Real-World Study on the Clinical Efficacy Comparison Between Bid-Winning Generic and Original Drugs of Bortezomib in the Centralized Procurement
Objective:The paper evaluates the difference in clinical efficacy between the bid-winning generic and original drugs in the centralized procurement of Bortezomib for the treatment of first-visit multiple myeloma based on multicenter real-world data.Methods:Data of patients treated with Bortezomib in the electronic medical record system of five hospitals in Shanghai from January 2017 to June 2024 were collected retrospectively.The first-visit patients were screened out and divided into the generic and original groups according to different medications.Patients'baseline data of the two groups were corrected by the propensity score matching method.The direct and indirect indexes of therapeutic effect,adverse reactions and residents'affordability were compared between the two groups.Results:There were 215 patients in both the generic and original groups,screened by 1:1 matching of baseline data.There was no significant difference between the two groups after 4 courses of Bortezomib-containing therapy(P>0.05).There was no significant difference in the changes of M protein,plasma cell ratio of myeloma,β2-microglobulin,creatinine,calcium and sFLC-λ between the two groups.The original group had an advantage in protecting renal function(P<0.05),and the centralized procurement group had an advantage in controlling LDH increase(P<0.05).In terms of safety,there was no significant difference in the incidence of lethargy,pain,peripheral neuropathy,rash and allergy between the two groups(P>0.05).However,the incidence of fatigue was higher in the original group(P<0.05).The generic drugs were more affordable.Conclusion:The overall effectiveness and safety of selected drugs in the centralized procurement of Bortezomib are not inferior to the original drugs,and some indicators have their own advantages.
Bortezomibmultiple myelomacentralized drug procurementgeneric drugoriginal drugreal-world study
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