奥拉西坦治疗血管性痴呆的疗效与安全性的系统评价

A Systematic Review of Efficacy and Safety of Oxiracetam for Vascular Dementia

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.