非肌层浸润性膀胱癌术后卡介苗诱导治疗与诱导加维持治疗效果的系统评价与Meta分析  

Efficacy of bacille Calmette-Guérin induction therapy and bacille Calmette-Guérin induction plus with maintenance therapy for postoperative non-muscle invasive bladder cancer:a systematic review and Meta-analysis

作　　者：秦丹梅[1,2] 杨晋如 李绪辉 娄佳奡 王云云 王永博 靳英辉 黄兴 曾宪涛 Qin Danmei;Yang Jinru;Li Xuhui;Lou Jia'ao;Wang Yunyun;Wang Yongbo;Jin Yinghui;Huang Xing;Zeng Xiantao(Department of Oncology,Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430061,China;Center for Evidence Based and Translational Medicine,Zhongnan Hospital of Wuhan University,Wuhan 430071,China;Department of Center of Oncology,Union Hospital Affiliated to Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Nursing Faculty,Medical College of Wuhan University of Science and Technology,Wuhan 430065,China;Department of Urology,Zhongnan Hospital of Wuhan University,Wuhan 430071,China)

机构地区：[1]湖北省中医院肿瘤科,武汉430061 [2]武汉大学中南医院循证与转化医学中心,武汉430071 [3]华中科技大学同济医学院附属协和医院肿瘤中心,武汉430022 [4]武汉科技大学医学院护理系,武汉430065 [5]武汉大学中南医院泌尿外科,武汉430071

出　　处：《中国医学前沿杂志（电子版）》2021年第10期57-66,共10页Chinese Journal of the Frontiers of Medical Science(Electronic Version)

基　　金：国家中医药管理局中医药循证能力建设项目(2019XZZX-ZL002);国家重点研发计划数字诊疗装备研发重点专项(2016YFC0106300);国家重点研发计划“科技助力经济2020”重点专项;国家发展改革委疑难病症诊治能力提升工程项目——肿瘤研究与转化平台工程项目;武汉科技大学大学生科技创新基金研究项目(20ZA071)。

摘　　要：目的评价非肌层浸润性膀胱癌(non-muscle invasive bladder cancer,NMIBC)术后卡介苗诱导治疗与卡介苗诱导加维持治疗的效果。方法计算机检索PubMed、Embase、Cochrane图书馆、Web of Science、中国知网、万方数据、维普和中国生物医学文献数据库,检索卡介苗诱导治疗与诱导加维持治疗NMIBC的随机对照试验。检索时限均为建库至2020年11月23日。由2名研究者独立筛选文献、提取资料、评价质量后,采用Stata 16.0软件进行Meta分析。结果共纳入13项随机对照试验,共计1625例患者。结果显示:与单纯卡介苗诱导治疗相比,卡介苗诱导加维持治疗降低了NMIBC术后复发生存风险(HR=0.62,95%CI:0.51~0.75,P<0.001)、进展生存风险(HR=0.71,95%CI:0.56~0.92,P=0.008)和总的肿瘤复发进展率(RR=0.78,95%CI:0.62~0.98,P=0.031)。亚组分析结果显示,无论维持治疗时间≥2年(HR=0.64,95%CI:0.51~0.80,P<0.001]还是<2年(HR=0.58,95%CI:0.40~0.84,P=0.004),均较单纯卡介苗诱导治疗对降低复发生存风险有优势;但维持治疗时间≥2年较维持治疗时间<2年对降低进展生存风险有优势(HR=0.74,95%CI:0.57~0.96,P=0.025);与维持治疗剂量>81 mg相比,维持治疗剂量≤81 mg在降低复发生存风险(HR=0.61,95%CI:0.48~0.74,P<0.001)、进展生存风险(HR=0.71,95%CI:0.54~0.93,P=0.012)和总的肿瘤复发进展率(RR=0.79,95%CI:0.68~0.92,P=0.003)方面均有优势。结论当前证据表明,与单纯卡介苗诱导治疗NMIBC相比,卡介苗诱导加维持治疗在降低复发生存风险、进展生存风险和总的肿瘤复发进展率方面均有优势,维持治疗剂量≤81 mg优于>81 mg,维持治疗时间≥2年优于<2年。Objective To evaluate the efficacy and safety of bacille Calmette-Guérin(BCG)induction therapy and BCG induction plus maintenance therapy for non-muscle invasive bladder cancer(NMIBC).Method PubMed,Embase,the Cochrane Library,Web of Science,CNKI,Wanfang Data,VIP and CBM databases were searched for randomized controlled trial(RCT)of BCG induction therapy and BCG induction plus maintenance therapy in the treatment of NMIBC.The retrieval time is from the establishment of the database to November 23,2020.Two researchers independently screened the literatures,extracted data and evaluated the quality of the original study.Stata 16.0 software was used for Meta-analysis.Result A total of 13 RCTs involving 1625 patients were included.Meta-analysis showed that compared with BCG induction therapy alone,BCG induction plus maintenance therapy reduced the survival risk of recurrence(HR=0.62,95%CI:0.51~0.75,P<0.001),the survival risk of progression(HR=0.71,95%CI:0.56~0.92,P=0.008),and the overall recurrence and progression rate(RR=0.78,95%CI:0.62~0.98,P=0.031).Subgroup analysis showed that whether the duration of maintenance treatment was≥2 years(HR=0.64,95%CI:0.51~0.80,P<0.001)or<2 years(HR=0.58,95%CI:0.40~0.84,P=0.004),BCG induction plus maintenance therapy was superior to BCG induction therapy alone in reducing the survival risk of recurrence.However,the duration of maintenance treatment≥2 years was better than that of maintenance treatment<2 years in reducing the survival risk of progression(HR=0.74,95%CI:0.57~0.96,P=0.025).Compared with maintenance treatment dose>81 mg,maintenance treatment dose≤81 mg had advantages in reducing recurrence survival risk(HR=0.61,95%CI:0.48~0.74,P<0.001),progression survival risk(HR=0.71,95%CI:0.54~0.93,P=0.012)and overall recurrence and progression rate(RR=0.79,95%CI:0.68~0.92,P=0.003).Conclusion Compared with BCG induction alone,BCG induction plus maintenance therapy has advantages in reducing the survival risk of recurrence and progression,and the overall tumor recurrence and progre

关 键 词：非肌层浸润性膀胱癌 卡介苗 维持治疗 诱导治疗 

分 类 号：R737.14[医药卫生—肿瘤]