• 제목/요약/키워드: adverse reaction

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EMR의 자발적 약물부작용보고 시스템을 이용한 한약약물유해반응 분석 (Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records)

  • 김미경;한창호
    • 대한한의학회지
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    • 제36권1호
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    • pp.45-60
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    • 2015
  • Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

삼성서울병원에서 보고된 의약품 부작용의 현황 조사 (The Surveillance of Adverse Drug Reactions (ADR) Reported in Samsung Medical Center)

  • 조정아;이후경;손기호;최경업
    • 한국임상약학회지
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    • 제10권1호
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    • pp.30-37
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    • 2000
  • Adverse drug reactions (ADR) may result in increased hospital admissions, morbidity and mortality, adding extra cost to healthcare expenditures. Thus, it is critical to activate ADR monitoring and reporting program in tertiary hospitals in developing countries such as Korea. This study was performed to identify the types of ADR being reported in a tertiary hospital, Samsung Medical Center, and to find out the ways to improve current ADR monitoring system. Of 464 ADR reports submitted to the pharmacy department during the 6-month survey period, $97.8\%$ of the reports were from out patient and $48.5\%$ were from patients aged between 50 and 60. The medical department with the highest frequency in ADR reporting was Internal Medicines $(35.6\%)$. The most common ADR manifestations were gastrointestinal complaints $(43.4\%)\;and\;75\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $32.8\%$. In terms of causality assessment, $85.1\%$ of the reports were probable cases by WHO causality assessment criteria. In regards to sources of report, $75.6\%$ of ADR were reported by physicians and $24.4\%$ by nurses. There were no ADR reported by pharmacists. In conclusion, there is an urgent need to improve ADR monitoring system for inpatient and to motivate pharmacist involvement in ADR monitoring and reporting in Korea.

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Oseltamivir 복용 이후 소아에서 발생한 이상행동 및 그 인과성 평가 (Psychiatric Symptoms after Taking Oseltamivir in a Child and Its Causality Assessment)

  • 손병우;최중혁;이승민;박선순;최은경;유봉규;지은희
    • 한국임상약학회지
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    • 제29권1호
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    • pp.56-60
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    • 2019
  • Oseltamivir is an antiviral medication prescribed to prevent and treat influenza A and B. A case from a community pharmacy in Korea was reported for an adverse event associated with oseltamivir administration. A 20-month-old boy had psychiatric symptoms after receiving 2 doses of oseltamivir. Therefore, an evaluation of whether the psychiatric symptoms were caused by oseltamivir was required. To determine whether the adverse event resulted from the administrated medication or other factors, three tools were used: the Naranjo scale, the Korean causality assessment algorithm (Ver.2), and the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria. The psychiatric symptoms occurred after oseltamivir administration, and were attenuated after oseltamivir termination. A possible cause of the psychiatric symptoms is high fever, but information on the body temperature of the patient was not sufficient. Therefore, it was unclear whether there were other nonpharmacological causes of adverse drug reaction. For these reasons, in terms of causality, the results evaluated by the three tools represented, "possible", "probable", and "probable/likely", respectively.

일부지역 항생제 소비자의 올바른 투약에 영향을 미치는 요인에 관한 연구 (A Study on Factors Influencing upon Right Medication of Antibiotic for Antibiotic Consumers)

  • 이미영;김명
    • 보건교육건강증진학회지
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    • 제11권2호
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    • pp.48-56
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    • 1994
  • In order to study the factors influencing upon right medication of antibiotic for the consumers who can easily buy antibiotic from pharmacy, the study carried out questionnaires to 568 consumers who bought antibiotics from pharmacies located in Seoul And Kyung-gi do from the 1st of February, 1994 to the 28th of the same month. Materials have been analyzed with $X^-test$ of SAS, and its results are as follows. 1. Among 568 objects of this study, the group which can medicare antibiotic properly (the right use group of antibiotic) is 45.5% with 258, while the group which does not recognize correctly the use of antibiotic or does not have any information about it (the abuse group of antibiotic) is 54.6% with 310. 2. Knowledge for advantage of antibiotic the right use group has is high in comparing with that of the abuse group (p<0.001), and also in case of pregnancy, understanding for an adverse reaction of antibiotic is high (p<0.001). The right use group has had many chances to take health education (p<0.001), and the way to buy antibiotic is very safe (p<0.001). But there is no outstanding difference for recognition of an adverse reaction of antibiotic between two groups. 3. In comparing with the abuse group, the right use group keeps well taking time of antibiotics as directions (p<0.001), and keeping rate of antibiotic dosage is high (p<0.001). Also the experiences of an adverse reaction of antibiotic is low (p<0.001). 4. In comparing with the abuse group, the right use group has high educational backgrounds (p<0.001) and many experiences of the education for health promotion (p<0.001), while there is no difference in age, sex, and economic status. 5. In comparing with the abuse group, the right use group has taken antibiotic many times (p<0.001), and there are many antibiotic takers of his/her family (p<0.01). 6. In comparing with the abuse group, the right use group has made much effort not only to check blood pressure and the pulse (p<0.05) but also for food habits (p<0.05). But there is no outstanding difference in the effort to get health information and the effort for regular exercises between these two group. 7. In comparing with the abuse group, the right use group has made an exertion in buying foodstuffs (p<0.001). But there is no big difference in efforts to keep the good attitude for physical health and mental heath, and sleeping hours between these two group.

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중등도-중증 궤양성 대장염 환자에서 infliximab의 치료효과에 대한 메타분석 (Meta-analysis of the Efficacy of Infliximab in Patients with Moderate-Severe Ulcerative Colitis)

  • 김종윤;이숙향;유기연
    • 한국임상약학회지
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    • 제22권3호
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    • pp.251-259
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    • 2012
  • Ulcerative colitis (UC) is characterized by a life-long chronic course with remissions and exacerbations. Use of biological therapies may reduce or delay the surgical procedures in patients with UC. The aim of this study was to determine the impact of infliximab (IFX) use on the rate of remission, surgical interventions, and the effect on quality of life in patients with moderate to severe UC. Literature was searched for studies that investigated the efficacy of IFX on the rate of remission, colectomy and quality of life (QoL) between January 1990 and June 2012 at MEDLINE, January 1988 and June 2012 at EMbase and others. Eleven trials were included in the meta-analysis; divided into placebo controlled 8 trials and intravenous corticosteroid controlled group 3 trials. In comparison to placebo control groups, patients who received IFX had an odds ratio (OR) of 3.712 (95% CI: 2.714, 5.079) for the short-term clinical remission, and 3.053 (95% CI: 2.044, 4.559) for the rate of long-term remission. In colectomy rate and quality of life (QoL), odds ratio were 0.566(95% CI: 0.387, 0.827) and 0.658 (0.505, 0.811) respectively. Any adverse reactions including infections, infusion reaction, rash and arthralgia were equivalent in both groups. Compared with intravenous corticosteroid controlled group, patients who received IFX had lower remission rate with short-term odds ratio 0.227 (95% CI: 0.033, 1.556) and long-term odds ratio 1.054 (95% CI: 0.317, 3.502) respectively. However, statistical significance was not showed with both two analyses. The higher adverse drug reaction (ADR) rates were occurred in the corticosteroid controlled groups. 73.3% of patients treated corticosteroid reported Cushing-like syndrome with moon face. In conclusion, IFX does increase remission rate and decrease the rate of colectomy in patients with UC without elevating any adverse reactions significantly. IFX also improves QoL in moderate to severe UC patients. It would not exceed the efficacy of intravenous corticosteroid, whereas intravenous corticosteroid also reported high rate of adverse reactions.

A Retrospective Study on the Clinical Safety of Bee Venom Pharmacopuncture at Craniofacial Acupuncture Points for the Treatment of Facial Disorders

  • Lee, Chang Hee;Yoon, Jin-Young;Shim, Sung-Eun;Kim, Jeong Hyun;Kim, Jun-Yeon;Kim, Ha-Na;Hwang, Ji-Min;Kim, Jung-Hyun;Goo, Bon Hyuk;Park, Yeon-Cheol;Seo, Byung-Kwan;Baek, Yong-Hyeon;Nam, Sang-Soo
    • Journal of Acupuncture Research
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    • 제36권4호
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    • pp.245-250
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    • 2019
  • Background: This study was designed to evaluate the clinical safety of Bee Venom (BV) pharmacopuncture at craniofacial acupuncture points. Methods: This was a retrospective study of 108 patients diagnosed with peripheral facial paralysis, trigeminal neuralgia, or facial spasm who were admitted to Kyung Hee University Korean Medicine Hospital at Gangdong, from April 1st, 2017 to August 30th, 2017. Patients were allocated into either, Group 1 (the non-allergy group of patients who did not have an allergic reaction to BV) or Group 2, the group who had allergic reactions to BV. To evaluate the clinical safety of BV pharmacopuncture after each treatment, several criteria were used to measure any side effects: outcome, Common Terminology Criteria for Adverse Events scale, Mueller HL scale, treatment decision after adverse reaction, causality, measures performed for patients with adverse reactions, and efficacy assessment. Results: BV pharmacopuncture delivered in 0.1-0.2 mL at a concentration of 1:30,000 at the craniofacial acupuncture points, showed no statistically significant differences in baseline characteristics between non-allergy Group 1 and allergy Group 2. Amongst the 108 patients, 11 reported side effects after BV pharmacopuncture treatment. These adverse events included rash (n = 7), pruritus (n = 5), swelling (n = 1), vesicles (n = 1), erythema (n = 1), and hives (n = 1). All side effects resolved without sequelae. Conclusion: In this study, BV pharmacopuncture delivered at low doses at the craniofacial acupuncture points, resulted in 10% of patients experiencing non serious side effects suggesting that BV pharmacopuncture was clinically well tolerated.

사례보고: 수술예방적 항생제 Cefotetan에 의한 아나필락시스 보고 및 World Allergy Organization 가이드라인활용 (Anaphylaxis Induced by Surgical Prophylactic Cefotetan and The Application of World Allergy Organization Guide: A Case Report)

  • 정경래;경은정;이희영;김은영
    • 한국임상약학회지
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    • 제22권3호
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    • pp.268-273
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    • 2012
  • The definition of anaphylaxis is 'a serious, life-threatening generalized or systemic hypersensitivity reaction' and is considered as the life threatening adverse drug reaction. We experienced a case of cefotetan induced anaphylaxis with negative pre-skin test, used for surgical prophylaxis. A 82-year-old female was scheduled for total knee replacement therapy. She had no previous history of allergy and her skin test results were also negative. On her right knee surgery, she underwent cefotetan therapy as a surgical prophylaxis for a week with no problems identified. Next left knee surgery, she also received the prophylaxis of intravenous cefotetan. However, a few minutes later, anaphylactic reaction developed with vomiting, severe hypotension, bronchospasm, and dyspnea. After immediate intensive care treatment, she recovered without significant complications. Though commonly used laboratory data in case reports, such as the specific IgE, tryptase, histamine, or allergic skin prick test were limited, we successfully confirmed anaphylaxis based on clinical criteria for diagnosing anaphylaxis based on WAO 2011 guideline with through concurrent patient°Øs medical history review and the process of identifying the causes.

열역학 평형 계산을 이용한 점화제의 점화반응 분석 (Equilibrium Analysis on the Pyrotechnic Reactions of Igniters)

  • 엄기헌;김경민;원용선
    • 한국추진공학회:학술대회논문집
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    • 한국추진공학회 2017년도 제48회 춘계학술대회논문집
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    • pp.1036-1037
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    • 2017
  • 본 연구는 3종류의 점화제(BKNO3, THPP, ZPP)에 대한 노화 반응을 수행하였다. 점화제의 수명은 대기에 포함된 산소와 수분의 영향을 받는다. 예를 들면 $BKNO_3$의 경우 산소, 수분과 결합하여 산화물 또는 수산화물의 형태로 반응이 이루어진다. 이러한 반응은 점화 반응에 있어서는 좋지 않으며, 점화제의 노화 현상의 분석에 있어 매우 중요한 정보가 될 수 있다. 열역학 계산은 점화제의 초기온도, 조성 등으로써 화염온도를 계산하며, 그로써 노화 반응을 설명할 수 있다. 노화에 의해 점화제가 불완전 연소 되었다면, 화염온도는 완전 연소 되었을 경우보다 낮은 범위에서 형성될 것이다. 본 연구에 대한 결과가 점화제의 노화 반응 분석에 대한 뒷받침이 될 것으로 기대된다.

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페니토인 사용에 따른 소뇌 위축 사례 (A case of phenytoin-induced cerebellar atrophy)

  • 김재현
    • 한국콘텐츠학회:학술대회논문집
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    • 한국콘텐츠학회 2016년도 춘계 종합학술대회 논문집
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    • pp.433-434
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    • 2016
  • Cerebellar atrophy was found that a patient was taking oral phenytoin for 3 years. 53 years old female patient with General tonic clonic(GTC) type seizure was prescribed phenytoin. In the process, she developed ataxic gate, dysarthria. Brain magnetic resonance imaging(MRI) finding was revealed differential diagnosis cerebellar atrophy. She was prescribed epileptol instead of phenytoin. But leukopenia, thrombocytopenia occurred. As a result, phenytoin restarted. Development of medical state decreased abuse of anticonvulsants. Considering various convulsive disorders, we must give attention to using anticonvulsants.

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