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[目的]探讨中度持续支气管哮喘患者使用氟替卡松/沙美特罗复合干粉吸入剂的临床疗效和安全性。[方法]对60例中度持续支气管哮喘患者随机分为治疗组和对照组,治疗组采用氟替卡松/沙美特罗复合干粉吸入剂(舒利迭)(英国葛兰素威康公司生产),250/50μg,1吸/次,2次/d;对照组采用BDP(必可酮)(英国葛兰素威康公司生产)吸入剂,250μg,2吸/次,2次/d。所有患者按需加用SABA(特布他林)。治疗3个月、6个月根据GINA标准已达完全控制后两组患者均开始减量,用最小治疗量维持,治疗1个月、3个月和6个月观察日间症状、夜间症状、SABA使用次数、肺功能及不良反应,1年内因哮喘急性发作再次住院率。[结果]第1个月两组日间症状及夜间症状无明显差异,P值﹥0.05;第3个月、第6个月治疗组日间症状及夜间症状均较对照组减少,两组比较其P值均﹤0.05;1年内因哮喘急性发作而再次住院率:治疗组较对照组低,P值﹤0.05;治疗组按需使用特布他林的次数均较对照组减少,P值﹤0.05;治疗6个月后肺功能改善率:FEV1实测值/预计值%及FEV1/FVC治疗组:均较对照组提高,P值﹤0.05。治疗组无1例发生不良反应,对照组4例口咽真菌感染,6例有不同程度的声音嘶哑、口干。[结论]绝大多数中度持续哮喘患者使用氟替卡松/沙美特罗复合干粉吸入剂治疗即可达到满意的疗效,且安全性高,可提高患者使用的方便程度和依从性,不良反应少。
[Objective] To investigate the clinical efficacy and safety of fluticasone / salmeterol combination dry powder inhalation in patients with moderate persistent bronchial asthma. [Methods] Sixty patients with moderate persistent bronchial asthma were randomly divided into treatment group and control group. The treatment group was treated with fluticasone / salmeterol dry powder inhaler (manufactured by Glaxo Wellcome UK), 250 / 50μg, 1 suction / time, 2 times / d; control group using BDP (British ketone Glaxo) inhalation, 250μg, 2 suction / times, 2 times / d. All patients on demand plus SABA (terbutaline). After treatment for 3 months and 6 months, the two groups of patients underwent full control according to the GINA standard, and both groups began to reduce the dose. The patients were maintained for a minimum of three weeks and six months for treatment of daytime symptoms, nocturnal symptoms, SABA use frequency, lung function and adverse reactions, 1 year re-hospitalization rate due to acute attack of asthma. [Results] There was no significant difference in daytime symptoms and nocturnal symptoms between the two groups at the first month, P> 0.05. The daytime symptoms and nocturnal symptoms in the third month and the sixth month were lower than those in the control group The P value was less than 0.05; the hospitalization rate of acute exacerbation of asthma in one year was lower in the treatment group than in the control group (P <0.05); the number of terbutaline on demand in the treatment group decreased compared with the control group, P < 0.05; improvement of pulmonary function after 6 months of treatment: the measured value / predicted value of FEV1 and the FEV1 / FVC treatment group: Compared with the control group, P value <0.05. No adverse reactions were found in the treatment group. In the control group, 4 cases were infected with oropharyngeal fungi, and 6 cases had hoarseness and dry mouth in varying degrees. [Conclusion] Most patients with moderate persistent asthma treated with fluticasone / salmeterol composite dry powder inhaler can achieve satisfactory efficacy, and have high safety, which can improve the convenience and compliance of patients and have fewer adverse reactions.