灯盏生脉胶囊联合盐酸多奈哌齐治疗阿尔茨海默病的临床研究

目的 观察灯盏生脉胶囊联合盐酸多奈哌齐对阿尔茨海默病患者认知功能、日常生活能力及安全性的影响。方法 将98例阿尔茨海默病患者随机分为治疗组与对照组各49例; 对照组给予每日口服盐酸多奈哌齐5 mg/次,1次/d,治疗组在对照组的基础上口服灯盏生脉胶囊0.36 g/次,3次/d; 比较2组患者治疗前与治疗3、6月后认知功能评分(MMSE、ADAS-cog)、日常生活能力评分(ADAS-ADL)、血清一氧化氮(NO)、内皮素(ET)水平及不良反应发生率。结果 治疗6月后治疗组MMSE评分为(21.85±2.58)分,对照组为(20.48±2.23)分(P<0.05); 治疗3、6月后治疗组ADAS-cog评分为(45.48±5.94)、(41.57±5.10)分,对照组为(48.69±6.23)、(414.24±5.53)分(P<0.05); 治疗3、6月后治疗组ADAS-ADL评分为(43.91±4.25)、(47.57±3.86),对照组为(41.77±4.44)分、(44.46±5.18)分(P<0.05); 治疗3、6月后治疗组NO水平为(41.95±7.62)、(37.89±5.93)μmol/L,对照组为(45.28±6.68)、(41.55±7.92)μmol/L(P<0.05); 治疗3、6月后治疗组ET水平为(140.48±22.94)、(132.04±10.08)ng/L,对照组为(152.08±17.39)、(143.91±17.60)ng/L(P<0.05); 2组药物不良反应主要有恶心、失眠、头痛、乏力、头晕、腹泻、皮疹,治疗组和对照组药物不良反应发生率分别为20.41%和14.28%(P>0.05)。结论 灯盏生脉胶囊联合盐酸多奈哌齐可提高阿尔茨海默病患者认知功能及日常生活能力,减少神经毒性物质NO、ET的生成,且安全性较好

Clinical trial of donepezil combination with dengzhan shengmai capsule in the treatment of Alzheimer's disease

ObjectiveTo observe the effects of dengzhan shengmai capsule combined with donepezil hydrochloride on cognitive function, daily living ability and safety in patients with Alzheimer's disease.Methods 98 patients with Alzheimer's disease were randomly divided into treatment group and control group. The control group was given 5mg of donepezil hydrochloride orally once a day, On the basis of the control group, the treatment group received 0.36 g of dengzhan shengmai capsule three times a day. The cognitive function score(MMSE, ADAS-cog)and daily life ability score(ADAS-ADL), serum nitric oxide(NO), endothelin(ET)levels and the incidence of adverse reactions were compared between the two groups before and after 3, 6 months of treatment.Results After 6 months of treatment, the MMSE score was(21.85±2.58)points in the treatment group and(20.48±2.23)points in the control group(P<0.05). After 3, 6 months of treatment the ADAS-cog scores of the treatment group were(45.48±5.94),(41.57±5.10)points, and the control group were(48.69±6.23)and(414.24±5.53)points(P<0.05). After 3, 6 months of treatment the ADAS-ADL scores of the treatment group were(43.91±4.25)and(47.57±3.86)points, and the control group was(41.77±4.44)and(44.46±5.18)points(P<0.05). After 3, 6 months of treatment the NO level in the treatment group was(41.95±7.62),(37.89±5.93)μmol/L, and the control group was(45.28±6.68),(41.55±7.92)μmol/L(P<0.05). After 3, 6 months of treatment the ET level of the treatment group was(140.48±22.94),(132.04±10.08)ng/L, and the control group was(152.08±17.39),(143.91±17.60)ng/L(P<0.05). The adverse reactions of the two groups were mainly nausea, insomnia, headache, fatigue, dizziness, diarrhea, rash. The incidences of adverse drug reactions in the treatment group and the control group were 20.41% and 14.28%, respectively(P>0.05).Conclusion Dengzhan shengmai capsule combined with donepezil hydrochloride could improve the cognitive function and daily living ability of patients with Alzheimer's disease, reduce the production of neurotoxic substances NO and ET, and have better safety