妥洛特罗贴剂治疗轻中度持续支气管哮喘患者的有效性和安全性

The efficacy and safety of tulobuterol tape in mild and moderate persistent asthma patients

目的评价妥洛特罗贴剂治疗支气管哮喘的有效性和安全性。方法多中心、随机、开放、平行对照研究。根据入选标准和排除标准共有233例轻中度持续哮喘患者进入本研究。贴剂组115例,妥洛特罗每贴2mg,每晚1次;片剂组118例,口服妥洛特罗,2片/次,2次/d。观察用药前后最大呼气流量(PEF)、肺功能、临床症状评分的变化及用于缓解症状的短效β_2受体激动剂的使用情况。结果 (1)2组患者的年龄、身高、体重、病程和病情程度分级、入组前肺功能指标和临床症状评分差异均无统计学意义。(2)给药4周后,晨起与睡前 PEF 绝对值及其改善率贴剂组较片剂组显著升高(P<0.05),且贴剂组在给药后 PEF 上升的幅度明显高于片剂组,贴剂组与片剂组患者晨起PEF 的改善率分别为9.1(0.38～19.4)%、4.2(-6.4～18.3)%。(3)肺功能、PEF 变异率、临床症状评分、短效β_2受体激动剂用量于给药后均有改善,但2组间差异无统计学意义。(4)贴剂组患者不良反应如心悸、手颤的发生率分别为2.6%、0.9%,明显低于片剂组的9.3%、8.5%(x^2=7.0919,P=0.0077)。贴剂组局部皮肤不良反应发生率仅2.6%,且程度轻。结论妥洛特罗贴剂是一种安全、有效、新剂型的哮喘治疗药物。

Objective To evaluate the efficacy and safety of tulobuterol tape in mild and moderate persistent asthma patients. Methods A muhicenter, randomized, controlled, open label study was performed. A total of 233 adult patients with mild and moderate persistent asthma were enrolled, and 115 patients were treated with tulobuterol tape and 118 with tulobuterol tablet. Result After 4 weeks of treatment, the morning peak expiratory flow （PEF） and evening PEF and the percent change in the tulobuterol tape group were increased significantly as compared to the tulobuterol tablet group （ P 〈 0. 05 ）. The rote of improvement in morning PEF with the tape group and the tablet group were 9. 1（0. 38 - 19.4）% and 4. 2（ -6. 4 ～ 18.3）% ,respectively. The pulmonary function, variation rote of PEF, asthma score and usage of short-acting [32 agonist were improved after 4 weeks of treatment, but the differences were not significant between the two groups. The incidence of adverse reactions including palpitations and tremor in the tulobuterol tape group was significantly lower than that in the tablet group（Χ^2 =7. 0919,P =0. 0077 ）, and the incidence of local skin adverse reactions in tape group was 2. 6%. Conclusion Tulobuterol tape is a newly formulated, effective and safe medication for the treatment of asthma.