Systemic enzyme therapy for postoperative inflammation and wound healing after orthopedic surgery: a randomized, placebo and active controlled clinical study

骨科手术后炎症和伤口愈合的全身酶疗法:一项随机、安慰剂和活性药物对照临床研究

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Abstract

This randomized, double-blind, placebo- and active-controlled clinical trial evaluated the efficacy and safety of EnMax tablets in managing postoperative inflammation and supporting wound healing following orthopedic surgery. A total of 105 patients were randomized to receive EnMax, a comparator enzyme formulation (trypsin-bromelain-rutoside), or placebo alongside standard care for 7 days. Baseline characteristics were statistically comparable across all groups. EnMax demonstrated significant clinical benefits, including substantial reductions in pain (93.10%), inflammation (89.77%), and key inflammatory biomarkers-C-reactive protein (CRP, 57% reduction) and erythrocyte sedimentation rate (ESR, 61.32% reduction) by the final visit. EnMax also outperformed both placebo and the comparator in reducing erythema, local irritation, discharge, and tenderness. Notably, EnMax patients required less analgesic use and reported no adverse events, with full study compliance. In contrast, the placebo group exhibited minimal improvement across all measured parameters. These results suggest that EnMax is a promising, safe, and effective therapeutic option for enhancing postoperative recovery. Additional larger, long-term studies are recommended to further establish its clinical benefits.

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