脑心通胶囊治疗短暂性缺血性脑发作的Meta分析

Meta-analysis of naoxintong capsules on transient ischemic attack

目的：采用Meta分析对步长脑心通胶囊治疗短暂性缺血性脑发作临床疗效和安全性进行评价。方法：计算机检索Pub Med、CENTRAL、EMbase、the ISI Web of Knowledge Databases、VIP、CNKI、CBM和Wangfangdate,查找所有步长脑心通胶囊治疗短暂性缺血性脑发作的随机对照试验（RCT）,检索时限均为建库至2015年4月31日。同时手检纳入文献的参考文献。按纳入排除标准由两人独立进行RCT的筛选、资料提取和质量评价后,采用Rev Man 5.1软件进行Meta分析。结果：共纳入18个RCT研究,2213例患者,疗效系统评价：①临床疗效改变12个试验的meta分析结果显示：脑心通组临床疗效改善明显优于对照组[M-H=5.70,95%CI（3.91,8.33）P〈0.00001];②血液流变学改变6-8个试验的meta分析结果显示：脑心通组改善血液流变学特征（全血高切粘度、全血低切粘度、血浆黏度）明显优于对照组[WMD=-1.08,95%CI（-1.57,-0.59）P〈0.0001]、[WMD=-1.17,95%CI（-1.93,-0.41）P=0.01]、[WMD=-0.27,95%CI（-0.46,-0.09）P=0.004]。2抗凝血改变2个试验的meta分析结果显示：脑心通组减低血小板粘附率、抑制血小板凝聚明显优于对照组[WMD=-5.93,95%CI（-8.01,-3.85）P〈0.00001。抗凝血作用中,5个试验的meta分析结果显示脑心通组减低纤维蛋白原明显优于对照组[WMD=-1.02,95%CI（-1.40,-0.64）P〈0.00001]。2个试验的meta分析结果显示：脑心通组减低血浆D-二聚体明显优于对照组[WMD=-0.03,95%CI（-0.06,-0.00）P=0.04]。③脑血流动力学变化2个试验的meta分析结果显示：脑心通组治疗2周后左椎动脉LVA平均峰流速度、右椎动脉RVA平均峰流速度、基底动脉BA平均峰流速度与对照组相比无显著性差异[WMD=2.83,95%CI（-1.31,6.97）P=0.18]、[WMD=2.64,95%CI（-2.59,7.86）P=0.32]、[WMD=5.46,95%CI（-2.72,13.63）P=0.19]。结论：步长脑心通胶囊治疗治疗短暂性缺血性脑发作可抑制血小板凝聚,抗凝血,改善血液流变学特征降低血黏度,优于常规治疗,但短期治疗对脑血流动力学的改善并不优于对照组。但因原始研究的质量均较低,建议临床上审慎选择使用;需要更多高质量、大样本的RCT进一步论证。

Objective： To objectively evaluate the efficacy buchang naoxintong capsules in treating transient ischemic attack（ TIA）. Methods：Such databases as Pub Med,Cochrane Central Register of Controlled Trials（ CENTRAL）,EMbase,the ISI Web of Knowledge databases,VIP,CNKI,CBM and Wanfang databases were searched from their stablishment to April 2015 for collecting the randomized controlled trials（ RCTs） about buchang naoxintong capsules for the treatment of transient ischemic attack,and the references of those RCTs were also searched by hand. After study selection,assessment and data extraction conducted by two reviewers independently,meta-analyses were performed by using the Rev Man 5. 1 software. Results： eighteen studies involving 2213 patients were included. The results of meta-analyses showed that： efficacy indicator： ① The change of clinical symptom： Meta-analysis of tweleve tests revealed that the group of naoxintong therapy combined with standard therapy is better than single standard drug therapy[M-H = 5. 70,95% CI（ 3. 91,8. 33） P〈 0. 00001]② The change of hemorrheology ： meta-analysis of eight tests revealed that the group of naoxintong therapy combined with standard therapy is better than single standard drug therapy： high shear viscosity of whole blood[WMD =-1. 08,95% CI（-1. 57,-0. 59） P〈 0. 0001],low shear viscosity of whole blood[WMD =-1. 17,95% CI（-1. 93,-0. 41） P = 0. 01]、plasma viscosity[WMD =-0. 27,95% CI（-0. 46,-0. 09） P = 0.004]. ③ Changes in coagulation： meta-analysis of five tests revealed that the group of naoxintong therapy combined with standard therapy is better than single standard drug therapy in platelet adhesion rate[WMD =-1. 02,95% CI（-1. 40,-0. 64） P 0. 00001],D-dimers[WMD =-0. 03,95% CI（-0. 06,-0. 00） P = 0. 04]. ④ The change of brain Hemodynamics Meta-analysis of two tests revealed that： There was no significant difference in left vertebral artery average peak flow velocity、right vertebral artery average peak flow velocity、Basilar artery average peak flow velocity between the group of naoxintong therapy combined with standard therapy and single standard drug therapy. [WMD = 2. 83,95% CI（-1. 31,6. 97） P = 0. 18],[WMD = 2. 64,95% CI（-2. 59,7. 86） P = 0. 32],[WMD = 5. 46,95% CI（-2. 72,13. 63） P = 0.19]. Conclusion： The therapeutic effect of buchang naoxintong capsules combined with standard therapy is better than single standard drug therapy in inhibition of platelet aggregation,anticoagulant,improvement of hemorrheology. Short-term treatment of naoxintong therapy combined with standard therapy is not superior to the control group in the change of brain Hemodynamics. A prudent choice is suggested; However,due to the small scale and low quality of included RCT,more high-quality,large-samplestudies are need.