出 处:《中国临床药理学杂志》2017年第12期1113-1115,1119,共4页The Chinese Journal of Clinical Pharmacology
基 金:杭州市科委基金资助项目(20130633B11)
摘 要:目的观察盐酸美金刚联合奥氮平治疗阿尔茨海默病(AD)伴精神行为症状(BPSD)的临床疗效及安全性。方法将176例阿尔茨海默病患者随机分为对照组89例和试验组87例。对照组予以口服盐酸美金刚,第1周每日5 mg,第2周每日10 mg,第3周每日15 mg,从第4周开始每日20 mg维持治疗;试验组在对照组盐酸美金刚治疗基础上,予以加用奥氮平,每日2.5 mg,每晚口服,最大剂量每日10 mg;2组患者一个疗程为2周,共治疗6个疗程。比较2组患者的临床疗效、日常生活能力量表(ADL)、神经精神症状问卷(NPI-1,NPI-2)评分,以及药物不良反应发生率。结果治疗后,试验组和对照组的总有效率分别为90.70%(78/86例)和75.29%(64/85例),差异有统计学意义(P<0.01)。试验组和治疗前及治疗第2,4,8,12周NPI-1评分分别为(25.18±4.17),(23.02±3.98),(20.51±3.65),(17.85±3.08),(16.56±2.95)分;NPI-2评分分别为(46.86±4.65),(45.78±4.62),(43.53±4.24),(40.53±4.31),(38.91±4.27)分;ADL评分分别为(44.34±4.59),(44.25±4.53),(42.85±4.01),(40.30±3.98),(39.21±3.48)分。对照组NPI-1评分分别为(25.27±4.23),(24.67±4.12),(23.68±3.98),(21.36±3.57),(19.92±3.24)分;NPI-2评分分别为和(46.56±4.72),(46.31±4.51),(45.82±4.42),(43.21±4.37),(42.74±4.33)分;ADL评分分别为(43.62±4.61),(43.36±4.49),(43.08±4.25),(42.18±4.31),(41.27±4.29)分。第2,4,8周,试验组与对照组的NPI-1,NPI-2,ADL差异均有统计学意义(P<0.01)。试验组的药物不良反应主要有嗜睡,体重增加,口干和便秘,对照组的药物不良反应主要有头晕,失眠,头痛和恶心。试验组和对照组的药物不良反应发生率分别为8.14%(7/86例)和7.06%(6/85例),差异无统计学意义(P>0.05)。结论盐酸美金刚联合奥氮平治疗阿尔茨海默病伴精神行为症状的疗效优于单用盐酸美金刚,且不增加药物不良反应的发生率。Objective To evaluate the clinical efficacy and safety of memantine combined with olanzapine in treating Alzheimer's disease patients with behavioral and psychological symptoms of dementia(BPSD).Methods One hundred and seventy-six cases of Alzheimer' s disease with BPSD were randomly divided into treatment group(n = 87) and control group(n = 89). The control group received oral administration of memantine 5-20 mg qd. The treatment group was given oral administration of olanzapine 2. 5-10 mg qn on the basis of control group. The treatmentcourse was two weeks. Both groups were treated for 6 courses. Clinical efficacy,neuropsychiatric inventory scale(NPI),activities of daily living(ADL) score,and the incidence of adverse drug reactions were compared between the two groups. Results After treatment,the total efficiency of the treatment group and the control group were 90. 70%(78/86 cases) and 75. 29%(64/85 cases) respectively,and the statistically significant difference was shown between the two groups(P〈0. 01). Before treatment and at week 2,4,8,12,NPI-1 in the treatment group and were(25. 18 ± 4. 17),(23. 02 ± 3. 98),(20. 51 ± 3. 65),(17. 85 ± 3. 08),(16. 56 ± 2. 95); NPI-2 were(46. 86 ± 4. 65),(45. 78 ± 4. 62),(43. 53 ± 4. 24),(40. 53 ± 4. 31),(38. 91 ± 4. 27); ADL were(44. 34 ± 4. 59),(44. 25 ± 4. 53),(42. 85 ± 4. 01),(40. 30 ± 3. 98),(39. 21 ± 3. 48). NPI-1 in the control group were(25. 27 ± 4. 23),(24. 67 ± 4. 12),(23. 68 ± 3. 98),(21. 36 ± 3. 57),(19. 92 ± 3. 24); NPI-2 were(46. 56 ± 4. 72),(46. 31 ± 4. 51),(45. 82 ± 4. 42),(43. 21 ± 4. 37),(42. 74 ± 4. 33); ADL were(43. 62 ± 4. 61),(43. 36 ± 4. 49),(43. 08 ± 4. 25),(42. 18 ± 4. 31),(41. 27 ± 4. 29). Statistical significant differences were found in NPI-1,NPI-2and ADL between the two groups at week 2,4,8(P〈0. 01). The adverse drug reactions in the treatment group were hy
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