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用于儿童特应性皮炎的生物制剂:系统评价和荟萃分析的方案。

Biologics for pediatric atopic dermatitis: A protocol of a systematic review and meta-analysis.

机构信息

North China University of Science and Technology, Hebei, Tangshan, China.

Tangshan Gongren Hospital, Hebei, Tangshan, China.

出版信息

PLoS One. 2023 Feb 3;18(2):e0271712. doi: 10.1371/journal.pone.0271712. eCollection 2023.

Abstract

BACKGROUND

Atopic dermatitis is a chronic pruritic inflammatory skin disease commonly occurring in children. The objective of this study is to evaluate the treatment of pediatric atopic dermatitis with biologics, as they have displayed immense promising results in several recent clinical trials on atopic dermatitis (AD).

METHODS

We will conduct an extensive search for RCTs in several databases, including Embase, Cochrane Library, Web of Science, and PubMed, from the inception of the study till 15th May 2022. The primary outcomes will be the proportion of patients with EASI 75/90/100 after 12-16 weeks of treatment. The secondary outcomes will include the Numerical Rating Scale (NRS), Investigator Global Assessment (IGA)0-1, body surface area (BSA), Dermatology Life Quality Index (DLQI) scores, and incidence of adverse reactions. All studies will be screened by two independent researchers. They will assess the risk of bias in the included studies according to the RCTs bias risk evaluation tool in Cochrane System Review Manual 5.1.0. Meta-analysis will be performed using RevMan V.5.3.0 software.

RESULTS

The research results will provide a reference for the clinical application of biological agents in pediatric atopic dermatitis.

CONCLUSION

We aim to evaluate the efficacy and safety of biologics in pediatric atopic dermatitis cases and provide evidence-based data for easy clinical application.

PROSPERO REGISTRATION NUMBER

CRD42022319052 (https://www.crd.york.ac.uk/PROSPERO/#joinuppage).

摘要

背景

特应性皮炎是一种常见于儿童的慢性瘙痒性炎症性皮肤病。本研究旨在评估生物制剂治疗儿童特应性皮炎的疗效,因为它们在最近几项特应性皮炎(AD)临床试验中显示出了巨大的前景。

方法

我们将在多个数据库(包括 Embase、Cochrane 图书馆、Web of Science 和 PubMed)中进行广泛搜索,检索时间为从研究开始到 2022 年 5 月 15 日。主要结局将是治疗 12-16 周后 EASI 75/90/100 的患者比例。次要结局将包括数字评分量表(NRS)、研究者全球评估(IGA)0-1、体表面积(BSA)、皮肤病生活质量指数(DLQI)评分和不良反应发生率。所有研究均由两名独立研究人员进行筛选。他们将根据 Cochrane 系统评价手册 5.1.0 中的 RCT 偏倚风险评估工具评估纳入研究的偏倚风险。Meta 分析将使用 RevMan V.5.3.0 软件进行。

结果

研究结果将为生物制剂在儿童特应性皮炎中的临床应用提供参考。

结论

我们旨在评估生物制剂在儿童特应性皮炎病例中的疗效和安全性,并为易于临床应用提供循证数据。

PROSPERO 注册号:CRD42022319052(https://www.crd.york.ac.uk/PROSPERO/#joinuppage)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/843f/9897544/9173c247a884/pone.0271712.g001.jpg

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