沙美特罗／丙酸氟替卡松对支气管哮喘患者转化生长因子β1／Smad通路的影响

目的观察沙美特罗／N酸氟替卡松对中重度持续支气管哮喘（简称哮喘）患者转化生长因子p1（transforminggrowthfactor—β1,TGF-β1）／Smad通路的影响。方法中重度持续哮喘患者30例,对照组20例。哮喘组给予规律吸入沙美特罗／N酸氟替卡松50／250／xg,2次／d,持续6个月。酶联免疫吸附试验（ELISA法）定量测血清TGF-β1、Smad2表达,宝石能谱高分辨率CT（HRCT）扫描测量气道壁厚度／气道外径（T／D）、气道壁面积占气道总面积百分比（WA％）评估气道重塑程度。结果哮喘组（治疗前）血清TGF-β1（301．5±27．3）ng／L、Smad2（1182．1±50．6）ng／L与对照组TGF—β1（55．2±12．8）ng／L、Smad2（796．4±56．2）ng／L比较差异有统计学意义（t=8．52,t=5．90,P值均〈0.05）,哮喘组（治疗后）TGF-β1,（96．1±25．6）ng／L、Smad2（853．4±49．7）ng／L与哮喘组（治疗前）比较差异具有统计学意义（t=7．21,t=3．13,P值均〈O．05）,哮喘组（治疗后）血清Smad2与对照组比较差异无统计学意义（t=0．24,P〉o．05）;哮喘组（治疗前）T／D（23．66士4．06）％较对照组（19．79士3．37）％增加,差异有统计学意义（t=3．45,P〈O．05）,哮喘组（治疗前）wA％（69．24±6．03）‰值与对照组（51．67±4．55）％比较差异有统计学意义（t=3．77,P〈O．05）。规律吸入沙美特罗／丙酸氟替卡松6个月后,哮喘组（治疗后）T／D（20,43±3．00）％、WA％（58．40±3．85）％下降,与哮喘组（冶疗前）比较差异有统计学意义（t=2．96,t=3．05．P值均〈0．05）,哮喘组（治疗后）T／D与对照组比较差异无统计学意义（t=0．95,P〉0．05）,气道重塑减轻。结论哮喘患者气道重塑伴随血TGF-β1、Smad2蛋白的表达增加,规律吸入沙美特罗j丙酸氟替卡松可以通过减少血清TGF-β1、Smad2蛋白的表达,从而减轻哮喘患者气道重塑。调节TGF-β1／Smad通路可能是治疗哮喘气道重塑的新策略。     

沙美特罗替卡松粉联合噻托溴铵治疗慢性阻塞性肺病稳定期C组患者的临床疗效观察

目的 观察吸入不同剂量沙美特罗替卡松粉（舒利迭）联合噻托溴铵治疗慢性阻塞性肺病（COPD）稳定期C组患者的疗效.方法 门诊选取72例COPD稳定期C组患者,随机分成3组,Ⅰ组单独吸入舒利迭（50μg沙美特罗/500 μg丙酸氟替卡松,2次/日）、Ⅱ组单独吸入噻托溴铵（18μg,1次/日）和Ⅲ组吸入舒利迭（50μg沙美特罗/250 μg丙酸氟替卡松,2次/日）＋噻托溴铵（18μg,1次/日）,共治疗12周.用药前后分别检测患者肺功能,应用改良的英国医学研究委员会呼吸困难量表（mMRC）进行评分、COPD评估测试（CAT）及6分钟步行试验（6MWT）.结果 Ⅰ、Ⅲ组患者肺功能指标、mMRC及CAT评分、6分钟步行距离均较治疗前明显改善（P＜0.05）;Ⅱ组患者肺功能指标改善不明显,6分钟步行距离、mMRC及CAT评分均较前改善（P＜0.05）.结论 沙美特罗替卡松粉（50 μg/250 μg,2次/日）联合噻托溴铵治疗COPD稳定期C组患者疗效确切,治疗风险未增加,值得临床推广.     

噻托溴铵联合沙美特罗替卡松治疗慢性阻塞性肺疾病稳定期患者的疗效观察

目的 观察噻托溴铵联合沙美特罗替卡松对慢性阻塞性肺疾病(COPD)稳定期的治疗效果.方法 采用随机、双盲的方法将62例COPD患者分为观察组和对照组,观察组给予噻托溴铵和沙美特罗替卡松治疗,对照组给予沙美特罗替卡松治疗,分别对两组患者治疗前后呼吸困难评分和肺功能检测进行比较.结果 治疗两个月后,与对照组比较观察组肺功能FEV1、FVC、FEV1/FVC%,呼吸困难评分改善差异有统计学意义(P＜0.05).结论 噻托溴铵与沙美特罗替卡松联合吸入治疗COPD,疗效优于沙美特罗替卡松单药治疗.     

沙美特罗替卡松粉剂在慢性阻塞性肺疾病稳定期应用的临床观察

目的观察长期吸入沙美特罗替卡松粉剂对于稳定期中重度慢性阻塞性肺疾病（COPD）患者肺功能及生活质量的影响。方法将50例COPD稳定期患者随机分为两组。治疗组长期给予沙美特罗替卡松粉剂2次/d,每次1吸;对照组仅在急性发作期吸入沙美特罗替卡松粉剂1,年后比较两组肺功能、呼吸困难指数、急性发作次数及平均入院天数。结果①治疗组一年后FEV1及FVC较对照组有明显改善;②治疗组呼吸困难明显改善;③治疗组急性发作次数及住院天数均少于对照组。结论对于稳定期中重度COPD患者长期吸入沙美特罗替卡松粉剂可改善肺功能及生活质量。     

沙美特罗替卡松在哮喘治疗中的控制作用

目的研究沙美特罗替卡松粉吸入剂治疗支气管哮喘的临床安全性及疗效。方法选择2009年2～10月笔者所在医院110例支气管哮喘患者,随机分成治疗组和对照组,每组各55例。治疗组患者选择沙美特罗替卡松粉吸入剂治疗;对照组患者只选择丙酸氟替卡松进行治疗,观察两组患者药物反应和症状改善情况,比较两组患者咳嗽、喘息及呼吸困难消失时间。结果治疗组患者咳嗽、喘息及呼吸困难消失时间都比对照组患者短,差异有统计学意义（P〈0.05）;治疗组用药后各项肺功能改变率与对照组比较,差异有统计学意义（P〈0.05）。结论应用沙美特罗替卡松粉吸入剂治疗哮喘,不但治疗效果好而且使用安全,值得临床上推广应用。     

孟鲁司特钠联合沙美特罗/氟替卡松治疗咳嗽变异性哮喘疗效分析

目的比较孟鲁司特钠联合沙美特罗/氟替卡松、沙美特罗/氟替卡松治疗咳嗽变异性哮喘的疗效。方法选择60名咳嗽变异性哮喘患者,随机分成两组：对照组：吸入沙美特罗/氟替卡松（50 ug/250 ug）早晚各1吸,治疗组：联合孟鲁司特钠10mg每晚口服。每组按需吸入沙丁胺醇气雾剂。观察两组病人的临床疗效、不良反应和复发率。结果治疗组临床疗效明显改善,与对照组相比有显著差异性（P〈0.05）。结论孟鲁司特钠联合沙美特罗/氟替卡松治疗咳嗽变异性哮喘疗效明显,值得推广。     

The Effects of Inhaled Albuterol and Salmeterol in 2- to 5-Year-Old Asthmatic Children as Measured by Impulse Oscillometry*

The functional assessment of the response to bronchodilators in 2- to 5-year-old asthmatic children is technically difficult. For this reason, there have been no reports on the effects of long-acting bronchodilators, such as salmeterol, in this age group. Of the several techniques available for measuring resistance to airflow, forced oscillation remains the most adaptable to young children and the most practical for research and clinical use. In this study we used the Jaeger MasterScreen Impulse Oscillometry System to assess the response of 2 to 5 year-old asthmatic children to an inhaled long-acting bronchodilator, salmeterol, by comparing it to the effect of a standard dose of the short-acting bronchodilator, albuterol. We performed a placebo-controlled, randomized, crossover study in 10 children aged 2 to 5 years who had a history of physician-diagnosed asthma and who were not on regular controller therapy. At weekly intervals after baseline measurements of reversibility, each child received two inhalations from an albuterol metered-dose inhaler (MDI) with a spacer (200 µg), or placebo MDI with spacer, or two inhalations from a salmeterol MDI (50 µg), or 50 µg from a salmeterol Diskus®. Measurements were obtained at 5, 30, 60, 360, and 540 min, the last time interval only on the salmeterol days. Based on previous studies, total respiratory system reactance at 5 Hz (X₅), calculated by the MasterScreen computer from mouth pressure and flow data, was used as the primary efficacy variable. The mean intra-individual variability in X₅ was 10.5% (range 3.6% to 17.9%). The mean (SE) changes from baseline X₅ at each time point were as follows: for placebo, 9.6 (3.0), 10.1 (2.6), 5.1 (2.9), 6.1 (3.5), p=0.36 vs. baseline; after treatment with albuterol, 32.7 (3.8), 53.9 (1.2), 47.3 (5.4), 18.1 (5.8), p<0.01 vs. baseline at all time points; after salmeterol MDI, 16 (6.4), 28.9 (5.2), 32.7 (3.9), 34.6 (4.4), 31.2 (4.8), p<0.05 at 60, 360, and 540 min; and after salmeterol Diskus®, 16.4 (4.0), 16.9 (6.6), 27.8 (5.9), 28.6 (5.6), 33.8 (4.0), p<0.05 at 540 min. No significant adverse events or electrocardiographic changes were noted at any time. Impulse oscillometry is an acceptable method of assessing airway responses to bronchoactive drugs in this age group. Compared to albuterol and to its effect in older children and adults, the response to salmeterol Diskus® appears to be somewhat blunted in this age group. The MasterScreen system is well suited for pharmacodynamic studies and clinical investigations in pre-school-aged children.     

The effect of fixed combination of fluticasone and salmeterol on asthma drug utilization,asthma drug cost,and episodes of asthma exacerbations

ABSTRACT

Objective: This study evaluated the use and drug costs of inhaled corticosteroids (ICSs), long-acting β₂-agonists (LABAs), and fluticasone propionate and salmeterol in a fixed-dose combination (FSC) and their relationship to asthma exacerbations before and after the market introduction of FSC in April 2001.

Methods: This is a retrospective analysis of employer-sponsored health insurance claims filed between January 1, 1998, and December 31, 2003 to detect impact of introduction of FSC (approved by the US Food and Drug Administration in August 2000) on utilization and cost of FSC, any ICS (excluding FSC), and any LABA (excluding FSC) along with utilization of medical services related to asthma exacerbations. Asthma medications were identified using National Drug Codes and Redbook, whereas asthma exacerbations were identified using ICD?9?CM primary diagnosis code 493.x. These medical and pharmacy claims were converted to rates per 100 asthma office visits.

Results: For all ICSs, the average pharmacy claims per 100 office visits increased from 383 in the year before FSC was introduced to 407 (120 [29.5%] were for FSC and 287 [70.5%] were for single-entity ICSs) in 2003. LABA prescribing increased from 72 in the year before FSC to 147 (120 from FSC, 27 single-entity LABA) in 2003 (?p < 0.001). An additional $13?511 per 100 asthma office visits was spent on the FSC product (?p < 0.001). After the introduction of FSC, there was no significant difference in asthma admissions (?p = 0.17), whereas emergency department (ED) visits increased by 0.92 visits per 100 office visits (?p = 0.03). The diagnosis and severity of asthma was inferred from the pharmacy claims and patients with chronic obstructive pulmonary disease could not be excluded. In addition, the study was not designed to assess the impact of other asthma medications on the disease and/or associated costs, and patient adherence to claimed medication could not be monitored.

Conclusions: The introduction of FSC was associated with increased LABAs/FSC patient exposure and expenditure with no change in asthma hospitalizations and an increase in ED visits.     

Fluticasone given once versus twice a day: meta-analysis

OBJECTIVE: The aim of this study was to examine the efficacy of fluticasone administered once daily compared to twice daily in asthma. METHODOLOGY: A meta-analysis was performed of randomized double-blind trials of at least 4 weeks duration that compared fluticasone administered once versus twice a day and presented data on at least one clinical outcome measure. RESULTS: Six studies of 1517 children and adults with asthma met the inclusion criteria. Studies were predominantly in subjects with moderate asthma, treated with doses of fluticasone ranging from 200 to 500 microg per day. Twice-daily dosing was associated with significantly greater efficacy compared with once-daily dosing, for all outcome measures except night wakenings. The mean (95% CI) differences between twice and once-daily administration for FEV(1) and peak expiratory flow were 0.11 L (0.07-0.16) and 12.9 L/min (8.6-17.1), respectively. Twice-daily fluticasone was associated with significantly fewer withdrawals due to asthma than once-daily fluticasone, with an odds ratio of 0.44 (0.30-0.67). CONCLUSION: The findings suggest that twice-daily administration of fluticasone will provide greater therapeutic benefit than a once-daily morning regimen.