Rodrigo Gustavo J, Neffen Hugo
Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay.
Centro de Alergia, Inmunología y Enfermedades Respiratorias, Santa Fe, Argentina.
Pediatr Allergy Immunol. 2017 Sep;28(6):573-578. doi: 10.1111/pai.12759.
Recently published data support the benefits and safety of the once-daily (OD) long-acting anticholinergic tiotropium bromide bronchodilator for the treatment of uncontrolled moderate-to-severe asthma in adults and adolescents. However, its role for the treatment of school-age asthmatics has not yet been clearly defined. The aim of this systematic review was to assess the efficacy and safety of tiotropium Respimat in children aged 6-11 years with moderate-to-severe symptomatic asthma.
Randomized, placebo-controlled trials were included. Primary outcomes were peak forced expiratory volume in 1 s measured within 3 h post-dosing) [FEV ] and trough FEV measured at the end of the dosing interval.
Three studies (more than 900 patients) were selected. Tiotropium was associated with significant improvements in FEV peak (mean change from baseline) by 102 mL (P<.0001) and trough by 82 mL (P<.0001) compared with placebo. Tiotropium 5 μg dose presented a trend (statistically non-significant) toward a greater bronchodilation in comparison with 2.5 μg dose. Tiotropium significantly increased the rate of the Asthma Control Questionnaire (ACQ-7) responders compared with placebo (82.2% vs 75.4%, number needed to treat for benefit [NNTB]=15) and significantly decreased the number of patients with at least one exacerbation in comparison with placebo (29.1% vs. 39.8%, with a NNTB of 10). There were no significant differences in rescue medication use, withdrawals, and adverse events.
OD tiotropium Respimat is efficacious and well tolerated as an add-on to inhaled corticosteroids plus one or more controller medications in school-age symptomatic asthmatics.
最近发表的数据支持每日一次（OD）长效抗胆碱能药物噻托溴铵支气管扩张剂治疗成人和青少年未控制的中重度哮喘的益处和安全性。然而，其在学龄期哮喘患者治疗中的作用尚未明确界定。本系统评价的目的是评估噻托溴铵软雾吸入剂治疗6至11岁中重度症状性哮喘儿童的疗效和安全性。
纳入随机、安慰剂对照试验。主要结局指标为给药后3小时内测得的1秒用力呼气容积峰值（FEV₁）和给药间隔结束时测得的FEV₁谷值。
选择了三项研究（超过900例患者）。与安慰剂相比，噻托溴铵使FEV₁峰值（相对于基线的平均变化）显著改善102 mL（P<0.0001），FEV₁谷值显著改善82 mL（P<0.0001）。与2.5μg剂量相比，5μg剂量的噻托溴铵有更大支气管扩张的趋势（无统计学意义）。与安慰剂相比，噻托溴铵显著提高了哮喘控制问卷（ACQ-7）应答者的比例（82.2%对75.4%，治疗获益所需人数[NNTB]=15），且与安慰剂相比显著降低了至少有一次病情加重的患者数量（29.1%对39.8%，NNTB为10）。在急救药物使用、退出研究和不良事件方面无显著差异。
对于学龄期有症状的哮喘患者，每日一次的噻托溴铵软雾吸入剂作为吸入性糖皮质激素加一种或多种控制药物的附加治疗有效且耐受性良好。
