目的 系统评价他克莫司治疗口腔扁平苔癣患者(OLP)的有效性和安全性,以期为临床合理使用该制剂和预防不良反应发生提供决策依据。方法 计算机联合手工检索PubMed、Web of Science、The Cochrane Library、MEDLINE、中国生物医学、中国知网、维普和万方数据库,搜集中英文全文发表的他克莫司对比OLP一线治疗药物糖皮质激素的相关随机对照试验(RCT),检索时限均从建库至2016年6月。根据Cochrane系统评价方法,综合分析最终纳入的15篇文献进行系统评价及Meta分析,结局指标为总有效率、不良反应发生率和复发率。结果 最终纳入15篇文章,合计894例患者。Meta分析结果发现:他克莫司组疗效优于曲安奈德组(RR=1.55,95%CI(1.27,1.89),P〈0.000 1),卤米松组(RR=1.27,95%CI(1.16,1.39),P〈0.000 01),和氟轻松组(RR=1.33,95%CI(1.05,1.69),P=0.02),与丙酸氯倍他索组疗效差异无统计学意义(RR=1.04,95%CI(0.95,1.14),P=0.44)。停药后复发率(RR=0.72,95%CI(0.48,1.09),P=0.12)与对照组相比无统计学差异,治疗期间不良反应发生率(RR=0.70,95%CI(0.49,1.00),P=0.05)与对照组相比有统计学差异。结论 目前临床证据表明局部外用他克莫司治疗口腔扁平苔藓是一种短期临床疗效较佳的治疗方案。本系统评价纳入的文献中通过病理检查明确诊断的文献较少,结果出现选择性偏倚的可能性增大。受纳入数量和质量影响,将来还需更多更高质量RCT来验证此药物疗效和安全的可靠性。
Objects To systematically evaluate the efficacy and safety of tacrolimus and glucocorticoid for oral lichen planus( OLP), and to provide strong basis for clinical rational use of drugs and prevention of adverse reactions. Methods The Cochrane review's method was adopted through manual and computer methods--based retrieval was performed on The PubMed, Coehrane Library, MEDLINE,EMbase,CBM,VIP, CNKI and WanFang Data (from their establishment to June 2016)to collect randomized controlled trials comparing the clinical efficacy of taerolimus in treating OLP with that of glueocorticoid. The study was selected according to Cochrane system evaluation method. Fifteen literature recommended by Cochrane were used to complete the Meta analysis of total effective rate, recuirence rate and rate of adverse reaction rate. Results Fifteen trials involving 894 patients were included. The resuhs of meta-analyses showed that the total effective rate of tacrolimus was higher than that of triamcinolone acetonide (RR = 1.55,95 % CI(1.27,1.89) , P〈0.000 1 ), mometasone ( RR = 1.27,95% CI( 1.16,1.39), P〈0.000 01 ), and fluorine relaxed ( RR = 1.33,95% CI( 1.05,1.69), P = 0.02) , but there was no significant difference between the tacrolimus group and the propionate group (RR = 1.04,95 % CI(0.95,1.14) , P = 0.44). There was no significant difference between the taerolimus group and the glueocorticoid group in recurrence rate after stopping taking the drug (RR = 0. 72,95% CI( 0.48,1.09 ), P = 0.12 ), while there was a significant difference between the experimental group and the control group in adverse reaction rate (RR = 0. 70,95%CI( 0.49,1.00), P = 0.05 ) during the treatment session. Conclusion Current evidence shows that using tacrolimus to treat oral lichen planus is a short-term clinical effective plan. While the literature included with explicit diagnosis of pathological examination is comparatively less. Due to the limited quality of included studies, the possibility of