脑梗死急性期中西医结合优化治疗方案临床研究
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摘要
目的：通过中西医结合优化方案(以下称中风醒脑口服液方案)与西医治疗方案治疗急性脑梗死的对比研究,研究中西医结合优化治疗方案对脑梗死急性期患者的治疗作用。
方法：本文全面回顾中医学历代典籍有关中风病的预防、治疗思想,结合现代医学关于缺血性卒中的研究进展,对脑梗死中、西医治疗现状进行了总结和评价。并采用回顾性研究的方法,将2006年1月至2009年1月在成都中医药大学附属医院住院的60例脑梗死急性期患者按住院期间治疗方案分为中风醒脑组(西医基础治疗+中风醒脑口服液)和西医对照组(单纯西医治疗),通过观察两组患者治疗后中医症状体征严重程度积分、中医症状体征对生活影响、神经功能缺损情况、残疾程度和日常生活活动能力水平等指标的改变,分析中西医结合优化治疗方案(西医基础治疗+中风醒脑口服液)和西医治疗方案(单纯西医治疗)治疗缺血性卒中的疗效。
结果：(1)病死率：中风醒脑组和西医对照组在治疗14±2天、28±3天和90±5天时急性脑梗死死亡病人数彼此比较无统计学意义。
(2)中医症状体征严重程度和中医症状体征对生活影响：中风醒脑组和西医对照组均具有改善中医症状体征的作用,治疗后(14±2天、28±3天)中医症状体征严重程度积分和对生活影响积分与治疗前比较有显著差异,治疗后积分小于治疗前；中风醒脑组在28±3天时中医症状和体征对生活影响的改善优于西医对照组,差异有统计学意义。
(3)mRS评分：中风醒脑组和西医对照组患者mRS评分治疗后均优于治疗前,差异有统计学意义；中风醒脑组和西医对照组治疗后mRS评分组间比较差异无统计学意义。
(5) NIHSS评分情况：中风醒脑组和西医对照组治疗后(包括14±2天、28±3天和90±5天时)NIHSS评分与治疗前比较差异有统计学意义,治疗后评分优于治疗前；中风醒脑组28±3天时NIHSS评分和西医对照组比较差异有统计学意义,中风醒脑组优于西医对照组。
(6)日常生活活动能力水平：中风醒脑组和西医对照组在14±2天、28±3天和90±5天生活轻度依赖和重度依赖患者人数比较无显著差异。
(7)中风醒脑组安全性指标未出现与中风醒脑口服液有关的治疗前正常／治疗后异常或治疗前异常／治疗后异常加重的情况。
结论：(1)中风醒脑口服液方案并不能比单纯西医治疗方案减少脑梗死急性期患者病死率；
(2)中风醒脑口服液方案改善中医症状体征对生活影响的疗效在治疗28±3天时优于单纯西医治疗方案。
(3)中风醒脑口服液方案改善脑梗死患者神经功能缺损的疗效在治疗28±3天时优于单纯西医治疗方案；
(4)结合前期临床研究、实验研究结果和应用体会,认为脑梗死急性期中风醒脑口服液方案疗效确切,使用安全方便,适合在城乡应用。
Objective:Study the influence of optimized treatment program integrated Traditional Chinese Medicine(TCM) and western medicine on acute cerebral infarction patients.
Methods:observe the change of TCM syndrome score, NIHSS, BI and mRS score at the position of pre-treatment,14 days after treatment,28 days after treatment and 90 days, through two kinds of treatment means include Western medicine therapy with. ZFXN oral preparation and simple Western medicine treatment on acute cerebral infarction patients.
Results:(1) mortality rate:the number of death patients with acute cerebral infarction do not exist significant difference between two group.
(2) TCM disease severity of symptoms:the effect of reduction of TCM symptoms in ZFXN group does not exist statistically significan compare with the Western medicine group.
(3) Impact on life of TCM symptoms:ZFXN group points compared with Western medicine group in the treatment of 28 days were statistically significant, ZFXN group less than the Western medicine group.
(4) modified Rankin score:ZFXN Group and Western Group mRS show no significant difference at 14 days, treatment 28 days and 90 days.
(5) NIHSS score:ZFXN group's NIHSS score in 28 days show statistically significant with Western medicine group on NIHSS score.
(6) life ability:there's no statistical significance between two group when 14 days,28 days and 90 days on BI.
(7) Security evaluation:there's no obviously laboratory test data exchange after take the ZFXN preparation.
Conclusion:(1) ZFXN preparation can not reduce mortality in cerebral infarction patients than Western medicine therapy;
(2) The effect of reducing severity of disease symptoms of ZFXN therapy is stronger than Western medicine therapy;
(3) ZFXN therapy improve the neurological deficits in cerebral infarction patients is better than Western,medicine group.
(4) ZFXN preparation is convient, safe and efficient for acute cerebral infarction patients.
方法：本文全面回顾中医学历代典籍有关中风病的预防、治疗思想,结合现代医学关于缺血性卒中的研究进展,对脑梗死中、西医治疗现状进行了总结和评价。并采用回顾性研究的方法,将2006年1月至2009年1月在成都中医药大学附属医院住院的60例脑梗死急性期患者按住院期间治疗方案分为中风醒脑组(西医基础治疗+中风醒脑口服液)和西医对照组(单纯西医治疗),通过观察两组患者治疗后中医症状体征严重程度积分、中医症状体征对生活影响、神经功能缺损情况、残疾程度和日常生活活动能力水平等指标的改变,分析中西医结合优化治疗方案(西医基础治疗+中风醒脑口服液)和西医治疗方案(单纯西医治疗)治疗缺血性卒中的疗效。
结果：(1)病死率：中风醒脑组和西医对照组在治疗14±2天、28±3天和90±5天时急性脑梗死死亡病人数彼此比较无统计学意义。
(2)中医症状体征严重程度和中医症状体征对生活影响：中风醒脑组和西医对照组均具有改善中医症状体征的作用,治疗后(14±2天、28±3天)中医症状体征严重程度积分和对生活影响积分与治疗前比较有显著差异,治疗后积分小于治疗前；中风醒脑组在28±3天时中医症状和体征对生活影响的改善优于西医对照组,差异有统计学意义。
(3)mRS评分：中风醒脑组和西医对照组患者mRS评分治疗后均优于治疗前,差异有统计学意义；中风醒脑组和西医对照组治疗后mRS评分组间比较差异无统计学意义。
(5) NIHSS评分情况：中风醒脑组和西医对照组治疗后(包括14±2天、28±3天和90±5天时)NIHSS评分与治疗前比较差异有统计学意义,治疗后评分优于治疗前；中风醒脑组28±3天时NIHSS评分和西医对照组比较差异有统计学意义,中风醒脑组优于西医对照组。
(6)日常生活活动能力水平：中风醒脑组和西医对照组在14±2天、28±3天和90±5天生活轻度依赖和重度依赖患者人数比较无显著差异。
(7)中风醒脑组安全性指标未出现与中风醒脑口服液有关的治疗前正常／治疗后异常或治疗前异常／治疗后异常加重的情况。
结论：(1)中风醒脑口服液方案并不能比单纯西医治疗方案减少脑梗死急性期患者病死率；
(2)中风醒脑口服液方案改善中医症状体征对生活影响的疗效在治疗28±3天时优于单纯西医治疗方案。
(3)中风醒脑口服液方案改善脑梗死患者神经功能缺损的疗效在治疗28±3天时优于单纯西医治疗方案；
(4)结合前期临床研究、实验研究结果和应用体会,认为脑梗死急性期中风醒脑口服液方案疗效确切,使用安全方便,适合在城乡应用。
Objective:Study the influence of optimized treatment program integrated Traditional Chinese Medicine(TCM) and western medicine on acute cerebral infarction patients.
Methods:observe the change of TCM syndrome score, NIHSS, BI and mRS score at the position of pre-treatment,14 days after treatment,28 days after treatment and 90 days, through two kinds of treatment means include Western medicine therapy with. ZFXN oral preparation and simple Western medicine treatment on acute cerebral infarction patients.
Results:(1) mortality rate:the number of death patients with acute cerebral infarction do not exist significant difference between two group.
(2) TCM disease severity of symptoms:the effect of reduction of TCM symptoms in ZFXN group does not exist statistically significan compare with the Western medicine group.
(3) Impact on life of TCM symptoms:ZFXN group points compared with Western medicine group in the treatment of 28 days were statistically significant, ZFXN group less than the Western medicine group.
(4) modified Rankin score:ZFXN Group and Western Group mRS show no significant difference at 14 days, treatment 28 days and 90 days.
(5) NIHSS score:ZFXN group's NIHSS score in 28 days show statistically significant with Western medicine group on NIHSS score.
(6) life ability:there's no statistical significance between two group when 14 days,28 days and 90 days on BI.
(7) Security evaluation:there's no obviously laboratory test data exchange after take the ZFXN preparation.
Conclusion:(1) ZFXN preparation can not reduce mortality in cerebral infarction patients than Western medicine therapy;
(2) The effect of reducing severity of disease symptoms of ZFXN therapy is stronger than Western medicine therapy;
(3) ZFXN therapy improve the neurological deficits in cerebral infarction patients is better than Western,medicine group.
(4) ZFXN preparation is convient, safe and efficient for acute cerebral infarction patients.
引文
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