• Title/Summary/Keyword: Safety Practice

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Development and Research into Functional Foods from Hydrolyzed Whey Protein Powder with Sialic Acid as Its Index Component - I. Repeated 90-day Oral Administration Toxicity Test using Rats Administered Hydrolyzed Whey Protein Powder containing Normal Concentration of Sialic Acid (7%) with Enzyme Separation Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - I. 효소분리로 7% Siailc Acid가 표준적으로 함유된 유청가수분해단백분말(7%)의 랫드를 이용한 90일 반복경구투여 독성시험 평가 연구 -)

  • Noh, Hye-Ji;Cho, Hyang-Hyun;Kim, Hee-Kyong
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.99-116
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    • 2016
  • We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

The Effect and Safety of Alveolar Recruitment Maneuver using Pressure-Controlled Ventilation in Acute Lung Injury and Acute Respiratory Distress Syndrome (급성폐손상과 급성호흡곤란증후군 환자에서 압력조절환기법을 이용한 폐포모집술의 효과와 안정성)

  • Chung, Kyung Soo;Park, Byung Hoon;Shin, Sang Yun;Jeon, Han Ho;Park, Seon Cheol;Kang, Shin Myung;Park, Moo Suk;Han, Chang Hoon;Kim, Chong Ju;Lee, Sun Min;Kim, Se Kyu;Chang, Joon;Kim, Sung Kyu;Kim, Young Sam
    • Tuberculosis and Respiratory Diseases
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    • v.63 no.5
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    • pp.423-429
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    • 2007
  • Background: Alveolar recruitment (RM) is one of the primary goals of respiratory care for an acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). The purposes of alveolar recruitment are an improvement in pulmonary gas exchange and the protection of atelectrauma. This study examined the effect and safety of the alveolar RM using pressure control ventilation (PCV) in early ALI and ARDS patients. Methods: Sixteen patients with early ALI and ARDS who underwent alveolar RM using PCV were enrolled in this study. The patients data were recorded at the baseline, and 20 minutes, and 60 minutes after alveolar RM, and on the next day after the maneuver. Alveolar RM was performed with an inspiratory pressure of $30cmH_2O$ and a PEEP of $20cmH_2O$ in a 2-minute PCV mode. The venous $O_2$ saturation, central venous pressure, blood pressure, pulse rate, $PaO_2/FiO_2$ ratio, PEEP, and chest X-ray findings were obtained before and after alveolar RM. Results: Of the 16 patients, 3 had extra-pulmonary ALI/ARDS and the remaining 13 had pulmonary ALI/ARDS. The mean PEEP was 11.3 mmHg, and the mean $PaO_2/FiO_2$ ratio was 130.3 before RM. The $PaO_2/FiO_2$ ratio increased by 45% after alveolar RM. The $PaO_2/FiO_2$ ratio reached a peak 60 minutes after alveolar RM. The Pa$CO_2$ increased by 51.9 mmHg after alveolar RM. The mean blood pressure was not affected by alveolar RM. There were no complications due to pressure injuries such as a pneumothorax, pneumomediastinum, and subcutaneous emphysema. Conclusion: In this study, alveolar RM using PCV improved the level of oxygenation in patients with an acute lung injury and acute respiratory distress syndrome. Moreover, there were no significant complications due to hemodynamic changes and pressure injuries. Therefore, alveolar RM using PCV can be applied easily and safely in clinical practice with lung protective strategy in early ALI and ARDS patients.

A Study on Piracy Matters and Introduction of the Privately Contracted Armed Security Personnel on Board Ships (해적사건 대응을 위한 무장경비원제도 도입방안에 관한 연구)

  • Roh, Ho-Rae
    • Korean Security Journal
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    • no.41
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    • pp.293-326
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    • 2014
  • Piracy is a worldwide issue, but the deteriorating security situation in the seas off Somalia, the Gulf of Aden and the wider Western Indian Ocean between 2005 and 2012 and in the increasing number of attacks in the Gulf of Guinea are a major problem. The depth of concern for the problem internationally is amply demonstrated by the levels of co-operation and coordination among naval and other forces from several countries that have assembled in the west Indian Ocean region and the Gulf of Aden to escort ships carrying humanitarian aid to Somalia and to protect vulnerable shipping. Notwithstanding this unprecedented effort, the vast sea area in which the pirates now operate makes it difficult to patrol and monitor effectively, particularly with the limited resources available. More resources, in the form of naval vessels and aircraft, are needed and at every opportunity the IMO encourages Member Governments to make greater efforts to provide the additional naval, aerial surveillance and other resources needed through every means possible. IMO provide interim guidance and recommendations to be taken into account when considering the use of PCASP(privately contracted armed security personnel) if and when a flag State determines that such a measure would be lawful and, following a full risk assessment, appropriate. The interim guidance and recommendations of IMO are not intended to endorse or institutionalize the use of armed guards. Therefore, they do not represent any fundamental change of policy by the Organization in this regard. It is for each flag State, individually, to decide whether or not PCASP should be authorized for use on board ships flying their flag. If a flag State decides to permit this practice, it is up to that State to determine the conditions under which authorization will be granted. Therefore, Korea should be introduced rationally PCASP for safe shipping. PCASP on board ships is much the same to special guard personnel of security services industry act. Act plan of Oceans and fisheries ministry on PCASP collides with special guard personnel system of National Police Agency. Rather than new law making, PCASP regukations have to be included in security services industry act. Management Agency of PCASP is to not Oceans and fisheries ministry, but Central Headquarters Korea Coast Guard of Public Safety and Security Ministry because of specialty and closely connection.

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Three-Dimensional Limit Equilibrium Stability Analysis of Spile-Reinforced Shallow Tunnel

    • Geotechnical Engineering
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    • v.13 no.3
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    • pp.101-122
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    • 1997
  • A spiting reinforcement system is composed of a series of radially installed reinforcing spites along the perimeter of the tunnel opening ahead of excavation. The reinforcing spill network is extended into the in-situ soil mass both radially and longitudinally The sailing reinforcement system has been successfully used for the construction of underground openings to reinforce weak rock formations on several occasions. The application of this spiting reinforcement system is currently extended to soft ground tunneling in limited occasions because of lack of reliable analysis and design methods. A method of threetimensional limit equilibrium stability analysis of the smile-reinforced shallow tunnel in soft ground is presented. The shape of the potential failure wedge for the case of smile-reinforced shallow tunnel is assumed on the basis of the results of three dimensional finite element analyses. A criterion to differentiate the spill-reinforced shallow tunnel from the smile-reinforced deep tunnel is also formulated, where the tunnel depth, soil type, geometry of the tunnel and reinforcing spites, together with soil arching effects, are considered. To examine the suitability of the proposed method of threedimensional stability analysis in practice, overall stability of the spill-reinforced shallow tunnel at facing is evaluated, and the predicted safety factors are compared with results from twotimensional analyses. Using the proposed method of threetimensional limit equilibrium stability analysis of the smile-reinforced shallow tunnel in soft ground, a parametric study is also made to investigate the effects of various design parameters such as tunnel depth, smile length and wadial spill spacing. With slight modifications the analytical method of threeiimensional stability analysis proposed may also be extended for the analysis and design of steel pipe reinforced multi -step grouting technique frequently used as a supplementary reinforcing method in soft ground tunnel construction.

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A pilot study of neuroprotection with umbilical cord blood cell transplantation for preterm very low birth weight infants (극소 저 출생체중 미숙아에서 자가 제대혈 줄기세포 이식을 통한 신경 손상 방지 연구)

  • Chae, Kyu Young;Lee, Kyu Hyung;Eun, So Hee;Choi, Byung Min;Eun, Baik-Lin;Kang, Hoon-Chul;Chey, Myung Jae;Kim, Nam Keun;Oh, Doyeun
    • Clinical and Experimental Pediatrics
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    • v.50 no.9
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    • pp.882-890
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    • 2007
  • Purpose : Preterm very low birth weight infant have high rate of adverse neurodevelopmental sequale. Recently, there have been lots of reports that human umbilical cord blood transplantation ameliorates functional deficits in animal models as hypoxic ischemic injury. This pilot study was undertaken to determine the clinical efficacy and safety of autologous umbilical cord blood cell transplantation for preventing neurodevelopmental sequale in perterm VLBW. Methods : Subjects were 26 preterm infants whose birth weight are less than 1,500 g and delivered under the intrauterine period 34 weeks. Autologous umbilical mononuclear cells (about $5.87{\times}10^7/kg$) were injected to neonate via the umbilical vein on the postnatal 24-48 hour. The therapeutic efficacy was assessed by numbers of nucleated RBC, urinary uric acid/creatinine ratio, concentration of neuron specific enolase (NSE), interleukin 6 (IL6), interleukin-$1{\beta}$ ($IL-1{\beta}$), and glial cell derived neurotrophic factor (GDNF) in serum and cerebrospinal fluid on day 1 and 7. Results : There were no significant differences in the numbers of the nucleated RBC, urinary uric acid/creatinine ratio, concentration of creatine kinase between the transplanted infants and controls. But the nucleated RBC is more likely to be rapidly discharged in the transplanted group. In the transplanted group, the concentrations of IL6, $IL-1{\beta}$, and GDNF were no significant difference between day 1 and 7, although GDNF seemed to be elevated. Serum NSE concentration was significantly elevated after transplantation, but not in CSF. Conclusion : It is suggested that autologous umbilical cord blood transplantation in preterm very low birth weight infant is safe to apply clinical practice. Long term follow up study should be needed to evaluate the potential therapeutic effect of umbilical cord blood transplantation for neuroprotection.

Design of Truck Escape Ramps (자동차 긴급 피난 차선의 계획 설계)

  • 구본충
    • Journal of the Korean Professional Engineers Association
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    • v.28 no.4
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    • pp.54-75
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    • 1995
  • This synthesis has been prepared from a review of literature on Truck Escape Ramps technology and a survey of current practice by state department of transportation. Their locations have been determined usually from a combination of accident experience and en-gineering judgement, but new tools are emerging that can identify needs and sites without waiting for catastrophic accidents to happen. The Grade Severity Rating Systems holds promise in this regard. Design Procedures for truck excape ramps continue to evolve. Gravel arrester beds are clearly the preferred choice across the country Rounded aggregate, uniformly graded in the approximate size range of 13 to 18mm. Tech-nical publications typically have dassified TER types as paved gravity, sandpile, and ar-rester bed ramps. The design speed for vehicle entry into the ramp in critical to the deter-mination of ramp length. An escape ramp should be designed for a minimum entry speed of 130km/hr, a 145km/hr design being preferred. The ramps should be straight and their angle to the roadway align-ment should be as possible. The grade of truck escape ramps show the adjustment of ramp design to local topography, such as the tradeoff of ramp length against earthwork requirements. A width of 9 to 12m would more safety acommodate two or more outof con-trol vehicles. Reguarding comments on the most effective material, most respondents cited their own specification or referred to single graded, rounded pea gravel. The consensus essentially Is that single graded, well -rounded gravel is the most desirable material for use in arrester beds. The arrester beds should be constructed with a minimum aggregate depth of 30cm. Successful ramps have used depths between 30 and 90cm.

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Analysis of Knowledge and Competency for the Fourth Industrial Revolution Based on Anderson's Revision of Bloom's Taxonomy: Focused on Achievement Standard in the 2015 revised Practical Arts(Technology·Home Economics) (Bloom의 신교육목표 분류체계에 기초한 4차 산업혁명 시대에 요구하는 지식과 역량 분석: 2015 개정 실과(기술·가정) 교육과정의 가정과 성취기준을 대상으로)

  • Yang, Ji Sun;Lee, Gyeong Suk
    • Journal of Korean Home Economics Education Association
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    • v.30 no.3
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    • pp.129-149
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    • 2018
  • This study has attempted to analyze the achievement standards in the 2015 revised curriculum, based on the revision of Bloom's Taxonomy and aims to identify the knowledge and required competencies in the fourth industrial era. The results of this study are as follows: First, the knowledge dimensions was the highest 'metacognitive knowledge' in middle school, while 'factual knowledge' was the highest in high school, and 'knowledge of specific details and elements' was the highest subtype of all of the knowledge dimensions. The dimensions of the cognitive process, such as the terms 'apply' and 'analyze' in middle school, as 'understand' and 'evaluate' in high school have been treated inattentively. Second, the knowledge dimension and the cognitive process dimension according to key concepts display the metacognitive knowledge and 'understand' in development, the conceptual knowledge and 'understand' in relationship. While the 'metacognitive knowledge' and 'apply' in life culture, the 'procedural knowledge' and 'evaluate' in safety, the 'factual knowledge' and 'apply' in management and the 'metacognitive knowledge' and 'understand' in life design were extremely high. Third, the verbs used in the achievement standards displayed as 'explore', 'understand', 'analyze', 'practice', 'suggest', 'recognize' and 'evaluate'. Since the statement of the action verb is the very basis for determining the performance process, specific competencies may be achieved by reflecting on the actual achievement standards. These standards should provide us with a effective cognitive process for to understand a learner's performance skills and support the direction of the education required, through a strategy that refines the connection between content elements and functions and develop their competences for the future.

Favorable Outcome in Elderly Asian Patients with Metastatic Renal Cell Carcinoma Treated with Everolimus: The Osaka Urologic Oncology Group

  • Inamoto, Teruo;Azuma, Haruhito;Nonomura, Norio;Nakatani, Tatsuya;Matsuda, Tadashi;Nozawa, Masahiro;Ueda, Takeshi;Kinoshita, Hidefumi;Nishimura, Kazuo;Kanayama, Hiro-Omi;Miki, Tsuneharu;Tomita, Yoshihiko;Yoshioka, Toshiaki;Tsujihata, Masao;Uemura, Hirotsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.4
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    • pp.1811-1815
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    • 2014
  • Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probably reflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratory analysis of elderly patients in the RECORD-1 Trial showed that patients ${\geq}$ 65 y.o. had superior median PFS than overall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relative benefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for older patients with metastatic renal cell cancer (mRCC), in daily practice. Materials and Methods: 172 consecutive IRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at 39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% had progressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had received other therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusion criterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters were mandatory. EVE administration was approved by the institutional review board at each participating institution and signed informed consent was obtained from all patients. Results: Median time of the whole cohort to last follow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup. There were 86 (50%) patients ${\geq}$ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Median survival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases, histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency of adverse events in elderly patients treated with EVE was no greater than that in younger patients, although such toxicity may have had a greater impact on their quality of life. Conclusions: Older patients should not generally be excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.

Review of 2014 Major Medical Decisions (2014년 주요 의료판결 분석)

  • Jeong, Hye Seung;Lee, Dong Pil;Yoo, Hyun Jung;Lee, Jung Sun
    • The Korean Society of Law and Medicine
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    • v.16 no.1
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    • pp.155-190
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    • 2015
  • The court sentenced meaningful decisions related to the medical service in 2014. The court assumed the negligence of medical staff in the accident if being broken while using the medical equipment for not an original purpose at the time of surgery and ruled that the compensation for damage can be recognized in recognition of the causal relationship between the explanation duty violation and side effect's happening when unproven surgery on safety is implemented regarding the duty of explanation, that in the case of cosmetic surgery, the subject on the duty of explanation needs to be expanded compared to the general medical practice and that the duty of explanation cannot be accepted for the range that cannot be expectable. Also, the court has provided the requirement and limitation of self-determination exercise in case of the crash between patient's self-determination and doctor's duty of care and has ruled that as automobile insurance contract is a contract with the insurance company to pay regarding liability for car accidents, treating patients and taking the insurance money is not illegal activity even for the unlicensed hospital violating the medical law while established. The judgment stating the opinion that medical practitioners cannot be punished according to the medical law prohibiting the receiving of rebate in case that medical practitioners did not receive benefit while the medical institution itself gained an unfair economic benefit also stands out. And the court has ruled that even if the medical institution who received a business suspension is closed, the suspension is still effective in case that the same operator opens a new medical institution in the same place, ruled on the requirement to conduct a medical service outside of the medical institution that the doctor opened and ruled that the administrative penalty cannot be conducted prior to the conviction on charge of violating the medical law.

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Clinical Investigation of Women with Asthma Worsened During Pregnancy (임신 중 천식의 악화로 내원한 환자의 임상적 고찰)

  • Kwon, Young-Hwan;Kim, Kyung-Kyu;Jung, Hye-Cheol;Lee, Sung-Yong;Kim, Je-Hyeong;Lee, So-Ra;Lee, Sang-Yeub;Lee, Sin-Hyeong;Cho, Jae-Yun;Shim, Jae-Jeong;Kang, Kyung-Ho;Yoo, Se-Hwa;In, Kwang-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.4
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    • pp.548-554
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    • 1999
  • Background : Asthma is the most common respiratory crisis encountered in clinical practice, occurring in up to 4% of all pregnancies. Pregnancy often appears to alter the course of asthma. But the mechanisms responsible for variable changes in the asthma course during pregnancy remain unknown. Poor control and exacerbations of asthma during pregnancy may result in serious maternal and fetal complications. To investigate the course of asthma during pregnancy in korean women, we did a retrograde study of 27 pregnant women who had been admitted to Korea University Hospital for asthma worsened. Method: Twenty seven pregnant women who had been visited to Korea University Hospital for asthma worsened were enrolled in our retrospective study. We reviewed medical recordings and interviewed patients with asthma. Results: Twenty seven pregnant women with asthma were evaluated, and 25 patients were enrolled to our study. Two patients experienced abortions at 6 weeks and 25 weeks gestation, respectively. The period of asthma worsened was commonly during weeks 20 to 28 of gestation. And all patients wosened were improved during the last 4 weeks of pregnancy. Twenty(80%) of 25 women whose asthma worsened during pregnancy reverted toward their prepregnancy status after delivery(p<0.002). The causes of asthma worsened during pregnancy are reduction or even complete cessaton of medication due to fears about its safety(40%), worsening after upper respiratory infection (28%), and unknown(32%). There were no adverse perinatal outcomes in 25 pregnant asthma subjects. Conclusions: A major problem of therapy for asthma during pregnancy is reduction or even complete cessation of medication due to fears of fetal effects. Therefore, maternal education and optimal clinical and pharmacologic management is necessary to mitigate maternal and fetal complications.

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