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Tytuł oryginału: Results and follow-up of a phase III randomized study of recombinant human-granulocyte stimulating factor as support for immunosuppressive therapy in patients with severe aplastic anaemia.
Autorzy: Gluckman Eliane, Rokicka-Milewska Ritta [Roma], Hann Ian, Nikiforakis Emmanouel, Tavakoli Filipos, Cohen-Scali Sophie, Bacigalupo Andrea
Źródło: Br. J. Haematol. 2002: 119 (4) s.1075-1082, il., tab., bibliogr. s. 1081-1082
Sygnatura GBL: 303,964

Hasła klasyfikacyjne GBL:
  • hematologia

    Typ dokumentu:
  • praca opublikowana za granicą
  • tytuł obcojęzyczny
  • praca kliniczna

    Wskaźnik treści:
  • ludzie
  • dzieci 2-5 r.ż.
  • dzieci 6-12 r.ż.
  • dzieci 13-18 r.ż.
  • dorośli 19-44 r.ż.
  • dorośli 45-64 r.ż.
  • dorośli = 65 r.ż.
  • płeć męska
  • płeć żeńska

    Streszczenie angielskie: In patients with idiopathic severe aplastic anaemia who are treated with immunosuppressive agents to combat T lymphocyte-mediated destruction of haematopoietic progenitor cells, neutropenia is a major cause of infections and toxicity. Evidence from preliminary studies suggests that recombinant human glycosylated granulocyte colony-stimulating factor (lenograstim) increases the number and functionality of neutrophils in patients with severe aplastic anaemia. This randomized, parallel-group, multicentre study was conducted to evaluate the efficacy and safety of subcutaneous lenograstim during the first 12 weeks of standard immunosuppressive therapy in 102 patients with de novo severe aplastic anaemia. The addition of lenograstim to standard therapy resulted in an increase in the proportion of patients showing complete neutrophil response (83ú0 p.c. vs 44ú9 p.c.; P 0ú0001). This was seen even among patients with very severe aplastic anaemia (69ú2 p.c. vs 31ú6 p.c.; P = 0ú012). In patietns receiving lonograstim, median time to complete neutrophil response was shorter (6ú3 vs 16ú1 weeks; P = 0ú0001) and mean duration of first neutrophil response was longer (P = 0ú0248) than in the control group. At a median follow-up of 5 years, no difference was observed between the grous in term of survival, haematological response and occurrence of secondary leukaemia (one patient in each group). We conclude that lenograstim support of immunosuppressive therapy might be used for patients with severe aplastic anaemia as it significantly enhances neutrophil recovery but does not modify the overall response and survival.

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