吡美莫司治疗口腔扁平苔藓的系统评价

Effect of Pimecrolimus on Oral Lichen Planus: A Systematic Review

目的系统评价吡美莫司治疗口腔扁平苔藓的疗效及安全性。方法运用Cochrane系统评价方法,检索Cochrane图书馆临床对照试验资料库(2007年第3期)、MEDLINE(1990～2007)、EMbase(1990～2007)和中国生物医学文献数据库(1990～2007),筛选吡美莫司治疗口腔扁平苔藓的随机对照试验(RCT)和交叉设计试验,并用RevMan4.2软件进行统计分析。结果共检索到10篇相关文献,评价后纳入3个RCT,未检索到交叉设计试验。Meta分析结果显示,与曲安耐德比较,吡美莫司治疗口腔扁平苔藓并没有明显减轻患者的口腔疼痛[WMD=–0.5,95%CI(–9.77,8.77)]和明显改善患者生活质量[WMD=0.9,95%CI(–0.6,2.4)],病损面积也没有明显缩小[WMD=0.00mm2,95%CI(–0.40,0.40)];与安慰剂比较,吡美莫司治疗口腔扁平苔藓并不能明显改善患者口腔疼痛[WMD=–3.30,95%CI(–20.20,13.92)]和明显缩小病损面积[WMD=–56.57,95%CI(–134.02,20.88)],也没有明显减少用药后口腔灼痛感的发生[OR=4.98,95%CI(0.49,50.22)]。结论吡美莫司治疗口腔扁平苔藓,在减轻患者口腔疼痛、改善生活质量、缩小病损面积和减轻口腔灼痛感方面并不优于曲安耐德和安慰剂。由于本系统评价纳入的病例数仅有72例,且纳入临床试验中疗效评价指标不尽相同,因此有必要继续开展高质量、大样本、统一疗效评价指标的随机对照试验,以获得更可靠的证据。

Objective To evaluate the efficacy and safety of pimecrolimus for oral lichen planus （OLP）. Methods We searched The Cochrane Library, MEDLINE （1990 to 2007）, EMBASE （1990 to 2007）, and the Chinese Biomedicine Database （1990 to 2007） to collect parallel group randomized controlled trials （RCTs） and cross-over trials comparing pimecrolimus with triamcinolone acctonide or placebo. The Cochrane Collaboration＇s RevMan 4.2 software was used for data analyses. Results Three RCTs were included. Meta-analyses showed that pimecrolimus did not improve oral cavity ache measured by VAS （visual analogue scale） （WMD -0.5, 95%CI -9.77 to 8.77）, OHIP （oral health impact profile） （WMD 0.9, 95%CI -0.6 to 2.4） and CSS （clinical status score） （WMD 0.00 mm^2, 95%CI -0.40 to 0.40）; compared with triamcinolone acctonide. In comparison to placebo, pimecrolimus did not improve oral cavity ache measured by VAS （WMD -3.30, 95%CI -20.20 to 13.92） or CSS （WMD -56.57, 95%CI -134.02 to 20.88） and did not reduce burning sensations （OR 4.98, 95%CI 0.49 to 50.22） as well. Conclusion Pimecrolimus should not be regarded as a better choice than triamcinolone acctonide or placebo for improving the VAS, OHIP or CSS of patients with oral lichen planus. Since the RCTs available for this systematic review are too small, further high-quality large-scale RCTs with standard clinical evaluation are required to provide more reliable evidence.