使用Dupilumab是否能緩解兒童異位性皮膚炎所引起之皮膚症狀

The Effectiveness of Using Dupilumab to Relieve Skin Symptoms Caused by Atopic Dermatitis in Children

形成臨床提問：異位性皮膚炎（Atopic dermatitis, AD）是兒童常見皮膚慢性發炎疾病，全球約15～25%的兒童受到影響，（Giavina-Bianchi, Giavina-Bianchi, 2021；朱，2019；廖，2020），其中約50%在1歲前出現症狀，85%在5歲前被診斷出來（林、陳，2024）。依據嚴重程度給予不同治療，臺灣皮膚科醫學會於2020年AD治療共識，針對中重度患者加入新型生物製劑療法的建議，健保署在2024年2月將新型生物製劑給付從12歲放寬到6歲以上符合給付條件之患者，而6歲以下的幼兒，或6歲以上但未符合健保給付條件者，則必須自費施打。由於生物製劑單價昂貴，長期治療不但是一筆龐大的負擔，且家屬對治療效果常有疑問，故藉實證探討使用新型生物製劑Dupilumab治療對緩解AD之成效。文獻搜尋的方法與分析：以P：異位性皮膚炎兒童、I：使用Dupilumab、C：常規照護、O：緩解皮膚症狀的中英文關鍵字，經PubMed MeSH Database找出MeSH term，用布林邏輯，做聯集及交集，搜尋PubMed、CINAHL、CEPS三個資料庫，設定Randomized Controlled Trial（RCT）、Meta-Analysis，及年份為2018－2023年，共30篇，刪除重覆文獻5篇，再經標題、摘要及內文排除不符合的22篇，共得3篇RCT文章。文獻的品質評讀：依National Health Service（NHS）之Critical Appraisal Skills Programme（CASP）2018年的Randomized controlled trial版本進行文獻評讀。據Oxford EBM Center 2011年版證據等級，此三篇證據等級為【Level 2】。結果、結論與建議：綜合實證結果，使用新型生物製劑Dupilumab治療中重度異位性皮膚炎患者，治療第16週濕疹面積與嚴重指數、症狀、生活品質明顯優於對照組，且在12歲以上兒童的用藥安全性與成人相同；6個月至小於6歲兒童的用藥安全性跟較大的兒童及成人一樣。因此建議未符合健保給付的兒童，家屬可依據家庭經濟負擔與醫師討論是否加入新型生物製劑於治療計畫中。

Ask an answerable question: Atopic dermatitis (AD) is a chronic inflammatory disease of the skin caused by genetic allergies and epidermal barrier defects. About 15~25% of children worldwide are affected, (Giavina-Bianchi & Giavina-Bianchi, 2021; Zhu, 2019; Liao, 2020). Different treatments are given according to the degrees of severity. The consensus of Taiwan Dermatology Association in 2020 on the treatment of atopic dermatitis recommends adding new biological agent therapy for moderate to severe patients with AD. The biological agent Dupilumab subcutaneous injection was approved by the National Health Insurance in February 2024 for those qualified candidates over 6 years old. About 50% of atopic dermatitis is diagnosed by the age of 1, and 85% is diagnosed by the age of 5 (Lin and Chen, 2024). Children who are under 6 years old, or over 6 years old but not qualified for health insurance benefits, must pay for the treatment by themselves. Biological agents are expensive and long-term treatment is a huge burden. Family members often have doubts about the effectiveness of this treatment. Therefore, the effectiveness of using the biological agent Dupilumab in relieving atopic dermatitis is empirically explored in this study. The Method and Analysis of Literature Review: Both Chinese and English keywords were used to search for MeSh terms by PubMed MeSH Databased (P: children with atopic dermatitis, I: use of Dupilumab, C: routine care, O: alleviating skin symptoms). Union and intersection of sets were conducted based on Bollinger logic through PubMed, CINAHL, and CEPS by setting Randomized Controlled Trial (RCT) and Meta- Analysis from 2018 to 2023. A total of 3 articles were obtained after excluding 5 duplicate articles and 22 incompatible articles. Critical Appraisal: The literature review was conducted based on the 2018 Randomized controlled trial version of the National Health Service (NHS) Critical Appraisal Skills Programme (CASP). According to the evidence level of the Oxford EBM Center (2011), the evidence level of these three articles is [Level 2]. Results, Conclusions and Recommendations: Based on the evidence, the experimental group, who received Dupilumab treatment for 12 weeks demonstrated significant differences in terms of the Eczema area, severity index, symptoms and life quality than those of the control group. As for the safety of using Dupilumab, those over 12 years old is the same as that for adults. For clients of 6-month-old to less 6-year-old, the safety of using Dupilumab is the same as older children and adults. Due to the high cost of biologics, patients who are not qualified for health insurance benefits are advised to pay for treatment by themselves, resulting in a heavy burden for the average family. It is recommended that financial issues should be included in medical consultation regarding to treatment plans.