• 제목/요약/키워드: Report on Adverse Drug Reactions

검색결과 21건 처리시간 0.026초

조영제로 유발된 약진(藥疹)환자 치험 1례 (A Clinical Case Report of Contrast-induced drug eruption patient Treated with Traditional Oriental Medicine)

  • 정의민;정종수;윤성우;박재우
    • 대한암한의학회지
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    • 제12권1호
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    • pp.75-82
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    • 2007
  • Drug eruption is a cutaneous reaction caused by various drugs. It is a very common drug induced adverse reaction. Contrast media induced drug eruption is rare. But approximately 10% of people injected with contrast media experience adverse reaction, and drug eruption accounts for more than 40% of all adverse reactions. We report a case of mild drug eruption and its treatment process based on korean traditional medicine. The patient is a 50 years old female diagnosed with functional dyspepsia. The patient had gastric discomfort and alternation between diarrhea and constipation. All symptoms showed nearly complete remission with continued korean traditional medical treatment. The patient had been injected with contrast media for Computed tomography(CT) evaluation of her breast cancer history. Rashes appeared on back and abdomen, and urticaria and pruritus appeared on the patient's finger 1 day after injection. We prescribed Goreisan(TSUMURA CO &, TJ-17) and acupuncture on Quchi(LI11), Zusanli(ST36), Yangxi(LI5), Yanggu(SI5). Consequently, the drug eruption showed remarkable improvement. So the author reports korean traditional medicine is effective complementary treatment for drug eruption.

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섬수약침 국소시술 이후 발생한 단순 피부 발진: 3 이상사례 보고 (Three Adverse Events Reports of Simple Exanthematous Eruption after Sumsu (Bufonis Venenum) Pharmacopuncture Topical Treatment)

  • 윤상훈;조희근;송민영;서형식
    • 한방재활의학과학회지
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    • 제28권3호
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    • pp.119-124
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    • 2018
  • Three cases of simple exanthematous eruption were suspected during Sumsu (Bufonis Venenum) pharmacopuncture (SP) topical anesthesia for acupotomy. Patients had skin rash with pruritus on both ankle, posterior neck, and left shoulder after 11, 12, and 7 times of SP treatment, respectively. There were no cases of systemic manifestations or changes in vital signs. As a result of using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment, all the cases were evaluated as 'unlikely'. However, the results of using the Korean algorithm for assessing the causality of drug adverse reactions version 2.0 were evaluated as 'possible'. This report is the first case report on adverse events suspected of occurring after SP treatment. Although the causal relationship between suspected intervention and the adverse event is not clear, there was a difficulty in completely excluding the possibility. Additional safety studies will be required to make SP more widely available.

신생아 B형 간염 예방 접종 후 하지 부종이 발생한 환아 치험 1례 (A Case Report of Extensive Limb Swelling in Newborn After Vaccination: Unusual Thigh Swelling After Hepatitis B vaccination)

  • 한주희;김덕곤;이진용
    • 대한한방소아과학회지
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    • 제28권1호
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    • pp.52-60
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    • 2014
  • Objectives The purpose of this study is to report the clinical effects of oriental medical treatment on Extensive limb swelling which is rare adverse reaction of vaccination. Methods A 11 months old infant who appealed unilateral thigh swelling after immunization and signs of local inflammation was administered a complex herbal medicine consisting of five decoctions; Gwakhyangjunggisan, Binsosan, Danggwisusan, Samchulgunbitang and Gwibitang. The length of the constant regions of the thigh circumference was measured every visit. Each process was recorded by photograph. After one year from the first visit, phone call was conducted to follow-up. Results The length of the thigh after administration of herbal medicine did not change much, but the part where swelled hard became little bit softer. A year later, patient's growth and walking was normal but the swollen part not changed. Since then the similar adverse effects did not recur on booster doses vaccines. Conclusions The adverse reactions of vaccination are rarely reported and there is no specific treatment for swelling from Hepatitis B vaccine. It will be more helpful to study if more cases reported about any adverse drug reactions or any side effects from the immunization.

약물감시사업과 약물유해반응에 대한 인식도 조사 (A Survey on Attitude and Awareness of Health-Care Professionals Regarding Pharmacovigilance System and Experience for Adverse Drug Reaction (ADR) from a Single University Hospital)

  • 경은정;류지현;오민아;김은영
    • 한국임상약학회지
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    • 제23권3호
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    • pp.256-268
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    • 2013
  • Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.

Quetiapine Fumarate의 제형 변경 후 발생한 피부 발진 1예 (A Case of Skin Eruption Occurred after Switching Formulation of Quetiapine Fumarate)

  • 권용석;임세원
    • 생물정신의학
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    • 제16권4호
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    • pp.266-270
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    • 2009
  • Adverse drug reactions are very common in clinical practice, and skin is one of the most frequent organs for adverse drug reactions. We report a case of a 71-year-old male patient who developed skin eruptions after switching formulation of quetiapine immediate release(IR) to quetiapine extended release(XR). He had been taking quetiapine IR(400mg/day) for treatment of manic episode which was developed one year ago. The patient showed great improvement of symptoms after taking quetiapine IR for about one year, thus dosage of medication was reduced to 50mg/day on the average. Unfortunately dose reduction has tended to worsen symptoms, so dose of quetiapine was increased again to 200mg/day with formulation changes to XR. Two days after he took new formulation, erythematous papules were occurred over his anterior neck and ventral side of left wrist. As he stopped quetiapine XR, the skin lesions gradually subsided. And he was successfully treated with readministration of quetiapine IR without any skin lesions.

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한약물의 유해반응에 대한 고찰: 간손상을 중심으로 (Consideration of adverse effects of herbal drug: focussing on hepatic damage)

  • 정종미;손창규
    • 혜화의학회지
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    • 제17권1호
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    • pp.53-57
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    • 2008
  • These day, herbal drugs have been widely used in all over the world, as primary therapeutics or supplements for treating various diseases. Herbal drugs are generally regarded as non-toxic due to their natural origin and long history traditionally used without serious adverse reactions. However, plenty warnings have been reported, particularly about the potential hepatotoxicity of herbal products. This report would be helpful for understanding theory of toxicology and prevent from herbal drug-derived hepatotoxicity in Oriental medicinal field.

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FDA 부작용 보고 시스템 데이터베이스를 이용한 Cyclosporine과 Tacrolimus의 주요 약물이상사례 및 실마리 정보 분석 (Analysis of Important Medical Adverse Events and Signals Related with Cyclosporine and Tacrolimus Using the FDA Adverse Event Reporting System (FAERS) Database)

  • 차승현;임지현;송윤경
    • 한국임상약학회지
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    • 제32권4호
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    • pp.352-361
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    • 2022
  • Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

조영제 투여 후 초발한 저린감에 대한 사물탕가미(四物湯加味) 치료 증례보고 (A Case Report of Treatment of Numbness Associated with Contrast Medium Injection using Modified Samul-tang)

  • 권정연;배지용;공경환;고호연
    • 대한한방내과학회지
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    • 제40권5호
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    • pp.983-989
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    • 2019
  • Objective: Many types of delayed adverse reactions, such as long-term numbness, occur after injecting contrast medium, but few clinical studies have reported effective treatments for these reactions. We report that herbal medicine can have a positive clinical effect in patients who have experienced long-term numbness after contrast medium injection. Method: A patient who had felt numbness in her head and whole limbs presented at Semyung University Korean Medicine hospital. Her numbness had first started 2 days after injection of contrast medium, and she had felt it constantly for almost 2 years. After admission at the hospital, she took "modified Samul-tang" herbal medicine (120 cc three times per day) from 29 January 2019 to 2 February 2019. We measured her numbness using a numeric rating scale (NRS) on 29 January and 2 February and we compared both scores to determine the degree of favorable and clinical effects of herbal medicine. Result: The NRS score for numbness was 5 for her head and limbs on the first day (29 January), but after 4 days (2 February), the NRS score decreased to 0 for her head and both arms and hands, and it decreased from 5 to 2 for both her legs and feet. Conclusion: Korean herbal medicine can have positive clinical effects on treating adverse reactions due to injection of contrast medium.

인삼 복용 후 발생한 비출혈 및 심계항진을 주소로 한 소양인 환자 1례 (A Case Study of a Soyangin Patient with Palpitation and Epistaxis that Occurred after Taking Panax Ginseng)

  • 이선영;황민우
    • 사상체질의학회지
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    • 제25권4호
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    • pp.406-413
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    • 2013
  • Objectives The purpose of this case study was to report improvement of palpitation, epistaxis, nausea, and anorexia after treatment with Dojeokgangki-tang gamibang in a middle-aged woman who has been taking Panax Ginseng continually. Methods Upon beginning her Dojeokgangki-tang gamibang regimen the patient was asked to self-evaluate the degree of discomfort in her symptoms using a using a number scale from 0 (no symptoms) to 10 (most severe). Evaluation of palpitation and chest discomfort was made a high priority. Results The palpitation the patient experienced, and self-evaluated as an "8" on the number scale at the time of her admission to the hospital, had disappeared (become "0") by the fourth day of hospitalization. The numerous symptoms which accompanied her palpitations (chest discomfort, nausea, anorexia, general weakness, weight loss, and depression) also improved accordingly. Conclusions Health functional food can pose serious health risks such as sudden bleeding and palpitations in individuals with pre-existing health problems. One must exercise extreme caution in deciding to take such supplements. As seen in the case of the middle-aged woman, the quality of life of patients who had experienced adverse reactions to such supplements can be treated through the administration of Dojeokgangki-tang gamibang.

영국의 일반의약품(Over-the-counter drugs) 관리법의 의료정책적 함의 (The NHS Over-the-Counter Drugs Policy in UK: Its Experiences and Implications)

  • 한동운
    • 의료법학
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    • 제12권2호
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    • pp.265-291
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    • 2011
  • Changes in a drug's availability from prescription only to over-the-counter (OTC) status is of concern to physicians from both public health and individual patient perspectives. Government has generally been supportive of changes in medications from prescription(Rx) to over-the-counter (OTC) status in Korea, however, recognizing that there are both benefits and risks to any health care intervention, health care professionals are conservative in implementing changes to either the process or structure of health care. Changes in status of a drug from Rx to OTC can represent a change in both structure and process. Cost and convenience seem to be major factors in determining whether, given the choice, patients purchase a medicine over the counter or obtain it on prescription. With current arrangements, exemption from prescription charges provides an incentive to continue to obtain products on NHS prescription even when they are available over the counter. There is therefore no simple relation between the availability of over the counter medicines and the level of prescribing of deregulated products. The appropriate use of over the counter medicines-particularly those that have only recently been deregulated-places a burden of care on community pharmacists and calls for closer working relationships with general practitioners. In particular, systems for referral and for recording details of both prescribed and over the counter medicines need to be developed, and a direct route needs to be established for community pharmacists to report adverse drug reactions to over the counter products. Reclassification of prescription medicines-by making them available through pharmacies without a prescription-provides the opportunity for consumers to purchase a wider range of medicinal products without making a demand on NHS resources. There is, however, no simple relation between availability of over the counter medicines and demand for NHS prescriptions. In the late 1980s the UK government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. To explore the influence of deregulation of medicines on NHS prescribing, this article presents analyses of consumer behaviour in using medicines and prescribers' attitudes to over the counter medication and collates findings from research. Policy makers should be aware that patients' expectations in relation to OTC medicines may be in conflict with evidence-based practice.

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