Primary studies included in this broad synthesis

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Primary study

Unclassified

升压治疗儿童哮喘不受控制接受吸入皮质类固醇。

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期刊 The New England journal of medicine
Year 2010
連結 Pubmed DOI PubMed Central

此文章收錄於 3 Systematic reviews Systematic reviews (3 references) 2 Broad syntheses Broad syntheses (2 references)

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背景：对于谁拥有不受控制的哮喘尽管使用低剂量吸入糖皮质激素（ICS）的证据来指导升压治疗缺乏的孩子。 方法：随机分配182名儿童（6至17岁），谁曾不受控制的哮喘而接受100微克氟替卡松，每日两次，连续16周获得每三个盲升压疗法以随机顺序：250微克氟替卡松每日两次（ICS升压），100微克氟替卡松的加50微克的长效每日两次β-受体激动剂（LABA升压）或氟替卡松100微克每日两次加5或10毫克白三烯受体的每天拮抗剂（LTRA升压）。我们使用了一个三分频器的设计和3的结果（加重，哮喘控制天，并在1秒内的用力呼气量）的复合，以确定一个微分响应于所述升压方案的频率是否为25％以上。 结果：鉴别反应发生在161 165的谁进行了评价性（P <0.001）的患者。到LABA升压治疗的反应是最有可能成为最好的回应，与反应LTRA升压比（相对概率，1.6，95％可信区间[CI]，1.1〜2.3，P = 0.004）和ICS升压（相对概率，1.7，95％CI，1.2〜2.4，P = 0.002）。在随机分组前的哮喘控制测试得分越高（表示更好的控制基线）预计LABA的升压（P = 0.009）更好的反应。白色人种预测LABA的升压更好的响应，而黑人患者是最不可能有LTRA升压（P = 0.005）一个最好的回应。 结论：几乎所有的孩子有不同的反应到每个升压治疗。LABA的升压是显著更有可能提供比ICS或LTRA升压最好的回应。然而，很多孩子不得不ICS或LTRA升压治疗的最好的回应，强调必须定期监测和适当地调整每个孩子的哮喘治疗。（ClinicalTrials.gov编号，NCT00395304）。

Primary study

Unclassified

定期与PRN雾化吸入治疗喘息学龄前儿童。

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期刊 Allergy
Year 2009
連結 Pubmed DOI

此文章收錄於 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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背景：国际准则建议定期频繁的喘息儿童吸入糖皮质激素治疗，但PRN单独或合并吸入性支气管扩张剂与糖皮质激素是在实践中也经常使用。我们的目的是评估是否定期雾化吸入糖皮质激素加一个PRN支气管扩张剂或一个PRN雾化吸入支气管扩张剂/糖皮质激素组合更有效，比PRN支气管扩张剂在学龄前儿童频繁哮鸣音。 方法：双盲，双模拟，随机，平行对照试验。经过2周的磨合期，276频繁的哮鸣音，症状的儿童1-4岁，随机分为三组，3个月的雾化吸入治疗：（1）400微克丙酸倍氯米松的报价，再加上2500微克沙丁胺醇PRN; （2）服用安慰剂的报价，再加上800微克beclomethasone/1600微克的沙丁胺醇组合PRN（3）服用安慰剂的报价，再加上2500微克沙丁胺醇PRN。症状无天的百分比是主要成果的措施。次要终点包括症状评分，使用缓解药物，发作频率。 结果：如PRN沙丁胺醇（61.0 + / - 24.83 [SD]）相比，症状无天的比例更高，定期倍氯米松（69.6％，SD 20.89，P = 0.034），但与PRN组合（64.9％， SD 24.74）。结果无异于儿童或不发展持续性哮喘的危险因素。PRN组合的效果是定期倍氯米松小学和几个重要的次要结果没有什么不同。 结论：常规吸入糖皮质激素是最有效的治疗，频繁的喘息在学龄前儿童。然而，PRN支气管扩张剂/糖皮质激素的组合可能是另一种选择，但需要进一步的研究。

Publication Thread

IA05

This thread includes 11 references

Primary study

Unclassified

Add-on salmeterol compared to double dose fluticasone in pediatric asthma: A double-blind, randomized trial (VIAPAED)

期刊 Pediatric pulmonology
Year 2009
連結 Pubmed DOI

此文章收錄於 1 Broad synthesis Broad syntheses (1 reference) 2 Systematic reviews Systematic reviews (2 references)

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Rationale: In asthmatic children whose symptoms are uncontrolled on standard doses of inhaled corticosteroids (ICS), guidelines recommend to either increase the ICS dose or to add further controller medication, e.g. a long acting ß2-agonist (LABA). The aim of this study was to compare the efficacy and safety of doubling the dose of ICS (fluticasone proprionate FP 200 mg twice daily) with adding a long-acting beta-2 agonist to the ICS (SFC, salmeterol 50 μg/ FP 100 μg twice daily) in children with uncontrolled asthma. Methods: Children between 4 and 16 years of age were eligible for this multicenter, randomized, double blind, double dummy, parallel-group study. During a 14-day run-in phase, all children inhaled FP 100 μg b.i.d.Patientswith persistent symptoms on≥7 of 14 days were randomized to 8 weeks treatment with a Diskus® containing either SFC 50 μg/ 100 μg b.i.d. or FP 200 μg b.i.d.. The primary endpoint was the mean change in morning (a.m.) PEF from baseline. The initial statistical hypothesis of non-inferiority of SFC vs. FP was confirmed in an adaptive interim analysis, so that the study was terminated prematurely. Results: 441 patients from 39 centers entered the run-in phase, and 64% of these were randomized to treatment (N=138 to SFC and N=145 to FP). After 8 weeks, patients on SFC had significantly better results for primary and secondary endpoints: The mean increase in morning PEF was 30.4±34.1 L/min in the SFC group and 16.7±35.8 L/min in the fluticasone group, and the mean (95% CI) improvement from baseline a.m. PEF in the ITT group was significantly larger after SFC (+8.6 L/min, CI: [1.3; ∞]). Patients in the SFC group experienced 8.7% (CI: [1.2;16.3]) more days without asthma symptoms and 8.0% (CI: [0.6;15.3]) more days without salbutamol than patients receiving FP. Good asthma control was achieved for a longer period in the SFC (3.4±2.7 weeks) group than in the FP group (2.7±2.7, P=0.02). Both treatments were generally well tolerated. Asthma exacerbations were recorded in 3 and 6 and SAEs in 2 and 1 patients from the SFC and FP groups, respectively. Conclusions: In children with persistent asthma inadequately controlled on low dose ICS alone, adding a long acting beta-2-agonist to ICS in a single inhaler was more effective than doubling the ICS dose.These results support recommendations of adding LABA to low-dose ICS as the preferred controller option for children older than 4 years with symptomatic asthma. © 2009 Wiley-Liss, Inc.

Primary study

Unclassified

氟替卡松或为与以哮喘-像的的症状的学龄前的儿童：随机对照试验;中的孟鲁司特。

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期刊 Pulmonary pharmacology & therapeutics
Year 2008
連結 Pubmed DOI

此文章收錄於 5 Systematic reviews Systematic reviews (5 references) 1 Broad synthesis Broad syntheses (1 reference)

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的理据：反-炎性疗法（，如丙酸氟替卡松（FP）和孟鲁司特（的Mk））的的中的实益的影响已被证明在患有哮喘的的学龄前的儿童。然而，的比较研究正在缺乏在这个年龄段的组中。因此，我们进行了评估和比较与以哮喘-像的的症状的的的FP和Mk的在学龄前的儿童的的的效果的一项研究，以。方法：在这项多中心中，随机，安慰剂-受控的的中，双击-盲目的的的的的的中，双击-假人的的临床试验，年龄介乎与以哮喘-像的的症状2-6多年的儿童的被列入。在总，63名儿童被随机分配到收到FP（二十五日），的Mk（18）或为3个月的安慰剂（20）。初级结果是的每日的的症状得分（哮鸣音，咳嗽，作者：气短），作为由在一个症状的的日记卡的照顾者录得的。次要终点是救援免费的天服药，血液嗜酸性粒细胞和肺函数（灭弧室技术和被迫的振荡技术（光纤收发器）的）。结果：在的3个月内的的研究期间期间，改善在的所有3组中，与在赞成的是FP组（p值= 0.021）的中之间的FP和安慰剂的有统计学显着的区别的中，的的症状。一个在循环后，3个月的治疗的嗜酸性粒细胞的的显着性减少被发现在的Mk组的唯一（P = 0.008），这是显着从在的安慰剂组（p值= 0.045）中发现的的变化的不同的中。随着的作者：频率的依赖关系（由光纤收发器量度），这表明与在赞成的是FP组（p值= 0.048）的中比较，之间的的FP和Mk后，3个月的治疗的的的区别的的的的例外中，群体范围内或之间的的没有在肺癌中函数的的差异被发现。结论：在尽管的一个缺乏的权力的，但，我们的的的研究结果表明，FP有一个关于上血液嗜酸性粒细胞的水平的的的症状和的的Mk作为与安慰剂相比，的有益的的的的效果。除为在一个例肺癌后，3的FP和Mk之间的个月，在赞成的是FP组的中的函数的参数的的的区别，本研究透露了的FP和Mk之间的无显着差异。

Primary study

Unclassified

Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing

期刊 The Journal of allergy and clinical immunology
Year 2008
連結 Pubmed DOI PubMed Central

此文章收錄於 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background: Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity. Objectives: We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing. Methods: In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results: The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76% (95% CI, 70% to 81%) for budesonide, 73% (95% CI, 66% to 79%) for montelukast, and 74% (95% CI, 65% to 81%) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38% [P = .003] and 37% [P = .003], respectively) and interference with activity scores (32% [P = .01] and 40% [P = .001], respectively) that were most evident in those with positive asthma predictive indices. Conclusions: In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices. © 2008 American Academy of Allergy, Asthma & Immunology.

Publication Thread

Organon and Co, Robertson CF

This thread includes 2 references

Primary study

Unclassified

孟鲁司特对支气管高反应性的学龄前儿童的影响。

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期刊 Chest
Year 2007
連結 Pubmed DOI

此文章收錄於 1 Broad synthesis Broad syntheses (1 reference)

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引言：对支气管高反应性（BHR）由乙酰甲胆碱激发试验学龄前儿童测量孟鲁司特治疗的效果尚未见报道。 目的：对BHR确定孟鲁司特（4毫克/天）的效果评价由物质的浓度挑衅造成了20％的跌幅在FEV（1）（PC（20））在学龄前哮喘患儿值。 患者：共有26个学前儿童（8女）年龄在3.3〜6.0年（平均[+/- SD]年龄，4.7±0.8岁），轻度哮喘。 设计：随机双盲，安慰剂对照，交叉研究。每个孩子接受4周的治疗用4毫克要么孟鲁司特或安慰剂由2周的清除期分隔开。主要成果是个人电脑（20）值和级数（三剂量），在该FEV（1）值下降了20％（。）后孟鲁司特治疗的PC（20）中的相比，那些为后安慰剂周期。 结果：按照4周孟鲁司特治疗，平均个人电脑（20）为4.79 +/- 4.69毫克/毫升，而4周安慰剂后的平均个人电脑（20）为2.07 +/- 2.37毫克/毫升（p值= 0.001 ）。孟鲁司特/安慰剂比用于PC（20）为2.56与1.71 95％置信区间（CI）到3.99。在阶段中位数的差异是一个三剂量为0.5的95％CI为1.5。 结论：四周与孟鲁司特治疗导致降低BHR与安慰剂相比。

Primary study

Unclassified

孟鲁司特与吸入低剂量布地奈德作为单一疗法在治疗轻度持续哮喘：一项随机双盲对照试验。

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期刊 Journal of tropical pediatrics
Year 2007
連結 Pubmed DOI

此文章收錄於 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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背景：指引建议轻度持续哮喘每日控制器治疗。孟鲁司特已经证明一致的利益，在控制哮喘症状，并可能替代，口服，治疗轻度哮喘的非类固醇剂。目的：确定是否有效容积（1）确定控制轻度持续哮喘布地奈德孟鲁司特。方法：2003年十一月至2005年10月，参加者年龄在5-15岁，最近诊断轻度持续哮喘组（n = 62），随机口服孟鲁司特（每天5毫克），N（1）= 30]或吸入布地奈德（400微克每天两剂），氮（2）= 32]在一个单一的中心，双盲研究。结果：基线人口和肺功能参数具有可比性。预测中位数的比例（95％置信区间）FEV（1）在12周的治疗后两组（布地奈德：76.70（67.96-90.53％），孟鲁司特：75（67.40-88.47）％，P = 0.44） 。有类似的改善肺功能参数，并在两个组的临床症状评分。有需要救援药品，以及由父母​​报告的副作用组之间没有统计学显着差异。结论：孟鲁司特吸入布地奈德的年龄在5-15岁的儿童轻度持续性哮喘的治疗是有效的。孟鲁司特可作为轻度持续哮喘管理的低剂量吸入糖皮质激素的替代。

Primary study

Unclassified

A randomized, double-blind trial of the effect of anti-asthma treatment on lung function in children with asthma

期刊 Pulmonary pharmacology & therapeutics
Year 2007
連結 Pubmed DOI

此文章收錄於 8 Systematic reviews Systematic reviews (8 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background: Pulmonary function tests (PFTs) and especially spirometry measures are useful tools in evaluating early response to treatment of asthma in children mainly due to their worldwide availability. The aim of our study was to determine the effects of anti-asthma treatment in children, equally on FEV1, FEF25-75%, Rint and SRaw values. Methods: Children 6-18 years of age with moderate atopic asthma were randomized to 4-week, placebo-controlled, double-blind trial. Patients were randomly allocated to receive 200 μg budesonide (B) (n=29), 5 or 10 mg (according to age) montelukast (M) (n=29), 200 μg B+5 or 10 mg M (n=29), 200 μg B+9 μg formoterol (F) (n=29) or placebo (n=27). FEV1, FEF25-75%, Rint, SRaw were measured before and after treatment. Results: Rint, SRaw, FEV1 improved significantly in all active treatment groups while FEF25-75% improved significantly only in BM group and M group. Combination therapy, showed significantly greater effects on Rint than monotherapy: BM group compared to B group (P=0.01) and M group (P=0.03) and BF group compared to B group (P=0.01) and M group (P=0.04). Conclusion: This study shows that using single parameter for monitoring asthma can be misleading. Using combination of lung function techniques provides better assessment of treatment. Results of our study confirm this hypothesis. The best effect on large and small airways was achieved with combined anti-inflammatory therapy. © 2006 Elsevier Ltd. All rights reserved.