• Title, Summary, Keyword: Adverse event

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Comparative Analysis of the Seriousness of the Adverse Events and Risk of Targeted Therapy for Metastatic Renal Cell Carcinoma Among Medical Professionals (전이성신세포암 표적치료제의 부작용 심각도 및 위해에 대한 전문가그룹별 비교분석)

  • Park, Mi-Hae;Rhee, Jin-Nie;Lee, Eui-Kyung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.2
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    • pp.100-105
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    • 2011
  • The perception of the 20 adverse events of targeted therapy for metastatic renal cell carcinoma was compared among medical professionals. Thirty-seven oncologists, 167 nurses and 79 pharmacists participated in the survey, and the response rate was 61.9%, 98.2%, 84.9%, respectively. Results showed that the most serious adverse event was GI perforation (8.83 points, 10 being the most serious), whereas the least serious was anemia (5.32 points). There were significant differences among oncologists, nurses and pharmacists especially for the moderately-serious adverse event such as wound-healing complication and lymphopenia. Adverse Events Composite Score (AECS) for each targeted therapy was calculated by multiplying adverse event incidence rate and seriousness score. Sunitinib had the highest score at 6.86 point and bevacizumab had the lowest at 2.1. Among professional groups oncologists showed the lowest AECS, whereas nurses had the highest. The gap on the perception of the adverse events among medical professionals needs to be reduced to get better outcomes of medical therapies for cancer patients.

Review of Adverse Events in Acupuncture Treatment (침치료 이상반응에 대한 고찰)

  • Park, Ji-Eun;Oh, Dal-Seok;Choi, Jun-Yong;Jung, So-Young;Kim, Ae-Ran;Koo, Chang-Mo;Jung, Hee-Jung;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.13 no.3
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    • pp.79-85
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    • 2007
  • Objective : To investigate documented surveys about adverse events of acupuncture therapy. Methods: We searched Medline with the terms of 'acupuncture/adverse event(s)', 'acupuncture/side effect(s)' and 'CAM/adverse event(s)' using Pubmed and set the limits to human study. Results: There were 5 prospective studies, 3 reviews and 3 surveys in our searching. There were 3 reports about acupuncture related adverse events in UK ranging from 10.7% to 15% of which the rate of significant events were from 0.13% to 0.14%. In Germany, there were 11% of acupuncture related adverse events in one report and 7.5%(significant events were 45 in 190,924 patients) in another report. In Australia, one study reported that every adverse event associated with acupuncture occurred in 8-9 month per one practitioner. In Japan, 0.14% of acupuncture related adverse events in 48 practitioners were reported in one systemic review. A cumulative review about significant adverse events associated with acupuncture reported 715 adverse events of which most frequent accidents were pneumothorax and central nervous system injury. Conclusion : The risk of adverse event associated with acupuncture is far lower than that associated with other general medical interventions. However, some safety guidelines about the acupuncture performance are needed.

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Management of Severe Fatigue Induced by Tyrosine Kinase Inhibitor in Radioiodine Refractory Thyroid Cancer (방사성요오드 불응성 갑상선암에서 티로신키나아제 억제제 투여로 유발된 중증 피로감의 관리)

  • Ahn, Byeong-Cheol
    • International journal of thyroidology
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    • v.11 no.2
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    • pp.75-77
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    • 2018
  • Tyrosine kinase inhibitor is known to prolong progression free survival in radioiodine refractory thyroid cancer patients. Fatigue/asthenia/malaise is one of most common adverse events by the tyrosine kinase inhibitor treatment, and management of the adverse event is important to keep the drug medication longer which is essential for the survival benefit. In the case report, a radioiodine refractory thyroid cancer patient receiving tyrosine kinase inhibitor experienced severe fatigue, and a pathologic fracture of right humerus occurred by slipping down which was tightly linked with the adverse event of the drug. The pathologic fracture was surgically well managed and the adverse event was well controlled by supportive managements combined with dose reduction of the tyrosine kinase inhibitor. The drug administration to the patient was kept more than 1 year without progression of the disease.

The Analysis of Incidence and Type of Adverse Events in Acupuncture & Moxibustion Clinical Trials (침구임상시험에서 나타난 이상반응 발생률 및 유형 분석)

  • Jung, Hee-Jung;Park, Ji-Eun;Liu, Yan;Kim, Ae-Ran;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.29 no.3
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    • pp.421-430
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    • 2012
  • Objectives : We investigated the incidence rate and type of adverse events associated with RCTs(Randomized Controlled Trials) of acupuncture and moxibustion. Methods : This study included 949 patients who received acupuncture or moxibustion or usual care from 8 RCTs. We collected data including gender and age of patients, intervention, treatment frequency and type of adverse events in clinical trials from their case report forms. Results : Among the 949 patients, 83 patients(8.7%) suffered at least one adverse event throughout the clinical trials. Types of adverse event in acupuncture & moxibustion clinical trials are common cold, skin changes, pain, dizziness, bruise, gastrointestinal diseases, changes of blood chemistry, burn. Adverse events were significantly correlated to patients' age, intervention, body mass index and treatment group. Conclusions : A Guide-line for collecting and managing adverse events of acupuncture & moxibustion clinical trials are needed.

Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting (의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이)

  • Lee, Ye Jin;Yoon, Chiho;Choi, Soo Jeong;Kang, Youngjoon;Kim, Jin Kuk;Kwon, Bum Sun;Lee, You Kyoung;Nam, Ki Chang
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.171-178
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    • 2019
  • This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

Development of Mining model through reproducibility assessment in Adverse drug event surveillance system (약물부작용감시시스템에서 재현성 평가를 통한 마이닝 모델 개발)

  • Lee, Young-Ho;Yoon, Young-Mi;Lee, Byung-Mun;Hwang, Hee-Joung;Kang, Un-Gu
    • Journal of the Korea Society of Computer and Information
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    • v.14 no.3
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    • pp.183-192
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    • 2009
  • ADESS(Adverse drug event surveillance system) is the system which distinguishes adverse drug events using adverse drug signals. This system shows superior effectiveness in adverse drug surveillance than current methods such as volunteer reporting or char review. In this study, we built clinical data mart(CDM) for the development of ADESS. This CDM could obtain data reliability by applying data quality management and the most suitable clustering number(n=4) was gained through the reproducibility assessment in unsupervised learning techniques of knowledge discovery. As the result of analysis, by applying the clustering number(N=4) K-means, Kohonen, and two-step clustering models were produced and we confirmed that the K-means algorithm makes the most closest clustering to the result of adverse drug events.

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Necessity of Adverse Event Reporting System through the Trend of Internet News about Safety of Herbal Medicine (한약의 안전성에 대한 인터넷 보도의 특성을 통해 본 한약 부작용 관리 체계 확립의 필요성)

  • Cheon, Chun-Hoo;Park, Jeong-Su;Park, Sun-Ju;Kweon, Kee-Tae;Shin, Yong-Cheol;Ko, Seong-Gyu
    • Journal of Society of Preventive Korean Medicine
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    • v.15 no.2
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    • pp.131-143
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    • 2011
  • Objective : The aims of this study are to investigate the trend of internet journalism about the toxicity and safety of the herbal medicine, and to suggest the regulatory solution of the issue. Method : In this study, we had searched the internet news article published from 2001 to 2011 in the five major portal sites-NAVER, DAUM, Nate, Google Korean, and Yahoo Korean. The search terms were 'herbal medicine', 'adverse event', 'toxicity'. If the articles described the same event in the same form and tone, the articles were considered overlapping. The overlapped articles were excluded. The articles were categorized by the form and tone. The form categories were straight news, interpretative story, editorial, interview, and the tone categories are the positive, the negative, and the neutral. The regulations were searched about the negative issue. Result : Total 56 articles were reviewed. There were 19 positive articles, 29 negative articles, 8 neutral articles. Most negative issues have the proper regulations, but insufficient measures for the adverse event reporting system. Conclusion : The herbal medicine specified adverse event reporting system is essential.

Clinical Characteristics of Poor Responders to Acupotomy and Safety Pretreatment Management (침도 침술시 부작용과 예방법에 관한 연구)

  • Kim, Sung-Chul
    • Journal of Acupuncture Research
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    • v.25 no.4
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    • pp.117-125
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    • 2008
  • Objectives : Analyze according to types of event causing the adverse outcome due to acupotomy, and discuss problems and safety reqirements to using this therapy in Korea. Methods : Based upon the indication, contraindication, treatment procedures, clinical obsevations, acupotomy-related adverse outcome case reports, the factors of damaging event were classified. Results : The main factors of adverse outcome by acupotomy were anatomical ignorance, contamination of device or hospital staff, failure to notice preexisting disease(cardiovascular disease, hypertension, renal failure, hemophilia, chronic Liver Disease, etc.), unskilled treatment procedures(massive bleeding) and techniques(nerve injury, hepatic and splenic injury, Pneumothorax). Conclusions : It is mandatory to prepare adequate sterilie aseptic technique. The clinician should ensure understand genernal health state of patient and anatomical direction.

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Review on Clinical Studies of Traditional Herbal Medicine and Acupuncture Treatments for Colorectal Cancer Patients (대장암 환자의 한약 및 침치료에 대한 국내외 임상연구 결과에 대한 고찰 - Pubmed를 중심으로)

  • Kang, Yun Hwan;Hong, Mi-na;Han, Chang Woo;Choi, Jun Yong;Park, Seong Ha;Kim, So Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.30 no.4
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    • pp.219-228
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    • 2016
  • The aim of this study was to collect and analyze the clinical studies of traditional herbal medicine and acupuncture treatments for colorectal cancer patients searched in Pubmed and Cochrane library in English. We collected the clinical studies, including randomized controlled trial, case control study and cohort study, in the PubMed and Cochrane library using keywords 'Colorectal Cancer', 'Korean Medicine', 'Traditional Chinese Medicine', 'Kampo' and 'Acupuncture'. Then we analyzed them according to the objective of the therapy, i.e. improving therapy prognosis, reducing chemotherapy's adverse event and reducing operational adverse event. In case RCT, we evaluate the quality of the study with jadad scale. Total 18 studies were selected. There were 3 studies about improving therapy prognosis, 6 studies about reducing chemotherapy's adverse event and 9 studies about reducing operational adverse event. Traditional medicine might improve therapy prognosis in terms of the survival rate, relapse/metastasis rate, quality of life and immune function. The specific herbal formula, 'Goshajinkigan' might not be successful about reducing chemotherapy's adverse event, peripheral neurotoxicity. 'Hangeshanshinto' might reduce the duration of oral mucositis but it is not clear to reduce the incidence of that. 'PHY906' might reduce the incidence of diarrhea. Acupuncture might reduce operational adverse event such as gastrointestinal dysfunction and pain. And 'Daikenchuto' might not be successful in reducing operational adverse event, gastrointestinal dysfunction. Further studies are needed to clarify the efficacy of traditional herbal medicine and acupuncture for colorectal cancer patients.

Identifying Adverse Events Using International Classification of Diseases, Tenth Revision Y Codes in Korea: A Cross-sectional Study

  • Ock, Minsu;Kim, Hwa Jung;Jeon, Bomin;Kim, Ye-Jee;Ryu, Hyun Mi;Lee, Moo-Song
    • Journal of Preventive Medicine and Public Health
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    • v.51 no.1
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    • pp.15-22
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    • 2018
  • Objectives: The use of administrative data is an affordable alternative to conducting a difficult large-scale medical-record review to estimate the scale of adverse events. We identified adverse events from 2002 to 2013 on the national level in Korea, using International Classification of Diseases, tenth revision (ICD-10) Y codes. Methods: We used data from the National Health Insurance Service-National Sample Cohort (NHIS-NSC). We relied on medical treatment databases to extract information on ICD-10 Y codes from each participant in the NHIS-NSC. We classified adverse events in the ICD-10 Y codes into 6 types: those related to drugs, transfusions, and fluids; those related to vaccines and immunoglobulin; those related to surgery and procedures; those related to infections; those related to devices; and others. Results: Over 12 years, a total of 20 817 adverse events were identified using ICD-10 Y codes, and the estimated total adverse event rate was 0.20%. Between 2002 and 2013, the total number of such events increased by 131.3%, from 1366 in 2002 to 3159 in 2013. The total rate increased by 103.9%, from 0.17% in 2002 to 0.35% in 2013. Events related to drugs, transfusions, and fluids were the most common (19 446, 93.4%), followed by those related to surgery and procedures (1209, 5.8%) and those related to vaccines and immunoglobulin (72, 0.3%). Conclusions: Based on a comparison with the results of other studies, the total adverse event rate in this study was significantly underestimated. Improving coding practices for ICD-10 Y codes is necessary to precisely monitor the scale of adverse events in Korea.