Adjunctive therapy in sepsis: a critical analysis of the clinical trial programme

被引：43

作者：

Cohen, J ^{[1
]}

机构：

[1] Imperial Coll Sch Med, Hammersmith Hosp, Dept Infect Dis & Microbiol, London W12 0NN, England

来源：

BRITISH MEDICAL BULLETIN | 1999年 / 55卷 / 01期

关键词：

D O I：

10.1258/0007142991902222

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Despite intensive efforts, the development of novel drugs for the treatment of sepsis has proved to be extremely difficult. A large number of clinical trials have ended in failure. A critical analysis of this record suggests that there is no single reason for these problems. Rather, the explanation lies in part with unexpected failures in the drugs themselves, and in part with the difficulties of trial design in this particular group of patients. In future, trials in this area are likely to be more highly focused, with even stricter protocol definitions to try and ensure a homogeneous patient population.

引用

页码：212 / 225

页数：14

共 45 条

[1] EFFICACY AND SAFETY OF MONOCLONAL-ANTIBODY TO HUMAN TUMOR-NECROSIS-FACTOR-ALPHA IN PATIENTS WITH SEPSIS SYNDROME - A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL-TRIAL [J].

ABRAHAM, E ;

WUNDERINK, R ;

SILVERMAN, H ;

PERL, TM ;

NASRAWAY, S ;

LEVY, H ;

BONE, R ;

WENZEL, RP ;

BALK, R ;

ALLRED, R ;

PENNINGTON, JE ;

WHERRY, JC .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1995, 273 (12) :934-941

[2]

Abraham E, 1998, LANCET, V351, P929

[3] p55 tumor necrosis factor receptor fusion protein in the treatment of patients with severe sepsis and septic shock - A randomized controlled multicenter trial [J].

Abraham, E ;

Glauser, MP ;

Butler, T ;

Garbino, J ;

Gelmont, D ;

Laterre, PF ;

Kudsk, K ;

Bruining, HA ;

Otto, C ;

Tobin, E ;

Zwingelstein, C ;

Lesslauer, W ;

Leighton, A .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1997, 277 (19) :1531-1538

[4]

APPELMELK BJ, 1992, BACTERIAL ENDOTOXIC, V2, P411

[5] ASSOCIATION BETWEEN PROTECTIVE EFFICACY OF ANTI-LIPOPOLYSACCHARIDE (LPS) ANTIBODIES AND SUPPRESSION OF LPS-INDUCED TUMOR NECROSIS FACTOR-ALPHA AND INTERLEUKIN-6 [J].

BAUMGARTNER, JD ;

HEUMANN, D ;

GERAIN, J ;

WEINBRECK, P ;

GRAU, GE ;

GLAUSER, MP .

JOURNAL OF EXPERIMENTAL MEDICINE, 1990, 171 (03) :889-896

[6]

BAUMGARTNER JD, 1985, LANCET, V2, P59

[7] The effects of ibuprofen on the physiology and survival of patients with sepsis [J].

Bernard, GR ;

Wheeler, AP ;

Russell, JA ;

Schein, R ;

Summer, WR ;

Steinberg, KP ;

Fulkerson, WJ ;

Wright, PE ;

Christman, BW ;

Dupont, WD ;

Higgins, SB ;

Swindell, BB .

NEW ENGLAND JOURNAL OF MEDICINE, 1997, 336 (13) :912-918

[8] A 2ND LARGE CONTROLLED CLINICAL-STUDY OF E5, A MONOCLONAL-ANTIBODY TO ENDOTOXIN - RESULTS OF A PROSPECTIVE, MULTICENTER, RANDOMIZED, CONTROLLED TRIAL [J].

BONE, RC ;

BALK, RA ;

FEIN, AM ;

PERL, TM ;

WENZEL, RP ;

REINES, HD ;

QUENZER, RW ;

IBERTI, TJ ;

MACINTYRE, N ;

SCHEIN, RMH ;

TRENHOLME, G ;

NIEDERMAN, M ;

CHALFIN, D ;

ABALOS, A ;

OROPELLO, J ;

EMPSON, P ;

CAMINITII, S ;

GREENMAN, R ;

BOOTH, F ;

PLOUFFE, J ;

RUSSELL, J ;

GIANAKOPOULOS, G ;

IANNINI, P ;

HINDES, R ;

COBLENS, K ;

KOHLER, R ;

MARTIN, M ;

BERNARD, G ;

EDWARDS, J ;

CRISLIP, M ;

FILLER, S ;

NASRAWAY, SA ;

SIGEL, PK ;

SOTTILE, FD ;

MARTIN, DH ;

DEBOISBLANC, BP ;

CHANDRASEKAR, PH ;

BROUGHTON, WA ;

MIDDLETON, RM ;

SEIBERT, AF ;

EMMANUEL, G ;

LIE, TH ;

ANDERSON, CLV ;

PANKEY, GA ;

ANDERSON, P ;

OLSEN, K ;

SANPEDRO, GS ;

GRAHAM, D ;

GROSSMAN, J ;

WELS, PB .

CRITICAL CARE MEDICINE, 1995, 23 (06) :994-1006

[9] DEFINITIONS FOR SEPSIS AND ORGAN FAILURE AND GUIDELINES FOR THE USE OF INNOVATIVE THERAPIES IN SEPSIS [J].

BONE, RC ;

BALK, RA ;

CERRA, FB ;

DELLINGER, RP ;

FEIN, AM ;

KNAUS, WA ;

SCHEIN, RMH ;

SIBBALD, WJ .

CHEST, 1992, 101 (06) :1644-1655

[10] SEPSIS SYNDROME - A VALID CLINICAL ENTITY [J].

BONE, RC ;

FISHER, CJ ;

CLEMMER, TP ;

SLOTMAN, GJ ;

METZ, CA ;

BALK, RA .

CRITICAL CARE MEDICINE, 1989, 17 (05) :389-393

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