清开灵注射液治疗急性缺血性中风的系统评价

Systemic Review of Qingkailing Injection of Treatment for Acute Ischemic Stroke

摘要:

目的：系统评价清开灵注射液治疗急性缺血性中风的临床疗效及安全性。方法：全面系统检索文献数据库中清开灵注射液治疗急性缺血性中风的随机对照试验，采用Cochrane风险评价表评价其研究质量，提取资料并通过RevMan5.2进行Meta分析。结果：共纳入8篇文献，共计受试者633例，仅1篇文献采用随机数字表法。Meta分析结果显示，清开灵注射液联合西医常规疗法治疗缺血性中风具有很好的疗效，可以提高总有效率[RR=1.28， 95%CI (1.18，1.39)， P<0.000 01]，降低死亡率[RR=0.32， 95%CI (0.11，0.91)， P=0.03]，降低神经功能缺损评分[MD=-5.61， 95%CI (-8.51，-2.72)， P=0.000 1，抑制肿瘤坏死因子（TNF-α）[MD=-5.56， 95%CI (-9.23，-1.90)， P=0.003]和白介素-6（IL-6）的产生，降低全血黏度[MD=-0.75， 95%CI (-1.47，-0.03)， P=0.04]，抑制血小板胞浆内-α颗粒膜上糖蛋白CD62P的表达[MD=-2.07， 95%CI (-2.53，-1.61)， P<0.000 01]等。有4篇研究表明确无不良反应，1篇研究报道了共8例不良事件，其中治疗组3例，无重大不良反应，其他文献均未对安全性做出说明。结论：临床治疗缺血性中风过程中，在常规治疗的基础上，加用清开灵注射液可以提高疗效，且较为安全，但仍需更多设计严谨的、大样本的随机双盲对照试验作进一步的评价。

Abstract:

Objective: To evaluate systematically the clinical efficacy and safety of Qingkailing injection (QKL) for treatment of acute ischemic stroke. Method: Randomized controlled trials (RCTs) about QKL for acute ischemic stroke were searched systemically and comprehensively. Two reviewers assessed the quality of the included studies by the Cochrane risk of bias, and extracted the information from the included studies independently. Meta-analysis was conducted with the software Review Manager 5.2.Result: A total of 8 studies with 633 participants were included, and the quality of the studies was relatively low, which only one study used the random number table to generate random sequence. Meta-analysis, the results of QKL group were significantly superior to the west conventional therapy group in the total effective rate [RR=1.28, 95%CI (1.18, 1.39), P<0.000 01], and the mortality rate [RR=0.32, 95%CI (0.11, 0.91), P=0.03], and the degree of neurological damage [MD=-5.61, 95%CI (-8.51,-2.72), P=0.000 1]. It also can inhibit the tumor factor (TNF-α) [MD=-5.56, 95%CI (-9.23,-1.90), P=0.003] and interleukin-6 (IL-6), decrease the index of viscosity of whole blood, suppress the expression of platelet cytosolic-alpha particle membrane glycoprotein CD62P [MD=-2.07, 95%CI (-2.53,-1.61), P<0.000 01], and so on. There were 4 studies mentioned clearly on adverse drug reactions (ADR), and 1 study reported 8 ADRS, 3 of which in the Cxperiment group. Conclusion: Comparing with the control group QKL combined with the conventional therapy was relatively effective and safe, which was based on the systematic review, and the more qualified RCTs are needed to make further study.