丁苯酞治疗血管性痴呆疗效及安全性的系统评价

The Efficacy and Safety of Butylphthalide for Patients with Vascular Dementia:a Systematic Review

目的系统评价丁苯酞治疗血管性痴呆的疗效和安全性。方法通过计算机检索及手工检索,全面收集丁苯酞治疗血管性痴呆的随机对照试验(RCT),按Cochrane协作网系统评价的方法进行评价。结果共纳入8个研究(717例患者)。8个研究采用MMSE评价患者痴呆程度改善情况,Meta分析示:丁苯酞组优于对照组[MD=3.76,95%CI(2.95,4.57)];5个研究(405例)采用ADL评价患者日常生活能力改善情况,Meta分析示:丁苯酞组优于对照组[MD=4.99,95%CI(2.29,7.69)];4个研究进一步采用CDS和HDS(各2个研究,计376例)评价患者痴呆程度改善情况,Meta分析示:丁苯酞组优于对照组[SMD=1.17,95%CI(0.36,1.97)]。3个研究(265例)给予临床有效性评价,Me-ta分析示:丁苯酞组优于对照组[RR=1.27,95%CI(1.09,1.47)]。共6个研究报道了药品不良事件,均无严重不良事件发生。结论本系统评价结果提示丁苯酞治疗血管性痴呆有效而且安全,但尚需更多更高质量的随机双盲对照试验进一步证实。

Objective To evaluate the efficacy and safety of butylphthalide for patients with acute ischemic stroke. Methods The randomized controlled trials were collected,which compared butylphthalide agents with placebo or open control in patients with vascular dementia, by searching the electronic bibliographic databases, scanning references listed in articles and hand-searching journals. Study selection and meta-analys!s was conducted according to the Cochrane Handbook for systematic re- views. Results Eight trials involving 717 patients were included. The efficacy were confirmed in terms of the increasing of MMSE score （ MD = 4.99,95 % CI： 2.29 to 7.69）, the reducing of ADL score （ MD = 4.99,95 % CI： 2.29 to 7.69 ）, the change of HDS and CDR score（SMD = 1.17,95% CI： 0.36 to 1.97）. and its clinical validity（ RR = 1.27,95% CI： 1.09 to 1.47）. Adverse e- vents were reported in 6 trials. No severe adverse events were reported. No dead patients at the end of follow-up were reported in the 8 included trials. Conclusion This analysis showed that butylphthalide is effective and safe for the patients with vascular dementia. However, further higher-quality randomized, double-blind, controlled trial was needed to confirm it.