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Objective: The topic to be through clinical research, observation shenwu capsule explore its therapeutic mechanism of senile dementia, senile dementia clinical efficacy and safety, and to lay the foundation for further study. Relieve the patient's pain, to improve the clinical efficacy and prevention of Alzheimer's disease is important. Method: 1. Cases was selected object (1) 50 ≤ age ≤ 80 years of age. (2) both men and women. (3) comply with a DSM-IV diagnosis of dementia Standard NINCDS-ADRDA senile dementia diagnostic criteria, as well as traditional Chinese medicine dialectical spleen and kidney deficiency, phlegm and blood stasis. (4) The mini-mental state examination (MMSE) score> 10 and ≤ 26 points, and be adjusted according to the level of education (illiteracy is not included in the primary school level ≤ 22-secondary level ≤ 26). (5) full-blown recession Scale (GDS) at 3-5, with mild to moderate dementia. (6) Haijinsiji ischemia Index Scale (HIS) ≤ 4 points, or without a history of stroke or stroke more than 3 months after the HIS for 5 points, 6 points, can also be included. (7) the Hamilton Depression Rating Scale (HAMD) ≤ 10. (8) of body weight between 45-90Kg. (9) the subjects voluntary and subjects or guardianship signed informed consent. (10) a correct understanding of drug research significance, researchers observe and evaluate compliance. (11) there is a certain level of education, to be able to write simple sentences. Who meet the above inpatients or outpatients can be included in the clinical trials of cases. Case exclusion object (1) to severe dementia, MMSE score ≤ 10 points, or GDS score> 5. (2) patients with vascular dementia (HIS ≥ 7 points), or there are other causes of dementia. (3) HAMD ≥ 11 points. (4) physical allergy, who can not tolerate or who are allergic to the party. (5) in the four weeks to participate or are participating in other clinical investigators. In all cases the Department in July 2007 - April Hubei Province Traditional Chinese Medicine Hospital of Neurology outpatient and inpatient admission priorities were randomly divided into a treatment group and the control group, 48 cases in which the treatment group, 24 cases of the control group. Were randomly divided into two groups in age, gender, disease duration, and severity of the basic balanced statistical test, there was no significant difference (P> 0.05), comparable. 4 Test group: capsule of shenwu, five at a time, three times a day, as early as 0.5-1 hours in after dinner warm water delivery service. Night a bedtime hydrochloride donepezil mimetic. Control group: donepezil hydrochloride, one at a time, day time, night bedtime. (Shenwu the capsules simulation agent plus three times, five at a time), warm water delivery service as early as noon after a meal 0.5-1 hours. Course of treatment: 3 months for a course, serving a total of two courses. Results: The clinical efficacy comparison: the treatment group of 48 patients, clinical recovery 0 cases, 12 cases were markedly and progress of the 24 cases, no progress 10 cases, ineffective in 2 cases. The control group of 24 patients, clinical recovery 0 cases, effective in 4 cases, progress in the six cases, no progress in 10 cases, 4 cases. After statistical analysis, the total efficiency, there is a significant difference (P <0.05). 2 the two groups and the symptom score comparison: the treatment group of 48 patients after treatment: before treatment, 39.63 ± 4.98, 23.53 ± 4.19; 24 cases of the control group: before treatment, 38.77 ± 5.63, 27.11 ± 5.23 after treatment. Compared with the group before treatment, P <0.01, with the control group at the same time segment compare, P <0.01. By paired t-test, the two groups after treatment and before treatment syndrome integral difference was significant (P <0.01), improvement in the treatment group than the control group (P <0.01) between the two groups was not significantly different P> 0.05. ADAS-cog scale score change before and after treatment showed improvement in the treatment group, 48 cases: before treatment, 34.52 ± 5.13, 14.21 ± 4.13 after treatment; 24 cases of the control group: before treatment, 32.13 ± 6.09, 16.67 ± after treatment 5.99. The paired t-test, the two groups after treatment and before treatment ADAS-cog points difference was significant (P <0.01), improvement in the treatment group than the control group (P <0.05) between the two groups was not significantly different P> 0.05 4 shenwu capsule of illness efficacy: GDS3 six cases markedly progress 14 cases, no progress 0 cases, 0 ineffective; GDS4 effective in five cases, progress in the six cases, no progress in 6 cases, 1 case was ineffective; period markedly GDS5 progress in four cases, no progress 4 cases, and 1 case; the statistical calculations P <0.05, the Shenwu capsule of GDS3 phase, GDS4 GDS5 of senile dementia efficacy significant difference. And after the efficient compared the GDS 3 were significantly better than GDS4 period, GDS5 efficacy. 5 adverse reactions and side effects: the treatment group and the control group during the clinical trials were not obvious adverse reactions and side effects. The two sets of laboratory test results (three regular, liver and kidney function) were not there before and after treatment, and treatment-related abnormal changes. Conclusion: The results of this study show that the treatment of Alzheimer's disease (AD) (spleen and kidney deficiency, phlegm and blood stasis) shenwu capsule, a significant effect and better than the hydrochloride donepezil, shenwu capsule can significantly improve Alzheimer's disease (AD ) in patients with learning and memory function. Relieve senile dementia symptoms and improve the patient's quality of life.
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