NanZhu Yang, AiChun Ju, Xin Li, XiangHua Yun
Department of Neurology, TianJin First Hospital.
The Second Hospital of Tianjin Medical University.
Medicine (Baltimore). 2018 Nov;97(47):e12374. doi: 10.1097/MD.0000000000012374.
To evaluate the effectiveness and safety of Salvianolate injection (SI) in the treatment of acute cerebral infarction (ACI).We electronically searched databases including PubMed, The Cochrane Library, EMBASE, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, and WanFang Data to collect randomized controlled trials (RCTs) focused on SI treating ACI up to August 2017. Two reviewers independently screened literatures, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software.A total of 39 RCTs involving 4516 patients were included. The results of meta-analysis showed that compared with the Western medicine (WM) therapies group [experimental group (EG)], the total effective rate of SI + WM [control group (CG)] was higher (relative risk = 1.29, 95% CI: 1.24-1.35, P < .00001) in 21 RCTs; SI could improve movement function evaluation scores, including National Institute of Health Stroke Scale, Barthel Index, activities of daily living (P < .00001). There was no significant difference in modified Rankin Scale scores between the 2 groups (P = .008) EG was better than CG in improving Montreal Cognitive Assessment scores (P = .001) and Mini-Mental State Examination scores (P < .00001). SI could improved not only the hemorheology indexes, including plasma viscosity, whole blood high-shear viscosity, whole blood low-shear viscosity, fibrinogen (P < .00001), but also high-sensitivity C-reactive protein and C-reactive protein. EG could achieve a better effect on improving the neural deficit scores (P < .00001). There was no significant difference about adverse drug reactions/adverse drug events between the EG and CG (P = .73).Salvianolate can promote recovery of the motor and cognitive function of patients with ACI. However, due to the limited quality and quantity of included studies, more high-quality studies are needed to verify the above conclusion.
评估丹参多酚酸盐注射液（SI）治疗急性脑梗死（ACI）的有效性和安全性。我们通过电子检索包括PubMed、Cochrane图书馆、EMBASE、中国生物医学文献数据库、中国知网和万方数据在内的数据库，收集截至2017年8月聚焦于SI治疗ACI的随机对照试验（RCT）。两名研究者独立筛选文献、提取数据并评估纳入研究的偏倚风险。然后，使用RevMan 5.3软件进行荟萃分析。
共纳入39项涉及4516例患者的RCT。荟萃分析结果显示，在21项RCT中，与西药（WM）治疗组[试验组（EG）]相比，SI+WM[对照组（CG）]的总有效率更高（相对危险度=1.29，95%可信区间：1.24-1.35，P<.00001）；SI可改善运动功能评估评分，包括美国国立卫生研究院卒中量表、巴氏指数、日常生活活动能力（P<.00001）。两组改良Rankin量表评分无显著差异（P=.008），EG在改善蒙特利尔认知评估评分（P=.001）和简易精神状态检查表评分（P<.00001）方面优于CG。SI不仅可改善血液流变学指标，包括血浆黏度、全血高切黏度、全血低切黏度、纤维蛋白原（P<.00001），还可改善高敏C反应蛋白和C反应蛋白。EG在改善神经功能缺损评分方面效果更好（P<.00001）。EG和CG之间药物不良反应/药物不良事件无显著差异（P=.73）。
丹参多酚酸盐可促进ACI患者运动和认知功能的恢复。然而，由于纳入研究的质量和数量有限，需要更多高质量研究来验证上述结论。
