Zeng Beibei, Jia Doudou, Li Shengen, Liu Xuna, Zhu Boxu, Zhang Yanqi, Zhuang Yan, Dai Fei
Department of Gastroenterology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Cardiology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Ann Med. 2025 Dec;57(1):2445192. doi: 10.1080/07853890.2024.2445192. Epub 2024 Dec 21.
Advancing the understanding of the pathophysiology of eosinophilic oesophagitis (EoE) and other eosinophilic gastrointestinal diseases (EGIDs) has spurred research into targeted biological therapies, while the conclusive therapeutic efficacy of biologics remains uncertain. In this review, we conducted a meta-analysis of all RCTS of biologics in the treatment of EoE to evaluate their efficacy and safety and discussed their treatment of non-EoE EGIDs.
We searched the PubMed, EMBASE, Cochrane Library, and Web of Science databases. Double-blind randomized controlled trials comparing biologics with placebo in patients with EoE and non-EoE EGIDs were collected and further screened for inclusion and exclusion. The caliber of the included literature was evaluated using the Cochrane risk assessment tool findings. Data extraction and meta-analysis were conducted using RevMan 5.4 and Stata 17.0. Clinical response and histological remission were the major endpoints.
Our search retrieved 3,237 articles. There were seven trials in total, comprising 792 people with EoE. Key outcomes of this meta-analysis include the following: Anti-IL-5 biologics exhibited statistically significant benefits in histological remission (RR 2.03 [CI 1.45-2.85]; < 0.0001) compared to the placebo, but there was no significant difference in symptom relief (RR 1.06 [CI 0.88 to 1.28]; = 0.53); anti-IL-4/13 biologics had significant effects on histologic improvement (RR 10.48 [CI 5.54-19.82]; < 0.00001) and symptom related score reduction (RR 1.44 [CI 1.08-1.93]; = 0.01), with a better outcome for endoscopic remission than with placebo (SMD-1.06 [CI-1.26-0.86], < 0.00001); no statistically significant differences in adverse effects were observed between the intervention and control groups.
Our findings suggest that the biologics currently being investigated are considered safe and effective treatments for EoE, while their efficiency varies. However, the discussion of biologics in non-pharyngitis EGID is hampered by a lack of research, necessitating more research in high-quality trials.
对嗜酸性粒细胞性食管炎(EoE)和其他嗜酸性粒细胞性胃肠道疾病(EGIDs)病理生理学认识的深入推动了针对生物疗法的研究,而生物制剂的确切治疗效果仍不确定。在本综述中,我们对生物制剂治疗EoE的所有随机对照试验(RCTs)进行了荟萃分析,以评估其疗效和安全性,并讨论了它们对非EoE的EGIDs的治疗情况。
我们检索了PubMed、EMBASE、Cochrane图书馆和Web of Science数据库。收集了比较生物制剂与安慰剂治疗EoE和非EoE的EGIDs患者的双盲随机对照试验,并进一步筛选纳入和排除标准。使用Cochrane风险评估工具对纳入文献的质量进行评估。使用RevMan 5.4和Stata 17.0进行数据提取和荟萃分析。临床反应和组织学缓解是主要终点。
我们的检索共获得3237篇文章。总共7项试验,包括792例EoE患者。该荟萃分析的主要结果如下:与安慰剂相比,抗IL-5生物制剂在组织学缓解方面显示出统计学上的显著益处(RR 2.03 [CI 1.45 - 2.85];P < 0.0001),但在症状缓解方面无显著差异(RR 1.06 [CI 0.88至1.28];P = 0.53);抗IL-4/13生物制剂对组织学改善(RR 10.48 [CI 5.54 - 19.82];P < 0.00001)和症状相关评分降低有显著影响(RR 1.44 [CI 1.08 - 1.93];P = 0.01),在内镜缓解方面比安慰剂有更好的结果(SMD -1.06 [CI -1.26 - 0.86],P < 0.00001);干预组和对照组在不良反应方面未观察到统计学上的显著差异。
我们的研究结果表明,目前正在研究的生物制剂被认为是治疗EoE的安全有效方法,但其疗效各不相同。然而,由于缺乏研究,关于生物制剂在非咽炎性EGID中的讨论受到阻碍,需要在高质量试验中进行更多研究。