Reports from the field-Obstetrics/gynecology
Reports from the field-Obstetrics/gynecology
Study finds little paroxetine in breast milk, blood samples
Breast-fed infants of mothers taking the antidepressant paroxetine hydrochloride had no significant traces of the medication in their blood and experienced no adverse events, says a recent study in the American Journal of Psychiatry.
Paroxetine is a selective serotonin reuptake inhibitor used to treat social anxiety disorder, depression, panic disorder, and obsessive compulsive disorder. "Due to the increased occurrence of mood and anxiety disorders during childbearing years, it is imperative that we continue to research and make treatment options such as [paroxetine] available for mothers who want the opportunity and benefit of breast-feeding their children," says Zachary N. Stowe, MD, director of Emory University School of Medi cine's Pregnancy and Postpartum Mood Disorders program and lead clinical investigator of the study.
Breast milk and paired maternal and infant sera were collected after 10 days of maternal treatment with paroxetine at a stable daily dose of 10 mg to 50 mg/daily. Blood samples were obtained from all mothers within two to five hours after the daily paroxetine dose and from the infants one to five hours after nursing. All samples were analyzed by means of high-performance liquid chromatography with ultraviolet detection. Breast milk paroxetine concentrations were present in all 108 breast milk samples.
Greater paroxetine concentrations were found in later samples of breast milk than in early samples. No clear time course of paroxetine excretion into breast milk concentrations over a 24-hour period was demonstrated. In 16 mother and serum pairs, no detectable concentrations of paroxetine were found in the serum of nursing infants. Neither parents nor pediatricians of infants in the study reported any changes in infant behavior, disposition, sleep, activity, or bowel movements during the course of the study. In addition, none of the pediatricians reported concerns about infant growth or development.
[Stowe ZN, Cohen LS, Hostetter A, et al. Paroxetine in human breast milk and nursing infants. Am J Psychiatry 2000; 157:185-189.]
Subcutaneous therapy improves outcomes
A new study of twin gestation pregnancies released at the recent Society of Maternal Fetal Medicine in Miami Beach found that pregnancy outcomes for women experiencing recurrent preterm labor treated with subcutaneous tocolytics were significantly better than for women treated with oral tocolytics.
More than 700 women participated in the study. Half of them were treated with oral tocolytics, and half were treated with subcutaneous tocolytics infusion therapy. The study found that subcutaneous therapy resulted in the following outcomes:
• increased average gestation age by nearly a week;
• reduced incidence of very low birth weight infants by roughly 50%;
• reduced rate of neonatal intensive care unit admission by roughly 30%;
• decreased average antepartum hospital days by more than 50%;
• reduced average infant nursery stays by more than 30%;
• reduced average total antepartum hospital, nursery, and outpatient costs by about $17,000.
"Our research was designed to evaluate the clinical and cost-effectiveness of using continuous subcutaneous terbutaline versus oral tocolytics to treat preterm labor. The results strongly suggest that prescribing subcutaneous terbutaline promotes improved patient outcomes and decreased costs," says Fung Lam, MD, vice chairman of the department of obstetrics and gynecology at Calif ornia Pacific Medical Center in San Francisco and lead researcher of the study.
Younger women need aggressive cancer therapy
Young age at diagnosis places women at greater risk of dying from breast cancer, according to a recent study in the British Journal of Medicine.
Researchers in Denmark conducted a retrospective cohort study using a population-based database of breast cancer patients containing detailed information on tumor characteristics, treatment regimens, and survival. Data for 10,356 women with primary breast cancer who were younger than 50 at diagnosis were included in the study. Overall, young women with low-risk disease who did not receive adjuvant treatment had a significantly increased risk of dying. The risk increased with decreasing age at diagnosis as follows:
• 45 to 49 years: 1;
• 40 to 44 years: 1.12;
• 35 to 39 years: 1.40;
• < 35 years: 2.18.
No similar trend was seen in patients who received adjuvant cytologic treatment. The increased risk in younger women who did not receive adjuvant treatment vs. those who did remained when women were grouped according to presence of node-negative disease and by tumor size.
Researchers concluded that the negative prognostic effect of young age is almost exclusively seen in women diagnosed with low-risk breast cancer who did not receive adjuvant cytologic treatment. The results suggest that young women with breast cancer, on the basis of age alone, should be regarded as high-risk patients and given cytologic treatment.
[Kroman N, Jensen MB, Wohlfart J, et al. Factors influencing the effect of age on prognosis in breast cancer: Population-based study. BMJ 2000; 320:474-479.]
Plan carefully to avoid postpartum relapses
Bipolar disorder often returns after baby comes
Pregnancy poses major challenges for the treatment of bipolar disorder. Concerns about fetal health often cause physicians to discontinue lithium maintenance during pregnancy. A new study in the American Journal of Psychiatry suggests that gradual discontinuation of lithium during pregnancy may lead to a lower recurrence risk in the postpartum period.
Researchers retrospectively compared recurrence rates and survival functions for 101 women with DSM-IV bipolar disorder during pregnancy and postpartum periods or during equivalent periods for age-matched nonpregnant subjects after either rapid or gradual discontinuation of lithium. Of women in the study, 68 had type I bipolar disorder and 33 had type II. Recurrence rates also were obtained for the year prior to lithium discontinuation. Findings include:
• Rates of recurrence during the first 40 weeks after lithium discontinuation were similar for pregnant (52%) and nonpregnant women (58%).
• Among subjects who remained stable over the first 40 weeks after lithium discontinuation, postpartum recurrences were 2.9 times more frequent (70%) than recurrences in nonpregnant women during weeks 41 through 64 (24%).
• Depressive or dysphoric-mixed episodes were more prevalent in pregnant women (63%) than nonpregnant women (38%).
• Recurrence risk was greater after rapid than after gradual discontinuation and for patients with more prior affective episodes, but it was similar for diagnostic types I and II.
Researchers noted that the rates of recurrence during the first 40 weeks after lithium discontinuation were similar for pregnant and nonpregnant women but then sharply increased for women in the postpartum period. Risk was much lower during treatment and lessened with gradual discontinuation of lithium. Treatment planning for pregnant or potentially pregnant women with bipolar disorder should consider the relative risks of fetal exposure to mood stabilizers vs. the high recurrence risks after discontinuing lithium, researchers concluded.
[Viguera AC, Nonacs R, Cohen LS, et al. Risk of recurrence of bipolar disorder in pregnant and nonpregnant women after discontinuing lithium maintenance. Am J Psychiatry 2000; 157:179-184.]
Combination therapy prevents HIV infection in newborns
Researchers presented evidence at the recent 7th Annual Conference on Retroviruses and Opportunistic Infections in San Francisco that anti-HIV combination therapy including the protease inhibitor nelfinavir mesylate in pregnant women prevented the transmission of HIV from mother to their newborn children in all eight participants who completed the trial. In addition to eliminating HIV transmission to their infants, mothers in the study experienced significantly fewer HIV-related symptoms.
Treatment is well-tolerated
HIV-infected women ranging from 14 to 34 weeks gestation were enrolled in the trial and received oral doses of nelfinavir mesylate 750 mg three times daily plus standard doses of the nucle oside analogues AZT and 3TC, both during and after pregnancy. In labor, nelfinavir mesylate and 3TC were administered orally, and AZT was administered intravenously. Newborns in the study received nelfinavir mesylate 10 mg/kg three times daily in combination with weight-adjusted doses of AZT and 3TC.
Treatment with nelfinavir mesylate during pregnancy and in newborn infants appeared to be well-tolerated. All eight infants were born free of HIV infection at a median gestational age of 38 weeks.
HPV testing detects cervical disease best
Study of 1,977 women presented at conference
Data presented at the Society of Gynecologic Oncologists' 30th Annual Meeting in San Diego indicates that human papilloma virus (HPV) testing detected more high-grade cervical disease and cervical cancer when compared with four other diagnostic methods, including liquid cytology collected at the time of a Pap smear and colposcopy.
A screening trial of 1,977 Chinese women between ages 35 and 45 found the following:
• The Hybrid Capture II HPV test from Digene in Gaithersburg, MD, had a sensitivity for detecting disease of 98% and a specificity of 85%.
• Liquid cytology had a sensitivity of 94% and a specificity of 74%.
• Colposcopy had a sensitivity of 81% and a specificity of 77%.
• Other tests such as direct visual inspection by acetic acid and fluorescent spectroscopy did not perform as well as either colposcopy or cytology methods and had considerably lower specificity and sensitivity.
Only one HPV test approved
"We can now design more cost-effective screening programs based on a population's resources and prevalence of disease," notes Jerome Belinson, MD, chairman of the department of gynecology and obstetrics at the Cleveland Clinic and lead author of the study.
"These data certainly support the incorporation of primary HPV testing in future screening programs in women over the age of 35," he explains.
The Hybrid Capture HPV test is the only one approved by the U.S. Food and Drug Adminis tration for HPV testing. The test is currently used in the United States as an adjunct to the Pap smear for cervical cancer screening and is marketed overseas as a primary cervical cancer screen whether in conjunction with or separate from the Pap smear.
[For additional information on the HPV test, visit the company's Web site at www.digene. com.]
Disease management
Sleep apnea increases risk of hypertension
Sleep apnea is a significant risk factor for hypertension, says a recent study in the British Medi cal Journal. Researchers evaluated 2,677 adults ages 20 to 85 who were patients in a Canadian sleep clinic. Medical history, demographic data, morning and evening blood pressure, and whole-night polysomnography were analyzed. Researchers concluded that sleep apnea is profoundly associated with hypertension, independent of all other relevant risk factors. Findings include:
• Blood pressure and number of patients with hypertension increased linearly with severity of sleep apnea, as shown by the apnea-hypopnea index.
• Multiple regression analysis of blood pressure levels of all patients not taking pressure-lowering medication showed that apnea was a significant predictor of both systolic and diastolic blood pressure after adjustment for age, body mass index, and sex.
• Multiple logistic regression showed that each additional apnea event per hour of sleep increased the odds of hypertension by about 1%.
• Each 10% decrease in nocturnal oxygen saturation increased the odds of hypertension by 13%.
[Lavie P, Herer P, Hoffstein V. Obstructive sleep apnea syndrome as a risk factor for hypertension: Population study. BMJ 2000; 320:479-482.]
St. John's Wort interferes with some medications
The popular herb St. John's Wort — gaining acceptance as a natural alternative to prescription drugs for mild to moderate depression — appears to interfere with the effectiveness of some medications used to control chronic illness, according to several letters and articles in the Feb. 12 issue of the British journal Lancet.
Correspondence and original research presented in that issue report that St. John's Wort can interfere with protease inhibitors used for treatment of HIV infection; appears to have contributed to heart transplant rejection by interfering with the drug cyclosporin; may decrease the effectiveness of oral contraceptives; and affects the body's metabolism of drugs in more than one way, leading to a risk of interactions with numerous medications taken for a wide range of chronic conditions.
At last year's Annual Congress for Clinical Pharmacology in Berlin, researchers presented evidence that St. John's Wort interferes with the heart drug digoxin and the blood-thinning drug warfarin, says Steven Bratman, MD, medical director for TheNaturalPharmacist.com (www. tnp.com), an interactive Web site based in Rose-ville, CA. "I recommend that individuals taking any medication critical to their health should avoid using St. John's Wort except on physician advice. This new information reminds us that 'safe natural products' are not always entirely safe. Harmful drug interactions are probably the most likely area for problems to develop."
Study finds 33% of ICU patients suffer from malnourishment
A multicenter study presented at the recent 24th Annual Clinical Congress of the American Society of Parenteral and Enteral Nutrition in Nashville, TN, found that caregivers underestimated the nutritional needs of one out of every three intensive care unit patients.
In this study, researchers used sensor technology instruments to measure the daily metabolic rate of critically ill patients. They found that current practices of estimating nutritional requirements resulted in caloric deficits of more than 10,000 calories in a third of patients during their ICU care.
In addition, patients who suffered those large caloric deficits required substantially more days on a respirator and more days in the ICU than patients who received adequate nutritional support.
Advances in sensor technology are likely to result in a simpler and much less expensive monitor of individual nutritional requirements by the end of this year, researchers note.
[For additional information on the study as well as others presented at the clinical congress, visit the American Society of Parenteral and Enteral Nutrition's Web site at this address: www.nutritioncare.org.]
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