摘要
目的评价阿米三嗪-萝巴新治疗轻度血管性痴呆(VD)的疗效和安全性。方法采用多中心、开放、自身对照试验研究方法,对128例临床诊断为轻度可能的 VD 患者,给予口服阿米三嗪-萝巴新,每日2片,早晚各1片。分别于服药前及服药后6周和12周,采用简易精神状态(MMSE)量表、AD 评估量表-认知部分、Mattis 痴呆评价(CDR)量表、日常生活能力(ADL)量表等神经心理分析工具对轻度 VD 患者的记忆力、注意力、定向力、语言能力、执行能力及生活能力进行评价,并观察有无恶心、头晕等副作用,进行安全性评估。结果经过3个月阿米三嗪-萝巴新治疗,轻度 VD 患者的MMSE 评分(治疗前16.98,治疗后17.97,P<0.05),CDR 评分(治疗前1.43,治疗后1.21,P<0.01),ADAS 总分(治疗前35.12,治疗后33.08,P<0.05)以及 ADAS 因子分中的记忆力和定向力评分、语言能力评分、实践能力评分和 ADL 评分(治疗前45.55,治疗后43.41,P<0.01)均有明显改善。阿米三嗪-萝巴新的安全性和依从性良好,在研究期间,3例患者出现皮疹,1例患者因药物作用不明显退出研究,不良事件发生率为2.3%。结论阿米三嗪-萝巴新可以改善轻度 VD 的认知功能,提高患者的生活能力,且药物的安全性好。
Objective To evaluate the therapeutic effects and safety of amitrine bismesylate in patients with mild vascular dementia. Methods An open multicenter self-controlled trial was carried out with 128 mild vascular dementia patients clinically diagnosed. Patients were treated with amitrine bismesylate in a dose of 2 tablets per day for 12 weeks. The neuro-psychological scale of MMSE, ADAS-cog, CDR, ADL were used to evaluate patients＇ cognitive condition before therapy and 6, 12 weeks after treatment. The adverse effects,such as nausea and vertigo and so on, were monitored at the same time to evaluate the safety of this drug. Results After 3 months of treatment, the MMSE score （ 16. 98 before therapy and 17. 97 after treatment, P 〈 0. 05 ）, the CDR score （ 1.43 before therapy and 1.21 after treatment, P 〈 0. 01 ）, the ADAS whole score （ 35. 12 before therapy and 33.08 after treatment, P 〈 0. 05 ） and individual score of memory, orientation, language and executive function in ADAS scale, the ADL scale （43.41 before therapy and 45.55 after treatment, P 〈0. 01 ） of patients were improved with statistic significance. Conclusions Amitrine bismesylate can improve cognitive function as well as daily performances in patients with mild vascular dementia with secured safety.
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2007年第3期203-206,共4页
Chinese Journal of Neurology
