PMID- 33054995
OWN - NLM
STAT- MEDLINE
DCOM- 20211101
LR  - 20211101
IS  - 1879-1409 (Electronic)
IS  - 0305-4179 (Linking)
VI  - 46
IP  - 8
DP  - 2020 Dec
TI  - Safety and efficacy of basic fibroblast growth factors for deep second-degree 
      burn patients.
PG  - 1857-1866
LID - S0305-4179(20)30440-X [pii]
LID - 10.1016/j.burns.2020.06.019 [doi]
AB  - 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, 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. 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 day to application (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.
CI  - Copyright (c) 2020 Elsevier Ltd and ISBI. All rights reserved.
FAU - Ahn, Hye-Na
AU  - Ahn HN
AD  - Daewoong Pharmaceutical Company HQ, Seoul, 06170, Republic of Korea.
FAU - Kang, Hee-Sung
AU  - Kang HS
AD  - Daewoong Pharmaceutical Company HQ, Seoul, 06170, Republic of Korea.
FAU - Park, Su-Jung
AU  - Park SJ
AD  - Daewoong Pharmaceutical Company HQ, Seoul, 06170, Republic of Korea.
FAU - Park, Mi-Hee
AU  - Park MH
AD  - Daewoong Pharmaceutical Company HQ, Seoul, 06170, Republic of Korea.
FAU - Chun, Wook
AU  - Chun W
AD  - Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym 
      University Medical Center, Seoul, 07247, Republic of Korea.
FAU - Cho, Eun
AU  - Cho E
AD  - College of Pharmacy, Sookmyung Women's University, Seoul, 04310, Republic of 
      Korea; College of Pharmacy, University of Texas at Austin, Austin, TX, 78712, 
      United States. Electronic address: eun-cho@sookmyung.ac.kr.
LA  - eng
PT  - Journal Article
DEP - 20200626
PL  - Netherlands
TA  - Burns
JT  - Burns : journal of the International Society for Burn Injuries
JID - 8913178
RN  - 62031-54-3 (Fibroblast Growth Factors)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Burns/classification/*drug therapy
MH  - Child
MH  - Female
MH  - Fibroblast Growth Factors/administration & dosage/*pharmacology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Safety/*standards/statistics & numerical data
MH  - Re-Epithelialization/drug effects
MH  - Republic of Korea
MH  - *Treatment Outcome
MH  - Wound Healing/drug effects
OTO - NOTNLM
OT  - Adverse event
OT  - Basic fibroblast growth factor
OT  - Post-marketing surveillance
OT  - Regenerative medicine
OT  - Second-degree burn
EDAT- 2020/10/16 06:00
MHDA- 2021/11/03 06:00
CRDT- 2020/10/15 17:11
PHST- 2020/03/27 00:00 [received]
PHST- 2020/06/12 00:00 [revised]
PHST- 2020/06/13 00:00 [accepted]
PHST- 2020/10/16 06:00 [pubmed]
PHST- 2021/11/03 06:00 [medline]
PHST- 2020/10/15 17:11 [entrez]
AID - S0305-4179(20)30440-X [pii]
AID - 10.1016/j.burns.2020.06.019 [doi]
PST - ppublish
SO  - Burns. 2020 Dec;46(8):1857-1866. doi: 10.1016/j.burns.2020.06.019. Epub 2020 Jun 
      26.