BCG低剂量与标准剂量治疗NMIBC有效性和安全性的Meta分析

Efficacy and safety of low dose and standard dose bacillus calmette guerin vaccine for non-muscle invasive bladder cancer:a meta-analysis

目的比较卡介苗(BCG)低剂量与标准剂量灌注治疗非肌层浸润性膀胱癌(NMIBC)的有效性和安全性。方法在PubMed、EMbase、The Cochrane Library、Web of Science、CNKI、万方数据库、重庆维普网和中国生物医学文献服务系统中检索,比较BCG低剂量与标准剂量灌注治疗NMIBC的随机对照试验,检索时限为建库至2020年11月23日。根据纳入和排除标准由两位研究者独立进行文献筛选、资料提取和方法学质量评价后,采用Stata 15.1软件进行Meta分析。结果共纳入13项随机对照试验,样本量2903例。在有效性方面:低剂量组的肿瘤进展生存风险较标准剂量组无明显统计学差异(HR=1.09,95%CI=0.86~1.38),低剂量组的肿瘤复发生存风险较标准剂量组高(HR=1.21,95%CI=1.06~1.39)。在安全性方面:低剂量组总不良反应(RR=0.64,95%CI=0.51~0.80)、全身不良反应(RR=0.67,95%CI=0.47~0.95)以及严重不良反应(RR=0.51,95%CI=0.35~0.73)的发生率均较标准剂量组低,局部不良反应在两组间无明显统计学差异。结论应用标准剂量的BCG诱导+维持治疗可以减少NMIBC术后复发,低剂量BCG治疗在有效性方面存在不足,但可降低毒性。建议针对不同危险程度的患者进行研究,以确定BCG最佳的使用方法。

Objective To compare the efficacy and safety between low dose Bacillus Calmette Guerin Vaccine(BCG)(low dose group)and standard dose BCG(standard dose group)in the treatment of non-muscle invasive bladder cancer(NMIBC).Methods In PubMed,Embase,The Cochrane Library,Web of Science,CNKI,Wanfang database,CQVIP and CBM database,we searched randomized controlled trials comparing low-dose versus standard-dose BCG in the treatment of NMIBC from the establishment of the database to November 23rd,2020.Stata 15.1 software was used for meta-analysis.Results A total of 13 randomized controlled trials with a total sample size of 2903 were included in this study.In terms of efficacy,the risk of tumor progression in the low dose group was not significantly different from that in the standard dose group(HR=1.09,95%CI=0.86-1.38),but the risk of tumor recurrence in the low dose group was higher than that in the standard dose group(HR=1.21,95%CI=1.06-1.39).In terms of safety,the incidence of total adverse reactions,systemic adverse reactions and severe adverse reactions in the low dose group were lower than those in the standard dose group(RR=0.64,95%CI=0.51-0.80;RR=0.67,95%CI=0.47-0.95;RR=0.51,95%CI=0.35-0.73),but there was no significant difference in local adverse reactions between the two groups.Conclusions The use of standard dose BCG induction and maintenance therapy can reduce the recurrence of NMIBC after surgery,while low dose BCG therapy can reduce the toxicity.However,the effectiveness of low dose BCG therapy is insufficient.Large sample randomized controlled studies of patients with different risk levels are needed to determine the best use of BCG.