BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise...BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.展开更多
Introduction Characterized as persistent and progressive pulmonary function declining,chronic obstructive pulmonary disease (COPD) can be accompanied by a systemic inflammatory response.A variety of psychiatric and so...Introduction Characterized as persistent and progressive pulmonary function declining,chronic obstructive pulmonary disease (COPD) can be accompanied by a systemic inflammatory response.A variety of psychiatric and somatic comorbidities can occur to the patients,such as depression,nutritional disorders,cardiovascular disease,and lung cancer.It is imposing great impacts on the quality of patients' life.In 2010 alone,the economic burden of COPD in the world was as high as 2.1 trillion dollars [1].The high prevalence,mortality,and morbidity have made this disease a major public health problem in socio-economic development with a rapidly aging population in China.展开更多
<strong>Background:</strong> A dual bronchodilator, long-acting anticholine drugs (glycopyrronium, LAMA) and the long running <em>β</em>-<sub>2</sub> stimulant (indacaterol, LABA),...<strong>Background:</strong> A dual bronchodilator, long-acting anticholine drugs (glycopyrronium, LAMA) and the long running <em>β</em>-<sub>2</sub> stimulant (indacaterol, LABA), are effective for the treatment of chronic obstructive pulmonary disease (COPD). To evaluate the effectiveness of the perioperative intervention of LAMA/LABA, a randomized prospective trial was performed for the lung cancer patients receiving a lobectomy with normal pulmonary function and COPD. <strong>Methods:</strong> Based on the results of the preoperative pulmonary function test, 25 patients were diagnosed with COPD [% forced expiratory volume in 1 second (%FEV<sub>1</sub>) < 70%]. Thirty-seven patients were enrolled as non-obstructive patients (70% ≤ %FEV<sub>1</sub>), who were randomized into two groups, the LAMA/LABA (n = 19) and the Control group (n = 18). The LAMA/LABA and the COPD groups daily received inhaled LAMA (50 μg) and LABA (110 μg) for 1 week before surgery and for least 4 weeks after surgery. The Control group had no treatment of the dual bronchodilator. The actual values were measured during the perioperative pulmonary function at three points of the preoperative baseline, the postoperative 1 week and the postoperative 4 weeks;these changes and changed ratios were then calculated. The patient-reported outcomes of the quality of life (PRO-QOL) were evaluated by the Cancer Dyspnea Scale (CDS), the COPD assessment test, and the St. George’s Respiratory Questionnaire. <strong>Results:</strong> Regarding the value of FEV<sub>1</sub> at the baseline, that in the LAMA/LABA group was 79.2% ± 6.4% and that in the Control group was 80.9% ± 6.4%, but that in the COPD groups was 57.9% ± 8.7%;there was a significant difference between the COPD and the Control group (p < 0.0001). At the postoperative 1 week point, the FEV<sub>1</sub> value in the Control group was 1.3 ± 0.5 L and that in the LAMA/LABA group was 1.7 ± 0.5 L. On the other hand, that in the COPD group was 1.7 ± 0.5 L, which was significantly higher compared to that in the Control group (p = 0.0251 and p = 0.0369). The intervention of LAMA/LABA for the COPD and non-obstructive patients resulted in the less decreased degree of the pulmonary function in FEV<sub>1</sub> compared to that in the Control group. Based on the PRO-QOL by the CDS, the intervention of LAMA/LABA significantly reduced the total dyspnea in the LAMA/LABA group compared to that in the Control group (p = 0.0348). <strong>Conclusion:</strong> The perioperative intervention of LAMA/LABA should lead to maintaining the postoperative pulmonary function of the FEV<sub>1</sub> during the lobectomy with COPD and non-obstructive patients and the improvement of PRO-QOL.展开更多
The aim of this study was to estimate the association between occupational, environmental, behavioral risk factors, and active pulmonary tuberculosis（PTB） among coal workers＇ pneumoconiosis（CWP） patients. A match...The aim of this study was to estimate the association between occupational, environmental, behavioral risk factors, and active pulmonary tuberculosis（PTB） among coal workers＇ pneumoconiosis（CWP） patients. A matched case-control study was conducted in 86 CWP patients with active PTB and 86 CWP controls without TB. A standardized questionnaire was used for risk factors assessment. Conditioned logistic regression analysis was used to identify associations between the risk factors and active PTB among CWP patients. The results showed that the stage of CWP, poor workplace ventilation, family history of TB, and exposure to TB were independent risk factors for active PTB in patients with CWP with which recommendations for improving work environments, and for case finding activities in patients with CWP could be made.展开更多
Objective Individuals with pulmonary hypertension(PH)have reduced exercise capacity and quality of life.Exercise-based rehabilitation may have beneficial effects to improve the exercise capacity and quality of life in...Objective Individuals with pulmonary hypertension(PH)have reduced exercise capacity and quality of life.Exercise-based rehabilitation may have beneficial effects to improve the exercise capacity and quality of life in patients with PH.We aim to assess the efficacy and safety of exercised-based rehabilitation for people eith PH by performing a randomized controlled trails(RCTs)meta-analysis of exercised-based rehabilitation for people with PH by performing a randomized controlled trails meta-analysis.展开更多
Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it deve...Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.展开更多
背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药...背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药治疗AECOPD临床试验设计和结局指标选择提供参考。方法计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、Embase、Web of Science、Cochrane Library、ClinicalTrials.gov、中国临床试验注册中心,获取口服中药治疗AECOPD的RCT和临床试验注册方案,检索时限为2018年1月—2022年10月。由2位评价员独立筛选文献、提取资料后,采用定性分析的方法,对纳入研究的结局指标选择情况进行描述。结果纳入578篇文献,包含574篇已报告试验结果的RCT及4个临床试验注册方案。574篇RCT共纳入51508例患者。88篇文献在纳入标准中限定了患者的疾病分级,361篇文献在纳入标准中限定了中医证型,6篇文献报告了盲法,6篇文献提及了随访。纳入文献共涉及4030个结局指标,单篇文献结局指标数量范围为1~24个。按照结局指标的功能属性,将其归为8个指标域:中医症状/证候、症状/体征、理化检测、生活质量、远期预后、经济学评估、安全性评价、其他,报告率最高的指标域是理化检测,报告频次排名前5位的结局指标项目是:有效率(11.5%)、第1秒用力呼气容积(7.5%)、中医症状/证候评分(7.0%)、第1秒用力呼气容积/用力肺活量(6.8%)、用力肺活量(4.6%)。445篇文献报告了有效率的组成,报告率排名前5位的研究指标依次为症状(423篇)、体征(281篇)、中医证候评分(203篇)、实验室检查(89篇)、肺功能(71篇)。结论口服中药治疗AECOPD的RCT涉及的结局指标数量多、范围广,纳入的文献在不同程度上关注了口服中药对AECOPD患者的症状体征、理化检测指标、生活质量、远期预后、经济学评价和安全性结局等方面的影响。但结局指标的选择仍存在多方面的问题:结局指标主次不清;主要关注替代终点,对临床终点的关注不足;对卫生经济学指标关注不足;有效性参考来源不一、判断标准不一。研究者可参考已发表的核心指标集,合理设计结局指标,以提高中医药临床研究的质量。展开更多
目的系统评价布地奈德联合肺表面活性物质(PS)治疗新生儿胎粪吸入综合征(MAS)的有效性与安全性。方法计算机检索PubMed、Cochrane Central Register of Controlled Trials(Central)、Embase、Web of Science、SinoMed、VIP、WanFang Dat...目的系统评价布地奈德联合肺表面活性物质(PS)治疗新生儿胎粪吸入综合征(MAS)的有效性与安全性。方法计算机检索PubMed、Cochrane Central Register of Controlled Trials(Central)、Embase、Web of Science、SinoMed、VIP、WanFang Data和CNKI数据库,搜集关于布地奈德联合PS治疗新生儿MAS的随机对照试验(RCT),检索时限均从建库至2023年9月2日。由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4软件进行Meta分析。结果共纳入6个RCT,包括544例患儿。Meta分析结果显示,与单用PS相比,布地奈德联合PS治疗患儿的总有效率较高[RR=1.29,95%CI(1.17,1.41),P<0.001]、住院时间较短[MD=-6.35,95%CI(-9.25,-3.46),P<0.001]、吸氧时间较短[MD=-1.61,95%CI(-2.23,-0.98),P<0.001]、呼吸机使用时间较短[MD=-26.46,95%CI(-35.98,-16.95),P<0.001],治疗后各时段患儿的血气分析指标均改善(P<0.05);布地奈德联合PS组患儿总并发症及不良反应发生率明显低于单用PS组[RR=0.35,95%CI(0.25,0.47),P<0.001]。亚组分析显示,布地奈德联合PS组患儿的持续肺动脉高压(PPHN)发生率[RR=0.38,95%CI(0.19,0.74),P=0.004]、肺出血发生率[RR=0.26,95%CI(0.10,0.69),P=0.007]均低于单用PS组;两组心力衰竭、败血症发生率差异均无统计学意义(P>0.05)。结论当前证据显示,布地奈德联合PS治疗新生儿MAS可改善患儿的症状、体征、血气分析指标,加快病情康复,缩短病程,有助于降低并发症、PPHN、肺出血的发生风险,而不会增加心力衰竭、败血症的发生风险。但受纳入研究数量的限制,上述结论尚需更多高质量、大样本的RCT予以验证。展开更多
基金supported by 2011 Special Fund for TCM-scientific Research in the Public Interest of Ministry of Finance, People’s Republic of ChinaState Administration of Traditional Chinese Medicine (No. 201107002)
文摘BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.
文摘Introduction Characterized as persistent and progressive pulmonary function declining,chronic obstructive pulmonary disease (COPD) can be accompanied by a systemic inflammatory response.A variety of psychiatric and somatic comorbidities can occur to the patients,such as depression,nutritional disorders,cardiovascular disease,and lung cancer.It is imposing great impacts on the quality of patients' life.In 2010 alone,the economic burden of COPD in the world was as high as 2.1 trillion dollars [1].The high prevalence,mortality,and morbidity have made this disease a major public health problem in socio-economic development with a rapidly aging population in China.
文摘<strong>Background:</strong> A dual bronchodilator, long-acting anticholine drugs (glycopyrronium, LAMA) and the long running <em>β</em>-<sub>2</sub> stimulant (indacaterol, LABA), are effective for the treatment of chronic obstructive pulmonary disease (COPD). To evaluate the effectiveness of the perioperative intervention of LAMA/LABA, a randomized prospective trial was performed for the lung cancer patients receiving a lobectomy with normal pulmonary function and COPD. <strong>Methods:</strong> Based on the results of the preoperative pulmonary function test, 25 patients were diagnosed with COPD [% forced expiratory volume in 1 second (%FEV<sub>1</sub>) < 70%]. Thirty-seven patients were enrolled as non-obstructive patients (70% ≤ %FEV<sub>1</sub>), who were randomized into two groups, the LAMA/LABA (n = 19) and the Control group (n = 18). The LAMA/LABA and the COPD groups daily received inhaled LAMA (50 μg) and LABA (110 μg) for 1 week before surgery and for least 4 weeks after surgery. The Control group had no treatment of the dual bronchodilator. The actual values were measured during the perioperative pulmonary function at three points of the preoperative baseline, the postoperative 1 week and the postoperative 4 weeks;these changes and changed ratios were then calculated. The patient-reported outcomes of the quality of life (PRO-QOL) were evaluated by the Cancer Dyspnea Scale (CDS), the COPD assessment test, and the St. George’s Respiratory Questionnaire. <strong>Results:</strong> Regarding the value of FEV<sub>1</sub> at the baseline, that in the LAMA/LABA group was 79.2% ± 6.4% and that in the Control group was 80.9% ± 6.4%, but that in the COPD groups was 57.9% ± 8.7%;there was a significant difference between the COPD and the Control group (p < 0.0001). At the postoperative 1 week point, the FEV<sub>1</sub> value in the Control group was 1.3 ± 0.5 L and that in the LAMA/LABA group was 1.7 ± 0.5 L. On the other hand, that in the COPD group was 1.7 ± 0.5 L, which was significantly higher compared to that in the Control group (p = 0.0251 and p = 0.0369). The intervention of LAMA/LABA for the COPD and non-obstructive patients resulted in the less decreased degree of the pulmonary function in FEV<sub>1</sub> compared to that in the Control group. Based on the PRO-QOL by the CDS, the intervention of LAMA/LABA significantly reduced the total dyspnea in the LAMA/LABA group compared to that in the Control group (p = 0.0348). <strong>Conclusion:</strong> The perioperative intervention of LAMA/LABA should lead to maintaining the postoperative pulmonary function of the FEV<sub>1</sub> during the lobectomy with COPD and non-obstructive patients and the improvement of PRO-QOL.
基金supported by the Research program on occupational poisoning and occupational lung disease[2014BAI12B01]
文摘The aim of this study was to estimate the association between occupational, environmental, behavioral risk factors, and active pulmonary tuberculosis（PTB） among coal workers＇ pneumoconiosis（CWP） patients. A matched case-control study was conducted in 86 CWP patients with active PTB and 86 CWP controls without TB. A standardized questionnaire was used for risk factors assessment. Conditioned logistic regression analysis was used to identify associations between the risk factors and active PTB among CWP patients. The results showed that the stage of CWP, poor workplace ventilation, family history of TB, and exposure to TB were independent risk factors for active PTB in patients with CWP with which recommendations for improving work environments, and for case finding activities in patients with CWP could be made.
文摘Objective Individuals with pulmonary hypertension(PH)have reduced exercise capacity and quality of life.Exercise-based rehabilitation may have beneficial effects to improve the exercise capacity and quality of life in patients with PH.We aim to assess the efficacy and safety of exercised-based rehabilitation for people eith PH by performing a randomized controlled trails(RCTs)meta-analysis of exercised-based rehabilitation for people with PH by performing a randomized controlled trails meta-analysis.
文摘Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.
文摘背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药治疗AECOPD临床试验设计和结局指标选择提供参考。方法计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、Embase、Web of Science、Cochrane Library、ClinicalTrials.gov、中国临床试验注册中心,获取口服中药治疗AECOPD的RCT和临床试验注册方案,检索时限为2018年1月—2022年10月。由2位评价员独立筛选文献、提取资料后,采用定性分析的方法,对纳入研究的结局指标选择情况进行描述。结果纳入578篇文献,包含574篇已报告试验结果的RCT及4个临床试验注册方案。574篇RCT共纳入51508例患者。88篇文献在纳入标准中限定了患者的疾病分级,361篇文献在纳入标准中限定了中医证型,6篇文献报告了盲法,6篇文献提及了随访。纳入文献共涉及4030个结局指标,单篇文献结局指标数量范围为1~24个。按照结局指标的功能属性,将其归为8个指标域:中医症状/证候、症状/体征、理化检测、生活质量、远期预后、经济学评估、安全性评价、其他,报告率最高的指标域是理化检测,报告频次排名前5位的结局指标项目是:有效率(11.5%)、第1秒用力呼气容积(7.5%)、中医症状/证候评分(7.0%)、第1秒用力呼气容积/用力肺活量(6.8%)、用力肺活量(4.6%)。445篇文献报告了有效率的组成,报告率排名前5位的研究指标依次为症状(423篇)、体征(281篇)、中医证候评分(203篇)、实验室检查(89篇)、肺功能(71篇)。结论口服中药治疗AECOPD的RCT涉及的结局指标数量多、范围广,纳入的文献在不同程度上关注了口服中药对AECOPD患者的症状体征、理化检测指标、生活质量、远期预后、经济学评价和安全性结局等方面的影响。但结局指标的选择仍存在多方面的问题:结局指标主次不清;主要关注替代终点,对临床终点的关注不足;对卫生经济学指标关注不足;有效性参考来源不一、判断标准不一。研究者可参考已发表的核心指标集,合理设计结局指标,以提高中医药临床研究的质量。
文摘目的系统评价布地奈德联合肺表面活性物质(PS)治疗新生儿胎粪吸入综合征(MAS)的有效性与安全性。方法计算机检索PubMed、Cochrane Central Register of Controlled Trials(Central)、Embase、Web of Science、SinoMed、VIP、WanFang Data和CNKI数据库,搜集关于布地奈德联合PS治疗新生儿MAS的随机对照试验(RCT),检索时限均从建库至2023年9月2日。由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4软件进行Meta分析。结果共纳入6个RCT,包括544例患儿。Meta分析结果显示,与单用PS相比,布地奈德联合PS治疗患儿的总有效率较高[RR=1.29,95%CI(1.17,1.41),P<0.001]、住院时间较短[MD=-6.35,95%CI(-9.25,-3.46),P<0.001]、吸氧时间较短[MD=-1.61,95%CI(-2.23,-0.98),P<0.001]、呼吸机使用时间较短[MD=-26.46,95%CI(-35.98,-16.95),P<0.001],治疗后各时段患儿的血气分析指标均改善(P<0.05);布地奈德联合PS组患儿总并发症及不良反应发生率明显低于单用PS组[RR=0.35,95%CI(0.25,0.47),P<0.001]。亚组分析显示,布地奈德联合PS组患儿的持续肺动脉高压(PPHN)发生率[RR=0.38,95%CI(0.19,0.74),P=0.004]、肺出血发生率[RR=0.26,95%CI(0.10,0.69),P=0.007]均低于单用PS组;两组心力衰竭、败血症发生率差异均无统计学意义(P>0.05)。结论当前证据显示,布地奈德联合PS治疗新生儿MAS可改善患儿的症状、体征、血气分析指标,加快病情康复,缩短病程,有助于降低并发症、PPHN、肺出血的发生风险,而不会增加心力衰竭、败血症的发生风险。但受纳入研究数量的限制,上述结论尚需更多高质量、大样本的RCT予以验证。
