• 제목/요약/키워드: Adverse Event

검색결과 317건 처리시간 0.033초

의학입문에 수록된 금침혈 연구 (A Study of Acupuncture Contraindications in Uihakipmun)

  • 채광민;권선오;윤동학;김승태
    • Korean Journal of Acupuncture
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    • 제36권3호
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    • pp.150-161
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    • 2019
  • Objectives : The authors aimed at contributing to the safety of acupuncture in the clinic by analyzing the information of contraindicated acupoints described in Uihakipmun. Methods : We investigated the contents related acupuncture contraindications in Uihakipmun, categorized the contraindicated acupoints by site and identified whether they can cause adverse events from the anatomical point of view. Results : In Uihakipmun, 49 acupoints - BL6, BL8, BL9, ST1, SI18, BL1, BL2, TE18, TE19, TE20, GB1, GB3, GV22, GV24, ST12, ST9, TE16, GV6, BL15, BL30, CV17, LU2, GB22, SP16, CV8, CV9, CV15, KI11, ST30, SP11, BL56, GB32, GB33, GB42, LI13, HT2, TE8, GV17, GB18, EX-HN11, GB21, GV11, GV10, ST17, CV5, CV1, ST42, SP6, LI4 - were described as contraindicated acupoints. Among them, the contraindications induced by acupuncture treatment were described for just 5 acupoints. Anatomically, acupuncture stimulation at the contraindicated acupoints can cause organ, nerve or vessel damage near the acupoints. And the number of contraindicated acupoints in Uihakipmun was increased compared to those in Hwangjenaegyeong, Chimgugabeulgyeong, Bigeupcheongeumyobang, Donginsuhyeolchimgudogyeong and Chimgujasaenggyeong. Conclusions : In Ming dynasty, the knowledge associated with adverse events on acupuncture was increased by the accumulation of medical knowledge. Acupuncture stimulation at the contraindicated acupoints described in Uihakipmun can cause tissue damage, therefore we should perform acupuncture procedure carefully to avoid adverse events when stimulating the contraindicated acupoints.

의약품부작용보고시스템 데이터베이스를 이용한 고강도 statin과 중·저강도 statin 관련 이상사례 비교 분석 (Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group)

  • 이세라;옥미영;김현아
    • 한국임상약학회지
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    • 제28권4호
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    • pp.293-299
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    • 2018
  • Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.

의약품부작용보고시스템 데이터베이스를 이용한 fluconazole 및 itraconazole 관련 이상사례 분석 (Real-world Adverse Events Associated with Fluconazole and Itraconazole: Analysis of Nationwide Data Using a Spontaneous Reporting System Database)

  • 이유경;이정민;천부순
    • 한국임상약학회지
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    • 제32권3호
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    • pp.204-214
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    • 2022
  • Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

Short-term safety profile of COVID-19 vaccination in children and adolescents with underlying medical conditions: a prospective cohort study

  • Naye Choi;Seung-Ah Choe;Yo Han Ahn;Young June Choe;Ju-Young Shin;Nam-Kyong Choi;Seong Heon Kim;Hee Gyung Kang
    • Childhood Kidney Diseases
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    • 제27권1호
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    • pp.34-39
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    • 2023
  • Purpose: This article was to collect data on the safety of coronavirus disease 2019 (COVID-19) vaccines in children with underlying medical conditions. Methods: We constructed a prospective cohort of children and adolescents aged 5 to 19 years who had received at least one dose of COVID-19 vaccine. Patients diagnosed with and treated for chronic kidney disease, autoimmune disease, or other chronic conditions at the Seoul National University Children's Hospital were recruited from June to December 2022. A mobile survey questionnaire was sent to their guardians. The presence of adverse events on the day (day 0), 3 weeks (day 21), and 6 months (day 180) after the 1st dose of COVID-19 vaccine was recorded by the guardians. Results: A total of 73 children participated. The median age was 14 years, and 64.4% of the patients were male. On the day of immunization, 65.8% of the patients reported at least one adverse event. Pain at the injection site, fatigue, headache, arthralgia, and myalgia were the most common symptoms. The prevalence of adverse events decreased over time (65.8% on day 0, 27.4% between days 0 and 21, and 24.6% between days 21 and 180). Severe acute respiratory syndrome coronavirus 2 infection after the 1st dose occurred in 17 patients (23.3%) and one of the patients (5.88%) was hospitalized due to infection. Conclusions: Adverse events after COVID-19 vaccination were generally mild in children and adolescents with underlying medical conditions. Our findings provide evidence for the safety of COVID-19 vaccination in the vulnerable pediatric population.

이식형 의료기기의 추적 및 회수 관리를 위한 통합전산관리시스템 설계 (Design of a Tracking & Recall Management System for Implantable Devices)

  • 박순만;유선국
    • 전자공학회논문지SC
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    • 제48권5호
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    • pp.74-80
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    • 2011
  • 본 연구는 유통되는 이식형(implantable) 의료기기의 추적(tracking) 및 회수(recall) 처리를 신속하고 정확하게 수행할 수 있는 통합 전산 관리시스템 설계하는 것을 목적으로 한다. 이를 위해 최신 FDA 규정을 만족하는 시스템을 MSF/CD 설계방법론을 기반으로 설계하였다. 추적과 회수의 주요한 4가지 가상 시나리오를 설정하고 workflow diagram을 작성하여 개념설계하였다. 또한 business workflow를 만족하는 서버의 논리 DB를 개발하여 논리설계 단계까지 시스템을 설계하였다. 제안된 시스템으로 이식형 의료기기의 심각한 부작용 등 문제 발생 시 신속하고 정확한 추적과 회수 처리가 가능하여 이식형 의료기기를 장착한 환자의 생명유지 및 국민 건강 보호를 위한 정부 차원의 효율적인 관리가 가능할 것으로 사료된다.

간호사가 인식한 이차 피해 경험이 삼차 피해 경험에 미치는 영향과 이차 피해 지지의 다중 매개효과 (Effects of Nurse's Second Victim Experiences on Third Victim Experiences: Multiple Mediation Effects of Second Victim Supports)

  • 김은미;김순애;김지인;이주리;나선경
    • 한국의료질향상학회지
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    • 제23권2호
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    • pp.23-34
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    • 2017
  • Purpose: Nurse's second victim experiences could influence organizational negative work-related outcome. The purpose of this study was to investigate the casual relationship between nurses' second victim experience and third victim experience and multiple mediation effects of second victim supports. Methods: A cross-sectional, self-report survey (the Second Victim Experience and Support Tool) was conducted with 305 nurses working in a general hospital. Data were collected from October 20 to November 25, 2016 and analyzed using SPSS Win version 23.0. Results: The nurses' perceived second victim experience was $3.24{\pm}0.61$ and the third victim experience was $3.12{\pm}0.92$. Nurses' second victim experience was found to have a direct effect on increasing third victim experience and indirect effect of colleague support as mediator (p<.05). However, institutional support and supervisor support had not a partial and indirect effect on third victim experience. Conclusion:This study is one of the first to connect second victim experience to third victim experience in South Korea. This study broadens the understanding of the negative effects of a second victim experience influence third victim experience. When involvement in patient safety events, the important role of colleague support in limiting nurse's third victim experience have been acknowledged. This study reinforces the efforts health care leaders are making to develop interventional programs to colleague support their staff as they recover from adverse event involvement.

암 환자의 삶의 질, 식욕 부진과 악액질에 대한 복합 한의 치료 프로그램의 효과: 후향적 차트 리뷰 (Effectiveness of comprehensive traditional Korean Medicine treatment on quality of life, anorexia and cachexia of cancer patients : Retrospective chart review)

  • 한원주;이은지;한가진;윤상훈;한가진;임정태
    • 대한한의학회지
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    • 제40권2호
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    • pp.119-132
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    • 2019
  • Purpose: This study was conducted to collect and analyze real world data to evaluate the effectiveness and safety of comprehensive traditional Korean Medicine treatment on quality of life, anorexia and cachexia of cancer patients. Methods: We analyzed medical records of 62 cancer patients admitted to O-I Dang Korean Medicine Hospital from February 2018 to February 2019. The primary outcome was a change score in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes were Functional Assessment of Cancer Therapy-General (FACT-G), Trial Outcome Index(TOI) of FAACT, 11 point Pain Intensity Numeric Rating Score (11 PI-NRS) and Patient Global Impression of Change (PGIC) and adverse event. Results: Cachexia and quality of life in cancer patients assessed by FAACT, increased by $5.59{\pm}14.83$ (p=0.004) after treatment. PI-NRS was reduced by $2.10{\pm}1.81$ (p<0.001) and TOI and FACT-G total scores were increased by $5.17{\pm}11.70$ (p=0.001) and $3.59{\pm}10.94$ (p=0.012), respectively. These results were also clinically meaningful assessed via minimal clinically important difference (MCID). There was no severe adverse event. Conclusion: These findings suggest that comprehensive traditional Korean Medicine treatment might be effective and safe strategy for improving quality of life, anorexia, cachexia and pain of cancer patients. Further advanced studies with controlled group and more participants with rigorous design are needed to ensure these findings.

쌍합탕 투약 후 수족부 저림증이 호전된 지주막하출혈 환자 증례보고 (A Case Report of a Subarachnoid Hemorrhage Patient whose Paresthesia Improved by Ssanghap-tang)

  • 홍승철;민선우;문지성;김학겸;김영지;송주연;안립;신길조;최동준
    • 대한중풍순환신경학회지
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    • 제21권1호
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    • pp.77-84
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    • 2020
  • ■ Objectives This case is to report the effect of Ssanghap-tang on paresthesia of a subarachnoid hemorrhage patient. ■ Methods A male Korean patient was treated with Ssanghap-tang and acupuncture, moxibustion for total 30 days. We observed limbs numbness, circumferences, other symptoms such as weakness and any adverse event. ■ Results After treatment, numeric rating scale of limb numbness was improved to 5 from 8 at admission without any adverse event. However, we could not find any significant differences on hand circumference and limb weakness. ■ Conclusion This case suggests that Ssanghap-tang and acupuncture, moxibustion therapy could be effective in improving paresthesia of subarachnoid hemorrhage patient.

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오령산 투여 및 침치료 후 당뇨병성 신증의 혈청 크레아티닌 수치가 호전된 뇌경색 환자 증례보고 (A Case Report of a Cerebral Infarction Patient whose Diabetic Nephropathy Improved with Serum Creatinine Level by Oryeong-san and Acupuncture Therapy)

  • 홍승철;박송원;이찬솔;노현석;하유경;최동준
    • 대한중풍순환신경학회지
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    • 제18권1호
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    • pp.13-22
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    • 2017
  • ■ Objectives This case is to report the effect of Oryeong-san and acupuncture therapy on serum creatinine level of a cerebral infarction patient with diabetic nephropathy. ■ Methods A female Korean patient was treated with Oryeong-san, acupuncture for total 32 days. We observed renal function test, input/output balance, body weight, hand and foot circumferences, and other symptoms like edema, urination, and any adverse event. ■ Results After treatment, serum creatinine level was improved to 2.48mg/dL from 3.45mg/dL at admission, and foot circumference was decreased to 18.5~18.9cm from 22.0~22.5cm without any adverse event. However, we couldn't find any significant differences on input/output balance, body weight, or symptoms of urination. ■ Conclusion This case suggests that Oryeong-san and acupuncture therapy could be effective in improving serum creatinine clearance of cerebral infarction patient with diabetic nephropathy.

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일본뇌염 백신의 이상반응 실태조사 (Investigation on the Frequency and Severity of Common Adverse Reactions of Japanese Encephalitis Vaccines)

  • 김부영;김동현;이훈재;정수경;이소산;박숙경;고은영;홍영진
    • Pediatric Infection and Vaccine
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    • 제16권2호
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    • pp.183-190
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    • 2009
  • 목 적: 본 연구에서는 일본뇌염 백신의 종류별 이상반응 발생실태를 조사하여 일본뇌염 백신의 안전성에 대한 평가를 통해 향후 일본뇌염 국가예방접종사업의 효율화를 위한 토대를 제공하고자 하였다. 방 법: 2006년 8월부터 2007년 2월까지 본 연구에 협력하기로 한 일개 대도시 지역의 보건소 4개소와 소아과 의원 9개소에서 실시되었다. 총 658명의 어린이를 대상으로 이상반응 평가가 완료되었다. 이들 어린이들을 대상으로 예방접종 당일부터 4일후까지 발적, 동통, 발열, 두통 등 상대적으로 흔한이상반응의 발생빈도 등을 전향적으로 추적 관찰하였다. 결과: 대상 소아의 평균 연령은 사백신이 1.4세(1-8.5), 생백신이 1.7세(1-8.3)였다. 그 중 보건소에서 사백신을 접종받았던 어린이는 425명(64.6%)이었으며 소아과 의원에서 생백신을 접종받은 경우는 233명(35.4%)이었다. 사백신의 경우 전체 접종 어린이 중 3.3%인 14명이 한 가지 이상의 국소 이상 반응이 나타났으며, 생백신 접종 어린이들의 2.6%가 한 가지이상의 국소 이상반응을 호소하였다. 이러한 차이는 통계적으로 유의한 수준은 아니었다(P =.607). 발열 등의 전신반응의 경우 사백신과 생백신 접종 어린이들의 각각 5.2%와 8.2%에서 나타났으나 역시 유의한 수준의 차이는 아니었다(P =.131). 사백신 접종 어린이들에서는 접종당일 발적이 4명(0.9%), 종창이 2명(0.7%), 동통이 7명(1.7%), 발열이 2명(0.5%) 나타났다. 반면 생백신 접종 어린이들의 경우 각각 4명(1.8%), 2명 (0.9%), 0명(0.0%), 6명(2.6%)에서 해당 증상을 호소하였다. 발열의 경우 통계적으로 유의하게 생백신 접종 어린이들에서 빈번하였다(P=.026). 발적, 종창, 동통, 발열 중 한 가지 이상 나타난 어린이들의 백분율은 사백신과 생백신 접종자들의 각각 3.3%와 5.2%였으며, 이는 유의한 수준의 차이는 아니었다(P =.243). 접종 1, 2, 3, 4일 후 주요 국소 및 전신 이상반응 발생빈도는 사백신과 생백신에서 유의한 차이를 보이지는 않았다. 이상반응의 세부 항목 중에서는 설사 증상만이 생백신접종 어린이들에서 유의하게 많이 나타났다(P =.044). 결 론 : 본 연구에서는 일본뇌염백신의 이상반응 발생률이 이전의 보고보다 낮았고, 접종 당일 사백신 접종자들에 비해 생백신 접종자들에서 발열이 빈번하게 관찰되었다. 그 외 사백신과 생백신의 이상반응 발생에 뚜렷한 차이가 없었다. 그러나 사백신의 경우 향후 더 많은 수의 인구 표본을 대상으로 안전성에 대한 전향적 연구가 필요하며, 생백신의 경우 안전성에 대한 객관적 경험이 더 축적되어야 할 것으로 생각된다. 아울러 가장 문제가 되고 있는 중증이상반응의 발생을 확인하기 위해서는 대규모 표본을 대상으로 지속적인 감시활동이 필요할 것으로 사료된다.

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