放射治疗前使用氨磷汀对头颈部癌症患者口干症等干预效果的Meta分析和GRADE评价  

Meta-analysis and GRADE evaluation of the intervention effects of using amifostine before radiotherapy on xerostomia in patients with head and neck cancer

作　　者：卫彬彬 胡慧维 刘玉娟 孙哲[2] 衣玉丽[1] Wei Binbin;Hu Huiwei;Liu Yujuan;Sun Zhe;Yi Yuli(Nursing School ofNanchang University,Nanchang 330006,China;Dept,of Oncology,The First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]南昌大学护理学院,南昌330006 [2]南昌大学第一附属医院肿瘤科,南昌330006

出　　处：《国际口腔医学杂志》2020年第5期547-556,共10页International Journal of Stomatology

基　　金：江西省重点研发计划项目(20161BBG70069)。

摘　　要：目的评价放射治疗前使用氨磷汀对头颈部癌症患者口腔干燥等不良反应的干预效果。方法检索中国知网(CNKI)、万方数据知识服务平台、中国生物医学文献数据库(CBMdisc)、维普中文科技期刊数据库(VIP)、PubMed、Cochrane Library、EMbase、Medline,从建库至2019年7月的相关中、英文文献,所检文献由2人按照纳入、排除标准进行筛选和质量评价,应用RevMan5.3软件进行Meta分析,并以GRADE证据分级系统对结局指标的证据质量进行评价。结果最终纳入9篇随机对照试验(RCT),共948例患者。Meta分析结果显示,与对照组相比:氨磷汀减少了患者急性期[RR=0.62,95% CI(0.44,0.87),P=0.005]、放射治疗结束后6个月[RR=0.58,95% CI(0.37,0.91),P=0.02]2级以上口干,差异有统计学意义;在放射治疗结束后腺体功能指标、放射治疗结束12个月之后的晚期口干、急性黏膜炎、疾病控制、总体生存方面,差异无统计学意义(P>0.05);在不良反应恶心呕吐、低血压、过敏反应方面,不利于氨磷汀,差异有统计学意义(P<0.05)。GRADE证据质量评价结果显示,2级以上急性口干、恶心呕吐、过敏反应、局部区域控制、总体生存5个结局指标为中等质量证据,2级以上晚期口干、急性黏膜炎、低血压为低质量证据,而腺体功能指标为极低质量证据。结论放射治疗前应用氨磷汀可减少头颈部癌症患者放射治疗急性期和放射治疗结束后6个月内的中重度口干发生,但对放射治疗后腺体功能、12个月之后的晚期口干和急性黏膜炎、肿瘤治疗效果没有积极影响,且其不良反应值得关注,还需更多大样本、高质量的研究来验证本结论。Objective To evaluate the intervention effect of using amifostine before radiotherapy on xerostomia and other side effects in patients with head and neck cancer.Methods First,related studies were collected from different databases,such as China National Knowledge Infrastructure(CNKI),WanFang Data Knowledge Service Platform,China Biology Medicine disc(CBMdisc),VIP Database for Chinese Technical Periodicals(VIP),PubMed,Cochrane Library,EMbase,and Medline,from the date of their establishment to July 2019.Second,the collected studies were screened and evaluated based on inclusion and exclusion criteria.Third,meta-analysis was performed using RevMan5.3 software.Lastly,the Grading of Recommendations,Assessment,Development,and Evaluations(GRADE)evidence quality grading system was used to evaluate the evidence quality of the outcome indexes.Results A total of 948 patients were enrolled in nine randomized control trials(RCTs).The results of the meta-analysis showed that compared with the control group,amifostine reduced acute xerostomia above grade 2[risk ratio(RR)=0.62,95%CI(0.44,0.87),P=0.005],six months after the end of radiotherapy[RR=0.58,95%CI(0.37,0.91),P=0.02].No significant difference was observed in the glandular function index after the radiotherapy,advanced xerostomia 12 months after radiotherapy,acute mucositis,disease control,and overall survival(P>0.05).Amifostine caused various side effects,including nausea and vomiting,hypotension,and allergic reactions,and the difference was statistically significant(P<0.05).The results of the GRADE evidence quality evaluation indicated that 1)the five outcome indexes of acute xerostomia above grade 2,nausea and vomiting,allergic reaction,disease control,and overall survival were moderate-level evidences;2)the outcome indexes of advanced xerostomia above grade 2,acute mucositis,and hypotension were low-level evidences;and 3)the glandular function index was an extremely low-level evidence.Conclusion Using amifostine before radiotherapy can reduce moderate to severe acute

关 键 词：氨磷汀 头颈部癌症 放射治疗 

分 类 号：R739.8[医药卫生—肿瘤]