摘要
目的:比较2种长效肾上腺素β2受体激动药福莫特罗治疗支气管哮喘的疗效和安全性。方法:采用多中心、随机、双盲、双模拟、平行对照试验方法,临床研究共分为2部分。(1)连续2 wk用药观察:试验组59例和对照组64例,分别口服福莫特罗试验药或对照药及模拟药40μg,bid,疗程14 d。观察病人症状、体征、肺功能(FEV1和PEF)的变化。(2)即刻疗效观察:试验组和对照组各24例,分别口服单一剂量的福莫特罗试验药或对照药40μg及模拟药。观察病人服药后FEV1和PEF改善达15％的时间和改善≥15％的疗效持续时间。结果: (1)治疗2 wk后,试验组哮鸣音的改善优于对照组(P< 0．05),咳嗽、痰量、喘息、呼吸困难及FEV1和PEF的2组间比较,无显著差异(P>0．05)。试验组临床有效率为95％,对照组为92％。试验组FEV1及PEF有效率分别为66％,75％,对照组FEV1及PEF有效率分别为55％,72％。2组间比较无显著差异(P>0．05)。(2)服用单一剂量药物后,试验组FEV1和PEF改善达15％的起始时间分别为(2．0±s 2．1)h, (2．6±2．8)h,对照组分别为(2．3±2．7)h,(3±4)h。试验组FEV1和PEF改善≥15％的疗效持续时间分别为(6±4)h, (6±4)h,对照组分别为(6±4)h,(5±4)h。2组间比较均无显著差异(P>0．05)。(3)2组治疗耐受性均较好,不良反应发生率均为30％。结论:2种福莫特罗治疗支气管哮喘均具有较好的临床疗效、肺功能疗效及安全性,且两者疗效和安全性相似。
AIM： To compare the efficacy and safety of two kinds of formoterol （long-acting adrenergic β2-agonist） in asthma. METHODS： A multicenter, randomized, double blind, double-dummy and parallelgroup trial was conducted. The trail had two parts. （1） Continuous medication： 59 patients in the experiment group and 64 patients in the control group were given formoterol or placebo （40 μg, bid） respectively for 2 wk. Symptom, sign and pulmonary function （FEV1 and PEF） of patients were observed. （2） Immediate effects： 24 patients in the experiment group and the same in the control group were given single dose of formoterol or placebo （40 μg） in order to obtain the time-lag to achieve 15 % improvement and the duration of ≥15 % improvement of FEVI and PEF. RESULTS： （1） After 2 wk treatment period, the improvement of wheezing in the experiment group was superior to that in the control group （P 〈 0.05）. The clinical effective rate was 95 % in the experiment group and 92 % in the control group. The effective rate of FEVI and PEF was 66 % and 75 % in the experiment group, and 55 % and 72 % in the control group respectively. There were no significant differences between the two groups （P 〉 0.05） . （2） The time-lag to achieve 15 % improvement of FEVI and PEF was （2.0±s 2.1） h and （2.6 ±2.8） h in the experiment group, and （2.3 ± 2.7） and （3± 4） h in the experiment group respectively after administration of a single dose of formoterol. The duration of ≥ 15 % improvement of FEV1 and PEF was （6 ± 4） h and （6 ± 4） h in the experiment group, and （6 ±4） h and （5 ±4） h in the control group respectively. There were no significant differences between the two groups （P 〉 0.05）. （3） Both regiments were well tolerated and with a same incidence of adverse events （30 %）. CONCLUSION： The efficacy and safety of two kinds of formoterol are same and have better clinical effects in asthma.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2006年第11期830-834,共5页
Chinese Journal of New Drugs and Clinical Remedies
