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一项比较性、多中心、前瞻性、随机研究,旨在评估基于神经酰胺的后生元保湿剂与基于石蜡的保湿剂在轻度至中度特应性皮炎中的疗效、安全性及复发延迟情况。

A Comparative, Multicenter, Prospective, Randomized Study to Evaluate the Efficacy, Safety, and Delay of Relapse of Ceramide-Based Post-biotic Moisturizer Versus Paraffin-Based Moisturizer in Mild to Moderate Atopic Dermatitis.

作者信息

De Abhishek, Halder Saswati, Madan Amit, Raja Uday Kiran, Guru Prasad Patnala, Dhoot Dhiraj, Jani Gaurang, Sharma Tripti

机构信息

Dermatology, Wizderm Speciality Skin and Hair Clinic, Kolkata, IND.

Dermatology, Calcutta School of Tropical Medicine, Kolkata, IND.

出版信息

Cureus. 2025 Jan 1;17(1):e76762. doi: 10.7759/cureus.76762. eCollection 2025 Jan.

DOI:10.7759/cureus.76762
PMID:39897204
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11785538/
Abstract

BACKGROUND

Atopic dermatitis (AD) is a chronic relapsing inflammatory disease that impacts the quality of life of affected individuals as well as their families. Its pathogenesis involves impaired skin barrier function and immune dysregulation. Moisturizers are used in AD management as they help in repairing the skin barrier.

OBJECTIVE

The objective of this study was to compare the efficacy, safety, and prevention of relapse with ceramide-based post-biotic moisturizer against paraffin-based moisturizer in mild to moderate AD.

METHOD

A total of 160 AD patients were grouped into two: Group I received desonide cream 0.05% and ceramide-based post-biotic moisturizer and Group II received desonide cream 0.05% and paraffin-based moisturizer. Both groups were given treatment for four weeks. Patients who achieved complete resolution entered the maintenance phase for a maximum duration of three months. They were followed up every two weeks telephonically or as and when the patient experienced a relapse.

RESULTS

All 160 patients were completely cured and entered the maintenance phase at week 4. A total of 96/160 (71.25%) patients relapsed, with 44 relapses in Group I (55%) and 52 (65%) in Group II (p=0.25). However, in terms of mean relapse time, Group I had a 72.52±15.01 day remission period, whereas Group II had a 47.44±21.49 day remission period (p=0.0001). Moreover, Group I showed a statistically significantly prolonged estimated median time to relapse compared with Group II (median: 85 days versus 71 days, p=0.05). Both moisturizers were tolerated very well.

CONCLUSION

Although both moisturizers were effective in resolving symptoms in the treatment phase, the ceramide-based post-biotic moisturizer was more effective and statistically significant in extending the remission period against the paraffin-based moisturizer in patients with mild to moderate AD.

摘要

背景

特应性皮炎(AD)是一种慢性复发性炎症性疾病,会影响患者及其家人的生活质量。其发病机制涉及皮肤屏障功能受损和免疫失调。润肤剂用于AD的治疗,因为它们有助于修复皮肤屏障。

目的

本研究的目的是比较基于神经酰胺的后生润肤剂与基于石蜡的润肤剂在轻度至中度AD中的疗效、安全性和复发预防情况。

方法

总共160名AD患者被分为两组:第一组接受0.05%的地奈德乳膏和基于神经酰胺的后生润肤剂,第二组接受0.05%的地奈德乳膏和基于石蜡的润肤剂。两组均接受为期四周的治疗。实现完全缓解的患者进入维持阶段,最长持续三个月。每两周通过电话随访,或者在患者复发时随访。

结果

所有160名患者在第4周时均完全治愈并进入维持阶段。总共96/160(71.25%)名患者复发,第一组有44例复发(55%),第二组有52例(65%)(p = 0.25)。然而,就平均复发时间而言,第一组的缓解期为72.52±15.01天,而第二组为47.44±21.49天(p = 0.0001)。此外,与第二组相比,第一组的估计中位复发时间在统计学上显著延长(中位数:85天对71天,p = 0.05)。两种润肤剂的耐受性都非常好。

结论

虽然两种润肤剂在治疗阶段缓解症状方面均有效,但基于神经酰胺的后生润肤剂在延长轻度至中度AD患者的缓解期方面比基于石蜡的润肤剂更有效且具有统计学意义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/75bd/11785538/3d5668c3e21f/cureus-0017-00000076762-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/75bd/11785538/6b47fce6a7c0/cureus-0017-00000076762-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/75bd/11785538/3d5668c3e21f/cureus-0017-00000076762-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/75bd/11785538/6b47fce6a7c0/cureus-0017-00000076762-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/75bd/11785538/3d5668c3e21f/cureus-0017-00000076762-i02.jpg

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