EARLY PHARMACOKINETIC AND CLINICAL-RESULTS FROM A NONCOMPARATIVE MULTICENTER TRIAL OF AMPHOTERICIN-B ENCAPSULATED IN A SMALL UNILAMELLAR LIPOSOME (AMBISOME(R))

被引：22

作者：

TOLLEMAR, J ^{[1
]}

RINGDEN, O ^{[1
]}

RICCI, P ^{[1
]}

TURA, S ^{[1
]}

MEUNIER, F ^{[1
]}

KLASTERSKY, J ^{[1
]}

VIVIANI, M ^{[1
]}

GORIN, NC ^{[1
]}

FENAUX, P ^{[1
]}

KUSE, ER ^{[1
]}

PRENTICE, HG ^{[1
]}

BLANCHE, S ^{[1
]}

CLUMECK, N ^{[1
]}

HAY, R ^{[1
]}

FRASCHINI, F ^{[1
]}

STOUTENBEEAK, C ^{[1
]}

MEUSERS, P ^{[1
]}

SCHROYENS, W ^{[1
]}

GOLDSTONE, A ^{[1
]}

LINDENMANN, A ^{[1
]}

RODENHUIS, S ^{[1
]}

WALDNER, R ^{[1
]}

ZITTOUN, R ^{[1
]}

PIERCE, P ^{[1
]}

ALEMELEH, R ^{[1
]}

ABECASSIS, M ^{[1
]}

GOUVEIA, A ^{[1
]}

ZIRKULNIG, R ^{[1
]}

机构：

[1] HUDDINGE HOSP,DEPT CLIN IMMUNOL,S-14186 HUDDINGE,SWEDEN

来源：

DRUG INVESTIGATION | 1992年 / 4卷 / 03期

关键词：

D O I：

10.1007/BF03258404

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

AmBisome (R) 0.5 to 4 mg/kg/day, a small unilamellar liposome encapsulating amphotericin B, was administered to 59 patients with mycologically confirmed infections (36 had candidiasis, 18 had aspergillosis and 5 had other infections). Of the treated patients, 37 (63%) were considered cured, 9 (15%) improved, and 13 (22%) failed to respond. The response rate in patients with candidiasis was 83% (30/36) compared with 61% (11/18) for aspergillosis (not significant). All other mycoses were cured or improved. 80% (16) of 20 evaluable patients were cured or improved when AmBisome (R) was used because of the prior failure of conventional amphotericin B in a compassionate basis trial. AmBisome (R) at dose levels ranging between 2 and 4 mg/kg produced peak plasma levels ranging from 16.0 +/- 6.7 to 46.0 +/- 10.2 mg/L. Tissue levels were highest in liver and spleen and were low in kidney and lung. Side effects associated with AmBisome (R) included increases in serum creatinine (n = 9) and alkaline phosphatase (2), hypokalaemia (3) and pancreatitis (1).

引用

页码：232 / 238

页数：7

共 25 条

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