis and pneumonitis without reducing the response rate in NSCLC patients treated by radiotherapy.