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N-乙酰半胱氨酸和己酮可可碱治疗局部卤倍他索治疗的斑秃患者的疗效、安全性、耐受性和满意度:一项三臂盲法随机对照试验。

Efficacy, safety, tolerability, and satisfaction of N-acetylcysteine and pentoxifylline in lichen planopilaris patients under treatment with topical clobetasol: A triple arm blinded randomized controlled trial.

机构信息

Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Dermatol Ther. 2022 Aug;35(8):e15639. doi: 10.1111/dth.15639. Epub 2022 Jun 24.

DOI:10.1111/dth.15639
PMID:35703373
Abstract

Lichen planoplaris (LPP) is one of the most common causes of inflammatory cicatricial alopecias. There is no definitive cure for the disease and most of the available therapeutic options can potentially lead to serious complications following their use for extended durations. In this study, we aimed to evaluate the efficacy, safety and tolerability of N-acetylcysteine (NAC) and pentoxyfillin (PTX), as adjunctive therapies, in the management of LPP. In a randomized, assessor- and analyst-blinded controlled trial, patients with proven LPP were randomly assigned to three groups of 10. Group I (the control group) received clobetasol 0.05%lotion; Group II, a combination of clobetasol 0.05% lotion and oral PTX; Group III, a combination of clobetasol lotion 0.05% and oral NAC. Lichen planopilaris activity index (LPPAI), the possible side effects, tolerability and patients satisfaction were assessed before and two and four months after the initiation of the treatments. Thirty patients, 96.7% women, with a mean age of 46.8 ± 13.3 years old, were included in the study. Four months into the treatments, the overall LPPAI and the severity and/or frequency of most of its determinants significantly decreased in all groups. In a comparison among the groups, patients who received either of the combination therapies showed more decline in their LPPAI than those receiving only clobetasol. The decline was more noticeable and statistically significant only in the NAC group. Three patients in the PTX group developed complications that were not statistically significant when compared with the other groups. There were no substantial differences in the tolerability of the treatments among the study arms. The use of oral NAC and PTX added to the therapeutic efficacy of topical clobetasol in the treatment of LPP, suggesting that they might be beneficial and safe adjuvant therapies and add to the efficacy of topical treatment without any noticeable impact on the adverse effects experienced by patients.

摘要

斑块状扁平苔藓(LPP)是最常见的炎症性瘢痕性脱发原因之一。目前尚无针对该疾病的明确治愈方法,并且大多数可用的治疗方法在长期使用后都可能导致严重的并发症。在这项研究中,我们旨在评估 N-乙酰半胱氨酸(NAC)和己酮可可碱(PTX)作为辅助疗法在 LPP 治疗中的疗效、安全性和耐受性。在一项随机、评估者和分析者盲法对照试验中,患有确诊 LPP 的患者被随机分为三组,每组 10 例。第 I 组(对照组)接受卤米松 0.05%洗剂;第 II 组,卤米松 0.05%洗剂联合口服 PTX;第 III 组,卤米松 0.05%洗剂联合口服 NAC。在开始治疗前和治疗后 2 个月和 4 个月评估斑块状扁平苔藓活动指数(LPPAI)、可能的副作用、耐受性和患者满意度。研究共纳入 30 例患者,96.7%为女性,平均年龄 46.8±13.3 岁。治疗 4 个月后,所有组的总体 LPPAI 以及其大多数决定因素的严重程度和/或频率均显著降低。在组间比较中,接受联合治疗的患者 LPPAI 的下降幅度大于仅接受卤米松治疗的患者。这种下降在 NAC 组更为明显且具有统计学意义。PTX 组的 3 例患者出现并发症,但与其他组相比无统计学意义。研究组间治疗的耐受性无明显差异。口服 NAC 和 PTX 联合卤米松治疗 LPP 可提高治疗效果,提示其可能是有益且安全的辅助治疗方法,可提高局部治疗的效果,而不会对患者的不良反应产生明显影响。

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