- 學位論文
運用網絡統合分析比較口服 JAK 抑制劑在治療12歲以上的中重度異位性皮膚炎患者的療效性與安全性;及臨床試驗計劃書
Comparative efficacy and safety of oral JAK inhibitors used in adults and adolescents with moderate-to-severe atopic dermatitis: a network meta-analysis and clinical trial protocol
摘要
背景:異位性皮膚炎是嚴重的全球性問題之一。JAK 抑制劑是目前最被關注的異位性皮膚炎的治療。 研究方法：檢索了兩個數據庫，檢索發布日期從 2019 年 1 月 1 日至 2020 年 12 月 31 日之間的資料。我們納入使用 JAK 抑制劑（abrocitinib、baricitinib和 upadacitinib）之雙盲、隨機並使用安慰劑做為控制組的臨床試驗。 使用 Stata. 16 軟體合併數據並進行多方面比較，如平均差 (MD)、勝算比 (OR) 與 95% 信賴區間 和風險比 (RR) 與 95% 信賴區間。 結果: 共有九個隨機安慰劑控制的臨床試驗，有 4546 名患者被納入此網絡統合分析。此網絡統合分析的結果顯示upadacitinib 30 mg的優越療效，但是任一 upadacitinib 劑量都有較高的感染風險。Abrocitinib 200 mg 在療效與安全性方面，整體表現良好，但是對比安慰劑有較高的腸胃道不良反應的風險。此外，baricitinib 4 mg 療效佳但會有較高風險引起神經系統不良反應。 結論：口服JAK抑制劑是新被核准治療中重度異位性皮膚炎的藥物。 建議未來還是必須進行藥品直接比較試驗以確定療效和不良反應的風險。
並列摘要
Background: Atopic dermatitis (AD) is one of the serious global problems. There were wide concerns about whether Janus kinase (JAK) inhibitor was an alternative treatment for AD. Method: Two databases were searched from the publication date available between 1 January 2019 to 31 December 2020. We included randomized placebo-controlled trials comparing JAK inhibitors (abrocitinib, baricitinib and upadacitinib) for AD. Data were pooled using Stata. 16 software and performed multi-aspect comparisons as mean differences (MD), odds ratio (OR) with 95% CI and risk ratios (RR) with 95% CI. Result: Nine randomized placebo-controlled, with 4546 patients were included in the synthesis. This network meta-analysis highlighted the superior efficacy outcomes of upadacitinib 30 mg. However, either of upadacitinib dose all had a higher risk of Infections (AEs). Abrocitinib 200 mg showed good performance under efficacy and safety outcome, except having a higher risk of gastrointestinal disorders (AEs). In addition, baricitinib 4 mg also had the good performance under efficacy and a higher risk of Nervous system disorders (AEs). Conclusion: Oral JAK inhibitor was newly approval for moderate-severe atopic dermatitis. Head-to-head comparisons are necessary to identify efficacy, and the risk of adverse effects.