Mengeaud Valerie, Phulpin Chloe, Bacquey Adeline, Boralevi Franck, Schmitt Anne-Marie, Taieb Alain
Pierre Fabre Applied Skin Research Centre, Pierre Fabre Dermo Cosmétique, Toulouse, France.
Pediatr Dermatol. 2015 Mar-Apr;32(2):208-15. doi: 10.1111/pde.12464. Epub 2014 Dec 22.
Although emollients are recommended in the management of atopic dermatitis (AD), regimens for emollient maintenance therapy are awaiting validation. We conducted an international, multicenter, open-label trial to assess the effects of a 3-month maintenance treatment regimen with a sterile, preservative-free emollient cream containing oat plantlets in children (ages 6 mos-6 yrs) with moderate AD. After a 14-day run-in stabilization phase using a topical corticosteroid (TCS) treatment of medium potency, 108 children with a SCORing Atopic Dermatitis (SCORAD) index of 20 or less were included in the study. Emollient was applied twice daily for 3 months. Rescue TCS treatment was used only in cases of flare-ups. The SCORAD index, Patient-Oriented SCORAD (PO-SCORAD) index, number of flares, TCS use, and tolerance were assessed at months 1, 2, and 3 (M1, M2, M3). AD severity improved, with a highly significant decrease in the SCORAD and PO-SCORAD indexes at M2 and M3 (p < 0.001). Changes from baseline to M3 were 48.6 ± 73.6% for SCORAD and 29.6 ± 125.3% for PO-SCORAD. The number of flares and TCS use significantly decreased by M3 (both p < 0.001). Very good tolerance was recorded in 100% of children at M2 and M3. Notwithstanding the limitations inherent in open-label trials, twice daily application of the oat-based sterile emollient cream led to a significant improvement of clinical symptoms, evidenced by parallel changes in the SCORAD and PO-SCORAD indexes and fewer flare-ups. Clinical benefit and less TCS use were maintained at M3. Tolerance was very good.
尽管润肤剂被推荐用于特应性皮炎（AD）的管理，但润肤剂维持治疗方案仍有待验证。我们进行了一项国际多中心开放标签试验，以评估含燕麦幼苗的无菌、无防腐剂润肤霜对中度AD儿童（6个月至6岁）进行3个月维持治疗方案的效果。在使用中效外用糖皮质激素（TCS）治疗14天的磨合稳定期后，108名特应性皮炎评分（SCORAD）指数为20或更低的儿童被纳入研究。润肤剂每天涂抹两次，持续3个月。仅在病情发作时使用急救TCS治疗。在第1、2和3个月（M1、M2、M3）评估SCORAD指数、患者导向的SCORAD（PO-SCORAD）指数、发作次数、TCS使用情况和耐受性。AD严重程度有所改善，在M2和M3时SCORAD和PO-SCORAD指数显著降低（p<0.001）。从基线到M3，SCORAD的变化为48.6±73.6%，PO-SCORAD的变化为29.6±125.3%。到M3时，发作次数和TCS使用量显著减少（均p<0.001）。在M2和M3时，100%的儿童记录到耐受性非常好。尽管开放标签试验存在固有局限性，但每天两次涂抹含燕麦的无菌润肤霜可显著改善临床症状，SCORAD和PO-SCORAD指数的平行变化以及发作次数减少证明了这一点。在M3时维持了临床益处且减少了TCS的使用。耐受性非常好。
