Xie Yulang, Xu Hao, Li Chunlei, Wang Yufeng, Lu Rui, Hua Hong, Tang Guoyao, Zhou Gang, Jin Xin, Shang Qianhui, Dan Pan, Zhang Chengli, Luo Xiaobo, Dan Hongxia, Zeng Xin, Zhou Yu, Chen Qianming
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Department of Oral Medicine, Peking University School and Hospital of Stomatology, Beijing, China.
Oral Dis. 2024 Jul;30(5):3126-3135. doi: 10.1111/odi.14746. Epub 2023 Oct 4.
This study was aimed to evaluate the safety and benefit of short-term application of hydroxychloroquine in the management of atrophic/erosive/ulcerative oral lichen planus (OLP).
This multicenter, randomized, controlled, evaluator-blinded, prospective clinical trial was performed from October 1, 2019, to September 1, 2022. A total of 99 patients were randomized to receive systemic use of hydroxychloroquine (n = 50), or topical use of 0.05% dexamethasone (n = 49) for 4 weeks. The response to both treatment modalities was evaluated according to reticulation, hyperemic, and ulceration (RHU) score and visual analog scale (VAS) score.
After 4 weeks of medication, both groups showed substantial reduction in RHU and VAS score (p < 0.05). In hydroxychloroquine group, the average of RHU score was reduced from 10.60 to 7.68 (dropped 27.49%), and the average of VAS score was reduced from 3.74 to 2.47 (dropped 34.09%). There were no differences between the two groups in reduction of RHU score and VAS score (p > 0.05). Single factor analysis found hyperemic area (p = 0.019) and erosive/ulcerative area (p = 0.024) had impacts on drug efficacy of hydroxychloroquine, and logistic regression revealed that no factors (p > 0.05) influenced its efficacy.
These findings indicate hydroxychloroquine is a safe and effective agent in treating atrophic/erosive/ulcerative OLP.
本研究旨在评估短期应用羟氯喹治疗萎缩性/糜烂性/溃疡性口腔扁平苔藓（OLP）的安全性和疗效。
本多中心、随机、对照、评估者盲法前瞻性临床试验于2019年10月1日至2022年9月1日进行。共99例患者被随机分为两组，分别接受为期4周的羟氯喹全身用药（n = 50）或0.05%地塞米松局部用药（n = 49）。根据网状、充血和溃疡（RHU）评分及视觉模拟量表（VAS）评分评估两种治疗方式的疗效。
用药4周后，两组的RHU和VAS评分均显著降低（p < 0.05）。羟氯喹组的RHU评分平均值从10.60降至7.68（下降27.49%），VAS评分平均值从3.74降至2.47（下降34.09%）。两组在RHU评分和VAS评分降低方面无差异（p > 0.05）。单因素分析发现充血面积（p = 0.019）和糜烂/溃疡面积（p = 0.024）对羟氯喹的药物疗效有影响，逻辑回归显示无因素（p > 0.05）影响其疗效。
这些研究结果表明羟氯喹是治疗萎缩性/糜烂性/溃疡性OLP的一种安全有效的药物。
