Fluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial

被引：12

作者：

Rubio-Gomis, E. ^{[1
,2
]}

Martinez-Mir, I ^{[3
]}

Morales-Olivas, F. J. ^{[2
]}

Martorell-Aragones, A. ^{[4
]}

Palop-Larrea, V ^{[5
]}

Bernalte-Sese, A. ^{[6
]}

Cerda-Mir, J. C. ^{[4
]}

Polo-Martin, P. ^{[7
]}

Febrer, I ^{[8
]}

Aranda-Grau, L. ^{[9
]}

Llosa-Cortes, I ^{[10
]}

Tejedor-Sanz, Ma J. ^{[11
]}

Julia-Benito, J. C. ^{[12
]}

Alvarez-de-Laviada-Mulero, T. ^{[7
]}

Planelles-Cantarino, M., V ^{[13
]}

Apolinar-Valiente, E. ^{[14
]}

Loriente-Tur, M. ^{[15
]}

Abella-Bazataqui, A. M. ^{[9
]}

Alvarez-Gonzalez, I ^{[16
]}

Morales-Carpi, C. ^{[17
]}

Burches-Greus, Ma E. ^{[18
]}

Ferrer-Bautista, A. B. ^{[13
]}

Felix-Toledo, R. ^{[4
]}

Marmaneu-Laguia, D. ^{[15
]}

Garcia-Martinez, V. E. ^{[15
]}

Beltran-Marques, M. A. ^{[14
]}

Rodriguez-Gracia, B. ^{[19
]}

机构：

[1] Consorcio Hosp Gen Univ Valencia, Unidad Farmacol Clin, Valencia, Spain

[2] Univ Valencia, Dept Farmacol, Valencia, Spain

[3] CHGUV, Direcc Gerencia Fdn HGU, Valencia, Spain

[4] CHGUV, Unidad Alergia Pediat, Valencia, Spain

[5] Dept Salud La Ribera, Subdirecc Med Asistencial, Valencia, Spain

[6] CHGUV, Serv Farm, Valencia, Spain

[7] Ctr Salud CS Barrio Luz, Valencia, Spain

[8] CHGUV, Serv Dermatol, Valencia, Spain

[9] Ctr Atenc Primaria Pobla de Vallbona, Valencia, Spain

[10] CS Monserrat, Valencia, Spain

[11] CS Torrente II, Valencia, Spain

[12] CS Alzira, Valencia, Spain

[13] CS Paiporta, Valencia, Spain

[14] CS Torrente I, Valencia, Spain

[15] CS Alacuas, Valencia, Spain

[16] CS Burjasot II, Valencia, Spain

[17] CS Picasent, Valencia, Spain

[18] CS Xirivella, Valencia, Spain

[19] CS Auxiliar Vedat de Torrent, Valencia, Spain

来源：

ALLERGOLOGIA ET IMMUNOPATHOLOGIA | 2018年 / 46卷 / 04期

关键词：

Atopic dermatitis; Fluticasone propionate; Intermittent dosing; Prevention; Clinical trial; MAINTENANCE TREATMENT; METHYLPREDNISOLONE ACEPONATE; CALCINEURIN INHIBITORS; PROPIONATE CREAM; DOUBLE-BLIND; SAFETY; MANAGEMENT; EFFICACY; CHILDREN; 0.05-PERCENT;

D O I：

10.1016/j.aller.2017.12.001

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

Background: The long-term efficacy of corticosteroids to prevent atopic dermatitis (AD) relapses has partially been addressed in children. This study compared an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% with its vehicle base in reducing the risk of relapse in children with stabilized AD. Methods A randomized controlled, multicentric, double-blind trial was conducted. Children (2-10 years) with mild/moderate AD (exclusion criteria: > 30% affected body surface area and/or head) were enrolled into an Open-label Stabilization Phase (OSP) of up to 2 weeks on twice daily FP. Those who achieved treatment success entered the Double-blind Maintenance Phase (DMP). They were randomly allocated to receive FP or vehicle twice-weekly on consecutive days for 16 weeks. The primary study endpoint was relapse rate; time to relapse and severity of disease were also studied. Kaplan-Meier estimates were calculated. Results: Fifty-four patients (29 girls) entered the OSP (23 mild AD) and 49 (26 girls) continued into the DMP. Mean age was 5.5 (SD: 2.8) and 5.1 (SD: 2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in every group). Patients treated with FP twice weekly had a 2.7 fold lower risk of experiencing a relapse than patients treated with vehicle (relative risk 2.72, SD: 1.28; p = 0.034). FP was also superior to vehicle for delaying time to relapse. Both treatment therapies were well tolerated. Conclusion: This long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD. (c) 2018 SEICAP. Published by Elsevier Espana, S.L.U. All rights reserved.

引用

页码：378 / 384

页数：7

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