复方丹参注射液联合西药治疗血管性痴呆有效性及安全性的系统评价

系统评价复方丹参注射液联合西药治疗血管性痴呆的有效性和安全性。计算机检索Cochrane Library,PubMed,EMbase及中国知网(CNKI)、中国生物医学文献数据库(SinoMed)、维普数据库(VIP)、万方数据库,收集复方丹参注射液联合西药与单纯西药比较治疗血管性痴呆的随机对照试验,检索时限从建库到2020年1月,2名研究人员独立筛选文献、提取资料并评价纳入研究的偏倚风险,使用RevMan 5.3软件进行Meta分析。共纳入5篇相关文献,累计588例患者,其中试验组299例,对照组289例。Meta分析结果显示,相比单用西药,复方丹参注射液联合西药在有效率(RR=1.23,95%CI1.14,1.33],P<0.00001)、MMSE评分(MD=3.54,95%CI3.01,4.06],P<0.00001)、ADL评分(MD=11.49,95%CI8.05,14.93],P<0.00001)、CRP水平(MD=-0.72,95%CI-1.25,-0.20],P=0.007)、IL-6水平(MD=-7.64,95%CI-9.65,-5.63],P<0.00001)上疗效更优。不良反应主要为皮疹与皮肤刺痛等,不影响治疗效果。基于此结果,联用复方丹参注射液治疗血管性痴呆可提高临床疗效,延缓精神状态的损伤,提高日常生活能力,不良反应轻微发生率低。但由于纳入的文献质量不高,尚需要大样本、高质量的随机对照试验进一步验证。

Systematic review of efficacy and safety of Compound Danshen Injection combined with Western medicine in treatment of vascular dementia

To evaluate the efficacy and safety of Compound Danshen Injection combined with Western medicine in the treatment of vascular dementia.Databases of Cochrane Library,PubMed,EMbase,CNKI,SinoMed,VIP,Wanfang Data were electronically retrieved for collecting randomized controlled trial(RCT)about vascular dementia treated with Western medicine alone or combined with Compound Danshen Injection from the year of database establishment to January 2020.Two researchers independently screened out literatures,extracted data,and evaluated the risk of bias for inclusion in the study.Meta-analysis was conducted using RevMan 5.3 software.A total of 5 RCTs were included,involving 588 patients,with 299 in treatment group and 289 in control group.Meta-analysis results showed that compared with Western medicine alone,Compound Danshen Injection combined with Western medicine was better in the effective rate(RR=1.23,95%CI1.14,1.33],P<0.00001),MMSE score(MD=3.54,95%CI3.01,4.06],P<0.00001),ADL score(MD=11.49,95%CI8.05,14.93],P<0.00001),the level of CRP(MD=-0.72,95%CI-1.25,-0.20],P=0.007)and the level of IL-6(MD=-7.64,95%CI-9.65,-5.63],P<0.00001).Adverse reactions mainly included rash and skin prick,which did not affect the treatment effect.Based on the findings,the combination of Compound Danshen Injection in the treatment of vascular dementia could improve the effective rates,relieve the mental state damage and improve the daily living ability,with mild ad-verse reactions and a low incidence.However,due to the low quality of the included literatures,high-quality and large-scale randomized controlled trials are needed for further verification.