p033

Transcription

p033
Annals of Burns and Fire Disasters - vol. XXVIII – Supplement EBA - September 2015
SUBGROUP
ANALYSIS
ON
REGENERATIVE
EFFECTS
OF
ERYTHROPOIETIN IN 84 PATIENTS WITH BURN AND SCALD INJURES
(P033)
*Ilg F.1, Günter C. I.1, Dornseifer U.2, Dunda S.3, Grieb G.3, Pallua N.3, Mailänder P.4,
Kestel A.5, Enert C.5, Siemers F.5, Steen M.5, Ninkovic M.2, Sievers R.6, Reichert B.6,
Thamm O.7, Spilker G.7, Schaller H.- E.8, Ryu S. M.9, Menke H.9, Bader A.10, Jelkmann
W.11, Ohmann C.12, Hapfelmeier A.13, Kehl V.13, Egert S.14, Machens H.- G.1
1
Klinikum rechts der Isar, Plastic Surgery, München, Germany
Klinikum Bogenhausen, Plastic Surgery, München, Germany
3
Uniklinikum Aachen, Plastic Surgery, Aachen, Germany
4
Uniklinikum Schleswig-Holstein, Plastic Surgery, Lübeck, Germany
5
BG Klinikum Bergmannstrost, Plastic Surgery, Halle, Germany
6
Klinikum Süd, Plastic Surgery, Nürnberg, Germany
7
Klinikum Mehrheim, Plastic Surgery, Köln, Germany
8
BGU Klinikum, Plastic Surgery, Tübingen, Germany
9
Klinikum Offenbach, Plastic Surgery, Offenbach, Germany
10
Universität Leipzig, BBZ, Leipzig, Germany
11
Universität Lübeck, Inst. Physiology, Lübeck, Germany
12
Universität Düsseldorf, KKS, Düsseldorf, Germany
13
Technische Universität München, IMSE, Munich, Germany
14
Technische Universität München, MSZ, Munich, Germany
2
Introduction: Erythropoietin (EPO) is well known as the hormone causing erythropoiesis.
Research of the last decade shows that EPO plays a pivotal role in the healing of acute and chronic
wounds based on its significant anti-inflammatory and pro-generative effect. To investigate the
effects of EPO in severely burned patients a prospective, randomized, double-blind, multi-center
phase IIa study was conducted. The primary endpoint was defined as the time until complete reepithelialization of a defined Skin Graft Donor Site (SGDS). Subgroups were formed for analysis of
interactions between EPO and concomitant medication with respect to time until complete reepithelialization of this defined Skin Graft Donor Site (SGDS).
Methods: Following subgroups were formed: Concomitant medication included nonsteroidal antiinflammatory drugs (NSAIDs), antibiotics and insulin. In addition, we analyzed subgroups
established on concomitant diseases and adverse events such as sepsis. We evaluated the rate of
wound re-epithelialization in one of the following groups: a) 50 -100 % re-epithelialization
achieved (yes/ no) at defined time points, b) 75% -100% and c) 100%. Analysis was performed by
life tables and cox-regression with dependent variable time to complete re-epithelialization and
independent factor variables such as treatment group and subgroups.
Results: A total of 84 patients have been enrolled of which 45 received study medication (rhEPO
150 IU/kg body weight) and 34 placebo. Parallel application of EPO and insulin showed a tendency
towards better wound healing compared with placebo and insulin, EPO and no insulin or placebo
and no insulin. Further analysis of subgroups is ongoing.
Conclusion: Insulin is recognized as an important contributor to wound healing. EPO and insulin
seem to have a positive effect on re-epithelialization, but clinical trials are needed to further prove
of this hypothesis.