Abstract: Objective To observe the clinical efficacy and safety of local injection of platelet-rich plasma （PRP） combined with Jiegumukang decoction in the treatment of distal tibial nonunion. Methods Eighty patients diagnosed with distal tibial nonunion admitted between January 2025 and January 2026 were enrolled and randomly assigned into a control group and an observation group, with 40 cases in each group. The control group received local PRP injection alone at the fractured bone ends once every four weeks for a 12-week treatment course. On the basis of identical PRP intervention administered to the control group, the observation group additionally took the syndrome-differentiated and modified Jiegumukang decoction orally, one dose per day for 12 consecutive weeks. The visual analogue scale （VAS） scores for pain recorded at baseline as well as week 4, week 8, and week 12 after treatment, the Lane-Sandhu radiographic bone-healing scores and American Orthopaedic Foot and Ankle Society （AOFAS） ankle-function scores before and after intervention, the overall effective rate at week 12 and the incidence of adverse reactions were compared between the two groups. Results Baseline VAS, Lane-Sandhu, and AOFAS scores exhibited no statistically significant inter-group differences before treatment （P>0.05）. VAS scores dropped markedly in both groups at 4, 8, and 12 weeks follow-ups relative to their respective baseline values, and scores in the observation group were significantly lower than those in the control group at all matched time-points （P<0.05）. After the 12-week therapy, Lane-Sandhu and AOFAS scores rose in both groups, with greater improvements detected within the observation group （P<0.05）. The overall effective rate reached 80.00% for the control group versus 95.00% for the observation group; the difference was significant （χ²=4.114, P=0.043）. The adverse reaction incidence stood at 5.00% in both groups （P>0.05）. Conclusion The combined regimen of orally administered syndrome-adapted Jiegumukang decoction and local PRP injection can effectively alleviate pain, stimulate callus formation, accelerate fracture repair, and restore ankle mobility among patients suffering from distal tibial nonunion. This combined therapy yields superior clinical outcomes to local PRP injection alone while maintaining favourable medication safety, and therefore merits widespread clinical promotion.

Key words: Distal tibial nonunion, Jiegumukang decoction, Platelet-rich plasma, Integrated traditional Chinese and Western medicine, Fracture healing