Agreement of Label Information on Anxiolytics and Antidepressants for Pregnant Women: Comparison among Korea, the USA, the UK and Japan / 대한정신약물학회지

OBJECTIVE: Anxiolytics and antidepressants are commonly used to treat depressive disorders in pregnant women. Specific and clear evidence is required when managing pregnant patients with such medications to ensure safety. However, information provided by approval label information is insufficient and often different among many countries. By analyzing label information of approval label and other references, this study aims to show the limitations and suggest appropriate directions for retrieving safety information. METHODS: We selected five anxiolytics and eleven antidepressants, which belongs to Korea drug classification codes 117 (psychotropic agents). We chose four countries, Korea, the United States of America (USA), the United Kingdom, Japan and collected safety information for pregnant women in label information. We evaluated the safety information based on recommendation level and evidence level. Then, kappa value and overall agreement were calculated using SAS 9.3. to assess data homogeneity. We further searched Reprotox and a textbook about contraindicated drugs in label information. RESULTS: Recommendation level and evidence level was different in each country. The number of commonly contraindicated drug in label information of four countries was none, and contraindicated drugs in labels were different respectively. Kappa value of evidence level between label information of Korea and Japan, the USA and Japan was 0.61, 0.43 respectively, corresponding to 'substantial agreement' and 'moderate agreement'. The overall agreement was 75%, 62.5% respectively. The information of label was different from that of other references, Reprotox and a textbook in terms of the clinical evidences and recommendation levels. CONCLUSION: Safety information of anxiolytics and antidepressants in label information needs to be updated on a regular basis both for health professionals and patients. With the implication of the inconsistent guidance for the safety information in pregnant women, reliable safety information in pregnant women would be needed.

Perceptions of Tetanus-diphteria-acellular pertussis (Tdap) Vaccination among Korean Women of Childbearing Age

BACKGROUND: The number of cases of pertussis reported has increased gradually in the last decade. Pertussis vaccination is the most effective strategy for the prevention of infection. Despite the fact that young infants are at the highest risk for pertussis, the rate of tetanus-diphtheria-acellular pertussis (Tdap) vaccination is presumed to be very low among women of childbearing age in Korea. The purpose of this study was to investigate the perceptions of women of childbearing age regarding Tdap vaccination in Korea. MATERIALS AND METHODS: Women of childbearing age, who visited the Department of Obstetrics and Gynecology at 3 University hospitals in the Seoul and Gyeonggi-do provinces of Korea, were surveyed. Individual questionnaires were administered from April to May 2012. Demographic data, Tdap vaccination history, general knowledge about pertussis, and information on factors associated with decision on vaccination were collected. RESULTS: Of the 500 reproductive-age women enrolled, only 4 (0.8%) had received the Tdap. The most common reason for non-vaccination was the lack of awareness of pertussis and information about the Tdap. Totally, 171 (34.2%) responded that they would receive a Tdap vaccination in the future. By multivariate analysis, general confidence in the effectiveness of the vaccine (odds ratio [OR] = 1.88, 95% confidence interval [CI] 1.17 to 3.01) was indicated as an important factor for deciding whether to receive the Tdap vaccine (P < 0.01). CONCLUSIONS: The coverage of Tdap vaccination of women of childbearing age, including pregnant women, is very low because of the lack of awareness of pertussis and the Tdap. Education of women of childbearing age about pertussis is very important to increase Tdap vaccination rates among these women, particularly during the perinatal period.

Perception on influenza vaccination in Korean women of childbearing age

PURPOSE: Women who are pregnant, planning to become pregnant in the influenza season or caring for infant 6-59 months of age are identified as priority groups for influenza vaccination. Vaccination rate is presumed to be low in those women. The purpose of this study was to investigate perceptions of childbearing age women about influenza vaccination. MATERIALS AND METHODS: Childbearing age women visiting the department of Obstetrics and Gynecology in 3 University hospitals in Seoul and Gyeonggi-do province were surveyed. Individual interviews were performed to them with questionnaire for 2 months from April to May 2012. Demographic data, Immunization history, general understanding and factors associated with vaccination were asked. RESULTS: Three hundred fifty-five (71.0%) of total 500 reproductive age women had the experience of influenza vaccination. Among 343 women who has been pregnant at least once, 48 women (16.4%) had vaccination during pregnancy, and 46 of them got vaccination since 2009. One hundred ninety women of total 500 women responded that they would get vaccination if pregnant in the next influenza season (38.0%). In multivariate analysis, statistically significant factors associated with plans of influenza vaccination in pregnancy were as follows: experience of childbirth (odds ratio [OR], 1.97; 95% CI, 1.32 to 2.93), high level of education (OR, 1.96; 95% CI, 1.22 to 3.15), previous influenza vaccination (OR, 1.88; 95% CI, 1.17 to 3.01). CONCLUSION: Influenza vaccine coverage on childbearing age women including pregnant women is low because of misperception of vaccination during pregnancy. It is necessary for healthcare provider to correct misunderstanding and to recommend vaccination actively.

When Can We Identify Fetal Male Gene By Using Maternal Plasma DNA? / 대한산부인과학회잡지

OBJECTIVE: To know when we can identify fetal Y chromosome SRY gene by using fetal DNA in maternal plasma. METHODS: DNA from maternal plasma of 62 pregnant women (48: inpatients, 14: outpatients) underwent a sensitive Y-PCR assay to identify SRY gene of Y chromosome. RESULTS: Of the patients, fetus-derived Y sequences were detected in 37 (88.1%) of the 42 maternal plasma samples from women bearing male fetuses. One of the 20 women bearing female fetuses had positive result from plasma DNA. Seventh gestational week was the earliest gestation of gender identification. CONCLUSION: We could identify fetal gender using fetal DNA in maternal plasma (sensitivity 88.1%). The earlist to detect was 7th gestational week.

Electrophysiological study on the modulation of uterine mechanoreceptor by substance P / 대한산부인과학회잡지

OBJECTIVE: In inflammation, hyperalgesia is a common phenomenon but its mechanism has not been clarified. Recently some reports suggested substance P might be important factors for inflammatory hyperalgesia in somatic tissue. This study was performed to see whether substance P modulate the activities of uterine afferent fibers in the hypogastric nerve of the cat. METHODS: While recording the electrical activities of nerve fibers, mechanical stimuli were applied as balloon distention using balloon inserted into uterine lumen before and during substance P infusion through uterine artery. RESULTS: Substance P increased the responses to balloon distension of uterus in 14 uterine mechanoreceptive afferent fibers of 24 over 10% compared to before substance P infusion, and decreased the responses of 3. And L-703,606, the neurokinin 1 receptor antagonist failed the modulation of mechano sensitive response by substance P and reduced the spontaneous activities. CONCLUSIONS: These results suggest that substance P modulated the activities of uterine nerve fibers and their responses to mechanical stimulus. It is hypothesized that this kind of modulation of afferent nerve fibers by substance P may be important for the development of inflammatory hyperalgesia.

Alterations in substance P and CGRP immunoreactivities in the uterus following the induction of inflammation in the rats / 대한산부인과학회잡지

OBJECTIVE: Recently some reports suggested substance P and CGRP might be important factors for inflammation and hyperalgesia. This study was performed to see whether substance P or CGRP containing nerve fibers might be changed by mustard oil-induced inflammation. METHODS: After injection of mustard oil(5%) into uterine lumen, the uteri were removed and examined with immunohistochemical methods for substance P and CGRP. RESULTS: In the normal uterus, most of the substance P- or CGRP-immunoreactive nerve fibers were observed along the vascular structure and some in the myometrium, only few in the endometrium. Mustard oil did not changed this pattern of nerve fiber distribution but after 48 hrs, the amount of substance P or CGRP immunoreactive nerve fibers were greatly reduced compared with the normal uterus. It is not clear whether the decrease of substance P and CGRP immunoreactive fibers in the uterus was resulted from the depletion of the neuropeptides in the nerve fibers or the retraction of nerve fibers. CONCLUSIONS: These results suggest that the inflammation should cause the change of nerve fibers included in the nociception. This change may attribute the generation of inflammation and inflammatory hyperalgesia.

A Case of Multifocal Concurrent Adenocarcinoma / 대한산부인과학회잡지

Synchronous primary tumor is uncommon form of gynecologic malignancy. Synchronous tumor is defined as primary tumor diagnosed simultaneously or within 6 months of one another. The prognosis of the patients with synchronous malignancies was reported to be more favorable when compared to the survival of patients harboring the same neoplasms individually. We report a case of multifocal concurrent adenocarcinoma involving salpinx, ovary, uterine cervix, and endometrium as well as omentum with a brief review of literatures.