培元开智汤治疗脑小血管病性认知功能障碍的临床研究
发布时间：2018-08-14 14:12
【摘要】：目的:探讨培元开智汤治疗脑小血管病性认知功能障碍的临床疗效及其可能机制。方法:采用随机数字表法将70例患者分为观察组和对照组,每组35例。对照组采用常规治疗;观察组在常规治疗基础上加服中药汤剂培元开智汤,每日一剂。疗程共60天。两组均于治疗前、治疗30天、治疗60天进行MoCABJ(蒙特利尔认知评估量表北京版)评定、MMSE(简易精神状态检查量表)评定及ADL(日常生活能力量表)评定,并于治疗前后进行中医证候积分、CRP(血清C反应蛋白)及MMP-3(基质金属蛋白酶3)含量测定,并进行中医证候疗效评定及认知功能疗效评定。结果:(1)临床观察过程中,两组各脱落2例,实际完成观察病例为66例(观察组33例,对照组33例)。两组治疗前性别、年龄、教育年限、既往史评分、伴发病评分、中医证候积分、MoCABJ评分、MMSE评分、ADL评分、血清CRP及MMP-3含量等方面比较均无显著性差异(P(29)05.0),具有可比性;(2)两组中医证候积分比较:治疗后两组中医证候积分与治疗前相比均有降低且差异显著(P(27)05.0);两组治疗后中医证候积分比较,观察组降低明显且差异显著(P(27)05.0);疗程结束后进行中医证候疗效评定,观察组疗效分级明显优于对照组且差异显著(P(27)05.0);(3)两组Mo CABJ、MMSE评分比较:治疗30天两组Mo CABJ、MMSE评分与治疗前相比均有升高且差异显著(P(27)05.0),与对照组比观察组MoCABJ、MMSE评分升高高于对照组且差异显著(P(27)05.0);治疗60天两组MoCABJ、MMSE评分与治疗前相比均有升高且差异显著(P(27)05.0),与对照组比观察组MoCABJ、MMSE评分升高高于对照组且差异显著(P(27)05.0);疗程结束后对MoCABJ各子项进行配对样本t检验,提示视空间与执行能力、命名能力、语言、延迟回忆及定向力较治疗前差异显著(P(27)05.0),注意力与抽象较治疗前差异无显著性(P(29)05.0),提示培元开智汤对各认知域的改善可能具有不均一性;疗程结束时,进行认知功能疗效评定,观察组疗效分级明显优于对照组且差异显著(P(27)05.0);(4)两组ADL评分比较:治疗30天两组ADL评分与治疗前相比均有升高且差异显著(P(29)05.0),与对照组比观察组ADL评分稍有升高但无显著性差异(P(29)05.0);治疗60天两组ADL评分与治疗前相比均有升高且差异显著(P(27)05.0),与对照组比观察组ADL评分升高高于对照组且差异显著(P(27)05.0);(5)两组血清CRP及MMP-3含量比较:治疗后两组血清CRP及MMP-3含量与治疗前相比降低明显且差异显著(P(27)05.0);疗程结束后,观察组与对照组比观察组血清CRP及MMP-3含量降低明显且差异显著(P(27)05.0);进一步对脑白质病变与血清CRP及MMP-3含量进行相关性分析,提示二者均与脑白质病变评分成正相关。结论:(1)培元开智汤用于治疗CSVCI患者临床疗效确切,可显著改善肾虚痰瘀型CSVCI患者中医临床症状,改善患者认知功能及日常生活能力(而在改善认知功能中尤其对视空间与执行能力、命名能力、语言、延迟回忆及定向力等方面较显著),其可能机制为拮抗炎症反应、保护血脑屏障。(2)培元开智汤临床应用安全,无明显不良反应。
[Abstract]:Objective: To explore the clinical effect and possible mechanism of Peiyuan Kaizhi Decoction in the treatment of cognitive impairment caused by cerebellar angiopathy. Methods: 70 patients were divided into observation group and control group by random number table method, each group had 35 cases. The two groups were treated for 60 days before and 30 days after treatment. MoCABJ (Montreal Cognitive Assessment Scale, Beijing version), MMSE (Simple Mental State Examination Scale) and ADL (Activity of Daily Living Scale) were assessed at 60 days after treatment. The scores of TCM syndromes, CRP (Serum C-reactive protein) and MMP-3 (Matrix Metalloproteinase 3) were also assessed before and after treatment. Results: (1) In the course of clinical observation, there were 2 cases in each group, 66 cases in the observation group (33 cases in the observation group, 33 cases in the control group). Before treatment, the gender, age, years of education, past history score, comorbidity score, TCM syndrome score, MoCABJ score, MM, MM were observed in the two groups. SE score, ADL score, serum CRP and MMP-3 content were not significantly different (P (29) 05.0), with comparability; (2) two groups of TCM syndrome score comparison: after treatment, two groups of TCM syndrome score compared with before treatment were reduced and significant difference (P (27) 05.0); two groups of TCM syndrome score after treatment, the observation group decreased significantly and poor. Significant difference (P (27) 05.0); after the end of treatment, the efficacy of TCM syndrome evaluation, the observation group was significantly better than the control group and the difference was significant (P (27) 05.0); (3) MoCABJ, MMSE scores of the two groups: 30 days after treatment, the two groups of MoCABJ, MMSE scores compared with before treatment were increased and significant difference (P (27) 05.0), compared with the control group MoCABJ, MMSE. The scores of MoCABJ and MMSE in the two groups were significantly higher than those in the control group (P (27) 05.0). The scores of MoCABJ and MMSE in the observation group were significantly higher than those in the control group (P (27) 05.0) after 60 days of treatment, and the scores of MoCABJ and MMSE in the control group were significantly higher than those in the control group (P (27) 05.0). Visual space and executive ability, naming ability, language, delayed recall and orientation were significantly different before treatment (P (27) 05.0), attention and abstraction were not significantly different (P (29) 05.0), suggesting that the improvement of cognitive domains by Peiyuan Kaizhi decoction may be inhomogeneous; at the end of treatment, cognitive function was evaluated, and the curative effect of observation group was not significant (P (29) 05.0). The ADL scores of the two groups were significantly higher than those of the control group (P (27) 05.0); (4) The ADL scores of the two groups were significantly higher than those before treatment at 30 days after treatment (P (29) 05.0). The ADL scores of the two groups were slightly higher than those of the control group, but there was no significant difference (P (29) 05.0); the ADL scores of the two groups at 60 days after treatment were both higher and higher than those before treatment (P (29) 05.0). The difference was significant (P (27) 05.0). Compared with the control group, the ADL score of the observation group was higher and the difference was significant (P (27) 05.0); (5) The serum CRP and MMP-3 levels of the two groups were compared: After treatment, the serum CRP and MMP-3 levels of the two groups were significantly lower than before treatment and the difference was significant (P (27) 05.0); After the treatment, the serum CRP of the observation group and the control group were significantly lower than that of the observation group (P (P 27) 05.0 Conclusion: (1) Peiyuan Kaizhi Decoction is effective in the treatment of CSVCI, and can significantly improve the clinical efficacy of kidney deficiency and phlegm stasis type of CSVCI patients. Bed symptoms, improvement of cognitive function and ability of daily living (especially in visual space and executive ability, naming ability, language, delayed recall and directional ability, etc.) may be related to antagonizing inflammation and protecting blood brain barrier. (2) Peiyuan Kaizhi Decoction is safe in clinical application without obvious adverse reactions.
【学位授予单位】：河南中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.7
本文编号：2183111
[Abstract]:Objective: To explore the clinical effect and possible mechanism of Peiyuan Kaizhi Decoction in the treatment of cognitive impairment caused by cerebellar angiopathy. Methods: 70 patients were divided into observation group and control group by random number table method, each group had 35 cases. The two groups were treated for 60 days before and 30 days after treatment. MoCABJ (Montreal Cognitive Assessment Scale, Beijing version), MMSE (Simple Mental State Examination Scale) and ADL (Activity of Daily Living Scale) were assessed at 60 days after treatment. The scores of TCM syndromes, CRP (Serum C-reactive protein) and MMP-3 (Matrix Metalloproteinase 3) were also assessed before and after treatment. Results: (1) In the course of clinical observation, there were 2 cases in each group, 66 cases in the observation group (33 cases in the observation group, 33 cases in the control group). Before treatment, the gender, age, years of education, past history score, comorbidity score, TCM syndrome score, MoCABJ score, MM, MM were observed in the two groups. SE score, ADL score, serum CRP and MMP-3 content were not significantly different (P (29) 05.0), with comparability; (2) two groups of TCM syndrome score comparison: after treatment, two groups of TCM syndrome score compared with before treatment were reduced and significant difference (P (27) 05.0); two groups of TCM syndrome score after treatment, the observation group decreased significantly and poor. Significant difference (P (27) 05.0); after the end of treatment, the efficacy of TCM syndrome evaluation, the observation group was significantly better than the control group and the difference was significant (P (27) 05.0); (3) MoCABJ, MMSE scores of the two groups: 30 days after treatment, the two groups of MoCABJ, MMSE scores compared with before treatment were increased and significant difference (P (27) 05.0), compared with the control group MoCABJ, MMSE. The scores of MoCABJ and MMSE in the two groups were significantly higher than those in the control group (P (27) 05.0). The scores of MoCABJ and MMSE in the observation group were significantly higher than those in the control group (P (27) 05.0) after 60 days of treatment, and the scores of MoCABJ and MMSE in the control group were significantly higher than those in the control group (P (27) 05.0). Visual space and executive ability, naming ability, language, delayed recall and orientation were significantly different before treatment (P (27) 05.0), attention and abstraction were not significantly different (P (29) 05.0), suggesting that the improvement of cognitive domains by Peiyuan Kaizhi decoction may be inhomogeneous; at the end of treatment, cognitive function was evaluated, and the curative effect of observation group was not significant (P (29) 05.0). The ADL scores of the two groups were significantly higher than those of the control group (P (27) 05.0); (4) The ADL scores of the two groups were significantly higher than those before treatment at 30 days after treatment (P (29) 05.0). The ADL scores of the two groups were slightly higher than those of the control group, but there was no significant difference (P (29) 05.0); the ADL scores of the two groups at 60 days after treatment were both higher and higher than those before treatment (P (29) 05.0). The difference was significant (P (27) 05.0). Compared with the control group, the ADL score of the observation group was higher and the difference was significant (P (27) 05.0); (5) The serum CRP and MMP-3 levels of the two groups were compared: After treatment, the serum CRP and MMP-3 levels of the two groups were significantly lower than before treatment and the difference was significant (P (27) 05.0); After the treatment, the serum CRP of the observation group and the control group were significantly lower than that of the observation group (P (P 27) 05.0 Conclusion: (1) Peiyuan Kaizhi Decoction is effective in the treatment of CSVCI, and can significantly improve the clinical efficacy of kidney deficiency and phlegm stasis type of CSVCI patients. Bed symptoms, improvement of cognitive function and ability of daily living (especially in visual space and executive ability, naming ability, language, delayed recall and directional ability, etc.) may be related to antagonizing inflammation and protecting blood brain barrier. (2) Peiyuan Kaizhi Decoction is safe in clinical application without obvious adverse reactions.
【学位授予单位】：河南中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.7
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