Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.
Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.
Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jun;129(6):585-590. doi: 10.1016/j.oooo.2020.02.014. Epub 2020 Mar 25.
The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP).
Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test.
Twenty-four patients (females n = 21; median age 64.5 years; range 45-80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58).
Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.
本单中心、开放标签、随机、二期研究的目的是评估 Mucolox 中地塞米松 0.1mg/mL 溶液（A 组）与单独使用地塞米松 0.1mg/mL 溶液（B 组）治疗口腔扁平苔藓（OLP）的安全性和疗效。
将具有临床 OLP 和视觉模拟量表（VAS）敏感性评分≥7 的患者随机分配至 A 组或 B 组。在基线和治疗结束时（4 周）完成网状/红斑/溃疡（REU）评分、VAS 敏感性评分和慢性口腔黏膜疾病问卷（COMDQ）。采用 Wilcoxon 秩和检验评估差异。
24 例患者（女性 n=21；中位年龄 64.5 岁；范围 45-80 岁）被随机分配至 A 组或 B 组。4 例患者被排除。地塞米松加或不加 Mucolox 均可有效降低 REU 评分，但含 Mucolox 的溶液效果相对更好（6 分降低 vs 4.3 分降低；P<0.001）。两组的总 COMDQ 评分均显著改善（A 组平均变化 1.8[B 组 2.5]）。两组之间的依从性无差异（P=0.58）。
与单独使用地塞米松 0.1mg/mL 溶液相比，Mucolox 中的地塞米松 0.1mg/mL 溶液更有效地治疗 OLP。需要更大的研究来证实这些初步发现。
