妥洛特罗贴剂和口服硫酸沙丁胺醇治疗儿童支气管轻中度哮喘急性发作期的有效性和安全性比较

Efficacy and safety of tulobuterol patch versus oral salbutamol sulfate in children with mild or moderate acute attack of bronchial asthma: a comparative study

摘要:

目的：比较妥洛特罗贴剂和口服硫酸沙丁胺醇治疗儿童轻中度支气管哮喘急性发作期的有效性和安全性。 方法：将92例轻中度哮喘急性发作期患儿随机分为沙丁胺醇组和妥洛特罗组，每组各46例。两组均给予抗组胺药、选择性白三烯受体拮抗剂、糖皮质激素治疗。沙丁胺醇组使用硫酸沙丁胺醇缓释胶囊，妥洛特罗组使用妥洛特罗贴剂。比较两组咳嗽、喘息、呼吸频率、哮鸣音、三凹征、呼气峰流速（PEF）评分变化及不良反应的发生情况。结果：两组症状评分随治疗的进行均下降。与治疗前评分比较，治疗第3天两组喘息、呼吸频率、哮鸣音、三凹征和PEF评分均显著下降（均P<0.05），但妥洛特罗组评分较沙丁胺醇组低，差异有统计学意义（均P<0.05）。与治疗前评分比较，两组咳嗽评分到治疗第14天开始显著下降(均P<0.05) ，妥洛特罗组评分较沙丁胺醇组低，差异有统计学意义 (P<0.05)。沙丁胺醇组有1例出现手震颤，妥洛特罗组未出现不良反应。结论：与口服硫酸沙丁胺醇比较，妥洛特罗贴剂治疗儿童轻中度哮喘急性发作期疗效更显著，安全性高。

Abstract:

OBJECTIVE: To compare tulobuterol patch and oral salbutamol sulfate in terms of efficacy and safety in children with mild or moderate acute attack of bronchial asthma. METHODS: A total of 92 children with mild and moderate acute asthmatic attack were randomly divided into salbutamol group (n=46) and tulobuterol group (n=46). Both groups received routine treatment with antihistamine, selective leukotriene receptor antagonist and glucocorticoid. In addition, the salbutamol group was given slow-release capsules of salbutamol sulfate, and the tulobuterol group was treated with tulobuterol patch. The two groups were compared with respect to symptom scores of cough, wheeze, respiratory rate, wheezing sound, three depression sign and peak expiratory flow, as well as adverse events. RESULTS: As the treatment proceeded, symptom scores decreased in both groups; on the third day of treatment, all symptom scores except cough score showed a significant decrease in both groups (P<0.05), but the tulobuterol group had significantly lower symptom scores than the salbutamol group (P<0.05). On the fourteenth day of treatment, both groups had a significant decrease in cough score (P<0.05), but the tulobuterol group had a significantly lower cough score than the salbutamol group (P<0.05). One child developed hand trembling in the salbutamol group, while no adverse event occurred in the tulobuterol group. CONCLUSIONS: Compared with oral salbutamol sulfate, tulobuterol patch has a better therapeutic efficacy and a higher safety in children with mild or moderate acute asthmatic attack.