• Title/Summary/Keyword: Adverse Event

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Intravenous levetiracetam versus phenobarbital in children with status epilepticus or acute repetitive seizures

  • Lee, Yun-Jeong;Yum, Mi-Sun;Kim, Eun-Hee;Ko, Tae-Sung
    • Clinical and Experimental Pediatrics
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    • v.59 no.1
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    • pp.35-39
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    • 2016
  • Purpose: This study compared the efficacy and tolerability of intravenous (i.v.) phenobarbital (PHB) and i.v. levetiracetam (LEV) in children with status epilepticus (SE) or acute repetitive seizure (ARS). Methods: The medical records of children (age range, 1 month to 15 years) treated with i.v. PHB or LEV for SE or ARS at our single tertiary center were retrospectively reviewed. Seizure termination was defined as seizure cessation within 30 minutes of infusion completion and no recurrence within 24 hours. Information on the demographic variables, electroencephalography and magnetic resonance imaging findings, previous antiepileptic medications, and adverse events after drug infusion was obtained. Results: The records of 88 patients with SE or ARS (median age, 18 months; 50 treated with PHB and 38 with LEV) were reviewed. The median initial dose of i.v. PHB was 20 mg/kg (range, 10-20 mg/kg) and that of i.v. LEV was 30 mg/kg (range, 20-30 mg/kg). Seizure termination occurred in 57.9% of patients treated with i.v. LEV (22 of 38) and 74.0% treated with i.v. PHB (37 of 50) (P=0.111). The factor associated with seizure termination was the type of event (SE vs. ARS) in each group. Adverse effects were reported in 13.2% of patients treated with i.v. LEV (5 of 38; n=4, aggressive behavior and n=1, vomiting), and 28.0% of patients treated with i.v. PHB (14 of 50). Conclusion: Intravenous LEV was efficacious and safe in children with ARS or SE. Further evaluation is needed to determine the most effective and best-tolerated loading dose of i.v. LEV.

Design for a Medical Devices Safety Information Reporting System for the Hospitals (의료기기 안전성 정보 원내 보고 시스템 설계)

  • Jang, Hye Jung;Choi, Young Deuk;Kim, Nam Hyun
    • Journal of the Institute of Electronics and Information Engineers
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    • v.52 no.1
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    • pp.140-147
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    • 2015
  • In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.

A Case Report of FOLFOX-induced Adverse Events in a Patient with Recurrent Advanced Gastric Cancer Treated with Korean Medicine (재발 진행성 위암 환자의 FOLFOX 유발 부작용 개선에 대한 한의 치료 1례)

  • Ko, Myung-hyun;Yang, Jae-ho;Jeon, Hyung-joon;Cho, Chong-kwan;Lee, Yeon-weol;Park, So-jung;Yoo, Hwa-seung
    • The Journal of Internal Korean Medicine
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    • v.41 no.1
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    • pp.81-87
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    • 2020
  • Objective: The purpose of this study was to report the clinical effectiveness of Korean medicine treatment on FOLFOX-induced symptoms such as nausea and dizziness in a patient with recurrent advanced gastric adenocarcinoma. Methods: The patient was diagnosed with recurrent advanced gastric cancer and had FOLFOX-induced nausea and dizziness. The patient was treated with Samchulgunbi-tang and Banhasashim-tang for symptom management. The clinical outcomes were measured by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) and a numeral rating scale (NRS). Results: After treatment, the patient's nausea and dizziness were relieved from NRS 9 to 2 and NRS 8 to 2 respectively. During and after treatment, no severe toxicities were detected on laboratory findings. Conclusion: This case study suggests that Samchulgunbi-tang and Banhasashim-tang may relieve symptoms of FOLFOX-induced nausea and dizziness.

Public Evacuation Time Estimates within EPZ of Ulchin Site (울진원전 방사선비상계획구역 내의 주민 소개시간 예측)

  • Chung Yang-Geun;Lee Gab-Bock;Bang Sun-Young;Kim Sung-Min;Lee Eun-Mi
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.3 no.4
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    • pp.359-372
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    • 2005
  • The strong protection method of radiation emergency preparedness is the evacuation when a great deal of radionuclide material is released to environment. Required factors for evacuation time estimate of Ulchin nuclear power plant site were investigated. The traffic capacity and the traffic volume by season were investigated for the traffic analysis and simulation within EPZ of Ulchin site. As a result, the background traffic volume by season were established. The NETSIM code was applied to simulate for 12 scenarios in the event of normal traffic/summer peak traffic/winter peak traffic, daytime/night, and normal weather/adverse weather conditions. The results showed that the evacuation time required for total vehicles to move out from EPZ took generally $210\~315$ minutes. The evacuation time took longer about 45 minutes at night than in the daytime, and 45 minutes in adverse weather than normal condition.

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Near Misses Experienced at a University Hospital in Korea

  • Park, Mi-Hyang;Kim, Hyun-Joo;Lee, Bo-Woo;Bae, Seok-Hwan;Lee, Jin-Yong
    • Quality Improvement in Health Care
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    • v.22 no.1
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    • pp.41-57
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    • 2016
  • Objectives: This study aimed to investigate how many healthcare professionals experienced near misses, what types of near misses occurred most often, and healthcare professionals' opinions about near misses at one university hospital in Korea. Methods: The authors developed a questionnaire including 26 core types of near misses and 4 questions about preventability and reporting barriers. The survey was conducted from Oct. 31st to Nov. 18th 2011, about 3 weeks, using a self-administrated questionnaire that was administered to 697 healthcare professionals (registered nurses, pharmacists, technicians, and nurses aides) who worked at a university hospital. Medical doctors and employees working in the department of administration were excluded. Results: About half of hospital workers experienced at least one or more near misses during the past one year. The drug dispensing process was the most common subcategory of near misses. Among the 26 items, patient falls was highest. Over 95% of respondents reported that the near miss they experienced was preventable. Also, more than half of respondents did not report the near miss and the main reason for omission was fear of blame. Conclusion: Regarding patient safety issues, a near miss is a very significant factor because it can be a potential adverse event. Therefore, we should grasp the size of the problem through tracking and analyzing near misses and should make an effort to reduce them. To do so, we should check whether our reporting system is well designed and functioning.

Economic Evaluation of Gemcitabine-cisplatin Chemotherapy for Non Small-Cell Lung Cancer Patient in an Outpatient Setting (비용-효과 분석 기법을 이용한 Gemcitabine 외래 항암 치료의 경제성 평가)

  • Min, Su-Hyun;Ko, Su-Kyoung;Lim, Ji-Young
    • Journal of Korean Academy of Nursing
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    • v.38 no.3
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    • pp.363-371
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    • 2008
  • Purpose: This analysis was conducted to evaluate the cost-effectiveness of gemcitabine-cisplatin chemotherapy for non small-cell lung cancer patients in an outpatient setting compared with the traditional inpatient setting. Methods: A cost-effective analysis was conducted from a societal perspective. The effects of treatment, which was measured as an adverse event rate, were abstracted from a published literature search and empirical data from one university hospital. The costs included both direct and indirect costs. Direct costs included hospitalizations, outpatient visits, and lab tests. Pharmaceutical costs were excluded in analysis because they were same for both options. Indirect costs included productivity loss of patients as well as care-givers. In order to determine the robustness of the results, sensitivity analysis on treatment protocol was conducted. Results: Literature search showed no difference in adverse effect rates between inpatient treatment protocol and outpatient treatment protocol. Therefore, this analysis is a cost-minimization analysis. Cost-savings in the outpatient setting was 555,936 won for one treatment cycle. Our sensitivity analysis indicated that the outpatient chemotherapy still showed cost-savings, regardless of changes in treatment protocol. Conclusion: The outpatient gemcitabine-cisplatin chemotherapy for non small-cell lung cancer resulted in cost savings compared to inpatient chemotherapy. More importantly, outpatient chemotherapy could improve the utilization of health service resources in terms of available beds.

Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (소시호탕연조엑스의 단회 경구투여 후 안전성 평가에 대한 단일기관 연구)

  • An, Sung-Hu;Park, Kyungtae;Yeom, Seung-Ryong;Kwon, Young-Dal;Cho, Hea-Young
    • Journal of Korean Medicine Rehabilitation
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    • v.30 no.2
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    • pp.153-164
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    • 2020
  • Objectives This study is designed to evaluate the safety of Soshihotang 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 incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, 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 Soshihotang soft extract were considered to be safe for healthy male volunteers.

Feasibility of the AtriClip Pro Left Atrium Appendage Elimination Device via the Transverse Sinus in Minimally Invasive Mitral Valve Surgery

  • Shirasaka, Tomonori;Kunioka, Shingo;Narita, Masahiko;Ushioda, Ryohei;Shibagaki, Keisuke;Kikuchi, Yuta;Wakabayashi, Naohiro;Ishikawa, Natsuya;Kamiya, Hiroyuki
    • Journal of Chest Surgery
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    • v.54 no.5
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    • pp.383-388
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    • 2021
  • Background: Achieving external access to and manual occlusion of the left atrial appendage (LAA) during minimally invasive mitral valve surgery (MIMVS) through a small right thoracotomy is difficult. Occlusion of the LAA using an epicardial closure device seems quite useful compared to other surgical techniques. Methods: Fourteen patients with atrial fibrillation underwent MIMVS with concomitant surgical occlusion of the LAA using double-layered endocardial closure stitches (n=6, endocardial suture group) or the AtriClip Pro closure device (n=8, AtriClip group) at our institution. The primary safety endpoint was any device-related adverse event, and the primary efficacy endpoint was successful complete occlusion of blood flow into the LAA as assessed by transthoracic echocardiography at hospital discharge. The primary efficacy endpoint for stroke reduction was the occurrence of ischemic or hemorrhagic neurologic events. Results: All patients underwent LAA occlusion as scheduled. The cardiopulmonary bypass and aortic cross-clamp times in the endocardial suture group and the AtriClip group were 202±39 and 128±41 minutes, and 213±53 and 136±44 minutes, respectively (p=0.68, p=0.73). No patients in either group experienced any device-related serious adverse events, incomplete LAA occlusion, early postoperative stroke, or neurologic complication. Conclusion: Epicardial LAA occlusion using the AtriClip Pro during MIMVS in patients with mitral valve disease and atrial fibrillation is a simple, safe, and effective adjunctive procedure.

Effects of Korean Medicine Treatment at Public Health Center for Post-acute COVID-19 Patients: A Retrospective Case-series of 11 patients (일개 보건지소에 내원한 급성기 후 코로나-19 환자들의 특성 및 한의 치료 효과 분석: 사례군 연구)

  • Chang-hwan Yu;Kwan-Il Kim;Hee-Jae Jung;Beom-joon Lee
    • The Journal of Korean Medicine
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    • v.44 no.2
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    • pp.132-148
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    • 2023
  • Objectives: The purpose of this study is to determine the clinical features of post-acute COVID-19 syndrome and the effectiveness and safety of Korean medicine treatment at the Public health center. Methods: The study was conducted among 11 patients with post-acute COVID-19 syndrome who attended a single public health center from January to December 2022. We retrospectively analyzed the charts of 11 patients and collected clinical characteristics, previous treatments, Korean medicine treatments, outcome variables (Numeral Rating Scale (NRS), Leicester Cough Questionnaire (LCQ), Visual Analog Scale (VAS)), adverse events, etc. Results: Of the 11 patients, six were women, and the average age of all patients was 68.27±12.31 years. The most common symptom were cough(n=9, 81.82%) and sore throat(n=9, 81.82%), followed by sputum, fatigue, rhinorrhea, and loss of appetite, etc. All 11 patients were treated with herbal medicine, with Samso-eum(n=6, 54.55%), Yeonkyopaedok-san(n=5, 45.45%), and Haengso-tang(n=3, 27.27%) being the most commonly used. After herbal medicine treatment, the median cough NRS decreased from 5 to 1, and the median sore throat NRS decreased from 4 to 1, both of which were statistically significant. One patient reported adverse event of dyspepsia and heartburn, but it was mild. Conclusions: The study presented the clinical features of the post-acute COVID-19 syndrome and suggested that Korean medicine treatment at public health centers may be effective and safe in alleviating associated symptoms.

A Systematic Review of Kinesiology Taping in Patients With Lymphedema

  • Jaehee Yang;Eun Jin Lim
    • Physical Therapy Korea
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    • v.30 no.4
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    • pp.288-305
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    • 2023
  • Background: The compression therapy, which is the standard treatment for lymphedema patients, may be difficult to implement and contraindicated to some patients depending on their health condition. Objects: The purpose of this study is to investigate whether kinesiology taping (KT) can be used effectively and safely in the management of lymphedema as an alternative treatment through systematic review and meta-analysis. Methods: In February 2023, the literature was systematically collected through eight search engines with a combination of terms, 'lymphedema' and 'kinesiology taping.' We qualitatively analyzed the differences and safety of KT methods, and quantitatively meta-analyzed the effects of volume reduction in edema, range of motion (ROM), and pain improvement using Review Manager ver. 5. 4. To assess the risk of bias in the randomized controlled trial (RCT) studies, Risk of Bias was used. Results: A total of 616 articles searched and 20 studies were selected, including 12 RCTs and eight case studies. KT intervention could not replace multilayer compression bandage (MLB), but it demonstrated similar or better results compared to compression garment (CG), with reduced pain and improved intervention comfort. Studies reported skin adverse events ranging from 2.5% to 20.68%, with a total adverse event incidence of 7.7%. There was no significant difference in the application method of KT. As a result of the meta-analysis from the 8 RCTs, the KT intervention showed a mean difference (MD) of -7.18 with a 95% confidence interval (CI) [-12.64 to -1.72] in the volume change of lymphedema, while the pain difference was MD 0.82 with CI 95% [0.50 to 1.15], in comparison to the MLB and CG intervention. Conclusion: KT therapy led to a reduction in edema size, volume, pain, and improved ROM and quality of life. KT may be a viable option for lymphedema patients who have trouble applying traditional compression therapies.