J Tradit Chin Med. 2014 Apr;34(2):131-9. doi: 10.1016/s0254-6272(14)60066-2.
To evaluate systematically the clinical efficacy and safety of Qingkailing (QKL) injection in the treatment of acute stroke.
Searches for randomized controlled trials into acute stroke treated with QKL injection were performed in the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wan fang Database, Chinese Biomedical Literature Database, PubMed and Cochrane Library, from January 1979 to March 2013. Two reviewers independently retrieved the RCTs and extracted the information. The Cochrane risk of bias method was used to assess the quality of the included studies, and a Meta-analysis was conducted with Review Manager 5.2 software.
A total of 13 studies with 1110 participants were included. The quality of the studies was generally low. The Meta-analysis indicated that the combined use of QKL and Western Medicine was significantly superior to control group therapy in terms of the total effective rate. The relative risk (RR) in the acute cerebral hemorrhage (ACH) sub-group was 1.17 [95% confidence interval (CI) (1.08, 1.26), P = 0.0001]. In the acute cerebral infarction (ACI) sub-group, RR was 1.27 [95% CI (1.14, 1.42), P < 0.0001], and in the ACH and ACI mixed sub-group, RR was 1.34 [95% CI (1.20, 1.50), P < 0.00001]. Additionally, QKL promoted the absorption of hematoma [mean difference (MD) = - 3.73, 95% CL (- 4.48, - 2.98), P < 0.000 01], decreased neurological damage in ACI [MD = - 5.60, 95% CI (- 8.50, - 2.70), P = 0.0002] and ACH [MD = - 4.08, 95% CI (- 8.00, - 0.16), P = 0.04], promoted the recovery of awareness [RR = 1.56, 95% CI (1.09, 2.21), P = 0.01] and reduced the whole blood viscosity coefficient [MD = - 0.75, 95% CI (- 1.47, - 0.03), P = 0.04]. There were no adverse drug reactions reported in the included studies.
Based on this systematic review, QKL combined with conventional therapy was effective compared with control treatment. However, because the articles used in the study were not of high quality, further studies should be conducted into the efficacy and safety of QKL in treating acute stroke.
系统评价清开灵注射液治疗急性脑卒中的临床疗效和安全性。
计算机检索中国知网、维普中文科技期刊数据库、万方数据库、中国生物医学文献数据库、PubMed 及 Cochrane 图书馆，收集 1979 年 1 月至 2013 年 3 月间关于清开灵注射液治疗急性脑卒中的随机对照试验（RCT），由 2 名评价员独立筛选文献、提取资料并评价纳入研究的质量后，采用 RevMan 5.2 软件进行 Meta 分析。
共纳入 13 个研究，包括 1110 例患者。纳入研究的质量总体较低。Meta 分析结果显示，清开灵注射液联合西医常规治疗在总有效率方面优于西医常规治疗，差异有统计学意义[急性脑出血（acute cerebral hemorrhage，ACH）亚组：相对危险度（relative risk，RR）为 1.17，95%可信区间（confidence interval，CI）（1.08，1.26），P=0.0001；急性脑梗死（acute cerebral infarction，ACI）亚组：RR 为 1.27，95%CI（1.14，1.42），P<0.00001；ACH 和 ACI 混合亚组：RR 为 1.34，95%CI（1.20，1.50），P<0.00001]。此外，清开灵注射液可促进血肿吸收[平均差（mean difference，MD）=-3.73，95%CI（-4.48，-2.98），P<0.00001]、减轻 ACI 患者的神经功能损伤[MD=-5.60，95%CI（-8.50，-2.70），P=0.0002]和 ACH 患者的神经功能损伤[MD=-4.08，95%CI（-8.00，-0.16），P=0.04]、促进意识恢复[RR=1.56，95%CI（1.09，2.21），P=0.01]、降低全血黏度系数[MD=-0.75，95%CI（-1.47，-0.03），P=0.04]。纳入研究均未报告不良反应。
基于现有证据，清开灵注射液联合西医常规治疗与西医常规治疗比较，可能更有效，但由于纳入研究质量不高，尚需开展更多高质量研究进一步评价清开灵注射液治疗急性脑卒中的疗效和安全性。
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