左旋咪唑或联合中药治疗复发性阿弗他口腔溃疡的系统评价与Meta分析

目的:系统评价左旋咪唑单独用药及联合中药治疗复发性阿弗他口腔溃疡的有效性和安全性。方法:计算机检索Cochrane图书馆、PubMed、CNKI、万方数据库在线知识服务平台,纳入有关左旋咪唑及联合中药治疗复发性阿弗他口腔溃疡的随机对照试验,根据Cochrane Reviewer’s Handbook 5.0.2评价标准和工具对纳入的研究进行质量评价,并使用RevMan5.2软件进行统计分析。结果:左旋咪唑单独用药共纳入9个随机对照试验,共331例患者,治疗组有效性高于安慰剂组,其差异具有统计学意义(OR=4.92,95%CI[2.14,11.32],P=0.0002),共有46例患者出现不良反应。左旋咪唑联合中药共纳入16个随机对照试验,共1854例患者,治疗组RAU的有效性明显高于对照组,其差异具有统计学意义(OR=5.97,95%CI[4.40,8.10],P<0.00001),无不良反应报道。结论:左旋咪唑联合中药用于复发性阿弗他口腔溃疡较单独采用左旋咪唑效果更好,并且避免了左旋咪唑单独用药副作用大的缺点,具有较好的临床研究和运用前景。但本系统评价纳入研究文献质量较差,增加了本次系统评价结论产生偏倚的风险,期待有高质量的临床试验报道。

Systematic Review and Meta Analysis of Levamisole or Combined with Traditional Chinese Medicine in the Treatment of Recurrent Aphthous Ulcer.

Objective: To evaluate the effectivness and safety of levamisole in the treatment of recurrent aphthous ulcer. Methods: The databases such as Cochrane Library, PubMed, CNKI and Wanfang Data were searched by computer to include randomized controlled trails(RCTs) on levamisole in the treatment of recurrent aphthous ulcer. Studies were screened according to the inclusion and exclusion criterion. Data were extracted and the meta-analyses were performed by using RevMan 5.2 software. Results: 9 studies(331 patients) were included in the review of levamisole in treatment of RAU. The results of meta-analyses showed, compared with placebo group, levamisole was superior in improving RAU(OR=4.92,95%CI[2.14,11.32],P=0.0002). 46 patients were reported adverse reactions. 16 studies(1854 patients) were included in the review of levamisole combined with traditional chinese medicine in treatment of RAU. The results of meta-analyses showed, compared with placebo group, levamisole was superior in improving RAU(OR=4.92,95%CI[2.14,11.32],P=0.0002). No one were reported with adverse reactions. Conclusion: Current evidences show that levamisole combined with TCM is likely to be more effective and safety in the treatment of RAU than using levamisole only. However, for the limited evidence and lower methodological quality of the included studies, this conclusion still needs to be verified with more high-quality RCTs.