Objective To systematically evaluate the efficacy and safety of Maixuekang Capsule (脉血康胶囊) in the treatment of acute cerebral infarction (ACI). Methods Randomized controlled trials (RCT) were retrieved from seven databases. The methodological quality of the included studies was evaluated by using the Cochrane 5.1.0 bias tool. Meta-analysis was performed to analyze the result indexes of clinical effective rate, neurological function score, fibrinogen (FIB), and adverse drug reaction using RevMan5.3 software. The evidence quality was evaluated according to the GRADE profile. Results A total of 19 articles were included. The results of Meta analysis showed that MXK + western medicine treatment (WMT) could significantly improve the clinical efficacy[RR_NIHSS=1.17, 95% CI[1.07, 1.28], P=0.000 8; RR_NDS=1.24, 95% CI[1.14, 1.34], P < 0.000 01; RR_{clinical symptoms}=1.55, 95%CI[1.20, 2.00], P=0.000 7], neurological function[MD_{severe stroke}=−6.24, 95%CI[−6.86, −5.62], P < 0.000 01; MD_{moderate stroke}=−1.97, 95% CI[−2.91, −1.03], P < 0.000 1; MD_NDS=−5.11, 95%CI[−7.36, −2.85], P < 0.000 01], and decrease plasma fibrinogen content[MD=−0.86, 95% CI[−1.13, −0.59], P < 0.000 01]. In terms of adverse reaction rate, there was no statistic difference between the combination of MXK + WMT and WMT[RR=0.58, 95% CI[0.29, 1.18], P=0.13]. MXK + arterial thrombolysis + WMT could improve the clinical efficacy evaluated by clinical nerve deficiency scale (NDS)[RR_NDS=1.30, 95% CI[1.14, 1.47], P < 0.000 1] and neurological function. In terms of improving the clinical efficacy evaluated by NIHSS and decreasing the plasma fibrinogen content and adverse reaction rate, there was no statistic difference between the combination of MXK + arterial thrombolysis + WMT and arterial thrombolysis + WMT[MD=−0.16, 95% CI[−0.33, −0.00], P=0.05; RR_NIHSS=1.15, 95% CI[0.97, 1.37], P=0.11]. MXK + rt-PA + WMT could improve neurological function and decrease plasma fibrinogen content with a statistically significant difference between the two groups (P < 0.05). Conclusion In treating ACI, MXK + WMT could improve the clinical efficiency, neurological function, plasma fibrinogen content decrease, and the adverse reaction rate was low. MXK + arterial thrombolysis + WMT could improve the clinical efficiency evaluated by NDS and neurological function. MXK + rt-PA + WMT could improve the neurological function and plasma fibrinogen content decrease. However, considering the limited quality of the literature included and low level of evidence in the study, more well-designed, high-quality and large-sample research are still needed to increase the level of evidence.

R285.64

国家重点研发计划（2018YFC1705001）