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M94A0115.TXT
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1994-10-01
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Document 0115
DOCN M94A0115
TI Treatment of systemic lupus erythematosus with lobenzarit: an open
clinical trial.
DT 9412
AU Hirohata S; Ohnishi K; Sagawa A; 2nd Department of Internal Medicine,
Teikyo University School of; Medicine, Tokyo, Japan.
SO Clin Exp Rheumatol. 1994 May-Jun;12(3):261-5. Unique Identifier :
AIDSLINE MED/94349650
AB An open clinical trial was designed to examine the efficacy and safety
of lobenzarit (CCA), a newly developed disease modifying anti-rheumatic
drug, in combination with conventional treatment with prednisolone for
patients with systemic lupus erythematosus (SLE). Fifteen patients with
SLE were given CCA 40 mg b.i.d. for the first 2 weeks, 80 mg b.i.d. for
the next 4 weeks, and 80 mg t.i.d. or b.i.d. until the end of the
12-month trial, in addition to prednisolone, whose doses were kept
unchanged throughout the trial. The patients' clinical responses to CCA,
including alterations in various laboratory parameters and the
development of complications, were evaluated at the end of 12 months.
Fourteen of the 15 patients completed the 12-month trial. Significant
increases in the white blood cell count and CD4/CD8 ratio, as well as
decreases in serum anti-DNA antibody, were noted after the trial. Five
patients presented with adverse effects, including mild liver
dysfunction, gastrointestinal symptoms and dizziness. Only one patient
who developed dizziness withdrew at 9 months. Eleven patients could be
reevaluated after discontinuation of CCA, and only 2 of them have
experienced recurrence of active disease 6 months after discontinuation.
In one additional patient who had not responded to prednisolone 35 mg
daily, administration of CCA resulted in improvement of the disease
activity. These results indicate that CCA in combination with
corticosteroids is a useful adjunct in the treatment of SLE. A
placebo-controlled study will be necessary to confirm these results.
DE Adolescence Adult Anthranilic Acids/ADVERSE
EFFECTS/STANDARDS/*THERAPEUTIC USE Anti-Inflammatory Agents,
Non-Steroidal/ADVERSE EFFECTS/STANDARDS/ *THERAPEUTIC USE Antibodies,
Antinuclear/BLOOD CD4-CD8 Ratio Dose-Response Relationship, Drug Drug
Therapy, Combination Female Human Leukocyte Count/DRUG EFFECTS
Leukocytes/DRUG EFFECTS/PATHOLOGY Lupus Erythematosus,
Systemic/BLOOD/*DRUG THERAPY/IMMUNOLOGY Male Middle Age
Prednisolone/THERAPEUTIC USE Support, Non-U.S. Gov't CLINICAL TRIAL
JOURNAL ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).