多奈哌齐治疗老年血管性痴呆的系统评价

Donepezil in the Treatment of Senile Vascular Dementia:A Systematic Review

目的系统评价多奈哌齐治疗老年血管性痴呆的有效性与安全性。方法计算机检索CNKI、CBM、VIP、WanFang Data、PubMed和Cochrane Library,同时手检相关期刊和会议论文集,检索时间均从建库至2010年5月,查找有关多奈哌齐治疗老年血管性痴呆的随机对照试验。按照纳入与排除标准选择文献、提取资料,并参照Jadad评分标准对纳入研究的方法学质量进行评估后,采用RevMan 5.0软件进行Meta分析。结果共纳入25个研究,共计3 586例患者,其中8个研究详细描述了具体的随机方法,3个研究详细描述双盲。Meta分析结果显示:多奈哌齐在改善血管性痴呆患者的认知水平[3个研究,MD=–1.25,95%CI(–1.61,–0.88),P<0.000 01]、智力精神水平[2个研究,MD=0.66,95%CI(0.35,0.97),P<0.000 1]、痴呆水平[3个研究,MD=–0.74,95%CI(–1.16,–0.31),P=0.004]和日常生活能力水平[2个研究,MD=–0.74,95%CI(–1.16,–0.31),P=0.000 6]方面优于空白安慰剂;多奈哌齐在改善血管性痴呆患者智力精神水平方面优于吡拉西坦[7个研究,MD=3.25,95%CI(2.15,4.35),P<0.000 01]、血塞通[2个研究,MD=6.12,95%CI(4.02,8.22)]、石杉碱甲片[3个研究,MD=2.45,95%CI(1.14,3.76),P=0.000 2]和维生素安慰剂[2个研究,MD=4.00,95%CI(2.73,5.27),P<0.000 01];多奈哌齐在改善血管性痴呆患者日常生活能力水平方面优于吡拉西坦[5个研究,MD=–3.86,95%CI(–4.83,–2.89),P<0.000 01]、血塞通[2个研究,MD=–5.49,95%CI(–7.18,–3.80),P<0.000 01]、石杉碱甲片[2个研究,MD=–0.78,95%CI(–4.23,–2.66),P=0.66]、维生素安慰剂[3个研究,MD=–5.88,95%CI(–8.29,–3.48),P<0.000 01]和尼莫地平[1个研究,MD=–7.09,95%(–10.81,–3.37),P=0.000 2];多奈哌齐在改善血管性痴呆患者痴呆水平方面(HDS量表)优于吡拉西坦[1个研究,MD=5.80,95%CI(2.78,8.82),P=0.000 2]、血塞通[1个研究,MD=3.95,95%CI(2.32,5.58),P<0.000 01]、维生素安慰剂[1个研究,MD=3.91,95%C(I0.94,6.88),P=0.010]和阿米三嗪[1个研究,MD=3.37,95%C(I1.10,5.64),P=0.004]。结论现有证据表明,多奈哌齐治疗老年血管性痴呆的临床有效性可能优于空白安慰剂和吡拉西坦、血塞通、石杉碱甲片、维生素安慰剂。但限于纳入研究较少及方法学质量上的局限,本系统评价结果尚需更多高质量的RCT进一步验证。

Objective To evaluate the effectiveness and safety of donepezil in the treatment of senile vascular dementia.Methods The databases such as the Chinese Journal Full-text Database,Chinese Biomedical Literature Database,Chinese Scientific Journals Full-text Database,Chinese Biomedicine Database,PubMed and The Cochrane Library were searched by computer,and the related journals and conference proceedings were also manually searched to include randomized controlled trials（RCTs） on donepezil in the treatment of senile vascular dementia.Studies were screened according to the inclusion and exclusion criteria,data were extracted,the methodological quality of the included studies was assessed according to Jadad score criterion,and meta-analyses were performed by using RevMan 5.0 software.Results Among 25 studies（3586 patients） included,eight described the randomization methods,and three described the double blind methods.The results of meta-analyses showed,compared with the placebo group,donepezil was superior in improving vascular dementia patients＇ cognition level（three studies,MD= -1.25,95%CI -1.61 to -0.88,P〈0.000？01）,intellectual spirit level（two studies,MD=0.66,95%CI 0.35 to 0.97,P〈0.000？1）,dementia level（three studies,MD= -0.74,95%CI -1.16 to -0.31,P=0.004）,and viability level（two studies,MD= -0.74,95%CI -1.16 to -0.31,P=0.000？6）.In improving the intellectual spirit level,donepezil was superior to piracetam（seven studies,MD=3.25,95%CI 2.15 to 4.35,P〈0.000？01）,Xuesaitong（two studies,MD=6.12,95%CI 4.02 to 8.22）,Huperzine A（three studies,MD=2.45,95%CI 1.14 to 3.76,P=0.000？2）,and vitamin（two studies,MD=4.00,95%CI 2.73 to 5.27,P〈0.000？01）.For improving the viability level,donepezil was superior to piracetam（five studies,MD= -3.86,95%CI -4.83 to -2.89,P〈0.000？01）,Xuesaitong（two studies,MD= -5.49,95%CI -7.18 to -3.80,P〈0.000？01）,Huperzine A（two studies,MD= -0.78,95%CI -4.23 to -2.66,P=0.66）,vitamin（three studies,MD= -5.88,95%CI -8.29 to -3.48,P〈0.000？01）,and nimodipine（one study,MD= -7.09,95%CI -10.81 to -3.37,P=0.000？2）.In improving the dementia level（HDS Scale）,donepezil was superior to piracetam（one study,MD=5.80,95%CI 2.78 to 8.82,P=0.000？2）,Xuesaitong（one study,MD=3.95,95%CI 2.32 to 5.58,P〈0.000？01）,vitamin（one study,MD=3.91,95%CI 0.94 to 6.88,P=0.010）,and almitrine（one study,MD=3.37,95%CI 1.10 to 5.64,P=0.004）.Conclusion Current evidence shows that donepezil is likely to be more effective in the treatment of vascular dementia than placebo,piracetam,Xuesaitong,Huperzine A and vitamin.However,for the limited evidence and lower methodological quality of the included studies,this conclusion still needs to be verified with more high-quality RCTs.