Maxine H. Dorin

Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile

OBJECTIVE To evaluate the effects of a tissue-selective estrogen complex (TSEC) composed of bazedoxifene/conjugated estrogens (BZA/CE) on menopausal symptoms, metabolic parameters, and overall safety. DESIGN Multicenter, double-blind, placebo- and active-controlled phase 3 trial (Selective estrogens, Menopause, And Response to Therapy [SMART]-1). SETTING Outpatient clinical. PATIENT(S) Healthy, postmenopausal women (n = 3,397) age 40 to 75 with an intact uterus. INTERVENTION(S) Single tablets of BZA (10, 20, or 40 mg), each with CE (0.625 or 0.45 mg); raloxifene 60 mg; or placebo taken daily for 2 years. MAIN OUTCOME MEASURE(S) Hot flushes, breast pain, vaginal atrophy, metabolic parameters, and adverse events. RESULT(S) BZA (20 mg)/CE (0.625 or 0.45 mg) significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy compared with placebo. At week 12, the daily number of hot flushes decreased by 51.7% to 85.7% with all BZA/CE doses vs. 17.1% for placebo. BZA/CE improved lipid parameters and homocysteine levels, did not significantly change carbohydrate metabolism, and had only minor effects on some coagulation parameters. The incidences of breast pain and adverse events were similar between BZA/CE and placebo. CONCLUSION The TSEC composed of BZA (20 mg)/CE (0.625 or 0.45 mg) is an effective and safe treatment for menopausal symptoms.

Aggressive angiomyxoma of the female pelvis and perineum: Review of the literature

Aggressive angiomyxoma is an uncommon neoplasm which predominantly involves the pelvis and perineum of young White females. Misdiagnosis is common. Treatment typically involves surgery, and in spite of apparently complete resection, recurrences are common. Local spread into the adjacent fascia and musculature is frequently reported, and rarely, extension into intestine and bladder. The first reported case of pubic bone involvement, including its histology, radiologic features, and operative management, is discussed. Including this patient, 26 women with this tumor have been reported in the literature and are reviewed, along with 2 previously reported cases from the University of New Mexico Tumor Registry.

Cervical papillomavirus infection and cervical dysplasia in Hispanic, Native American, and non-Hispanic white women in New Mexico.

BACKGROUND Human papillomavirus infections of the cervix are found with varying frequencies in different populations worldwide, and have been associated with cervical cytologic abnormalities. METHODS We studied 1,603 randomly selected Hispanic, Native American, and non-Hispanic White women in New Mexico to determine the prevalence of cervical HPV infection in these ethnic groups, and its association with Pap smear abnormalities, using a new commercial dot-blot hybridization assay. RESULTS Nine percent of all women screened had evidence of cervical HPV infection (13.7% of non-Hispanic White women, 9.7% of Hispanics, and 6.6% of Native American women). Prevalence was higher in younger women ages 14-19 years than in older age groups. Over half of women with cervical HPV infection (n = 145) had normal Pap smears. The proportion of infected women increased among those with more advanced cytopathologic abnormalities; 5.6 percent with normal Pap smears had cervical HPV vs 66.7 percent with moderate-severe dysplasia. CONCLUSIONS Cervical HPV infection is common among New Mexico clinic attendees, varies in prevalence among the three major ethnic groups, and is strongly associated with cervical cytopathologic abnormalities.

In vivo light scattering for the detection of cancerous and precancerous lesions of the cervix

A noninvasive optical diagnostic system for detection of cancerous and precancerous lesions of the cervix was evaluated in vivo. The optical system included a fiber-optic probe designed to measure polarized and unpolarized light transport properties of a small volume of tissue. An algorithm for diagnosing tissue based on the optical measurements was developed that used four optical properties, three of which were related to light scattering properties and the fourth of which was related to hemoglobin concentration. A sensitivity of ~77% and specificities in the mid 60% range were obtained for separating high grade squamous intraepithelial lesions and cancer from other pathologies and normal tissue. The use of different cross-validation methods in algorithm development is analyzed, and the relative difficulties of diagnosing certain pathologies are assessed. Furthermore, the robustness of the optical system for use by different doctors and to changes in fiber-optic probe are also assessed, and potential improvements in the optical system are discussed.