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Titolo:
ASSESSMENT OF THE SAFETY AND EFFICACY OF THE MONOCLONAL ANTITUMOR NECROSIS FACTOR ANTIBODY-FRAGMENT, MAK 195F, IN PATIENTS WITH SEPSIS AND SEPTIC SHOCK - A MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY
Autore:
REINHART K; WIEGANDLOHNERT C; GRIMMINGER F; KAUL M; WITHINGTON S; TREACHER D; ECKART J; WILLATTS S; BOUZA C; KRAUSCH D; STOCKENHUBER F; EISELSTEIN J; DAUM L; KEMPENI J;
Indirizzi:
UNIV JENA,ANASTHESIOL & INTENS THERAPIE KLIN,DEPT ANAESTHESIOL & OPERAT INTENS CARE D-07740 JENA GERMANY UNIV GIESSEN,DEPT MED GIESSEN GERMANY KNOLL AG,DEPT CLIN RES LUDWIGSHAFEN GERMANY ROYAL LONDON HOSP,DEPT ANAESTHESIOL LONDON ENGLAND ST THOMAS HOSP,DEPT INTENS CARE MED LONDON ENGLAND MED CTR,DEPT ANAESTHESIOL AUGSBURG GERMANY BRISTOL ROYAL INFIRM & GEN HOSP,INTENS THERAPY UNIT BRISTOL AVON ENGLAND HOSP GREGORIO MARANON,DEPT INTENS CARE MED MADRID SPAIN DEPT ANAESTHESIOL BERLIN GERMANY AKH,DEPT MED 4,INTENS CARE UNIT VIENNA AUSTRIA FREE UNIV BERLIN,MED CTR STEGLITZ,DEPT ANAESTHESIOL & OPERAT INTENS CARE W-1000 BERLIN GERMANY MED CTR,DEPT ANAESTHESIOL & OPERAT INTENS CARE AUGSBURG GERMANY DEPT ANAESTHESIOL & OPERAT INTENS CARE BERLIN GERMANY CHARING CROSS HOSP,DEPT ANAESTHESIOL LONDON ENGLAND HOSP LARCHET,DEPT INTENS CARE NICE FRANCE WESTMINSTER MED SCH & HOSP,DEPT ANAESTHESIOL LONDON ENGLAND ST JOSEPHS HOSP,DEPT INTENS CARE PARIS FRANCE ALLGEMEINES KRANKENHAUS WIEN,DEPT SURG VIENNA AUSTRIA UNIV COLOGNE,DEPT SURG W-5000 COLOGNE GERMANY CHU VAUDOIS,DEPT MED CH-1011 LAUSANNE SWITZERLAND
Titolo Testata:
Critical care medicine
fascicolo: 5, volume: 24, anno: 1996,
pagine: 733 - 742
SICI:
0090-3493(1996)24:5<733:AOTSAE>2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Soggetto:
GRAM-NEGATIVE SEPSIS; FACTOR-ALPHA; FACTOR CACHECTIN; CYTOKINE LEVELS; SERUM; INTERLEUKIN-1; ENDOTOXIN; PLASMA; INFECTION; DISEASE;
Keywords:
SEPSIS; SEPTIC SHOCK; CLINICAL TRIAL; TUMOR NECROSIS FACTOR; INTERLEUKIN-6; CYTOKINES; MONOCLONAL ANTIBODIES; CRITICAL ILLNESS; INFECTION;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
48
Recensione:
Indirizzi per estratti:
Citazione:
K. Reinhart et al., "ASSESSMENT OF THE SAFETY AND EFFICACY OF THE MONOCLONAL ANTITUMOR NECROSIS FACTOR ANTIBODY-FRAGMENT, MAK 195F, IN PATIENTS WITH SEPSIS AND SEPTIC SHOCK - A MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY", Critical care medicine, 24(5), 1996, pp. 733-742

Abstract

Objective: To investigate the safety, biological effects, and efficacy of the anti-tumor necrosis factor (TNF) antibody fragment, MAK 195F,in a phase II trial in patients with severe sepsis. Design: Prospective, randomized, open label, placebo controlled, dose ranging, multicenter, multinational clinical trial, Setting: Sixteen academic medical centers' intensive care units in six European countries, Patients: One hundred twenty two patients with severe sepsis or septic shock who received standard supportive care and antimicrobial therapy. Interventions: Patients received one of three different doses of the anti TNF antibody (0.1 mg/kg, 0.3 mg/kg, or 1.0 mg/kg) or placebo; the antibody or placebo was given in nine doses at 8-hr intervals over 3 days, Measurements and Main Results: There were no significant differences in mortality rates among the groups receiving various doses of the anti-TNF antibody or placebo, but patients with baseline serum interleukin (IL)-6concentrations of >1000 pg/mL appeared to benefit from MAK 195F in a dose-dependent fashion, Increased circulating IL-6 concentrations, butnot TNF concentrations, were found to be important prognostic indicators for mortality for the patients in the placebo and the two lower dosage groups but not in the high dosage group (1 mg/kg), IL-6 concentrations decreased during the first 24 hrs of treatment in all three anti-TNF groups but not in the placebo group, MAK 195F was well tolerated by all patients, Human antimurine antibodies developed in 40% of the patients receiving the antibody, Conclusions: There was no increase in survival from sepsis for the patients receiving anti-TNF treatment in the overall study population, Retrospective stratification of patientsby IL-6 concentrations suggests beneficial effects of the drug for patients with baseline circulating IL-6 concentrations of >1000 pg/mL, This hypothesis requires validation in a larger, blinded, prospective study.

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Documento generato il 05/07/20 alle ore 22:35:31