INTENSIV-News
Intravenous immunoglobulin or high-dose methylprednisolone, with
or without oral prednisone, for adults with untreated severe autoimmune
thrombocytopenic purpura: a randomised, multicentre trial.
Godeau B, Chevret S, Varet B, et al. Lancet 2002; 359:23-9
Laboratoire d´Immunologie Leucoplaquettaire, EFS Ile de France, France.
BACKGROUND:
Treatment of adults with autoimmune thrombocytopenic purpura (AITP) is
based more on individual experience than on results of controlled
studies. We compared intravenous immunoglobulin with high-dose
methylprednisolone in untreated adults with severe AITP and assessed
efficacy of subsequent oral steroids compared with placebo. Primary
outcome was number of days with platelet count greater than 50x10(9)/L
within the first 21 days.
METHODS: We did a randomised multicentre
trial based on a 232 design. 122 adults with severe AITP (platelet count
either oral prednisone or placebo (randomisation B) on days 4-21.
Analysis was by intention to treat.
FINDINGS: Six patients were
excluded from the analysis. The number of days on which platelet counts
were above 50x10(9)/L was 18 in 56 patients receiving intravenous
immunoglobulin and 14 in 60 receiving high-dose methylprednisolone
(p=0.02). Percentage of patients who had platelet counts over 50x10(9)/L
on days 2 and 5 was 7% and 79%, respectively, in the intravenous
immunoglobulin group compared with 2% and 60%, respectively, in the
high-dose methylprednisolone group (p=0.04). During the second treatment
period, prednisone was more effective than placebo for all short-term
endpoints. Patients who received intravenous immunoglobulin and
prednisone had platelet count greater than 50x10(9)/L for 18.5 days
(p=0.005), and those treated with high-dose methylprednisolone and
prednisone had this count for 17.5 days.
INTERPRETATIONS: Intravenous
immunoglobulin and oral prednisone seems to be more effective than
high-dose methylprednisolone and oral prednisone in adults with severe
AITP, although the latter treatment is effective and well tolerated.
Die akute Autoimmunthrombozytopenie (ITP) ist eine seltene Erkrankung (2,6 Fälle/100.000/Jahr), die aber nur in wenigen Fällen lebensbedrohende Blutungen macht. In solchen Fällen ist ein rasches Anheben der Thrombozytenzahlen notwendig, da die Transfusion von Thrombozytenkonzentraten immer wirkungslos ist. Diese methodologisch einwandfreie kontrollierte Studie von Godeau et al. zeigt deutlich, dass die Infusion von hochdosierten Immunglobulinkonzentraten einen signifikant rascheren und höheren Thrombozytenanstieg bewirkt als die Therapie mit hochdosiertem Kortison.
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Tags: intensiv-news thrombozytopenie immunglobulin prednisolon
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