Department of Pulmonology, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, Zhejiang, China.
Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, Zhejiang, China.
PLoS One. 2021 Feb 23;16(2):e0237620. doi: 10.1371/journal.pone.0237620. eCollection 2021.
A combination of ipratropium bromide (IB) and salbutamol is commonly used to treat asthma in children and adolescents; however, there has been a lack of consistency in its usage in clinical practice.
To evaluate the efficacy and safety of IB + salbutamol in the treatment of asthma in children and adolescents.
The MEDLINE, Embase, and Cochrane Library as well as other Chinese biomedical databases (including China Biological Medicine Database, Chinese National Knowledge Infrastructure, Chongqing VIP, and Wanfang Chinese language bibliographic database) were systematically searched from the earliest record date to September 2020 for randomized controlled trials in children and adolescents (≤18 years) with asthma who received IB + salbutamol or salbutamol alone. The primary outcomes included hospital admission and adverse events. A random effects model with a 95% confidence interval (CI) was used. Subgroup analysis was performed according to age, severity of asthma, and co-interventions with other asthma controllers. This study was registered with PROSPERO.
Of the 1061 studies that were identified, 55 met the inclusion criteria and involved 6396 participants. IB + salbutamol significantly reduced the risk of hospital admission compared with salbutamol alone (risk ratio [RR] 0.79; 95% CI 0.66-0.95; p = 0.01; I2 = 40%). Subgroup analysis only showed significant difference in the risk of hospital admission in participants with severe asthma exacerbation (RR 0.73; 95% CI 0.60-0.88; p = 0.0009; I2 = 4%) and moderate-to-severe exacerbation (RR 0.69; 95% CI 0.50-0.96; p = 0.03; I2 = 3%). There were no significant differences in the risk of adverse events between IB + salbutamol group and salbutamol alone group (RR 1.77; 95% CI 0.63-4.98).
IB + salbutamol may be more effective than salbutamol alone for the treatment of asthma in children and adolescents, especially in those with severe and moderate to severe asthma exacerbation. The very low to high quality of evidence indicated that future well-designed double-blind RCTs with large sample are needed for research on evaluating the effectiveness of IB + salbutamol treatment for asthma in children and adolescents.
在儿童和青少年哮喘的治疗中,常将溴化异丙托品(IB)和沙丁胺醇联合使用,但在临床实践中其使用方法并不统一。
评估 IB+沙丁胺醇治疗儿童和青少年哮喘的疗效和安全性。
系统检索 MEDLINE、Embase、Cochrane 图书馆以及其他中文生物医学数据库(包括中国生物医学文献数据库、中国知网、重庆维普、万方中文期刊数据库),检索时限均从建库至 2020 年 9 月,收集 IB+沙丁胺醇或沙丁胺醇单独治疗哮喘的儿童和青少年(≤18 岁)的随机对照试验。主要结局包括住院和不良事件。采用 95%置信区间(CI)的随机效应模型进行分析。根据年龄、哮喘严重程度和其他哮喘控制药物的联合使用情况进行亚组分析。本研究已在 PROSPERO 注册。
共纳入 1061 项研究,其中 55 项符合纳入标准,涉及 6396 例参与者。与沙丁胺醇单药治疗相比,IB+沙丁胺醇显著降低了住院风险(风险比 [RR] 0.79;95%CI 0.66-0.95;p=0.01;I2=40%)。亚组分析仅显示在重度哮喘加重(RR 0.73;95%CI 0.60-0.88;p=0.0009;I2=4%)和中重度加重(RR 0.69;95%CI 0.50-0.96;p=0.03;I2=3%)的参与者中,住院风险有显著差异。IB+沙丁胺醇组与沙丁胺醇单药组的不良事件风险无显著差异(RR 1.77;95%CI 0.63-4.98)。
与沙丁胺醇单药治疗相比,IB+沙丁胺醇可能对儿童和青少年哮喘更有效,尤其是对重度和中重度哮喘加重的患者。证据质量为极低到高,表明需要进一步开展设计良好的、针对儿童和青少年哮喘的 IB+沙丁胺醇治疗有效性的大型双盲 RCT 研究。