• Title/Summary/Keyword: Adverse Event

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Enzyme Replacement Therapy in Patients Who Have Mucopolysaccharidosis and Are younger than 5 years old (5세 미만 뮤코다당체침착증 환자에서의 효소 대체 요법)

  • Park, Seong-Won;Son, Yeong-Bae;Kim, Se-Hwa;Jo, Seong-Yun;Ji, Seon-Tae;Jin, Dong-Gyu
    • Journal of The Korean Society of Inherited Metabolic disease
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    • v.10 no.1
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    • pp.59-66
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    • 2010
  • Enzyme replacement of therapy (ERT) is one of the most promising therapeutic strategies for the treatment of lysosomal storage disorders. ERT is available in three types of Mucopolysaccharidosis (MPS): for MPS I (Aludrazyme$^{(R)}$), MPS II (Elaprase$^{(R)}$) and MPS VI (Naglazyme$^{(R)}$) patients who are over 5 years old. But recently, early diagnosis can be done by expert clinicians and even in prenatal case. We describe the case of ERT under 5 years old MPS patients. Up to June, 2010 in Samsung Medical Center, there are 6patients who were diagnosed as MPS and started ERT under 5 years old. 3 patients were MPS I, 3 patients were MPS II. 2 patient who was diagnosed as MPS I was female and others were male. Their age at diagnosis were 4 to 37month-old (4, 13, 16, 25, 27, 37 month-old) and they are now 9 to 60 month-old (9, 39, 32, 81, 60 month-old). The youngest patient was started ERT at 4 month-old and others were started at their 13 to 49 month-old (13, 29, 27, 28, 49 month-old). First manifested symptoms of patients were macrocephaly, kyphosis and coarse face appearance. Especially, in 2 of them, one was MPS I and the other was MPS II had elder brother with same disease. And the youngest one was diagnosed by the iduronate-2-sulfatase (IDS) gene analysis from chorionic villi sampling. His mother knew that she was a heterozygous carrier of IDS gene mutation because her younger brother died from MPS II. All of them confirmed as MPS by the enzyme assay in leukocytes and fibroblast skin culture. We started ERT with ${\alpha}$-L-iduronidase(Aldurazyme$^{(R)}$) to MPS I and did recombinant human iduronate-2-sulfatase (Elaprase$^{(R)}$) to MPS II patients as recommended dose as over 5 years old. But for MPS II patient who was 4 month old, we started ERT by recombinant human IDS (Elaprase$^{(R)}$) with reduced dose 0.1 mg/kg and increased dose every 2 weeks by 0.1mg/kg up to 0.5mg/kg IV infusion. During ERT, all patients had no adverse effects and the excretion of GAGs were decreased. We have evaluated other clinical symptoms such as liver/ spleen volume, heart function and neurologic evaluation. We describe a successful ERT to MPS I and MPS II patient under 5 years old without any adverse event. It indicates that ERT in young children are well tolerated and that it has several effects which may confer clinical benefits with long-term therapy.

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Safety of Bojungikgi-tang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (보중익기탕연조엑스의 1회 경구투여 후 안전성 평가에 관한 단일기관 연구)

  • An, Sung-Hu;Jeong, Yeong-jin;Kim, Jong-gyu;Shin, Hyeryung;Kwon, Young-Dal
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.157-166
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    • 2021
  • Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

A Study on the Identification of Hazardous Factors and Prevention of Accident in Old Boilers (노후보일러 유해인자 발굴 및 사고예방에 관한 연구)

  • Sa, Min-Hyung;Woo, In-Sung
    • Journal of the Korean Institute of Gas
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    • v.23 no.4
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    • pp.1-9
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    • 2019
  • Large-scale industrial boilers operating at high temperature and high pressure, have a large amount of water, and a large amount of energy is released at the time of explosion. Currently, most industrial boilers use gas fuel such as LNG and LPG, etc. and fuel exists in the same space as equipment, so there is a high possibility of secondary damage such as fire or explosion in the event of a boiler accident. Both special care and management are required to operate the very dangerous equipment that causes casualty 2.51 per accident. For boilers of a certain size or more, the Korea Energy Agency conducts inspections in accordance with the Energy Usage Rationalization Act, KS, and public notice of the Ministry of Industry, Trade and Resources. In this research, based on the results of the inspection, the hazard factorss are configured, and a questionnaire is conducted to the inspector, the equipment manager, the maintenance person, and the person in charge of the manufacturer. We analyzed the results by using AHP (Analytic Hierarchy Process). As a result of analysis, generally recognized hazard factorss are not good management, measurement failure, specification failure, water leak, leak analysis, but connection, welding, scale, and corrosion, etc. are relatively less important. It is judged that the adverse factors that are recognized to be highly important among all groups and careers are already well managed, but less important and adverse factors should be well managed to ensure that the safe usage of the boiler.

Developing national level high alert medication lists for acute care setting in Korea (국내 급성기 의료기관 고위험 의약품 목록 도출)

  • Han, Ji Min;Heo, Kyu-Nam;Lee, Ah Young;Min, Sang il;Kim, Hyun Jee;Baek, Jin-Hee;Rho, Juhyun;Kim, Sue In;Kim, Ji yeon;Lee, Haewon;Cho, Eunju;Ah, Young-Mi;Lee, Ju-Yeun
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.2
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    • pp.116-124
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    • 2022
  • Background: High-alert medications (HAMs) are medications that bear a heightened risk of causing significant patient harm if used in error. To facilitate safe use of HAMs, identifying specific HAM lists for clinical setting is necessary. We aimed to develop the national level HAM list for acute care setting. Methods: We used three-step process. First, we compiled the pre-existing lists referring HAMs. Second, we analyzed medication related incidents reported from national patient safety incident report data and adverse events indicating medication errors from the Korea Adverse Event Reporting System (KAERS). We also surveyed the assistant staffs to support patient safety tasks and pharmacist in charge of medication safety in acute care hospital. From findings from analysis and survey results we created additional candidate list of HAMs. Third, we derived the final list for HAMs in acute care settings through expert panel surveys. Results: From pre-existing HAM list, preliminary list consisting of 42 medication class/ingredients was derived. Eight assistant staff to support patient safety tasks and 39 pharmacists in charge of medication safety responded to the survey. Additional 44 medication were listed from national patient safety incident report data, KAERS data and common medications involved in prescribing errors and dispensing errors from survey data. A list of mandatory and optional HAMs consisting of 10 and 6 medication classes, respectively, was developed by consensus of the expert group. Conclusion: We developed national level HAM list for Korean acute care setting from pre-existing lists, analyzing medication error data, survey and expert panel consensus.

Influence of Fear about Middle East Respiratory Syndrome Event of Hospital Worker and General Public on Socio-Psychological Health : Mediating Effect of Posttraumatic Stress (중동호흡기증후군에 대한 공포감이 병원종사자와 일반인의 사회심리적 건강에 미치는 영향 : 외상 후 스트레스의 매개효과)

  • Kim, Shinil;Kim, Taehyung;Choi, Malrye;Jeong, Joori;Kwon, Hyukmin;Kim, Hyoungwook;Kim, Byoungjo;Eun, Hunjeong
    • Anxiety and mood
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    • v.15 no.1
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    • pp.45-52
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    • 2019
  • Objective : The objective of this study is to determine the effects of fear of Middle East respiratory syndrome (MERS) on socio-psychological health during an outbreak of MERS and the post-traumatic stress as a mediator on the relationship between stress and socio-psychological health. Methods : Visual Analog Scale, Impact of Event Scale -Revised, Psychosocial well-being index short form was implemented for 150 medical persons who worked at the hospital in which exposure to MERS cases had been confirmed and 96 ordinary people. A Pearson correlation coefficient and a hierarchical multiple regression was carried out to confirm the effect of fear of MERS and the mediating effect of post-traumatic stress between fear and socio-psychological health. Results : The higher the fear, the lower the socio-psychological health in both healthcare workers and the public (r=0.32, p<0.01) and the higher post-traumatic stress (r=0.32, p<0.01). But, the research results showed that only healthcare workers had a partially mediating effect of post-traumatic stress in the relationship between fear and socio-psychological health (${\beta}=0.45$, t=6.33 p<0.001), (${\beta}$ value : 0.39>0.26). Conclusion : This study demonstrated that the post-traumatic stress can indirectly lead to a negative effect on the socio-psychological health of healthcare workers when under the fear of MERS and shows adverse effects on psycho-social wellbeing. This suggests that clinical intervention and psycho-social approach aiming at reducing post-traumatic stress is important to maintain mental health during crisis development.

Taegeuk Acupuncture for Patients with Chronic Musculoskeletal Pain: A Retrospective Analysis of Medical Records (만성 근골격계 통증환자에 대한 태극침법의 임상적 유효성: 후향적 의무기록 분석 연구)

  • Kim, Jae Kyu;Kim, Kun Hyung;Noh, Seung Hee;Kim, Yu Ri
    • Journal of Acupuncture Research
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    • v.31 no.2
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    • pp.145-152
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    • 2014
  • Objectives : This study aimed to assess the effectiveness and safety of Taegeuk acupuncture for patients with chronic musculoskeletal pain. Methods : A retrospective analysis of the electronic medical records of Pusan National University Korean Medicine Hospital from March 2012 to March 2013 was performed. Eligible cases were outpatients who had received at least six sessions of Taegeuk acupuncture for their pain and had agreed to the use of their medical records for research purposes. Pain levels, heart rate variability, and patients' perceptions of the safety of acupuncture were investigated through the medical records and follow-up telephone interviews. Results : Fifteen cases were selected for analysis. All had suffered from musculoskeletal pain for at least one year. After six sessions of Taegeuk acupuncture, the average score on the pain numeric rating scale decreased from $6.7{\pm}2.0$ to $2.9{\pm}2.2$(a 43 % reduction). Follow-up telephone interviews revealed that patients experienced no adverse event after Taegeuk acupuncture. Conclusions : Patients with chronic musculoskeletal pain showed a reduction of more than half of the baseline pain after six sessions of Taegeuk acupuncture. However, the beneficial effects observed in this retrospective analysis should be interpreted with caution due to selection and recall bias. Further randomized controlled trials of Taegeuk acupuncture for chronic musculoskeletal pain are warranted.

Impact of the Smoke Aerosol from Russian Forest Fires on the Atmospheric Environment over Korea during May 2003 (2003년 5월 러시아지역에서 발생한 산불로 인한 스모크 에어로졸 플룸의 영향)

  • Lee, Kwon-Ho;Kim, Jeong-Eun;Kim, Young-Joon;Kim, Joon
    • Journal of Korean Society for Atmospheric Environment
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    • v.20 no.5
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    • pp.603-613
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    • 2004
  • Extensive forest fires occurred across the border in Russia. particularly east of Lake Baikal between the Amur and Lena rivers in May 2003. These forest fires released large amounts of particulates and gases into the atmosphere. resulting in adverse effects on regional air quality and the global radiation budget. Smoke pollution from the Russian fires near Lake Baikal was sometimes transported to Korea through Mongolia and eastern China. In this study ground based radiation (visible and UV-B) data measured during May 2003 at Seoul and Kwangju were analyzed to estimate smoke aerosol impacts on solar radiation. Surface criteria air pollutants ($PM_{10}$, CO, $O_3$) data were also obtained from National Institute of Environmental Research (NIER) during smoke aerosol event period (19 May~24 May 2003). Large Aerosol Optical Depth (AOD) 1.0~3.0 was observed during this period due to the influence of the long range transport of smoke aerosol plume from the Russian fires, resulting in short-wavelength direct aerosol radiative forcing of -90~ -200W/$m^2$. These smoke aerosol plume caused decrease in surface UV-B radiation up to 80% and increase in PM_(10) concentration up to 200${\mu}g/m^3$ exceeding the 24 hour ambient air quality standard.

Maxillary implant-supported fixed prosthesis engaged by distal-extension removable partial denture for 10 years: a case report (상악의 임플란트 고정성 보철물과 후방연장 국소의치를 이용하여 수복한 10년 경과 관찰 증례)

  • Ryu, Ri;Park, Yeon-Hee;Oh, Won-suk;Lee, Jung-Jin;Park, Ju-mi
    • Journal of Dental Rehabilitation and Applied Science
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    • v.36 no.2
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    • pp.121-127
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    • 2020
  • Prosthodontic decision and management should be considered the patient's aesthetic need for anterior teeth in maxillary edentulism. This case report describes 10-year clinical outcome of a maxillary edentulous patient was rehabilitated by means of an implant-supported fixed dental prosthesis (ISFDP) for the anterior region and a distal-extension removable partial denture (RPD) for the posterior region. The ISFDP was designed to splint 4 endosseous implants as one unit and engaged by the RPD. The edentulous mandible was restored by means of an implant-supported overdenture. Over the course, no major adverse event occurred other than wear, discoloration, and breakage of resin veneers and artificial teeth.

A Case of Total Lung Collapse due to Hemoptysis in Pregnancy (임신 중 발생한 객혈로 인한 전폐허탈 1예)

  • Cho, Jung Je;Ra, Seung Won;Lee, Kwang Ha;Lee, Jung A;Kang, Chae Hoon;Gwon, Dong Il;Oh, Yeon-Mok
    • Tuberculosis and Respiratory Diseases
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    • v.65 no.1
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    • pp.34-36
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    • 2008
  • Pregnancy induces many physiologic changes, and it can cause hemoptysis in relation to the underlying or potential pulmonary diseases. Although hemoptysis is not a frequent event during pregnancy, a thorough search for its etiology and then immediate management should be initiated for a case of massive hemoptysis to avoid serious adverse effects on both the fetus and the mother. Most hemoptysis events during pregnancy are related to well known etiologies, but there are a few reported cases of hemoptysis in pregnant women who are without any underlying lung lesion. We report here on a case of a pregnant woman with total lung collapse due to hemoptysis, and a thorough search for the etiology after delivery could not reveal any etiology.

National Level Response to Pandemic (H1N1) 2009 (정부의 신종인플루엔자 A(H1N1) 대응)

  • Lee, Dong-Han;Shin, Sang-Sook;Jun, Byung-Yool;Lee, Jong-Koo
    • Journal of Preventive Medicine and Public Health
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    • v.43 no.2
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    • pp.99-104
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    • 2010
  • The World Health Organization (WHO) announced the emergence of a novel influenza on April 24, 2009, and they declared pandemic on June 11. In Korea, the proportion of influenza-like illness and the consumption of antiviral agents peaked in early November. The government established the Central Headquarters for Influenza Control and operated the emergency response system. In the quarantine stations, we checked the body temperature and collected quarantine questionnaires from all the arrivals from infected countries. We also isolated the confirmed cases in the national isolation hospitals. However, as the community outbreaks were reported, we changed strategy from containment to mitigation. We changed the antiviral agent prescription guideline so that doctors could prescribe antiviral agents to all patients with acute febrile respiratory illness, without a laboratory diagnosis. Also the 470 designated hospitals were activated to enhance the efficacy of treatment. We vaccinated about 12 million people and manage the adverse event following the immunization management system. In 2010, we will establish additional national isolation wards and support hospitals to establish fever clinics and isolation intensive care unit (ICU) beds. We will also make a computer program for managing the national isolation hospitals and designated hospitals. We will establish isolation rooms and expand the laboratory in quarantine stations and we will construct a bio-safety level 3 laboratory in each province. In addition, we plan to construct a bio-safety level 4 laboratory at a new Korea Centers for Disease Control and Prevention (KCDC) facilities in Ossong.