扶正祛邪法治疗老年肺炎的临床研究
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摘要
目的
肺炎是老年人的常见病和多发病,被比作为“老年人的朋友”,临床表现常不典型,容易漏诊和误诊,在老年人死亡直接原因中占主要地位。随着社会老龄化的深入和生存环境的变化,老年肺炎必将严重挑战和威胁老年人的健康和生命。中医药治疗老年肺炎有着自身的优势,多年来在临床应用中积累了一定的经验。因此,积极开展关于老年肺炎的中医药研究已成为了亟待解决的课题。为了科学的研究中医药治疗老年肺炎,本课题设计了随机、双盲、对照试验方法,针对老年肺炎“正气亏虚,毒瘀互结”的基本病机,临床研究扶正祛邪法治疗老年肺炎,以期得到中医药治疗老年肺炎的科学结论。同时,根据临床数据资料,采用统计分析的方法,归纳总结老年肺炎的证候特点。由于老年肺炎存在症状、体征等临床表现不典型,起病隐匿,常规实验室检查指标特异性及敏感性差等不足,所以,本课题研究欲通过寻找特异性和敏感性较高的生物标志物,并探讨其在老年肺炎的诊断及病情判断上的价值,促进生物标志物在老年肺炎诊疗方面的应用。
方法
理论研究
通过对于本病相关文献分析以及临床研究总结,探讨老年肺炎的中医基本病机及相应治法。
临床研究
1.本研究设计了严格的随机、双盲、对照试验方法,运用整体随机化方法,在网络数据库上增加受试者、申请随机号,依据网络随机的结果,将入组的76例老年社区获得性肺炎(CAP)患者分配至治疗组或对照组。治疗组在西医基础抗感染治疗上应用扶正解毒化瘀颗粒治疗,对照组在西医基础抗感染治疗上加用安慰剂治疗,研究扶正祛邪法治疗老年肺炎的疗效及安全性。
2.对76例老年CAP患者进行中医证候调查,并通过软件建立数据库。运用聚类分析的统计方法,归纳老年CAP中医证候信息,研究老年CAP的证候特点。实验研究
基于文献分析,选择近期开始应用于感染性疾病诊断但在肺炎中研究较少的生物标志物降钙素原(PCT)和肾上腺髓质素(ADM)为老年CAP的研究指标。采集老年CAP患者入院及治疗后的血清,利用ELISA方法测定患者血清PCT、ADM的浓度,并通过肺炎PSI评分及CURB-65评分对患者肺炎严重程度进行分组,探究血清PCT、ADM的浓度与肺炎严重程度之间相关性,以期明确PCT、ADM在老年CAP诊断及判断肺炎严重程度上的价值。
结果
理论研究
以文献分析及临床研究为基础,确立了本病的基本病机及治法。老年肺炎以正气亏虚为发病之本,气阴两虚贯穿于疾病的始终,故治疗上应扶正为法,以益气养阴为主。老年肺炎以热、毒、痰、瘀为标,热毒伤肺,痰瘀互结,故治疗上应以祛邪为法,清热解毒,活血化瘀,宣肺化痰。
临床研究
1.研究结果：(1)疾病疗效比较：治疗组总有效率高于对照组总有效率,两组比较差异有统计学意义(P<0.05)。(2)证候疗效比较：治疗组总有效率高于对照组总有效率,两组比较差异有统计学意义(P<0.05)。(3)单项症状比较：治疗组在缓解咳嗽、发热、胸闷痛、喘息未见明显的优势,但咯痰、口干咽燥治疗组较对照组明显改善,两组比较差异有统计学意义(P<0.05)。(4)两组患者白细胞计数、动脉血氧分压、动脉二氧化碳分压水平在治疗后均有显著下降,但两组治疗后的差值比较无统计学意义；两组患者中性粒细胞百分比水平在治疗后均有显著下降,治疗组治疗后的差值减少高于对照组,两组比较有统计学意义(P<0.05)。
2.通过专业知识与临床经验,我们将老年CAP患者的常见症状进行聚类分析分为了5大类：1类：咳嗽,便秘,大便干结,红舌,脉细。此类提示为邪热壅肺证的表现。2类：咳痰,黄痰,痰粘,痰难咯,发热。此类提示为痰热壅肺证的表现。3类：五心烦热,口干,咽干,口渴,白痰。此类提示为肺阴虚证的表现。4类：咳嗽无力,喘息,气短,胸闷,汗出,乏力,心慌,易感冒,纳呆。此类提示为肺气虚证的表现。5类：唇甲紫暗,暗红舌,黄苔,腻苔,脉弦,脉滑。此类提示为痰瘀阻肺证的表现。
实验研究
将30例老年CAP患者分成低危、中危、高危组,各组间的PCT、ADM浓度差异有统计学意义(P<0.01),其结果示随着严重程度的升高PCT、ADM浓度随之升高。
结论
理论研究
“正气亏虚、毒瘀互结”为老年肺炎之基本病机,以正气亏虚为本,以热、毒、痰、瘀为标,针对此病机,在治疗老年肺炎时应以扶正祛邪为大法,在治疗时既扶正,又祛邪,两者兼顾,方可收到满意疗效。临床研究
1.通过严格的随机、双盲、对照试验方法,观察了扶正解毒化瘀颗粒治疗38例老年CAP患者,研究发现“扶正祛邪”法可以明显提高老年CAP患者的治愈率,可以有效改善老年肺炎患者部分临床症状,临床应用安全有效。
2.通过专业知识与临床经验,综合聚类分析的5类结果和症状的出现频率,本研究发现老年CAP最常见的证型为“气阴两虚、痰热瘀阻”。这与我们临床中观察的老年CAP证候特点较为一致,与扶正解毒化瘀颗粒治疗老年CAP的病机相吻合。
实验研究
结果显示血清PCT、ADM浓度与PSI和CURB-65评分存在相关性,血清PCT、ADM浓度与老年CAP病情严重程度存在相关性,与病情程度成正比。因此,本研究初步认为,血清PCT、ADM浓度水平可以反应老年CAP的严重程度,可以用来判断疾病的预后。
Objective
Pneumonia is a very common disease among the elder and is often thought as "an old friend of the elder's". For the unspecific clinical symptoms, it is hard to diagnose pneumonia in the elder in time and the pneumonia becomes the primary direct cause of the elder's death. Due to its significant mortality rate among the elderly, we need to make better managements of the disease with our aging population. A randomized, double-blind, parallel-group clinical trial is conducted to assess the treatments of elderly pneumonia using Chinese medicine. The etiology of elderly pneumonia is weak healthy qi and the invasion of stasis toxin, thus our study uses Chinese medicine to reinforce healthy qi and purge toxins. Concurrently, with the results from the study, a statistical analysis is conducted to sum up various patterns and syndromes of elderly pneumonia. Another aspect of this study is to search for a more specific biomarker for elderly pneumonia. Then analyze its significance and further its uses in future diagnosis of elderly pneumonia.
Method
Theoretical Study
By analysis of the relevant literature and clinical studies of elderly pneumonia, investigate its TCM pathogenesis and discuss its appropriate treatments.
Clinical Study
1.Randomized, double-blind, parallel group clinical trial with 76 patients with newly diagnosed Community-acquired Pneumonia (CAP) in the elderly. The treatment group was given antibiotics with Chinese medicine, while the control group was given antibiotics with placebo.
2.Cluster analysis of Chinese medicine patterns and syndromes of 76 patients.
Laboratory Study
Pneumonia Severity Index (PSI) and CURB-65 score were used to assess the severity of CAP in the elderly in this study. The blood serum was collected from patients both before and after treatments. Then ELISA test was used to obtain the concentration of Procalcitonin (PCT) and Adrenomedullin (ADM) in the blood serum. The aim is to establish relations of PCT and ADM with the severity of CAP in the elderly.
Results
Theoretical Study
Based on a literature review and clinical study, the basic pathogenesis of the disease and treatment were established. The basic pathogenesis of elderly pneumonia was the weak healthy qi, and Qi and Yin deficiency existed throughout the disease. The treatments should be to enforce the healthy qi, including enforcing qi and yin. The secondary pathogenesis of senile pneumonia are heat, poison, phlegm and blood stasis. The treatments should be make dispelling evil qi as basic principle, including detoxification, promoting blood circulation, removing blood stasis and clearing phlegm.
Clinical Study
1.Clinical results:(1)Effect on disease:The total efficient rate of the treatment group is higher than that of the control group (p<0.05).(2)Effect on TCM syndrome:The total efficient rate of the treatment group is higher than that of the control group (p<0.05).(3) Effect on every single symptom:On clearing phlegm and relieving dry mouth and throat, the treatment group was more effective than the control group. But there was no significant difference in control of cough, fever, wheezing and chest distress between the two group. (4)In both groups, there was a significant decrease in white blood cell count, neutrophil percentage and PaCO2 respectively. However, only the difference of neutrophil percentage between the two group is statistically significant.
2.By means of professional knowledge and clinical experience, the cluster analysis of CAP in the elderly was summed up into 5 categories. Type 1:Cough, constipation, hard stools, red tongue and thready pulse. Type 2:Yellow sputum, weak cough and fever. Type 3: dysphoria in chestpalms-soles, white sputum, dry mouth, dry throat and thirst. Type 4: Difficulty in expectoration of sputum, wheezing, breathlessness, chest tightness, sweat, lethargy, palpitation, prone to cold spells, poor appetite. Type 5:Dark lips and fingernails, dusky red tongue, yellow coating, greasy coating, wiry pulse and slippery pulse.
Laboratory Study
The severity of 30 elderly CAP patients were categorized into 3 groups (low-risk, medium-risk, high-risk) and the concentrations of PCT and ADM between these groups were statistically significant (p<0.01). As the severity of CAP increased, the concentration of PCT and ADM increased.
Conclusions
Theoretical Study
The etiology of elderly pneumonia is weakened healthy qi and the invasion of stasis toxin, thus our study uses Chinese medicine to reinforce healthy qi and purge toxins. We must both reinforce healthy qi and purge toxins, so a satisfactory outcome can be received.
Clinical Study
1. The Chinese medicine methods of reinforcing healthy qi and purging toxins were able to improve the treatments of CAP in the elderly patients and got excellent response. By comparing accumulated points on specific symptoms of the two group, the sputum production acquired best and significant results after treatments, which may prove that this therapeutic principle could improve the symptoms of elderly pneumonia.
2.By means of professional knowledge and clinical experience, the most common syndrome of elderly CAP was deficiency of qi-yin and obstruction of both phlegm-heat and blood stasis.
Laboratory Study
The results show the relationships of blood serum PCT and ADM concentration with PSI and CURB-65. PCT and ADM levels can reflect CAP severity. And it is a direct correlation. Therefore, PCT and ADM could be used in the prognosis of CAP in the elderly.
肺炎是老年人的常见病和多发病,被比作为“老年人的朋友”,临床表现常不典型,容易漏诊和误诊,在老年人死亡直接原因中占主要地位。随着社会老龄化的深入和生存环境的变化,老年肺炎必将严重挑战和威胁老年人的健康和生命。中医药治疗老年肺炎有着自身的优势,多年来在临床应用中积累了一定的经验。因此,积极开展关于老年肺炎的中医药研究已成为了亟待解决的课题。为了科学的研究中医药治疗老年肺炎,本课题设计了随机、双盲、对照试验方法,针对老年肺炎“正气亏虚,毒瘀互结”的基本病机,临床研究扶正祛邪法治疗老年肺炎,以期得到中医药治疗老年肺炎的科学结论。同时,根据临床数据资料,采用统计分析的方法,归纳总结老年肺炎的证候特点。由于老年肺炎存在症状、体征等临床表现不典型,起病隐匿,常规实验室检查指标特异性及敏感性差等不足,所以,本课题研究欲通过寻找特异性和敏感性较高的生物标志物,并探讨其在老年肺炎的诊断及病情判断上的价值,促进生物标志物在老年肺炎诊疗方面的应用。
方法
理论研究
通过对于本病相关文献分析以及临床研究总结,探讨老年肺炎的中医基本病机及相应治法。
临床研究
1.本研究设计了严格的随机、双盲、对照试验方法,运用整体随机化方法,在网络数据库上增加受试者、申请随机号,依据网络随机的结果,将入组的76例老年社区获得性肺炎(CAP)患者分配至治疗组或对照组。治疗组在西医基础抗感染治疗上应用扶正解毒化瘀颗粒治疗,对照组在西医基础抗感染治疗上加用安慰剂治疗,研究扶正祛邪法治疗老年肺炎的疗效及安全性。
2.对76例老年CAP患者进行中医证候调查,并通过软件建立数据库。运用聚类分析的统计方法,归纳老年CAP中医证候信息,研究老年CAP的证候特点。实验研究
基于文献分析,选择近期开始应用于感染性疾病诊断但在肺炎中研究较少的生物标志物降钙素原(PCT)和肾上腺髓质素(ADM)为老年CAP的研究指标。采集老年CAP患者入院及治疗后的血清,利用ELISA方法测定患者血清PCT、ADM的浓度,并通过肺炎PSI评分及CURB-65评分对患者肺炎严重程度进行分组,探究血清PCT、ADM的浓度与肺炎严重程度之间相关性,以期明确PCT、ADM在老年CAP诊断及判断肺炎严重程度上的价值。
结果
理论研究
以文献分析及临床研究为基础,确立了本病的基本病机及治法。老年肺炎以正气亏虚为发病之本,气阴两虚贯穿于疾病的始终,故治疗上应扶正为法,以益气养阴为主。老年肺炎以热、毒、痰、瘀为标,热毒伤肺,痰瘀互结,故治疗上应以祛邪为法,清热解毒,活血化瘀,宣肺化痰。
临床研究
1.研究结果：(1)疾病疗效比较：治疗组总有效率高于对照组总有效率,两组比较差异有统计学意义(P<0.05)。(2)证候疗效比较：治疗组总有效率高于对照组总有效率,两组比较差异有统计学意义(P<0.05)。(3)单项症状比较：治疗组在缓解咳嗽、发热、胸闷痛、喘息未见明显的优势,但咯痰、口干咽燥治疗组较对照组明显改善,两组比较差异有统计学意义(P<0.05)。(4)两组患者白细胞计数、动脉血氧分压、动脉二氧化碳分压水平在治疗后均有显著下降,但两组治疗后的差值比较无统计学意义；两组患者中性粒细胞百分比水平在治疗后均有显著下降,治疗组治疗后的差值减少高于对照组,两组比较有统计学意义(P<0.05)。
2.通过专业知识与临床经验,我们将老年CAP患者的常见症状进行聚类分析分为了5大类：1类：咳嗽,便秘,大便干结,红舌,脉细。此类提示为邪热壅肺证的表现。2类：咳痰,黄痰,痰粘,痰难咯,发热。此类提示为痰热壅肺证的表现。3类：五心烦热,口干,咽干,口渴,白痰。此类提示为肺阴虚证的表现。4类：咳嗽无力,喘息,气短,胸闷,汗出,乏力,心慌,易感冒,纳呆。此类提示为肺气虚证的表现。5类：唇甲紫暗,暗红舌,黄苔,腻苔,脉弦,脉滑。此类提示为痰瘀阻肺证的表现。
实验研究
将30例老年CAP患者分成低危、中危、高危组,各组间的PCT、ADM浓度差异有统计学意义(P<0.01),其结果示随着严重程度的升高PCT、ADM浓度随之升高。
结论
理论研究
“正气亏虚、毒瘀互结”为老年肺炎之基本病机,以正气亏虚为本,以热、毒、痰、瘀为标,针对此病机,在治疗老年肺炎时应以扶正祛邪为大法,在治疗时既扶正,又祛邪,两者兼顾,方可收到满意疗效。临床研究
1.通过严格的随机、双盲、对照试验方法,观察了扶正解毒化瘀颗粒治疗38例老年CAP患者,研究发现“扶正祛邪”法可以明显提高老年CAP患者的治愈率,可以有效改善老年肺炎患者部分临床症状,临床应用安全有效。
2.通过专业知识与临床经验,综合聚类分析的5类结果和症状的出现频率,本研究发现老年CAP最常见的证型为“气阴两虚、痰热瘀阻”。这与我们临床中观察的老年CAP证候特点较为一致,与扶正解毒化瘀颗粒治疗老年CAP的病机相吻合。
实验研究
结果显示血清PCT、ADM浓度与PSI和CURB-65评分存在相关性,血清PCT、ADM浓度与老年CAP病情严重程度存在相关性,与病情程度成正比。因此,本研究初步认为,血清PCT、ADM浓度水平可以反应老年CAP的严重程度,可以用来判断疾病的预后。
Objective
Pneumonia is a very common disease among the elder and is often thought as "an old friend of the elder's". For the unspecific clinical symptoms, it is hard to diagnose pneumonia in the elder in time and the pneumonia becomes the primary direct cause of the elder's death. Due to its significant mortality rate among the elderly, we need to make better managements of the disease with our aging population. A randomized, double-blind, parallel-group clinical trial is conducted to assess the treatments of elderly pneumonia using Chinese medicine. The etiology of elderly pneumonia is weak healthy qi and the invasion of stasis toxin, thus our study uses Chinese medicine to reinforce healthy qi and purge toxins. Concurrently, with the results from the study, a statistical analysis is conducted to sum up various patterns and syndromes of elderly pneumonia. Another aspect of this study is to search for a more specific biomarker for elderly pneumonia. Then analyze its significance and further its uses in future diagnosis of elderly pneumonia.
Method
Theoretical Study
By analysis of the relevant literature and clinical studies of elderly pneumonia, investigate its TCM pathogenesis and discuss its appropriate treatments.
Clinical Study
1.Randomized, double-blind, parallel group clinical trial with 76 patients with newly diagnosed Community-acquired Pneumonia (CAP) in the elderly. The treatment group was given antibiotics with Chinese medicine, while the control group was given antibiotics with placebo.
2.Cluster analysis of Chinese medicine patterns and syndromes of 76 patients.
Laboratory Study
Pneumonia Severity Index (PSI) and CURB-65 score were used to assess the severity of CAP in the elderly in this study. The blood serum was collected from patients both before and after treatments. Then ELISA test was used to obtain the concentration of Procalcitonin (PCT) and Adrenomedullin (ADM) in the blood serum. The aim is to establish relations of PCT and ADM with the severity of CAP in the elderly.
Results
Theoretical Study
Based on a literature review and clinical study, the basic pathogenesis of the disease and treatment were established. The basic pathogenesis of elderly pneumonia was the weak healthy qi, and Qi and Yin deficiency existed throughout the disease. The treatments should be to enforce the healthy qi, including enforcing qi and yin. The secondary pathogenesis of senile pneumonia are heat, poison, phlegm and blood stasis. The treatments should be make dispelling evil qi as basic principle, including detoxification, promoting blood circulation, removing blood stasis and clearing phlegm.
Clinical Study
1.Clinical results:(1)Effect on disease:The total efficient rate of the treatment group is higher than that of the control group (p<0.05).(2)Effect on TCM syndrome:The total efficient rate of the treatment group is higher than that of the control group (p<0.05).(3) Effect on every single symptom:On clearing phlegm and relieving dry mouth and throat, the treatment group was more effective than the control group. But there was no significant difference in control of cough, fever, wheezing and chest distress between the two group. (4)In both groups, there was a significant decrease in white blood cell count, neutrophil percentage and PaCO2 respectively. However, only the difference of neutrophil percentage between the two group is statistically significant.
2.By means of professional knowledge and clinical experience, the cluster analysis of CAP in the elderly was summed up into 5 categories. Type 1:Cough, constipation, hard stools, red tongue and thready pulse. Type 2:Yellow sputum, weak cough and fever. Type 3: dysphoria in chestpalms-soles, white sputum, dry mouth, dry throat and thirst. Type 4: Difficulty in expectoration of sputum, wheezing, breathlessness, chest tightness, sweat, lethargy, palpitation, prone to cold spells, poor appetite. Type 5:Dark lips and fingernails, dusky red tongue, yellow coating, greasy coating, wiry pulse and slippery pulse.
Laboratory Study
The severity of 30 elderly CAP patients were categorized into 3 groups (low-risk, medium-risk, high-risk) and the concentrations of PCT and ADM between these groups were statistically significant (p<0.01). As the severity of CAP increased, the concentration of PCT and ADM increased.
Conclusions
Theoretical Study
The etiology of elderly pneumonia is weakened healthy qi and the invasion of stasis toxin, thus our study uses Chinese medicine to reinforce healthy qi and purge toxins. We must both reinforce healthy qi and purge toxins, so a satisfactory outcome can be received.
Clinical Study
1. The Chinese medicine methods of reinforcing healthy qi and purging toxins were able to improve the treatments of CAP in the elderly patients and got excellent response. By comparing accumulated points on specific symptoms of the two group, the sputum production acquired best and significant results after treatments, which may prove that this therapeutic principle could improve the symptoms of elderly pneumonia.
2.By means of professional knowledge and clinical experience, the most common syndrome of elderly CAP was deficiency of qi-yin and obstruction of both phlegm-heat and blood stasis.
Laboratory Study
The results show the relationships of blood serum PCT and ADM concentration with PSI and CURB-65. PCT and ADM levels can reflect CAP severity. And it is a direct correlation. Therefore, PCT and ADM could be used in the prognosis of CAP in the elderly.
引文
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