中国循证医学杂志

中国循证医学杂志

羟氯喹及氯喹治疗口腔扁平苔藓有效性和安全性的 Meta 分析

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目的 系统评价羟氯喹(hydroxychloroquine,HCQ)和氯喹(chloroquine,CQ)治疗口腔扁平苔藓(oral lichen planus,OLP)的有效性和安全性。 方法 计算机检索 PubMed、The Cochrane Library、Web of Science、CNKI、CBM、VIP 和 WanFang Data 数据库,搜集 HCQ 和 CQ 治疗 OLP 的随机对照试验(randomized controlled trial,RCT),检索时限均从建库至 2018 年 9 月。由 2 名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 Meta 分析。 结果 共纳入 10 个 RCT,包括患者 726 名。Meta 分析结果显示:HCQ 和 CQ 组的临床疗效优于安慰剂组(P<0.05),但劣于口服中药组[RR=0.75,95%CI(0.69,0.82),P<0.000 01]。HCQ 和 CQ 治疗后,患者外周血 CD4+/CD8+T 细胞比值升高[MD=–0.28,95%CI(–0.44,–0.13),P=0.000 3]。HCQ 和 CQ 组不良反应发生率显著高于口服中药组[RR=11.80,95%CI(4.85,28.68),P<0.000 01],其差异有统计学意义。 结论 当前证据显示,HCQ 和 CQ 治疗 OLP 的疗效优于安慰剂,但其疗效及安全性均劣于口服中药。HCQ 和 CQ 的治疗作用可能是通过调节 CD4+/CD8+T 细胞比值,改善机体的细胞免疫功能而发挥。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of hydroxychloroquine (HCQ) and chloroquine (CQ) for oral lichen planus (OLP). Methods PubMed, The Cochrane Library, Web of Science, CNKI, CBM, VIP and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) of HCQ and CQ for OLP from inception to September, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 10 RCTs involving 726 patients were included. The results of meta-analysis showed that: HCQ or CQ were more effective than placebo (P<0.05). Nevertheless, they were inferior to orally traditional Chinese medicine (RR=0.75, 95%CI 0.69 to 0.82,P<0.000 01). In addition, the ratio of CD4+/CD8+ T cell increased significantly in peripheral blood of OLP patients after treatment with HCQ or CQ (MD=–0.28, 95%CI –0.44 to –0.13, P=0.000 3). The incidences of adverse reaction of HCQ or CQ were higher than orally traditional Chinese medicine (RR=11.80, 95%CI 4.85 to 28.68, P<0.000 01), and the difference was statistically significant. Conclusion Current evidence shows that the efficacy of HCQ or CQ for OLP were significantly superior to placebo, while inferior to orally traditional Chinese medicine. The possible therapeutic mechanism of HCQ or CQ for OLP may be related to the regulation of the ratio of CD4+/CD8+ T cells and cellular immunity of OLP patients. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 口腔扁平苔藓; 羟氯喹; 氯喹; 系统评价; Meta 分析; 随机对照试验

Key words: Oral lichen planus; Hydroxychloroquine; Chloroquine; Systematic review; Meta-analysis; randomized controlled trial

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