加味星蒌承气汤治疗脑卒中后遗症患者社区获得性肺炎的临床研究
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摘要
目的肺炎是脑卒中后遗症患者常见并发症之一,此类患者多为高龄,基础疾病多,因肢体障碍而长期卧床,因吞咽困难易引起误吸,常伴有营养不良、免疫力低下等因素,感染后易发展为重症肺炎,死亡率高,治疗难度大,社会经济负担重。现有文献研究提示中医药干预治疗脑卒中后遗症患者社区获得性肺炎疗效优于单纯西医治疗,故发挥中医优势,中西医结合、多途径综合治疗是今后研究的方向和趋势。由于脑卒中后遗症疾病特点的特殊性,现有社区获得性肺炎中医证候诊断标准很难为临床工作者辨治脑卒中后遗症患者社区获得性肺炎提供有效指导。本课题通过分析研究脑卒中后遗症患者社区获得性肺炎的中医四诊信息及中医证候调查情况,以期总结出脑卒中后遗症患者社区获得性肺炎的中医证候特点；通过前瞻随机对照临床试验,评价加味星蒌承气汤治疗痰热腑实型脑卒中后遗症患者社区获得性肺炎的疗效及安全性,为临床辨治脑卒中后遗症患者社区获得性肺炎提供依据。
方法本研究收集病例均来源于2012年10月至2014年2月中日友好医院中医肺病科住院的患者。通过横断面1：1匹配病例对照研究方法,对新诊断的144例脑卒中后遗症患者社区获得性肺炎及同期住院、同性别、年龄相差5岁以内的144例老年社区获得性肺炎患者进行中医四诊信息采集和中医证候调查。通过前瞻随机对照的研究方法,将67例痰热腑实型脑卒中后遗症患者社区获得性肺炎随机分为试验组34例和对照组33例。对照组给予西医常规治疗,试验组在对照组的基础上采用星蒌承气汤加味方口服或鼻饲。7天为一疗程,治疗2个疗程,检查统计相关评价指标,包括临床总疗效、炎性指标变化、中医证候积分、单项症状改善、退热时间、住院天数、日常生活活动能力(Barthel指数评分)及次均住院费,并记录相关不良反应。采用SPSS17.0软件包对资料进行分析处理。
结果
1脑卒中后遗症患者社区获得性肺炎中医证候匹配病例对照研究
1.1两组中医四诊信息比较
脑卒中后遗症患者社区获得性肺炎除特有症状肢体障碍、吞咽困难等,临床多表现为意识障碍、喉中痰鸣、腹胀、便秘,舌苔黄腻,脉涩、弱(P<0.05),而对于老年社区获得性肺炎患者咳嗽、胸闷气短、神疲乏力,脉弦、数更为常见(P<0.05)
1.2两组中医证型比较
脑卒中后遗症患者社区获得性肺炎临床以痰热腑实证、痰瘀阻肺证为常见证型(P<0.05)。两组气阴两虚证比较无显著性差异(P>0.05),但两组病例所占比例均较高,脑卒中后遗症患者社区获得性肺炎所占比例为60.42%,老年社区获得性肺炎所占比例为50.69%。
2加味星蒌承气汤治疗脑卒中后遗症患者社区获得性肺炎的临床研究
2.1两组治疗后临床总疗效比较
总有效率=痊愈+显效+有效。试验组总有效率为94.12%,对照组总有效率为75.76%,两组临床总有效率比较差异有统计学意义(P<0.05),表明试验组疗效优于对照组。
2.2两组治疗前后炎症指标变化比较
炎性指标包括血常规中性粒细胞百分数和C-反应蛋白。两组治疗后各炎症指标均改善明显(P<0.05),治疗后两组炎症指标改善程度相近(P>0.05),表明治疗后两组对炎症指标的疗效相当。
2.3两组治疗前后中医证候积分比较
两组中医证候积分治疗后较治疗前均明显减少,差异有统计学意义(P<0.05)试验组治疗后中医证候积分较对照组治疗后显著降低,差异有统计学意义(P<0.05)提示试验组疗效优于对照组。
2.4两组治疗后各单项症状改善及退热时间比较
两组治疗后各单项症状(发热、咳嗽、痰色、痰量、胸痛、口干咽燥、腹胀便秘),经非参数检验或t检验,试验组在发热、痰量、腹胀便秘方面具有统计学意义(P<0.05),说明试验组在发热、痰量、腹胀便秘方面,症状改善优于对照组。在退热时间比较方面差异也较显著(P<0.05),试验组优于对照组。
2.5两组患者治疗前后日常生活活动能力比较
两组治疗前后Barthel指数评分均较治疗前显著提高(P<0.05),但治疗后两组比较无统计学意义(P>0.05)
2.6两组患者住院天数及次均住院费比较
两组患者住院天数及次均住院费,经t检验,试验组与对照组比较差异均有统计学意义(P<0.05),结果提示试验组较对照组住院天数短,次均住院费低。
2.7不良反应：两组患者在治疗过程中均未见明显不良反应。
结论
1脑卒中后遗症患者社区获得性肺炎中医证候特点为正虚为本,以气虚、阴虚为主,痰热腑实为其标,是疾病早期常见证候,血瘀贯穿疾病始终。
2在西医综合治疗的基础上,采用星蒌承气汤加味方干预治疗痰热腑实型脑卒中后遗症患者社区获得性肺炎,可明显改善其临床症状,提高其疗效,缩短住院天数,减少住院费用,有效节约了社会医疗资源,且安全性高,值得进一步研究推广。
Objective
Pneumonia is a common complication of patients with stroke sequela, many of which are older and having more basic diseases. Because of their physical barriers activities, they are in bed for a long time, and can easy cause aspiration by swallowing difficulties. They often accompany by factors such as malnutrition, low immunity, and easily deteriorate into severe pneumonia after infection. Meanwhile the mortality rate is high, the treatment is difficult, and the social and economic burden is heavy. The existing medical research suggests that the treatment of TCM on patients with stroke sequela of CAP is better than western medicine. So, based on the advantages of TCM, the integrative medicine and comprehensive treatment of a variety of ways is the trend of future research. But the existing diagnosis criteria of TCM syndrome on CAP is difficult to provide effective guidance for clinicians who want to treat patients with stroke sequela of CAP. To investigate the TCM syndrome types and clinical characteristics of patients with stroke sequela of CAP, the study analysis the information of TCM syndromes. This randomized, controlled trial study is to observe the clinical efficacy of patients with stroke sequela of CAP treated by supplemented xinglouchengqi decoction, and in order to lay the foundation that provide an effective combined Chinese and Western medicine for patients with stroke sequela of CAP.
Methods
All cases were collected from TCM Lung Disease Department of China-Japen Friendship Hospital from October2012to February2014. The information of TCM syndrome were investigated from the patients including144patients with stroke sequela of CAP and144cases of elderly suffered from CAP, who are from the same place, the same gender and the similar age. According to the random number table method,67patients with stroke sequela of CAP were phlegm-heat accumulation by the TCM syndrome differentiation, and were randomly divided into treatment group (n=34cases) and control group (n=33cases). All patients were received the western medicine treatment, while patients in treatment group were also given the treatment by supplemented xinglouchengqi decoction. After treated14days, the efficacy and adverse reactions were observed, including clinical effect, inflammatory index, TCM syndromes, symptoms, the cooling time, days of average be in hospital, activity ability of daily life (Barthel index), money of average be in hospital and record related adverse reactions. The datas were analyzed by SPSS17.0.
Result
1The TCM syndrome characteristics of patients with stroke sequela of CAP
In addition to limbs movement disorder and dysphagia, patients with stroke sequela of CAP can have disturbance of consciousness, phlegm rale in the throat, abdominal distension, constipation, yellow tongue fur, pulse astringent or weak (P<0.05), while the elderly suffered from CAP can have cough, chest tightness, shortness of breath, lassitude, pulse string or rapid (P<0.05).
Phlegm-heat accumulation by the TCM syndrome differentiation is the same as phlegm and blood stasis, and they are commonly in patients with stroke sequela of CAP (P<0.05). There is no significant difference between two groups of Qi and Yin deficiency syndrome (P>0.05), but the proportions of the two groups were high, the proportion of patients with stroke sequela of CAP is60.42%and the elderly suffered from CAP is50.69%.
2The results of clinical research on the TCM treatment
2.1Comparison of clinical efficacy in two groups after treatment
The total efficacy rate including clinical cure, effectiveness and failure was94.12%in the treatment group, and the control group was75.76%, it was statistically significant difference (P<0.05).
2.2Comparison of inflammatory indexes in two groups after treatment
The inflammatory indexes in the two groups were significantly improved after treatment (P<0.05), but the improved degree of inflammation indexes in the two groups were similar (P>0.05).
2.3Comparison of TCM syndrome scores in two groups after treatment
TCM syndrome scores in two groups after treatment were obviously decreased than before treatment, the difference was statistically significant (P<0.05), but compared with the control group, the difference of TCM syndrome scores in the treatment group was statistically significant (P<0.05).
2.4Comparison of the symptoms and the cooling time in two groups after treatment
Comparison of each symptom (fever, cough, sputum color, sputum volume, chest pain, mouth parched and tongue scorched, abdominal distension and constipation) in the two group after treatment, the treatment group had statistical significance in fever, sputum volume, abdominal distension and constipation (P<0.05), residual symptoms had no significant difference (P>0.05). In the same time the cooling time in the treatment group was shorter than the control group (P<0.05).
2.5Comparison of the Barthel index scores in two groups after treatment
Barthel index scores in two groups were significantly improved after treatment (P<0.05), but the two groups had no statistical significance (P>0.05).
2.6Comparison of days and money of average be in hospital
Comparison of days and money of average be in hospital, there were both significant difference between the treatment group and the control group (P<0.05).
2.7Adverse reactions
Two groups of patients during treatment showed no obvious adverse reaction.
Conclusion
Patients with stroke sequela of CAP are healthy energy deficiency and evil excess, healthy energy deficiency is Qi deficiency and Yin deficiency, and evil excess is phlegm-heat accumulation by the TCM syndrome differentiation. Evil excess is a common symptom in early disease, and blood stasis throughout the disease has always been.
Based on the treatment of western medicine treatment, the clinical efficacy of patients with stroke sequela of CAP treated by supplemented xinglouchengqi decoction is better. The treatment of TCM can obviously improve the clinical symptoms and the clinical efficacy, shorten the hospital days, reduce hospitalization costs, effectively save the social medical resources, and high safety, worth further study and promotion.
方法本研究收集病例均来源于2012年10月至2014年2月中日友好医院中医肺病科住院的患者。通过横断面1：1匹配病例对照研究方法,对新诊断的144例脑卒中后遗症患者社区获得性肺炎及同期住院、同性别、年龄相差5岁以内的144例老年社区获得性肺炎患者进行中医四诊信息采集和中医证候调查。通过前瞻随机对照的研究方法,将67例痰热腑实型脑卒中后遗症患者社区获得性肺炎随机分为试验组34例和对照组33例。对照组给予西医常规治疗,试验组在对照组的基础上采用星蒌承气汤加味方口服或鼻饲。7天为一疗程,治疗2个疗程,检查统计相关评价指标,包括临床总疗效、炎性指标变化、中医证候积分、单项症状改善、退热时间、住院天数、日常生活活动能力(Barthel指数评分)及次均住院费,并记录相关不良反应。采用SPSS17.0软件包对资料进行分析处理。
结果
1脑卒中后遗症患者社区获得性肺炎中医证候匹配病例对照研究
1.1两组中医四诊信息比较
脑卒中后遗症患者社区获得性肺炎除特有症状肢体障碍、吞咽困难等,临床多表现为意识障碍、喉中痰鸣、腹胀、便秘,舌苔黄腻,脉涩、弱(P<0.05),而对于老年社区获得性肺炎患者咳嗽、胸闷气短、神疲乏力,脉弦、数更为常见(P<0.05)
1.2两组中医证型比较
脑卒中后遗症患者社区获得性肺炎临床以痰热腑实证、痰瘀阻肺证为常见证型(P<0.05)。两组气阴两虚证比较无显著性差异(P>0.05),但两组病例所占比例均较高,脑卒中后遗症患者社区获得性肺炎所占比例为60.42%,老年社区获得性肺炎所占比例为50.69%。
2加味星蒌承气汤治疗脑卒中后遗症患者社区获得性肺炎的临床研究
2.1两组治疗后临床总疗效比较
总有效率=痊愈+显效+有效。试验组总有效率为94.12%,对照组总有效率为75.76%,两组临床总有效率比较差异有统计学意义(P<0.05),表明试验组疗效优于对照组。
2.2两组治疗前后炎症指标变化比较
炎性指标包括血常规中性粒细胞百分数和C-反应蛋白。两组治疗后各炎症指标均改善明显(P<0.05),治疗后两组炎症指标改善程度相近(P>0.05),表明治疗后两组对炎症指标的疗效相当。
2.3两组治疗前后中医证候积分比较
两组中医证候积分治疗后较治疗前均明显减少,差异有统计学意义(P<0.05)试验组治疗后中医证候积分较对照组治疗后显著降低,差异有统计学意义(P<0.05)提示试验组疗效优于对照组。
2.4两组治疗后各单项症状改善及退热时间比较
两组治疗后各单项症状(发热、咳嗽、痰色、痰量、胸痛、口干咽燥、腹胀便秘),经非参数检验或t检验,试验组在发热、痰量、腹胀便秘方面具有统计学意义(P<0.05),说明试验组在发热、痰量、腹胀便秘方面,症状改善优于对照组。在退热时间比较方面差异也较显著(P<0.05),试验组优于对照组。
2.5两组患者治疗前后日常生活活动能力比较
两组治疗前后Barthel指数评分均较治疗前显著提高(P<0.05),但治疗后两组比较无统计学意义(P>0.05)
2.6两组患者住院天数及次均住院费比较
两组患者住院天数及次均住院费,经t检验,试验组与对照组比较差异均有统计学意义(P<0.05),结果提示试验组较对照组住院天数短,次均住院费低。
2.7不良反应：两组患者在治疗过程中均未见明显不良反应。
结论
1脑卒中后遗症患者社区获得性肺炎中医证候特点为正虚为本,以气虚、阴虚为主,痰热腑实为其标,是疾病早期常见证候,血瘀贯穿疾病始终。
2在西医综合治疗的基础上,采用星蒌承气汤加味方干预治疗痰热腑实型脑卒中后遗症患者社区获得性肺炎,可明显改善其临床症状,提高其疗效,缩短住院天数,减少住院费用,有效节约了社会医疗资源,且安全性高,值得进一步研究推广。
Objective
Pneumonia is a common complication of patients with stroke sequela, many of which are older and having more basic diseases. Because of their physical barriers activities, they are in bed for a long time, and can easy cause aspiration by swallowing difficulties. They often accompany by factors such as malnutrition, low immunity, and easily deteriorate into severe pneumonia after infection. Meanwhile the mortality rate is high, the treatment is difficult, and the social and economic burden is heavy. The existing medical research suggests that the treatment of TCM on patients with stroke sequela of CAP is better than western medicine. So, based on the advantages of TCM, the integrative medicine and comprehensive treatment of a variety of ways is the trend of future research. But the existing diagnosis criteria of TCM syndrome on CAP is difficult to provide effective guidance for clinicians who want to treat patients with stroke sequela of CAP. To investigate the TCM syndrome types and clinical characteristics of patients with stroke sequela of CAP, the study analysis the information of TCM syndromes. This randomized, controlled trial study is to observe the clinical efficacy of patients with stroke sequela of CAP treated by supplemented xinglouchengqi decoction, and in order to lay the foundation that provide an effective combined Chinese and Western medicine for patients with stroke sequela of CAP.
Methods
All cases were collected from TCM Lung Disease Department of China-Japen Friendship Hospital from October2012to February2014. The information of TCM syndrome were investigated from the patients including144patients with stroke sequela of CAP and144cases of elderly suffered from CAP, who are from the same place, the same gender and the similar age. According to the random number table method,67patients with stroke sequela of CAP were phlegm-heat accumulation by the TCM syndrome differentiation, and were randomly divided into treatment group (n=34cases) and control group (n=33cases). All patients were received the western medicine treatment, while patients in treatment group were also given the treatment by supplemented xinglouchengqi decoction. After treated14days, the efficacy and adverse reactions were observed, including clinical effect, inflammatory index, TCM syndromes, symptoms, the cooling time, days of average be in hospital, activity ability of daily life (Barthel index), money of average be in hospital and record related adverse reactions. The datas were analyzed by SPSS17.0.
Result
1The TCM syndrome characteristics of patients with stroke sequela of CAP
In addition to limbs movement disorder and dysphagia, patients with stroke sequela of CAP can have disturbance of consciousness, phlegm rale in the throat, abdominal distension, constipation, yellow tongue fur, pulse astringent or weak (P<0.05), while the elderly suffered from CAP can have cough, chest tightness, shortness of breath, lassitude, pulse string or rapid (P<0.05).
Phlegm-heat accumulation by the TCM syndrome differentiation is the same as phlegm and blood stasis, and they are commonly in patients with stroke sequela of CAP (P<0.05). There is no significant difference between two groups of Qi and Yin deficiency syndrome (P>0.05), but the proportions of the two groups were high, the proportion of patients with stroke sequela of CAP is60.42%and the elderly suffered from CAP is50.69%.
2The results of clinical research on the TCM treatment
2.1Comparison of clinical efficacy in two groups after treatment
The total efficacy rate including clinical cure, effectiveness and failure was94.12%in the treatment group, and the control group was75.76%, it was statistically significant difference (P<0.05).
2.2Comparison of inflammatory indexes in two groups after treatment
The inflammatory indexes in the two groups were significantly improved after treatment (P<0.05), but the improved degree of inflammation indexes in the two groups were similar (P>0.05).
2.3Comparison of TCM syndrome scores in two groups after treatment
TCM syndrome scores in two groups after treatment were obviously decreased than before treatment, the difference was statistically significant (P<0.05), but compared with the control group, the difference of TCM syndrome scores in the treatment group was statistically significant (P<0.05).
2.4Comparison of the symptoms and the cooling time in two groups after treatment
Comparison of each symptom (fever, cough, sputum color, sputum volume, chest pain, mouth parched and tongue scorched, abdominal distension and constipation) in the two group after treatment, the treatment group had statistical significance in fever, sputum volume, abdominal distension and constipation (P<0.05), residual symptoms had no significant difference (P>0.05). In the same time the cooling time in the treatment group was shorter than the control group (P<0.05).
2.5Comparison of the Barthel index scores in two groups after treatment
Barthel index scores in two groups were significantly improved after treatment (P<0.05), but the two groups had no statistical significance (P>0.05).
2.6Comparison of days and money of average be in hospital
Comparison of days and money of average be in hospital, there were both significant difference between the treatment group and the control group (P<0.05).
2.7Adverse reactions
Two groups of patients during treatment showed no obvious adverse reaction.
Conclusion
Patients with stroke sequela of CAP are healthy energy deficiency and evil excess, healthy energy deficiency is Qi deficiency and Yin deficiency, and evil excess is phlegm-heat accumulation by the TCM syndrome differentiation. Evil excess is a common symptom in early disease, and blood stasis throughout the disease has always been.
Based on the treatment of western medicine treatment, the clinical efficacy of patients with stroke sequela of CAP treated by supplemented xinglouchengqi decoction is better. The treatment of TCM can obviously improve the clinical symptoms and the clinical efficacy, shorten the hospital days, reduce hospitalization costs, effectively save the social medical resources, and high safety, worth further study and promotion.
引文
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