沙美特罗替卡松联合孟鲁司特钠治疗儿童变异性哮喘疗效和安全性分析

目的探讨沙美特罗替卡松联合孟鲁司特钠治疗儿童变异性哮喘（variant asthma,VA）的临床疗效及安全性。方法分析我院自2008年4月～2012年4月收治的变异性哮喘患儿124例,按随机数字表法分为治疗组64例、对照组60例。治疗组给予沙美特罗替卡松和孟鲁司特钠。对照组单用沙美特罗替卡松。两组均以6个月为一个疗程。观察两组肺功能变化、临床总体疗效及安全性问题。结果 （1）治疗前两组肺功能达标率（25.0%、23.3%）,两组比较差异无统计学意义（P〉0.05）。治疗后3个月（67.2%、41.4%）、6个月（79.7%、57.1%）、12个月（87.5%、65.0%）,两组肺功能达标率比较差异有统计学意义（P〈0.05）。（2）治疗组与对照组总有效率分别为95.3%（61/64）、80.0%（48/60）,两组比较差异有统计学意义（χ2=6.828,P〈0.01）。（3）治疗组与对照组复发率分别为4.7%、18.6%,两组比较差异有统计学意义（P〈0.05）。结论沙美特罗替卡松联合孟鲁司特钠治疗儿童变异性哮喘可以增加患者肺功能,提高临床有效率,减少疾病的复发,值得临床推广。     

Efficacy of Rhizophora mangle aqueous bark extract (RMABE) in the treatment of aphthous ulcers: a pilot study

SUMMARY

The introduction of combination products, for the co-administration of an inhaled corticosteroid (ICS) with a long-acting β2-agonist in a single inhaler, has greatly simplified asthma therapy. The two combination inhalers currently available, Symbicort* (budesonide/formoterol in a single inhaler) and Seretidet (salmeterol/fluticasone), comply with Step 3 of international guidelines that recommend the addition of a long-acting β2-agonist to ICS in patients who are inadequately controlled on ICS alone. Importantly, combination inhalers ensure that patients cannot neglect their ICS maintenance therapy in favour of the long-acting β2-agonist -which may improve adherence and overall asthma control. In vitro experiments suggest that ICS and long-acting β2-agonists may interact beneficially when they are administered via one inhaler. The efficacy and tolerability of budesonide/formoterol and salmeterol/fluticasone have been demonstrated. There are currently two approaches for treating asthma using combination therapy - fixed and adjustable dosing. Fixed dosing with budesonide/ formoterol or salmeterol/fluticasone provides effective asthma control in line with guideline goals. However, given the inherent variability of asthma, there is increasing evidence that adjusting the dose of ICS according to fluctuations in symptoms is beneficial. Findings from a series of studies comparing fixed and adjustable symptom-guided dosing regimens demonstrate that adjustable dosing may improve asthma control at an overall lower steroid dose. Ultimately, if adjustable dosing proves to be an effective treatment option, it may be possible to use budesonide/formoterol for both maintenance therapy and symptom relief, thereby overcoming the need for a separate reliever inhaler. This is because formoterol has a more rapid onset and greater dose-related effects than salmeterol in salmeterol/fluticasone. Given that all patients are different, with different disease severities and treatment preferences, both fixed and adjustable dosing strategies are likely to be important in the long-term management of asthma. It is possible that different treatment options will be used for different patients, depending on their disease severity, personality and ability to adhere to therapy.     

Budesonide/formoterol maintenance and reliever therapy: a new treatment approach for adult patients with asthma

ABSTRACT

Background: An inhaled corticosteroid (ICS) or an ICS/long-acting β₂-agonist (LABA) combination plus short-acting β₂-agonist (SABA) as needed for symptom relief is recommended for persistent asthma. Additionally, budesonide/formoterol maintenance and reliever therapy (Symbicort SMART, AstraZeneca, Sweden) has been approved for adults in the European Union. This option is well tolerated and offers greater reductions in asthma exacerbations together with similar improvements in daily symptom control, at a lower overall steroid load, compared with fixed-dose ICS/LABA plus SABA.

Scope: Two large clinical trials investigated the use of budesonide/formoterol as maintenance and reliever compared with medium or high doses of an ICS/LABA combination as controller plus SABA as reliever in adults (aged ≥ 12 years). COMPASS was a 6-month, double blind, randomized trial while COSMOS was a 1?year, dose titration study which reflected routine clinical practice. The current review focuses on the findings in both studies, among adult patients only (aged ≥ 18 years).

Findings: Among adults, the studies confirmed a 21–39% reduction in severe exacerbations in patients treated with budesonide/formoterol maintenance and reliever therapy compared with titrated salmeterol/fluticasone plus SABA (COSMOS) or fixed higher budesonide/formoterol or salmeterol/fluticasone plus SABA (COMPASS), respectively. Similar levels of daily asthma control were achieved with budesonide/formoterol maintenance and reliever therapy at a significantly lower overall steroid load compared with salmeterol/fluticasone or budesonide/formoterol plus SABA. Budesonide/formoterol maintenance and reliever therapy was as well tolerated as combination therapies.

Conclusions: In adult patients, budesonide/formoterol maintenance and reliever therapy is a safe and simplified approach to asthma management, using a single inhaler, which reduces severe exacerbations and maintains similar daily asthma control at a lower drug load compared with the traditional strategy of ICS/LABA plus SABA.     

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma

ABSTRACT

Objective: This study compared the bronchodilator efficacy and safety of indacaterol with placebo, salbutamol and salmeterol, in patients with persistent asthma, at single therapeutic and supratherapeutic doses.

Research design and methods: This was a randomised, open-label crossover study in adult subjects with asthma (forced expiratory volume in 1 second [FEV₁] ≥?60% predicted). In part A, patients (n = 20) received single doses of indacaterol 200?µg, salbutamol 200?µg, salmeterol 50?µg and placebo. In part B, patients (n = 19) received single doses of indacaterol 1000?µg, salbutamol 1000?µg, salmeterol 250?µg and placebo.

Main outcomes measures; Results: For the primary endpoint, FEV₁ area under the effect curve during 0–24?h, indacaterol 200?µg was statistically superior to placebo and salbutamol. Indacaterol 200?µg FEV₁ was higher than placebo (5?min to 24?h), salbutamol 200?µg (4–24?h), and salmeterol 50?µg (5 and 15?min and 22 and 24?h). Few adverse events were reported; all were mild or moderate in severity. Initial changes were observed in glucose, potassium, heart rate and QTc interval, but all values remained within normal ranges. Values matched placebo levels after a shorter time for indacaterol 1000?µg than for salmeterol 250?µg.

Conclusions: In this single-dose, open-label study, indacaterol 200?µg provided effective 24‐h bronchodilation, with a longer duration than salmeterol 50?µg and a good overall safety profile. The sustained bronchodilation of indacaterol 1000?µg was not associated with sustained systemic adverse effects.     

Efficacy of nebulized fluticasone propionate compared with oral prednisolone in children with an acute exacerbation of asthma

The aim of the present study was to investigate the efficacy and safety of nebulized fluticasone propionate (FP Nebules) compared with oral soluble prednisolone in children with an acute exacerbation of asthma. The study used an international, multi-centre, randomized, double-blind, parallel group design. Three hundred and twenty-one patients, aged 4-16 years old, who presented with an acute exacerbation of asthma, were randomly allocated to either nebulized FP (1 mg b.d.) or oral prednisolone (2 mg kg(-1) day(-1) for 4 days then 1 mg kg(-1) day(-1) for 3 days) for 7 days. Patients in the FP group showed a significantly greater increase in diary card morning peak expiratory flow (PEF) over 7 days compared with patients in the prednisolone group (difference = 9.51 min(-1), CI = 2.1, 16.8, P = 0.034). Similar increases for both treatments were shown for evening PEF. Clinic PEF improved with both treatments, but was significantly greater in patients taking FP after 7 days (difference = 11.41 min(-1), CI = 2.8, 20.0, P = 0.029). Both treatments reduced symptom scores to a similar extent. The two treatments were well tolerated, and there was no difference in the incidence of adverse events. The present study demonstrated that nebulized FP is at least as effective as oral prednisolone in the treatment of children presenting with an acute exacerbation of asthma.     

沙美特罗替卡松治疗支气管哮喘的临床效果研究

目的探讨分析沙美特罗替卡松粉吸入剂治疗支气管哮喘的临床疗效。方法回顾性分析2009年4月～2012年5月本院收治的100例支气管哮喘患者临床资料,将100例患者随机分为两组,观察组50例患者使用沙美特罗替卡松粉吸入剂治疗,对照组50例患者采用布地奈德粉吸入治疗。比较两组患者治疗前后肺功能指标及临床症状变化。结果两组患者治疗后,临床症状、肺功能各项指标均有明显改善;治疗后观察组临床症状及肺功能改善情况明显优于对照组。结论沙美特罗替卡松粉吸入剂治疗支气管哮喘安全有效。     

沙美特罗／替卡松粉吸入剂对慢性阻塞性肺疾病患者糖代谢的影响

目的探讨沙美特罗／替卡松粉吸入剂对慢性阻塞性肺疾病患者糖代谢的影响。方法将稳定期慢性阻塞性肺疾病患者120例根据数字表法平分为两组,即治疗组与对照组各60例,对照组患者采用常规疗法．治疗组在对照组治疗基础上给予沙美特罗／替卡松吸人剂吸入治疗。结果经过观察,治疗后治疗组的FEV1、FEV1／FVC与PEF值明显高于对照组（P〈0．05）,表明其肺功能状况有了明显恢复。同时两组治疗前后的空腹血糖、餐后2h血糖比较差异均无统计学意义（P〉0．05）。结论沙美特罗／替卡松粉吸人剂的应用能在改善慢性阻塞性肺疾病患者肺功能状况的基础上,不影响糖代谢,值得临床推广应用。