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奥马珠单抗治疗中重度哮喘儿童的疗效和安全性:一项荟萃分析。

Efficacy and safety of omalizumab in children with moderate-to-severe asthma: a meta-analysis.

机构信息

Tianjin Medical University, Tianjin, PR China.

Respiratory Department, Tianjin Children's Hospital, Tianjin, PR China.

出版信息

J Asthma. 2021 Oct;58(10):1350-1358. doi: 10.1080/02770903.2020.1789875. Epub 2020 Jul 16.

Abstract

OBJECTIVE

To assess the efficacy and safety of omalizumab in children with moderate-to-severe asthma.

DATA SOURCES

We systematically searched MEDLINE, EMBASE, and Cochrane for randomized controlled trials (RCTs ) (inception to January 2020).

STUDY SELECTIONS

All RCTs which were conducted in childhood and adolescence with asthma and compared the efficacy or safety of omalizumab were adopted.

RESULTS

Three studies with four publications including 1380 pediatric patients met our criteria. For children with moderate-to-severe asthma, omalizumab decreased asthma exacerbations rate (OR 0.51, 95% CI: 0.44-0.58,  < 0.001) compared with placebo with no evidence of heterogeneity. Omalizumab reduced the rate of asthma exacerbations 0.58) with treatment period ≥30 weeks (p for heterogeneity = 0.03). Omalizumab treated patients had an excellent or good response rate of treatment effectiveness assessed by physicians (2.75, 2.45-3.09) and a bigger reduction in the dosage of inhaled corticosteroid (ICS) at the end of follow-up. For children with severe asthma, omalizumab also reduced the likelihood of asthma exacerbations and increased the odd of treatment effectiveness rated as excellent or good. Patients receiving omalizumab had a lower incidence of severe adverse events (0.36, 0.22-0.57).

CONCLUSIONS

These findings suggested that omalizumab had beneficial effects on moderate-to-severe asthma in children. Patients may benefit more from long-term use of omalizumab. In addition, omalizumab reduces the rate of serious adverse events requiring hospitalizations.

摘要

目的

评估奥马珠单抗治疗中重度哮喘儿童的疗效和安全性。

资料来源

我们系统地检索了 MEDLINE、EMBASE 和 Cochrane 中的随机对照试验(RCT)(从创建到 2020 年 1 月)。

研究选择

所有纳入的 RCT 均为儿童和青少年哮喘患者,并比较了奥马珠单抗的疗效或安全性。

结果

3 项研究(4 篇文献)共纳入 1380 例儿科患者,符合我们的标准。对于中重度哮喘儿童,与安慰剂相比,奥马珠单抗降低了哮喘恶化率(OR 0.51,95%CI:0.44-0.58,<0.001),且无明显异质性。奥马珠单抗降低哮喘恶化率的效果在治疗期≥30 周时更为显著(p 异质性=0.03)。奥马珠单抗治疗患者的医生评估治疗有效性的良好或极好反应率更高(2.75,2.45-3.09),且在随访结束时吸入性皮质激素(ICS)的剂量减少更多。对于重度哮喘儿童,奥马珠单抗也降低了哮喘恶化的可能性,增加了治疗有效性评为良好或极好的可能性。接受奥马珠单抗治疗的患者严重不良事件发生率较低(0.36,0.22-0.57)。

结论

这些发现表明奥马珠单抗对儿童中重度哮喘有有益的效果。患者可能从奥马珠单抗的长期使用中获益更多。此外,奥马珠单抗降低了需要住院治疗的严重不良事件的发生率。

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