Feíto-Rodríguez Marta, Ramírez-Boscà Ana, Vidal-Asensi Santiago, Fernández-Nieto Diego, Ros-Cervera Gonzalo, Alonso-Usero Vicent, Prieto-Merino David, Núñez-Delegido Eva, Ruzafa-Costas Beatriz, Sánchez-Pellicer Pedro, Genovés Salvador, Navarro-López Vicente
Department of Dermatology, University Hospital La Paz, Madrid, Spain.
Department of Dermatology, Centro Dermatológico-Estético, Alicante, Spain.
Clin Exp Dermatol. 2023 Apr 27;48(5):495-503. doi: 10.1093/ced/llad007.
The intestinal microbiota is altered in patients with atopic dermatitis (AD) when compared with those of the healthy population. Some interventions with specific probiotic preparations already demonstrate a change in composition of this microbiota accompanied by improvement in the disease.
This research work was designed to evaluate clinical efficacy of the probiotic preparation, and to measure the effect of the intervention on the total dose of corticosteroids administered to subjects.
This double-blind, randomized, placebo-controlled clinical trial including 70 participants with AD aged 4-17 years was designed to evaluate the clinical effect, compared with placebo, of a probiotic mixture of Bifidobacterium lactis, Bifidobacterium longum and Lactobacillus casei at a total daily consumption of 1 × 109 colony-forming units per capsule, over 12 weeks. After randomization and exclusion, 35 patients were allocated to probiotic and 35 to placebo. Clinical variables analysed were SCORAD (SCORing of Atopic Dermatitis) and Investigator Global Assessment (IGA) indices; effect on the amount of topical corticosteroids used; and assessment of safety.
Mean SCORAD index at 12 weeks showed a statistically significant difference of -5.43 (95% confidence interval -10.65 to -0.21) between probiotic (SCORAD 13.52) and placebo groups (SCORAD 18.96); P = 0.04. Comparison between groups showed a statistically significant difference in the number of patients with IGA score improvement over the 12-week intervention: 29 of 32 (90.5%) in the probiotic group vs. 17 of 30 (56.7%) in the placebo group (P < 0.002). A comparison between groups of the proportions of days using corticosteroids and the total dose (g) of corticosteroids between baseline and end of study showed no significant difference, but between weeks 6 and 12 there was a statistically significant reduction in the probiotic group when compared with the placebo group in both variables. Numbers of adverse events were similar in both groups of treatment.
The probiotic mix used in this clinical trial demonstrated efficacy on the change in activity index of AD compared with placebo. Furthermore, the total number of days and total amount of topical corticosteroids required by participants in the probiotic group showed a significant reduction compared with placebo between 6 and 12 weeks.
与健康人群相比，特应性皮炎（AD）患者的肠道微生物群发生了改变。一些使用特定益生菌制剂的干预措施已显示出这种微生物群组成的变化，并伴有疾病改善。
本研究旨在评估益生菌制剂的临床疗效，并测量该干预措施对受试者使用皮质类固醇总剂量的影响。
这项双盲、随机、安慰剂对照临床试验纳入了70名4 - 17岁的AD患者，旨在评估每日总摄入量为每粒胶囊1×10⁹菌落形成单位的乳酸双歧杆菌、长双歧杆菌和干酪乳杆菌的益生菌混合物在12周内与安慰剂相比的临床效果。随机分组并排除后，35例患者被分配到益生菌组，35例被分配到安慰剂组。分析的临床变量包括特应性皮炎评分（SCORAD）和研究者整体评估（IGA）指数；对局部使用皮质类固醇量的影响；以及安全性评估。
12周时，益生菌组（SCORAD为13.52）和安慰剂组（SCORAD为18.96）的平均SCORAD指数显示出统计学上的显著差异，差值为 -5.43（95%置信区间 -10.65至 -0.21）；P = 0.04。组间比较显示，在12周的干预期间，IGA评分改善的患者数量存在统计学上的显著差异：益生菌组32例中有29例（90.5%），安慰剂组30例中有17例（56.7%）（P < 0.002）。比较两组在基线和研究结束之间使用皮质类固醇的天数比例和皮质类固醇的总剂量（克），未显示出显著差异，但在第6周和第12周之间，益生菌组与安慰剂组相比，这两个变量均有统计学上的显著降低。两组治疗中的不良事件数量相似。
本临床试验中使用的益生菌混合物与安慰剂相比，在AD活动指数变化方面显示出疗效。此外，在第6至12周期间，益生菌组参与者所需的局部皮质类固醇的总天数和总量与安慰剂相比显著减少。
