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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 in the treatment of bronchial asthma. Methods Multicenter, randomized, open, parallel controlled study. A total of 233 mild to moderate persistent asthma patients were included in the study based on inclusion criteria and exclusion criteria. 115 in the patch group, 2 mg in the tulobuterol group, and 1 in the night. 118 in the tablet group were treated with tulobuterol twice daily and 2 times daily. The change of maximum expiratory flow (PEF), pulmonary function, clinical symptom scores before and after treatment and the use of short-acting β 2 receptor agonist to relieve the symptoms were observed. Results (1) The age, height, weight, course of disease and severity of illness of two groups were graded. There was no significant difference in the indexes of pulmonary function and clinical symptom before the admission. (2) After 4 weeks of administration, the absolute value of PEF and its improvement rate before and after bedtime in the patch group were significantly higher than those in the tablet group (P <0.05), and the PEF amplitude in the patch group was significantly increased The improvement rate of morning PEF in tablet group, patch group and tablet group were 9.1 (0.38 ~ 19.4)% and 4.2 (-6.4 ~ 18.3)%, respectively. (3) The lung function, mutation rate of PEF, score of clinical symptoms and the amount of short-acting beta-2 receptor agonist were all improved after administration, but there was no significant difference between the two groups. (4) The incidences of adverse reactions such as palpitation and tremor in the patch group were 2.6% and 0.9%, respectively, which were significantly lower than those in the tablet group (9.3% and 8.5%, respectively) (x ~ 2 = 7.0919, P = 0.0077). Local skin adverse reactions in the patch group occurred only 2.6%, and to a lesser extent. Conclusion The tulobuterol patch is a safe, effective and new dosage form of asthma medication.