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卒中急性期并发症中西医结合综合方案的临床研究
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摘要
目的:本项临床研究的目的旨在前期20余年运用中风醒脑液治疗脑卒中的基础上,通过多中心、随机对照的临床观察,对脑卒中急性期并发症(肺部感染、出血性梗死)进行中西医结合综合方案的治疗,以期建立卒中急性期并发症(肺部感染、出血性梗死)的综合方案。
     方法:本试验研究的受试对象来源于由成都中医药大学附属医院、都江堰人民医院、川北医学院附属医院、攀枝花中西医结合医院、广元市中医院住院的符合卒中急性期并发肺部感染210例、急性缺血性卒中并发出血性梗死患者100例,分别随机分2组,两组均给予西医基础治疗加中风醒脑液口服,治疗组在上述基础上加用中药复方汤剂鼻饲或口服,50ml, tid,疗程为3~14天不等。观察周期3个月,填写原始病历和CRF表。疗效判定:观察治疗后患者病死率、住院天数、肺部感染症状及体征,总体疗效,NIHSS评分、mRS评分、GCS评分、生活能力、生存质量等。评价治疗后14天、28天的疗效,并观察治疗过程中可能出现的不良反应。利用SPSS20.0软件包对资料进行分析处理。
     结果:
     1.急性缺血性卒中并发出血性梗死痰热腑实证患者结果
     本研究通过急性缺血性卒中并发出血性梗死痰热腑实证治疗组25例,对照组25例的疗效观察,结果表明:在病死率方面,治疗组和对照组的病死率分别为16.0%、24.0%,对照组高于治疗组,但两组间的差异无统计学意义;在疗后14天、与疗后28天,在中医证候积分、体征积分、GOS残障程度方面,治疗组和对照组进行组间比较,差异具有统计学意义(P<0.05);生存质量方面,治疗组对于改善患者生存质量,优于对照组,两者具有统计学意义(P<0.05)。
     2.急性缺血性卒中并发出血性梗死痰湿蒙神证患者结果
     本研究通过急性缺血性卒中并发出血性梗死痰湿蒙神证治疗组25例,对照组25例的疗效观察,结果表明:在病死率方面,治疗组和对照组的病死率分别为24.0%、12.0%,治疗组高于对照组,但两组间的差异无统计学意义:在疗后14天、与疗后28天,在中医证候积分、体征积分,治疗组和对照组进行组间比较,差异具有统计学意义(P<0.05):生存质量方面,治疗组对于改善患者生存质量,优于对照组,差异具有统计学意义(P<0.05)。
     3.卒中急性期并发肺部感染痰热壅肺证患者结果
     本研究通过卒中急性期并发肺部感染痰热壅肺证治疗组52例,对照组53例的疗效观察,结果表明:在病死率方面,治疗组和对照组的病死率分别为11.5%、18.9%,对照组高于治疗组,但两组间的差异无统计学意义;在疗后14天、与疗后28天,在中医证候积分、体征积分、GOS残障程度方面,治疗组和对照组进行组间比较,具有统计学意义(P<0.05);在疗后14天,治疗组和对照组的GCS评分进行组间比较,差异具有统计学意义(P<0.05)。生存质量方面,治疗组对于改善患者生存质量,优于对照组,两者具有统计学意义(P<0.05)。
     4.卒中急性期并发肺部感染痰浊蕴肺证患者结果
     本研究通过卒中急性期并发肺部感染痰浊蕴肺证治疗组53例,对照组52例的疗效观察,结果表明:在病死率方面,治疗组和对照组的病死率分别为11.3%、21.2%,对照组高于治疗组,但两组间的差异无统计学意义;在疗后14天、与疗后28天,在中医证候积分、体征积分、GOS残障程度方面,治疗组和对照组进行组间比较,具有统计学意义(P<0.05);在疗后14天,治疗组和对照组的GCS评分进行组间比较,差异具有统计学意义(P<0.05)。生存质量方面,治疗组对于改善患者生存质量,优于对照组,两者具有统计学意义(P<0.05)。
     结论:
     1急性缺血性卒中并发出血性梗死结论
     治疗组能明显缩短急性缺血性卒中并发出血性梗死的住院天数、住院费用;明显改善急性缺血性卒中并发出血性梗死的症状、体征;在显效率、总有效率方面,治疗组优于对照组。
     2卒中急性期并发肺部感染结论
     治疗组能明显缩短卒中急性期并发肺部感染的住院天数、住院费用;明显改善座中急性期并发肺部感染的症状、体征;在显效率、总有效率方面,治疗组优于对照组。治疗组在降低痰培养阳性率和中性粒细胞百分比方面无统计学意义(P>0.05)。
Objective:The purpose of this clinical study is settle a project which is confirmed by randomized controlled trial (RCT), multicenter observation,to treat the complications of the stroke in the acute phase. This project is connection the western medicine and the Rraditional Chinese Medicine,zhongfengxingnao oral liquid, which has been applied for more than20years.
     Method: The subjects of this study are from the inpatients departments of Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,the People's Hospital of Dujiangyan, Affiliated Hospital of North Sichuan Medical College, Panzhihua Hospital Integrative Medicine, the Affiliated Hospital of the the Guangyuan Hospital. There are210cases with lung infection and100cases of hemorrhagic infarction.The subjects are randomly diveded into two groups. Both groups were given the same treatments,the western medicine and the zhongfengxingnao oral liquid,however, the treatment group add the Chinese formulaes by nasogastric or ora50ml, tid, the course of14days.Observation period is3month, followed up and finished the origenal record and the CRF tables.Therapeutic efficacy: mortality,the number of days of hospitalization,lung infection syndrome,overall effcts,NIHSS score,(mRS) score, GCS score, life skills, and quality of life. will be observed to evaluate the effect of14days and28days,after treatment,and observe adverse reactions that may occur during the process of treatment. And use SPSS20.0analysis the data.
     Results:
     1Acute ischemic stroke with hemorrhagic infarction the phlegm heat Fushi patients results
     There are25cases in both treatment group and in control group of the study of the acute phase of stroke and issude hemorrhagic infarction phlegm-heat Fu shi syndrome. The results are:the mortality of treat group is16.0%,in the control group is 24.0%,but there is no statistically significant difference between the two groups; After14days treatment and28days treatment,there is a statistically significant(p<0.05) of the data in the symptom score in signs points, GOS degree of disability, between two groups, what is more,the treatment group's quality of life is better than the control group,and there is a statistically significant as well.(P<0.05).
     2Acute ischemic stroke patients with hemorrhagic infarction phlegm God permit results
     There are25cases in both treatment group and in control group of the study of the Acute stroke patients with hemorrhagic infarction phlegm God permit results.The results are:the mortality of treat group is24.0%,in the control group is12.0%,but there is no statistically significant difference between the two groups;After14days treatment and28days treatment, there is a statistically significant(p<0.05) of the data in the symptom score in signs points, GOS degree of disability, between two groups, what is more.the treatment group's quality of life is better than the control group.and there is a statistically significant as well.(P<0.05).
     3Acute stroke patients with pulmonary infection in patients with Phlegm obstruct the lung
     There are53cases in treatment group and52cases in control group of the study of the Acute stroke patients with pulmonary infection in patients with Phlegm obstruct the lung syndrome..The results are:the mortality of treat group is11.5%,in the control group is18.9%,but there is no statistically significant difference between the two groups; After14days treatment and28days treatment,there is a statistically significant(p<0.05) of the data in the symptom score in signs points, GOS degree of disability, between two groups. After14days treatment, there is a statistically significant(p<0.05) of the data in GCS score,what is more.the treatment group's quality of life is better than the control group.and there is a statistically significant as well.(P<0.05).
     4Acute stroke patients with pulmonary infection in patients with lung phlegm Yun results
     There are53cases in treatment group and52cases in control group of the study of the Acute stroke patients with pulmonary infection in patients with lung phlegm Yun syndrome.The results are:the mortality of treat group is11.3%,in the control group is21.2%,but there is no statistically significant difference between the two groups; After14days treatment and28days treatment, there is a statistically significant(p<0.05) of the data in the symptom score in signs points,GOS degree of disability, between two groups. After14days treatment, there is a statistically significant(p<0.05) of the data in GCS score,what is more,the treatment group, s quality of life is better than the control group,and there is a statistically significant as well.(P<0.05).
     Conclusions:
     1The conclusion of acute ischemic stroke and complication of hemorrhagic infarction
     The number of days of hospitalization, hospitalization expenses,has been reduced in the treatment group,besides those,there are significant changes of the syndrome of acute stroke and complication of hemorrhagic infarction,in the treatment group,and the treatment group is better than the in control group,in the remarkable efficiency,total efficiency.
     2The conclusions of stroke in the acute phase and with the complication of pulmonary infection
     The number of days of hospitalization, hospitalization expenses,has been reduced in the treatment group,besides those,there are significant changes of the syndrome of acute stroke and complication of pulmonary infection,in the treatment group,and the treatment group is better than the in control group,in the remarkable efficiency,total efficiency.However,there is not obvious advantage of treatment group in reducing sputum culture positive rate and the percentage of neutrophils,and we need to expand the sample size for further study.
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