Objective  To evaluate the effectiveness, safety and economy of the clinical application of levetiracetam (LEV) concentrated solution for injection generic drug and the original drug in the national centralized volume-based procurement.

Methods  The information of inpatients using original LEV concentrated solution for injection in the Xuanwu Hospital of Capital Medical University (original drug group) and inpatients using generic LEV concentrated solution for injection in the First Affiliated Hospital of Wannan Medical College (generic drug group) was retrospectively analyzed after the implementation of the procurement policy (from November 2021 to March 2022). To compare the effectiveness, safety and economy of the two in the prevention and treatment of epilepsy.

Results  In the original drug group and the generic drug group, 18 and 17 patients were enrolled in the treatment of epilepsy respectively, the effective rates were 50.00% and 58.82%, the incidence of adverse reactions were both 0%, and the median daily cost was 255.00 (255.00, 510.00) yuan and 131.78 (131.78, 131.78) yuan. After propensity score matching, both the original drug group and the generic drug group had 76 patients each received preventive medication, the effective rates were 97.37% and 100% (P>0.05), and the incidence of adverse reactions were both 0%. The median daily fee for the original the generic drug group was 170.00 (170.00, 170.00) yuan and 131.78 (131.78, 131.78) yuan, there were significant difference (P<0.01).

Conclusion  The clinical effect of generic and original LEV concentrated solution for injection in preventing epilepsy is basically the same, the clinical safety are equivalent, the generic has better economy than the original. The effective rate of the treatment of epilepsy is similar, while the sample size needs to be further expanded to verify the results.

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