目的: 系统评价乌帕替尼治疗中至重度特应性皮炎的疗效及安全性。方法: 检索PubMed、Cochrane Library、Web of Science、Embase、中国知网、维普、万方数据库中有关乌帕替尼治疗特应性皮炎的文献,检索时限为建库至2024年6月。对纳入的研究进行质量评价后,使用RevMan 5.4.1系统评价软件对2组患者疗效及安全性的结局指标进行Meta分析。结果: 共纳入4篇文献,包含5项随机对照研究（randomized controlled trials,RCTs）,涉及3 023例患者。结果显示,与对照组相比,试验组在湿疹面积及严重程度指数缓解75%（75% improvement in eczema area and severity index,EASI-75）反应率（RR=3.97,95%CI ：3.21~4.92）、研究者总体评估（investigator's global assessment,IGA）反应率（RR=6.33,95%CI：5.40~7.42）及患者峰值瘙痒严重程度数值（numerical rating scale,NRS）反应率（RR=4.57,95%CI：4.02~5.20）方面表现出更高的水平。此外,对照组治疗期间不良事件的发生率低于试验组（RR=1.16,95%CI：1.10~1.22）,两组间严重不良事件的发生率无明显差异（RR=0.74,95%CI：0.50~1.11）。在常见不良反应中,试验组更容易出现痤疮（RR=5.26,95%CI：3.49~7.93）、血清磷酸肌酸激酶升高（RR=2.19,95%CI：1.38~3.48）和带状疱疹（RR=2.76,95%CI：1.16~6.56）,而鼻咽炎（RR=1.28,95%CI：1.00~1.64）和上呼吸道感染（RR=1.32,95%CI：0.98~1.76）的不良事件发生率在两组之间的差异无统计学意义。结论: 乌帕替尼对中至重度特应性皮炎患者有良好的疗效,可改善皮肤状态,减轻瘙痒,不良反应可耐受。
Abstract
Objective Systematic evaluation of the clinical efficacy and safety of upadacitinib in the treatment of moderate-to-severe atopic dermatitis in adolescents and adults. Method The literatures about upadacitinib treatment for atopic dermatitis were searched from PubMed, Cochrane Library, Web of Science, Embase, CNKI, VPCS and WanFang databases during the inception to June 2024. After quality evaluation of the included studies, Revman 5.4.1 system evaluation software was used to conduct a meta-analysis on the efficacy and safety of the two groups. Results A total of four articles comprising five randomized controlled trials (RCTs) involving 3 023 patients were included. Meta analysis showed that compared with the control group, the experimental group showed a higher level in 75% improvement in Eczema Area and Severity Index (EASI-75), response rate (RR=3.97, 95%CI: 3.21-4.92) and Investigator's Global Assessment (IGA) response rate (RR=6.33, 95%CI: 5.40-7.42), and the improvement of Numerical Rating Scale (NRS) scores (RR=4.57, 95%CI: 4.02-5.20) was more significant. In addition, the incidence of Treatment-Emergent Adverse Event (TEAE) was greater in the experimental group compared to the control group (RR=1.16, 95%CI: 1.10-1.22), and the difference was statistically significant. While there was no significant difference in Serious Adverse Event (SAE) between the two groups (RR=0.74, 95%CI: 0.50-1.11). Among common adverse reactions, the test group is more likely to experience acne (RR=5.26, 95%CI: 3.49-7.93), creatine phosphokinase elevation (RR=2.19, 95%CI: 1.38-3.48), and herpes zoster (RR=2.76, 95%CI: 1.16-6.56). There was no significant difference in the incidence of nasopharyngitis (RR=1.28, 95%CI: 1.00-1.64) and upper respiratory tract infection (RR=1.32, 95%CI: 0.98-1.76) between the two groups. Conclusion Upadacitinib demonstrates efficacy and safety in individuals diagnosed with moderate-to-severe atopic dermatitis. It can improve the skin condition, alleviate itching, and the adverse reactions can be tolerated.
关键词
乌帕替尼 /
JAK抑制剂 /
特应性皮炎 /
疗效 /
安全性 /
Meta分析
Key words
upadacitinib /
JAK inhibitors /
atopic dermatitis /
efficacy /
safety /
meta-analysis
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参考文献
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基金
长沙市科学技术局2024年度指导性科技计划项目“儿童特应性皮炎皮肤敏化的中医护理方案构建及应用研究”（kzd2401024）;湖南中医药大学2023年“一方”研究生创新项目“滋阴解毒外洗方（一方颗粒剂）治疗学龄前儿童特应性皮炎的临床疗效研究”（2023YF03）
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