• 제목/요약/키워드: Maternal Effect

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Permitted Daily Exposure for Diisopropyl Ether as a Residual Solvent in Pharmaceuticals

  • Romanelli, Luca;Evandri, Maria Grazia
    • Toxicological Research
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    • 제34권2호
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    • pp.111-125
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    • 2018
  • Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.

분만 2기 산모의 직립자세가 분만결과에 미치는 효과: 체계적 문헌고찰 (Effect of Postpartum Outcomes in Mother's Upright Position During the Second Stage of Labor: Systematic Review)

  • 박성희;황정해;최윤경;강창범
    • 여성건강간호학회지
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    • 제18권3호
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    • pp.209-222
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    • 2012
  • Purpose: The purpose of this study was to determine whether upright position is effective in labor through systematic review in randomized controlled trials. Methods: We established the PICO (Patient-Intervention-Comparator-Outcome) strategy, and reviewed 282 literatures from national and international electronic databases, and finally selected 9 references based on inclusion and exclusion criteria. We evaluated the quality of references and carried out a meta-analysis. Results: The maternal outcomes showed that the duration of their second-stage labor was 2.29 minutes shorter than that of the women in the recumbent position, and were less likely to have episiotomy. The other outcomes, including the mode of delivery, blood loss, hemoglobin level, use of oxytocin, use of analgesics, and perineal laceration, did not differ between the groups. The fetal heart rate abnormality occurred less than in the control group. The Apgar scores of the groups did not differ. Conclusion: There is evidence that an upright position in the second stage of labor reduces the duration of the second stage of labor, the incidence of episiotomy, and an abnormal fetal heart rate.

초산모의 이유실천에 관한 조사연구 (A Survey on doing Weaning Activities of First-time Mother)

  • 장인순;전경자;박은옥;이건세
    • Child Health Nursing Research
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    • 제8권1호
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    • pp.55-66
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    • 2002
  • It is an important task to give adequate nutritions to infants and to wean properly for rapid growth. This study was conducted to survey on doing the weaning activities of the first-time mother. This study was to provide basic data of health teaching and nursing intervention for the promotion of ideal weaning activities. Survey was done from January to February in 2001. Total 444 mothers who have first-time baby under twelve month old were interviewed in five community health center around contry (Seoul, Choung-ju, Asan, Cheon-an, Jeju). The results are summarized as follows; Starting time of weaning was common in four month old(40.4%). Most common daily weaning times by age showed once(under 3 months), twice(4 to 7 months), three times(8 to 12 months). The younger, the more commercial weaning products(p<0.01). Education level showed relatively positive relation with home-made weaning food(p<0.05). Items showed low scores in 4 to 7 months group were starting new food item, waiting at least one week interval to new food, feeding by milk bottle, allowing grasping spoon, consulting pediatrician for problems after weaning, starting from morning, regular schedule. Items showed low scores in 8 to 12 months group were feeding whole egg rather than yolk only up to 12 months, keeping weaning interval were increased, feeding by milk bottle, trying various cooking method, not giving commerical cooking and instant food and unproper raw milk feeding. In weaning activities by general factors, mother age, health status, marriage duration, monthly income were statistically significant (p<0.05). To improve good weening activities, targetting on low maternal age and poor health status, and low income group, developing teaching materials and training program for items showed low scores and proper weaning time, type of easy home-made food and easy cooking method should be provided. Further study on effect of nursing intervention to improve weaning activities are needed.

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Gestational Diabetes Affects the Growth and Functions of Perivascular Stem Cells

  • An, Borim;Kim, Eunbi;Song, Haengseok;Ha, Kwon-Soo;Han, Eun-Taek;Park, Won Sun;Ahn, Tae Gyu;Yang, Se-Ran;Na, Sunghun;Hong, Seok-Ho
    • Molecules and Cells
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    • 제40권6호
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    • pp.434-439
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    • 2017
  • Gestational diabetes mellitus (GDM), one of the common metabolic disorders of pregnancy, leads to functional alterations in various cells including stem cells as well as some abnormalities in fetal development. Perivascular stem cells (PVCs) have gained more attention in recent years, for the treatment of various diseases. However, the effect of GDM on PVC function has not been investigated. In our study, we isolated PVCs from umbilical cord of normal pregnant women and GDM patients and compared their phenotypes and function. There is no significant difference in phenotypic expression, response to bFGF exposure and adipogenic differentiation capacity between normal (N)-PVCs and GDM-PVCs. However, when compared with N-PVCs, early passage GDM-PVCs displayed decreased initial rates of cell yield and proliferation as well as a reduced ability to promote wound closure. These results suggest that maternal metabolic dysregulation during gestation can alter the function of endogenous multipotent stem cells, which may impact their therapeutic effectiveness.

기계판막을 갖고있는 임산부에서 항응고요법 (Anticoagulant Therapy in Pregnant Women with Mechanical Cardiac valve Prostheses)

  • 최순호;고광표;한재오;최종범;김경호
    • Journal of Chest Surgery
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    • 제33권6호
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    • pp.502-506
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    • 2000
  • Background: Anticoagulant therapy can be required during pregnancy with prosthetic heart valves. Warfarin and heparin provide real protection against thromboembolic phenomena, but they also carry serious risks for the fetus and the mother. In an attempt to identify the best treatment for pregnant women with cardiac valve prostheses who are receiving anticoagulant, we studied 19 pregnancies, the warfarin was discontinued and heparin was administered every 12 hours by subcutaneous injection in doses adjusted to keep the midinterval aPTT in the therapeutic range(at least 2-2.5 control) from the conception to the 12th week of gestation and oral antiocagulant was then administered until the middle of the third trimester in the therapeutic range(at least 2 INR), and heparin therapy was restared until delivery. Also in order to avoid an anticoagulant effect during delivery, it has been our practice to instruct women to either discontinue their heparin injections with the onset of labur or to stop heparin injections 12 hours prior to the elective induction of labour. Result: The outcome of 19 pregnancies managed with above protocol was spontaneous abortion in 3 cases, voluntary termination in 2 cases, premature delivery at 35 weeks in 1 case and delivery at full-term in 14 cases. There was no maternal morbidity and moratality and fetopathy. Conclusion: We conclude that in the second and third trimester of pregnancy, warfarin provide effective protection against thromboembolism, Oral antiocagulant therapy should be avoided in 2 weeks before delivery because of the risk of serious perinatal bleeding caused by the trauma of delivery to the anticoagulated fetus. However, the substitution of heparin at first trimester and 2 weeks before delivery reduce the incidence of complications.

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Correlations of Genic Heterozygosity and Variances with Heterosis in a Pig Population Revealed by Microsatellite DNA Marker

  • Zhang, J.H.;Xiong, Y.Z.;Deng, C.Y.
    • Asian-Australasian Journal of Animal Sciences
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    • 제18권5호
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    • pp.620-625
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    • 2005
  • Correlation of microsatellite heterozygosity with performance or heterosis was reported in wild animal populations and domestic animal populations, but the correlation with heterosis in a crossbreeding F$_1$ pig population remained uncertain. To explore this, we had random selected and mated Yorkshire${\times}$Meishan (F, n = 82) and their reciprocal (G, n = 47) to F$_1$, and used the two straightbreds as control groups (Yorkshire = 34, Meishan = 55), and observed the heterosis of birth weight (BWT), average daily gain (ADG) and feed and meat ratio (FMR). Two Kinds of measurement-individual heterozygosity (IH) and individual mean d$^2$ (lg value, ID) were used as index of heterozygosity and variance from 39 microsatellite marker loci to perform univariate regression analysis against heterosis. We detected significant correlation of IH with BWT in all of F$_1$ (F+G) and in F. We observed significant correlation of ID with ADG in all of F$_1$ (F+G), and with FMR in all of F$_1$ (F+G) and in F. There was significant maternal effect on heterosis, which was indicated by significant difference of means and distribution of heterosis between F and G. This difference was consistent with distributions of IH and ID, and with difference of means in F and G. From this study, it would be suggested that the two kinds of genetic index could be used to explore the genetic basis of heterosis in crossbreeding populations but could not determine which is better.

자궁절제 여성의 부담감에 관한 연구 (The Burden in Women with Hysterectomy)

  • 성미혜
    • 여성건강간호학회지
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    • 제3권2호
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    • pp.180-191
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    • 1997
  • When women are removed with their matrix which is a emotionally significant organ of symbol in psychologically adapting themselves to mother and woman, that is threatened and injured with woman role decisively. The nursing for women with hysterectomy is limited to medical treatment and the nursing related to troubles in psychology, emotion they experience in general situation due to operations is hardly realized. New basis for nursing can be realized when we both have relation with lived human experience related th health and become to be a part of it. We need to catch their experience due to the loss of matrix to understand women with hysterectomy. The subjects of the study were nine patients who were admitted to a gynecological ward of a hospital in Seoul, suffering from vaginal bleeding, back pain, abdominal pain and so on and diagnosing as non-cancer. The data were collected from April to May 1997 by listening to the subjects' expression of their experience and by participant observation of the subjects' reactions. A tape-recorder was used under the permission of the subjects, to prevent the loss of spoken information. The result of the study was as follows : The data on burden content from the interview were categorized as psych-emotional, physical, personal interaction, financial burden and maternal role burden. The factors which have influence on the burden of the subjects are an offer of information, support system, age, occupation, economic situation, family history, character, season, the existence of ovary and religion. In conclusion, since we ascertained that the nursing in the process of recovery decide the quality of life, though women with hysterectomy undergo various burden experience and adapt to it in the end, it is necessary to give them enough information and educate husband, having on important effect on the burden experience, to be a good supporter. And technically skilled nurses of consultant are thought to be able to contrive better qualitative life of women with hysterectomy as an important bridge between the subjects and their required information, since the nurses have their well-formed position of relationship of confidence through continuous contact with patients and their family.

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Embryotoxicity and Toxicokinetics of the Antimalarial Artesunate in Rats

  • Chung, Moon-Koo;Yu, Wook-Joon;Lee, Jin-Soo;Lee, Jong-Hwa
    • Toxicological Research
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    • 제29권1호
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    • pp.27-34
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    • 2013
  • This study was conducted to investigate the potential embryo-fetal toxicity and toxicokinetics of the antimalarial agent artesunate (ARTS) in Sprague-Dawley rats. Pregnant rats were administered ARTS daily from gestational day 6~15 via oral gavage, at test doses of 0, 2, 4, or 8 mg/kg (22 females per group). The fetuses were examined for external, visceral, and skeletal abnormalities on gestational day 20. With regard to the dams, there were no deaths, treatment-related clinical signs, changes in body weight, or food intake in any of the treatment groups. There were no treatment-related gross findings at necropsy in any treatment group. In the 8 mg/kg group, there was a decrease in gravid uterine weight and in the weight of female fetuses. There was also an increase in fetal deaths (primarily late resorptions) and an increase in post-implantation losses (37%) at 8 mg/kg. An increase in the incidence of visceral and skeletal variations at 4 and 8 mg/kg was observed. These defects included minor changes in the appearance of the kidney and thymus, as well as absent ribs or thoracic vertebrae. Toxicokinetics were assessed in a parallel study, using 4 mated females per group. Using liquid chromatography-mass spectrometry (LC-MS) analysis, the concentration of ARTS and its metabolite dihydroartemisinin (DHA) were quantified in plasma from rats on gestational days 5, 6, 10, and 15. Amniotic fluid was assayed for ARTS and DHA on gestational day 15. There was evidence of rapid conversion of ARTS to the metabolite DHA in maternal plasma, since ARTS could not be consistently detected in plasma at the three doses tested. ARTS and DHA were not detected in amniotic fluid at gestational day 15, indicating limited placental transfer of the two agents. The embryo-fetal no-observable-adverse-effect level (NOAEL) of the test item was considered to be 8 mg/kg/day for dams, and 2 mg/kg/day for embryo-fetal development.

Quercus Brantii Lindl. Vaginal Douche Versus Clotrimazole on Vaginal Candidiasis - A Randomized Clinical Trial -

  • Moshfeghy, Zeinab;Asadi, Khadegeh;Akbarzadeh, Marzieh;Zare, Atefeh;Poordast, Tahereh;Emamghoreishi, Masoumeh;Najib, Fatemeh S.;Sayadi, Mehrab
    • 대한약침학회지
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    • 제21권3호
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    • pp.185-194
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    • 2018
  • Objectives: Vaginal Candidiasis with an approximate prevalence of 30% is the second cause of vaginal infections. Antifungal azole is the first treatment for Vaginal Candidiasis; however, some side effects have been reported for this chemical medicine. Based on the antifungal activity of Inner Stratum of Quercus Brantii (Q. Brantii), the aim of our study was to compare the effects of vaginal douche of Q. Brantii extract and clotrimazole on vaginal candidiasis symptoms before and after the treatments, in women. Methods: 89 non-pregnant women with positive KOH test which is capable of identifying the presence of hyphae and mycelium by adding KOH (10%), and a positive vaginal candidiasis culture were randomly divided into two experimental groups, using permuted block randomization method. One group received clotrimazole vaginal cream (1%) and the other group received vaginal douche of Q. Brantii extract. Groups were treated for 7 days and KOH tests and cultures were evaluated again. Data were analyzed via chi-square and independent t-test, using SPSS software. Results: According to the results, there were no significant differences between experimental groups for demographic characteristics like age (p=0.403), BMI (p=0.911), educational levels (p=0.862) and contraceptive methods (p=0.702). Moreover, significant differences were seen in vaginal discharge between the groups after the treatments (P=0.043). Conclusion: The results suggested that the therapeutic effect of vaginal douche of Q. Brantii extract was approximately similar to that of clotrimazole vaginal cream.

Dietary supplementation with different types of fiber in gestation and lactation: effects on sow serum biochemical values and performance

  • Weng, Ruey-Chee
    • Asian-Australasian Journal of Animal Sciences
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    • 제33권8호
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    • pp.1323-1331
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    • 2020
  • Objective: Three types of dietary fiber were fed to sows during gestation and lactation stages to monitor their physiological and metabolic adaptations during the pre-partum period and to determine how these effects may influence the lactation period and sow performance. Methods: Soon after breeding, 54 sows were selected and were fed with 20% supplementation as fed of wheat bran (WB), soya hulls (SH), or rice hulls (RH) in diets during gestation and lactation. Sows were weighed, backfat thickness was measured ultrasonically and jugular blood samples were collected from all sows. The litter size was equalized to 10, by fostering piglets from sows on the same treatment. Results: Sows gained 22.0, 21.8, and 25.5 kg of net maternal body weight during gestation (for WB, SH, and RH sows, respectively; p = 0.007). There was no treatment effect on the body weight change during lactation (p = 0.158), however RH sows consumed an average of 133.66 kg of feed, WB sows took 121.29 kg and SH sows took 126.77 kg during lactation (p<0.001). The SH litters gained an average of 59.34 kg of weight during lactation, while other litters gained 51.58 and 49.98 kg (for WB and RH litters, respectively; p<0.001). Exception for aspartate aminotransferase and alanine aminotransferase, measured serum biochemical values were broadly in agreement with earlier reports. Despite the use of additional vegetable oil to balance the energy level, RH sows still had lower concentrations of serum triglycerides in late gestation. Conclusion: Different types of fibrous ingredients in the gestation diet influenced most of the investigated reference values for sows. The values of serum biochemical parameters were generally not affected by fiber type during the lactation stage. The SH supplementation for sows is an effective approach to give heavier litters at birth and weaning and to increase voluntary feed intake in early lactation.