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目的观察布地耐德(BUD)联用福莫特罗(FOM)与单用双倍剂量BUD干粉吸入疗法对轻度持续性哮喘患儿的有效性和安全性,探讨儿童轻度持续性哮喘的理想治疗方案。方法选取2005-01—2005-06在广州医学院附属第一医院呼研所专科门诊就诊的轻度持续哮喘患儿50例,采取开放、随机、平行对照方法把50例患儿分为两组,分别吸入BUD联用FOM(B+F组)或双倍剂量BUD(Double B组)8周,药物均用都保干粉吸入装置吸入。8周的观察期内由患儿或家长记录哮喘日记,包括日间和夜间症状评分、无症状天数、其它平喘药物(包括应急用速效β2-受体激动剂、长效缓释茶碱、口服长效β2-受体激动剂、全身用糖皮质激素)使用情况,同时以简易峰流速仪监测其呼气峰流速值(PEF)作为主要肺功能指标。结果B+F组和Double B组在治疗8周后,日间症状及PEF均较治疗前明显改善,无症状天数明显增加,差异具有统计学意义(均P<0.05);与治疗前比较,B+F组在治疗8周后夜间症状评分明显下降(P<0.05),而Double B组治疗前后比较差异无统计学意义(P>0.05);两组间日间症状评分、夜间症状评分、无症状天数及PEF治疗前及治疗后比较差异均无统计学意义(均P>0.05)。两组间病情反复发作次数、需联合应用速效β2-受体激动剂次数及口服强的松、长效缓释茶碱或口服长效β2-受体激动剂的天数均无统计学意义(均P>0.05)。结论低剂量吸入糖皮质激素(ICS)联用长效β2-受体激动剂(LABA)与单用双倍剂量ICS治疗儿童轻度持续性哮喘的疗效相当。但从减少或避免ICS潜在的全身性副反应方面考虑,联用低剂量ICS+LABA可能是更好的选择。
Objective To observe the efficacy and safety of BUD in combination with formoterol (FOM) and double-dose BUD dry powder inhalation therapy in children with mild persistent asthma and to explore the efficacy and safety of BUD in children with mild persistent asthma Ideal treatment options. Methods From January 2005 to June 2005, 50 children with mild persistent asthma were enrolled in the Specialist Outpatient Department of the Research Institute of the First Affiliated Hospital of Guangzhou Medical College from January 2005 to June 2005. Fifty children were divided into two groups according to open, random and parallel control methods , Were inhaled BUD combined with FOM (B + F group) or double-dose BUD (Double B group) for 8 weeks, drugs were insured dry powder inhalation device. The asthma diary, including daytime and nighttime symptom scores, asymptomatic days, and other antiasthmatic medications (including rapid-acting β2-agonist for urgency, sustained release theophylline, Oral long-acting β2-agonist, systemic glucocorticoid) use, while the simple peak flow meter to monitor its peak expiratory flow rate (PEF) as a major lung function indicators. Results After 8 weeks of treatment, the symptoms of daytime and PEF in B + F group and Double B group were significantly improved compared with those before treatment, and the number of asymptomatic days was significantly increased (all P <0.05). Compared with those before treatment, The scores of nighttime symptoms in B + F group were significantly decreased after 8 weeks of treatment (P <0.05), while there was no significant difference in Double B group before and after treatment (P> 0.05). The scores of daytime symptom score, nighttime symptom score, Asymptomatic days and PEF before and after treatment were no significant difference (all P> 0.05). There were no significant differences in the number of recurrent episodes between the two groups, the number of combined use of fast-acting β 2 -agonist and oral prednisone, long-acting sustained-release theophylline or oral long-acting β 2 -agonist P> 0.05). Conclusions Low-dose inhaled glucocorticoid (ICS) combined with long-acting β2-agonist (LABA) is comparable to double-dose ICS alone in the treatment of mild persistent asthma in children. However, low-dose ICS + LABA may be the better choice to reduce or avoid the potential systemic side effects of ICS.