Use of inhaled fluticasone propionate to control respiratory manifestations of relapsing polychondritis

Effective management of respiratory tract involvement is very important in improving the prognosis of relapsing polychondritis (RPC). This case report describes a 19-year-old patient with RPC, who required frequent hospitalization due to recurrent exacerbations of airway obstruction. Use of high-dose fluticasone propionate effectively reduced the amount of oral corticosteroid necessary to control inflammation of the airway mucosa and dramatically decreased the patient's obstructive airway impairment. This report is the first illustrating the effectiveness and safety of inhaled corticosteroids in the control of the respiratory manifestations of RPC.     

沙美特罗替卡松粉吸入剂联合孟鲁司特钠治疗儿童哮喘的疗效及复发情况分析

目的 分析沙美特罗替卡松粉吸入剂联合孟鲁司特钠治疗儿童支气管哮喘的临床疗效及复发情况.方法 将98例哮喘患儿按就诊先后顺序分为治疗组58例和对照组40例.对照组采用沙美特罗替卡松粉吸入剂治疗,共6个月;治疗组则在吸入沙美特罗替卡松粉吸入剂同时予孟鲁司特钠口服,5 mg/d,睡前服用,6个月后停用.观察两组的治疗效果及复发情况.结果 治疗组临床控制率和肺功能达标率均明显高于对照组,复发率明显低于对照组,差异均有统计学意义(P<0.05).结论 沙美特罗替卡松粉吸入剂联合孟鲁司特钠控制儿童哮喘疗效确切,复发率低,值得临床推广.     

The functional impact of adding salmeterol and tiotropium in patients with stable COPD

The aim of this double-blind, double-dummy, crossover, randomised, pilot study was to explore the acute effects of adding salmeterol and tiotropium in patients with stable COPD. A total of 20 outpatients with stable COPD were enrolled. Single doses of 18-microg tiotropium, 50-microg salmeterol, and 18-microg tiotropium+ 50-microg salmeterol were given. Serial measurements of forced expiratory volume in 1 s (FEV1) were performed over 24h. The mean maximum increases in FEV1 from pre-dosing value on each of the dosing days were 0.165l (95% CI: 0.098-0.232) for tiotropium, 0.241 l (95% CI: 0.151-0.332) for salmeterol, and 0.290 l (95% CI: 0.228-0.353) for the combination and occurred 4 h after inhalation of tiotropium or salmeterol and 3 h after the combination. At 12h, the mean increases in FEV1 from pre-dosing value were 0.071 l (95% CI: 0.001-0.141; P = 0.047) for tiotropium, 0.069 l (95% CI: 0.018-0.120; P = 0.010) for salmeterol, and 0.108 l (95% CI: 0.047-0.170; P = 0.001) for the tiotropium + salmeterol combination. Only the difference between salmeterol and tiotropium + salmeterol was statistically significant (P = 0.009). At 24h, the mean FEV1 value was still higher than the mean pre-dosing value for tiotropium (0.042 l; 95% CI: -0.012-0.097; P=0.119) and the tiotropium+salmeterol combination (0.051 l; 95% CI: 0.01 5-0.087; P = 0.007), but not for salmeterol alone (-0.013 l; 95% CI: -0.041-0.014; P = 0.324). The FEV1 area under the curve (AUCs0-12h) were 1.657 l (95% CI: 1.152-2.162) for tiotropium, 2.068 (95l CI: 1.385-2.752) for salmeterol, and 2.541 l (95% CI: 1.954-3.129) for tiotropium + salmeterol. Only the difference between tiotropium and the tiotropium +salmeterol combination was statistically significant (P = 0.01). The FEV1 AUCs0-24h were 2.854 l (95% CI: 1.928-3.780) for tiotropium, 2.786 l (95% CI: 1.913-3.660) for salmeterol, and 3.640 l (95% CI: 2.674-4.605) for tiotropium + salmeterol. ALL differences between treatments were not statistically significant (P> 0.05). These results seem to indicate that the use of the tiotropium + salmeterol combination is more efficacious than the single agents alone, but the once-daily administration of the two drugs is inadvisable due to the broncholytic profile of salmeterol.     

吸入沙美特罗氟替卡松对COPD缓解期的影响

目的研究吸入沙美特罗氟替卡松干粉对缓解期慢性阻塞性肺疾病(COPD)患者肺功能的影响。方法将缓解期COPD患者随机分为两组,实验组在对照组基础加用沙美特罗氟替卡松干粉吸入,于入组时、用药后4周及l2周症状评分和肺功能检查。结果两组症状评分和肺功能在4周和l2周时均有改善,实验组改善程度远高于对照组。结论吸入沙美特罗氟替卡松干粉能改善中重度COPD缓解期患者的症状评分和肺功能。     

Maintaining asthma control in persistent asthma: comparison of three strategies in a 6-month double-blind randomised study

In patients controlled with SFC250 Diskus bd, this double-blind, randomised 6-month study compared continuing SFC250 to stepping down to either SFC100 bd or FP250 bd. Six hundred and three patients previously using 1,000 microg BDP (or equivalent) daily +LABA and controlled according to investigator's judgement were recruited. Patients received SFC250 bd during an 8-week open run-in period. Four hundred and seventy six patients (mean age=43 years, mean FEV(1)=2.9+/-1.0) who fulfilled the randomisation criterion ('Well-controlled' asthma according to the GOAL weekly definition for the last 2 weeks of the run-in period) entered a 24-week treatment period. The statistical hypothesis was based on a non-inferiority of SFC100 or FP250 compared to SFC250. The main criterion was the change from baseline in morning PEF over weeks 1-12 in the per-protocol population. The non-inferiority limit was -15 L/min. At inclusion, the three treatment groups were well balanced. Mean morning PEF was 476, 470 and 465 L/min in the SFC250, SFC100 and FP250 groups, respectively. The adjusted mean change in morning PEF over weeks 1-12 was +1.76+/-2.43 L/min for SFC250, -3.07+/-2.32 L/min for SFC100 and -16.51+/-2.46 L/min for FP250. SFC100 was at least as effective as SFC250 (treatment difference -4.83 [-12.39; 2.72], p=0.151) whereas FP250 was not (treatment difference -18.27 [-26.05; -10.49], p<0.001). Similar results were observed over weeks 13-24 in morning PEF (SFC100-SFC250=-4.54+/-3.84, p=0.238; FP250-SFC250=-20.11+/-3.92, p<0.0001). Secondary endpoints showed a similar pattern. Over weeks 1-12, SFC250 was significantly more effective than FP250 on evening PEF, daily symptoms and bronchodilator use. There was no difference between SFC100 and SFC250. The mean annual rate of moderate exacerbations was 0.16 in both SFC 250 and SFC 100 groups, and 0.21 in FP 250 group (ns, Poisson analysis). All treatments were well tolerated. CONCLUSION: In patients achieving asthma control with SFC250, stepping treatment down with SFC100 was at least as effective on lung function and symptoms as continuing SFC250, whereas FP250 was not.     

沙美特罗／氟替卡松联合吸入治疗慢性阻塞性肺疾病急性加重期患者的疗效分析

目的探讨吸入沙美特罗／氟替卡松对慢性阻塞性肺疾病急性加重期患者的疗效。方法慢性阻塞性肺疾病急性加重期患者46例,全部病例入组前1个月无使用过任何剂型的激素、B受体激动剂、抗胆碱药,无氧疗史。随机分成两组,每组23例,疗程15d。舒利迭组吸入沙关特罗／氟替卡松;丙酸氟替卡松组吸入丙酸氟替卡松。两组患者其他治疗均按常规治疗。观察两组患者在治疗前后的疗效、肺功能、圣一乔治呼吸问卷（SGRQ）评分和不良反应。结果在治疗结束时,两组治疗效果比较,差异无统计学意义（P〉0．05）。舒利迭组的第1秒用力呼气量占预计值百分比（FEVI／预计值）和第1秒用力呼气量占用力肺活量的百分比（FEVl／FFVC）、SGRQ评分（包括呼吸症状、活动能力、疾病影响、SGRQ总分）较治疗前有不同程度的改善（P〈0．05）,与丙酸氟替卡松组比较差异明显,差异有统计学意义（P〈0．05）。丙酸氟替卡松组FEVl／预计值和FEVl／FVC治疗前后差异不明显（P〉0．05）,SGRQ评分中呼吸症状在治疗前后有明显差异（P〈0．05）;活动能力、疾病影响、SGRQ总分治疗前后差异不明显,无统计学意义（P〉0．05）。结论沙美特罗／氟替卡松联合吸入是治疗慢性阻塞性肺疾病急性加重期安全有效的方法。     

舒利迭和顺尔宁联合应用对CODP肺功能的影响

目的探讨沙美特罗替卡松（舒利迭）联合孟鲁斯特钠（顺尔宁）对慢性阻塞性肺疾病（COPD）患者肺功能的影响。方法40例患者随机分为舒利迭组（对照组）和舒利迭加顺尔宁组（试验组）各20例。两组入院期间均给于常规抗感染、吸氧、化痰和平喘对症治疗。对照组加用舒利迭,试验组加用舒利迭和顺尔宁,两组平喘治疗包括普通氨茶碱,按需使用喘康速气雾剂（特布他林）。出院后对照组继续使用舒利迭,试验组继续使用舒利迭和顺尔宁,共随访观察12周。两组均于治疗前查肺功能,治疗症状好转出院,12周后再次测定上述指标。结果两组治疗前肺功能无明显差异;治疗后两组肺功能较治疗前均有显著改善。试验组较对照组第一秒用力呼气容积（FEV1）、用力肺活量（FVC）、第一秒用力呼气容积／用力肺活量（FEV1／FVC）和第一秒用力呼气容积占预计值百分比（FEV1 ％ Pred）等明显改善,差异有显著性;试验组较对照组每天按需使用特布他林次数减少,差异有显著性。结论舒利迭和顺尔宁共同作用对COPD患者肺功能更有显著的改善作用。     

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.     

噻托溴铵联合沙美特罗氟替卡松对重度支气管哮喘疗效观察

目的探讨噻托溴铵联合沙美特罗氟替卡松对重度支气管哮喘的临床疗效,提高患者的生活质量。方法对照组给予大剂量沙美特罗氟替卡松粉吸入剂,观察组给予吸人噻托溴铵粉吸入剂联合中等剂量沙美特罗氟替卡松粉吸入剂。结果观察组治疗总有效率为88.0%,对照组治疗总有效率为62.0%,两组对比差异显著,P<0.05。治疗后两组的肺功能较治疗前均有改善,差异有统计学意义,P<0.05;且观察组较对照组改善更明显,差异有统计学意义,P<0.05。结论噻托溴铵联合沙美特罗氟替卡松改善患者生活质量,减少急性加重发作的次数,值得临床推广。