“聪圣胶囊”治疗血管性痴呆的临床研究

【作者】 贾绍燕；

【导师】 高颖；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2003， 硕士

【摘要】 血管性痴呆（Vascular Dementia,VD）是老年期痴呆的主要类型之一，是由一系列脑血管因素（缺血或出血及急慢性缺氧性脑血管病）导致脑组织损害而引起的获得性智能损害综合征，在古代文献中解释为呆者，痴也，癫也，不慧也，不明事理之谓也。本文在综述了血管性痴呆的中西医病因病机及治疗的基础上，提出了肝肾亏虚为本，痰瘀阻络为标的发病机理并运用中医基础理论加以分析，对其中医证候特点加以阐发，肯定了益肾养肝、活血化浊、健脑益智是治疗血管性痴呆的有效方法。临床研究部分，采用WHO公布的美国精神神经病学会血管性痴呆的诊断标准（DSM-IV），结合国际公认的智力测定量表（简易智能状态检查MMSE）、日常生活能力量表（ADL和BBS）及中医辨证标准，经患者同意符合纳入标准者，列入研究对象计48例，随机分为治疗组和对照组各24例；采用“双盲双模拟”法用药，治疗组口服聪圣胶囊每次4粒，每日3次，以及模拟喜德镇片每次2片，每日3次；对照组口服喜德镇片每次2片，每日3次，以及模拟聪圣胶囊每次4粒，每日3次；连续用药12周，每月随访1次。用药前及用药后每月记录一次认知功能及行为能力、中医症状及舌、脉象；疗前、疗后记录面色、唇色、体型、病理征、脑电图及进行安全性指标观测。对治疗组和对照组各项指标进行疗效观察，统计分析，突出MMSE、中医证候及脑电图的观察。疗效评定及安全性分析，48例患者中有42例按方案完成临床试验（治疗组23例、对照组19例），治疗组1例、对照组5例脱落或剔除。MMSE疗效：治疗组的控显率17.39%，总有效率69.57%；对照组的控显率15.79%，总有效率52.63%。两组疗效经统计学分析，差异无统计学意义。根据简易智能状态检查（MMSE）对治疗前后痴呆程度的评价，治疗组患者的向愈率65.22%、回转率21.74%、控制率13.04%、恶化率0.00%；对照组患者的向愈率33.33%、回转率14.29%、控制率52.38%、恶化率0.00%，经统计学分析，治疗组对智能状态的疗效优于对照组（P<0.05）。BBS疗效:治疗组的控显率17.39%，总有效率69.57%；对照组的控显率5.26%，总有效率42.11%。两组疗效经统计学分析，差异无统计学意义，治疗组对患者的行为能力的疗效优于对照组(P<0.05)。ADL疗效: 治疗组的控显率4.35%，总有效率43.48%；对照组的控显率5.26%，总有效率31.58%。两组疗效经统计学分析，差异无统计学意义。中医证候疗效：治疗组的控显率34.78%，总有效率78.26%；对照组的控显率15.79%，总有效率63.16%。两组疗效经统计学分析，差异无统计学意义。两组中医证候疗效比较，治疗组疗效优于对照组。A、B两组对主要症状智能减退均有显著疗效（P<0.01），治疗组对喜怒不定、头晕而鸣、目涩咽干有明显疗效（P<0.05），对照组对喜怒不定有明显疗效（P<0.05）。A、B两组对神情呆滞、腰膝酸软均无显著疗效（P>0.05）。治疗组对患者的苔白<WP=4>腻有显著改善（P<0.05），A、B两组对(血管性痴呆)患者的舌质淡或紫暗、脉细或兼弦、滑、涩均无显著疗效（P均>0.05）。脑电图结果 48例VD患者中47例做此项检查，36例患者做服药前后对照检查。47例患者中异常脑电图36例（76.6%）。其中临界脑电图13例，轻度异常13例，中度异常10例。 36例患者服药前后对照检查，脑电图无明显改变。患者服药过成中未发生不良事件，安全性良好。结果表明肝肾亏虚、痰瘀阻络是老年期血管性痴呆的主要病机，采用具有益肾养肝、活血化浊、健脑益智的“聪圣胶囊”治疗VD疗效显著，安全可靠。更多还原

【Abstract】 Vascular Dementia is one of the senile dementia ’ principal forms, is the gained mental impairment syndrome caused by a series of cerebrovascular factors such as ischemia or haemorrhage leading to brain tissue impairment. In ancient literature it was explained for "dai", "chi", "dian"ect. This article put forward the mechanism of the disease which is deficient of the liver and kidney being root cause, phlegm stagnation obstructing meridian being symptoms and apple the TCM basic theory to analyse on basis of reviewing VD’s chinese and western medicine etiology and pathogenesis and therapy. At same time this article set forth VD’s TCM symptoms and signs distinetive feature and positive that replenishing kidney and liver, promote blood circulation and remove blood stasis, strengthening brain and nourishing mentality is an effective method in treating VD.In the part of clinical study we adopt DSM-Ⅳ,MMSE,ADL,BBS and TCM syndrome differentiation standard and choose 48 cases who take part in this study freely and conforming with the observation criteria. 48 cases are randomly divided into two groups. The treating method adopt double-blind and double-simulator.24 cases in treated group take CSC 4 capsules each time three times a day orally and simulated hydergine 2 tablets each time three times a day orally.24 cases in control group take hydergine 2 tablets each time episode and the states of tongue and pulse are recorded every month. Before treatment and after treatment complexion, lips,body type, pathologic symptom and electroencephalogram are recorded meanwhile safety parameters are abserved. To abserve the effect of every parameter in two groups and ca three times a day orally and simulated CSC 4 capsules each time three times a day orally. Taking medicine continues 12 weeks and follow-up is one time every month. Before taking medicine and after taking medicine MMSE,ADL, BBS ,TCM rry on statistical analysis, especially abserve MMSE, TCM episode and electroencephalogram.In evaluation of the therapeutic efficiency and safety analysis, 42cases had finished the clinical test according to plan (the treated group 23 cases, the control group 19 cases), one case in the treated group and 5 cases in the control group had been dropped off.MMSE effectiveness: in the treated group the control excellent rate reached 17.39% and the total effective rate reached 69.57%, in the control group the control excellent rate reached 15.79% and the total effective rate reached 52.63%. To analyse the results of therapy<WP=6>of two groups, there was no statistically difference. According to MMSE in before and after treatment’s assessing, in the treated group the tendentious heal rate reached 65.22%，the turn-round rate reached 21.74%,the control rate reached 13.04%,the deteriorate rate reached 0.00% and in the control group the tendentious heal rate reached 33.33%,the turn-round rate reached 14.29%,the control rate reached 52.38%,the deteriorate rate reached 0.00%. The treated group’s effectiveness in MMSE advantage over the control group’s effectiveness in MMSE through statistical analysis(P<0.05).BBS effectiveness: in the treated group the control excellent rate reached 17.39% and the total effective rate reached 69.57%, in the control group the control excellent rate reached 5.26% and the total effective rate reached 42.11%. To analysis the results of therapy of two groups, there was no statistically difference. The treated group’s effectiveness in behavior ability advantage over the control group’s effectiveness in behavior ability through statistical analysis(P<0.05).ADL effectiveness: in the treated group the control excellent rate reached 4.35% and the total effective rate reached 43.48%, in the control group the control excellent rate reached 5.26% and the total effective rate reached 31.58%. To analysis the results of therapy of two groups, there was no statistically difference.TCM episode effectiveness: in the treated group the control excellent rate reached 34.78% and the total effective rate reached 78.26%, in更多还原