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阿维 A 治疗抗疟药难治/不耐受盘状红斑狼疮:一项前瞻性、开放标签、非对照研究。

Acitretin treatment in antimalarial-refractory/intolerant discoid lupus erythematosus: A prospective, open-label, uncontrolled study.

机构信息

Faculty of Medicine, Division of Dermatology, Department of Internal Medicine, 37686Chiang Mai University, Thailand.

出版信息

Lupus. 2022 Apr;31(5):575-581. doi: 10.1177/09612033221086878. Epub 2022 Mar 20.

DOI:10.1177/09612033221086878
PMID:35306922
Abstract

BACKGROUND

The treatment of discoid lupus erythematosus (DLE) is often challenging, especially in patients who are refractory or intolerant to topical treatments and first-line systemic drugs, specifically antimalarial drugs. Although acitretin has been shown to be effective in patients with DLE in a few studies, there is no published study describing the long-term efficacy of acitretin with a validated score.

OBJECTIVES

To evaluate the efficacy and safety of acitretin in patients with antimalarial-refractory/intolerant DLE.

METHODS

A prospective, open-label, uncontrolled study was conducted in patients with antimalarial-refractory/intolerant DLE. All patients were treated with an initial dosage of 10 mg acitretin daily. Clinical response was assessed using the Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) at weeks 4, 8, 12, and 24. Acitretin was increased to 25 mg daily unless an adequate response was achieved at week 8.

RESULTS

Fourteen patients were recruited. Of these, 10 were antimalarial-refractory and four were antimalarial-intolerant. The acitretin therapy was discontinued in one patient after 20 weeks of treatment because of active systemic disease. Of the 13 remaining patients, the mean RCLASI activity scores declined from 21 ± 9 at baseline to 9 ± 4 at week 24. A significant reduction in RCLASI was initially observed at week four and consistently noted at each follow-up visit ( ≤ 0.01). At the end of the study, a marked response was achieved in approximately 80% of patients. There were no statistically significant differences in the clinical response or in the requirement of the up-dosing of acitretin between the refractory and intolerance groups ( = 0.88 and = 0.326, respectively). Age ≥50 years old, female sex, and generalized DLE were the favorable prognostic factors. No serious adverse events were noted.

CONCLUSIONS

Acitretin appears to be an effective treatment with acceptable safety profiles for antimalarial-refractory/intolerant DLE.

摘要

背景

盘状红斑狼疮(DLE)的治疗常常具有挑战性,尤其是对于那些对局部治疗和一线全身药物(特别是抗疟药物)耐药或不耐受的患者。虽然已有研究表明阿维 A 酯在 DLE 患者中有效,但尚无研究描述用经过验证的评分系统评估阿维 A 酯的长期疗效。

目的

评估阿维 A 酯治疗抗疟药物耐药/不耐受的 DLE 的疗效和安全性。

方法

对 14 例抗疟药物耐药/不耐受的 DLE 患者进行前瞻性、开放标签、非对照研究。所有患者初始剂量为 10 mg 阿维 A 酯/d。在第 4、8、12 和 24 周时,采用修订后的皮肤狼疮红斑疾病面积和严重程度指数(RCLASI)评估临床反应。除非在第 8 周时获得足够的反应,否则将阿维 A 酯剂量增加至 25 mg/d。

结果

共纳入 14 例患者,其中 10 例为抗疟药物耐药,4 例为抗疟药物不耐受。1 例患者在 20 周的治疗后因活动性全身性疾病而停用阿维 A 酯。在其余 13 例患者中,平均 RCLASI 活动评分从基线时的 21 ± 9 降至 24 周时的 9 ± 4。在第 4 周时,RCLASI 显著降低,并且在每次随访时均观察到这种变化( ≤ 0.01)。在研究结束时,大约 80%的患者获得了明显的反应。在耐药和不耐受组之间,临床反应或需要增加阿维 A 酯剂量方面没有统计学差异( = 0.88 和 = 0.326,分别)。年龄≥50 岁、女性和广泛性 DLE 是有利的预后因素。未观察到严重不良事件。

结论

阿维 A 酯似乎是一种有效且安全的治疗方法,可用于治疗抗疟药物耐药/不耐受的 DLE。

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引用本文的文献

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Cutaneous Lupus Erythematosus: An Update on Pathogenesis and Future Therapeutic Directions.皮肤红斑狼疮:发病机制及未来治疗方向的最新进展。
Am J Clin Dermatol. 2023 Jul;24(4):521-540. doi: 10.1007/s40257-023-00774-8. Epub 2023 May 4.
2
An update on the management of refractory cutaneous lupus erythematosus.难治性皮肤红斑狼疮的治疗进展
Front Med (Lausanne). 2022 Sep 23;9:941003. doi: 10.3389/fmed.2022.941003. eCollection 2022.