Biomedical subjects

Philip C Fox

Publications and source records attributed to Philip C Fox.

7 recordsLinked to original sources

PubMed2003

Treatment of primary Sjögren's syndrome with low-dose human interferon alfa administered by the oromucosal route: combined phase III results.

OBJECTIVE: This study tested the safety and efficacy of human interferon (IFN) alfa for treatment of salivary hypofunction and dry mouth symptoms in primary Sjögren's syndrome patients. METHODS: Combined results are reported from 2 phase III clinical trials in which a total of 497 subjects with primary Sjögren's syndrome received 150 international units of human IFN alfa or matching placebo 3 times per day for 24 weeks by the oromucosal route. RESULTS: Subjects given IFN alfa had a significantly (P = 0.01) greater mean increase in unstimulated whole saliva (UWS) flow, compared with subjects given placebo. In IFN alfa patients, increases in UWS correlated positively and significantly with improvements noted in 7 of 8 symptoms associated with oral and ocular dryness. The coprimary endpoints of stimulated whole saliva flow and oral dryness were not significantly improved in the IFN alfa group relative to placebo. No significant differences were found between the groups with respect to overall adverse event incidence or severity. CONCLUSION: IFN alfa given at low dosage by the oromucosal route can significantly increase UWS flow in patients with primary Sjögren's syndrome, without causing significant adverse events.

Administration, Oral↗

PubMed2003

Sex steroid hormones in primary Sjögren's syndrome.

OBJECTIVE: To investigate the relationships between concentrations of sex hormones and measures of disease activity in patients with primary Sjögren's Syndrome (pSS). METHODS: Fifty-four women were evaluated: 39 patients (age, Q1,Q3: 57.0 yrs; 46, 66) diagnosed with pSS and 15 patients (49.0 yrs; 45, 60) who did not meet diagnostic criteria for pSS. The following measures of disease activity were assessed: serological data [antinuclear antibody, rheumatoid factor, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), serum immunoglobulin levels (IgG, IgA, IgM), serum protein, anti-SSA, and anti-SSB], labial minor salivary gland focus score, salivary flow rates, and objective measures of eye dryness (fluorescein corneal staining and unstimulated Schirmer's I test). Spearman correlations were calculated between these indices of disease activity and serum levels of sex hormones: dehydroepiandrosterone (DHEA), DHEA sulfate, androstenedione, testosterone, dihydrotestosterone (DHT), estrone, estradiol, and sex hormone binding globulin (SHBG). RESULTS: Numerous differences were noted between cases and controls with disease activity measures. All median values of sex steroid hormones were within the range of normal for pSS cases. Positive correlations were noted between testosterone and ESR (r = 0.36, p = 0.03), testosterone and serum protein (r = 0.37, p = 0.05), and testosterone and focus score (r = 0.44, p = 0.007). Negative correlations were present between SHBG and anti-SSA (r = -0.33, p = 0.05), SHBG and anti-SSB (r = -0.43, p = 0.009), and DHT and CRP (r = -0.41, p = 0.05). No correlations were noted between estrogens and measures of pSS disease activity. CONCLUSION: Higher levels of disease activity (ESR, serum protein, and focus score) were associated with higher concentrations of testosterone. No correlation between disease activity and estrogens was found.

Androstenedione↗

PubMed2002

Prevalence and clinical significance of lymphocytic foci in minor salivary glands of healthy volunteers.

OBJECTIVE: To determine the prevalence and severity of focal lymphocytic sialadenitis in minor salivary glands of healthy, asymptomatic individuals, in whom Sjögren's syndrome (SS) has been excluded. METHODS: Charts of 54 healthy volunteers who had salivary gland biopsies at the National Institutes of Health from January 1992 to August 1998 were reviewed. The healthy volunteers served as control subjects in various studies of salivary dysfunction. Significant medical conditions including SS were excluded. A biopsy with a focus score (FS) >1 was regarded as positive. Descriptive statistics were used to summarize the population's characteristics. RESULTS: The frequency of focal lymphocytic infiltration in the healthy volunteers was about 15% (8 of 54). None of these individuals had subjective xerostomia or dry eyes. The positive FS ranged from 2 to 6. FS did not correlate with age, smoking, serologic findings, or salivary flow in these patients. CONCLUSION: Lymphocytic infiltration in minor salivary glands is not uncommon among individuals without a history of salivary gland dysfunction. This finding is in agreement with the result of a previous autopsy survey study, indicating that focal sialadenitis may occur in the absence of SS.

Adult↗

PubMed2002

Decision-making on the use of antimicrobial prophylaxis for dental procedures: a survey of infectious disease consultants and review.

There is debate concerning use of antibiotic prophylaxis before invasive dental procedures for patients at risk of acquiring distant site infection (DSI). We determined the opinions and practices of infectious disease consultants (IDCs) regarding antimicrobial prophylaxis to prevent DSIs that result from invasive dental procedures by conducting a survey of the 797 members of the Infectious Diseases Society of America Emerging Infections Network (477 members [60%] responded). Ninety percent of respondents closely follow the American Heart Association guidelines for antibiotic prophylaxis for patients with valvular heart disease who undergo invasive dental procedures. In contrast, few IDCs recommend prophylaxis for patients with lupus erythematosus, poorly controlled diabetes mellitus, dialysis catheters or shunts, cardiac pacemakers, or ventriculoperitoneal shunts. Twenty-five percent to forty percent of respondents recommended prophylaxis for prosthetic vascular grafts, orthopedic implants, or chemotherapy-induced neutropenia. We conclude that IDCs differ considerably in their assessment of the need for prophylaxis for patients who have noncardiac risk factors for DSI. These differences underscore the need for definitive studies to delineate appropriate candidates for antimicrobial prophylaxis in dental practice.

Antibiotic Prophylaxis↗

PubMed2002

Treatment of xerostomia: a systematic review of therapeutic trials.

The results of the present systematic review of randomized controlled trials published in peer-reviewed journals demonstrate the presence of a wide variety of biases and the weakness of the existing literature of xerostomia treatment. The report of statistically significant efficacy on an outcome measure is only meaningful in the setting of a well-controlled, appropriately designed clinical trial. This points to the importance of evaluating the quality of the clinical trial closely when deciding if study results are applicable to a specific patient population. Future studies in the management of xerostomia will require an increased effort on the part of investigators to eliminate easily recognized flaws during the planning stages of a clinical trial. Minimizing bias in clinical studies will allow for easier interpretation and comparisons of different studies. Better clinical trial design is vital to provide maximal confidence in the efficacy of xerostomia interventions.

Acupuncture Therapy↗

PubMed2002

Relationship between bleeding time test and postextraction bleeding in a healthy control population.

OBJECTIVE: We sought to determine whether cutaneous bleeding time (BT) is related to bleeding outcome measures after a single tooth extraction. STUDY DESIGN: This was a prospective clinical pilot study of 30 subjects. Cutaneous BT was evaluated before a single tooth extraction. After extraction, an oral BT was determined. Subjects were contacted 3 to 7 hours and 2 days after extraction to assess further postoperative bleeding. RESULTS: The mean cutaneous BT was 5.9 minutes (range 1.5-10.0 minutes). The mean oral BT was 7.5 minutes (range 0-20 minutes). Cutaneous BT did not correlate with oral BT or any of our measures of postoperative bleeding. However, the oral BT correlated with the number of hours of bleeding after surgery (R(s) = 0.54, P =.03). The time necessary to perform the extraction correlated with the extraction site bleeding 3 to 7 hours after surgery (R(s) = 0.67, P =.0006). CONCLUSION: Cutaneous BT did not correlate with measures of postoperative bleeding in the present study, but oral BT immediately after extraction correlated with the duration of subsequent postoperative bleeding.

Adult↗

PubMed2002

A third study on the use of orally administered anhydrous crystalline maltose for relief of dry mouth in primary Sjögren's syndrome.

OBJECTIVES: To examine the safety and efficacy of anhydrous crystalline maltose for treatment of dry mouth and other symptoms of dryness in patients with primary Sjögren's syndrome. DESIGN: Anhydrous crystalline maltose was delivered orally as a 200-mg lozenge given three times daily over a 24-week period to a total of 100 subjects. All participants had prominent complaints of persistent dry mouth associated with primary Sjögren's syndrome. Patients were examined at baseline and every 6 weeks of treatment. SETTINGS: Patients were seen in outpatient clinics at a total of 27 sites within the United States. OUTCOME MEASURES: Unstimulated whole saliva output, a measure of basal salivary gland function, was determined at each visit. Symptoms associated with oral and ocular dryness were assessed at the same time with the use of 100-mm visual analogue scales. Safety was assessed by physical examination and laboratory studies. RESULTS: During this clinical trial, a majority of evaluable subjects (39/76) demonstrated an increase in unstimulated whole saliva output, and the treatment exhibited an excellent safety profile. The anhydrous crystalline maltose treatment led to significant improvement in several subjective measures of oral and ocular comfort. CONCLUSIONS: In this study, anhydrous crystalline maltose lozenges administered three times daily for 24 weeks improved salivary output and decreased complaints of dry mouth and eyes in patients with primary Sjögren's syndrome. Side-effects were minimal, and treatment was without significant adverse events. These results are similar to the benefits observed in two prior studies reported by the authors. This safe and simple intervention appears to provide clinical benefit to primary Sjögren's syndrome patients with distressing dry mouth symptoms.

Administration, Oral↗