| 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. |