Tolerability And Pharmacokinetics Of Recombinant Lysostaphin In Burned Patients

Lysostaphin,a glycylglycine endopeptidase,shows a high bactericidal activity against gram-positive pathogens,especially to methicillin-susceptible S.aureus (MSSA) and methicillin-resistant S.aureus (MRSA).The aim of this paper is to study the tolerability and pharmacokinetics of recombinant lysostaphin, after external therapy in deep-partial thickness burn injury wounds in patients.MethodThirty-two volunteers with deep-partial thickness burn injury respectively received single administration at the does of0.8,3.2,8.0,16.0,24.0,32.0U/cm2or multi-administration of24.0,32.0U/cm2.Blood samples were taken at predetermined time. Dual antibody enzyme linked immunosorbent assay method was used to detect the serum recombinant lysostaphin concentrations.ResultsThe results were that the serum A/G and albumin of the8th volunteer and the38th volunteer were lower than before,but after given nutrition and infusion electrolytes,the two patients returned to normal.Elevated ALT was seen in the43th patient.Untreated,but the patient with ALT up returned to normal after9days. The three adverse enents were judged to have nothing to do with recombinant lysostaphin.And the serum recombinant lysostaphin concentrations in all of the volunteers were less than the quantitative lower limit of dual antibody enzyme linked immunosorbent assay method.ConclusionThe recombinant lysostaphin cannot be detected in blood in deep-partial thickness burn injury patients after they received external therapy of rLysn.The safety of clinical application of recombinant lysostaphin within0.8-32.0U/cm2is good.