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12.
J Am Acad Dermatol ; 38(1): 69-76, 1998 Jan.
Article in English | MEDLINE | ID: mdl-9448208

ABSTRACT

BACKGROUND: Tacrolimus is a potent immunosuppressant used in organ transplant recipients; an ointment formulation is being developed as a therapeutic agent for atopic dermatitis. OBJECTIVE: Our purpose was to define the pharmacokinetics and evaluate tacrolimus 0.3% ointment as therapy for moderate to severe atopic dermatitis. METHODS: Thirty-nine patients, 5 to 75 years of age, received 14 applications over 8 days. Serial blood samples were collected on days 1 and 8, with predose samples collected on days 2 through 7. Overall response and signs/symptoms were rated daily on days 1 through 11. Incidence of adverse events and laboratory profile were determined. RESULTS: Mean area under the curve (0.9 to 42.5 ng x hr/ml) was highly variable and appeared to be related to size of application area. No systemic accumulation of tacrolimus was observed. Comparison to historical intravenous data indicates that absolute bioavailability of topical tacrolimus was less than 0.5%. Ninety-five percent of patients showed at least good improvement. All adverse events were transient. Burning was the most common application site adverse event and vasodilatation ("flushing/warmth") was the most common nonapplication site adverse event. No drug-related changes in laboratory profile were observed. CONCLUSION: The results of this study suggest that tacrolimus 0.3% ointment may be a safe and effective therapy for atopic dermatitis.


Subject(s)
Dermatitis, Atopic/drug therapy , Immunosuppressive Agents/therapeutic use , Tacrolimus/therapeutic use , Administration, Cutaneous , Adolescent , Adult , Aged , Area Under Curve , Biological Availability , Child , Child, Preschool , Female , Flushing/chemically induced , Follow-Up Studies , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/blood , Immunosuppressive Agents/pharmacokinetics , Incidence , Injections, Intravenous , Male , Middle Aged , Ointments , Remission Induction , Sensation Disorders/etiology , Tacrolimus/administration & dosage , Tacrolimus/adverse effects , Tacrolimus/blood , Tacrolimus/pharmacokinetics , Vasodilation/drug effects
13.
J Natl Med Assoc ; 84(8): 677-80, 1992 Aug.
Article in English | MEDLINE | ID: mdl-1507257

ABSTRACT

This article reports the results of a pathoepidemiological study of a cohort of black men who had prostatic surgery at Howard University Hospital between 1968 and 1989. The median age of patients at diagnosis of prostate cancer increased by 8 years during the study period, indicating either a delay in seeking medical care or a true delay in onset of the disease. The trends of prevalence of biopsies with cancer in various age groups suggested a sharp rise in the incidence of prostate cancer after the age of 70. The significant increase in popularity of needle biopsy during the period 1982 to 1989 after a 7-year plateau is an indication of increased perceived value of this procedure with experience and technical improvement. The prevalence of biopsies with cancer in all successive time periods of the study showed a bimodal distribution with an early hump in the 50- to 54-year-old age group. This hump is analogous to the break in the rising incidence of breast cancer between the ages of 47 and 52 (Clemmesen hook). This similarity could be explained on the basis of hormonal dependence of the two cancers.


Subject(s)
Black or African American , Prostatectomy/trends , Prostatic Neoplasms/surgery , Adult , Age Factors , Aged , Biopsy, Needle/trends , Cohort Studies , District of Columbia/epidemiology , Humans , Male , Middle Aged , Prevalence , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/epidemiology
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