甲氨蝶呤与羟氯喹预防扁平苔藓性毛发扁平苔藓进展的临床疗效及安全性：一项随机临床试验
Clinical Efficacy and Safety of Methotrexate versus Hydroxychloroquine in Preventing Lichen Planopilaris Progress: A Randomized Clinical Trial.
作者信息
Naeini Farahnaz Fatemi, Saber Mina, Asilian Ali, Hosseini Sayed Mohsen
机构信息
Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Biostatics and Epidemiology, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.
出版信息
Int J Prev Med. 2017 May 25;8:37. doi: 10.4103/ijpvm.IJPVM_156_17. eCollection 2017.
BACKGROUND
Lichen planopilaris is an inflammatory cicatricial alopecia, and its management is a challenge for dermatologists. We aimed to compare the efficacy of methotrexate and hydroxychloroquine on refractory lichen planopilaris.
METHODS
In a randomized clinical trial, 29 patients were randomly allocated to receive either 15 mg methotrexate/week or 200 mg hydroxychloroquine twice a day for 6 months. Side effects, symptoms/signs, and laboratory tests were assessed periodically. Lichen Planopilaris Activity Index (LPPAI) was measured before intervention and at 2, 4, and 6 months after. The changes from baseline to the end of the study were analyzed within each group and between the two groups by per-protocol and intention-to-treat analysis.
RESULTS
After 2 months, mean (standard deviation [SD]) decrease in LPPAI in methotrexate group was significantly more than that in hydroxychloroquine group (1.68 [1.24] vs. 0.8 [0.71], respectively, = 0.047). Furthermore, after 6 months, mean (SD) decrease in LPPAI in methotrexate group was significantly higher than that in hydroxychloroquine group (3.3 [2.09] vs. 1.51 [0.91], respectively, = 0.01). The following symptoms/signs showed significant improvements in frequency and/or severity in methotrexate group after intervention: pruritus ( = 0.007), erythema ( = 0.01), perifollicular erythema ( = 0.01), perifollicular scaling ( = 0.08), spreading ( = 0.001), and follicular keratosis ( = 0.04). In hydroxychloroquine group, only erythema ( = 0.004) showed significant improvement.
CONCLUSIONS
Methotrexate was more effective than hydroxychloroquine in treating refractory lichen planopilaris.
背景
扁平苔藓性毛发角化病是一种炎症性瘢痕性脱发，其治疗对皮肤科医生来说是一项挑战。我们旨在比较甲氨蝶呤和羟氯喹对难治性扁平苔藓性毛发角化病的疗效。
方法
在一项随机临床试验中，29例患者被随机分配，分别接受每周15mg甲氨蝶呤或每日2次、每次200mg羟氯喹治疗，为期6个月。定期评估副作用、症状/体征及实验室检查结果。在干预前以及干预后2、4和6个月测量扁平苔藓性毛发角化病活动指数（LPPAI）。通过符合方案分析和意向性分析，对每组内以及两组之间从基线到研究结束的变化进行分析。
结果
2个月后，甲氨蝶呤组LPPAI的平均（标准差[SD]）下降显著大于羟氯喹组（分别为1.68[1.24]和0.8[0.71]，P = 0.047）。此外，6个月后，甲氨蝶呤组LPPAI的平均（SD）下降显著高于羟氯喹组（分别为3.3[2.09]和1.51[0.91]，P = 0.01）。干预后，甲氨蝶呤组以下症状/体征在频率和/或严重程度上有显著改善：瘙痒（P = 0.007）、红斑（P = 0.01）、毛囊周红斑（P = 0.01）、毛囊周鳞屑（P = 0.08）、扩散（P = 0.001）和毛囊角化病（P = 0.04）。在羟氯喹组，只有红斑（P = 0.004）有显著改善。
结论
在治疗难治性扁平苔藓性毛发角化病方面，甲氨蝶呤比羟氯喹更有效。
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