Adenine Arabinoside Monophosphate (Vidarabine Phosphate) in Combination with Human Leukocyte Interferon in the Treatment of Chronic Hepatitis B
| Autor: | C. Smith, Jack Bissett, B Mastre, S. Rosno, D Roskamp, Mark Eisenberg, Prem V. Nair, Jed I. Weissberg, Karen Waterman, Gabriel Garcia |
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| Rok vydání: | 1987 |
| Předmět: |
Adult
Liver Cirrhosis Male Hepatitis B virus medicine.medical_specialty Cirrhosis Placebo-controlled study medicine.disease_cause Placebo Gastroenterology law.invention Random Allocation chemistry.chemical_compound Double-Blind Method Randomized controlled trial law Internal medicine Internal Medicine medicine Humans Hepatitis Chronic Hepatitis Clinical Trials as Topic Arabinonucleotides business.industry General Medicine Hepatitis B medicine.disease Combined Modality Therapy chemistry Chronic Disease Interferon Type I Immunology Vidarabine phosphate Female Nervous System Diseases business Vidarabine Phosphate |
| Zdroj: | Annals of Internal Medicine. 107:278 |
| ISSN: | 0003-4819 |
| DOI: | 10.7326/0003-4819-107-2-278 |
| Popis: | Study objective To determine the efficacy of adenine arabinoside monophosphate (Ara-AMP vidarabine phosphate) with or without human leukocyte interferon in chronic hepatitis B. Study design Randomized, double-blinded, placebo-controlled trial with 6-month treatment and an 18-month follow-up. Setting Referral-based liver-disease clinics at three university medical centers. Patients Twenty-five patients with chronic active hepatitis or cirrhosis and 39 with chronic persistent hepatitis. Interventions Thirteen patients received intramuscular Ara-AMP, 2.5 mg/kg body weight, twice daily, alternated monthly for 6 months with subcutaneous human leukocyte interferon, 5 million units, twice daily. Painful paresthesia of the legs necessitated dosage reduction and early discontinuation of enrollment. Twenty-four patients received intramuscular Ara-AMP, 2.5 mg/kg, twice daily, alternated monthly for 6 months with a matching placebo given subcutaneously twice daily. Twenty-seven patients received placebo by intramuscular and subcutaneous injections twice daily for 6 months. Measurements and main results Of the 64 patients, 95% had symptomatic and virologic data available and 64% had biopsies at 12 months; at 24 months, 77% had data available and 56% had repeat biopsies. The highest dropout rate was seen in the group receiving Ara-AMP. The group receiving the placebo was less symptomatic (Karnofsky score of 96% compared with 91% in the group receiving Ara-AMP/placebo and 92% in the group receiving Ara-AMP/human leukocyte interferon, p = 0.02) at 12 but not at 24 months. Loss of DNA polymerase, the hepatitis B e antigen, and the serum hepatitis B virus DNA was similar in all three groups. Histologically, erosion of the limiting plate and lobular activity favored Ara-AMP at 12 but not at 24 months and these differences did not result in differences in the histologic diagnosis. Conclusion These results do not support the use of Ara-AMP and human leukocyte interferon in chronic persistent or chronic active hepatitis B. |
| Databáze: | OpenAIRE |
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