培磊能对血管性认知功能障碍的疗效及安全性研究

目的观察新型甲磺酸二氢麦角碱缓释剂培磊能对伴有认知功能障碍的脑血管功能不全患者的疗效及其安全性。方法采用自身对照设计方法,对43例脑血管功能不全所致认知功能障碍的患者给予口服培磊能,1粒/次,2次/d,于治疗后45d和90d观察该药物对认知功能和主观症状的改善程度及药物的副作用。结果(1)对认知功能的影响:与治疗前相比,治疗后45d和90d患者的MMSE总评分提高(P<0.001);但治疗后90d与45d相比,差异无显著性意义(P>0.05)。治疗后45d以记忆力、计算力及言语功能障碍改善最为明显(P<0.05或P<0.01);治疗后90d,除注意力外,其余各单项评分均明显提高(P<0.05)。治疗后90d记忆力和定向力的改善程度优于45d(P<0.05)。(2)对主观症状的影响:治疗后90d,患者头痛、头晕、睡眠障碍、易疲劳和情绪不佳等主观症状明显改善;在治疗后45d和90d,对头痛、头晕两项症状改善的总有效率分别为66.7%、61.5%和83.3%、84.6%;对睡眠障碍和易疲劳改善的总有效率分别为22.2%、12.5%和44.4%、50.0%;但对情绪不佳的疗效欠佳,治疗后90d的总有效率仅为16.6%。(3)药物安全性:治疗期间发生的相关不良反应为恶心、鼻塞、口干等,症状较轻。结论培磊能是治疗血管性认知功能障碍安全、有效的药物。

The study of efficacy and safety of perenan in vascular cognitive dysfunction

Objective To evaluate the efficacy and safety of perenan,a novel slow released agent of dihydroergot alkloid mesylate in treatment of cerebrovascular insufficiency patients associated with cognitive impairment.Meth ods A self-controlled trial was carried out in43patients with cognitive dysfunction result-ed from brain insufficiency,perenan was prescribed oral administration1tablet bid for90d.The cognitive function,subjective symptom and side-effect were recorded at45d and90d after administration of perenan.Re sults1)Influence on cognitive function:the mini-mental state examination(MMSE)scores of patients were higher at45d and90d than pretreatment (P<0.001),but there was no significant difference between45d and90d(P>0.05).The dysfunction of memory,calculation and speech were improved significantly after45d treatment (P<0.05or P<0.01),and with exception of attention,the scores of the other items were im-proved significantly(P<0.05)after90d treatment.The ability of memory and orientation were much improved in90d than that in45d after treatment (P<0.05).2)Effect on subjective symptoms:the subjective symp-toms e.g.headache,vertigo,dyssomnia,tiredness and bad feeling were significanlly relieved after90d treat-ment.The total effective rate of relieving headache and vertigo was66.7%,61.5%and83.3%,84.6%respec-tively in45d and90d post-treatment.The total effective rate of relieving dyssomnia and tiredness was22.2%,12.5%and44.4%,50.0%respectively.But the therapeutic effect was poor in relieving bad feeling,the total effective rate for it was only16.6%after90d treatment .3)Drug safety:the related adverse effects in treatment with perenan were nausea,nasal obstruction,xerostomia etc.but mild.Conclusion Perenan is a safe and effective drug in treatment of vascular cognitive dysfunction.