补肾健脾化痰法治疗遗忘型轻度认知损害的临床研究

发布时间：2018-03-11 04:32

本文选题：补肾健脾化痰法　切入点：meta分析　出处：《北京中医药大学》2016年博士论文　论文类型：学位论文

【摘要】：目的：评价补肾健脾化痰法治疗遗忘型轻度认知损害(amnestic Mild cognitive impairment,aMCI)的有效性及安全性。方法：本研究正文共分三节。第一节对已发表的轻度认知损害(MCI)中药临床药物试验进行系统评价,计算机检索2000-2015年中国学术期刊网络出版总库,中国医学数据库,万方数据库,PubMed,Embase中有关中药治疗MCI的临床随机对照试验,运用RevMan5.3.0软件对纳入研究进行数据提取并进行Meta分析。第二节采用横断面设计,招募aMCI受试者,进行神经心理学测评、神经影像学、生化检查及中医证候辨证分型,评估患者合并的血管因素,观察aMCI患者合并血管因素是否加重认知损害,分析认知功能与血管因素、中医证候及人口学特征的相关性。第三节为空白对照研究,治疗组选用依据补肾健脾化痰法制定颗粒剂对aMCI患者进行干预,治疗时间为12周,以认知功能及中医证候作为疗效指标,同时评价药物安全性。结果：1.循证医学研究共纳入36项中药治疗MCI的临床试验,meta分析显示中药组在改善MCI患者简易精神状态检查(MMSE)评分[MD=1.76,P0.05]及降低痴呆转化率[MD=0.21, P0.05]方面优于安慰剂组；中药组在提高患者MMSE [MD=0.90,P0.05]及记忆商(MQ)[MD=6.62,P0.05]和画钟测试(CDT)[MD=0.26,P0.05]评分方面优于基础治疗组；中药组在改善MMSE[MD=0.78,P0.05]评分及中医症状[MD=-6.85,P0.05]方面优于西坦类药物组；中药在改善MMSE[MD=4.12,P0.05]和中医症状[MD=-4.14,P0.05]方面优于麦角碱类药物组；中药组在对MCI患者MMSE[MD=-0.27,0.20),P0.05]、 ADAS-cog[MD=0.38,P0.05]、工具性生活能力(IADL)[MD=-0.58,P0.05]和中医症状([MD=-1.16,P0.05]的改善方面与盐酸多奈哌齐组疗效无显著差异。但36项研究中,35项(97.2%)临床试验未详细记录用药安全性,无法进行中药治疗MCI安全性的meta分析。2.横断面临床观察性研究发现aMCI伴有血管因素组(aMCI+VF)与不伴血管因素组(aMCI-VF)在中医证候阳亢上存在统计学差异(P=0.024),两组ADAS-cog与MMSE评分无明显差异(P0.05)。ADAS-cog分项中单词辨认与心率呈正相关(r=0.304,P=0.002)；指令测试与BMI呈正相关(r=0.290,，P=0.003)。3.补肾健脾化痰法治疗aMCI的空白对照研究：试验组78例,空白对照组15例,治疗12周后,试验组阿尔茨海默病评估量表-认知部分(ADAS-cog)评分变化均值为-0.82,对照组变化均值为0.33,差异有统计学意义(P=0.027)；试验组MMSE评分变化均值为1.14,对照组变化均值为-0.67,差异有统计学意义(P=0.000)；试验组中医证候肾虚、脾虚、痰浊评分变化均值依次为-1.09,-1.17,-0.89,对照组中医证候肾虚、脾虚、痰浊评分变化均值依次为1.67,0.63,1.27,差异有统计学意义(P=0.001,P=0.026,P=0.000)。治疗过程中不良事件发生5例,不良反应发生率为6.4%,1例判定与用药相关(中药过敏),无严重不良事件。结论：横断面观察性研究揭示尽管血管因素可能是导致认知损害的原因,但血管因素并没有影响aMCI患者总体认知水平。补肾健脾化痰法可能成为治疗aMCI的新途径,需要开展长疗程大样本的临床研究进一步证实。
[Abstract]:Objective: To evaluate the effect of Bushen Jianpi Huatan therapy of amnestic mild cognitive impairment (amnestic Mild cognitive impairment, aMCI) efficacy and safety. Methods: This study consists of three sections. The first section of mild cognitive impairment (MCI) has published the systematic evaluation of traditional Chinese medicine clinical trials, 2000-2015 years China academic journal network publishing database retrieval, China medical database, Wanfang database, PubMed, Embase in the randomized clinical trials of traditional Chinese medicine in the treatment of MCI, using RevMan5.3.0 software for data extraction and Meta analysis were included in the study. The second section cross-sectional design, aMCI subjects were recruited, neuropsychological, neuroimaging, biochemical check and TCM syndrome differentiation, vascular factors evaluation in patients with the observation of aMCI in patients with vascular cognitive impairment is aggravating factors, analysis of cognitive function With vascular factors, correlation between TCM syndromes and demographic characteristics. The third section is the control of blank, the treatment group selection method of Bushen Jianpi Huatan granules intervention in aMCI patients, the treatment time was 12 weeks, based on the cognitive function and TCM syndrome as indicators of efficacy, and drug safety evaluation. Results: 1.. Certificate of medical research 36 clinical trials of traditional Chinese medicine in the treatment of MCI were included. Meta analysis showed that the Chinese medicine group in improving the mini mental state examination (MMSE) score in patients with MCI [MD=1.76 P0.05], and reduce the dementia conversion [MD=0.21, P0.05] better than the placebo group; Chinese medicine group in improving patients with MMSE [MD=0.90, P0.05] and memory quotient (MQ) of [MD=6.62. P0.05] and clock drawing test (CDT) [MD=0.26, P0.05] score were better than the treatment group; Chinese medicine group in improving MMSE[MD=0.78, P0.05] scores and TCM symptoms of [MD=-6.85, P0.05] is better than that of zetham Drug group; traditional Chinese medicine in the improvement of MMSE[MD=4.12, P0.05] and [MD=-4.14 P0.05] is better than that of TCM symptoms, ergot drugs group; Chinese medicine group in patients with MCI MMSE[MD=-0.27,0.20), P0.05], ADAS-cog[MD=0.38, P0.05], the ability of life tools (IADL) [MD=-0.58, P0.05] ([MD=-1.16, P0.05] and TCM symptoms improved and the curative effect of donepezil hydrochloride there was no significant difference. But in the 36 study, 35 (97.2%) clinical trials without detailed records of drug safety, can not be meta MCI security analysis of traditional Chinese medicine in the treatment of.2. clinical cross-sectional observational study found that aMCI was associated with vascular factors group (aMCI+VF) and without vascular factors group (aMCI-VF) there were significant differences in the TCM syndrome Yang Kang on (P=0.024), no significant difference between the two groups of ADAS-cog and MMSE score (P0.05) in identifying sub word.ADAS-cog (heart rate had positive correlation with r=0.304, P=0.002 and BMI); test instruction Positive correlation (r=0.290, P=0.003,.3.) control study of Bushen Jianpi Huatan therapy aMCI blank: test group 78 cases, 15 cases of the control group after 12 weeks of treatment, the experimental group of Alzheimer's disease assessment scale cognitive subscale (ADAS-cog) score changes of mean -0.82, mean change in the control group was 0.33, there was statistical significant differences (P=0.027); test group MMSE score changes mean 1.14, control group mean -0.67, the difference was statistically significant (P=0.000); experimental group of TCM syndrome of kidney deficiency, spleen deficiency, phlegm and mean change in score were -1.09, -1.17, -0.89, the control group of TCM syndrome of kidney deficiency, spleen deficiency, phlegm score mean change in the order of 1.67,0.63,1.27, the difference was statistically significant (P=0.001, P=0.026, P=0.000). 5 cases of adverse events during the treatment, the incidence of adverse reaction was 6.4%, 1 cases were judged associated with medications (Chinese medicine allergy), no serious adverse events. Theory: a cross-sectional observational study revealed vascular factors may be the cause of cognitive impairment, but no overall cognitive level and vascular risk factors in patients with aMCI. Effect of Bushen Jianpi Huatan method may be a new way for the treatment of aMCI, clinical research need to carry out the long course of large sample further confirmed.

【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R277.7

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