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度普利尤单抗治疗中度至重度特应性皮炎的疗效和安全性:一项随机对照试验的荟萃分析

Efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis: a meta-analysis of randomized controlled trials.

作者信息

Wu Shuying, Wang Huiping

机构信息

Department of Dermatovenereology, Tianjin Medical University General Hospital/Tianjin Institute of Sexually Transmitted Disease, Tianjin, China.

Department of Dermatology, Tianjin Union Medical Center, Tianjin, China.

出版信息

Postepy Dermatol Alergol. 2022 Jun;39(3):601-610. doi: 10.5114/ada.2022.117740. Epub 2022 Jul 14.

Abstract

INTRODUCTION

Patients with atopic dermatitis (AD) have high disease burden negatively affecting quality of life.

AIM

To assess the efficacy and safety of dupilumab in patients with moderate-to-severe AD.

MATERIAL AND METHODS

A systematic literature search was performed using the main-stream databases of PubMed, Web of Science, and Embase. Standard mean difference (SMD) or risk ratios (RR) with 95% confidence interval (95% CI) were calculated using a fixed-effects or random-effects model.

RESULTS

A total of 11 studies with 4094 patients met the inclusion criteria and were included in this meta-analysis. Pooled estimate showed that dupilumab significantly improved the mean change in the Eczema Area and Severity Index (EASI) score (SMD = -10.90, 95% CI: -12.13, -9.68; < 0.001), percentage of body surface area (BSA) affected (SMD = -10.87, 95% CI: -13.04, -8.70; < 0.001), pruritus numeric rating scale (NRS) scores (SMD = -9.29, 95% CI: -10.34, -8.25; < 0.001), and Dermatology Life Quality Index (DLQI) scores (SMD = -9.66, 95% CI: -11.50, -7.82; < 0.001). In addition, dupilumab was associated with a significantly higher Investigator's Global Assessment (IGA) response (RR = 3.57, 95% CI: 2.53, 5.03; < 0.001). The overall incidence of adverse events was comparable between dupilumab and other treatments (RR = 1.00, 95% CI: 0.96, 1.03; = 0.832). However, the injection-site reaction, headache and conjunctivitis were more frequently seen in patients treated with dupilumab.

CONCLUSIONS

Dupilumab is well tolerated, and could improve signs and symptoms of AD. However, the results should be interpreted cautiously since there was significant heterogeneity among the studies.

摘要

引言

特应性皮炎(AD)患者疾病负担沉重,对生活质量产生负面影响。

目的

评估度普利尤单抗治疗中度至重度AD患者的疗效和安全性。

材料与方法

使用PubMed、Web of Science和Embase等主流数据库进行系统文献检索。采用固定效应或随机效应模型计算95%置信区间(95%CI)的标准平均差(SMD)或风险比(RR)。

结果

共有11项研究、4094例患者符合纳入标准并纳入本荟萃分析。汇总估计显示,度普利尤单抗显著改善了湿疹面积和严重程度指数(EASI)评分的平均变化(SMD = -10.90,95%CI:-12.13,-9.68;P < 0.001)、受影响的体表面积(BSA)百分比(SMD = -10.87,95%CI:-13.04,-8.70;P < 0.001)、瘙痒数字评定量表(NRS)评分(SMD = -9.29,95%CI:-10.34,-8.25;P < 0.001)和皮肤病生活质量指数(DLQI)评分(SMD = -9.66,95%CI:-11.50,-7.82;P < 0.001)。此外,度普利尤单抗与显著更高的研究者整体评估(IGA)反应相关(RR = 3.57,95%CI:2.53,5.03;P < 0.001)。度普利尤单抗与其他治疗的不良事件总体发生率相当(RR = 1.00,95%CI:0.96,1.03;P = 0.832)。然而,注射部位反应、头痛和结膜炎在接受度普利尤单抗治疗的患者中更常见。

结论

度普利尤单抗耐受性良好,可改善AD的体征和症状。然而,由于研究间存在显著异质性,结果应谨慎解读。

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