丁苯酞软胶囊联合多奈哌齐片治疗阿尔茨海默病的临床研究  

Clinical trial of donepezil combination with butylphthalide in the treatment of Alzheimer's disease

作　　者：陆守荣[1] 温浩[2] 宋惠珠[2] 张云云[1] 蔡小军[2] 

机构地区：[1]南京医科大学附属无锡人民医院老年医学科,江苏无锡214023 [2]南京医科大学附属无锡人民医院药学部,江苏无锡214023

出　　处：《中国临床药理学杂志》2016年第22期2042-2045,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察丁苯酞软胶囊联合多奈哌齐片对阿尔茨海默病(AD)的近期疗效及安全性。方法 36例阿尔茨海默病患者随机分为对照组和试验组,每组18例。对照组每日口服多奈哌齐5 mg,试验组在对照组的基础上口服丁苯酞软胶囊0.2 g,每日3次。比较2组患者治疗前与治疗后3,6,9个月的简易智能状态检查量表(MMSE)、日常生活能力量表(ADL)、AD评估量表认知分量表(ADAS-cog)评分及C反应蛋白(CRP)、同型半胱胺酸(Hcy)水平。结果治疗后9个月,试验组MMSE评分为(18.17±1.43)分,对照组为(16.83±1.98)分,差异有统计学意义(P<0.05)。治疗后6,9个月,试验组ADL评分分别为(46.78±5.22),(48.50±5.38)分,对照组ADL评分分别为(42.50±5.30),(43.83±5.21)分,差异有统计学意义(P<0.05)。治疗后9个月,试验组CRP为(5.35±0.90)mg·L^(-1),对照组为(6.05±1.10)mg·L^(-1),差异有统计学意义(P<0.05)。治疗后9个月,试验组Hcy为(13.83±1.46)μmol·L^(-1),对照组为(14.92±1.63)μmol·L^(-1),差异有统计学意义(P<0.05)。药物不良反应主要表现为胃肠道反应、失眠、头晕,头痛、转氨酶升高等,试验组药物不良反应发生率为27.78%(5/18例),对照组为16.67%(3/18例),差异无统计学意义(P>0.05)。结论多奈哌齐联合丁苯酞治疗阿尔茨海默病的近期疗效显著,可有效减缓患者认知功能和总体功能衰退进程。Objective To evaluate the short -term efficacy and safety of donepezil combination with butylphthalide in the treatment of patients with Alzheimer＇ s disease （AD）. Methods Totally 36 patients with AD were randomly divided into control group （n = 18 ） and treatment group （ n = 18 ）. Control group received donepezil 5 mg. d - 1, while the treat- ment group was administrated with butylphthalide 0. 2 g, qd on the basis of control group. The improvements of mental state, recognitive ability, activities of daily 1 ire and adverse drug reaction were graded by mini - mental state examination （MMSE）, activity of daily living （ADL）, Alzheimer＇ s disease assessment scale- cog（ADAS- cog）. The scores and C - reactive protein （CRP） , homoeysteine （ Hey ） levels were com- pared between the two groups before treatment and 3, 6, 9 months after treatment. Results After 9 months treatment, the MMSE score in treat- ment group was 18.17 ± 1.43, had significant difference with16.83 ± 1.98 in control group （ P 〈 0. 05 ）. The ADL scores in treatment group after 6, 9 months treatment were 46.78±5.22, 48.50 ± 5.38, had significant difference with 42.50 ± 5.30,43.83 ± 5.21 in control group （P 〈 0. 05 ）. The level of CRP in treatment group after 9 months treatment was （ 5.35 ± 0. 90 ） mg . L-1, had significant difference with （6. 05 ± 1.10） mg .L-1 in control group（P 〈0. 05）. The level of Hey after 9 months treatment in treatment group was （ 13.83 _± 1.46 ） μmol. L-1 , had significant difference with （ 14. 92 ± 1.63 ） μmol . L- 1 in control group （ P 〈 0. 05 ）. The main adverse drug reactions were gastrointestinal reactions, insomnia, dizziness, headache and elevated serum aminotransferase in two groups. The incidence of adverse drug reactions in treatment group was 27.78% （5/18 cases）, and the incidence of adverse drug reactions in control group was 16. 67% （3/18 cases, P 〉 0. 05 ）. Conclusion Donepezil combination with butylphthalide might be

关 键 词：阿尔茨海默病 多奈哌齐 丁苯酞 

分 类 号：R971.9[医药卫生—药品]