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目的针对美国上市的治疗哮喘的长效β2-肾上腺素受体激动剂(LABA),确定各年龄段发生与哮喘-相关严重事件的风险性。方法美国FDA对照临床试验进行了荟萃分析,这些试验对4～11,12～17,18～64及>64岁年龄段者,将使用LABA与未使用LABA患者的风险进行了临床对照试验。就年龄对哮喘-死亡、气管插管和住院综合因素(哮喘综合指数)的影响及共用吸入性皮质类固醇(ICS)的影响进行了分析。结果此荟萃分析含110个试验,60 954例患者。与未使用LABAs患者相比,用LABAs所有年龄段混合事件发生率差异为6.3件/1 000人-年〔95%CI(2.2,10.3)〕。4～11岁组发生率较其他年龄组的差异最大〔30.4件/1 000人-年,95%CI(5.7,55.1)〕。源于年龄的差异有统计学意义(P=0.020)。共用ICS亚群组患者的结果与总结果相似(n=36 210);给予ICS(n=15 192)的患者发生率差异为0.4件/1 000人-年〔95%CI(-3.8,-4.6)〕,各年龄组间差异无统计学意义。结论儿童因用LABA而发生哮喘相关严重事件的最多。评估LABA用于使用ICS儿童的风险还需要其他数据。
Aim To determine the long-acting β2-adrenergic receptor agonist (LABA) for the treatment of asthma in the United States and to determine the risk of developing asthma-related serious events of all ages. Methods The US FDA conducted a meta-analysis of controlled clinical trials in which clinical controlled trials comparing the risk of using LABA with those without LABA were conducted in patients 4 to 11, 12 to 17, 18 to 64, and> 64 years of age. The impact of age on asthma-death, tracheal intubation and general hospitalization factors (asthma composite index) and the impact of inhaled corticosteroids (ICS) were analyzed. Results This meta-analysis consisted of 110 trials with 60 954 patients. The difference in incidence of mixed events among all age groups with LABAs was 6.3 per 1000 person-years [95% CI (2.2,10.3)] compared to those not using LABAs. The difference between the age groups of 4 and 11 was the highest among other age groups (30.4 cases / 1000 person-years, 95% CI 5.7 and 55.1). The age-dependent differences were statistically significant (P = 0.020). Patients who shared ICS subgroups had similar overall outcomes (n = 36,210); those who received ICS (n = 15,192) had a difference of 0.4 per 1,000 person-years [95% CI (-3.8, 4.6)], no significant difference between the age groups. Conclusions Children have the highest incidence of asthma-related events due to LABA. Other data are needed to assess the risk of LABA use in children with ICS.