ABSTRACT
This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the "6+1" dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0. After entering the market, Ginkgolide Injection has been subjected to phase Ⅳ clinical trial, spontaneous reporting system(SRS)-based data monitoring, systematic review and Meta-analysis, acute toxicity and long-term toxicity assays, active monitoring, and RCTs, and the evidence of safety was sufficient. The results of active monitoring showed that the incidence of adverse reactions was 0.09%(rare), mainly manifested as flushing, dizziness, rash, nausea, and vomiting. According to the nested case-control study, the adverse reactions of this drug had nothing to do with the product batch, implying that the drug quality was controllable. The adverse reactions mainly resulted from the pharmacodynamic reactions. Because the drug was effective in resisting platelet aggregation, the resulting adverse reactions such as flushing, dizziness, headache, and phlebitis were caused by vasodilation. Skin rash and gastrointestinal symptoms were mainly attributed to the patients' sensitivity to drugs and their own allergic constitution. According to the sufficiency of evidence and the incidence of adverse reactions in the safety research, the safety of Ginkgolide Injection was grade A. The results of Meta-analysis showed that Ginkgolide Injection combined with conventional western medicine was superior to conventional western medicine in improving the clinical effective rate, neurological function score, and activity of daily living score of patients with cerebral infarction. The validity evidence was evaluated according to the PICO principle to be high. According to the GREAD evaluation principle, the quality of such evidence as clinical effective rate, National Institute of Health stroke scale(NIHSS), and Barthel Index(BI) was evaluated, and the results demonstrated that the evidence quality of clinical effective rate and activity of daily living score was medium. The effectiveness of Ginkgolide Injection was grade A. According to the economic report of Ginkgolide Injection, it had short-term and long-term pharmacoeconomic advantages in the treatment of ischemic stroke, and the economic evidence value was good. According to the CASP economic evaluation checklist, the overall quality evaluation results of the economic report are basically clear. To be specific, the economic evidence quality was high. Based on the comprehensive economic evidence quality and economic value, the economy of this drug was grade A. The innovation of this product was evaluated from three aspects: clinical innovation, enterprise service system innovation, and industrial innovation. Ginkgolide Injection could be used 24 h after intravenous thrombolysis for improving patients' neurological function without increasing bleeding, indicating its important clinical innovation. There were many innovations in ensuring drug supply, especially at the grass roots, drug safety, effectiveness, and reasonable price, which has provided reference for establishing enterprise philosophy, managing drug resources, developing process and technology, and determining enterprise management and marketing. Therefore, its innovation was grade A. The drug had no special medication plan in use, exhibiting good suitability for doctors, nurses, and patients. The suitability was grade B. Compared with similar drugs, its price was at a medium level, meaning good affordability, sufficient production capacity, and easy accessibility. Its accessibility was therefore grade B. This drug belonged to Chinese medicinal injection. The large-sample real-world research revealed rich human use experience, so it was grade C for the traditional Chinese medicine characteristic. According to the comprehensive evaluation, the clinical value of Ginkgolide Injection in the treatment of cerebral infarction fell into class A. It is suggested that it can be transformed into the relevant policy results of basic clinical medication management according to the procedure.
Subject(s)
Humans , Case-Control Studies , Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Ginkgolides/therapeutic use , Medicine, Chinese TraditionalABSTRACT
OBJECTIVE：To eval uate therapeutic effic acy，safety and economical efficiency of Ginkgolide injection versus Butylphthalide injection in the treatment of ischemic stroke. METHODS ：Among the GISAA of Ginkgolide injection in the treatment of ischemic stroke of large-artery atherosclerosis ，106 patients who were given Ginkgolide injection+Asprin enteric-coated tablets but did not use butylphthalide in any dosage in previous trial group were selected as ginkgolide group ；56 patients who were given Butylphthalide injection+Ginkgolide injection+Asprin enteric-coated tablets in previous placebo group were selected as control group. The effects ，safety and economical efficiency were compared between 2 groups. Effect indexes included recurrence rate ， mortality，NIHSS score ，modified Rankin score （mRS），Barthel index and comprehensive efficacy. The safety indexes included incidence of bleeding event and adverse event during treatment. Cost-minimization analysis was used for economic evaluation. RESULTS：There was no statistical difference in recurrence rate ，mortality，NIHSS score ，the proportion of subjects with mRS 0-2，Barthel index ，comprehensive efficacy and the incidence of adverse event between 2 groups on 28th day after treatment （P＞ 0.05）. NIHSS score of ginkgolide group was better than that of control group on 7th and 14th day （P＜0.05）. Results of cost-minimization analysis showed that total cost of ginkgdide group was （13 768.19±4 981.54）yuan on 14th day of treatment ， which was significantly lower than （22 578.52±7 523.23）yuan of control group （P＜0.01）. The results of sensivity analysis indicated that the minimum lost analysis was stable. CONCLUSIONS ：For the treatment of ischemic stroke ，ginkgolide+aspirin is similar to butylphthalide+aspirin in improving clinical outcome and safety of 28 days，but is better than it in short-term efficacy of improving neurological deficit ， and better short-term economical efficiency.
ABSTRACT
Objective To evaluate the effect and mechanism of ginkgolide injection combined with edaravone on acute cerebral infarction.Methods 120 acute cerebral infarction patients were divided into observation group and control group,60 cases in each group.The control group was treated with edaravone,and the observation group was treated with ginkgolide injection combined with edaravone.The neuron specific enolase (NSE),S100β,tumor necrosis factor-α (TNF-α),interleukin-6 (IL-6),C reactive protein (CRP),National Institutes of Health stroke scale(NIHSS) and clinical efficacy were compared between the two groups.Results After treatment,the levels of NSE,S100β,CRP,IL-6 and TNF-α of the observation group were (7.1 ± 1.5) μg/L,(0.2 ±0.1) μg/L,(14.5 ± 3.7) mg/L,(20.9 ± 5.3) ng/L and (11.2 ± 3.0)μg/L,respectively,which of the control group were (8.9 ± 2.0) μg/L,(0.4 ± 0.2) μg/L,(21.3 ± 4.2) mg/L,(29.7 ± 3.2) ng/L and (18.8 ± 3.6) μg/L,respectively,those of the observation group were significantly lower than comrol group (t =2.898,2.894,3.012,2.998,3.025,all P ＜0.05).After treatment for 7d and 14d,the NIHSS scores of the observation group were (11.8 ± 3.0) points and (7.3 ±2.2) points,respectively,which of the control group were (15.2 ± 3.9) points and (10.5 ± 3.0) points,respectively,the observation group were significantly lower than control group(t =2.984,3.037,all P ＜ 0.05).The clinical efficacy of the observation group was significantly better than that of the control group (83.3 ％ vs.61.7％) (x2 =7.064,P ＜0.05).Conclusion Ginkgolide injection combined with edaravone in the treatment of acute cerebral infarction caninhibit inflammation reaction,alleviate nerve function damage,its effect is better than edaravone.