艾迪莎治疗轻中度溃疡性结肠炎的有效性及安全性的Meta分析  

Efficacy and safety of Etiasa for treatment of mild-to-moderate ulcerative colitis:A Meta-analysis

作　　者：凌方梅 陆斐楠 王胜难 朱良如[1] Fang-Mei Ling;Fei-Nan Lu;Sheng-Nan Wang;Liang-Ru Zhu(Division of Gastroenterology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,Hubei Province,China;dMed Biopharmaceutical Co.,Ltd.,Shanghai 201210,China;Department of Prevention and Control of Chronic Infectious Diseases,Shanghai Putuo District Center for Disease Control and Prevention,Shanghai 200333,China)

机构地区：[1]华中科技大学同济医学院附属协和医院消化内科,湖北省武汉市430022 [2]缔脉生物医药科技(上海)有限公司,上海市201210 [3]上海市普陀区疾病预防控制中心,上海市200333

出　　处：《世界华人消化杂志》2021年第15期880-892,共13页World Chinese Journal of Digestology

基　　金：国家重点研发计划,No.2018YFC0114604;国家自然科学基金,NO.81873558.

摘　　要：背景近年来,我国溃疡性结肠炎病例数迅猛增加,艾迪莎治疗轻中度溃疡性结肠炎的有效性及安全性需要高质量的科学证据进行评估,既往的Meta分析存在一定缺陷,需采用更加严格的循证医学方法进行分析.目的系统性地分析评价艾迪莎(美沙拉嗪缓释颗粒)治疗中国成人轻中度溃疡性结肠炎的有效性及安全性.方法检索中国生物医学文献数据库(SinoMed)、中国知网(China National Knowledge Infrastructure,CNKI)、万方数据资源系统、Medline,Embase和The Cochrane Central Register of Controlled Trials数据库,检索公开发表的艾迪莎治疗中国成人诊断为轻中度UC有效性及安全性的RCT文献.采用R和Stata/SE 8.0统计软件进行Meta分析.使用Egger’s回归对称性检验评价(统计显著性标准为0.1)评估研究的发表偏倚.同时进行敏感性分析探讨基线病情严重程度和文献质量对终点指标的影响.结果本次研究自六个数据库中共检索出828篇文献,最终纳入用于有效性分析的文献9篇,用于安全性分析的文献24篇.结果显示,艾迪莎组的总有效率明显优于对照组柳氮磺吡啶组,其差异具有统计学意义(risk difference,RD),(RD=0.18,95%CI:0.10-0.25,P<0.0001).艾迪莎组的缓解率明显优于对照组,其差异具有统计学意义(RD=0.20,95%CI:0.12-0.27,P<0.0001).剔除总有效率差值最大的文献,剩余文献关于总有效率的差值的异质性不显著,且Meta分析结果依旧显示艾迪莎组的总有效率明显优于对照组,其差异具有统计学意义(RD=0.13,95%CI:0.08-0.18,P<0.0001).在Jadad评分3分或2分(不含盲态评分)的亚组中,艾迪莎组的总有效率仍明显优于对照组,其差异具有统计学意义(Jadad=2分:RD=0.19,95%CI:0.10-0.28,P<0.0001;Jadad=3分:RD=0.11,95%CI:0.06-0.16,P<0.0001).对于只包含轻中度UC患者的6篇文献,艾迪莎组的总有效率明显优于对照组,其差异具有统计学意义(RD=0.17,95%CI:0.06-0.27,P<0.0001).6项艾迪莎与SABACKGROUND In recent years,the incidence of ulcerative colitis has increased rapidly in China,and the efficacy and safety of Etiasa in treating mild-to-moderate ulcerative colitis require high quality scientific evidence for evaluation.Thus,a more rigorous evidence-based study is needed.AIM To systematically evaluate the efficacy and safety of Etiasa(mesalazine sustained-release granules)in the treatment of mild-to-moderate ulcerative colitis(UC)in Chinese adults.METHODS An electronic search was performed using the Chinese databases including SinoMed,China National Knowledge Infrastructure(CNKI),and Wanfang Data,and the English databases including Medline,Embase,and the Cochrane Central Register of Controlled Trials for the published RCT literature on the efficacy and safety of Etiasa in the treatment of Chinese adults diagnosed with mild-to-moderate UC.Meta-analysis was carried out by using R and Stata/SE 8.0 statistical software.Egger’s regression symmetry test evaluation(statistical significance criterion was 0.1)was used to assess publication bias.Sensitivity analysis was carried out to explore the influence of baseline severity and literature quality on end-point indexes.RESULTS A total of 828 articles were retrieved from six databases.Of these,9 studies were eventually included for efficacy analysis,and 24 for safety analysis.The results showed that the total effective rate of the Etiasa group was significantly higher than that of the control group(risk difference[RD]=0.18,95%CI:0.10-0.25,P<0.0001).The remission rate of the Etiasa group was significantly higher than that of the control group(RD=0.20,95%CI:0.12-0.27,P<0.00001).Excluding the literature with the largest difference in total effective rate,the difference in total effective rate in the remaining literature was not significantly heterogeneous,and Meta-analysis results still showed that the total effective rate of the Etiasa group was significantly better than that of the control group(RD=0.13,95%CI:0.08-0.18,P<0.0001).In the subgroups of Jadad s

关 键 词：溃疡性结肠炎 艾迪莎 有效性 META分析 

分 类 号：R574.62[医药卫生—消化系统]