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Biological factors affecting concentrations of serum LpAI lipoprotein particles in serum, and determination of reference limits.

We used an electroimmunoassay to measure LpAI lipoprotein particles (lipoproteins containing apolipoprotein AI but not apolipoprotein AII) in serum of a presumably healthy population of about 1000 subjects, noting sex- and age-related variations for the age interval four to 70 years. Results were higher for women than men. For males, the value for the 50th percentile of the distribution was highest in the 10- to 14-year subgroup, 0.69 g/L, decreasing to 0.60 g/L in adults. For females, the values increased regularly, from 0.59 g/L at ages four to 10 years to 0.79 g/L after age 55 years. The influence of puberty, menopause, oral contraceptives, alcohol consumption, and morphometric characteristics was studied. Only being overweight by more than 20% statistically influenced LpAI values in men and in women. We used these results to select a reference population and to establish reference limits of LpAI at ages 25 to 35 years: 0.40-0.95 g/L for men and 0.46-1.05 g/L for women.

Adolescent↗

Pharmacokinetic comparison of two triphasic oral contraceptive formulations containing levonorgestrel and ethinylestradiol.

The pharmacokinetics of levonorgestrel (LNG) and ethinylestradiol (EE2) were determined in 24 women (aged 21 to 35 years), following the administration of a single tablet from the second phase of two different triphasic preparations (Triphasil and Trinordiol. Each tablet contained 0.075 mg of LNG and 0.040 mg of EE2. The data were compared to the pharmacokinetics of LNG and EE2 obtained following the oral administration of a hydroalcoholic solution (standard) containing the same steroids and dose. The study consisted of a randomized design in which the three formulations were administered to each of the 24 subjects in a three-period crossover pattern. Blood samples were taken at frequent intervals after dosing. Serum levels of LNG and EE2 were measured by specific radioimmunoassays. The results show that both LNG and EE2 in the Triphasil and Trinordiol tablets are bioequivalent with respect to rate and extent of absorption. Furthermore, LNG, but not EE2, in both tablet formulations was bioequivalent to the solution dose. The serum concentration-time profiles for the three formulations showed that the range of mean peak levels was 2.3-2.8 ng/ml for LNG and 116-159 pg/ml for EE2. These levels were achieved within 2 hours in the majority of subjects. The ranges of mean values calculated for the areas under the curves were 15-16 ng.hr/ml for LNG and 1053-1390 pg.hr/ml for EE2. The ranges of mean values calculated for other pharmacokinetic parameters were: volume of distribution: LNG--1.6-1.8 L/kg, EE2--7.7-9.1 L/kg; clearance: LNG--84-88 ml/hr/kg, EE2--0.67-0.99 ml/hr/kg; half-life: LNG--13-15 hr, EE2--7-12 hrs.

Adult↗

Insertion site complications during the first year of NORPLANT use.

Although review articles have provided much information on the NORPLANT system, information on insertion site complications based on multi-country trials has been limited to infection rates. This paper examines 2,674 NORPLANT acceptors from seven countries who were enrolled and followed for one year. The one-year incidence rates of infection (0.8%), expulsion (0.4%) and local reaction (4.7%) varied widely among countries and clinics within a country. In contrast to previous reports that insertion site complications occur during the first few weeks of use, these data show that a substantial proportion of insertion site infections (34.6%) and implant expulsions (64.3%) were reported after the first two months of use, while 35.7% of local reactions were reported after 4.5 months of use. Of the 16 women with infections who did not have the implants immediately removed, 8 eventually required or requested removal, indicating that the ICCR recommendation for immediate removal in case of infection appears appropriate. An awareness of the frequency of insertion site complications, distribution of the time of onset post-insertion and potential sequelae of complications will aid clinicians in better client counseling and complication management.

Adult↗

Is use of exogenous estrogen associated with temporomandibular signs and symptoms?

BACKGROUND: Studies of historical data suggest a link between exogenous estrogen use and referral for treatment for temporomandibular disorders, or TMDs. The purpose of the authors' study was to determine the association between exogenous estrogen use and signs and symptoms of TMD assessed by direct physical examination in a randomly selected community sample of primarily postmenopausal women. METHODS: A calibrated clinical examiner examined a stratified random sample of 510 women aged 37 to 82 years using the Craniomandibular Index, or CMI. All medications that subjects were taking at the time of the examination were identified by interview and examination of subjects' medication containers on two occasions. One hundred seventy-four subjects were taking medications containing estrogen, and 336 were taking no such medications. RESULTS: The muscle and joint signs and symptoms of women taking and not taking estrogen were not significantly different after the authors controlled for sociocultural, demographic and health care utilization variables. Estrogen use also failed to distinguish women receiving relatively high and low scores on the CMI. CONCLUSION: Estrogen replacement therapy does not place women at increased risk of developing TMDs. CLINICAL IMPLICATIONS: Clinicians need not be concerned that patients taking oral contraceptives or replacement estrogens are at increased risk of developing TMDs.

Adult↗

District-level religious composition and adoption of sterilization in India.

This paper examined the influence of religion on the adoption of female sterilization, using data from the 1992/93 Indian National Family Health Survey. The influence of religion at both individual and district levels was examined, and a multi-level modelling methodology was used for assessing community variations in the influence of religion on the adoption of sterilization. Individual religion was a strong predictor of the decision to adopt sterilization, and residence in a district in which more than 20% of the people were Muslims significantly lowered the odds of adoption of sterilization. There was more variation in the adoption of sterilization between districts for Muslim women and women from minority religious groups. The results demonstrate the influence of community conservatism on the choice of contraceptive methods and point to the mediating effects that community characteristics can have on access to sterilization services for women from religious minority sub-groups.

Adolescent↗

The effect on lipids and lipoproteins of a contraceptive vaginal ring containing levonorgestrel and estradiol.

Lipids and lipoproteins were studied in controls and women using contraceptive vaginal rings (CVRs). The groups were comparable for race, age, parity, obesity indices, alcohol ingestion, smoking, diet and exercise. Fasting blood samples were obtained twice before CVR treatment, after 2 and 7 weeks of treatment and 1 week thereafter. The women using the CVR had a significant incremental reduction of cholesterol from baseline to treatment which was distributed among all the lipoprotein classes. The cholesterol/HDL-C ratio was significantly increased with treatment. All mena changes were within the reference range. The reduction in HDL and especially in the subclasses HDL 2a and HDL 2b were significant and outside the reference range. The LDL/HDL ratio increased significantly, while the LDL/HDL 2a+2b ratio increased significantly outside the reference range with treatment. Of the lipid and lipoprotein measurements that changed significantly with treatment, HDL-C, HDL, HDL 2a LDL/HDL and LDL/HDL 2a+2b changed significantly towards baseline in the 1-week-off treatment. The potential reduction in predicted coronary risk with the use of the CVR suggested by a reduction in cholesterol was counterbalanced by a reduction in HDL-C and increases in the cholesterol/HDL-C and LDL/HDL ratios. The potential clinical implications of these findings remain to be determined.

Adult↗

Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol.

OBJECTIVE: To compare two oral contraceptive pills, both containing 150 micrograms desogestrel, but with either 20 micrograms (Mercilon) or 30 micrograms (Marvelon/Desolett) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile. DESIGN: A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards. SETTING: University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark. SUBJECTS: One thousand women aged 18 to 40 years requesting oral contraceptive pills. MAIN OUTCOME MEASURES: Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin. RESULTS: In a total of 4543 cycles with the 20 micrograms EE dose pill and 4688 cycles with the 30 micrograms EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial. CONCLUSIONS: Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding.

Adolescent↗

Hospital admissions due to adverse drug reactions: a comparative study from Jerusalem and Berlin.

A comparative study of adverse drug reactions (ADR) leading to hostpial admission showed that 103 (4.1%) out of 2499 medical admissions in Jerusalem and 167 (5.7%) out of 2933 admissions in Berlin were due to such reactions. Sex distribution in the two patient--populations was almost equal but the Jerusalem patients were younger. The most frequent ADRs were digitalis intoxication (in Berlin) and reactions to antibiotics (in Jerusalem). Other important differences were noted in the relative frequencies of ADRs associated anticoagulants, hypoglycemic agents and oral contraceptives. They were probably related to differences in drug usage in the two countries. The most common major side effects were arrhythmias, allergic reactions, bleeding, congestive heart failure, bronchospasm and hypoglycemia. The following risk factors were identified in both cities: old age, female sex, impaired renal function, previous history of ADR and polypragmasia.

Adult↗

Preference for sons, family size, and sex ratio: an empirical study in Korea.

This study investigates the effects of son preference on sex ratio and fertility at the family level, utilizing World Fertility Survey data for Korea, whose population is known to have a strong preference for sons and a fairly high level of contraceptive use. The sex ratio (number of males per 100 females) of siblings in small families is considerably higher than in large families. The sex ratio of last-born children in families of any size is markedly higher than that of the previous children. The sex distribution of children for a given family size, if less than five, deviates significantly from the Bernoulli sequence. The observed frequency of all-girl families is especially small in comparison with the expected value. The sex of the last child strongly influences couples' decision making regarding additional births in all steps of family building except for bearing a second child. In increasing their families to moderate size, parents appear to take into consideration the sex distribution of all earlier births.

Adult↗

The impact of contraceptive methods on the onset of symptomatic vulvovaginal candidiasis within the menstrual cycle.

OBJECTIVE: Vulvovaginal candidiasis is the second most common cause of vaginal discharge. Low-dose oral contraceptives are no longer thought to increase the absolute risk of episodic vulvovaginal candidiasis. This study investigates the possible impact that hormonal contraception may have on the timing of onset of symptoms within the menstrual cycle. STUDY DESIGN: In a retrospective chart review of reproductive-aged women seen at the Women's Health Care Clinic at Harbor-University of California, Los Angeles, Medical Center, data from the records of 448 symptomatic women who had 507 episodes of vulvovaginal candidiasis were extracted and analyzed for timing of onset of symptoms within the menstrual cycle. Diagnosis was based on symptoms, physical findings, and microscopy. Onset was divided into five physiologic ranges within an idealized 28-day menstrual cycle. Comparisons among groups were made with use of chi 2 and p < 0.05 thresholds for statistical significance. RESULTS: No differences were found in the onset of symptoms within the idealized menstrual cycle ranges between women using hormonal birth control methods and those using nonhormonal ones. The distribution was remarkably uniform throughout the cycle with the exception of the first few days (during menses). CONCLUSION: The timing of onset of symptoms of vulvovaginal candidiasis within a woman's menstrual cycle is not affected by her method of birth control.

Candidiasis, Vulvovaginal↗

Influence of sex and oral contraceptive steroids on antipyrine metabolite formation.

Our study was undertaken to determine the influence of sex and the use of oral contraceptive steroids on antipyrine clearance and metabolite formation. Our subjects were eight men (M), eight women (F), and eight women who had been using oral contraceptive steroids (OC) for at least 6 mo; all were healthy. The groups were matched for age and smoking and drinking habits. Antipyrine elimination half-life (t1/2) was longer in the OC than in the F group (12.9 +/- 2.0 and 9.7 +/- 1.7 hr) and clearance was lower (2.0 +/- 0.1 and 2.8 +/- 0.5 l/hr), while volume of distribution (Vd) was essentially the same (37.1 +/- 5.7 and 38.5 +/- 4.6 l). The M group had longer t1/2s than the F (11.8 +/- 1.2 and 9.7 +/- 1.7 hr) and greater Vds (47.1 +/- 5.4 and 38.5 +/- 4.6 l), but clearance values were the same (2.8 +/- 0.5 and 2.8 +/- 0.5 l/hr) in the two groups. Compared to the F, the three metabolic pathways of antipyrine appeared to be inhibited in the OC group. Partial clearances for production for the F and OC groups were (l/hr); norantipyrine (NORA) 0.70 +/- 0.13 and 0.42 +/- 0.12, 4-hydroxyantipyrine (OHA) 1.19 +/- 0.37 and 0.83 +/- 0.25, and 3-hydroxymethylantipyrine (HMA) 0.45 +/- 0.10 and 0.33 +/- 0.09. Partial clearance for production in the F group was higher than in the M for OHA (1.19 +/- 0.37 and 0.78 +/- 0.15 l/hr) and NORA (0.07 +/- 0.13 and 0.56 +/- 0.13 l/hr), but not for HMA (0.45 +/- 0.10 and 0.40 +/- 0.05 l/hr). In the F group, total metabolite recovery was higher than the M. We conclude that sex and OC steroids have differential effect on the several metabolic pathways of antipyrine.

Adult↗

Comparative trial between two soft jelly capsules containing nonoxynol as spermicidal contraceptives.

The rupture time of two types of soft jelly capsules (treated and non-treated) containing Nonoxynol-9 after its vaginal insertion was investigated in 96 women. Subjects were allocated in four study groups: Group I (n = 24), women with clinical vaginal infection; Group II (n = 24), subjects without vaginal infection; Group III (n = 24), patients with vaginal infection; and Group IV (n = 24), women without vaginal infection. Groups I and II received the treated capsules, and Groups III and IV the non-treated capsules. The capsules remained in the vagina for 2.5 to 5 minutes. The weight of the capsules was measured before insertion and after their extraction. Additionally, vaginal pH and distribution of the compound were assessed. The results disclosed that in Groups I, III and IV, the capsules ruptured within 2.5 minutes, whereas in Group II the rupture did not occur until 3 minutes. The largest number of non-ruptured capsules was observed in Group II. The major capsule weight loss occurred at minute 5 in most of the groups. The conditions currently observed in cases of non-ruptured capsules were: alkaline pH, multiparity and vaginal dryness. The vaginal distribution of the compound was observed at its upper portion. In women with vaginal infections, there were more cases of rupture and a significant weight loss between the treated capsules than the non-treated capsules. Further postcoital tests are required to assess its effectiveness.

Administration, Intravaginal↗

Response rate according to title and length of questionnaire.

The purpose of this study was to investigate how response rates to a postal questionnaire are affected by title and length of the survey instrument. Five questionnaires, which differed according to title and length, were designed. Each questionnaire was mailed to a random sample of one thousand Norwegian women aged, 35-49 years. A total of 3,106 questionnaires were returned (62.1%). The highest response rate (70.2%) was achieved by a two-page questionnaire entitled "Women and Cancer". An otherwise identical questionnaire entitled "Oral Contraceptives and Cancer" had a response rate of 60.7%. Questionnaires entitled "Women and Cancer" with a length of four and six pages had a response rate of 62.8% and 63.3%, respectively. The four page questionnaire entitled "Women, Lifestyle and Health" had the lowest response rate of 57.1%. This study shows that in a general population of Norwegian women the title of a postal questionnaire influences the response rate. The results indicate that although the shortest questionnaire had the highest response rate, the most extensive survey instrument did not have the lowest response rate. The distribution of risk factors for breast cancer did not vary according to response rate or design of questionnaire. The overall findings of this study suggest that the benefits from the increased information obtained from extensive postal questionnaires out-weighs a potential non-response bias due to a somewhat lower response rate.

Adult↗

[Does previous exposure to oral contraceptives modify survival in breast cancer?].

The influence of a positive history of oral contraceptive (OC) use on survival of breast cancer was studied in 471 patients. 297 (63%) of them were ever users of OCs and 202 (43%) were long-term users (> or = 49 months). The median follow-up amounted to 56 (6-96) months. Except for a significantly higher frequency of poorly differentiated tumours in OC users (p = 0.01) there was no difference in the distribution of histopathological features between OC users and non-users. Nevertheless, compared to non-users OC user showed a significantly increased 5-year-survival (p = 0.017). This effect was strongly correlated with duration of use (p = 0.004) and time since last use (p = 0.02). The influence of OC use achieved significance after a duration of use of four or more years or in case of OC use at the time of diagnosis. The positive effect persisted in multivariate analyses and was mainly attributed to long-term OC users with tumours of a generally expected poor prognosis.

Adult↗

Long-term outcome of migraine.

Migraine prevalence increases from childhood up until 40 years of age, and thereafter declines. Several hypotheses can be advanced to explain the decrease in migraine with advancing age: (i) favorable effect of preventive treatments; (ii) increased mortality in migraineurs (due to higher vulnerability to other fatal diseases); (iii) cohort effect (increased incidence in young subjects); (iv) spontaneous remission. The first two theses are poorly supported by data in the literature. Although a cohort effect may exist, a spontaneous remission of migraine in middle and old age (at least partially due to the loss of sex hormone changes after the menopause in females) is the more likely hypothesis. In a small subgroup of patients (most of them drug abusers), migraine has a "malignant" course and changes into chronic daily headache. The risk factors for a poor outcome of migraine have been little studied. In a case-control study, we found that a history of head trauma and a long duration of contraceptive intake were risk factors for a bad outcome, whilst a long duration of prophylactic treatments had a protective effect.

Age Distribution↗