Evidence-based Evaluation Of Over-indications On Xingnaojing And Edaravone

Objective It will be conducted for the evidence-based evaluation of over-indications on xingnaojing injection and edaravone injection to identify their safety and efficacy in order to provide the basis for clinical rational drug use.Methods Through searching the Cochrane library, PubMed, EMbase, CNKI, CBM and Wanfang database, and collecting randomized controlled trials(RCTs) on xingnaojing injection in treatment of viral encephalitis, data of RCTs were extracted and evaluated by two reviewers independently, we conducted Meta analysis on efficacy and safety of xingnaojing injection in treatment of viral encephalitis using RevMan5.0 software. Using the same method to search the databases, we also collected RCTs on edaravone in the treatment of acute severe craniocerebral injury, and conducted evidence-based evaluation on efficacy and safety of edaravone in treatment of acute severe craniocerebral injury.Results Xingnaojing (XNJ) injection for viral encephalitis:Fourteen RCTs involving 1114 patients were included. The results of Meta-analyses showed the following:compared with control group, XNJ group improved cure rate significantly[children:OR=3.18,95%CI (2.28,4.44), P<0.01, adult:OR=3.26, 95%CI (1.29,8.23), P=0.01]; and shortened the time of fever fadeaway [MD=-1.97, 95%CI(-2.43,-1.51), P<0.01], headache disappearance [MD=-1.86,95%CI(-2.58,-1.14), P<0.01], stopping vomiting [MD=-0.76,95%CI (-1.08,-0.43), P<0.01], stopping convulsions [MD=-1.51,95%CI(-2.20,-0.82), P<0.01], consciousness disorders recovery [MD=-1.57,95%CI(-2.38,-0.76), P<0.01]; and all of differences were significant. There was no significant difference in incidence of adverse drug reaction(ADR) between XNJ group and control group[OR=0.86,95%CI (0.41,1.82), P=0.69].Edaravone for acute severe craniocerebral injury:Twenty-four RCTs involving 1909 patients were included. The results of Meta-analyses showed the following: edaravone group increased significantly Glasgow coma score(GCS) compared to the control group with statistical significance [MD=1.60,95%CI (1.04,2.17), P<0.01]; there were fewer patients of GCS<8 in edaravone group than the control group with statistical significance[OR=0.46,95%CI(0.31,0.68), P<0.01]; there was no difference in patients of GCS=9-12 between edaravone group and control group [OR=0.97,95%CI (0.67,1.39), P=0.85]; there were more patients of GCS=13-15 in edaravone group than the control group with statistical significance [OR=2.34, 95%CI(1.54,3.56), P<0.01]; edaravone increased Glasgow outcome score (GOS) compared to the control group with statistical significance [MD=0.80,95%CI (0.49, 1.10), P<0.01]; edaravone increased good recovery rate compared to the control group with statistical significance [OR=3.13,95%CI (2.27,4.31), P<0.01]; there was no significant difference in incidence of ADR between edaravone group and control group [OR=1.41,95%CI (0.79,2.50), P=0.24].Conclusion The existed evidence showed:Xingnaojing injection can significantly increase the cure rate of viral encephalitis patients, improve the patient’s clinical symptoms, and its safety is good; edaravone can significantly increase GCS, GOS and the good recovery rate in patients with acute severe brain injury, and its safety is good; Meta-analysis results of xingnaojing injection and edaravone injection provide new evidences for clinical treatment of viral encephalitis and acute severe traumatic brain injury. However, further clinical trials should be carried out to evaluate its long-term effectiveness.