小剂量布地奈德粉吸入剂治疗轻度支气管哮喘患者的远期疗效

目的　探讨小剂量布地奈德粉吸入剂(商品名:普米克都保)长期吸入治疗轻度支气管哮喘(简称哮喘)的远期疗效和不良反应。方法　将52例轻度哮喘患者分为3组。吸入糖皮质激素组(A组)22例:每晚吸入布地奈德粉吸入剂200μg。口服糖皮质激素组(B组)15例:在哮喘发作期给予泼尼松5mg每天1次口服,茶碱控释片(商品名:舒弗美)02g每天2次口服;沙丁胺醇(商品名:喘乐宁)气雾剂2揿(每揿100μg)每天3次吸入。非糖皮质激素组(C组)15例:发作期只给茶碱控释片02g每天2次口服,沙丁胺醇气雾剂2揿每天3次吸入。全部病例连续治疗3年,停药后随访1年。在此4年间,检测各组患者治疗前、后一秒钟用力呼气容积(FEV1)、气道阻力(Raw)、气道传导率(Gaw)、气道高反应性(BHR)、临床疗效、血浆皮质醇浓度以及促肾上腺皮质激素(ACTH)刺激后的反应等。结果　(1)治疗前A、B、C3组绝大多数病例的BHR均在3~4级,分别为91%(20/22)、100%(15/15)、93%(14/15)。治疗后A组18例(82%)转为1~2级;B组13例(87%)仍为3~4级;C组15例(100%)病例为3~5级。A、B、C3组间比较差异有统计学意义(P均<001)。(2)A、B、C3组Raw治疗前分别为(623±103)%、(605±90)%、(638±108)%,治疗后分别为(158±24)%、(340±61)%、(420±81)%,3组间比较差异有统计学意义(P均<001)。(3     

布地奈德干粉吸入剂对老年哮喘患者的疗效评价

目的 观察布地奈德干粉吸入剂对老年哮喘患者的临床疗效。方法 将５９例老年哮喘患者分厉三组,分别吸布地奈德干粉吸入剂２次／ｄ,每次２００ｍｇ,倍氯米松气雾剂２次／ｄ,每次２００μｇ,特布他林２次／ｄ,每次０．５μｇ,连续治疗４组。结果 治疗４周后布地奈德组患者肺功能（ＦＥＶ１和ＰＥＦ）的改善和临床疗效均较倍氯米松和特布他林组患者明显。结论 吸入布地奈德干粉吸入剂对哮喘有良好疗效,且吸入方法易于掌握,     

吸烟对轻度支气管哮喘患者吸入激素疗效的影响

目的　观察吸烟对轻度支气管哮喘患者吸入激素疗效的影响。方法　对不吸烟 (1 8例 )及吸烟 (1 7例 )的支气管哮喘患者每日吸入二丙酸倍氯米松 5 0 0μg治疗 4周 ,治疗前后进行肺功能测定及气道反应性试验 ,用药过程中监测呼气峰流速 (peak expiratory flow,PEF)。结果　不吸烟组患者治疗后的清晨 PEF、睡前 PEF、FEV1 %及气道反应性均较治疗前改善 (P<0 .0 5 )。而吸烟组患者在治疗前后上述指标却变化不大 (P>0 .0 5 )。结论　吸烟能明显减弱支气管哮喘患者吸入激素的疗效 ,支气管哮喘患者应积极戒烟以取得较好的疗效     

糖皮质激素治疗支气管哮喘缓解期患者对血清总IgE水平的影响

糖皮质激素治疗支气管哮喘缓解期患者对血清总ＩｇＥ水平的影响周燕斌容中生本实验旨在观察不同严重程度的支气管哮喘缓解期患者血清总ＩｇＥ（ＴＩｇＥ）水平的变化及糖皮质激素（ＧＣ）治疗对其的影响。１．对象：哮喘缓解期患者６０例，男２８例，女３２例，年龄１４～...     

布地奈德/福莫特罗干粉吸入剂治疗成人咳嗽变异性哮喘的临床研究

目的:评价联合应用布地奈德/福莫特罗粉吸入剂及孟鲁司特钠口服片剂,治疗成人咳嗽变异性哮喘的疗效。方法:咳嗽变异性哮喘患者42例,随机分为观察组22例(联合应用布地奈德/福莫特罗粉吸入剂及孟鲁司特钠口服片剂治疗),对照组20例(单用孟鲁司特钠口服片剂),连用4w。在治疗前、治疗2w、4w后分别记录患者的咳嗽症状积分及视觉模拟评分(VAS),比较2组的疗效。结果:两组治疗2w及4w后,咳嗽积分及VAS较治疗前均有下降,观察组下降明显,观察组在治疗2w后与对照组咳嗽积分比较P<0.05;4w后显著下降,两组比较P<0.001。结论:联合应用布地奈德/福莫特罗粉吸入剂及孟鲁司特钠口服片剂治疗成人咳嗽变异性哮喘比单用孟鲁司特钠疗效显著。     

长效抗胆碱能药物治疗支气管哮喘的机制及临床应用

支气管哮喘通常是由多种细胞以及细胞组分共同参与的慢性气道炎症性疾病.2017年,全球哮喘发病率为0. 56％,患病率3. 57％,吸入性糖皮质激素(Inhaled corticosteroids,ICS)联合长效 β 受体激动剂( long-acting beta agonists, LABA )是最为广泛应用的方案,...     

支气管哮喘防治指南(支气管哮喘的定义、诊断、治疗及教育和管理方案)

一、定义支气管哮喘 (简称哮喘 )是由多种细胞 (如嗜酸性粒细胞、肥大细胞、Ｔ淋巴细胞、中性粒细胞、气道上皮细胞等 )和细胞组份 (ｃｅｌｌｕｌａｒｅｌｅｍｅｎｔｓ)参与的气道慢性炎症性疾患。这种慢性炎症导致气道高反应性的增加 ,通常出现广泛多变的可逆性气流受限 ,并引起反复发作性的喘息、气急、胸闷或咳嗽等症状 ,常在夜间和 (或 )清晨发作、加剧 ,多数患者可自行缓解或经治疗缓解。二、诊断诊断标准 :(1)反复发作喘息、气急、胸闷或咳嗽 ,多与接触变应原、冷空气、物理、化学性刺激、病毒性上呼吸道感染 ,运动等有关。 (2 )发作…     

布地奈德治疗妊娠合并支气管哮喘临床疗效观察

目的探讨布地奈德治疗妊娠合并支气管哮喘临床疗效。方法分析我院收治入院的经确诊60例妊娠合并支气管哮喘急性发作患者的临床资料,根据治疗方法不同分为两组,每组各30例,两组均给予常规治疗,治疗组加用布地奈德吸入治疗。观察两组治疗后FEV1%(1 s用力呼气量),及日间哮喘症状、夜间憋醒次数和安全性等。结果治疗组喘憋消失时间、哮鸣音消失时间、住院时间均明显低于对照组,P<0.05;治疗组治疗后FEV1、FEV1/FVC、PEF等指标明显改善,与治疗前比较具有显著差异,P<0.05;两组治疗后FEV1、FEV1/FVC、PEF等指标比较差异有显著性(P<0.05)。结论布地奈德气雾剂对于控制妊娠合并支气管哮喘患者的症状、减少发作具有良好疗效。     

沙美特罗/丙酸氟替卡松干粉与布地奈德干粉吸入治疗成人支气管哮喘的临床疗效和安全性对照研究

目的比较低剂量的沙美特罗/丙酸氟替卡松干粉剂(SM/FP)与中等剂量的布地奈德干粉(BUD)吸入治疗成年轻、中度支气管哮喘(简称哮喘)患者的临床疗效和安全性。方法采用多中心、随机、开放、平行对照试验,389例18～70岁哮喘患者按随机数字表法分为试验组[199例,吸入SM/FP1泡/次(每泡SM50μg、FP100μg),每天2次]和对照组(193例,吸入BUD,每次400μg,每天2次)。结果试验组和对照组患者晨间呼气峰流速(PEFam)在治疗的第1周末较基线值分别提高(26±2)L/min和(7±5)L/min(P均<0.01);6周后两组的改善分别为(54±6)L/min和(31±8)L/min(P均<0.01);治疗期间试验组每周均改善更明显;晚间呼气峰流速(PEFpm)与PEFam结果相似;日间和夜间症状评分在试验组和对照组治疗第1周比较差异均有统计学意义(P<0.05);6周时试验组下降的程度与对照组比较差异有统计学意义(P<0.01);全天无症状天数的百分数试验组由治疗前的6.9%增加至治疗后的55.2%,对照组则由8.4%增加至36.1%。沙丁胺醇气雾剂的揿数在两组分别由治疗前的(3.32±3.15)揿和(3.21±3.23)揿下降至治疗结束时的(1.06±1.79)揿和(2.03±3.17)揿,两组比较差异有统计学意义(P<0.01),试验组的用药揿数显著少于对照组;无需沙丁胺醇的天数试验组与对照组比较差异有统计学意义(P<0     

布地奈德联合多索茶碱治疗支气管哮喘的疗效观察

目的 观察布地奈德联合多索茶碱治疗支气管哮喘的疗效.方 法47例支气管哮喘患者随机分为治疗组(24例)和对照组(23例).对照组采用常规方法治疗,治疗组在对照组基础上加用布地奈德和多索茶碱联合治疗.两组疗程均为14 d.观察两组治疗总有效率和治疗前后患者肺通气功能变化.结果 治疗组总有效率为95.8％,对照组总有效率为82.6％,差异有统计学意义(P＜0.05);治疗组治疗后肺通气功能较对照组治疗后明显缓解(P＜0.05).治疗组治疗过程中未出现明显不良反应.结论 布地奈德联合多索茶碱治疗支气管哮喘有良好的临床疗效,且安全性较高.     

Comparative efficacy of once-daily therapy with inhaled corticosteroid, leukotriene antagonist or sustained-release theophylline in patients with mild persistent asthma

The purpose of this study was to compare the efficacy and safety of the inhaled budesonide, sustained-release theophylline and montelukast, a leukotriene receptor antagonist, in patients with mild persistent asthma. In this single-center, randomized, parallel-group study that not designed blindly and placebo-controlled manner, 74 patients with mild persistent asthma were treated with either inhaled budesonide 400 microg once daily, oral montelukast 10 mg once daily, or sustained-release theophylline 400 mg once daily for 3 months. In all three treatment groups, improvements were attained in overall asthma control. Asthma symptom scores and supplemental beta2-agonist use were quite the same in all three treatment groups (P>0.05). Although inhaled budesonide group resulted in significantly greater improvements compared with the other two groups in the lung functions (P<0.05), the changes in FEV1 and PEF are within the baseline variability and there was no statistically significant difference among the groups when analyzed by treatment month (P>0.05). Exacerbations of asthma were experienced by 16% of the patients in the montekulast group, by 12.5% of the patients in the theophylline group, and by none of the patients in the budesonide group. The adverse event in each of the three groups was 12%, 16% and 16.7%, respectively. It is concluded that the most important clinical parameters do not point that one of the treatments is more effective than others. Treatment with inhaled corticosteroid is preferred, but sustained-release theophylline and leukotriene antagonists are alternative controller medications in mild persistent asthma.     

小量吸入布地乃德对支气管哮喘的疗效

目的研究小剂量吸入激素合用茶碱对中度哮喘患者症状、肺功能的影响。方法通过4周较大剂量(布地乃德BUD400ug bid)治疗,66例中度哮喘患者随机分为3组,包括A组吸入BUD300μg bid;B组BUD100μg bid;C组BUD100μg bid并加用茶碱缓释片200mg口服每天2次,以上治疗共6月。结果4周大剂量基础治疗后,患者症状明显缓解、肺功能明显改善,并且在以后4个月的治疗研究阶段患者多较稳定,只有少数急性发作,急性发作次数或天数,C组少于B组(P<0.05),各组患者肺功能进一步好转,但B组肺功能变化与基础治疗后比较差异不显著。结论大剂量BUD吸入对中度哮喘具有良好的治疗效果,在稳定阶段给予小剂量BUD加用茶硷似有更好疗效。     

妥洛特罗贴剂治疗轻中度持续支气管哮喘患者的有效性和安全性

目的评价妥洛特罗贴剂治疗支气管哮喘的有效性和安全性。方法多中心、随机、开放、平行对照研究。根据入选标准和排除标准共有233例轻中度持续哮喘患者进入本研究。贴剂组115例,妥洛特罗每贴2mg,每晚1次;片剂组118例,口服妥洛特罗,2片／次,2次／d。观察用药前后最大呼气流量（PEF）、肺功能、临床症状评分的变化及用于缓解症状的短效β2受体激动剂的使用情况。结果（1）2组患者的年龄、身高、体重、病程和病情程度分级、入组前肺功能指标和临床症状评分差异均无统计学意义。（2）给药4周后,晨起与睡前PEF绝对值及其改善率贴剂组较片剂组显著升高（P〈0．05）,且贴剂组在给药后PEF上升的幅度明显高于片剂组,贴剂组与片剂组患者晨起PEF的改善率分别为9．1（0．38—19．4）％、4．2（-6．4—18．3）％。（3）肺功能、PEF变异率、临床症状评分、短效β2受体激动剂用量于给药后均有改善,但2组间差异无统计学意义。（4）贴剂组患者不良反应如心悸、手颤的发生率分别为2．6％、0．9％,明显低于片剂组的9．3％、8．5％（Χ^2=7．0919,P=0.0077）。贴剂组局部皮肤不良反应发生率仅2．6％,且程度轻。结论妥洛特罗贴剂是一种安全、有效、新剂型的哮喘治疗药物。     

支气管哮喘患者痰嗜酸粒细胞相对计数与糖皮质激素治疗反应性的关系

目的观察支气管哮喘（简称哮喘）患者不同气道炎症类型（嗜酸粒细胞炎症与非嗜酸粒细胞炎症）对吸人糖皮质激素（简称激素）治疗的反应性。方法选择近3个月内未接受激素治疗的慢性持续性哮喘患者42例，根据诱导痰嗜酸粒细胞百分比将患者分为嗜酸粒细胞增高组（嗜酸粒细胞〉3％，23例）与非嗜酸粒细胞增高组（嗜酸粒细胞〈3％，19例），进行哮喘症状评分、肺功能检查、诱导痰细胞分类计数。采用酶联免疫荧光法测定痰液嗜酸粒细胞阳离子蛋白（ECP）的浓度。吸人激素治疗1、3个月时进行随访，重复上述哮喘疗效的评价指标。结果嗜酸粒细胞增高组痰嗜酸粒细胞比值、ECP水平基线值分别为0．080（0．063～0．178）、（324±149）μg／L，非嗜酸粒细胞增高组分别为0．017（0．006～0．021）、（152±68）μg／L，两组比较差异有统计学意义（t值分别为4．40、3．33，P均〈0、01）。嗜酸粒细胞增高组第一秒用力呼气容积（FEV1）、FEV1占预计值百分比（FEV1占预计值％）、症状评分的基线值分别为（1．98±0．67）L、（65±20）％、7．0（5．0～10．0）分，非嗜酸粒细胞增高组分别为（2．07±1．05）L、（66±27）％、5．0（2．0～9．0）分，两组比较差异无统计学意义（t值分别为-0．62、-0．09、1．32，P均〉0．05）。吸入激素治疗1、3个月后嗜酸粒细胞增高组的嗜酸粒细胞比值、ECP水平、症状评分、FEV1和FEV1占预计值％分别为[0．019（0．010～0．060）、[0．036（0．006～0．070）、（173±153）μg／L、（173±122）μg／L、3．0（1．0～6．0）分、3．0（1．0～5．0）分、（2．42±0．64）L、（2．43±0．76）L、（77±13）％、（77±18）％，与基线值比较差异有统计学意义（F值分别为6．73、6．71、5．93、7．38、5．78，P均〈0．05）。非嗜酸粒细胞增高组分别为0．013（0．000～0．025）、0．012（0．004～0．031）、（111±50）μg／L、（117±50）μg／L、3．0（0．0～6．0）分、3．0（1．0～7．3）分、（2．22±0．86）L、（2．21±0．24）L、（71±20）％、（65±21）％，与基线值比较，嗜酸粒细胞比值、FEV1和FEV1占预计值％均无统计学意义（F值分别为1．98、0．80、1．37，P均〉0．05），而ECP水平和症状评分比较差异有统计学意义（F值分别为3．78、3．59，P均〈0．05）。多元线性回归分析显示，病情严重度、基线FEV1和痰嗜酸粒细胞百分比与FEV1改善程度相关（r值分别为-0．27、-0．02、0．03，P均〈0．05）。痰嗜酸粒细胞比值的基线值对激素治疗反应的阴性预测值最高（89．5％）。结论对于痰嗜酸粒细胞增高的哮喘患者，吸人激素治疗能够抑制嗜酸粒细胞炎症，改善肺功能和症状评分。非嗜酸粒细胞增高哮喘患者对激素治疗反应性差，FEV1无改善。痰嗜酸粒细胞比值不高是激素治疗反应性差的最佳预测指标。     

Efficacy and safety of the single-capsule combination of fluticasone/formoterol in patients with persistent asthma: a non-inferiority trial

OBJECTIVE:

Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR), fluticasone alone (FLU), and the single-capsule combination of fluticasone/formoterol (FLU/FOR) on lung function in patients with mild-to-moderate persistent asthma.

METHODS:

This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV₁ (in L) at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use.

RESULTS:

We randomized 243 patients to three groups: FLU/FOR (n = 79), BUD/FOR (n = 83), and FLU (n = 81). In terms of the mean FEV₁ after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: −0.06 to 0.49), whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: −0.002 to 0.52). Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (−0.06 vs. −0.002). The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations.

CONCLUSIONS:

The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety, making it a new treatment option for persistent asthma.     

Effects of long-term treatment with inhaled cromoglycate and budesonide on bronchial hyperresponsiveness in patients with allergic asthma

Twenty two allergic patients with bronchial asthma completed this study. Effects of long-term treatment with inhaled cromoglycate 4 x 2 mg.day-1 were compared to the effects of inhaled budesonide 4 x 0.1 mg.day-1 on symptoms, additional beta 2-agonist use, lung function and bronchial hyperresponsiveness measured by the provocation concentration of histamine producing a 20% fall in forced expiratory volume in one second (FEV1) (PC20 histamine) and exercise-induced fall in FEV1. The study was carried out in a double-blind way with a randomized crossover design using a double-dummy technique. After a single-blind placebo period, the two active treatment periods of 6 weeks were separated by a single-blind placebo period. Symptom score and beta 2-agonist use decreased during both active treatment periods, which showed no mutual differences. Morning and evening peak expiratory flow rates were significantly higher during treatment with budesonide versus placebo (p less than 0.01 and p less than 0.001), and also versus cromoglycate (p less than 0.02 and p less than 0.05). FEV1 showed improvement after a 6 week treatment with budesonide versus placebo (p less than 0.05), although there was no significant difference between the two active treatments. PC20 histamine did not change during treatment with cromoglycate. Budesonide showed a significant increase in PC20 histamine versus placebo (p less than 0.05) and was marginally significantly better than cromoglycate (p = 0.05). Exercise-induced fall in FEV1 was not changed by cromoglycate, but improved significantly during budesonide in comparison with placebo (p less than 0.01) and also with cromoglycate (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Relationship between house dust mite (HDM) allergen exposure level and inhaled corticosteroid dosage in HDM-sensitive asthma patients on a self management program.

AIM: To assess whether exposure to house dust mite (HDM) allergens hampers a tapering off of inhaled corticosteroid (ICS) dosage in HDM-sensitive asthma patients. METHODS: Asthma patients sensitised to HDM allergens and using ICS were selected from general practices for this observational study. Dust samples from bed mattresses were taken to assess exposure ('no', 'low', 'intermediate' or 'high') to HDM allergens with a semi-quantitative test (Acarex). Patients were trained to use a self management plan to adjust the dose of ICS according to symptoms and peak flow. The observation period was three months. RESULTS: Outcomes from 123 patients were analysed. Within the 'no' and 'low' HDM exposure groups the proportion of patients who increased the dosage of their ICS medication was significantly lower than the proportion who tapered off or remained on the same dose of ICS. The group with high exposure to HDM allergens had the highest proportion of patients who increased their dose of ICS (p = 0.055). CONCLUSIONS: High exposure to HDM allergens seems to coincide with the use of higher dose ICS treatment in asthma patients sensitised to HDM allergens.     

Patient compliance in a clinical trial with inhaled budesonide in children with mild asthma.

Children's use of inhalation devices can give valuable information about their adherence to asthma therapy. The aim of this study was to examine treatment adherence of low dose inhaled budesonide or placebo administered via Turbuhaler twice daily in children with mild asthma participating in an asthma trial, by comparing diary registration with the number of doses remaining in the inhaler. A total of 163 children (age 7-16 yrs, 56 females, 107 males) with mild asthma (mean baseline forced expiratory volume in one second (FEV1) was 103% of predicted), were included into a double blind, randomized study. After a two-week run-in period, the children received inhaled budesonide, either 100 microg or 200 microg daily, and/or placebo for 12 weeks. All patients used daily diary cards throughout the study. Results from 161 patients were analysed. Mean compliance according to the diary was 93%, whereas estimated mean compliance when counting remaining doses in the Turbuhaler was 77%. Overuse of medication was found in 7% of the children. There was no significant difference in compliance between sex in the study group, whereas children aged < or =9 yrs had significantly better drug adherence than older children. No significant relationship was found between symptom score and compliance. In conclusion, even with optimal patient follow-up in a clinical trial, adherence to prophylactic asthma treatment is considerably lower than the patients own reports from the use of daily diary cards.