三乙醇胺防治放射性皮炎有效性的Meta分析及GRADE证据质量评价  

Meta-analysis of the Effectiveness of Trolamine for Preventing and Treating Radiation Dermatitis and Quality Evaluation of GRADE Evidence

作　　者：龙小庆[1] 王继生[2] 贾霖[1] 陈静[2] 楚明明 韩建军[1] 何霞[1] 曹莉莎[2] 赵德华[1] LONG Xiaoqing;WANG Jisheng;JIA Lin;CHEN Jing;CHU Mingming;HAN Jianjun;HE Xia;CAO Lisha;ZHAO Dehua(Dept. of Oncology,Mianyang Third People’s Hospital/Sichuan Mental Health Center,Sichuan Mianyang 621000,China;Dept. of Clinical Pharmacy,Mianyang Third People’s Hospital/Sichuan Mental Health Center,Sichuan Mianyang 621000,China;Dept. of Clinical Pharmacy,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)

机构地区：[1]绵阳市第三人民医院/四川省精神卫生中心肿瘤科,四川绵阳621000 [2]绵阳市第三人民医院/四川省精神卫生中心临床药学科,四川绵阳621000 [3]陆军军医大学第二附属医院临床药学科,重庆400037

出　　处：《中国药房》2019年第2期258-263,共6页China Pharmacy

基　　金：四川省应用基础研究计划项目(No.2014JY0058)

摘　　要：目的:系统评价三乙醇胺防治放射性皮炎(RD)的有效性,并评价结局指标的证据质量,为临床治疗提供参考。方法:计算机检索PubMed、Cochrane图书馆、Embase、中国知网数据库、万方数据库、维普数据库,收集三乙醇胺(试验组)对比常规护理(对照组)用于防治RD的随机对照试验(RCT),提取资料并按Cochrane偏倚风险评估工具5.0.2评价文献质量后,采用Rev Man5.3统计软件对数据进行Meta分析。采用GRADE证据质量分级系统对结局指标的证据质量进行评价。结果:共纳入7项RCT,合计782例患者。Meta分析结果显示,两组患者RD总发生率[OR=0.50,95%CI(0.23,1.11),P=0.09]、Ⅰ级RD发生率[OR=1.32,95%CI(0.96,1.81),P=0.09]、Ⅱ级RD发生率[OR=1.07,95%CI(0.80,1.42),P=0.66]、Ⅲ级RD发生率[OR=0.69,95%CI(0.45,1.04),P=0.07]、Ⅳ级RD发生率[OR=0.43,95%CI(0.17,1.05),P=0.07]比较,差异均无统计学意义。GRADE证据质量评价结果显示,两组患者RD总发生率以及Ⅱ级、Ⅳ级RD发生率为中级证据质量,Ⅰ级和Ⅲ级RD发生率为低级证据质量。结论:三乙醇胺不能用于防治RD,也不能降低RD的发生率。OBJECTIVE:To evaluate the effectiveness of trolamine for preventing and treating radiation dermatitis(RD)and evidence quality,and to provide reference for clinical use.METHODS:Retrieved from PubMed,Cochrane library,Embase,CNKI,Wanfang and VIP database,randomized controlled trials(RCTs)about trolamine(trial group)versus usual care(control group)for preventing and treating RD were collected.After data extraction,Cochrane bias risk assessment tool 5.0.2 was used to assess the bias risk,and Rev Man 5.3 statistical software was used to perform the Meta-analysis.GRADE evidence quality grading system was used to evaluate the evidence quality of outcome indexes.RESULTS:Seven RCTs were included,involving 782 patients.Results of Meta-analysis showed that there was no statistical significance in total incidence of RD[OR=0.50,95%CI(0.23,1.11),P=0.09],and the incidence of gradeⅠRD[OR=1.32,95%CI(0.96,1.81),P=0.09],gradeⅡRD[OR=1.07,95%CI(0.80,1.42),P=0.66],gradeⅢRD[OR=0.69,95%CI(0.45,1.04),P=0.07]or gradeⅣRD[OR=0.43,95%CI(0.17,1.05),P=0.07]between 2 groups.Results of Grade evidence quality evaluation showed that total incidence of RD,and the incidence of gradeⅡRD and gradeⅣRD were recommended by moderate-level evidence in 2 groups,while the incidence of gradeⅠand gradeⅢRD were recommended by low-level evidence.CONCLUSIONS:Trolamine is not effective in preventing and treating RD,and can not reduce the incidence of RD.

关 键 词：三乙醇胺 放射性皮炎 防治 有效性 META分析 GRADE证据质量评价 

分 类 号：R730.55[医药卫生—肿瘤] R818[医药卫生—临床医学]