复智胶囊治疗血管性痴呆的临床疗效观察

【作者】 周晓卿；

【导师】 马云枝；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2010， 博士

【摘要】 目的：观察复智胶囊对血管性痴呆患者的临床疗效。观测复智胶囊对VD患者患者血清TNF-α、IL-6、SOD活性、MDA. NO的含量影响,从而验证“毒损脑络”所致痴呆假说的合理性,进一步探讨复智胶囊治疗VD的机理。方法：研究采用临床随机、平行对照法,根据DSM IV(美国《精神病诊断和统计手册》)及NINDS-AIREN(美国国立神经系统疾病与卒中研究所和瑞士神经科学研究国际协会)关于VD的诊断标准进行病例筛选,用临床痴呆分级量表(CDR)、“临床试验目的的血管性痴呆辨证量表”(SDSVD)、《蒙特利尔认知评估量表》《Blessed行为量表》对患者进行整体评定。将符合纳入标准并签订知情同意书的患者列为研究对象共计60例,随机分为治疗组和对照组各30例；治疗组口服复智胶囊每次5粒,每日3次；对照组口服安理申,5mg/次,1次／日。两组均连续用药12周。治疗前、治疗12周后对患者中医证候疗效、认知功能、行为能力进行评定。安全性观测采用血、尿、粪常规及肝、肾功、心电图监测,治疗前后各1次。用药前后检查血脂、血糖、血流变各1次；头颅CT检查用药前后各一次。在复智胶囊治疗VD患者实验前后分别观测其对患者血清TNF-α、IL-6、SOD活性、MDA、NO含量影响。结果：60例患者按方案完成临床试验,无脱落及剔除病例。中药复智胶囊和安理申均可以明显改善血管性痴呆患者的各项认知功能和行为能力的积分(P<0.01)。对VD的总体疗效,两药物效果相近(P>0.05)。两药对记忆、认知的作用也近似(P>0.05)。在中医证候积分的改善方面,复智胶囊的作用明显优于安理申(P<0.05)。在安全性方面,中药复智胶囊和安理申均未发现对人体存在明显的毒副作用。在降低血粘度、降脂、改善心肌供血方面,复智胶囊较安理申有优势,显示出中药的综合性、多靶点的治疗作用。在对细胞因子及神经毒性物质如TNF-α、IL-6、SOD活性、MDA的含量、NO等的影响方面,复智胶囊和安理申组在治疗后均较治疗前有极显著性差异(P<0.01),但在治疗后组间比较复智胶囊组较安理申组有极显著性差异(P<0.01),表明复智胶囊对VD患者细胞因子及神经毒性物质的影响明显优于安理申。结论：复智胶囊和安理申在改善VD患者认知功能、行为能力方面效果相近；在改善中医证候及对细胞因子、神经毒性物质的影响方面,复智胶囊明显优于安理申。因此说中药复智胶囊对VD有确切的疗效,在改善全身症状及减少神经毒性物质方面作用明显,也印证中医毒损脑络所致VD病机理论的合理性。更多还原

【Abstract】 Objective:To observe the FUZHI Capsule on vascular dementia in patients with clinical efficacy. Observed in patients with VD Fuzhi capsule on serum TNF-α, IL-6, SOD activity, MDA, NO levels of influence, thus verify that "poisonous network of brain damage" caused by dementia, a reasonable hypothesis, further explore the mechanism of VD was treated by Fuzhi Capsule.Methods:The study used randomized, parallel control method, according to DSM IV (the United States, "Diagnostic and Statistical Manual of mental illness") and the NINDS-AIREN (the United States National Institute of Neurological Diseases and Stroke Neuroscience Research Institute and the International Association of Switzerland) on the diagnosis of VD Case selection criteria, using the clinical dementia rating scale (CDR), "the purpose of clinical trials in vascular dementia Syndrome Scale" (SDSVD), "the Montreal Cognitive Assessment Scale" "Blessed-Roth Behavior Checklist" on patients to conduct an overall assessment. Will meet the inclusion criteria and signed informed consent of patients as a total of 60 subjects were randomly divided into treatment group and control group 30 cases; treatment group oral 5 Fuzhi capsules per day, three times; the control group was treated with Aricept,5mg/times,1 time/day. Both groups were continuous medication for 12 weeks. Before treatment, after 12 weeks of treatment efficacy in patients with TCM, cognitive and behavioral abilities (BBS) to be assessed. Safety observations using blood, urine, stool and liver, renal function, electrocardiogram monitoring, treatment before and after a time. Check before and after treatment blood lipids, blood glucose, blood flow changes of a meeting; cranial CT examination before and after medication once. FuzhiCapsule treatment of patients with VD were observed before and after experiment of its serum TNF-a, IL-6, SOD activity, MDA, NO content effect.Results:60 patients completed clinical trials, according to the program, non-shedding and exclusion cases. Fuzhi capsule and Aricept may significantly improved in patients with vascular dementia of the cognitive function and capacity points (P<0.01). The overall effect of the VD, the two drug effects is similar (P> 0.05). Two drugs on memory, cognitive role similar (P> 0.05). In TCM points improvement, Fuzhi capsule was superior to Aricept (P<0.05). With respect to security, traditional Chinese medicine Fuzhi capsule and Aricept were not found to exist on the human body side effects. In reducing blood viscosity, lipid-lowering, improving myocardial blood supply, the Fuzhi capsule has an advantage compared with Aricept, showing that traditional Chinese medicine a comprehensive, multi-target therapeutic effect. In cytokines and neurotoxic substances, such as TNF-a, IL-6, SOD activity, MDA content, NO, etc. impact, Fuzhi capsule and Aricept group than those before treatment after treatment there was a significant difference (P<0.01), but after treatment, compared Fuzhi capsule group than in the Aricept group significant difference (P<0.01), showed that patients with VD Fuzhi capsule on cytokines and neurological effects of toxic substances much better than Aricept. Conclusion:The FUZHI Capsule and Aricept in improving cognitive function in patients with VD, behavioral effects of similar capacity; in improving the TCM and cell factor, neural effects of toxic substances, FUZHI Capsule is better than Aricept. So, to say FUZHI Capsule on the VD with definite efficacy in improving symptoms and reduce the systemic role of neurotoxic substances obvious, which can show that envelope the brain damage caused by toxic VD patients the theory is reasonable.更多还原