脑心通治疗血管性痴呆效果的Meta分析

摘要

目的 评价脑心通与西药治疗血管性痴呆(VaD)患者的疗效.方法 计算机检索1990年至2011年11月30日间Sinomed,VIP,CNKI和WANFANG数据库中关于脑心通与西药比较治疗VaD的随机对照试验,同时手检纳入研究的参考文献.由2名评价者独立进行文献质量评价和资料提取后,采用RevMan 5.1软件进行Meta分析.结果 共纳入8个研究的536例患者.结果 显示,与西药组相比,脑心通能够:①显著改善痴呆临床疗效总有效率,差异有统计学意义(RR=1.25,95%CI:1.12～1.40,P＜0.01);②能够提高中医证侯疗效总有效率,但差异无统计学意义(RR=1.23,95%CI:0.95～1.60,P=0.11);③能够提高简易智能量表(MMSE)评分,差异有统计学意义(MD=1.70,95%CI:1.17～2.23,P＜0.01);④能够提高长谷川痴呆量表(HDS)评分,差异有统计学意义(SMD=0.61,95%CI:0.41～0.82,P＜0.01);⑤能够降低日常生活活动量表(ADL)评分,但差异无统计学意义(MD=-1.87,95%CI:-4.81～1.07,P=0.21);⑥能够降低不良反应发生率,但差异无统计学意义(RR=0.75,95%CI:0.38～1.50,P=0.42).结论 脑心通是治疗血管性痴呆安全有效的中成药物,其疗效优于西药.但鉴于纳入研究的局限性,建议按照CONSORTS标准设计高质量、大样本的随机盲法对照试验对其有效性及安全性进一步评价.%Objective To review the curative effects of Naoxintong Capsules and Western medications on vascular dementia ( VaD ). Methods The literature of randomized and controlled trials ( RCT ) about compared treatment of VaD with Naoxintong Capsules and Western medications were retrieved from Sinomed, VIP, CNKI and WANFANG from 1990 to Nov. 30,2011 ,and at the same time the reference document were manually retrieved. After the quality of literature was reviewed and materials were extracted by 2 independent reviewers, all data was given Meta analysis by u-sing RevMan 5. 1 software. Results There were 8 RCT enclosed involving 536 patients. Compared with Western medications , Naoxintong Capsules ①increased significantly the total effective rate in clinical curative effect and difference was statistically significant (RR = l. 25,95% CI-A. 12 ~ 1. 40,P <0. 01 );②increased the total effective rate in curative effect on TCM syndromes but difference was not statistically significant ( RR = 1. 23 ,95% CI:0. 95 ~ 1. 60,P = 0.11); ③increased MMSE scores and difference was statistically significant ( MD = 1. 70,95% CI: 1. 17 ~ 2. 23 , P < 0.01);④increased HDS scores and difference was statistically significant ( SMD =0.61,95% CI:0. 41 ~ 0. 82, P < 0. 01 ) ;⑤decreased ADL scores but difference was not statistically significant ( MD = - 1. 87,95% CI: -4. 81 ~ 1.07, P =0. 21 );and ⑥decreased occurrence rate of adverse reactions by but difference was not statistically significant ( RR = 0. 75,95% CI-.0. 38 ~ 1.50,P =0. 42 ). Conclusion Naoxintong Capsules is a safe and effective Chinese patent medicine for treating VaD and its curative effect is better than that of Western medications. As the limitation of the RCT in this study,high-quality and large-sample randomized,blinding and controlled trials designed according to CONSORTS are required to prove and review its effect further.