■症状性口腔扁平苔藓(OLP)可能具有挑战性。
■为了比较口服阿维A联合局部曲安奈德(TAC)的疗效,0.1%,TAC单药治疗有症状的OLP患者。
■这个单中心,调查员发起的,安慰剂对照,研究者和患者盲的随机临床试验于2018年12月至2020年6月在医学教育和研究研究生院进行,昌迪加尔的三级转诊中心,印度。通过连续抽样招募了64名18岁或以上有症状OLP的患者。2020年7月至12月的数据分析。
■患者随机接受口服阿维A(25-35mg/d)和TAC(治疗组)或TAC与安慰剂(安慰剂组)联合治疗28周,治疗结束后再进行8周的无治疗随访(总研究持续时间为36周)。
■使用口腔疾病严重程度评分(ODSS)评估疾病严重程度和治疗反应,口腔健康影响概况14(OHIP-14),和视觉模拟量表(VAS)。主要目的是评估两组在28周和36周结束时达到ODSS-75(与基线相比,ODSS减少75%)的患者人数。
■在64名患者中,治疗组31人和安慰剂组30人完成了研究(平均[SD]年龄,50.6[15.2]岁vs49.2[14.4]岁;男女比例,13:19vs16:16)。基线ODSS,视觉模拟量表,和口腔健康影响概况14评分在两组中具有可比性。在意向治疗分析中,在28周结束时,与安慰剂组相比,治疗组ODSS降低75%或更高的患者人数有统计学意义(28[88%]vs15[47%],组间41[95%CI,20-61]个百分点的差异;P<.001;CramérV=0.47)和36周(27[84%]vs13[41%],组间差异为43[95%CI,23-67]个百分点;P<.001;CramérV=0.47)。在治疗后随访8周期间,治疗组和安慰剂组患者的复发较低(1[3%]vs2[6%],组间差异为3[95%CI,-13至7]个百分点;P>.99;CramérV=0.07)。
■在这项随机临床试验中,对于有症状的OLP患者,口服阿维A和TAC联合治疗比TAC单药治疗更有效.
■印度临床试验注册标识符:CTRI/2018/11/016448。
Symptomatic oral lichen planus (OLP) can be challenging to treat.
To compare the efficacy of oral
acitretin plus topical triamcinolone acetonide (TAC), 0.1%, with TAC monotherapy in patients with symptomatic OLP.
This monocentric, investigator-initiated, placebo-controlled, investigator- and patient-blinded randomized clinical trial was conducted from December 2018 to June 2020 at the Postgraduate Institute of Medical Education and Research, a tertiary referral center in Chandigarh, India. Sixty-four patients 18 years or older with symptomatic OLP were recruited by consecutive sampling. Data were analyzed from July to December 2020.
The patients were randomized to receive either a combination of oral acitretin (25-35 mg/d) and TAC (treatment group) or TAC in combination with placebo (placebo group) for 28 weeks, with an additional 8 weeks of treatment-free follow-up after the end of treatment (36 weeks of total
study duration).
The disease severity and treatment response were assessed using Oral Disease Severity Score (ODSS), Oral Health Impact Profile 14 (OHIP-14), and visual analog scale (VAS). The primary aim was to assess the number of patients achieving ODSS-75 (75% reduction in ODSS compared with baseline) in both groups at 28 weeks and at the end of 36 weeks.
Among 64 patients, 31 in the treatment group and 30 in the placebo group completed the
study (mean [SD] age, 50.6 [15.2] years vs 49.2 [14.4] years; male-female ratio, 13:19 vs 16:16). Baseline ODSS, visual analog scale, and Oral Health Impact Profile 14 scores were comparable in both groups. In the intention-to-treat analysis, there was a statistically significant higher number of patients achieving 75% or higher reduction in ODSS in the treatment group compared with the placebo group at the end of 28 weeks (28 [88%] vs 15 [47%], a 41 [95% CI, 20-61] percentage point difference between groups; P < .001; Cramér V = 0.47) and 36 weeks (27 [84%] vs 13 [41%], a 43 [95% CI, 23-67] percentage point difference between groups; P < .001; Cramér V = 0.47). Relapses during the posttreatment follow-up of 8 weeks were low among patients in both treatment and placebo groups (1 [3%] vs 2 [6%], a 3 [95% CI, -13 to 7] percentage point difference between groups; P > .99; Cramér V = 0.07).
In this randomized clinical
trial, the combination of oral
acitretin and TAC was more effective than TAC monotherapy in patients with symptomatic OLP.
Clinical
Trial Registry of India Identifier: CTRI/2018/11/016448.