Safety and efficacy of basic fibroblast growth factors for deep second–degree burn patients |
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| Institution: | 1. Daewoong Pharmaceutical Company HQ, Seoul, 06170, Republic of Korea;2. Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, 07247, Republic of Korea;3. College of Pharmacy, Sookmyung Women’s University, Seoul, 04310, Republic of Korea;4. College of Pharmacy, University of Texas at Austin, Austin, TX, 78712, United States;1. Department of Pharmaceutical Sciences, Beijing Institute of Radiation Medicine, Beijing 100850, China;2. Institute of Pharmacy, Shandong University of Traditional Chinese Medicine, Jinan 250355, China;3. Institute of Pharmacy, Anhui Medical University, Hefei 230032, China;4. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China;1. Department of Dermatology, Weill Cornell Medical College, New York, New York;2. Division of Biostatistics and Epidemiology, Weill Cornell Medical College, New York, New York;1. Yale Center for Asthma and Airways Disease, Yale School of Medicine, New Haven, CT 06520-8057, USA;2. Respiratory Therapeutic Area, GlaxoSmithKline (GSK), Research Triangle Park, NC, USA;3. Respiratory Medical Franchise, GlaxoSmithKline (GSK), Research Triangle Park, NC, USA;4. Clinical Statistics, GSK, Stockley Park, Middlesex, UK;5. Respiratory Therapy Area, GSK, Stockley Park, Middlesex, UK;6. Value Evidence and Outcomes, GSK, Collegeville, PA, USA;7. Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA;8. l''Institut du Thorax, Universite de Nantes, CHU de Nantes, Nantes, France;1. Division of Pulmonary, Allergy and Critical Care Medicine, Birmingham, AL 35294, USA;2. UAB Lung Health Center, University of Alabama at Birmingham, Birmingham, AL 35294, USA;1. Harvard Medical School, Combined Dermatology Residency Program, Boston, Massachusetts, USA;2. University of Massachusetts Medical School, Worcester, Massachusetts, USA;3. Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, USA;4. Harvard Medical School, Boston, Massachusetts, USA;1. Institute of Industrial Science, The University of Tokyo, 4-6-1 Komaba, Meguro-ku, Tokyo 153-8505, Japan;2. Department of Physics, Tokyo Gakugei University, 4-4-1 Nukuikitamachi, Koganei-shi, Tokyo 184-8501, Japan |
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| Abstract: | IntroductionBurn 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 methodsA total of 3173 patients treated at 15 hospitals were used for PMS of bFGF in South Korea for six years. In total, 1630 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.ResultsAEs 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 day to application (5.4 vs. 8.8 days) and re-epithelialization time (7.1 vs. 13.7 days).ConclusionOur 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. |
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| Keywords: | Basic fibroblast growth factor Second–degree burn Post-marketing surveillance Regenerative medicine Adverse event |
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