摘要
目的对清开灵注射液治疗急性中风临床疗效及安全性进行系统评价。方法全面检索中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方数据知识服务平台、维普期刊资源整合服务平台(VIP)、Corchrane Library、Pub Med。选取临床随机对照试验,对符合入选标准者,采用Cochrane风险评价表评价偏倚风险,提取资料,采用Rev Man5.3进行Meta分析。结果最终纳入18项临床研究,其中脑出血11项,脑缺血7项,总病例数1722例。分析结果显示,清开灵组治疗急性中风与对照组相较,有效率[RR:1.22,95%CI(1.16,1.29)P<0.00001];死亡率[RD:-0.08,95%CI(-0.17,0.01),P=0.05]。以痰热型中风为研究对象者,其有效率与非辨证研究有效率无显著差异。神经功能缺损评分减少程度[MD:4.07,95%CI(2.02,6.12)];颅内血肿吸收程度[MD=4.62,95%CI(-3.02,12.26),P=0.24]。血清肿瘤坏死因子-α(TNF-α)水平降低情况[MD:6.86,95%CI(2.93,10.79),P=0.0006]。血清白介素-6(IL-6)减少情况:[MD:96.54,95%CI(-80.65,273.73),P=0.29]。全血黏度降低程度[MD:0.50,95%CI(0.18,0.81),P=0.002]。有1篇文献报道了不良事件,无严重不良反应,4篇文献明确说明无不良反应,余文献未作说明。结论治疗急性中风不论出血性或缺血性,痰热型或非痰热型,在常规治疗基础上加用清开灵都能提高有效率,并在促进血肿吸收、降低炎症因子TNF-α、降低全血黏度方面有一定优势。但由于所纳入研究文献质量偏低,有待高质量、大样本、随机双盲临床试验提供证据,以进一步验证。
Objective： To systematically review the clinical effects and safety of Qingkailing Injection for the treatment of acute stroke. Methods： CBM,CNKI,and Wanfang Database,VIP,Corchrane Library,Pubmed and other databases were retrieved for randomized controlled trials. Risk of bias was assessed with Cochrane. Data is extracted and Meta-analyzed with Rev Man5.3. Results：18 RCTs（1722 patients） were included,including 11 studies of cerebral hemorrhage and 7 cerebral ischemia. With meta-analysis,the results of Qingkailing Injection group,compared with the control group,were as follows： the effective rate [RR：1.22,95% CI（1.16,1.29）,P 0.00001],the mortality [RD：-0.08,95%CI（-0.17,0.01）,P = 0.05],the degree of reduction of neurological function score [MD：4.07,95% CI（2.02,6.12）],the degree of the hematoma absorption [MD =4.62,95% CI（-3.02,12.26）,P = 0.24],the decrease of TNF-αin serum：[MD：6.86,95%CI（2.93,10.79）,P = 0.0006];the reduction of IL-6： [MD：96.54,95%CI（-80.65,273.73）,P = 0.29],and the whole blood viscosity： [MD：0.50,95% CI（0.18,0.81）,P = 0.002]. There was one study reported adverse events,no serious adverse reactions. There were four documents clearly stating no adverse reactions. Conclusion： For the treatment of acute stroke,whether hemorrhage or ischemia,phlegm-heat type or non-syndrome differentiation,Qingkailing Injection combined with the west conventional therapy can improve efficiency and is safe compared with the control group,but yet high-quality RCTs are needed for further verification.
出处
《中国中医急症》
2016年第5期772-776,857,共6页
Journal of Emergency in Traditional Chinese Medicine
基金
国家自然科学基金项目(539/02432)
关键词
清开灵注射液
急性中风
脑出血
脑缺血
系统评价
META分析
Qingkailing Injection
Acute stroke
Cerebral hemorrhage
Cerebral ischemia
System review
Meta-analysis
