Zhonghua Jie He He Hu Xi Za Zhi. 2025 Mar 12;48(3):208-248. doi: 10.3760/cma.j.cn112147-20241013-00601.
Bronchial asthma (asthma) is a common chronic respiratory disease. Standardized diagnosis, treatment and effective clinical management are critical to improving asthma control, improving patients' quality of life, and reducing the disease burden. Based on the latest evidence-based research from both domestic and international references, the Asthma Group of the Chinese Thoracic Society has revised the " ()". This revision supplements the diagnostic pathway, and updates clinical staging, and severity grading of asthma. Furthermore, adjustments have been made in asthma evaluation, maintenance therapy, acute exacerbation management, severe asthma, atypical asthma, and treatment principles of asthma, according to the latest research evidence. The updated guideline serves as a comprehensive resource for healthcare professionals in China, providing the latest recommendations to improve their knowledge and competence in the standardized diagnosis and management of asthma.The key recommendations are listed below. Bronchial provocation test should be considered when forced expiratory volume in one second (FEV) is ≥70% predicted (excluding respiratory infections within the past 4 weeks) (1, D). When clinical symptoms suggest asthma but the bronchial provocation test is not available or does not meet the diagnostic criteria for variable airflow limitation, reliance on cutoff value alone to exclude asthma should be avoided. A presumptive diagnostic pathway may be initiated to improve the diagnostic accuracy (1, D). Diagnostic anti-inflammatory therapy may be initiated to confirm the diagnosis if any of the following criteria are met: (1) positive results (≥20% increase from baseline) in peak expiratory flow (PEF)-based bronchodilation test when spirometry is unavailable, excluding respiratory infections within the past 4 weeks; (2) FEV variability≥12% and absolute change ≥200 ml between two prior tests, excluding respiratory tract infections within the past 4 weeks; (3) small airway dysfunction [met 2 of 3 ≤65% predicated among the maximum instantaneous forced expiratory flow with 25% of the forced vital capacity (FVC) remaining to be exhaled (MEF25), MEF50, maximal mid-expiratory flow(MMEF)], or FEV improvement ≥ 10% with fractional exhaled nitric oxide (FeNO)≥35 ppb in bronchodilation test when baseline FEV ≥ 80% predicted (1, C). After biologic therapy or other anti-asthma therapy, patients who achieve≥ 1 year of symptom-free status, no exacerbation, normal/near-normal lung function, and no need for oral corticosteroids (OCS) may be considered to have achieved "clinical remission" (1, D). It would be better to classify asthma severity based on the treatment steps required to achieve asthma control rather than relying on the patient's pre-treatment (1, D). Type 2 airway inflammation characterized by elevated blood/sputum eosinophils, and/or FeNO, and/or atopy or elevated total immunoglobulin E (IgE) is predominant in severe asthma. Non-type 2 inflammation, defined as not meeting any of the above criteria, should be identified only after excluding confounders (e.g., infections and medications) (1, D). Patients should undergo psychosocial assessment (e.g., anxiety/depression scales) and evaluation for comorbidities if they suffered from dyspnea/chest tightness after routine therapy, and had normalized lung function, peripheral blood eosinophil, and FeNO simultaneously (1, D). Provocative dose that causes a 20% decrease in FEV in bronchial provocation test may reflect airway hyperresponsiveness and may be used in disease monitoring and therapeutic evaluation (2, D). Induced sputum eosinophil is one of the gold standard biomarkers for airway inflammation assessment, asthma phenotype classification, corticosteroid response prediction, and exacerbation risk assessment (1, A). Peripheral blood eosinophil ≥ 150/μl can be used to identify eosinophil phenotype or type 2 inflammatory endotype, as well as one of the key biomarkers to predict and evaluate biologic responses (1, C). Long-term treatment of inhaled corticosteroids (ICS) with the recommended clinical dose range is safe in asthma patients. However, prolonged high-dose ICS therapy may lead to systemic adverse effects, including osteoporosis, suppression of hypothalamic-pituitary-adrenal axis, and increased risk of pneumonia (1, D). For adults with severe asthma, low-dose OCS (≤7.5 mg/day prednisone equivalent) may be added as the last choice (1, D). ICS-long-acting β-agonists (LABA) demonstrate synergistic anti-inflammatory and anti-asthmatic effects, achieving efficacy equivalent to or better than doubling the ICS dose, and may improve patient's adherence and reduce the high-dose ICS-related adverse effects, and are particularly recommended for the long-term treatment of patients with moderate to severe asthma (1, A). Triple combination inhalers can be prescribed to improve symptoms, lung function, and reduce exacerbations when asthma remains uncontrolled on medium- or high-dose of ICS-LABA ( 1, A). Subcutaneous immunotherapy in adults with asthma may reduce required dosage of ICS and improve asthma-specific quality of life and lung function (2, B). For house dust mite (HDM)-sensitized adolescents or adults with FEV>70% predicted, HDM sublingual immunotherapy may be added to reduce symptoms and ICS dose if symptoms persist despite low-to-medium-dose ICS-containing therapy (2, B). Step 1 treatment for asthma: As-needed low-dose ICS-formoterol is recommended for patients with limited to occasional transient daytime symptoms (<2 times/month, lasting hours), no nocturnal symptoms, no risk of exacerbations, and FEV>80% predicted (1, A). Step 2 treatment for asthma: As-needed low-dose ICS-formoterol is recommended, and significantly reduces moderate-to-severe exacerbations compared with short-acting β-agonist (SABA) monotherapy (1, A). Patients with persistent symptoms or exacerbations despite correct inhalation technique and adherence to Step 4 treatment should be referred to asthma specialists or specialized clinics for further evaluation (1, D). Follow-up visits should be scheduled every 2-4 weeks after initial therapy, then every 1-3 months if there is a response. Regular training of patients to in the correct use of inhaler techniques is essential for optimal asthma control (1, B). Risk factors associated with asthma-related death include: (1) a history of asthma that is requiring intubation and mechanical ventilation; (2) hospitalization or emergency care visit for asthma exacerbation in the past year; (3) currently use or recent cessation of OCS; (4) no current ICS use; (5) overuse of SABA, especially more than 1 canister of salbutamol (or equivalent) per month; (6) psychiatric illness or psychosocial problems, including sedative use; (7) poor adherence; (8) confirmed food allergy history; (9) comorbidities including pneumonia, diabetes, and arrhythmias (1, D). In the early stages of mild to moderate asthma exacerbations, when budesonide-formoterol combination therapy is used as an anti-inflammatory reliever, 1-2 additional inhalations of budesonide-formoterol (160/4.5 μg strength) may be taken. However, the daily dose should not exceed 8 inhalations (1, D). Severe asthma is uncontrolled asthma despite prescribing 3 or more months of continuous standardized use of a medium- or high-dose ICS-LABA and has been treated for comorbidity diseases and avoid environmental stimulus, or worsening after stepping down to a lower dose ICS-LABA (1, D). Patients with severe type 2 asthma can be treated with biologic therapy, those who had a good response to type 2-targeted biologic therapies can prioritize decrease or stop maintenance OCS therapy, but should not completely stop maintenance therapy with ICS-LABA (1, A). Adult patients with persistent symptomatic asthma despite step 5 treatment, add-on low-dose azithromycin therapy, such as azithromycin 250 to 500 mg/day, three times a week, for 26-48 weeks, may be prescribed to reduce exacerbations (2, A). Bronchial thermoplasty is indicated for adult patients whose asthma remains uncontrolled despite optimized asthma treatment and referral to a specialist severe asthma center, or for whom targeted biological therapy is not available or appropriate (2, A). The treatment principles for cough variant asthma (CVA) are the same as those of typical asthma, and most patients respond to ICS or ICS-LABA. ICS-LABA is recommended as the first choice and should be used for more than 8 weeks (1, B). There are different phenotypes and treatment responses in CVA. For CVA patients with poor therapeutic response and severe airway inflammation, the addition of leukotriene receptor antagonist therapy or short-term use of OCS (10-20 mg/d, 3-5 d) may be considered (2, D). In asthma associated with fungal sensitization, antifungal drugs can reduce airway inflammation and reduce the dose of systemic corticosteroids by minimizing fungal colonization and burden (1, D). In asthma associated with fungal sensitization, anti-IgE, anti-interleukin (IL)-5, anti-IL-5Rα, anti-IL-4Rα monoclonal antibodies, and other targeted biologic therapies can reduce exacerbations, improve asthma control and lung function, and improve quality of life. However, large-scale trials are needed to further investigate their efficacy and safety (1, B). The most effective way to prevent aspirin-induced asthma (AIA) is to avoid reapplication of this drug, and desensitization therapy may be considered in AIA patients who require high-dose ICS to control asthma symptoms, or who have failed to improve nasal inflammation and polyposis with conventional treatment, or who require aspirin for other diseases (2, B). Severe asthma with chronic rhinosinusitis with nasal polyps may benefit from anti-IgE monoclonal antibodies, anti-IL-5 monoclonal antibodies, anti-IL-5Rα monoclonal antibodies, and anti-IL-4Rα monoclonal antibodies (1, B). Patients with a diagnosis of asthma should be considered for the diagnosis of asthma-COPD overlap (ACO) if they have persistent airflow limitation (FEV/FVC<70% after bronchodilator inhalation), a history of exposure to noxious gases or substances (smoking or previous history of smoking≥10 pack-years), emphysema as assessed by high-resolution computerized tomography, and decreased diffusion capacity after 3 to 6 months of standardized treatment (1, D). When developing control goals for asthma with patients, the health care system, availability of medications, cultural differences, and personal preferences should be considered (1, D).
支气管哮喘是一种常见的慢性呼吸道疾病。标准化诊断、治疗及有效的临床管理对于改善哮喘控制、提高患者生活质量及减轻疾病负担至关重要。基于国内外最新循证医学研究,中华医学会呼吸病学分会哮喘学组对《( )》进行了修订。此次修订补充了诊断路径,更新了哮喘的临床分期及严重程度分级。此外,依据最新研究证据,在哮喘评估、维持治疗、急性加重管理、重症哮喘、非典型哮喘及哮喘治疗原则等方面也做出了调整。更新后的指南为我国医疗卫生专业人员提供了全面的参考资料,就标准化诊断和管理哮喘提供了最新建议,以提高他们的专业知识和能力。关键建议如下:当一秒用力呼气容积(FEV)≥预测值的70%(过去4周内无呼吸道感染)时,应考虑进行支气管激发试验(1,D)。当临床症状提示哮喘,但无法进行支气管激发试验或不符合可变气流受限的诊断标准时,应避免仅依靠临界值来排除哮喘。可启动推定诊断路径以提高诊断准确性(1,D)。若符合以下任何一条标准,可启动诊断性抗炎治疗以确诊:(1)在无法进行肺量计检查时,基于呼气峰值流速(PEF)的支气管舒张试验结果为阳性(较基线增加≥20%),过去4周内无呼吸道感染;(2)两次先前检查之间FEV变异率≥12%且绝对变化≥200 ml,过去4周内无呼吸道感染;(3)小气道功能障碍[在呼出25%用力肺活量(FVC)时的最大瞬间用力呼气流量(MEF25)、MEF50、最大呼气中期流量(MMEF)中,3项中有2项≤预测值的65%],或当基线FEV≥预测值的80%时,支气管舒张试验中呼出一氧化氮分数(FeNO)≥35 ppb且FEV改善≥10%(1,C)。生物治疗或其他抗哮喘治疗后,症状缓解≥1年、无加重、肺功能正常/接近正常且无需口服糖皮质激素(OCS)的患者可被视为达到“临床缓解”(1,D)。基于实现哮喘控制所需的治疗步骤对哮喘严重程度进行分类,优于依赖患者治疗前的情况(1,D)。以血/痰嗜酸性粒细胞、和/或FeNO、和/或特应性或总免疫球蛋白E(IgE)升高为特征的2型气道炎症在重症哮喘中占主导。非2型炎症(定义为不符合上述任何标准)应在排除混杂因素(如感染和药物)后才能确定(1,D)。如果患者在常规治疗后仍有呼吸困难/胸闷,且肺功能、外周血嗜酸性粒细胞和FeNO同时恢复正常,应进行心理社会评估(如焦虑/抑郁量表)和合并症评估(1,D)。支气管激发试验中导致FEV下降20%的激发剂量可反映气道高反应性,可用于疾病监测和治疗评估(2,D)。诱导痰嗜酸性粒细胞是气道炎症评估、哮喘表型分类、糖皮质激素反应预测和加重风险评估的金标准生物标志物之一(1,A)。外周血嗜酸性粒细胞≥150/μl可用于识别嗜酸性粒细胞表型或2型炎症内型,也是预测和评估生物反应的关键生物标志物之一(1,C)。哮喘患者长期使用推荐临床剂量范围的吸入糖皮质激素(ICS)是安全的。然而,长期高剂量ICS治疗可能导致全身不良反应,包括骨质疏松、下丘脑 - 垂体 - 肾上腺轴抑制和肺炎风险增加(1,D)。对于成年重症哮喘患者,可作为最后选择加用低剂量OCS(≤7.5 mg/天泼尼松等效剂量)(1,D)。ICS与长效β受体激动剂(LABA)联合使用具有协同抗炎和抗哮喘作用,疗效等同于或优于将ICS剂量加倍,可提高患者依从性并减少高剂量ICS相关不良反应,尤其推荐用于中重度哮喘患者的长期治疗(1,A)。当哮喘在中高剂量ICS - LABA治疗下仍未得到控制时,可开具三联吸入器以改善症状、肺功能并减少加重发作(1,A)。成人哮喘患者皮下免疫治疗可减少ICS用量,改善哮喘特异性生活质量和肺功能(2,B)。对于尘螨(HDM)致敏、FEV>预测值70%的青少年或成人,若在含低至中剂量ICS治疗下症状仍持续,可加用HDM舌下免疫治疗以减轻症状并减少ICS剂量(2,B)。哮喘的第1步治疗:对于日间症状局限于偶尔短暂发作(<每月2次,持续数小时)、无夜间症状、无加重风险且FEV>预测值80%的患者,推荐按需使用低剂量ICS - 福莫特罗(1,A)。哮喘的第2步治疗:推荐按需使用低剂量ICS - 福莫特罗,与短效β受体激动剂(SABA)单药治疗相比,可显著减少中重度加重发作(1,A)。尽管正确吸入技术并坚持第4步治疗,但仍有持续症状或加重发作的患者,应转诊至哮喘专科医生或专科门诊进行进一步评估(1,D)。初始治疗后应每2 - 4周安排一次随访,若有反应则随后每1 - 3个月随访一次。对患者进行正确使用吸入器技术的定期培训对于优化哮喘控制至关重要(1,B)。与哮喘相关死亡的危险因素包括:(1)有需要插管和机械通气的哮喘病史;(2)过去1年内因哮喘加重住院或急诊就诊;(3)目前正在使用或近期停用OCS;(4)目前未使用ICS;(5)过度使用SABA,尤其是每月超过1罐沙丁胺醇(或等效药物);(6)精神疾病或心理社会问题,包括使用镇静剂;(7)依从性差;(8)确诊的食物过敏史;(9)合并症,包括肺炎、糖尿病和心律失常(1,D)。在轻度至中度哮喘加重的早期阶段,如果使用布地奈德 - 福莫特罗联合治疗作为抗炎缓解药物,可额外吸入1 - 2次布地奈德 - 福莫特罗(160/4.5 μg规格)。然而,每日剂量不应超过8吸(1,D)。重症哮喘是指尽管连续规范使用中高剂量ICS - LABA 3个月以上,且已对合并症进行治疗并避免环境刺激,但哮喘仍未得到控制,或降至较低剂量ICS - LABA后病情恶化(1,D)。重症2型哮喘患者可接受生物治疗,对2型靶向生物治疗反应良好的患者可优先减少或停用维持性OCS治疗,但不应完全停止ICS - LABA维持治疗(1,A)。尽管进行了第5步治疗,但仍有持续性症状性哮喘的成年患者,可加用低剂量阿奇霉素治疗,如阿奇霉素250 - 500 mg/天,每周3次,持续26 - 48周,以减少加重发作(2,A)。支气管热成形术适用于尽管优化了哮喘治疗并转诊至专科重症哮喘中心,但哮喘仍未得到控制的成年患者,或无法获得或不适合进行靶向生物治疗的患者(2,A)。咳嗽变异性哮喘(CVA)的治疗原则与典型哮喘相同,大多数患者对ICS或ICS - LABA有反应。推荐ICS - LABA作为首选,应使用超过8周(1,B)。CVA存在不同的表型和治疗反应。对于治疗反应不佳且气道炎症严重的CVA患者,可考虑加用白三烯受体拮抗剂治疗或短期使用OCS(10 - 20 mg/d,3 - 5 d)(2,D)。在真菌致敏相关的哮喘中,抗真菌药物可通过减少真菌定植和负荷来减轻气道炎症并减少全身糖皮质激素剂量(1,D)。在真菌致敏相关的哮喘中,抗IgE、抗白细胞介素(IL) - 5、抗IL - 5Rα、抗IL - 4Rα单克隆抗体及其他靶向生物治疗可减少加重发作,改善哮喘控制和肺功能,提高生活质量。然而,需要大规模试验进一步研究其疗效和安全性(1,B)。预防阿司匹林诱发哮喘(AIA)最有效的方法是避免再次使用该药物,对于需要高剂量ICS控制哮喘症状、或常规治疗未能改善鼻炎症和鼻息肉、或因其他疾病需要使用阿司匹林的AIA患者,可考虑脱敏治疗(2,B)。伴有慢性鼻窦炎鼻息肉的重症哮喘患者可能从抗IgE单克隆抗体、抗IL - 5单克隆抗体、抗IL - 5Rα单克隆抗体和抗IL - 4Rα单克隆抗体治疗中获益(1,B)。如果诊断为哮喘的患者存在持续气流受限(吸入支气管扩张剂后FEV/FVC<70%)、接触有害气体或物质史(吸烟或既往吸烟史≥10包年)、高分辨率计算机断层扫描评估为肺气肿以及标准化治疗3至6个月后弥散功能降低,则应考虑诊断为哮喘 - 慢性阻塞性肺疾病重叠综合征(ACO)(1,D)。在与患者制定哮喘控制目标时,应考虑医疗保健系统、药物可及性、文化差异和个人偏好(1,D)。