目的 评价益肺灸治疗慢性阻塞性肺疾病(COPD)的临床疗效.方法 检索中国知网、PubMed等数据库从建库至2021 年5 月公开发表的益肺灸治疗COPD的随机对照试验(RCT),按照纳入排除标准筛选文献,对文献质量进行评价,双人独立提取研究数据,采用RevMan5.3 软件对结局指标(急性加重次数、呼吸困难、肺功能等)进行Meta分析.结果 共筛选107 篇文献,纳入15 个研究,1 355 例患者.对照组为西医常规治疗,试验组在对照组基础上进行益肺灸(督灸)治疗.由于受外治法技术限制,导致文献方法学质量较低,风险偏倚较大.Meta分析结果显示:呼吸困难评分[95％CI(-0.40～-0.09),P＜0.05],6 min步行距离(6MWD)[95％CI(20.15～52.08),P＜0.05],1 s用力呼吸容积(FEV1)％[95％CI(3.36～9.52),P＜0.05]等12 个结局指标组间差异具有统计学意义,不良反应发生率较低,未见卫生经济学评价报告.结论 益肺灸治疗COPD稳定期患者能够改善呼吸困难,提高生存质量,减少COPD急性加重,提高运动耐力,改善临床症状,改善肺功能.所得结论有待高质量临床研究进一步证实.加强外治法盲法设计有助于提高益肺灸技术循证研究质量和水平;加强卫生经济学评价,能够更客观评价益肺灸技术的比较效益.

目的 探讨哮喘中医证候与炎症表型、生存质量的相关性.方法 采用前瞻性横断面研究,收集2018年11月-2020年12月于河南中医药大学第一附属医院就诊的哮喘患者进行辨证分型,检测诱导痰确定炎症表型,填写相关生存质量问卷.用SPSS 25.0建立数据库,运用单因素分析、logistic回归分析及Spearman相关分析进行统计,3种方法中有2种具有统计学意义的被筛选为相关因素.结果 收集哮喘患者390例,信息完整、符合研究标准184例患者.结果 显示:外寒内饮证与性别、年龄、吸烟史、EA,风痰阻肺证与过敏性鼻炎、年龄、EA,痰热壅肺证与EA、NA,肺气虚证与EA,肺脾气虚证与EA、NA、ACQ-7评分,肺肾气虚证与年龄、咳喘VAS评分、ACQ-7评分、LCQ评分、CSS评分,肺肾阳虚证与ACQ-7评分、AQLQ评分分别具有相关性(P＜0.05).结论 哮喘中医证候与炎症表型具有相关性,外寒内饮证、风痰阻肺证、肺气虚证患者多表现为EA;痰热壅肺证、肺脾气虚证患者多表现为EA、NA;哮喘中医证候与生存质量具有相关性,ACQ-7评分、咳喘VAS评分、LCQ评分、CSS评分、AQLQ评分可作为哮喘症状控制情况、生存质量水平的评估工具.

慢性阻塞性肺疾病( COPD)是以气流受限为特征呈进行性发展的疾病,居全球死亡原因第4 位, 2020年居全球死亡原因第3位,造成严重经济和社会负担〔1～4〕. 2007年中国40岁以上人群COPD患病率为8. 2％ 〔5〕,2014～2015年中国40岁以上人群COPD患病率为13. 6％,较2007 年增长约1 倍〔6〕.Wang等〔7〕基于2012年6月至2015年5月中国10省5万余名居民调查显示,40岁以上COPD患病率为13. 7％,患病人数近1亿人.

Background The various inflammatory phenotypes of asthma, a common heterogeneous respiratory disease, are closely related to the pathogenesis, treatment, and prognosis of the disease. So screening the associated factors of inflammatory phenotypes will be helpful for the evaluation of patient condition and delivery of individualized diagnosis and treatment services. Objective To explore the distribution of inflammatory phenotypes and associated factors in bronchial asthma patients, providing a basis for the implementation of individualized diagnosis and treatment of the disease. Methods A cross-sectional study design was used. Clinical data of bronchial asthma outpatients and inpatients (n=184) were collected from the First Affiliated Hospital of Henan University of Chinese Medicine from November 2018 to December 2020. Inflammatory phenotypes in the patients were classified into four categories according to the type of inflammatory cells in the induced sputum: neutrophilic asthma (NA) , eosinophilic asthma (EA) , mixed granulocytic asthma (MA) , and paucigranulocytic asthma (PA) . Factors possibly associated with each of the inflammatory phenotypes were screened by three statistical methods (univariate analysis, multivariate Logistic regression analysis, and Spearman rank correlation analysis) , and were determined as the associated factors if they had significant associations with the phenotype by two of the aforementioned three methods. Results The prevalence of NA, EA, MA, and PA was 45.7% (84/184) , 20.7% (38/184) , 20.7% (38/184) , and 13.0% (24/184) , respectively. Univariate analysis showed that the prevalence of allergic rhinitis and fractioned exhaled nitric oxide (FeNO) level differed significantly between NA and non-NA patients (P<0.05) . And they also varied significantly between EA and non-EA patients (P<0.05) . There was significant difference in FeNO level between MA and non-MA patients (P<0.05) . There were significant differences in mean age, prevalence of previous respiratory disease and mean FeNO level between PA and non-PA patients (P<0.05) . Multivariate Logistic regression analysis showed that allergic rhinitis〔OR=0.417, 95%CI (0.205, 0.848) 〕 and FeNO〔OR=0.978, 95%CI (0.968, 0.989) 〕were associated with NA (P<0.05) ; FeNO〔OR=1.017, 95%CI (1.009, 1.025) 〕 was associated with EA (P<0.05) ; FeNO〔OR=1.007, 95%CI (1.000, 1.014) 〕was associated with MA (P<0.05) ; BMI〔OR=1.165, 95%CI (1.015, 1.337) 〕 and FeNO〔OR=0.981, 95%CI (0.965, 0.998) 〕were associated with PA (P<0.05) . Spearman rank correlation analysis indicated that NA prevalence decreased with increased allergic rhinitis prevalence and FeNO level (rs=-0.244, -0.361, P<0.05) ; EA prevalence increased with increased allergic rhinitis prevalence and FeNO level (rs=0.157, 0.341, P<0.05) ; MA prevalence increased with increased FeNO (rs=0.236, P<0.05) ; PA prevalence decreased with older age, prevalence of previous respiratory disease and increased FeNO (rs=-0.156, -0.163, -0.159, all P<0.05) . Based on the above analyses, allergic rhinitis and FeNO were associated factors for both EA and NA; FeNO was associated factors of MA; age, prevalence of previous respiratory disease and FeNO were associated factors of PA. Conclusion NA accounted for the largest percentage of the inflammatory phenotypes, while PA accounted for the least. FeNO was the associated factor for each inflammatory phenotype. It has specificity in recognizing EA and MA. FeNO combined with allergic rhinitis was associated with NA and EA. FeNO combined with age was associated with PA.

目的 评价二陈汤合三子养亲汤治疗慢性阻塞性肺疾病急性加重期(AECOPD)的临床疗效与安全性.方法 检索中国知网、万方、维普、CBM、PubMed、Embase、Cochrane Library数据库,检索时间从建库至2020年6月27日.由2位研究者独立筛选文献、提取资料及评价偏倚风险后,使用RevMan5.3软件进行Meta分析.结果 共纳入27篇文献,2444例AECOPD患者.Meta分析结果显示:二陈汤合三子养亲汤联合西医常规治疗临床总有效率明显优于单用西医常规治疗(P<0.00001);呼吸困难(mMRC)评分、圣乔治呼吸问卷(SGRQ)评分明显低于西医常规治疗;第1秒用力呼气量(FEV1)、FEV1占用力肺活量百分比(FEV1/FVC)、FEV1占预计值的百分比(FEV1％)均明显优于单用西医常规治疗.依据推荐分级的评估、制定与评价(GRADE)系统进行证据分级,总有效率为中等质量证据,mMRC评分为低质量证据,SGRQ评分为极低质量证据.结论 二陈汤合三子养亲汤联合西医常规治疗AECOPD的疗效优于单用西医常规治疗,安全性高,但仍缺乏高质量证据支持.

Background Asthma is a complex heterogeneous disease, whose frequent acute attacks seriously affect the quality of life of patients, and cause a heavy economic burden. The recent development of serum biomarkers provides a new idea for accurate treatment of asthma and diagnosis and treatment of refractory asthma. Objective To analyze the difference of serum biomarkers between different stages of asthma patients and healthy people, and to explore the predictive potential of different serum biomarkers for acute asthma attack. Methods A cross-sectional design was used. Participants were recruited from the First Affiliated Hospital of Henan University of Chinese Medicine during November 2018 to December 2020, including 293 asthma patients (155 in the acute attack stage, and 138 in non-acute attack stage) , and 39 healthy volunteers from physical examinee center of this hospital. ELISA was used to detect the contents of serum biomarkers〔interleukin 4 (IL-4) , interleukin 6 (IL-6) , interleukin 8 (IL-8) , interleukin17 (IL-17) , interferon-γ (IFN-γ) , transforming growth factor-β2 (TGF-β2) , tumor necrosis factor-α (TNF-α) , total immunoglobulin E (TIgE) , specific immunoglobulin E (SIgE) , eosinophil-selective chemokine (Eotaxin) , eosinophil cationic protein (ECP) , periostin, leukotriene D4 (LTD4) , high mobility group protein B1 (HMGB1) , chitinase 3-like protein 1 (YKL-40) 〕. Results Compared with healthy volunteers, both acute and non-acute attack asthma patients had higher levels of serum IL-4, IL-6, IL-8, IL-17, TGF-β2, TNF-α, HMGB1, TIgE and SIgE, and lower level of serum IFN-γ (P<0.05) . The levels of serum Eotaxin and YKL-40 in acute attack asthma patients were higher than those in non-acute attack asthma patients and healthy volunteers (P<0.05) . The levels of Eotaxin and YKL-40 in non-acute attack asthma patients were higher than those in healthy volunteers (P<0.05) . In addition, the level of periostin in non-acute attack asthma patients was lower than that in healthy volunteers (P<0.05) . Conclusion Serum IL-4, IL-6, IL-8, IL-17, IFN-γ, TGF-β2, TNF-α, SIgE, TIgE, HMGB1 may be related to asthma, but their expression levels may not be related to disease stage. Eotaxin and YKL-40 may be potential predictors of the acute attack of asthma.

慢性阻塞性肺疾病( COPD )急性加重( AECO-PD)是患者肺功能下降、生存质量恶化、经济负担加重及最终死亡的重要因素,对疾病预后产生严重影响﹝1﹞.AECOPD患者出院后易于反复再住院,出院后6个月内有44％再次住院、超过50％出院后6个月至少再入院1次﹝2﹞.导致AECOPD患者再入院情况的影响因素,主要包括患者个人及既往疾病情况、临床症状、生存质量、肺功能、实验室指标等方面.

OBJECTIVE To establish a risk prediction model for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) using regression analysis and verify the model. METHODS The risk factors and acute exacerbation of 1 326 patients with chronic obstructive pulmonary disease (COPD) who entered the stable phase and followed up for 6 months in the four completed multi-center large-sample randomized controlled trials were retrospectively analyzed. Using the conversion-random number generator, about 80% of the 1 326 cases were randomly selected as the model group (n = 1 074), and about 20% were the verification group (n = 252). The data from the model group were selected, and Logistic regression analysis was used to screen independent risk factors for AECOPD, and an AECOPD risk prediction model was established; the model group and validation group data were substituted into the model, respectively, and the receiver operating characteristic (ROC) curve was drawn to verify the effectiveness of the risk prediction model in predicting AECOPD. RESULTS There were no statistically significant differences in general information (gender, smoking status, comorbidities, education level, etc.), body mass index (BMI) classification, lung function [forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), etc.], disease status (the number and duration of acute exacerbation in the past year, duration of disease, etc.), quality of life scale [COPD assessment test (CAT), etc.] and clinical symptoms (cough, chest tightness, etc.) between the model group and the validation group. It showed that the two sets of data had good homogeneity, and the cases in the validation group could be used to verify the effectiveness of the risk prediction model established through the model group data to predict AECOPD. Logistic regression analysis showed that gender [odds ratio (OR) = 1.679, 95% confidence interval (95%CI) was 1.221-2.308, P = 0.001], BMI classification (OR = 0.576, 95%CI was 0.331-1.000, P = 0.050), FEV1 (OR = 0.551, 95%CI was 0.352-0.863, P = 0.009), number of acute exacerbation (OR = 1.344, 95%CI was 1.245-1.451, P = 0.000) and duration of acute exacerbation (OR = 1.018, 95%CI was 1.002-1.034, P = 0.024) were independent risk factors for AECOPD. A risk prediction model for AECOPD was constructed based on the results of regression analysis: probability of acute exacerbation (P) = 1/(1+e-x), x = -3.274+0.518×gender-0.552×BMI classification+0.296×number of acute exacerbation+0.018×duration of acute exacerbation-0.596×FEV1. The ROC curve analysis verified that the area under ROC curve (AUC) of the model group was 0.740, the AUC of the verification group was 0.688; the maximum Youden index of the model was 0.371, the corresponding best cut-off value of prediction probability was 0.197, the sensitivity was 80.1%, and the specificity was 57.0%. CONCLUSIONS The AECOPD risk prediction model based on the regression analysis method had a moderate predictive power for the acute exacerbation risk of COPD patients, and could assist clinical diagnosis and treatment decision in a certain degree.

背景 重症哮喘临床控制较差,且欠缺有效的治疗方法 ,故亟需更多相关临床研究;临床注册试验可为临床防治工作奠定基础,而目前重症哮喘临床注册现状尚不清楚,尚不能为临床试验提供新视角.目的 基于WHO国际临床试验注册平台(ICTRP)数据,了解重症哮喘临床试验注册特点.方法 计算机检索WHO ICTRP数据库,搜集建库起至2019-12-15注册的重症哮喘相关临床试验资料.由2名研究者独立筛选文献、提取资料后,对纳入试验进行描述性分析.结果 共检索到重症哮喘相关临床试验235个,临床试验注册数量自建库起逐年上升,近4年有下降趋势.试验申请国家分布不均,重症哮喘患病率较高国家试验申请极少.各注册中心试验大多来自本国家.资金主要来源于单位和企业.研究病种以重症哮喘为主(89.36％),涉及年龄以成人为主(90.64％).试验类型以干预性为主(65.96％),干预性试验中随机试验占67.10％,仅9个试验描述其采用的随机方法 ;观察性研究中以队列研究居多(38.75％);44.26％的试验未注明盲法情况,其余试验双盲占据较多(25.53％);试验分期以N/A(32.77％)、Ⅲ期试验(20.00％)最多.干预措施以药物干预为主(77.42％).结局指标以肺功能、哮喘加重情况、生存质量评价为主.结论 重症哮喘临床试验近几年呈下降趋势,试验申请国家分布不均,研究病种以重症哮喘为主,研究类型以干预性为主,干预措施多为西药干预.

支气管哮喘(简称哮喘)是一组由多种炎症细胞,如嗜酸性粒细胞( EOS)、肥大细胞、淋巴细胞、中性粒细胞( PMN )、平滑肌细胞、气道上皮细胞等和细胞组分参与的慢性气道炎症性疾病〔1〕,属中医学中"哮病"的范畴.中医学认为,哮喘是因痰气交阻,闭塞气道,肺的升降失职所致.病因多以风、寒、痰、热、瘀、湿为标,以肺、脾、肾三脏俱虚为本,证属本虚标实.哮喘的炎症表型的异质性与中医辨证论治的理论相类似,因此推测哮喘炎症表型与中医证候可能存在一定的相关性〔2〕.

支气管哮喘中医学认为其属“哮病”范畴,辨证论治是中医治疗支气管哮喘的优势和特色所在,实现对支气管哮喘中医证候动态定性及定量的把握是提高支气管哮喘临床疗效的关键环节.生物标志物是生物体受刺激或扰动后,生物学介质中可以检测到细胞、生物化学或分子改变;而生物标志物与支气管哮喘中医证候具有一定相关性,其可能是实现支气管哮喘中医证候的定性和量化的突破点,且相关的研究较少,故本文以期找到可以划分各证候的客观参考指标,从而提高支气管哮喘的中医诊疗能力,同时为以后的研究提供参考.