支气管哮喘动态监测和症状感知模型的建立
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摘要
支气管哮喘严重程度评估及哮喘控制依赖于患者的症状及肺功能改变,然而,哮喘患者呼吸症状与气道阻塞并不完全相关,相当多患者的症状表现不能准确反映肺功能变化。目前对于支气管哮喘患者的症状感知类型仍未有明确定义,各类型患者的分布、临床特点、影响症状感知的因素仍不明确。当前的哮喘指南推荐应用日志对哮喘患者进行监测,以明确症状与肺功能的变异性。指南理论在向临床转化的过程中,首先需要确定患者对日志监测这种方法的依从性及准确性。本研究旨在确立支气管哮喘动态监测的方法,并初步建立哮喘症状感知模型,探讨影响动态监测及症状感知的相关因素。
本研究包括四部分内容：第一、二部分建立支气管哮喘症状-肺功能监测的方法,明确其依从性及准确性,决定其是否适用于临床；第三部分为临床应用；第四部分建立支气管哮喘症状感知模型,确定支气管哮喘患者的症状感知类型；分析影响症状感知准确性的相关因素。
第一部分为支气管哮喘患者动态监测的依从性。106例有症状的支气管哮喘患者应用日志研究方法,每天3次在固定时间段进行症状、用药(纸版日志)、肺功能(电子日志)监测,连续14天。结果表明,纸版日志依从性低于电子日志(72%vs.80%)。纸版日志较低的依从性主要来自于“无法确定”的记录(12%),这部分记录无法排除伪造的可能性。患者对日志的依从性在每天有规律性变化,早晨依从性较低,晚上对日志的依从性高。依从性随监测时间的延长而下降。年龄、性别、教育水平、哮喘严重程度对患者监测的依从性没有影响。高焦虑特质的患者对日志的依从性比低焦虑水平低的患者差。研究提示,应用界面友好的电子设备作为哮喘患者的日志监测手段、监测计划考虑到患者的便利,能够使患者接受动态监测并获得良好的依从性。
第二部分为支气管哮喘患者动态肺量监测的准确性。128例支气管哮喘患者,应用便携式肺量计每天3次完成肺量测定,基线时便携式肺量计与实验室肺量计有很好一致性。14天监测中,肺量测定的总体可接受性为95%。能满足F-V曲线可接受、BEV<150ml、FEV1和FVC可重复性<200ml 4项标准的准确测定占74%；另有21%能满足可接受性标准,但不能或只能部分达到可重复性要求。28%的操作FET≥6s,48%的操作FET在3～6s,24%的操作FET在1～3s。早晨、下午、晚上不同时间段、不同监测周对操作的可接受性均无影响。下午及晚上有更多的测定可以同时满足FEV1和FVC可重复标准；第2周能同时达到可重复性要求的操作较第1周增加了4%～5%。年龄、性别、教育水平、PEF变异率对操作的可接受性均无影响。FEV1可重复性在年轻组及教育水平高组更好,焦虑状态评分低的患者操作可接受性高。PEF变异率对测定的可接受性没有影响,可重复性随着PEF变异率的增加而降低,但是没有达到统计学差异。研究表明,支气管哮喘患者能够在家中无监督的情况下完成最大用力呼气操作,便携式肺量计具有很大程度的操作准确性,结果与实验室肺量计相当,大部分患者能够达到国际标准化指南对操作准确性的要求,发生支气管痉挛的风险不大。
第三部分讨论动态肺量测定在支气管哮喘诊断和鉴别诊断中的价值。与动态心电图捕捉心电异常类似,动态肺量监测通过多时点测定,能够捕捉发作性气道阻塞,弥补了单次实验室肺功能检查的缺陷。通过FEV1及PEF变异率这些客观指标掌握气道反应的动态变化,能够明确症状与肺功能之间的关系,确定或排除支气管哮喘诊断,揭示潜在的合并疾病,正确指导临床应用抗哮喘药物。145例医生诊断的支气管哮喘患者中,87%的患者诊断被证实,9.5%存在误诊,3.5%过度诊断。
第四部分为支气管哮喘症状感知模型的建立。100例有效测定在30次以上的支气管哮喘患者,通过症状与肺功能的对应关系建立感知区间。共有54%的患者为症状感知正常,32%患者为感知迟钝,14%患者为感知过敏。正常感知患者有少部分测定位于感知过敏或感知迟钝区间；感知过敏或感知迟钝患者也有少部分测定在感知正常区间,但感知过敏及感知迟钝这两类患者的测定并不重叠。患者在早晨、下午、晚上不同时间段对症状感知的准确性有差异,下午有更多症状感知在正常区间,晚上的不准确感知略多。男性比女性感知准确性差,感知迟钝较女性多25%。焦虑水平高的患者过度感知所占比例明显增多。哮喘严重程度对症状感知有明确影响,PEF变异率在20%-30%的患者正常感知占73%,而PEF变异率在30%以上的患者正常感知仅占50%,后者感知迟钝的比例高达43%,明显多于哮喘严重程度较轻患者。
通过以上四部分内容,本研究确立了支气管哮喘的动态监测方法,构建了症状感知类型识别模型,并探讨了相关影响因素。
The current asthma guidelines encourage use of a diary of assessing and monitoring symptoms and airway function. However, the compliance with the diary and the accuracy of the monitoring are the guarantee of clinical value. Inaccurate symptom perception has long been noticed in asthma patients, but never has a clear definition, factors affect asthma symptom perception remain unsolved.
This study consists of four sections. The method of symptom-lung function monitoring was established in the first and the second section. The third section was about it's clinical value. The last section was the construction of asthma symptom perception model, identifying patients in the model, and discussing possible factors influencing symptom perception.
In the first chapter,106 asthmatic patients were recruited into the compliance study, who underwent a fixed-time thrice-daily assessment schedule for a period lasting two weeks. Symptoms and medication use were recorded in a booklet (paper diary), and airway function measured by a portable spirometer (electronic diary). Patient compliance with paper diary was significantly lower than that of electronic diary (72% of paper diary vs.80% of electronic diary). The lower compliance with paper diary was particularly due to the uncertain compliance observed in paper diary entries (12%), which were unable to be verified by the electronic record of the date and time of the entry. A significant difference was found in different recording time, the highest compliance was obtained in the evening, whereas the lowest was in the early morning. Patient compliance fell in the second week, as compared to the first week of diary keeping. Among demographics and clinical factors, age, gender, education level and asthma severity were not found to be related to patient compliance with diary keeping. Patients with high anxiety level were less compliant with diary keeping, as compared with patients with lower anxiety level.
In the second chapter, the accuracy of unsupervised spirometry manoeuvre in asthmatic patients was discussed.128 patients finished 4249 compliant spirometry tests.95% manoeuvres were acceptable, and 74% met the four criteria of strict accuracy, in terms of "F-V curve acceptability+ BEV＜150ml+FEV1 reproducibility＜200ml+FVC reproducibility＜200ml".28% manoeuvres had the FET≥6s, and 48% FET was between 3-6s. Better reproducibility was obtained in the afternoon and evening, which was the same in the second week. FEV1 reproducibility was better in the patients who were under 40 years and who had college and above education. Patients with lower STAI-State score had better acceptability in spirometry tests. Lower FVC reproducibility was accompanied by higher PEF variability.
Chapter 3 evaluated the specificity in diagnosis and differential diagnosis of dynamic assessment and monitoring in asthma patients, which may have the advantage of capturing diurnal changes of airway function. Of 145 patients with physician-diagnosed asthma,126 (87%) could be conclusively confirmed for a diagnosis of asthma. Asthma was misdiagnosed in 14 patients (9.5%). Overdiagnosis of asthma was observed in 5 patients (3.5%). It was concluded that dynamic assessment and monitoring using a portable spirometer by revealing variability and reversibility of airway obstruction may provide an additional tool for diagnosis and differential diagnosis of asthma.
Chapter 4 was the establishment of asthma symptom perception model.100 asthmatic patients finished more than 30 dynamic symptom-lung function data points in 14 days were recruited into the study. Symptom perception zones were plotting out according to the symptom score-FEV,%Predicted relationship, thus patients were classified as normal-perception, under-perception and over-perception with the percentage of 54%,32% and 14% respectively. Normal-perception patients had a small part of monitoring in over-perception or under-perception zones, but over-perception and under-perception wouldn't be in the same patient. Patients had more accurate perception in the afternoon, and inaccurate perception in the evening. Males had a quarter under-perception more than females. Over-perception was associated with high anxiety level. Asthma severity affected symptom perception in terms of PEF variability. Patients with PEF variability between 20%～30% had 73% normal-perception records, however the normal-perception records decreased to 50% in patients with PEF variability more than 30%, the latter had 43% under-perception records, which was much higher than mild and moderate asthma patients.
In conclusion, the study evaluated the dynamic monitoring method in asthma patients, established a symptom perception model, and discussed the possible influential factors.
本研究包括四部分内容：第一、二部分建立支气管哮喘症状-肺功能监测的方法,明确其依从性及准确性,决定其是否适用于临床；第三部分为临床应用；第四部分建立支气管哮喘症状感知模型,确定支气管哮喘患者的症状感知类型；分析影响症状感知准确性的相关因素。
第一部分为支气管哮喘患者动态监测的依从性。106例有症状的支气管哮喘患者应用日志研究方法,每天3次在固定时间段进行症状、用药(纸版日志)、肺功能(电子日志)监测,连续14天。结果表明,纸版日志依从性低于电子日志(72%vs.80%)。纸版日志较低的依从性主要来自于“无法确定”的记录(12%),这部分记录无法排除伪造的可能性。患者对日志的依从性在每天有规律性变化,早晨依从性较低,晚上对日志的依从性高。依从性随监测时间的延长而下降。年龄、性别、教育水平、哮喘严重程度对患者监测的依从性没有影响。高焦虑特质的患者对日志的依从性比低焦虑水平低的患者差。研究提示,应用界面友好的电子设备作为哮喘患者的日志监测手段、监测计划考虑到患者的便利,能够使患者接受动态监测并获得良好的依从性。
第二部分为支气管哮喘患者动态肺量监测的准确性。128例支气管哮喘患者,应用便携式肺量计每天3次完成肺量测定,基线时便携式肺量计与实验室肺量计有很好一致性。14天监测中,肺量测定的总体可接受性为95%。能满足F-V曲线可接受、BEV<150ml、FEV1和FVC可重复性<200ml 4项标准的准确测定占74%；另有21%能满足可接受性标准,但不能或只能部分达到可重复性要求。28%的操作FET≥6s,48%的操作FET在3～6s,24%的操作FET在1～3s。早晨、下午、晚上不同时间段、不同监测周对操作的可接受性均无影响。下午及晚上有更多的测定可以同时满足FEV1和FVC可重复标准；第2周能同时达到可重复性要求的操作较第1周增加了4%～5%。年龄、性别、教育水平、PEF变异率对操作的可接受性均无影响。FEV1可重复性在年轻组及教育水平高组更好,焦虑状态评分低的患者操作可接受性高。PEF变异率对测定的可接受性没有影响,可重复性随着PEF变异率的增加而降低,但是没有达到统计学差异。研究表明,支气管哮喘患者能够在家中无监督的情况下完成最大用力呼气操作,便携式肺量计具有很大程度的操作准确性,结果与实验室肺量计相当,大部分患者能够达到国际标准化指南对操作准确性的要求,发生支气管痉挛的风险不大。
第三部分讨论动态肺量测定在支气管哮喘诊断和鉴别诊断中的价值。与动态心电图捕捉心电异常类似,动态肺量监测通过多时点测定,能够捕捉发作性气道阻塞,弥补了单次实验室肺功能检查的缺陷。通过FEV1及PEF变异率这些客观指标掌握气道反应的动态变化,能够明确症状与肺功能之间的关系,确定或排除支气管哮喘诊断,揭示潜在的合并疾病,正确指导临床应用抗哮喘药物。145例医生诊断的支气管哮喘患者中,87%的患者诊断被证实,9.5%存在误诊,3.5%过度诊断。
第四部分为支气管哮喘症状感知模型的建立。100例有效测定在30次以上的支气管哮喘患者,通过症状与肺功能的对应关系建立感知区间。共有54%的患者为症状感知正常,32%患者为感知迟钝,14%患者为感知过敏。正常感知患者有少部分测定位于感知过敏或感知迟钝区间；感知过敏或感知迟钝患者也有少部分测定在感知正常区间,但感知过敏及感知迟钝这两类患者的测定并不重叠。患者在早晨、下午、晚上不同时间段对症状感知的准确性有差异,下午有更多症状感知在正常区间,晚上的不准确感知略多。男性比女性感知准确性差,感知迟钝较女性多25%。焦虑水平高的患者过度感知所占比例明显增多。哮喘严重程度对症状感知有明确影响,PEF变异率在20%-30%的患者正常感知占73%,而PEF变异率在30%以上的患者正常感知仅占50%,后者感知迟钝的比例高达43%,明显多于哮喘严重程度较轻患者。
通过以上四部分内容,本研究确立了支气管哮喘的动态监测方法,构建了症状感知类型识别模型,并探讨了相关影响因素。
The current asthma guidelines encourage use of a diary of assessing and monitoring symptoms and airway function. However, the compliance with the diary and the accuracy of the monitoring are the guarantee of clinical value. Inaccurate symptom perception has long been noticed in asthma patients, but never has a clear definition, factors affect asthma symptom perception remain unsolved.
This study consists of four sections. The method of symptom-lung function monitoring was established in the first and the second section. The third section was about it's clinical value. The last section was the construction of asthma symptom perception model, identifying patients in the model, and discussing possible factors influencing symptom perception.
In the first chapter,106 asthmatic patients were recruited into the compliance study, who underwent a fixed-time thrice-daily assessment schedule for a period lasting two weeks. Symptoms and medication use were recorded in a booklet (paper diary), and airway function measured by a portable spirometer (electronic diary). Patient compliance with paper diary was significantly lower than that of electronic diary (72% of paper diary vs.80% of electronic diary). The lower compliance with paper diary was particularly due to the uncertain compliance observed in paper diary entries (12%), which were unable to be verified by the electronic record of the date and time of the entry. A significant difference was found in different recording time, the highest compliance was obtained in the evening, whereas the lowest was in the early morning. Patient compliance fell in the second week, as compared to the first week of diary keeping. Among demographics and clinical factors, age, gender, education level and asthma severity were not found to be related to patient compliance with diary keeping. Patients with high anxiety level were less compliant with diary keeping, as compared with patients with lower anxiety level.
In the second chapter, the accuracy of unsupervised spirometry manoeuvre in asthmatic patients was discussed.128 patients finished 4249 compliant spirometry tests.95% manoeuvres were acceptable, and 74% met the four criteria of strict accuracy, in terms of "F-V curve acceptability+ BEV＜150ml+FEV1 reproducibility＜200ml+FVC reproducibility＜200ml".28% manoeuvres had the FET≥6s, and 48% FET was between 3-6s. Better reproducibility was obtained in the afternoon and evening, which was the same in the second week. FEV1 reproducibility was better in the patients who were under 40 years and who had college and above education. Patients with lower STAI-State score had better acceptability in spirometry tests. Lower FVC reproducibility was accompanied by higher PEF variability.
Chapter 3 evaluated the specificity in diagnosis and differential diagnosis of dynamic assessment and monitoring in asthma patients, which may have the advantage of capturing diurnal changes of airway function. Of 145 patients with physician-diagnosed asthma,126 (87%) could be conclusively confirmed for a diagnosis of asthma. Asthma was misdiagnosed in 14 patients (9.5%). Overdiagnosis of asthma was observed in 5 patients (3.5%). It was concluded that dynamic assessment and monitoring using a portable spirometer by revealing variability and reversibility of airway obstruction may provide an additional tool for diagnosis and differential diagnosis of asthma.
Chapter 4 was the establishment of asthma symptom perception model.100 asthmatic patients finished more than 30 dynamic symptom-lung function data points in 14 days were recruited into the study. Symptom perception zones were plotting out according to the symptom score-FEV,%Predicted relationship, thus patients were classified as normal-perception, under-perception and over-perception with the percentage of 54%,32% and 14% respectively. Normal-perception patients had a small part of monitoring in over-perception or under-perception zones, but over-perception and under-perception wouldn't be in the same patient. Patients had more accurate perception in the afternoon, and inaccurate perception in the evening. Males had a quarter under-perception more than females. Over-perception was associated with high anxiety level. Asthma severity affected symptom perception in terms of PEF variability. Patients with PEF variability between 20%～30% had 73% normal-perception records, however the normal-perception records decreased to 50% in patients with PEF variability more than 30%, the latter had 43% under-perception records, which was much higher than mild and moderate asthma patients.
In conclusion, the study evaluated the dynamic monitoring method in asthma patients, established a symptom perception model, and discussed the possible influential factors.
引文
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