Evaluation of effectiveness and safety of polaprezinc as an adjuvant therapy in enhancing fracture healing in adults with closed fractures: a prospective study
摘要
Fracture healing is a complex biological process that can be delayed by systemic or local factors. Polaprezinc, a zinc–L-carnosine complex with antioxidant, anti-inflammatory, and regenerative properties, has shown promise in tissue repair, but its role in bone regeneration remains underexplored. To evaluate the effectiveness and safety of polaprezinc as an adjuvant therapy in enhancing fracture healing among adults with closed fractures. A prospective, single-center, controlled, non-randomized interventional study was conducted over a 3 months period at a tertiary care hospital in Hyderabad. A total of 100 adults (18–85 years) with radiologically confirmed closed fractures were assigned to two groups: an intervention group receiving standard orthopedic care plus oral polaprezinc (75 mg twice daily) and a control group receiving standard care alone. Clinical outcomes were assessed using the Visual Analogue Scale (VAS) for pain and weight-bearing ability, while radiological outcomes were measured using the Radiographic Healing Scale (RHS) and REBORNE Scale at 4, 8, and 12 weeks. Safety was monitored through laboratory tests and adverse event reporting. The polaprezinc group demonstrated significantly faster radiological union and stronger callus formation compared with controls (RHS and REBORNE scores, p < 0.05). Pain reduction was greater in the intervention group (VAS improvement: t = 5.696, p < 0.05). Mean fracture healing time was shortened by approximately one week. No serious adverse events were reported, and compliance was high. Polaprezinc as an adjunct to standard fracture care significantly improved radiological and clinical healing outcomes, reduced pain, and maintained an excellent safety profile. These findings support its potential as a safe and effective adjuvant in fracture management, warranting confirmation in larger multicenter trials.