他克莫司治疗面部脂溢性皮炎的疗效和安全性：一项系统综述和荟萃分析

Efficacy and Safety of Tacrolimus in the Treatment of Facial Seborrheic Dermatitis: A Systematic Review and Meta-Analysis

摘要: 目的：对他克莫司治疗面部脂溢性皮炎的疗效和安全性进行系统评价。方法：检索Pubmed、Embase、Cochrane图书馆、美国临床试验数据库、知网、万方、CBM等数据库，纳入各数据库自建库以来至2023年4月有关他克莫司治疗面部脂溢性皮炎的随机对照试验(RCT)。纳入的随机对照试验质量通过Cochrane系统评估手册5.1.0进行评估，使用RevMan 5.4软件进行荟萃分析。结果：本研究共纳入5篇文献，共388例患有面部脂溢性皮炎的患者。研究的结果表明，与对照组相比，试验组治疗的总有效率更高(OR = 2.56, 95% CI: 1.55~4.53, P = 0.0004)，试验组与对照组的不良反应发生情况差异没有统计学意义(OR = 1.00, 95% CI: 0.29~3.41, P = 0.99)，治疗前后的临床症状积分结果试验组高于对照组(MD = 1.83, 95% CI: 1.23~2.42, P < 0.0001)，干预时间的亚组分析结果显示患者不良反应的发生与干预时间无关(OR = 1.00, 95% CI: 0.29~3.41, P = 0.99)，故猜测不良反应的发生可能与其他一些因素有关。结论：他克莫司治疗面部脂溢性皮炎的临床效果显著，可有效改善患者的临床症状，安全性较高，但未来仍需要多中心、大样本的RCT加以证实。

Abstract: Objective: To systematically evaluate the efficacy and safety of tacrolimus in the treatment of facial seborrheic dermatitis. Methods: Pubmed, Embase, the Cochrane Library, the American Clinical Trials Database, CNKI, Wanfang, CBM and other databases were searched, and randomised controlled trials (RCTs) of tacrolimus for the treatment of facial seborrheic dermatitis were included in each database from its inception until April 2023. The quality of the included randomised controlled trials was assessed by the Cochrane Handbook for Systematic Reviews 5.1.0 and meta-analyses were performed using RevMan 5.4 software. Results: A total of 388 patients suffering from facial seborrheic dermatitis were included in this study from five publications. The results of the study showed that the overall efficacy of the treatment was higher in the test group compared to the control group (OR = 2.56, 95% CI: 1.55~4.53, P = 0.0004), the difference in the incidence of adverse effects between the test group and the control group was not statistically significant (OR = 1.00, 95% CI: 0.29~3.41, P = 0.99), and the pre- and post-treatment clinical symptoms Score results of the experimental group was higher than that of the control group (MD = 1.83, 95% CI: 1.23~2.42, P < 0.0001), and the results of the subgroup analysis of the intervention time showed that the occurrence of adverse reactions in the patients was not related to the time of the intervention (OR = 1.00, 95% CI: 0.29~3.41, P = 0.99), therefore, it was speculated that the occurrence of adverse reactions may be related to some other factors. Conclusion: The clinical efficacy of tacrolimus in the treatment of facial seborrheic dermatitis is significant, which can effectively improve the clinical symptoms of patients and has a high safety profile, but it still needs to be confirmed by multicentre, large-sample RCTs in the future.