Clinical Comprehensive Evaluation of Propofol in Gastroscopy/Colonoscopy
Objective:To evaluate the safety,efficacy,economy,innovation,appropriateness and accessibility of domestic propofol injection in order to provide evidence for the selection of anesthetic induction agents for clinical endoscopy.Methods:Literature survey and questionnaire investigation were used to construct clinical comprehensive evaluation index system for propofol.Systematic literature review,Meta-analysis,real-world studies and other relevant data analysis methods were used to qualitatively and quantitatively compare the investigational drug (domestic/generic:Dishile) and the reference listed drug (imported/originator:Jingan).Results:In terms of safety,Meta-analysis showed that there was no statistically significant difference in the changes of vital signs between the two groups before and after anesthesia (P>0.05).The results of the real-world study showed that the incidence of hypotension and injection pain in the study group was lower than that in the control group (P<0.05).In terms of efficacy,Meta-analysis showed that there was no statistically significant difference in anesthesia induction time and recovery time between the two groups (P>0.05).The results of the real-world study showed that the patients in the study group had shorter awakening time and higher endoscopist satisfaction (P<0.05).In terms of economy,the cost of the investigational product was lower than that of the reference listed drug.In terms of innovation,the investigational product is innovative in dosage form.In terms of appropriateness,the preparation process and excipient selection of the investigational product were appropriate,but while its shelf life was less appropriate than the reference listed drug.In terms of accessibility,the investigational product has an available policy advantage,but a lower market share than the reference listed drug.Conclusion:The domestic varieties of propofol injection have good performance in the four dimensions of safety,effectiveness,economy and innovation,but is less appropriate in terms of shelf life and less market share than the reference listed drug.The clinical comprehensive value of the domestic propofol injection is higher,which can provide reference for the selection of drug list in medical institutions and the improvement of national drug policy.
propofolgastroscopy/colonoscopyclinical comprehensive evaluationliterature researchMeta analysisreal-world research
万方数据
维普
