• Title/Summary/Keyword: Adverse Event

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급성 중독 환자에서 지질 유탁액 정맥투여의 효과: 체계적 고찰 (Effect of Intravenous Lipid Emulsion in the Patient with Acute Poisoning : A Systematic Review)

  • 명진우;고동률;공태영;주영선;유제성;정성필
    • 대한임상독성학회지
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    • 제13권1호
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    • pp.1-10
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    • 2015
  • Purpose: The purpose of this study was to evaluate the usefulness of intravenous lipid emulsion as well as adverse events in acute poisoning patients. Methods: Literature was accessed through PubMed, EMBASE, Cochrane library, Web of science, and KoreaMed. All forms of literatures relevant to human use of intravenous lipid emulsion for acute poisoning were included. Cases reports or letters without description of clinical outcomes for each case were excluded. The literature search was conducted by two investigators in March, 2015, with publication language restricted to English and Korean. The effect, onset time, and adverse event of lipid emulsion and final outcome of each case were analyzed. Results: Eighty-one published articles were included, excluding articles whose title and abstract were not relevant to this study. No articles were classified as high level of evidence. Sixty-eight case reports were identified, consisting of 25 local anesthetics and 43 other drugs, such as tricyclic antidepressants and calcium channel blockers. Although most cases described significant clinical improvements, some of them showed no beneficial effect or worsening of clinical course. Several adverse events including hyperamylasemia and laboratory interference were reported. Conclusion: Although there were many case reports illustrating successful use of lipid for various drug poisonings, the effect cannot be estimated due to significant possibility of publication bias. Therefore, lipids might be considered in severe hemodynamic instability resulting from lipophilic drug poisoning, however further studies should follow to establish the use of lipid as the standard of care.

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인터넷 신문기사에 보도된 한약 유해사례 분석 (Herbal-drug-associated Adverse Events Reported in the Internet Newspaper Articles)

  • 김미경;한창호
    • 대한한의학회지
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    • 제36권1호
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    • pp.33-44
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    • 2015
  • Objectives: The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs. Methods: We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of 'herbal drug' and 'side effects'. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea. Results: From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not. Conclusions: Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

전산 데이타를 활용한 약물이상반응검토 및 시그널 (Adverse Drug Event Surveillance System using Electronic Data and the Signals)

  • 김은영;강원구;권광일
    • 한국임상약학회지
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    • 제21권4호
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    • pp.383-389
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    • 2011
  • 약물요법에 있어 약물이상반응은 환자의 사망률과 이환율에 영향을 미치는 중요한 요인이다. 약물이상반응 발생시 이를 신속히 보고하는 것과 함께 약물치료과정에서 일어날 수 있는 약물 관련부작용을 조기에 인지하고 능동적으로 조치함으로써 환자에게 가해지는 위해를 최소화하는 것 또한 실제 환자치료의 질적인 관리에서 중요한 부분이다. 본 연구에서는 의료기록의 전산화에 따른 전산데이터들을 활용한 약물이상반응감시방법 중 하나로 평가 받고 있는 Computerized surveillance system (CSS)에 대한 사례 연구들의 방법들을 비교해 보고, 제시된 관련 시그널들 중 약물이상반응을 능동적인 방법 즉 실시간 혹은 예방적으로 적용 가능한 시그널들을 찾아 정리해 보고자 하였다. 이를 위해 가장 대표적인 연구가 진행되었던 연구사례들을 분석하였고 약 20여 개의 시그널들을 선정하여 분야별로 제시하였다.

Pembrolizumab과 통합의학치료로 호전된 뇌전이 동반 말기 비소세포성 폐암 환자 1례 (A Case of End-stage non-small cell Lung Cancer Patient with Brain Metastasis Treated with Pembrolizumab with Integrative Medicine Therapy)

  • 서한길;진용재;송미화;김인태;박지혜;정준석;조성규;신광순
    • 대한암한의학회지
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    • 제23권2호
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    • pp.11-25
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    • 2018
  • Objective: The purpose of this study is to report the case of a patient with non-small cell lung cancer (NSCLC) with Programmed cell death protein 1 (PD-1) mutation treated by Integrative Medicine Therapy (IMT). Methods: A patient with metastatic NSCLC received pembrolizumab 200mg intravenously for every 3 weeks from July 2017. Repeat cycle every 3 weeks since July 2017. The patient has been treated with Integrative Medicine Therapy (IMT) since December 2016. The tumor size was measured by computed tomography (CT) and magnetic resonance imaging(MRI). Adverse events were evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. Results: After combined treatment, the extent of proximal portion of primary tumor in the left lower lobe was decreased and disease status was stable radiologically. No evidence of newly developed metastatic lesions in the brain since May 2017. The patient did not experience any adverse event according to NCI-CTCAE ver. 5.0. Conclusion: This case study suggests that Integrative Medicine Therapy (IMT) may contribute to tumor response, in conjunction with Pembrolizumab on the treatment of patients with NSCLC.

Complications reported with the use of orthodontic miniscrews: A systematic review

  • Giudice, Antonino Lo;Rustico, Lorenzo;Longo, Miriam;Oteri, Giacomo;Papadopoulos, Moschos A.;Nucera, Riccardo
    • 대한치과교정학회지
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    • 제51권3호
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    • pp.199-216
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    • 2021
  • Objective: The aim of this systematic review was to evaluate the complications and side effects associated with the clinical use of orthodontic miniscrews by systematically reviewing the best available evidence. Methods: A survey of articles published up to March 2020 investigating the complications associated with miniscrew insertion, in both the maxilla and mandible, was performed using 7 electronic databases. Clinical studies, case reports, and case series reporting complications associated with the use of orthodontic miniscrew implants were included. Two authors independently performed study selection, data extraction, and risk-of-bias assessment. Results: The database survey yielded 24 articles. The risk-of-bias assessment revealed low methodological quality for the included studies. The most frequent adverse event reported was root injury with an associated periradicular lesion, vitality loss, pink discoloration of the tooth, and transitory loss of pulp sensitivity. Chronic inflammation of the soft tissue surrounding the miniscrew with mucosal overgrowth was also reported. The other adverse events reported were lesion of the buccal mucosa at the insertion site, soft-tissue necrosis, and perforation of the floor of the nasal cavity and maxillary sinus. Adverse events were also reported after miniscrew removal and included secondary bleeding, miniscrew fracture, scars, and exostosis. Conclusions: These findings highlight the need for clinicians to preliminarily assess generic and specific insertion site complications and side effects.

Assessing the Effectiveness and Safety of Direct-acting Antiviral Treatment in Korean Patients with Hepatitis C Virus Genotype 1b or 2 at a Tertiary Care Hospital

  • Park, Mi Seon;Yang, Young-Mo;Park, Ki Hyun;Yoon, Hyonok;Kim, Ju Sin;Choi, Eun Joo
    • 한국임상약학회지
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    • 제32권3호
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    • pp.191-203
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    • 2022
  • Background: Direct-acting antivirals are recommended for the treatment of chronic hepatitis C virus in Korea. However, evaluation of direct-acting antiviral regimens in a real-world setting is limited. The aims of this study were to investigate the effectiveness and safety of direct-acting antiviral treatment in Korean patients infected with chronic hepatitis C virus genotype 1b or 2 at a tertiary care hospital. Methods: This was a retrospective study conducted with patient data obtained between August 2015 and August 2019 at Jeonbuk National University Hospital. The primary effectiveness endpoint was sustained virological response 12 weeks post-treatment (SVR12) via intention-to-treat (ITT) and modified intention-to-treat (mITT) analyses. Results: Of the 270 patients, 47.0% were infected with genotype 1b and 53.0% with genotype 2. ITT analysis revealed that SVR12 was achieved in 78.9% of all patients, 77.2% in genotype 1b patients, and 80.4% in genotype 2 patients. Of the 21.1% of all patients who did not achieve SVR12, the majority of treatment failures were non-virologic failures (19.7%). mITT analysis revealed that SVR12 was achieved in 98.2% of all patients, 98.0% in genotype 1b patients, and 98.3% in genotype 2 patients. Almost half of all patients experienced one or more adverse events (43.3%), leading to 2.6% discontinuing scheduled treatment. The most common adverse event was anemia. Conclusions: Direct-acting antiviral-based treatment regimens showed high effectiveness and safety. Non-virological factors, such as premature treatment discontinuation due to adverse events or loss of follow-up, were the major disruptors in achieving SVR12.

Adverse Events Following Immunizations in Infants Under 1 Year of Age in Lorestan Province, Western Iran

  • Anbari Khatereh;Ghanadi Koruosh;Toulabipour Alireza;Jamebozuorghi Daryuosh;Baharvand Parastoo
    • Journal of Preventive Medicine and Public Health
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    • 제56권2호
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    • pp.172-179
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    • 2023
  • Objectives: Vaccination is an important intervention for preventing disease and reducing disease severity. Universal vaccination programs have significantly reduced the incidence of many dangerous diseases among children worldwide. This study investigated the side effects after immunization in infants under 1 year of age in Lorestan Province, western Iran. Methods: This descriptive analytical study included data from all children <1 year old in Lorestan Province, Iran who were vaccinated according to the national schedule in 2020 and had an adverse event following immunization (AEFI). Data were extracted from 1084 forms on age, sex, birth weight, type of birth, AEFI type, vaccine type, and time of vaccination. Descriptive statistics (frequency, percentage) were calculated, and the chi-square test and Fisher exact test were used to assess differences in AEFIs according to the abovelisted variables. Results: The most frequent AEFIs were high fever (n=386, 35.6%), mild local reaction (n=341, 31.5%), and swelling and pain (n=121, 11.2%). The least common AEFIs were encephalitis (n=1, 0.1%), convulsion (n=2, 0.2%), and nodules (n=3, 0.3%). Girls and boys only showed significant differences in mild local reactions (p=0.044) and skin allergies (p=0.002). The incidence of lymphadenitis (p<0.001), severe local reaction (p<0.001), mild local reaction (p=0.007), fainting (p=0.032), swelling and pain (p=0.006), high fever (p=0.005), and nodules (p<0.001) showed significant differences based on age at vaccination. Conclusions: Immunization is a fundamental public health policy for controlling vaccine-preventable infectious diseases. Although vaccines such as the Bacillus Calmette-Guérin vaccine, oral poliovirus vaccine, and pentavalent vaccine are well-researched and reliable, AEFIs are inevitable.

유방암 환자의 통함 암 치료를 통한 항암화학요법 유발 말초신경병증, 전신통 호전에 대한 증례 보고 (A Case Report on Improvement of Chemotherapy-Induced Peripheral Neuropathy and Pantalgia Side Effects with Integrated Cancer Treatment in a Breast Cancer Patient)

  • 김은지;배혜리;이남헌
    • 대한암한의학회지
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    • 제28권1호
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    • pp.11-24
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    • 2023
  • Objectives: To report the improvement of chemotherapy-induced peripheral neuropathy and pantalgia with integrative cancer treatment on adverse effects of chemotherapy in a breast cancer patient. Methods: A 63-year-old female patient who has been diagnosed with breast cancer got treated for 103 days with integrative cancer treatment including acupuncture, moxibustion, herbal medicine, physiotherapies, hand and foot bath to decrease side effects of chemotherapy. The patient was also treated Western immunotherapies like Thymosin, Viscum album. Paclitaxel, Carboplatin, Doxorubicin, Cyclophosphamide was applied and chemotherapy-induced peripheral neuropathy(CIPN), pantalgia and nausea occured. The efficacy of treatment was measured by a numeric rating scale(NRS) of symptoms, National Cancer Institute Common Terminology Criteria for Adverse Event(NCI-CTCAE) and Eastern Cooperative Oncology Group(ECOG) Performance Status Scale. Results: The NRS scroes for CIPN, pantalgia, nausea were improved. There was no adverse effects of 3 or higher assessed by the NCI-CTCAE. The ECOG grade improved from grade 2 to 1. Conclusions: This study suggests that integrative cancer treatment could improve CIPN, pantalgia after chemotherapy in breast cancer.

Immunotherapy-Related Imaging Findings in Patients with Gynecological Malignancies: What Radiologists Need to Know

  • Luca Russo;Giacomo Avesani;Benedetta Gui;Charlotte Marguerite Lucille Trombadori;Vanda Salutari;Maria Teresa Perri;Valerio Di Paola;Elena Rodolfino;Giovanni Scambia;Riccardo Manfredi
    • Korean Journal of Radiology
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    • 제22권8호
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    • pp.1310-1322
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    • 2021
  • Immunotherapy is an effective treatment option for gynecological malignancies. Radiologists dealing with gynecological patients undergoing treatment with immune checkpoint inhibitors should be aware of unconventional immune-related imaging features for the evaluation of tumor response and immune-related adverse events. In this paper, immune checkpoint inhibitors used for gynecological malignancies and their mechanisms of action are briefly presented. In the second part, patterns of pseudoprogression are illustrated, and different forms of immune-related adverse events are discussed.

Role of interventional endoscopic ultrasound in a developing country

  • Hasan Maulahela;Nagita Gianty Annisa;Achmad Fauzi;Kaka Renaldi;Murdani Abdullah;Marcellus Simadibrata;Dadang Makmun;Ari Fahrial Syam
    • Clinical Endoscopy
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    • 제56권1호
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    • pp.100-106
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    • 2023
  • Background/Aims: Endoscopic ultrasound (EUS) has become an essential diagnostic and therapeutic tool. EUS was introduced in 2013 in Indonesia and is considered relatively new. This study aimed to describe the current role of interventional EUS at our hospital as a part of the Indonesian tertiary health center experience. Methods: This retrospective study included all patients who underwent interventional EUS (n=94) at our center between January 2015 and December 2020. Patient characteristics, technical success, clinical success, and adverse events associated with each type of interventional EUS procedure were evaluated. Results: Altogether, 94 interventional EUS procedures were performed at our center between 2015 and 2020 including 75 cases of EUS-guided biliary drainage (EUS-BD), 14 cases of EUS-guided pancreatic fluid drainage, and 5 cases of EUS-guided celiac plexus neurolysis. The technical and clinical success rates of EUS-BD were 98.6% and 52%, respectively. The technical success rate was 100% for both EUS-guided pancreatic fluid drainage and EUS-guided celiac plexus neurolysis. The adverse event rates were 10.6% and 7.1% for EUS-BD and EUS-guided pancreatic fluid drainage, respectively. Conclusions: EUS is an effective and safe tool for the treatment of gastrointestinal and biliary diseases. It has a low rate of adverse events, even in developing countries.