title: Study of the role of vitamin B12 and folinic acid supplementation in preventing hematologic toxicity of zidovudine.
abstract: A prospective, randomized study was conducted to evaluate the role of vitamin B12 and folinic acid supplementation in preventing zidovudine (ZDV)-induced bone marrow suppression. Seventy-five human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts < 500/mm3 were randomized to receive either ZDV (500 mg daily) alone (group I, n = 38) or in combination with folinic acid (15 mg daily) and intramascular vitamin B12 (1000 micrograms monthly) (group II, n = 37). Finally, 15 patients were excluded from the study (noncompliance 14, death 1); thus, 60 patients (31 in group I and 29 in group II) were eligible for analysis. No significant differences between groups were found at enrollment. During the study, vitamin B12 and folate levels were significantly higher in group II patients; however, no differences in hemoglobin, hematocrit, mean corpuscular volume, and white-cell, neutrophil and platelet counts were observed between groups at 3, 6, 9 and 12 months. Severe hematologic toxicity (neutrophil count < 1000/mm3 and/or hemoglobin < 8 g/dl) occurred in 4 patients assigned to group I and 7 assigned to group II. There was no correlation between vitamin B12 or folate levels and development of myelosuppression. Vitamin B12 and folinic acid supplementation of ZDV therapy does not seem useful in preventing or reducing ZDV-induced myelotoxicity in the overall treated population, although a beneficial effect in certain subgroups of patients cannot be excluded.
authors.affiliation: Service of Internal Medicine, Arnau de Vilanova Hospital, Lleida, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Falguera
authors.forename: J
authors.initials: J
authors.lastname: Perez-Mur
authors.forename: T
authors.initials: T
authors.lastname: Puig
authors.forename: G
authors.initials: G
authors.lastname: Cao
mesh_terms: D000328:Adult; D000740:Anemia / Q000139:chemically induced; D001855:Bone Marrow Diseases / Q000139:chemically induced; D018791:CD4 Lymphocyte Count; D005260:Female; D005492:Folic Acid / Q000097:blood; D015658:HIV Infections / Q000188:drug therapy*; D006402:Hematologic Diseases / Q000139:chemically induced / Q000517:prevention & control*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D015215:Zidovudine / Q000009:adverse effects*
chemical_list: D015215:Zidovudine; D005492:Folic Acid; D014805:Vitamin B 12; D002955:Leucovorin