Efficacy, Safety And Economy Evaluation Of Shuxuetong Injection In Treatment Of Cerebral Infarction

ObjectivesTo assess the efficacy, safety and economy of shuxuetong for cerebral infarctioncompared with open control or placebo. Through this study，it could provide evidence forclinical use of shuxuetong injection, selection and adjustment of drug list.MethodsRandomized controlled trails （RCTs） or quasi-randomized control trials onshuxuetong injection in the treatment of cerebral infarction were retrieved from theCochrane Library, PubMed, CBMdisc, CNKI, VIP and Wanfang database. Methodologicalquality evaluation was assessed by using risk of bias assessment tool. We conductedmeta-analysis to analyze the efficacy shuxuetong with the software RevMan5.0. Systematicreview method and cost-effectiveness analysis method were used to evaluate the adverseeffect and economy of shuxuetong injection respectively. We evaluated evidence quality degreeand strength of evidence recommendation by referring to GRADE system．Results1. This study included18randomized controlled trails, involving1962patients.18articles described total effective rate. The number of articles describing the neurologicaldeficit score, blood rheology indicators and adverse drug reaction was10,10and17respectively.2.Efficacy evaluation：The results of meta-analysis revealed that the difference of total effective rate (RR=1.17,95%CI:1.13to1.22, P<0.00001) and improvement of theneurological deficit (WMD=-2.44,95%CI:-4.22to-0.65, P=0.007) between shuxuetonginjection and control groups were statistically significant. Shuxuetong injection was betterthan the control groups in improving the low shear rate (WMD=-2.09,95%CI：-3.28to-0.91, P=0.0006) and high shear rate (WMD=-0.60,95%CI:-1.16to-0.04, P=0.04)ofwhole blood viscosity, erythrocyte aggregation index (WMD=-0.35,95%CI:-0.64to-0.05,P=0.02), plasma viscosity(WMD=-0.23,95%CI:-0.33to-0.13, P<0.00001) and plasmafibrinogen(WMD=-0.78,95%CI:-1.24to-0.32, P=0.0009), but hematocrit (WMD=0.32,95%CI:-3.46to4.09, P=0.87) had no statistical significance.3. Safety evaluation: The number of adverse drug reaction of shuxuetong injectionreported was small, and it was mainly allergic reaction and the symptom was not serious.4. Pharmacoeconomic evaluation was conducted among four drug treatment schedules,cost-effectiveness analysis results revealed that drug cost of shuxuetong injection was high,but its treatment effect of cerebral infarction was significantly better than drugs in thecontrol groups.5. In this study, we establish evidence-based evaluation system for the selection andadjustment of drug list initailly. Based on GRADE, the evidence quality degree of efficacyindicators was low or moderate, and the strength of evidence recommendation was weak．ConclusionsCurrent clinical evidences show that, compared with control groups, shuxuetonginjection is an effective, safe and economy drug schedule in treating patients with cerebralinfarction. Due to the low quality among the included studies, more high quality clinicaltrials are required.Innovation and drawbacks 1. The innovation point of this study was to conduct evidence-based evaluation ofshuxuetong injection in treatment of cerebral infarction by using the risk of bias assessmenttool, GRADE standard and cost-effectiveness analysis method, etc. Through this study，itcould provide a quick, convenient, standardized, strong operability evaluation method forselection and adjustment of drug list, and guide drug decision by relying on expert’sexperience to rely on evidence-based evidence.2. The shortcomings of this study included:(1) The methodological quality of theliteratures included was low and had an influence on the result credibility and strength ofevidence;(2)Due to methodological limitations and the heterogeneity, evidence quality ofshuxuetong injection was relatively low;(3) We did not judge publication bias of someindicators for the number of their literatures did not meet the requirements;(4) Quantitativeanalysis for safety of shuxuetong injection was not conducted for lack of detailedinformation of adverse reactions;(5) Pharmacoeconomic evaluation of to the shuxuetonginjection lacked original cost data, which will have a certain influence on analysis result.