丁苯酞软胶囊治疗血管性痴呆疗效和安全性的Meta分析

Efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia:a meta-analysis

目的系统评价丁苯酞软胶囊治疗血管性痴呆(vascular dementia,Va D)的疗效和安全性。方法计算机检索CNKI、WanFang Data、VIP、CBM、PubMed、EMbase和The Cochrane Library数据库,搜集关于丁苯酞软胶囊治疗血管性痴呆的随机对照试验,检索时限均从2002年9月至2018年7月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果最终纳入15个RCT,共1149例患者,其中丁苯酞软胶囊治疗组578例,对照组(盐酸多奈哌齐片或盐酸美金刚片或银杏叶提取物片或阴性对照)571例。Meta分析结果显示,与对照组相比,丁苯酞软胶囊治疗组在MMSE评分[MD=3.52,95%CI(2.59,4.46),P<0.01]、CDR评分[MD=-0.72,95%CI(-0.80,-0.65),P<0.01]和治疗有效率[RR=1.31,95%CI(1.20,1.43),P<0.01]方面,差异均有统计学意义,但两组在不良反应发生率方面差异无统计学意义。结论丁苯酞软胶囊单独使用治疗轻中重度VaD,具有改善认知功能和临床痴呆程度、提高治疗有效率的作用;其联合其它改善认知药物具有协同增效的作用,尚未发现其导致不良反应增加。但由于纳入研究质量较低,纳入受试者较少,临床实际疗效强度存疑,上述结论仍需更多高质量随机对照试验加以验证。

Objectives To systematically evaluate the efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia(VaD).Methods Databases including CNKI,WanFang Data,VIP,CBM,PubMed,EMbase,The Cochrane Library were electronically searched to collect randomized controlled trials of butylphthalide soft capsule in the treatment of vascular dementia published from September 2002 to July 2018.Two reviewers independently screened literature,extracted data and assessed risk of bias of included studies.Then,meta-analysis was performed using RevMan 5.3 software.Results A total of 15 studies involving 1149 patients were included.The butylphthalide soft capsule treatment group included 578 patients and the control group included 571 patients.The results of meta-analysis showed that compared with the control group(donepezil hydrochloride tablets or memantine hydrochloride tablets or EGb761 or negative control),the butylphthalide soft capsule treatment group improved the MMSE score of patients with VaD(MD=3.52,95%CI 2.59 to 4.46,P<0.01),CDR score(MD=-0.72,95%CI-0.80 to-0.65,P<0.01),and treatment efficiency(RR=1.31,95%CI 1.20 to 1.43,P<0.01).However,there was no statistical difference in the number of adverse reactions between the treatment and control groups.Conclusions Butylphthalide soft capsule can be used in the treatment of patients with mild to moderate VaD.It can improve the cognitive function,raking of clinical dementia,and increase the effect rate of treatment.It can also work in conjunction with other drugs that improve cognitive function and no increase in adverse reactions has been found.However,due to the low quality of the included studies and small sample size,the actual efficacy strength is uncertain and the above conclusions are still required to be verified by more high-quality randomized controlled trials.