妥洛特罗贴剂改善小儿喘息性疾病肺功能的有效性和安全性评价

Evaluation of safety and efficacy of tulobuterol patch(Amiaid)in improving pulmonary function of children with wheezing disorders

目的评价在常规治疗的基础上合并外用妥洛特罗贴剂对改善小儿喘息性疾病肺功能的有效性和安全性。方法选取2018年1月至12月广州市妇女儿童医疗中心呼吸专科收治门诊及住院的喘息性疾病患儿200例,随机分为观察组和对照组各100例。观察组外用妥洛特罗贴剂;对照组口服盐酸丙卡特罗口服溶液,疗程均为7 d。采用潮气呼吸法测定婴幼儿流速-容量环,观察治疗前后患儿肺功能的变化情况,并观察药物不良反应和依从性。结果(1)肺功能结果显示:观察组治疗前后各项肺功能指标均有明显改善,差异有统计学意义(P<0.05)。而观察组较对照组更能明显改善喘息性患儿的气道阻塞,差异有统计学意义(P<0.05)。(2)用药意愿的比较显示:观察组结果明显优于对照组,证明观察组药物以其独特的给药方式在使用上具有优势,差异有统计学意义(P<0.05)。(3)安全性方面:妥洛特罗贴剂与盐酸丙卡特罗口服溶液比较差异无统计学意义(P>0.05),安全性相当。结论认为妥洛特罗贴剂对改善小儿喘息性疾病肺功能有明显疗效且非常安全。

Objective To evaluate the safety and effect of conventional therapy combined with tulobuterol patch in improving lung function of children with wheezing disorders.Methods A total of 200 children with wheezing disorders were treated in Guangzhou Women and Children’s Medical Center from January to December of 2018,who were randomly divided into observation group(100 children)and control group(100 children).The observation group was given tulobuterol patch for external use,and the control group took procaterol hydrochloride oral solution,the treatment course being 7 days for both groups.The flow-volume loop was determined by tidal breathing method in the infants;the changes in the lung function of infants were observed before and after treatment,and the adverse reactions and medication compliance were also observed.Results(1)The results of lung function showed that all pulmonary indexes were significantly improved after treatment in observation group(P<0.05),and the improvement in airway obstruction was more obvious in observation group than in control group(P<0.05).(2)The comparison of the willingness in taking drugs showed that the observation group was better than the control group,which proved that the special way of administration in observation group had its advantage,and there was statistical difference(P<0.05).(3)In terms of Safety,there was no statistical differences between tulobuterol patch and procaterol hydrochloride oral solution(P>0.05),and their safety was similar.Conclusion It is believed that tulobuterol patch has significant effect in improving lung function of children with wheezing disorders,and it is very safe.