Safety and efficacy of basic fibroblast growth factors for deep second–degree burn patients
| Autor: | Eun Jeong Cho, Wook Chun, Hee-sung Kang, Mi-hee Park, Su-jung Park, Hye-na Ahn |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Application site pain Adolescent Basic fibroblast growth factor Postmarketing surveillance Critical Care and Intensive Care Medicine Fibroblast growth factor 030207 dermatology & venereal diseases 03 medical and health sciences chemistry.chemical_compound Wound care 0302 clinical medicine Re-Epithelialization Republic of Korea Humans Second-Degree Burn Medicine Child Adverse effect Aged Wound Healing business.industry 030208 emergency & critical care medicine General Medicine Middle Aged Fibroblast Growth Factors Treatment Outcome chemistry Anesthesia Emergency Medicine Female Surgery Patient Safety Burns business Medical costs |
| Zdroj: | Burns. 46:1857-1866 |
| ISSN: | 0305-4179 |
| DOI: | 10.1016/j.burns.2020.06.019 |
| Popis: | Introduction Burn injuries are common afflictions; however, conservative wound care frequently leads to poor treatment compliance and physical disability in deep burn patients. Therefore, regenerative biologic materials, which are more effective for tissue repair, are required, particularly for deep second-degree burns. A novel spray formulation of basic fibroblast growth factors (bFGF) was produced by synthesizing fibroblast growth factor proteins. In this post-marketing surveillance (PMS) study, we assessed the safety and efficacy of bFGF and indirectly compared this formulation with cultured epidermal autografts (CEAs) for treating deep second-degree burns. Materials and methods A total of 3173 patients treated at 15 hospitals were used for PMS of bFGF in South Korea for six years. In total, 1635 patients with deep second–degree burns were selected for assessing adverse events (AEs) of bFGF treatments. Efficacy was evaluated according to time periods until re-epithelialization, and clinical usefulness of bFGF was indirectly compared with that of CEAs. Results AEs occurred in 37 patients (2.3%) and included application site pain (1.7%) and contact dermatitis (0.6%). All AEs were mild and were evaluated as probably unrelated with bFGF. The average time for re-epithelialization was 8 days; this time span was significantly longer after major burns (9.7 days) than after minor (7.8 days) or moderate burns (7.9 days). Most treated burn wounds (99.8%) were assessed as improved. The indirect comparison included 534 patients using the same inclusion criteria for CEA patients (n = 35). The bFGF treatment demonstrated superior efficacy compared to CEAs by significantly reducing the average post-burn day of application time (5.4 vs. 8.8 days) and re-epithelialization time (7.1 vs. 13.7 days). Conclusion Our study demonstrated that bFGF is a compelling regenerative therapy with competitive clinical efficacy and safety for deep second–degree burns and reduced treatment time, which is expected to reduce medical costs, particularly for deep second–degree burn patients. |
| Databáze: | OpenAIRE |
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