卡介菌多糖核酸治疗口腔扁平苔藓有效性和安全性的荟萃分析

目的   荟萃分析卡介菌多糖核酸治疗口腔扁平苔藓的有效性和安全性。方法   检索美国医学文献数据库、Embase、Cochrane图书馆、万方数据库、维普数据库、中国期刊全文数据库、中国生物医学文献数据库、中国临床试验注册中心、美国临床试验注册中心，搜集卡介菌多糖核酸与非卡介菌多糖核酸比较治疗口腔扁平苔藓的临床随机对照试验。筛选文献和提取有效数据后，根据Jadad质量评分法对纳入荟萃分析的文献进行评分。采用STATA 15.0统计软件进行荟萃分析、敏感性分析和发表偏倚分析。结果   6篇文献符合纳入标准，共计484例患者。荟萃分析结果显示卡介菌多糖核酸治疗组（试验组）总有效性优于非卡介菌多糖核酸治疗组（对照组）（优势比＝2.29，95％置信区间：1.57~3.35，P<0.05），复发率低于对照组（相对危险度＝0.50，95％置信区间：0.32~0.79，P<0.05），差异具有统计学意义。两组均无严重不良反应发生，且发生不良反应例数无统计学差异（相对危险度＝0.57，95％置信区间：0.19~1.71，P＞0.05）。Begg’s 检验结果显示未存在明显发表偏倚。结论  卡介菌多糖核酸治疗口腔扁平苔藓的临床效果优于对照组，且尚无严重不良反应发生，临床上值得推广应用。

Meta-analysis of the efficacy and safety of BCG polysaccharide nucleic acids in the treatment of oral lichen planus#br#

 Objective   To evaluate the efficacy and safety of BCG polysaccharide nucleic acids in the treatment of oral lichen planus by meta-analysis. Method  Nine databases (PubMed, Embase, the Cochrane Library, the Wanfang Database, Weipu Database for Chinese Technical Periodicals, the Chinese National Knowledge Infrastructure, China Biology Medicine disc, Chinese clinical trial registry and American clinical trial registry) were searched for randomized controlled trials (RCTs) about BCG polysaccharide nucleic acids (trial group) versus non-BCG polysaccharide nucleic acids treatment (control group) on oral lichen planus. RCTs,quality was assessed based on the modified Jadad scale after literature screening and data extraction were completed. Sensitivity analysis and publication bias were performed. The Meta analysis was performed with STATA 15.0 software. Results  Six RCTs including a total of 484 cases were identified. Meta analysis results showed that trial group had significantly higher total efficiency (odds ratio =2.29, 95% confidence interval：1.57~3.35, P<0.05) and lower recurrence rate(relative risk＝0.50, 95％confidence interval：0.32~0.79 , P<0.05) than control group. No serious adverse reaction was observed in both groups.There was no statistical significance in the number of adverse reaction cases between trial group and control group (relative risk＝0.57, 95％confidence interval: 0.19~1.71, P＞0.05). Begg’s test results showed that there was no significant publication bias. Conclusion  The current evidence indicates that BCG polysaccharide nucleic acids has a better therapeutic effect in oral lichen planus treatment than control group with currently no serious adverse reactions, so it is worth using in clinical treatment.