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比较 0.1%他克莫司软膏与 0.05%卤倍他索丙酸酯软膏作为口服羟氯喹的附加治疗在盘状红斑狼疮中的疗效。

Comparison of effectiveness of topical tacrolimus 0.1% vs topical halobetasol propionate 0.05% as an add-on to oral hydroxychloroquine in discoid lupus erythematosus.

机构信息

Department of Dermatology and Venereology, Chittagong Medical College, Chittagong, Bangladesh.

Department of Dermatology, University of Rzeszow, Rzeszow, Poland.

出版信息

Dermatol Ther. 2021 Jan;34(1):e14675. doi: 10.1111/dth.14675. Epub 2020 Dec 21.

Abstract

In recent years, calcineurin inhibitors have been used as the first line alternative to topical corticosteroids in the treatment of discoid lupus erythematosus (DLE). We aim to evaluate the efficacy and safety of topical tacrolimus 0.1% vs topical halobetasol propionate 0.05% in patients with DLE. This comparative study was carried out in the Department of Dermatology and Venereology, Chittagong Medical College Hospital (CMCH), Bangladesh between the period of July 2018 and June 2019. The change of DLE activity assessed with the cutaneous lupus erythematosus disease area and severity index was used as a primary outcome measure. The effective sample was 40 patients in each group. Both groups were similar in terms of baseline demographic and clinical characteristics. After 8 weeks of treatment, the mean total erythema score decreased significantly in both groups (in tacrolimus treated group [TTG] from 12.53 ± 8.05 to 8.03 ± 5.69, [P < .001] and in halobetasol propionate treated group [HTG] from 11.83 ± 7.17 to 7.30 ± 4.56 [P < .001]), as well as the mean total scale/hypertrophy score (in TTG from 8.08 ± 5.30 to 4.33 ± 3.21; [P < .001] and in HTG from 7.40 ± 4.73 to 3.68 ± 2.01, [P < .001]. The magnitude of reduction was significantly better in HTG [P = .032]). The mean total activity score decreased significantly in both groups (in TTG from 22.95 ± 13.40 to 14.33 ± 8.89, [P < .001] and in HTG from 22.15 ± 11.95 to 13.7 ± 7.22, [P < .001]). The present study demonstrated that tacrolimus 0.1% ointment and halobetasol propionate 0.05% ointment had a comparable efficacy in DLE patients; however, halobetasol showed significantly better improvement regarding scaly, hypertrophic lesions.

摘要

近年来,钙调神经磷酸酶抑制剂已被用作治疗盘状红斑狼疮(DLE)的一线替代药物,替代局部皮质类固醇。我们旨在评估他克莫司 0.1%软膏和卤倍他索丙酸酯 0.05%软膏治疗 DLE 患者的疗效和安全性。这项比较研究是在孟加拉国吉大港医学院医院(CMCH)皮肤科和性病科进行的,时间为 2018 年 7 月至 2019 年 6 月。使用皮肤狼疮红斑疾病面积和严重程度指数评估 DLE 活动的变化作为主要观察指标。每组有效样本为 40 例患者。两组在基线人口统计学和临床特征方面相似。治疗 8 周后,两组的总红斑评分均显著下降(他克莫司治疗组[TGG]从 12.53±8.05 降至 8.03±5.69,[P<.001],卤倍他索丙酸酯治疗组[HTG]从 11.83±7.17 降至 7.30±4.56 [P<.001]),总评分/肥大评分也显著下降(TGG 从 8.08±5.30 降至 4.33±3.21;[P<.001],HTG 从 7.40±4.73 降至 3.68±2.01,[P<.001])。HTG 组的降幅明显更大 [P=.032])。两组的总活动评分均显著下降(TGG 从 22.95±13.40 降至 14.33±8.89,[P<.001],HTG 从 22.15±11.95 降至 13.7±7.22,[P<.001])。本研究表明,他克莫司 0.1%软膏和卤倍他索丙酸酯 0.05%软膏治疗 DLE 患者的疗效相当;然而,卤倍他索在改善鳞屑性、肥大性病变方面明显更好。

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