卡介菌多糖核酸注射液治疗扁平疣的系统评价及试验序贯分析  

Meta-analysis and trial sequential analysis of BCG Polysaccharide Nucleic AcidInjection in treatment of verruca plana

作　　者：张志清 谢宁 周云喜 张振贤 务勇圣 颜冬兰 ZHANG Zhiqing;XIE Ning;ZHOU Yunxi;ZHANG Zhenxian;WU Yongsheng;YAN Donglan(Jiuzhitang Co.,Ltd.,Beijing 100020,China;Hunan Siqi Biological Pharmaceutical Co.,Ltd.,Changsha 410331,China;Key Laboratory of Glycopeptides of Heilongjiang Province,Mudanjiang 157000,China)

机构地区：[1]九芝堂股份有限公司,北京100020 [2]湖南斯奇生物制药有限公司,湖南长沙410331 [3]黑龙江省糖肽类药物重点实验室,黑龙江牡丹江157000

出　　处：《药物评价研究》2023年第9期1997-2005,共9页Drug Evaluation Research

基　　金：湖南创新型省份建设专项(2020SK2043)。

摘　　要：目的 系统评价卡介菌多糖核酸注射液(BCG-PSN)治疗扁平疣的有效性及安全性。方法 检索中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库(Wanfang Data)、中国生物医学文献数据库(CBM)和英文数据库Science Direcct、PubMed、Web of Science,从建库到2023年5月国内外发表的BCG-PSN治疗扁平疣的临床随机对照试验(RCT),利用Note Express文献管理软件筛选文献,采用数据提取表提取资料并评价其质量,最后采用Rev Man 5.1软件及TSA v0.9软件进行Meta分析。结果 共纳入14项RCTs,包括患者1 258例。Meta分析结果显示:肌肉注射卡介菌多糖核酸治疗扁平疣的痊愈率[RR=1.62,95%CI(1.41,1.87),P<0.000 01]和有效率[RR=1.17,95%CI(1.12,1.22),P<0.000 01]均高于对照组,复发率[RR=0.34, 95%CI (0.21, 0.56), P<0.000 1]和不良反应发生率[RR=0.67,95%CI(0.54,0.84),P=0.000 6]均低于对照组。试验序贯分析结果显示,BCG-PSN治疗扁平疣的痊愈率证据安全可靠。结论 肌肉注射BCG-PSN治疗扁平疣有良好的临床疗效,且安全性良好。Objective To evaluate the efficacy and safety of BCG Polysaccharide Nucleic Acid Injection(BCG-PSN)in the treatment of verruca plana.Methods The databases of CNKI,Wanfang Data,VIP,CBM,PubMed,Web of Science and Science Direct were searched,limited the clinical randomized controlled trials(RCT)of BCG-PSN for the treatment of verruca plana published at home and abroad from the establishment of the database to May 2023.Note Express was used to screen the literature according to the inclusion and row criteria,and data extraction table was used to extract data and evaluate its quality.Finally,the Rev Man 5.1,and TSA v0.9 software was used to Meta-analyze.Results A total of 14 RCTs were included,including 1258 patients.Meta-analysis results showed that intramuscular injection of BCG-PSN in the treatment of verruca plana showed a higher recovery rate[RR=1.62,95%CI(1.41,1.87),P<0.00001]and effective rate[RR=1.17,95%CI(1.12,1.22),P<0.00001]than the control group,the intramuscular injection of BCG polysaccharide nucleic acid can also reduce the recurrence rate[RR=0.34,95%CI(0.21,0.56),P<0.0001]and the incidence of adverse reactions[RR=0.67,95%CI(0.54,0.84),P=0.0006].The sequential analysis of experiments results showed that the recovery rate of BCG-PSN was reliable.Conclusions The intramuscular injection of BCG BCG-PSN has good efficacy and safety in the treatment of verruca plana,which can provide evidence for future clinical use.

关 键 词：卡介菌多糖核酸注射液 扁平疣 随机对照试验 META分析 试验序贯分析 

分 类 号：R986[医药卫生—药品] R969.3[医药卫生—药学]