Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients: A randomized, placebo-controlled trial

Elizabeth C. Reed, John L. Wolford, Kenneth J. Kopecky, Kathryn E. Lilleby, Paula S. Dandliker, Jane L. Todaro, George B. McDonald, Joel D. Meyers

Research output: Contribution to journalArticle

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Abstract

Study Objective: To determine the efficacy of ganciclovir for the treatment of cytomegalovirus enteritis after bone marrow transplant. Design: A randomized, double-blind, placebo-controlled trial. Setting: Inpatient units of a cancer center. Patients: Consecutive patients with biopsy-documented cytomegalovirus infection of the gastrointestinal tract. Cytomegalovirus was identified by culture or by immunohistologic or standard histologic analysis. Interventions: Ganciclovir, 2.5 mg/kg body weight every 8 hours for 14 days, or placebo, with dosage adjusted for decreases in renal function. Therapy was discontinued if the neutrophil count or creatinine clearance fell below preset criteria. Measurements and Main Results: Virus cultures of throat, urine, and blood specimens were done before, 3 times weekly during, and weekly for 3 weeks after therapy. Endoscopy was repeated after treatment. Patients were examined, and blood counts, electrolytes, and renal and hepatic function were monitored during therapy. Ganciclovir recipients had cessation of oropharyngeal (P = 0.001) and urinary (P = 0.004) cytomegalovirus excretion and negative cultures of repeat esophageal specimens (P = 0.002) more often than placebo recipients. No difference existed in either clinical symptoms or endoscopic appearance between the groups after treatment. Cytomegalovirus pneumonia occurred in four patients who received ganciclovir and in six who received placebo. One ganciclovir recipient and four placebo recipients were withdrawn from treatment because of neutropenia, but there was no overall difference in the proportional decrease in leukocyte counts between groups. Conclusions: Although ganciclovir suppressed cytomegalovirus replication, 2 weeks of treatment was not associated with clinical or endoscopic improvement when compared with supportive care.

Original languageEnglish (US)
Pages (from-to)505-510
Number of pages6
JournalAnnals of internal medicine
Volume112
Issue number7
DOIs
StatePublished - Apr 1 1990

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Ganciclovir
Gastroenteritis
Cytomegalovirus
Randomized Controlled Trials
Bone Marrow
Placebos
Transplants
Therapeutics
Kidney
Enteritis
Cytomegalovirus Infections
Pharynx
Neutropenia
Leukocyte Count
Electrolytes
Endoscopy
Gastrointestinal Tract
Inpatients
Creatinine
Pneumonia

ASJC Scopus subject areas

  • Internal Medicine

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Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients : A randomized, placebo-controlled trial. / Reed, Elizabeth C.; Wolford, John L.; Kopecky, Kenneth J.; Lilleby, Kathryn E.; Dandliker, Paula S.; Todaro, Jane L.; McDonald, George B.; Meyers, Joel D.

In: Annals of internal medicine, Vol. 112, No. 7, 01.04.1990, p. 505-510.

Research output: Contribution to journalArticle

Reed, Elizabeth C. ; Wolford, John L. ; Kopecky, Kenneth J. ; Lilleby, Kathryn E. ; Dandliker, Paula S. ; Todaro, Jane L. ; McDonald, George B. ; Meyers, Joel D. / Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients : A randomized, placebo-controlled trial. In: Annals of internal medicine. 1990 ; Vol. 112, No. 7. pp. 505-510.
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abstract = "Study Objective: To determine the efficacy of ganciclovir for the treatment of cytomegalovirus enteritis after bone marrow transplant. Design: A randomized, double-blind, placebo-controlled trial. Setting: Inpatient units of a cancer center. Patients: Consecutive patients with biopsy-documented cytomegalovirus infection of the gastrointestinal tract. Cytomegalovirus was identified by culture or by immunohistologic or standard histologic analysis. Interventions: Ganciclovir, 2.5 mg/kg body weight every 8 hours for 14 days, or placebo, with dosage adjusted for decreases in renal function. Therapy was discontinued if the neutrophil count or creatinine clearance fell below preset criteria. Measurements and Main Results: Virus cultures of throat, urine, and blood specimens were done before, 3 times weekly during, and weekly for 3 weeks after therapy. Endoscopy was repeated after treatment. Patients were examined, and blood counts, electrolytes, and renal and hepatic function were monitored during therapy. Ganciclovir recipients had cessation of oropharyngeal (P = 0.001) and urinary (P = 0.004) cytomegalovirus excretion and negative cultures of repeat esophageal specimens (P = 0.002) more often than placebo recipients. No difference existed in either clinical symptoms or endoscopic appearance between the groups after treatment. Cytomegalovirus pneumonia occurred in four patients who received ganciclovir and in six who received placebo. One ganciclovir recipient and four placebo recipients were withdrawn from treatment because of neutropenia, but there was no overall difference in the proportional decrease in leukocyte counts between groups. Conclusions: Although ganciclovir suppressed cytomegalovirus replication, 2 weeks of treatment was not associated with clinical or endoscopic improvement when compared with supportive care.",
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AU - Lilleby, Kathryn E.

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N2 - Study Objective: To determine the efficacy of ganciclovir for the treatment of cytomegalovirus enteritis after bone marrow transplant. Design: A randomized, double-blind, placebo-controlled trial. Setting: Inpatient units of a cancer center. Patients: Consecutive patients with biopsy-documented cytomegalovirus infection of the gastrointestinal tract. Cytomegalovirus was identified by culture or by immunohistologic or standard histologic analysis. Interventions: Ganciclovir, 2.5 mg/kg body weight every 8 hours for 14 days, or placebo, with dosage adjusted for decreases in renal function. Therapy was discontinued if the neutrophil count or creatinine clearance fell below preset criteria. Measurements and Main Results: Virus cultures of throat, urine, and blood specimens were done before, 3 times weekly during, and weekly for 3 weeks after therapy. Endoscopy was repeated after treatment. Patients were examined, and blood counts, electrolytes, and renal and hepatic function were monitored during therapy. Ganciclovir recipients had cessation of oropharyngeal (P = 0.001) and urinary (P = 0.004) cytomegalovirus excretion and negative cultures of repeat esophageal specimens (P = 0.002) more often than placebo recipients. No difference existed in either clinical symptoms or endoscopic appearance between the groups after treatment. Cytomegalovirus pneumonia occurred in four patients who received ganciclovir and in six who received placebo. One ganciclovir recipient and four placebo recipients were withdrawn from treatment because of neutropenia, but there was no overall difference in the proportional decrease in leukocyte counts between groups. Conclusions: Although ganciclovir suppressed cytomegalovirus replication, 2 weeks of treatment was not associated with clinical or endoscopic improvement when compared with supportive care.

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