吸入沙美特罗/氟替卡松或福莫特罗/布地奈德对支气管哮喘慢性持续期的疗效评价

目的 观察吸入沙美特罗/氟替卡松和福莫特罗/布地奈德对支气管哮喘慢性持续期的疗效.方法 将120例中度支气管哮喘慢性持续期的患者随机分为两组,一组吸入沙美特罗/氟替卡松(50/250),250 μg/次,2次/d,另一组吸入福莫特罗/布地奈德,(4.5/160),160 μg/次,2次/d.评价3个月、6个月内的急性发作次数、夜间发作次数、使用短效β2受体激动剂的次数和哮喘控制调查表评分.结果 治疗3月的沙美特罗组急性发作次数、使用短效β2受体激动剂的次数和哮喘控制调查表评分多于布地奈德组,夜间发作次数少于布地奈德组,但差异没有统计学意义;治疗6月时沙美特罗组急性发作次数、夜间发作次数、使用短效β2受体激动剂的次数和哮喘控制调查表评分均少于布地奈德组,但差异仍没有统计学意义.结论 中度支气管哮喘慢性持续期的患者吸入沙美特罗/氟替卡松或福莫特罗/布地奈德干粉剂均能取得同样的哮喘控制.     

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.     

A One-Week Dose-Ranging Study of Inhaled Salmeterol in Children with Asthma

This was a 1-week study evaluating the safety and efficacy of two dosage regimens of salmeterol in children with asthma. A total of 243 children, aged 4-11 years, with mild-to-moderate asthma were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating salmeterol xinafoate 21 μg and 42 μg administered via metered-dose inhaler (MDI) twice daily for 1 week. Patients were allowed to use albuterol MDI as needed for relief of acute symptoms. Inhaled corticosteroids and/or cromolyn at fixed dosages could be continued during the study, but theophylline and oral β-agonists were not allowed. Twelve-hour serial spirometry (for patients aged 6-11 years) and serial peak expiratory flow rate (PEFR) (all patients) were performed on days 1 and 8 of treatment; morning and evening PEFR were recorded each day prior to inhalation of the study drug. Safety was assessed by monitoring adverse events, clinical laboratory values, vita signs, electrocardiogram (ECC), and 24-hr ECG (Holter) monitoring. Both the 21 -μg and 42-μg doses of salmeterol produced significantly greater bronchodilation, as measured by 12-hr serial forced expiratory volume in 1 sec (FEV₁) (p ≤ 0.02) and PEFR (p ≤ 0.001), than did placebo on days 1 and 8. A small dose-response was observed, with the 42-μg dosage producing consistently higher serial FEV₁and PEFR than did the 21 -μg dosage, although the differences were not statistically significant. Morning and evening PEFR increased significantly (p ≤ 0.008) with both dosages of salmeterol compared with placebo. Twelve patients (5%) experienced potentially drug-related adverse events, with headache (4% in each salmeterol group) being the most common. There were no clinically significant changes in heart rate as measured by Holter monitoring, ECCs, vital signs, or clinical laboratory values following treatment with either dose of salmeterol. Salmeterol 21 μg or 42 μg twice daily was effective in producing bronchodilation in children aged 4-11 years, and both dosages had good safety profiles. Patients treated with salmeterol 42 μg twice daily showed a trend toward greater improvement in asthma control compared with those who received salmeterol 21 μg.     

吸入舒利迭对重度稳定期慢性阻塞性肺疾病的肺功能临床分析

目的探讨沙美特罗/氟替卡松治疗是否能改善慢性阻塞性肺疾病(chronicobstructive pulmonary disease,COPD)缓解期患者的肺通气功能。方法重度COPD稳定期患者64例随机分为治疗组和对照组。对照组给予常规治疗,应用氨茶碱、异丙托溴铵等。治疗组在常规治疗的基础上吸入沙美特罗/氟替卡松(50/250μg)。在治疗前,治疗后24周测定肺功能,评价肺功能改善状况。结果治疗组在治疗后24周肺功能有明显改善,和对照组相比有显著差异(P0.05)。结论沙美特罗/氟替卡松是改善稳定期重度COPD患者肺功能的一种有效治疗方法。     

沙美特罗/丙酸氟替卡松干粉剂吸入治疗成人支气管哮喘60例疗效观察

目的:探讨沙美特罗/丙酸氟替卡松干粉剂(商品名:舒利迭,葛兰素史克公司出品)吸入治疗支气管哮喘的疗效。方法:90例患者随机分为2组,治疗组采用沙美特罗/丙酸氟替卡松干粉剂50/250"g每日2次吸入,对照组采用丙酸氟替卡松气雾剂(商品名:辅舒酮,葛兰素史克公司出品)250"g每日2次吸入,治疗第4、8周两次评价患者哮喘症状和疗效。结果:在治疗第4、8周,治疗组哮喘症状和对照组相比明显减轻。结论:舒利迭为沙美特罗/丙酸氟替卡松混合吸入剂,是控制哮喘的一个良好选择。     

噻托溴铵联合福莫特罗与沙美特罗替卡松治疗稳定期慢性阻塞性肺疾病的疗效观察

目的 探讨噻托溴铵联合福莫特罗治疗稳定期慢性阻塞性肺疾病患者的临床疗效.方法 选取我院诊治的130例中重度慢性阻塞性肺疾病患者.采用数字表法随机分为噻托溴铵联合福莫特罗组(A组)和沙美特罗替卡松组(B组),每组各65例,治疗12周后,比较2组的肺功能(第1秒用力肺活量、用力肺活量)和CAT评分.结果 治疗12周后,2组患者FEV1、FVC及CAT评分较治疗前均明显增高,治疗前后比较差异均有统计学意义(P＜0.05).治疗后,A组患者FEV1、FVC高于B组,2组比较差异有统计学意义(P＜0.05).CAT评分2组差异无统计学意义(P＞0.05).结论 治疗12周后,噻托溴铵联合福莫特罗组对中重度COPD患者的肺功能的提高明显优于沙美特罗替卡松.     

沙美特罗替卡松粉吸入剂对哮喘急性发作患者肺功能的影响

目的观察支气管哮喘急性发作患者应用沙美特罗替卡松粉(50μg/250μg)吸入剂治疗后的肺功能变化情况,探讨肺功能检测的临床应用价值。方法回顾性分析北京军区总医院呼吸内科2009年3月至2010年3月收治的106例支气管哮喘急性发作患者的临床资料。所有患者均用使用沙美特罗替卡松粉吸入剂进行治疗,12 h/次,2次/d。观察治疗后患者的肺功能变化情况,并用哮喘控制测试表(ACT)评价哮喘控制情况。结果治疗后患者的肺功能明显改善,1秒用力呼气容积,1秒用力呼气容积/用力呼气肺活量、呼气峰流量等反映肺功能的指标在治疗前后比较差异有统计学意义(P<0.05)。哮喘控制情况治疗前后比较差异有统计学意义(P<0.05)。无明显不良反应。结论沙美特罗替卡松粉吸入剂能改善支气管哮喘急性发作患者的肺功能。肺功能测定可作为评估哮喘控制程度的重要依据之一,具有一定的临床应用价值。     

沙美特罗替卡松吸入剂预防急性高原反应的效果观察

目的：观察沙美特罗替卡松粉吸入荆预防急性高原反应的效果。方法：55名青年随机分为沙美特罗组（n=31）和安慰剂组（n=24），自海拔1400m历时4天进入5200m，第2天开始，沙美特罗组每天早晚各吸入沙美特罗替卡松粉一个剂量（沙美特罗50μg，丙酸氟替卡松100μg），连续7天；安慰荆组用同样方法吸入少量生理盐水。以军用卫生标准GJB1098-91《急性高原反应的诊断和处理原则》随访观察第2天、4天、7天急性高原反应的严重程度、SaO2和脉率。结果：进入海拔5200m第7天安慰剂组急性高原反应症状较沙美特罗组严重（P〈0．05），第2天、4天安慰剂组脉率较沙美特罗组减慢（P〈0．05），SaO2两组无显著性意义（P〉0．05）。随访期间沙美特罗组发生一例高原脑水肿，安慰剂组发生一例高原肺水肿。结论：沙美特罗替卡松粉吸入剂预防急性高原反应无确切效果。     

Validation of a reverse-phase high performance liquid chromatographic method for concurrent assay of a weak base (salmeterol xinafoate) and a pharmacologically active steroid (fluticasone propionate)

The analysis of weakly basic drugs such as salmeterol xinafoate (SX) by reverse-phase liquid chromatography remains a problem, particularly when present in combination with other drugs such as steroids and weak acids. This study describes the validation of an assay for a weakly basic drug, salmeterol (SB), its weakly acidic counter-ion, 1-hydroxy-2-naphthoic acid (XA), and the neutral glucocorticoid, fluticasone propionate (FP) using a second-generation silica stationary phase (Inertsil ODS-2). The assay utilized an Inertsil ODS-2 base-deactivated 250 mm × 4.6 mm, 5 μm HPLC column, with 75:25 methanol:0.6% aqueous ammonium acetate as the mobile phase. Under these near neutral conditions, SB demonstrated a good peak shape (tailing factor = 1.21 ± 0.02, n = 85). The method provided a short analysis time: XA, t_R = 2.96 min; SB, t_R = 5.23 min and FP, t_R = 7.01 min. The assay displayed good sensitivity for both XA (LOD for SX = 0.22 μg mL⁻¹) and SB (LOD for SX = 0.26 μg mL⁻¹). The limit of detection for FP was 0.19 μg mL⁻¹. Neither of the drugs was found to interfere in the determination of the other and the assay accuracy (% recovery) was high (the recoveries were: 99.58 ± 1.85% for XA, 99.49 ± 1.88% for SB and 100.24 ± 1.28% for FP). The assay reproducibility was determined with a mean coefficient of variance for the five calibration concentrations of XA = 0.71 ± 0.18%; SB = 1.11 ± 0.64% and FP = 0.92 ± 0.14%. Analysis of a pressurized metered dose inhaler formulation demonstrated recovery of the analytes that are within pharmacopoeial limits. It was shown that RP-HPLC was suitable for the high throughput analysis of the combination of SX and FP.     

Improved Ability to Perform Strenuous Activities After Treatment with Fluticasone Propionate/Salmeterol Combination in Patients with Persistent Asthma

Patients with asthma experience disruptions in usual activities that can impair their quality of life, and in patients whose daily routine involves an active lifestyle, these disruptions can be severe. We assessed the patient-perceived effect of treatment with fluticasone propionate/salmeterol combination (FSC), compared with fluticasone propionate (FP) or salmeterol (SAL) alone, on activity limitations, particularly strenuous physical activities. The Asthma Quality of Life Questionnaire (AQLQ) was administered in two 12-week, randomized, double-blind, placebo-controlled trials comparing FSC 100/50 or 250/50 µg twice daily vs. the individual components alone in 686 adults and adolescents with asthma. In one study, patients were stratified by prior treatment [low to medium doses of inhaled corticosteroids (ICS) or SAL], and in the other study, all patients were previously treated with medium to high doses of ICS. Patients prospectively identified five activities they performed regularly and were asked how these activities were limited by their asthma. The effect of randomized treatment on strenuous activities (e.g., aerobics, cycling, hiking, and basketball) was assessed. In both studies, treatment with FSC resulted in clinically meaningful improvements (i.e., change in AQLQ of ≥0.5) and was statistically significantly better than SAL in both studies and FP in one study. Treatment of the two main components of asthma—inflammation and bronchoconstriction—with FSC results in clinically meaningful improvements in the ability of patients with persistent asthma to perform not only their usual activities but also strenuous activities.