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Facts about oral contraceptives and their use are provided for the practcing generalist and specialist. Identification of oral contraceptives is given in chart form including company, name, contents, pill color, number in pack and special markings. Section 2 entitled "facts that may be helpful in prescribing or changing the prescription of oral contraceptives" includes potency of progestins and estrogens and symptoms indicating excessive or deficient progestin and estrogen activity. Contraindications such as migraine headaches, epilepsy, hepatic disease, renal disease and hypertension are among the reasons for obtaining a complete family history prior to prescription of oral contraceptives. This information provides the basis for choice of contraception tailored to the individual. A 100 pound 17 year old with a normal menstrual history and with adequate estrogen production would be safest with a medication low in estrogen and progestin. An older heavier woman with prolonged menstruation and cramps would require a pill which is potent in progestins since these are excellent for causing endometrium regression and vascular reduction. Length of time on oral c ontraceptives depends upon the patient's general health. If responding well to contraceptives the patient should continue to use them because 1) the body is programmed for lengthy periods of ovulation suppression; 2) the patient becomes accustomed to infertility and 3) too many unplanned pregnancies occur during rest intervals. Complaints of nausea, migraine headaches, change in libido, chloasma or thrombophlebitis determine the termination of the drug.
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PMID:The identification, selection and use of oral contraceptives. 112 61

During the past decade, the development of various gonadotrophin-releasing hormone (Gn-RH) agonists, which induce reversible hypo-oestrogenism has opened a new area in the medical management of endometriosis. In an open, multicentre phase III study, the efficacy, tolerance and safety of the Gn-RH agonist leuprorelin acetate were tested. The preliminary results of 104 women treated in seven German centres are presented. Pelvic endometriosis was diagnosed by laparoscopy and classified according to the American Fertility Society scoring system: 33% of patients had minimal, 22% mild, 28% moderate and 8% severe endometriosis and in 9% no pathological results were obtained. The patients' mean age was 30 +/- 6 years and 66 had infertility problems. Treatment was started within the first 3 days of the menstrual cycle and consisted of a subcutaneous injection of leuprorelin acetate 3.75 mg, repeated once monthly over 24 weeks. A follow-up period of 12 months after the last injection has been completed in 70 patients, including a second laparoscopy. At all visits, symptoms were evaluated, physical examinations performed, and blood samples collected for haematological screening, serum chemistry determinations and measurement of the gonadotrophins oestradiol and progesterone and leuprorelin acetate. The median score at laparoscopy fell from 12 before operation to 8 after operation and 2 after treatment with leuprorelin acetate. Of the total number of patients, 89% had improvements in their endometriosis, 8% a deterioration and 3% no change. Patients reported improvement in the following: dysmenorrhoea 93%, dyspareunia 62% and pelvic pain 70%. However, all women complained of at least one of the following symptoms: hot flushes 86%, sleep disturbance 62%, sweating 61%, headache 41%, nausea 32% and depression 20%. Fifty-five percent of patients reported additional side effects such as vaginal dryness, fatigue and lower abdominal pain. After the third injection, amenorrhoea persisted in 94% of the women. Four weeks after the first leuprorelin acetate injection median concentrations of oestradiol fell from 45 pg/ml to 11 pg/ml, follicle-stimulating hormone from 7 U/L to 3 U/L and luteinising hormone from 5 U/L to 1 U/L and remained almost unchanged over the observation period. During the 6 months' treatment, laboratory parameters showed no significant deviations from normal; only total cholesterol, high-density lipoprotein cholesterol and alkaline phosphatase increased. Treatment results were judged as good and satisfactory in 82% and 11% of cases, respectively. On the basis of this study, it can be concluded that leuprorelin acetate treatment is safe, well tolerated and effective in the medical management of endometriosis and endometriosis-related complaints.
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PMID:Treatment of endometriosis with leuprorelin acetate depot: a German multicentre study. 153 21

This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

Oral contraceptives (OCs, long-acting progestins (LAPs), and IUDS are reviewed in terms of new information on safety and efficacy. OC formulations are described and their mechanism of action and efficacy indicated. Reports are provided for thromboembolism, hemorrhagic and thrombotic stroke, ischemic heart diseases, alterations in lipid and hypoprotein and carbohydrate metabolism, hypertension, coagulation changes, breast and cervical cancers, and such minor side effects as menstrual irregularities, nausea, headaches, weight gain, premenstrual syndrome effects, and mood and libido changes. Noncontraceptive health benefits and clinical considerations are discussed. Norplant, as the only long acting progestin available in the US is described in terms of its formulations, mechanism of action, sequelae and metabolic effects, menstrual irregularities, metabolic effects, nuisance side effects, candidates for insertion, method of insertion and removal, and continuation rates. 2 IUD types are identified as the only ones available in the US, Progestasert T and T-Cu-380A (Paragard). Mechanism of action, efficacy, candidates, major sequelae such as salpingitis, infertility, and uterine perforation, minor sequelae such as metrorrhagia and dysmenorrhea, and other considerations are indicated. OCs in the US contain an average of 35 mg of ethinyl estradiol and assorted progestins e.g.s, ethynodiol diacetate, norethindrone acetate, nortestosterone derivatives with a complex mechanism of action. The failure rate for use effectiveness is 6 pregnancies/100 woman years. Modern formulations have combined rates of no more than 50 to 100 adverse events/100,000 users. Some of the effects are indicated as follows: Thromboembolism accounts for 60% of adverse effects and appears to be declining along with hemorrhagic and thrombotic stroke, however, modern use studies are only partially available. Myocardial infarction related to OC use may be embolic, and has a low risk at 7/100,000 users. Low-dose contraceptives substantially reduce the associated risks. Those with risk factors need close monitoring. Norplant is useful for those not wanting to take a daily regimen and is commonly accompanied by menstrual irregularity and sometimes headaches. Continuation is 80% after the 1st year and 40% after 5 years. Candidates for IUDs are parous women in monogamous relationships, who are not at risk for salpingitis, which is related to IUD use, or sexually transmitted diseases. Continuation is 70% after 1 year compared with 50% of OC users.
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PMID:Modern trends in contraception. 212 11

Thirty-two women with ovarian dysfunction due to hyperprolactinemia were treated with a new derivative of lisuride-terguride. Twenty-three patients were treated for infertility. A microadenoma was confirmed in five, and three other patients had had a macroprolactinoma surgically removed. The finding in one of the patients was diagnosed as the syndrome of empty sella. Galactorrhea was present in 18 women. The duration of treatment ranged from 2 to 33 months. The determination of therapeutic dosages was based on individual responses on the prolactin levels within a range from 0.1 to 4.5 mg per day. Increased prolactin levels were successfully normalized in twenty-one treated patients. Regular periods were reappeared in 59% of the women. Thirteen (56%) became pregnant, seven gave birth to healthy babies, two of the patients aborted in the first trimester. Four women are still in later stages of pregnancy. Galactorrhea disappeared in 56% of the patients, being markedly inhibited in the remaining ones. In two cases, microadenoma disappeared after treatment, and in those after surgery the postoperative findings were decreased, in one patients there is no alteration in the pathology. Side effects were seen in 34% of the patients, being mostly mild in nature, and including in most cases nausea, headache and stomach pain. The complaints were transient, receding after prolonged treatment.
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PMID:Terguride in the treatment of hyperprolactinemia. 215 Feb 71

Risk factors for ectopic pregnancy include previous ectopic pregnancy, current intrauterine device use, prior fallopian tube surgery, previous pelvic inflammatory disease and a prior history of infertility. Abdominal pain is the most common symptom, followed by amenorrhea or vaginal bleeding, nausea, vomiting, syncope and dizziness. Referred shoulder pain following the onset of abdominal pain is characteristic of intraperitoneal bleeding and, in the appropriate clinical setting, strongly suggests a ruptured ectopic pregnancy. A coordinated evaluation includes measurement of serum human chorionic gonadotropin concentration and transabdominal or, preferably, transvaginal ultrasonography. Treatment is primarily by one of a variety of surgical techniques. Medical therapy with methotrexate or other drugs is currently under investigation.
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PMID:Management of ectopic pregnancy. 218 38

The potential for recall bias in case-control studies is a common concern. The authors assessed whether recall bias was present in exposure information reported at postpartum interview by mothers of malformed and nonmalformed infants who delivered at Brigham and Women's Hospital, Boston, during 1984. Accuracy of exposure reporting was measured by comparing interview data with exposure information documented during pregnancy in obstetric records. The authors' measure of recall bias, relative sensitivity (RS), is the ratio of exposure-reporting accuracy for mothers of malformed infants to that of mothers of nonmalformed infants. Relative sensitivity estimates that are greater than 1.0 indicate that mothers of malformed infants are more accurate reporters than mothers of nonmalformed infants. Relative sensitivity was estimated for eight exposure factors: antibiotic or antifungal drug use (RS = 1.2), urinary tract or yeast infection (RS = 2.7), history of infertility (RS = 1.4), use of birth control after conception (RS = 7.6), elective abortion history (RS = 1.1), any over-the-counter drug use (RS = 1.0), spotting or bleeding (RS = 1.2), and nausea or vomiting (RS = 0.8) These data suggest the presence of recall bias for some exposure factors. The authors advise the use of malformed controls to reduce potential recall bias in case-control studies of selected malformations and many etiologic factors.
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PMID:Reporting accuracy among mothers of malformed and nonmalformed infants. 232 34

The role of maternal risk factors in the development of nausea and vomiting in pregnancy was studied in a historical cohort of 825 women who gave birth at the University of California (Los Angeles) Medical Center during a one-year period (April 1983-March 1984). The roles of demographic factors, reproductive history, and consumption of alcohol and tobacco in affecting the risk of developing nausea and vomiting were studied using both bivariate and multivariate statistical methods. Interpretations of the statistical analyses identify three risk factor associations correlated with decreased risk of nausea and vomiting and one factor associated with increased risk. The most apparent pattern was that women who were ethnically white, of white collar or professional occupation, and who consumed alcohol prior to conception, were at decreased risk for nausea and vomiting. The second pattern of decreased risk consisted of women over 35 years old with a history of infertility for one or more years prior to the current conception. The third low-risk pattern consisted of women without a history of nausea during prior pregnancies. The only factor associated with an increased risk was housewife occupational status. The results of this study are consistent with an endocrinologic model for the etiology of pregnancy-induced nausea and vomiting.
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PMID:The association of reproductive history, demographic factors, and alcohol and tobacco consumption with the risk of developing nausea and vomiting in early pregnancy. 334 60

Gossypol is a phenolic compound isolated from the seeds, stems, and roots of the cotton plant. The chemical has been known for years as the toxic principle left in the cottonseed cake after cottonseed oil extraction. It is also present in the cold pressed cottonseed oil from which it may be removed through reactions with alkali. Extremely low birthrates in China's Hebeth province were traced to the use of crude cotton seed oil for cooking purposes. After prolonged investigation, it was determined that male infertility was related to the gossypol content of the oil. After a short period of animal studies, the Chinese in 1972 undertook widespread clinical trials of gossypol as a contraceptive agent. Over 4000 men have undergone treatment with the drug, some for as long as 4 years. Infertility resulted after 2 months of a daily dose of 20 mg and then the participants were maintained on 150-220 mg/month in divided doses. The drug apparently did not decrease libido in most test subjects and had not been reported to impair potency. Semen analysis at various intervals showed a decrease in motile sperm, malformed spermatozoa, and then a decrease in sperm count, leading to azoospermia. On discontinuation of the substance, the antifertility effect completely reversed itself within 3 months. No obvious toxic effects of pathological changes were observed in human and animal studies. Levels of luteinizing hormone and testosterone were unchanged and apparently indicated that gossypol does not affect hormonal balances. Adverse reactions reported to date include transient and reversible weakness in 10% of the test subjects on initiation of therapy. In addition, appetite changes, gastric discomfort, and nausea have been noted. A few cases of slight EKG changes and disturbances in potassium metabolism have occurred. No chromosomal changes have been observed nor have tests shown any mutagenic effects of the drug. In conclusion, preliminary data indicated that gossypol may offer an excellent new approach to contraception. Further testing is required to elucidate the drug's mechanism of action and to determine its adverse and possible toxic effects.
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PMID:Gossypol as an oral contraceptive for men. 692 15

Ovulation-induction agents are commonly used in the treatment of infertility in patients with or without ovulatory disturbances. These agents include clomifene, bromocriptine, gonadotrophin preparations and gonadotrophin-releasing hormone (GnRH) and its analogues. Each agent is associated with its own specific adverse effects. Although many of these adverse effects are benign and self-limited, some, in particular those effects associated with gonadotrophins, may be life-threatening. Commonly noted adverse effects encountered with the use of pharmacological agents to treat infertility include the following. Clomifene has been associated with hot flushes, multiple gestation, visual disturbances, cervical mucus abnormalities and luteal phase deficiency. Similarly, most of the adverse symptoms associated with bromocriptine are short-lived, such as nausea and postural hypotension. On the other hand, gonadotrophin therapy, even when used appropriately, may lead to the ovarian hyperstimulation syndrome (which is occasionally life-threatening) and a high incidence of multiple gestation. Pulsatile GnRH therapy maybe accompanied by similar adverse effects to those of gonadotrophins, but with a far lower incidence. With regards to the long term safety of these medications, the relationship between fertility drugs and epithelial ovarian cancer is controversial, and causality has yet to be proven. Indeed, a working knowledge of the many adverse effects associated with these medications is essential to any physician prescribing ovulation induction agents, in order to ensure maximum patient safety, compliance and understanding.
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PMID:Adverse effects of fertility drugs. 772 51


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