Siponen M, Huuskonen L, Kallio-Pulkkinen S, Nieminen P, Salo T
Institute of Dentistry, University of Oulu, Oulu, Finland.
Cancer and Translational Medicine Research Unit, University of Oulu, Oulu, Finland.
Oral Dis. 2017 Jul;23(5):660-668. doi: 10.1111/odi.12653. Epub 2017 Mar 31.
To carry out a double-blind randomized controlled trial (RCT) to compare the effectiveness of topical tacrolimus (TAC), triamcinolone acetonide (TRI), and placebo (PLA) in symptomatic oral lichen planus (OLP).
A clinical score (CS, range 0-130) was developed to measure the clinical signs and symptoms of OLP. Twenty-seven OLP patients with a CS of ≥20 were randomly allocated to receive 0.1% TAC ointment (n = 11), 0.1% TRI paste (n = 7), or Orabase paste as PLA (n = 9) for 3 weeks. If the CS dropped ≥20% (interpreted as response), the patients continued the same medication for another 3 weeks. If the CS dropped <20% or increased (non-response), the patients were switched to TAC for 6 weeks. A 6-month follow-up period ensued. The primary outcome variable was the change in CS from baseline to week 3. In primary outcome analysis, CS values between the treatment arms were compared.
Tacrolimus and TRI were more effective (P = 0.012 and 0.031, respectively) than PLA in reducing the CS at week 3. No difference in the efficacy was noted between TAC and TRI (P = 0.997).
This pilot RCT provides evidence for the effectiveness of TAC and TRI over PLA in the management of OLP.
开展一项双盲随机对照试验（RCT），比较外用他克莫司（TAC）、曲安奈德（TRI）和安慰剂（PLA）治疗有症状口腔扁平苔藓（OLP）的有效性。
制定了一个临床评分（CS，范围0 - 130）来衡量OLP的临床体征和症状。27例CS≥20的OLP患者被随机分配接受0.1% TAC软膏（n = 11）、0.1% TRI糊剂（n = 7）或作为PLA的奥拉巴糊剂（n = 9），为期3周。如果CS下降≥20%（判定为有反应），患者继续使用相同药物再治疗3周。如果CS下降<20%或升高（无反应），患者改用TAC治疗6周。随后进行6个月的随访。主要结局变量是从基线到第3周CS的变化。在主要结局分析中，比较了各治疗组之间的CS值。
在第3周时，他克莫司和TRI在降低CS方面比PLA更有效（P分别为0.012和0.031）。TAC和TRI之间的疗效无差异（P = 0.997）。
这项初步RCT为TAC和TRI在OLP治疗中比PLA更有效提供了证据。
