沙利度胺治疗严重复发性阿弗他溃疡的系统评价

Systematic Review of Thalidomide for Severe Recurrent Aphthous Ulcer

目的:对沙利度胺治疗严重复发性阿弗他溃疡的疗效及安全性进行评价。方法:系统检索所有相关文献,根据纳入标准筛选后对纳入的研究进行严格评价和Meta分析。结果:有效性Meta分析结果显示2组的差异具有统计学意义(P<0.0001);按剂量不同进行亚组分析,较高剂量亚组Meta分析结果显示2组的差异具有统计学意义(P<0.0001);较低剂量亚组Meta分析结果显示2组的差异无统计学意义(P=0.48)。严重不良反应方面,Meta分析显示2组的差异具有统计学意义(P=0.0004);对具体不良反应分别进行Meta分析,2组发生嗜睡的差异具有统计学意义(P<0.0001);2组发生神经病变的差异无统计学意义(P=0.18);2组发生皮疹的差异具有统计学意义(P=0.0001);2组发生恶心的差异无统计学意义(P=0.15)。结论:沙利度胺可有效促进严重复发性阿弗他溃疡的愈合,但安全性较差,需严格把握适应证及剂量。

OBJECTIVE：To evaluate the therapeutic efficacy and safety of thalidomide for severe recurrent aphthous ulcer（RAU）.METHODS：All relative literatures were searched systematically and screened according to the inclusion criteria.Included studies were evaluated critically and Meta-analysis was conducted.RESULTS：Meta-analysis reveals that there was significant difference in effectiveness between 2 groups（P〈0.000 1）.By different dose,Meta-analysis of higher dose sub-group indicated there was significant difference between 2 groups（P〈0.000 1）;while lower dose sub-group indicated there was no significant difference between 2 groups（P=0.48）.There was significant difference in serious adverse drug reaction between 2 groups（P=0.000 4）;statistical significant difference was revealed in the incidence of somnolence（P〈0.000 1）and rash（P=0.000 1）;difference was not significant statistically in neuropathy（P=0.18）and nausea（P=0.15）.CONCLUSION：Thalidomide can effectively contribute to the recovery of severe RAU while it is poor in safety.It should be applied to a proper indication with appropriate dosage.