摘要
目的:系统评价奥拉西坦治疗血管性痴呆(VD)的有效性与安全性。方法:计算机检索Cochrane Library、PubMed、EMbase、中国期刊全文数据库、中国生物医学文献数据库、维普数据库和万方数据库中关于奥拉西坦治疗VD的随机对照试验(RCT)和半随机对照试验(QRCT)。对所纳入的RCT或QRCT,按Cochrane系统评价的方法进行评价,采用Rev Man 5.1.7统计软件进行Meta分析。结果:共纳入15项研究,合计1 195例患者。Meta分析结果表明,奥拉西坦在改善VD患者智力精神水平[MD=3.40,95%C(I2.87,3.94),P<0.01]、痴呆水平[MD=-0.80,95%C(I-0.88,-0.72),P<0.01]、神经功能缺损评分[MD=-4.92,95%CI(-6.68,-3.17),P<0.01]方面优于安慰剂,而对改善VD患者日常生活能力水平[MD=4.80,95%C(I-10.22,19.81),P=0.53]方面的作用尚不能认为其优于安慰剂;奥拉西坦在改善VD患者智力精神水平方面优于吡拉西坦[MD=2.40,95%CI(0.57,4.22),P=0.01]、茴拉西坦[MD=4.05,95%CI(1.79,6.30),P<0.01]、胞二磷胆碱[MD=-3.51,95%CI(1.34,5.69),P<0.01]和尼莫地平[MD=-3.05,95%C(I1.77,4.33),P<0.01],但尚不能认为其优于多奈哌齐(MD=-0.30,95%C(I-3.06,2.46),P=0.83)。11项研究报道了不良反应的发生情况,各研究的试验组与对照组的不良反应发生率比较,差异无统计学意义(P>0.05)。结论:奥拉西坦治疗VD有效且安全。此结论尚需更多高质量的RCT进一步验证。
OBJECTIVE: To evaluate the efficacy and safety of oxiracetam in the treatment of vascular dementia. METHODS: We searched the databases, such as Cochrane Library, PubMed, EMbase, CNKI, CBM, VIP and Wanfang database. The included studies were evaluated according to Cochrane Handbook for systematic reviews, and Meta-analyses were performed by using Rev Man 5.1.7 software. RESULTS: 15 trials were included, involving 1 195 patients. Results of Meta-analyses showed oxiracetam was superior to blank placebo in improving intellectual spirit level [MD=3.40,95%CI(2.87,3.94),P〈0.01], dementia level [MD=-0.80,95%CI( -0.88, -0.72) ,P〈0.01] and NIHSS scores of vascular dementia patients [MD=-4.92,95%CI( -6.68, -3.17), P〈 0.01 ], but not in activity of daily living [MD=4.80, 95 % CI (- 10.22,19.81 ), P= 0.53]; oxiracetam was superior to piracetam [MD=2.40, 95%CI(0.57,4.22), P=0.01], aniracetarn [MD=4.05, 95%CI(1.79,6.30), P〈0.01], citicoline [MD=-3.51, 95% CI (1.34,5.69), P〈0.01], nimodipine [MD = - 3.05,95 % CI (1.77,4.33), P〈0.01] in improving intellectual spirit level of vascular dementia patients, but not superior to donepezil [MD=-0.30,95%CI(-3.06,2.46), P=0.83]. 11 studies reported the occurrence of adverse drug reactions, and the incidence of adverse drug reactions had no significant difference between 2 groups (P〉 0.05). CONCLUSIONS: Oxiracetam is effective and safe for vascular dementia. However, this conclusion still needs to be verified with more high-quality RCTs.
出处
《中国药房》
CAS
CSCD
2013年第48期4581-4585,共5页
China Pharmacy
关键词
奥拉西坦
血管性痴呆
系统评价
随机对照试验
Oxiracetam
Vascular dementia
Systematic review
Randomized controlled trials