Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD (COLUMBUS): Study protocol for a randomised controlled trial

ABSTRACT: BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterised by progressive development of airflow limitation that is poorly reversible. Because of a poor understanding of COPD pathogenesis, treatment is mostly symptomatic and new therapeutic strategies are limited. There is a direct relationship between the severity of the disease and the intensity of the inflammatory response. Besides smoking, one of the hypotheses for the persistent airway inflammation is the presence of recurrent infections. Macrolide antibiotics have bacteriostatic as well as anti-inflammatory properties in patients with cystic fibrosis and other inflammatory pulmonary diseases. There is consistent evidence that macrolide therapy reduces infectious exacerbations, decreases the requirement for additional antibiotics and improves nutritional measures. Because of these positive effects we hypothesised that maintenance macrolide therapy may also have beneficial effects in patients with COPD who have recurrent exacerbations. The effects on development of bacterial resistance to macrolides due to this long-term treatment are unknown. Until now, studies investigating macrolide therapy in COPD are limited. The objective of this study is to assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year decreases the exacerbation rate in the year of treatment and to establish microbial resistance due to the long-term treatment. Methods/design The study is set up as a prospective randomised double-blind placebo-controlled single-centre trial. A total of 92 patients with COPD who have had at least three exacerbations of COPD in the previous year will be included. Subjects will be randomised to receive either azithromycin 500 mg three times a week or placebo. Our primary endpoint is the reduction in the number of exacerbations of COPD in the year of treatment. DISCUSSION: We investigate whether long-term therapy with macrolide antibiotics can prevent exacerbations in patients with COPD. Additionally, our study aims to assess the effect of long-term use of macrolide on the development of antimicrobial resistance and on inflammatory parameters related to COPD. We believe this study will provide more data on the effects of macrolide treatment in patients in COPD and will add more knowledge on its working mechanisms. Trial registration www.clinicaltrials.gov NCT00985244.     

Chronic obstructive pulmonary disease and glucose metabolism: a bitter sweet symphony

Chronic obstructive pulmonary disease, metabolic syndrome and diabetes mellitus are common and underdiagnosed medical conditions. It was predicted that chronic obstructive pulmonary disease will be the third leading cause of death worldwide by 2020. The healthcare burden of this disease is even greater if we consider the significant impact of chronic obstructive pulmonary disease on the cardiovascular morbidity and mortality. Chronic obstructive pulmonary disease may be considered as a novel risk factor for new onset type 2 diabetes mellitus via multiple pathophysiological alterations such as: inflammation and oxidative stress, insulin resistance, weight gain and alterations in metabolism of adipokines. On the other hand, diabetes may act as an independent factor, negatively affecting pulmonary structure and function. Diabetes is associated with an increased risk of pulmonary infections, disease exacerbations and worsened COPD outcomes. On the top of that, coexistent OSA may increase the risk for type 2 DM in some individuals. The current scientific data necessitate a greater outlook on chronic obstructive pulmonary disease and chronic obstructive pulmonary disease may be viewed as a risk factor for the new onset type 2 diabetes mellitus. Conversely, both types of diabetes mellitus should be viewed as strong contributing factors for the development of obstructive lung disease. Such approach can potentially improve the outcomes and medical control for both conditions, and, thus, decrease the healthcare burden of these major medical problems.     

The month of July: an early experience with pandemic influenza A (H1N1) in adults with cystic fibrosis

Chronic obstructive pulmonary disease (COPD) represents a significant burden for healthcare systems that is expected to grow further in the future. Inhaled long-acting bronchodilators, including tiotropium, represent the cornerstone of management of COPD patients. Economic studies evaluating the cost-effectiveness ratio of inhaled bronchodilators have to take into account several parameters, including the reduction of COPD exacerbations and related hospitalizations, as well as disease modification and improvement in quality of life and mortality. At an era when the healthcare resources are unlikely to grow as quickly as demand, economic analyses remain the cornerstone for the justification of the broad use of medication with an acceptable cost-effectiveness ratio. The greatest importance of such studies in COPD is the identification of subgroups of patients that will have the most benefit with an acceptable cost-effectiveness ratio for the healthcare providers. The development of models that will incorporate a global evaluation of the different aspects of this multi-component disease, in order to provide the best available care to each individual patient is urgently needed.     

Blood and sputum protein biomarkers for chronic obstructive pulmonary disease (COPD)

ABSTRACT

Introduction: Chronic obstructive pulmonary disease (COPD) is a heterogeneous set of disorders, characterized by airflow limitation, and reduced lung function. Despite increasing knowledge regarding its pathophysiology, there has been limited advancement in therapeutics and the current treatment strategy is symptom management and prevention of exacerbations.

Areas covered: Biomarkers represent important tools for the implementation of precision medicine. As fundamental molecules of all living processes, proteins could provide crucial information about how genes interact with the environment. Proteomics studies could act as important tools in identifying reliable biomarkers to enable a more precise therapeutic approach. In this review, we will explore the most promising blood and sputum protein biomarkers in COPD that have been consistently reported in the literature.

Expert commentary: Given the complexity of COPD, no single protein biomarker has been able to improve the outcomes of COPD patients. According to preliminary studies, precision medicine in COPD will likely require a combination of different proteins in a biomarker panel for clinical translation. With advancements in current mass spectrometry techniques, an enhancement in the identification of new biomarkers will be observed, and improvements in sequence database search can fill in potential gaps between biomarker discovery and patient care.     

COPD symptoms in the morning: impact,evaluation and management

Chronic obstructive pulmonary disease (COPD) symptoms in the morning, including dyspnea and sputum production, affect patients’ quality of life and limit their ability to carry out even simple morning activities. It is now emerging that these symptoms are associated with increased risk of exacerbations and work absenteeism, suggesting that they have a more profound impact on patients than previously thought. The development of validated patient-reported outcome (PRO) questionnaires to capture patients’ experience of COPD symptoms in the morning is, therefore, vital for establishing effective and comprehensive management strategies. Although it is well established that long-acting bronchodilators are effective in improving COPD symptoms, the limited available data on their impact on morning symptoms and activities have been obtained with non-validated PRO questionnaires. In this review, we discuss the impact of COPD symptoms in the morning and available tools used to evaluate them, and highlight specific gaps that need to be addressed to develop standardized instruments able to meet regulatory requirement. We also present available evidence on the effect of pharmacological therapies on morning symptoms.     

Association of MicroRNA-196a2 Variant with Response to Short-Acting β2-Agonist in COPD: An Egyptian Pilot Study

Chronic obstructive pulmonary disease (COPD) is a multifactorial chronic respiratory disease, characterized by an obstructive pattern. Understanding the genetic predisposition of COPD is essential to develop personalized treatment regimens. MicroRNAs (miRNAs) are small, endogenous, non-coding RNAs that modulate the expression levels of specific proteins based on sequence complementarity with their target mRNA molecules. Emerging evidences demonstrated the potential use of miRNAs as a disease biomarker. This pilot study aimed to investigate the association of the MIR-196a2 rs11614913 (C/T) polymorphism with COPD susceptibility, the clinical outcome and bronchodilator response to short-acting β₂-agonist. Genotyping of rs11614913 polymorphism was determined in 108 COPD male patients and 116 unrelated controls using real-time polymerase chain reaction technology. In silico target prediction and network core analysis were performed. COPD patients did not show significant differences in the genotype distribution (p = 0.415) and allele frequencies (p = 0.306) of the studied miRNA when compared with controls. There were also no associations with GOLD stage, dyspnea grade, disease exacerbations, COPD assessment test for estimating impact on health status score, or the frequency of intensive care unit admission. However, COPD patients with CC genotype corresponded to the smallest bronchodilator response after Salbutamol inhalation, the heterozygotes (CT) had an intermediate response, while those with the TT genotype showed the highest response (p < 0.001). In conclusion MIR-196a2 rs11614913 polymorphism is associated with the bronchodilator response of COPD in our sample of the Egyptian population, generating hypothesis of the potential use of MIR-196a2 variant as a pharmacogenetic marker for COPD.     

A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

ABSTRACT: BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. DESIGN: A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George's Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients' randomization groups. DISCUSSION: This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care. Trial registration ACTRN12610000592044\     

Antimuscarinic treatment for lung diseases from research to clinical practice

Inhaled antimuscarinic drugs are the treatment of choice, recommended by guidelines, in chronic obstructive pulmonary disease (COPD). In long-term clinical studies ipratropium shows important effects beyond relaxation of airway smooth muscle, e.g. reduction of exacerbations of COPD. In phase III clinical trials the new generation antimuscarinic tiotropium, inhaled once daily, has provided more than 24 hours of stable bronchodilation, that was sustained over the one year treatment period. In addition, tiotropium in comparison to placebo and even ipratropium, has been shown to provide improvement in dyspnea, reduction of exacerbations of COPD, reduced hospital admissions for exacerbations, reduced duration of hospitalisations as well as improved health-related quality of life. Chronic effects, such as reduction of hospitalisations, are conventionally attributed to an anti-inflammatory action and not to symptomatic bronchodilation. The 24 hour stabilisation of airway patency, avoiding fluctuations of the diameter with occasional closure and consequent need for reopening, may explain the extended therapeutic profile of tiotropium. Inhibition by antimuscarinics of pro-inflammatory cholinergic effects may also occur, e.g. inhibition of 5-HETE release from epithelial cells and inhibition of release of neutrophil and eosinophil chemotactic activity from alveolar macrophages. Antimuscarinics have shown increasing value as a therapeutic approach in COPD. The elucidation of their anti-inflammatory potential constitutes an interesting target for future studies.     

D-二聚体测定在慢性阻塞性肺疾病的疗效评价及预后意义的研究进展

慢性阻塞性肺疾病(简称慢阻肺)是一种呼吸科常见病,其并发症多,病死率高。在慢阻肺急加重期,细胞因子、炎症介质及内毒素首先损伤血管内皮,引发全身凝血功能障碍和负氮平衡。作为体内高凝状态和纤溶亢进的分子标志物之一,D-二聚体是交联纤维蛋白在纤溶酶作用下产生的一种特异性降解产物,其反映继发性纤溶活性意义。多项研究表明,D-二聚体水平对慢阻肺的治疗效果的评价及预后有重要意义。本文将通过总结D-二聚体的结构及与吸烟、年龄、血气分析及肺功能等方面的关系来阐述D-二聚体与慢阻肺相关性,并总结D-二聚体相关的慢阻肺的治疗方法及其对慢阻肺预后方面的相关意义。     

Concomitant therapy with Cineole (Eucalyptole) reduces exacerbations in COPD: A placebo-controlled double-blind trial

Background

The clinical effects of mucolytics in patients with chronic obstructive pulmonary disease (COPD) are discussed controversially. Cineole is the main constituent of eucalyptus oil and mainly used in inflammatory airway diseases as a mucolytic agent. We hypothesised that its known mucolytic, bronchodilating and anti-inflammatory effects as concomitant therapy would reduce the exacerbation rate and show benefits on pulmonary function tests as well as quality of life in patients with COPD.

Methods

In this double-blind, placebo-controlled multi-center-study we randomly assigned 242 patients with stable COPD to receive 200 mg of cineole or placebo 3 times daily as concomitant therapy for 6 months during winter-time. The frequency, duration and severity of exacerbations were combined as primary outcome measures for testing as multiple criteria. Secondary outcome measures included changes of lung function, respiratory symptoms and quality of life as well as the single parameters of the exacerbations.

Results

Baseline demographics, lung function and standard medication of both groups were comparable. During the treatment period of 6 months the multiple criteria frequency, severity and duration of exacerbations were significantly lower in the group treated with cineole in comparison to placebo. Secondary outcome measures validated these findings. Improvement of lung function, dyspnea and quality of life as multiple criteria were statistically significant relative to placebo. Adverse events were comparable in both groups.

Conclusion

Concomitant therapy with cineole reduces exacerbations as well as dyspnea and improves lung function and health status. This study further suggests cineole as an active controller of airway inflammation in COPD by intervening in the pathophysiology of airway inflammation of the mucus membrane.

Trial registration

ISRCTN07600011     

Evaluation of real-time PCR for the detection and quantification of bacteria in chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) embraces a number of pathological processes including chronic bronchitis, chronic bronchiolitis and emphysema. The chronic and progressive course of COPD is often aggravated by short periods of increasing symptoms. Respiratory tract infections (RTIs) are the most common causes of COPD exacerbations. Detection and enumeration of respiratory bacteria are important techniques in diagnosing RTIs and in the validation of new treatment methods. We describe here the development and evaluation of real-time PCR assays for the simultaneous direct detection and quantification of a range of respiratory bacteria in individuals with COPD during stable periods and during acute exacerbations of the disease. Sputum samples from 30 subjects in a COPD study were analysed, and results compared with the current gold standard of culture. Real-time PCR assays proved highly sensitive, with no cross-reactivity with other species. The prevalence of bacteria detected by real-time PCR compared with that by culture was substantially higher for Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus spp. and Moraxella catarrhalis. Multiple pathogens were also found with real-time PCR but were not detected by culture. This study demonstrates the potential of such methods in the detection and enumeration of respiratory bacteria.     

Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) represents a significant cause of global morbidity and mortality, with a substantial economic impact. Recent changes in the Global initiative for chronic Obstructive Lung Disease (GOLD) guidance refined the classification of patients for treatment using a combination of spirometry, assessment of symptoms, and/or frequency of exacerbations. The aim of treatment remains to reduce existing symptoms while decreasing the risk of future adverse health events. Long-acting bronchodilators are the mainstay of therapy due to their proven efficacy. GOLD guidelines recommend combining long-acting bronchodilators with differing mechanisms of action if the control of COPD is insufficient with monotherapy, and recent years have seen growing interest in the additional benefits that combination of long-acting muscarinic antagonists (LAMAs), typified by tiotropium, with long-acting β₂-agonists (LABAs), such as formoterol and salmeterol. Most studies have examined free combinations of currently available LAMAs and LABAs, broadly showing a benefit in terms of lung function and other patient-reported outcomes, although evidence is limited at present. Several once- or twice-daily fixed-dose LAMA/LABA combinations are under development, most involving newly developed monotherapy components. This review outlines the existing data for LAMA/LABA combinations in the treatment of COPD, summarizes the ongoing trials, and considers the evidence required to inform the role of LAMA/LABA combinations in treatment of this disease.     

慢性阻塞性肺疾病与代谢综合征及颈动脉内膜厚度的相关性研究

目的:研究慢性阻塞性肺疾病与代谢综合征及颈动脉内膜厚度的关系。方法:选择2014年8月至2015年4月在我院就诊的慢性阻塞性肺疾病患者60例作为研究组,另选择同期在我院接受健康体检的60名志愿者作为对照组。比较两组空腹血糖、甘油三酯及高密度脂蛋白胆固醇水平、代谢综合征的发生率、颈动脉内膜厚度以及合并与不合并代谢综合征的慢性阻塞性肺疾病患者的肺功能和颈动脉内膜厚度,并采用多元回归分析颈动脉内膜厚度与慢性阻塞性肺疾病及代谢综合征的相关性。结果:与对照组相比,研究组患者空腹血糖(FPG)明显升高,而甘油三酯(TG)水平明显降低,差异具有统计学意义(P0.05);两组高密度脂蛋白胆固醇(HDL-C)比较差异无统计学意义(P0.05)。研究组代谢综合征的发病率、颈动脉内膜厚度均明显高于对照组,差异具有统计学意义(P0.05);慢性阻塞性肺疾病合并代谢综合征患者的肺功能明显优于无代谢综合征的慢性阻塞性肺疾病患者,差异具有统计学意义(P0.05);合并代谢综合征的慢性阻塞性肺疾病患者FEV1占预计值百分比及FEV1/FVC均明显高于无代谢综合征慢性阻塞性肺疾病患者的对应值,差异具有统计学意义(P0.05)。Logistic回归分析结果显示慢性阻塞性肺疾病与颈动脉内膜厚度呈独立相关性,而代谢综合征与颈动脉内膜厚度无直接相关性。结论:慢性阻塞性肺疾病与颈动脉内膜厚度呈独立相关,且慢性阻塞性肺疾病合并代谢综合征患者发生颈动脉粥样硬化的风险更高。     

参苓白术散联合沙美特罗治疗COPD的临床疗效分析

目的：探讨参苓白术散结合沙美特罗治疗对慢性阻塞性肺疾病（COPD）的临床疗效。方法：采用前瞻性随机对照设计。将93例COPD患者随机均分为三组（称为A、B、C组）,A组给予中药参苓白术散口服和沙美特罗喷雾剂吸入治疗,B组给予中药参苓白术散颗粒剂口服治疗,C组给予沙美特罗喷雾剂吸入治疗,治疗疗程3个月,观察治疗前后三组患者的临床症状和体征、中医症状评分以及肺功能包括FEV1、FVC和PEF变化情况。结果：治疗3个月后,给予中药参苓白术散剂口服和沙美特罗喷雾剂吸入治疗的A组患者临床症状和体征、中医症状评分以及肺功能较治疗前明显改善,FEV1和FVC分别提高了0-3L和0-37L,PEF也增加了44L／min,并且这两种药物联合治疗疗效也明显优于B、c组（P〈0．05）。结论：参苓白术散结合沙关特罗治疗能明显改善COPD患者临床表现和肺功能。     

Chronic obstructive pulmonary disease.

Outpatient management of chronic obstructive pulmonary disease (COPD) is reviewed in this paper. Smoking cessation is probably important, although its benefit in established COPD is unproven. Bronchodilator therapy may be of more than symptomatic benefit and is indicated in virtually all patients. Specific beta 2-agonists are the most widely used agents and can be given in substantially larger doses than are usually recommended. Ipratropium bromide, an anticholinergic drug, is about as effective as a beta 2-agonist, but in large doses the two drugs do not seem to have additive effects, unlike theophylline and beta 2-agonists. Systemic corticosteroids decrease airway obstruction substantially in a small number of patients with COPD; these agents should be reserved for these patients and used sparingly. Inhaled steroids are of little benefit, as are respiratory stimulants and depressants. Broad-spectrum antibiotic therapy helps to relieve symptomatic exacerbations of COPD, particularly those characterized by increased dyspnea, sputum volume and sputum purulence. Cor pulmonale is best managed by diuretics and oxygen, with digoxin reserved for left ventricular failure and supraventricular arrhythmias. Continuous oxygen therapy at home is indicated for the patients who have chronic arterial hypoxemia.     

Characterisation of COPD heterogeneity in the ECLIPSE cohort

Background

Chronic obstructive pulmonary disease (COPD) is a complex condition with pulmonary and extra-pulmonary manifestations. This study describes the heterogeneity of COPD in a large and well characterised and controlled COPD cohort (ECLIPSE).

Methods

We studied 2164 clinically stable COPD patients, 337 smokers with normal lung function and 245 never smokers. In these individuals, we measured clinical parameters, nutritional status, spirometry, exercise tolerance, and amount of emphysema by computed tomography.

Results

COPD patients were slightly older than controls and had more pack years of smoking than smokers with normal lung function. Co-morbidities were more prevalent in COPD patients than in controls, and occurred to the same extent irrespective of the GOLD stage. The severity of airflow limitation in COPD patients was poorly related to the degree of breathlessness, health status, presence of co-morbidity, exercise capacity and number of exacerbations reported in the year before the study. The distribution of these variables within each GOLD stage was wide. Even in subjects with severe airflow obstruction, a substantial proportion did not report symptoms, exacerbations or exercise limitation. The amount of emphysema increased with GOLD severity. The prevalence of bronchiectasis was low (4%) but also increased with GOLD stage. Some gender differences were also identified.

Conclusions

The clinical manifestations of COPD are highly variable and the degree of airflow limitation does not capture the heterogeneity of the disease.     

Modulation of cytokine and nitric oxide by mesenchymal stem cell transfer in lung injury/fibrosis

Background

Chronic obstructive pulmonary disease (COPD) is a complex condition with pulmonary and extra-pulmonary manifestations. This study describes the heterogeneity of COPD in a large and well characterised and controlled COPD cohort (ECLIPSE).

Methods

We studied 2164 clinically stable COPD patients, 337 smokers with normal lung function and 245 never smokers. In these individuals, we measured clinical parameters, nutritional status, spirometry, exercise tolerance, and amount of emphysema by computed tomography.

Results

COPD patients were slightly older than controls and had more pack years of smoking than smokers with normal lung function. Co-morbidities were more prevalent in COPD patients than in controls, and occurred to the same extent irrespective of the GOLD stage. The severity of airflow limitation in COPD patients was poorly related to the degree of breathlessness, health status, presence of co-morbidity, exercise capacity and number of exacerbations reported in the year before the study. The distribution of these variables within each GOLD stage was wide. Even in subjects with severe airflow obstruction, a substantial proportion did not report symptoms, exacerbations or exercise limitation. The amount of emphysema increased with GOLD severity. The prevalence of bronchiectasis was low (4%) but also increased with GOLD stage. Some gender differences were also identified.

Conclusions

The clinical manifestations of COPD are highly variable and the degree of airflow limitation does not capture the heterogeneity of the disease.     

Hospital at home for patients with acute exacerbations of chronic obstructive pulmonary disease: systematic review of evidence

Objectives To evaluate the efficacy of hospital at home schemes compared with inpatient care in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD).Design A systematic review of randomised controlled trials.Main outcome measure Mortality and readmission to hospital.Results Seven trials with 754 patients were included in the review. Hospital readmission and mortality were not significantly different when hospital at home schemes were compared with inpatient care (relative risk 0.89, 95% confidence interval 0.72 to 1.12, and 0.61, 0.36 to 1.05, respectively). However, compared with inpatient care, hospital at home schemes were associated with substantial cost savings as well as freeing up hospital inpatient beds.Conclusions Hospital at home schemes can be safely used to care for patients with acute exacerbations of COPD who would otherwise be admitted to hospital. Clinicians should consider this form of management, especially as there is increasing pressure for inpatient beds in the United Kingdom.     

中医辨证治疗对改善缓解期儿童哮喘肺功能的临床疗效分析

目的:研究中医辨证治疗对缓解期哮喘患儿肺功能的改善情况,从而为持续肺功能异常的哮喘缓解期患儿提供更好的治疗手段。方法:收集2019.1.1～2019.12.31在上海儿童医学中心呼吸哮喘门诊就诊的儿童哮喘缓解期患儿共88例,收集其相关临床资料,并根据其是否接受中医辨证治疗分为中医辨证治疗组和非中医辨证治疗组,比较其治疗3月后的相关肺功能参数。结果:两组在性别、年龄、病程时间及规范抗哮喘治疗时间之间对比无统计学差异(P0.05)。两组患儿均按照儿童肺功能系列指南肺容积和通气功能部分的肺功能检查流程分别在其入组时及随访3月后进行常规肺通气功能检查,对其肺功能检查结果进行评价。治疗前,两组FEV1%(实测/预计)%、FEV1/VCmax%(实测/预计)%、FEF50%(实测/预计)%、MMEF%(实测/预计)%、FEF75%(实测/预计)%对比差异无统计学意义(P0.05);治疗3个月后,中医辨证治疗组的上述指标均显著升高(P0.05),非中医辨证治疗组的上述指标与治疗前差异无统计学意义(P0.05),组间比较显示中医辨证治疗组的上述指标显著高于非中医辨证治疗组(P0.05)。结论:中医辨证治疗能改善缓解期哮喘患儿的肺功能水平,中医辨证治疗辅以西医规范化抗哮喘治疗能获得更好的临床疗效。