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PubMed1997

Population pharmacokinetics of lamotrigine monotherapy in patients with epilepsy: retrospective analysis of routine monitoring data.

AIMS: To examine the population pharmacokinetics of lamotrigine in patients newly diagnosed with epilepsy and receiving oral lamotrigine monotherapy for up to 48 weeks. METHODS: The population consisted of 158 Caucasians and 5 Asians of whom 81 were males and 82 females. Age and weight ranged between 14 and 76 years and 41-107 kg, respectively. A one-compartment compartment model with first-order absorption and elimination was fitted to plasma lamotrigine concentration-time profiles from retrospective drug monitoring, using non-linear mixed effect modelling (NONMEM), with first-order estimation. Oral clearance (CLo), apparent volume of distribution (V/F) and absorption rate constant (Ka) were the main pharmacokinetic parameters. RESULTS: CLo was not significantly influenced by body weight, age, gender, oral contraceptives and dose. However, due to auto-induction CLo increased by 17.3% during the 48 weeks of therapy, from 1.94 to 2.28 l h(-1), and was 28.7% lower in Asians than Caucasian. The final magnitude in interpatient variability was 32%. The effect of the covariates weight, age, race and gender on V/F was examined and none was statistically significant. The final population estimate of V/F was 77.4 l with an interpatient variability of 34%. CONCLUSIONS: In view of the wide therapeutic margin of lamotrigine and the 21% residual variability in plasma concentrations, the modest significant effects of race and auto-induction on clearance are unlikely to be clinically significant and, thus, no dosage adjustment is warranted for these effects.

Adolescent↗
PubMed2001

A population-based cohort study of HRT use and breast cancer in southern Sweden.

The overall tumour incidence and breast cancer incidence related to hormone replacement therapy (HRT) were followed in a population-based cohort of 29 508 women, aged 25-65 when interviewed in 1990-92. By the end of the follow up in December 1999, there were 226 611 person-years of observation. A total of 1145 malignant tumours were recorded (expected 1166.6; SIR = 0.98, 95% CI 0.93-1.04). There was a small excess of breast cancer with 434 observed and 387.69 expected (SIR = 1.12, 95% CI 1.02-1.23). Among about 3 663 ever users of HRT, there was no increase in overall tumour incidence (SIR = 0.98, 95% CI 0.86-1.12) but a significant excess of breast cancer (SIR = 1.35, 95% CI 1.09-1.64) compared with never users (SIR = 1.07, 95% CI 0.96-1.19). Breast cancer increased with increasing duration of use and for 48-120 months use the SIR was 1.92 (95% CI 1.32-2.70). There was no significant interaction with family history of breast cancer although an independent additive effect was suggested between HRT use and family history. In a Cox regression model time to breast cancer in relation to duration of HRT use was analysed adjusting for age at menarche, age at menopause, age at first full term pregnancy, parity and age at diagnosis. A significantly higher risk was seen for longer duration of HRT use compared with never users. No increased risk is seen in women beyond 5 years after stopping HRT. There was no interaction between previous use of oral contraceptives and later HRT use.

Adult↗
PubMed1980

Oral contraceptive steroids: effects on iron and zinc levels and on tryptophan pyrrolase and alkaline phosphatase activities in tissues of iron-deficient anemic rats.

Weanling Wistar-strain female rats were fed a normal or an iron-deficient diet for 8 weeks and oral contraceptive steroids (OCS) were added for the last 4 weeks. Hemoglobin content, serum iron and zinc levels, liver iron levels, and tryptophan pyrrolase activities, and liver, kidney, and brain zinc levels and alkaline phosphatase activities were determined. Compared to control rats given the normal diet (N group), elevated liver zinc levels and tryptophan pyrrolase activity were found in rats fed the normal diet containing OCS ( + S group), but other parameters did not alter. In rats fed the iron-deficient diet alone (D group), only liver zinc levels were significantly higher, while other parameters were in general lower than those in the N group. In rats fed the iron-deficient diet containing OCS (D + S group), all hematological values, tissue mineral contents with the exception of liver zinc levels, and liver tryptophan pyrrolase and kidney alkaline phosphatase activities were lowered, compared to the N or N + S group. However, compared to the D group, the values of most parameters in the D + S group did not differ significantly, apart from an increase in serum zinc levels. These observations suggest that OCS does not greatly influence the various changes caused by iron-deficient anemia.

Alkaline Phosphatase↗
PubMed2005

Light and exercise and melatonin production in women.

Melatonin may protect against breast cancer. Light and other factors influence melatonin, but the evidence is limited. The authors conducted a study to determine factors related to melatonin. Women volunteers recruited in Toronto, Canada, from 2002 to 2004 collected urine for three nights (winter and summer), took periodic light measurements, and recorded exposures in a diary. The relation of each variable to log-transformed creatinine-corrected 6-sulfatoxymelatonin in overnight urine was determined by use of generalized estimating equation linear regression. The final model was based on 1,054 measurement days from 213 participating women. None of the light variables was related to the log of 6-sulfatoxymelatonin. A significant interaction between season and day length was included in the final model. The most significant factor was duration of exercise (beta = 0.072; p = 0.004, two-tailed), which increased the amount of melatonin produced. Exercise duration later in the day was more significant (beta = 0.108; p = 0.0009, two-tailed). There was no difference between moderate or strenuous exercise. The failure to find a relation between light brightness and melatonin may be due to the difficulty of measuring this, as well as the importance of the light spectrum, which could not be measured. It is possible that the protective effect of exercise with respect to breast cancer may operate in part through an effect on melatonin.

Adult↗
PubMedDate not supplied

Invasive and in situ carcinoma of the cervix in young Nigerians: a clinico-pathologic study of 27 cases.

A study of young Nigerians aged 30 years and below with invasive and in-situ cervical carcinoma confirms the notion that cervical cancer occurs in all age group. All patients except one were married while all were parous. Forty four percent of the patients presented with stages III and IV disease and hence, were unsuitable for surgery. The youngest patient was aged 17 years, indicating the need tare cancer screening among adolescents and a vigorous family planning programme that emphasizes barrier contraception.

Adolescent↗
PubMed1990

Risk factors for cardiovascular disease in U.S. medical students: the Preventive Cardiology Academic Award Collaborative Data Project.

Risk factors for cardiovascular disease are commonly obtained in freshman medical students for the purpose of increasing interest and awareness in preventive cardiology. What would be a normal range of values for this select group? This paper describes the major cardiovascular risk factors for 3,811 male and female freshman medical students from eight U.S. medical schools that were obtained in a standardized fashion as part of the Preventive Cardiology Academic Award (PCAA) programs at these institutions. The distributions of height, weight, Quetelet index, systolic and diastolic blood pressures, total cholesterol, triglycerides, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol are presented for male and female medical students stratified by race into white, black, Asian, and Hispanic groups. The sex and race distributions of cardiovascular risk factors such as previously diagnosed hypertension, diabetes mellitus, smoking, lack of regular exercise (three times a week or more), oral contraceptive use in women, and family history of coronary heart disease are presented. The cardiovascular risk of freshman medical students is compared to other epidemiologic studies of young adults. The use and limitations of these race- and sex-specific data on cardiovascular risk, including physiologic measurements, are discussed in the context of educational programs for medical students and house staff in preventive cardiology.

Adult↗
PubMed1998

Young women's attitudes toward injectable and implantable contraceptives.

STUDY OBJECTIVE: To assess the potential acceptability of implantable and injectable contraceptive characteristics by young women of diverse ethnic and educational backgrounds. DESIGN: A cross-sectional self-administered survey. SETTINGS: The waiting room of three clinical sites: an elite women's college health service, a coeducational state university health service, and an inner city hospital-based adolescent clinic. PARTICIPANTS: 328 young women awaiting medical care in one of three clinical sites, aged 13 to 21 years (85% 18-21 years); ethnic distribution differed significantly by site. The majority (83%) were sexually active, and of those who were sexually experienced, 25% had been pregnant. OUTCOME MEASURES: A 47-item questionnaire examining attitudes toward characteristics of injectable and implantable contraceptive methods, menstrual, sexual, and gynecologic history. RESULTS: Sixty-two percent of the sample agreed that they would get an injectable method. There was little variation in agreement to get an injectable method by sexual or pregnancy history. Fewer subjects (24%) agreed that they would like to get subdermal implants and agreement to get an implantable method of contraception did not vary by sexual history; however, ever-pregnant young women (33%) were significantly more likely to agree to implants than never-pregnant subjects (21%; chi2, 4.109; p = 0.04). Seventy-four percent of subjects said they would stop using a contraceptive that caused irregular menses, whereas 65% would stop using a method that caused amenorrhea. CONCLUSIONS: An injectable contraceptive method has universal appeal across ethnic, educational, and age categories, whereas implants are less appealing. Irregular bleeding and amenorrhea are poorly perceived side effects of long-acting contraceptives.

Adolescent↗
PubMedDate not supplied

Taiwan's transition from high fertility to below-replacement levels.

This article compares the fertility experience of Taiwanese in the eight years since the total fertility rate reached 2.1 with that before fertility reached replacement levels. During the earlier period, two-thirds of the fertility decline resulted from falling marital fertility and one-third from higher age at marriage. The changing age distribution retarded this decline. Since 1983, the further decline to 1.7-1.8 has been entirely the result of the trend toward later marriage. Older age distributions now facilitate the decline. Births postponed by those marrying later make the conventional TFR misleading. Computation based on parity-progression ratios raise TFRs from 1.7 to 2.0, a number less alarming to policymakers. Contraceptive prevalence is at saturation levels in all major populations strata. The "KAP-GAP" has disappeared. What would have happened without Taiwan's effective family planning program is impossible to determine, but clearly, contraceptive services supplied by the program were the major proximate cause of Taiwan's fertility decline.

Adolescent↗
PubMed1997

Impact of menstrual phase on false-negative mammograms in the Canadian National Breast Screening Study.

BACKGROUND: The efficacy of breast carcinoma screening should be enhanced if false-negative mammography were reduced. Prospectively collected data from the Canadian National Breast Screening Study were used to examine whether menstrual cycle phase was associated with false-negative outcomes for mammographic screening. METHODS: Of 8887 women ages 40-44 years at the onset of screening, randomized to receive annual mammography and clinical breast examination, reporting menstruation no more than 28 days prior to their screening examination, and with a valid radiologic report, 1898 had never used oral contraceptives or replacement estrogen with or without progesterone. The remainder were past (6573) and current (416) estrogen users. Similar selection criteria were applied at subsequent screens. The distribution of false-negative and false-positive mammography in relation to true-negative and true-positive mammography was examined with respect to the follicular (Days 1 to 14) and luteal (Days 15-28) menstrual phases. RESULTS: Comparing luteal with follicular mammograms in 6989 patients who ever used estrogen, the unadjusted odds ratio (2-sided P-values) for false-negatives versus true-negatives was 2.16 (0.05) and the adjusted odds ratio was 1.47 (0.05). In 1898 never-users, parallel odds ratios for luteal false-negatives were 0.55 (1.0) and 0.74 (1.0), respectively. CONCLUSIONS: These results suggest that menstruating women who have used hormones may have an increased risk of false-negative results for screening mammograms performed in the luteal phase of the menstrual cycle. An increased risk of false-negative mammography might adversely affect screening efficacy. The impact of menstrual phase on mammographic interpretation, especially for women who ever used hormones, requires further investigation.

Adult↗
PubMed1982

Biliary lipids, bile acids, and gallbladder function in the human female: effects of contraceptive steroids.

Individuals who take contraceptive steroids or estrogens are at increased risk of developing cholesterol gallstones. The mechanisms of the increased stone formation are incompletely understood. In this study we report biliary lipid composition and secretion, bile acid composition and kinetics, and gallbladder function in a group of healthy, nonobese women taking a contraceptive steroid preparation. A comparable group of healthy women served as controls. Bile-rich duodenal fluid was obtained after stimulation of gallbladder contraction; bile acid, phospholipid, and cholesterol concentrations were determined. Biliary lipid secretion rate was measured by the marker perfusion technique. Bile acid distribution was determined by gas-liquid chromatography. The pool size, FTR, and synthesis rate of each bile acid were measured by using CA and CDCA labeled with the stable isotope of carbon, 13C. In some of the subjects gallbladder storage and emptying were measured during the kinetic study, by real-time ultrasonography. Contraceptive steroid use was associated with a significant increase in biliary cholesterol saturation and in the lithogenic index of bile. The rate of cholesterol secretion in the contraceptive steroid group was 50% greater than in the control (p much less than 0.001) and the rate of bile acid secretion was reduced (p less than 0.02). The total bile acid pool size was significantly increased by contraceptive steroids. The major increase occurred in the CA pool (p less than 0.04). The daily rate of enterohepatic cycles of the bile acid pool was decreased by contraceptive steroids from 6.6 to 4.3 (p less than 0.01). The only effect of contraceptive steroids on gallbladder function was a slower emptying rate in response to intraduodenal amino acid infusion. No index of gallbladder function correlated significantly with any parameter of bile acid kinetics in this small group of subjects. The findings confirm the lithogenic effect of contraceptive steroids and indicate that its causes are an increase in cholesterol secretion and a decrease in bile acid secretion.

Bile↗
PubMed1991

The prevalence of Gardnerella vaginalis, Trichomonas vaginalis and Candida albicans in the cytology clinic at Ibadan, Nigeria.

In a study of 2224 adult women from the cytology clinic of the University College Hospital, Ibadan, Nigeria, the prevalence of 'specific vaginal infection' (i.e. Gardnerella vaginalis, Trichomonas vaginalis and Candida albicans) was 14.5%. For individual organisms, the rates were 9.76% for G. vaginalis, 2.52% for T. vaginalis and 2.20% for C. albicans. About half of the patients were asymptomatic while others were referred from other clinics with vaginal discharge, cervical erosion, post-coital bleeding, intermenstrual bleeding and various other symptoms and signs. The infections were almost uniformly distributed in all age groups studied. Increasing promiscuity either as a result of increased mobility of husbands (due to economic depression) or increased use of contraception by older women was thought to be responsible for the persistence of these infections in those aged 45 years and above. In addition, Gardnerella vaginalis, Trichomonas vaginalis and Candida albicans infections can also be easily diagnosed from cervical cytology, by identification either of the organism or of characteristic cytological cellular changes.

Adult↗
PubMed2006

Comparison of knowledge, attitudes, experience, and opinions between teachers and guardians regarding the emergency contraceptive pill in Chiang Mai, Thailand.

Teachers and guardians (parents or authorized persons) are expected to collaborate in educating female students about emergency contraceptive pills (ECPs) but it is unknown whether they have similar perspectives on ECPs. This study aimed to compare their knowledge, attitudes, experience, and opinions regarding ECPs. Questionnaires were distributed to 720 female teachers and guardians of eight randomly selected high schools and vocational schools in Chiang Mai, Thailand. There were significantly more teachers who knew about the existence of ECPs than guardians. More guardians reported some accurate information regarding ECPs than did teachers. More teachers than guardians believed that the use of ECPs was not morally wrong. Both teachers and guardians had similar experience with ECP use and similar agreement in teaching female adolescents about ECPs. The teachers and guardians had some different opinions on teaching barriers. It is suggested that both teachers and guardians are suited to teach female adolescents about ECPs, but they need preparation in different aspects.

Adolescent↗
PubMed1997

Early elevation of lipoprotein(a) levels in chronic renal insufficiency.

Serum lipoprotein(a) [Lp(a)] concentrations in chronic renal failure patients were investigated in relation to the degree of renal insufficiency, treatment by maintenance hemodialysis, and correction of uremia by renal transplantation with or without cyclosporin immunosuppression. Fast serum levels of Lp(a) (mg/100 mL) were determined in 34 chronic renal failure patients not in need of maintenance dialysis (16 with serum creatinine 2.0-4.0 mg/100 mL; 18 with serum creatinine higher than 4.0 mg/100 mL), 40 patients treated by hemodialysis, 55 successful renal transplant recipients (28 under cyclosporin treatment and 27 receiving no cyclosporin), and 34 healthy controls. Age and sex distributions were similar among groups. Pregnant women; non-White individuals; subjects with obesity, diabetes, nephrotic syndrome, and hepatic and thyroid diseases; and those treated with oral contraceptives or lipid-lowering drugs were excluded from the study. Compared to controls, median Lp(a) was increased in nondialyzed renal failure patients (11 vs. 47.5 p < 0.001) and this was the only lipid abnormally observed in the group. There was no significant difference in Lp(a) levels between nondialized renal failure patients with serum creatinine 2.0-4.0 and > 4.0 mg/100 mL (47 vs. 49, NS). Moreover, Pearson correlation coefficient (r = 0.01, NS) showed that Lp(a) values were not related to serum creatinine in nondialyzed patients, In hemodialysis subjects Lp(a) concentrations (median = 29) were intermediate between those observed in nondialyzed patients and controls but the differences were not significant. Lp(a) levels in renal transplant patients treated with cyclosporin (median = 6) and not receiving cyclosporin (median = 13) were similar and did not differ from controls. Serum Lp(a) increases and attains maximum levels with mild/moderate reduction in renal function, and does not seem to change through late renal failure stages or in relation to the introduction of maintenance hemodialysis treatment. Correction of uremia by successful renal transplant caused normalization of Lp(a) levels regardless of the use of cyclosporin. Increased Lp(a) levels may be the earliest and more consistent lipid alteration seen in predialysis renal failure.

Adult↗
PubMed2002

Local delivery of mitoxantrone for the treatment of malignant brain tumors in rats.

OBJECT: Mitoxantrone is a drug with potent in vitro activity against malignant brain tumor cell lines; however, its effectiveness as a systemic agent has been hampered by poor central nervous system penetration and dose-limiting myelosuppression. To avoid these problems, we incorporated mitoxantrone into biodegradable polymeric wafers to be used for intracranial implantation, a strategy that has been shown to be safe and successful in the treatment of malignant gliomas. The authors investigated the release kinetics, toxicity, distribution, and efficacy of mitoxantrone delivered from intracranially implanted biodegradable wafers in the treatment of 9L gliosarcoma in Fischer 344 rats. METHODS: Mitoxantrone released from the biodegradable wafer matrix reached therapeutic drug concentrations in the brain for at least 35 days. Only animals with implanted wafers of the highest drug loading dose (20% mitoxantrone by weight) showed signs of significant toxicity. In three separate efficacy experiments, animals treated with mitoxantrone-loaded biodegradable wafers had significantly improved survival compared with control animals. The combined median survival for each treatment group was the following: 0% mitoxantrone wafers, 19 days; 1%, 30 days, p < 0.0001; 5%, 34 days, p < 0.0001; and 10%, 50 days, p < 0.0001. CONCLUSIONS: These findings establish that mitoxantrone delivered from intracranially implanted biodegradable wafers is effective in the treatment of malignant gliomas in rodents and should be considered for future clinical application in humans.

Animals↗