Efficacy, Safety, and Economic Evaluation of Originator Versus Generic Moxifloxacin Hydrochloride Injection in the Treatment of Community-Acquired Pneumonia Under China's National Centralized Drug Procurement Policy: A Retrospective Study
Abstract
PURPOSE
To investigate the efficacy, safety and economic outcomes of moxifloxacin hydrochloride injection in the treatment of community-acquired pneumonia (CAP) under the centralized volume-based procurement policy, and to provide a basis for its rational clinical application.
METHODS
Inpatients with CAP who received moxifloxacin hydrochloride injection as initial therapy across 4 tertiary hospitals from January 2019 to March 2024 were retrospectively enrolled and divided into the originator group (Group A) and the NCDP-selected generic group (Group B) based on the drug source. Inverse probability of treatment weighting (IPTW) was applied to balance baseline confounding factors. Efficacy was evaluated by comparing primary and secondary outcomes such as the clinical efficacy and microbial clearance rates; for missing data regarding efficacy outcomes, complete-case analysis and baseline observation carried forward (BOCF) were adopted for sensitivity testing. Concurrently, exploratory subgroup analyses based on different treatment regimens and the concurrent-use period were conducted to evaluate the stability of moxifloxacin's efficacy and control for potential temporal confounding. Safety was assessed based on the incidence of total and specific adverse reactions. Economic evaluation utilized a cost-consequences analysis (CCA), and the robustness of the conclusions was assessed through sensitivity analyses (including a generalized linear model and bootstrap resampling).…
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