Katsunuma Toshio, Kamata Miho, Ishikawa Yasuyuki
Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine.
Clinical Development Center, Kyorin Pharmaceutical Co., Ltd.
Arerugi. 2020;69(5):341-352. doi: 10.15036/arerugi.69.341.
The combination drug of inhaled corticosteroid (ICS)/long-acting β2 agonist is being used as a long-term control medication for pediatric asthma patients for those who are poorly controlled by ICS alone. Long-term efficacy and safety of Fluticasone propionate/formoterol fumarate hydrate (FP/FM) was evaluated in pediatric patients with bronchial asthma.
Two inhales of FP/FM (50/5μg) at one time, twice daily were administered for 24 weeks to Japanese asthma patients aged 5 to ＜16 years who had asthma symptoms during the observation period while using the same dosage of ICS during a certain period of time. Adverse drug reactions, morning peak flow (mPEF) and asthma symptoms were evaluated 24 weeks after administration.
FP/FM was administered to 53 subjects. 52 subjects completed the 24 week administration. The incidence of adverse drug reactions was 9.4% (5 of 53), and all of the adverse drug reactions were mild. The mPEF increased from the starting value and was maintained through the treatment period. The average change from baseline in the mPEF after 24 weeks of treatment was 21.39±2.93L/min (Least squares mean±standard error). Changes in asthma symptoms were similar to that of morning peak flow.
It was considered that FP/FM could be useful for long-term control of pediatric asthma.
吸入性糖皮质激素（ICS）/长效β2受体激动剂的联合用药正被用作儿科哮喘患者的长期控制药物，用于那些仅使用ICS控制不佳的患者。对丙酸氟替卡松/富马酸福莫特罗水合物（FP/FM）在支气管哮喘儿科患者中的长期疗效和安全性进行了评估。
对5至＜16岁的日本哮喘患者，在观察期内有哮喘症状且在一定时期内使用相同剂量ICS的情况下，每日两次，每次吸入两吸FP/FM（50/5μg），持续给药24周。给药24周后评估药物不良反应、晨峰流速（mPEF）和哮喘症状。
53名受试者接受了FP/FM治疗。52名受试者完成了24周的给药。药物不良反应发生率为9.4%（53例中的5例），所有药物不良反应均为轻度。mPEF从起始值升高，并在治疗期间维持。治疗24周后mPEF相对于基线的平均变化为21.39±2.93L/分钟（最小二乘均值±标准误差）。哮喘症状的变化与晨峰流速相似。
认为FP/FM对儿科哮喘的长期控制可能有用。
