Department of Family Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
Pediatrics. 2012 Sep;130(3):e650-7. doi: 10.1542/peds.2012-0162. Epub 2012 Aug 27.
To compare the efficacy of inhaled corticosteroids (ICS) plus long-acting β2 agonist (LABA) versus higher doses of ICS in children/adolescents with uncontrolled persistent asthma.
Randomized, prospective, controlled trials published January 1996 to January 2012 with a minimum of 4 weeks of LABA+ICS versus higher doses of ICS were retrieved through Medline, Embase, Central, and manufacturer's databases. The primary outcome was asthma exacerbations requiring systemic corticosteroids; secondary outcomes were the pulmonary function test (PEF), withdrawals during the treatment period, days without symptoms, use of rescue medication, and adverse events.
Nine studies (n = 1641 patients) met criteria for inclusion (7 compared LABA+ICS versus double ICS doses and 2 LABA+ICS versus higher than double ICS doses). There was no statistically significant difference in the number of patients with asthma exacerbations requiring systemic corticosteroids between children receiving LABA+ICS and those receiving higher doses of ICS (odds ratio = 0.76; 95% confidence interval: 0.48-1.22, P = .25, I(2) = 16%). In the subgroup analysis, patients receiving LABA+ICS showed a decreased risk of asthma exacerbations compared with higher than twice ICS doses (odds ratio = 0.48; 95% confidence interval: 0.28-0.82, P = .007, I(2)= 0). Children treated with LABA+ICS had significantly higher PEF, less use of rescue medication, and higher short-term growth than those on higher ICS doses. There were no other significant differences in adverse events.
There were no statistically significant group differences between ICS+LABA and double doses of ICS in reducing the incidence of asthma exacerbations but it did decrease the risk comparing to higher than double doses of ICS.
比较吸入性皮质类固醇(ICS)加长效β2 激动剂(LABA)与高剂量 ICS 治疗未控制持续性哮喘患儿/青少年的疗效。
检索 Medline、Embase、CENTRAL 和制造商数据库,获取 1996 年 1 月至 2012 年 1 月发表的随机、前瞻性、对照试验,至少有 4 周 LABA+ICS 与高剂量 ICS 比较。主要结局是需要全身皮质类固醇的哮喘加重;次要结局为肺功能测试(PEF)、治疗期间停药、无症状天数、急救药物使用和不良事件。
9 项研究(n=1641 例患者)符合纳入标准(7 项比较 LABA+ICS 与双倍 ICS 剂量,2 项 LABA+ICS 与高于双倍 ICS 剂量)。接受 LABA+ICS 治疗的患儿与接受高剂量 ICS 治疗的患儿在需要全身皮质类固醇的哮喘加重患者数量上无统计学差异(比值比=0.76;95%置信区间:0.48-1.22,P=0.25,I²=16%)。在亚组分析中,与接受高于两倍 ICS 剂量的患儿相比,接受 LABA+ICS 治疗的患儿哮喘加重的风险降低(比值比=0.48;95%置信区间:0.28-0.82,P=0.007,I²=0)。接受 LABA+ICS 治疗的患儿的 PEF 更高,急救药物使用更少,短期生长速度更快,而接受高剂量 ICS 治疗的患儿则没有其他显著差异。
ICS+LABA 与双倍剂量 ICS 在降低哮喘加重发生率方面无统计学差异,但与高于双倍剂量 ICS 相比,风险降低。