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局部用毛果芸香碱治疗寻常型天疱疮难治性口腔损害的有效性:一项开放标签、前瞻性、试点研究的结果

Effectiveness of topical pilocarpine in refractory oral lesions of pemphigus vulgaris: Results from an open-label, prospective, pilot study.

作者信息

De Dipankar, Bishnoi Anuradha, Kamboj Parul, Arora Amanjot Kaur, Pal Arnab, Mahajan Rahul, Handa Sanjeev

机构信息

Department of Dermatology, Venereology and Leprology.

Department of Biochemistry, Postgraduate Institute of Medical Education and Research; Chandigarh, 160012, India.

出版信息

Dermatol Ther. 2022 Mar 14:e15449. doi: 10.1111/dth.15449.

DOI:10.1111/dth.15449
PMID:35289044
Abstract

BACKGROUND

The literature suggests a beneficial role of cholinomimetic agents in the treatment of pemphigus. In the present open-label, prospective pilot study, we assessed the effectiveness of topical pilocarpine 2% eye-drops in the treatment of recalcitrant oral lesions of pemphigus.

METHODS

Twenty patients with recalcitrant oral lesions of pemphigus were recruited and instructed to apply pilocarpine 2% eye-drops twice daily on the resistant oral lesions for 180 days. The systemic immunosuppression at the time of inclusion in the present study was continued at the same dose throughout the study duration. The photographs of the lesions were obtained at baseline and an interval of 30 days. The area representing the erosion was measured on clinical photographs using the imageJ software (National Institute of Health). Visual analogue scale and oral health impact profile-14 questionnaire were used to assess the degree of subjective improvement. Anti-desmoglein 1 and 3, and anti-acetylcholine M3 receptor antibodies were measured both in serum and saliva; at baseline and at the completion of the study.

RESULTS

Twenty patients were recruited in this pilot study. Mean total duration of illness was 3.4±1.3 years. The mean area of the erosions decreased significantly from 142.01±130.05 mm to 44.38±67.78 mm at study completion at 180 days (p 0.002, paired t-test). Repeated measures ANOVA demonstrated a significant trend in the reduction of the mean area of the erosions from baseline to day 180 (p 0.002). Mean VAS decreased significantly from 7.2±1.0 at baseline to 5.1±1.9 at day 180 (paired t-test, p 0.001). Mean OHIP-14 decreased significantly from 10.1±2.7 at baseline to 8.4±2.9 at day 180. No significant difference was observed between pre- and post-treatment levels of anti-desmoglein 1, anti-desmoglein 3, and anti-acetylcholine M3 receptor antibodies, in both serum and saliva.

LIMITATIONS

The depth component in the erosions could not be measured. An orabase formulation could be used in future studies to facilitate retention of the medication at the site of application.

CONCLUSION

Topical pilocarpine holds potential for the treatment of recalcitrant oral lesions of pemphigus vulgaris. It probably brings about re-epithelialization without imparting any immunomodulatory activity. This article is protected by copyright. All rights reserved.

摘要

背景

文献表明拟胆碱药在天疱疮治疗中具有有益作用。在本项开放标签的前瞻性初步研究中,我们评估了2%毛果芸香碱滴眼液治疗天疱疮顽固性口腔损害的有效性。

方法

招募20例天疱疮顽固性口腔损害患者,指导其每天两次将2%毛果芸香碱滴眼液涂于耐药性口腔损害处,持续180天。本研究纳入时的全身免疫抑制在整个研究期间以相同剂量持续使用。在基线和每间隔30天拍摄病损照片。使用ImageJ软件(美国国立卫生研究院)在临床照片上测量糜烂面积。采用视觉模拟量表和口腔健康影响程度量表-14问卷评估主观改善程度。在基线和研究结束时检测血清和唾液中的抗桥粒芯糖蛋白1和3以及抗乙酰胆碱M3受体抗体。

结果

本初步研究招募了20例患者。平均总病程为3.4±1.3年。在180天的研究结束时,糜烂的平均面积从142.01±130.05平方毫米显著减小至44.38±67.78平方毫米(配对t检验,P=0.002)。重复测量方差分析显示从基线到第180天糜烂平均面积减小有显著趋势(P=0.002)。平均视觉模拟量表评分从基线时的7.2±1.0显著降至第180天的5.1±1.9(配对t检验,P=0.001)。平均口腔健康影响程度量表-14评分从基线时的10.1±2.7显著降至第180天的8.4±2.9。血清和唾液中抗桥粒芯糖蛋白1、抗桥粒芯糖蛋白3以及抗乙酰胆碱M3受体抗体治疗前后水平无显著差异。

局限性

糜烂的深度无法测量。未来研究中可使用口腔糊剂剂型以促进药物在用药部位的留存。

结论

局部使用毛果芸香碱治疗寻常型天疱疮顽固性口腔损害具有潜力。它可能促使上皮再形成而不具有任何免疫调节活性。本文受版权保护。保留所有权利。

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