PMID- 1370264
OWN - NLM
STAT- MEDLINE
DCOM- 19920212
LR  - 20190819
IS  - 0090-1229 (Print)
IS  - 0090-1229 (Linking)
VI  - 62
IP  - 1 Pt 2
DP  - 1992 Jan
TI  - Recombinant human granulocyte-colony-stimulating factor in the treatment of 
      patients with neutropenia.
PG  - S39-46
AB  - The results of an open-label, randomized, Phase III trial of r-methionyl human 
      granulocyte-colony-stimulating factor (r-metHuG-CSF) in 41 patients with severe 
      chronic neutropenia (SCN) are reported. Patients with diagnoses of congenital, 
      cyclic, and idiopathic neutropenia, with histories of recurrent infections, were 
      evaluated. The primary objective of the trial was to evaluate the ability of 
      r-metHuG-CSF to increase the ANC to greater than 1500/mm3. A secondary objective 
      was to evaluate variables associated with infection-related morbidity in SCN. 
      r-metHuG-CSF treatment consisted of 1 month of dose titration followed by 4 
      months of treatment at an optimal dose. Patients were randomized to either 
      immediate treatment with r-metHuG-CSF (Group A) or four months of observation 
      followed by r-metHuG-CSF treatment (Group B). r-metHuG-CSF was administered by 
      daily, subcutaneous injection with initial doses of 3 to 10 micrograms/kg/day. 
      Forty of 41 patients who received r-metHuG-CSF had a complete response (median 
      ANC greater than 1500/mm3 during 4 months of r-metHuG-CSF treatment). All cases 
      of gingivitis and severe mouth ulcers resolved upon treatment with r-metHuG-CSF. 
      Serious infections were also eliminated. Only one patient failed to show clinical 
      improvement in response to r-metHuG-CSF treatment. Adverse reactions during the 
      first 5 months of treatment were mild. Splenomegaly (mild) was noted in some 
      patients. The administration of r-metHuG-CSF in patients with SCN significantly 
      increased the ANC (P less than 0.001) and was accompanied by a marked reduction 
      in infectious complications.
FAU - Boxer, L A
AU  - Boxer LA
AD  - Department of Pediatrics, University of Michigan, Ann Arbor 48109.
FAU - Hutchinson, R
AU  - Hutchinson R
FAU - Emerson, S
AU  - Emerson S
LA  - eng
GR  - AI20065/AI/NIAID NIH HHS/United States
GR  - HL31963/HL/NHLBI NIH HHS/United States
GR  - RR00042/RR/NCRR NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PT  - Review
PL  - United States
TA  - Clin Immunol Immunopathol
JT  - Clinical immunology and immunopathology
JID - 0356637
RN  - 0 (Recombinant Proteins)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
SB  - IM
MH  - Agranulocytosis/therapy
MH  - Chronic Disease
MH  - Granulocyte Colony-Stimulating Factor/*therapeutic use
MH  - Humans
MH  - Neutropenia/*therapy
MH  - Recombinant Proteins/therapeutic use
RF  - 42
EDAT- 1992/01/01 00:00
MHDA- 1992/01/01 00:01
CRDT- 1992/01/01 00:00
PHST- 1992/01/01 00:00 [pubmed]
PHST- 1992/01/01 00:01 [medline]
PHST- 1992/01/01 00:00 [entrez]
AID - 10.1016/0090-1229(92)90039-q [doi]
PST - ppublish
SO  - Clin Immunol Immunopathol. 1992 Jan;62(1 Pt 2):S39-46. doi: 
      10.1016/0090-1229(92)90039-q.