Comprehensive Clinical Evaluation of Xueshuantong for Injection（Lyophilized） in Treatment of Acute Cerebral Infarction / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo systematically review the existing studies on Xueshuantong for injection（lyophilized） in the treatment of acute cerebral infarction（ACI）， and to clarify the clinical value of Xueshuantong for injection（lyophilized） through comprehensive clinical evaluation， so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection（lyophilized） in terms of safety， effectiveness， economy， innovation， suitability， accessibility， traditional Chinese medicine（TCM） characteristics（6+1 dimensions） and information service was comprehensively collected. Evidence-based medicine， questionnaire survey， health technology assessment， pharmacoeconomic evaluation and other research methods were used， and the multi-criteria decision analysis model was used to measure each dimension， in order to comprehensively evaluate the clinical value of Xueshuantong for injection（lyophilized）. ResultSpontaneous reporting system， Meta-analysis of adverse reactions， and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection（lyophilized） were rash， pruritus， chest tightness， headache， dizziness and other general adverse reactions， the incidence of serious adverse reactions was judged to be rare， the known risk was small， the evidence was sufficient， and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection（lyophilized） combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score， improving daily activity score and clinical efficacy， and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection（lyophilized） combined with conventional treatment was relatively economic compared with conventional treatment alone， with the total clinical effective rate as the effect parameter， but the incremental effect was not significant， the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease， the drug also had good clinical efficacy in central retinal vein occlusion， and had a wider range of indications and awarded 16 patents， and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements， and the suitability was evaluated as grade B. Xueshuantong for injection（lyophilized） had reasonable price， good affordability， certain prescription restrictions and general availability， the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM， no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection（lyophilized） showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions， the clinical comprehensive evaluation of Xueshuantong for injection（lyophilized） in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection（lyophilized） is good， and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.