塞来昔布预防卡培他滨所致手足综合征的Meta分析及GRADE证据质量评价  

Meta-analysis of Celecoxib for Preventing Hand-foot Syndrome Caused by Capecitabine and Quality Evaluation of GRADE Evidence

作　　者：韩梅[1] 葛明 刘月娥[3] Han Mei;Ge Ming;Liu Yuee(Department of Pharmacy,Kailuan General Hospital,Hebei Tangshan 063001,China;Tang-shan Hongci Hospital;People’s Hospital of Zunhua)

机构地区：[1]开滦总医院药剂科,河北唐山063001 [2]唐山弘慈医院 [3]河北省遵化市人民医院

出　　处：《中国药师》2020年第8期1587-1591,共5页China Pharmacist

基　　金：2018年河北省医学科学研究重点课题计划项目(编号:20181445)。

摘　　要：目的:系统评价塞来昔布防治卡培他滨所致手足综合征(HFS)的有效性和安全性,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、Embase、the Cochrane Library、VIP、Wan Fang Data和CNKI数据库,搜集加用塞来昔布(试验组)对比安慰剂或维生素B6(对照组)预防卡培他滨相关HFS的随机对照试验(RCT),检索时限均为建库至2019年5月。两名研究者独立进行文献筛选、数据提取和偏倚风险评价后,采用Rev Man 5.3软件进行Meta分析,并采用GRADE profile 3.6软件对结果证据质量进行评价。结果:共纳入9个RCT,共计592例患者。Meta分析结果显示,试验组HFS的总发生率[OR=0.41,95%CI(0.29,0.60),P<0.00001]、2级HFS发生率[OR=0.53,95%CI(0.32,0.88),P=0.01]、3级HFS发生率[OR=0.27,95%CI(0.11,0.68),P=0.005]均低于对照组,差异均有统计学意义。试验组的1级HFS发生率与对照组比较降低不明显,两组的差异无统计学意义[OR=0.66,95%CI(0.44,1.00),P=0.05]。GRADE证据质量评价结果显示,HFS总发生率,1、2级HFS发生率均为高级证据质量,3级HFS发生率为中级证据质量。结论:当前证据显示,塞来昔布能有效预防卡培他滨相关HFS,可降低HFS的总发生率和2级、3级HFS发生率。Objective: To evaluate the efficacy and safety of celecoxib for preventing hand-foot syndrome( HFS) caused by capecitabine and quality evaluation of GRADE evidence to provide reference for clinical use. Methods: PubMed,Embase,the Cochrane Library,CNKI,Wan Fang Date and VIP database were electronically searched to collect the randomized controlled trials( RCTs) about celecoxib( the experimental group) versus the control group for preventing HFS. Two reviewers independently screened the literature,extracted the data and assessed the risk of bias of the included studies. Rev Man 5.3 software was used for Meta-analysis.GRADE quality of evidence grading system was used to assess the evidence quality of outcome indices. Results: A total of 9 RCTs involving 592 patients were included. The results of Meta-analysis showed that celecoxib group was lower than the control group in the total incidence of HFS( OR = 0.41,95%CI 0.29 to 0.60,P<0.000 01),grade Ⅱ HFS( OR = 0.53,95%CI 0.32 to 0.88,P = 0.01) and grade Ⅲ HFS( OR = 0.27,95%CI 0.11 to 0.68,P = 0.005),and the difference was with statistical significance. However,there was no statistical significance in the incidence of grade Ⅰ HFS between the two groups( OR = 0.66,95%CI 0.44 to 1.00,P = 0.05). The results of grade evidence quality evaluation showed that the total incidence of HFS and the incidence of grade Ⅰ/Ⅱ HFS were high,and grade Ⅲ was moderate as assessed by GRADE-quality of evidence system.Conclusion: Current evidence suggests that celecoxib is effective in preventing HFS caused by capecitabine,and can reduce the total incidence of HFS and that of grade Ⅱ/Ⅲ HFS.

关 键 词：塞来昔布 手足综合征 预防 META分析 GRADE证据 质量评价 

分 类 号：R971.1[医药卫生—药品]