• 제목/요약/키워드: Adverse Drug Event

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PharmacoNER Tagger: a deep learning-based tool for automatically finding chemicals and drugs in Spanish medical texts

  • Armengol-Estape, Jordi;Soares, Felipe;Marimon, Montserrat;Krallinger, Martin
    • Genomics & Informatics
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    • 제17권2호
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    • pp.15.1-15.7
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    • 2019
  • Automatically detecting mentions of pharmaceutical drugs and chemical substances is key for the subsequent extraction of relations of chemicals with other biomedical entities such as genes, proteins, diseases, adverse reactions or symptoms. The identification of drug mentions is also a prior step for complex event types such as drug dosage recognition, duration of medical treatments or drug repurposing. Formally, this task is known as named entity recognition (NER), meaning automatically identifying mentions of predefined entities of interest in running text. In the domain of medical texts, for chemical entity recognition (CER), techniques based on hand-crafted rules and graph-based models can provide adequate performance. In the recent years, the field of natural language processing has mainly pivoted to deep learning and state-of-the-art results for most tasks involving natural language are usually obtained with artificial neural networks. Competitive resources for drug name recognition in English medical texts are already available and heavily used, while for other languages such as Spanish these tools, although clearly needed were missing. In this work, we adapt an existing neural NER system, NeuroNER, to the particular domain of Spanish clinical case texts, and extend the neural network to be able to take into account additional features apart from the plain text. NeuroNER can be considered a competitive baseline system for Spanish drug and CER promoted by the Spanish national plan for the advancement of language technologies (Plan TL).

감비환과 가르시니아 캄보지아 병용 투여의 체중감량 효과와 안전성: 후향적 관찰연구 (Effect and Safety of Combined Treatment of Gambihwan and Garcinia Cambogia on Weight Loss: A Retrospective Observational Study)

  • 윤상훈;이은지;조현정;한예지;김현호;윤영희;최예용;박종승;임정태
    • 한방비만학회지
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    • 제20권1호
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    • pp.31-39
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    • 2020
  • Objectives: Obesity is becoming more popular disease worldwide. Because of the side effects of conventional obesity treatment modality, herbal medicine treatment is becoming more preferred. Gambihwan which including Ephedra sinica Staph is widely used in traditional Korean Medicine practice for obesity treatment. Garcinia cambogia is a kind of health functional food that has body fat reducing effect. Nowadays, ephedra and Garcinia cambogia are often used simultaneously in clinical practice of Korean Medicine. However, the effectiveness and safety of combination therapy in obesity treatment is not well established. Methods: We conducted retrospective observational study to explore effectiveness and safety of combination therapy. We evaluated effect of combined treatment of Gambihwan and Garcinia cambogia on body weight, body mass index, body fat mass, and waist hip ratio reduction. We also assessed safety via liver function test and adverse event. Results: Finally, 23 patients were included. In paired t-test, body weight significantly decreased from 64.50±14.50 kg to 62.94±13.85 kg (P<0.001) and body mass index were also significantly decreased from 24.43±3.79 kg/㎡ to 23.83±3.59 kg/㎡ (P<0.001). Body fat mass was also reduced. Aspartate transaminase and alanine aminotransferase were not significantly increased. There were no drug-induced liver injury and no severe adverse event. Conclusions: In our retrospective review, we found combination therapy of Gambihwan and Garcinia cambogia reduce body weight, body mass index and body fat mass. There were no severe adverse event and drug induced liver injury which indicated safety of combination therapy in obesity treatment.

궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구 (Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study)

  • 안성후;신희라;박경태;이윤승;김종규;염승룡;권영달;조혜영
    • 한방재활의학과학회지
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    • 제29권4호
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    • pp.101-108
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    • 2019
  • Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers. Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug. Conclusions Gunghatang tablet were found to be safe for healthy male volunteers.

Peripheral Blood Immune Cell-based Biomarkers in Anti-PD-1/PD-L1 Therapy

  • Kyung Hwan Kim;Chang Gon Kim;Eui-Cheol Shin
    • IMMUNE NETWORK
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    • 제20권1호
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    • pp.8.1-8.15
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    • 2020
  • Immune checkpoint blockade targeting PD-1 and PD-L1 has resulted in unprecedented clinical benefit for cancer patients. Anti-PD-1/PD-L1 therapy has become the standard treatment for diverse cancer types as monotherapy or in combination with other anticancer therapies, and its indications are expanding. However, many patients do not benefit from anti-PD-1/PD-L1 therapy due to primary and/or acquired resistance, which is a major obstacle to broadening the clinical applicability of anti-PD-1/PD-L1 therapy. In addition, hyperprogressive disease, an acceleration of tumor growth following anti-PD-1/PD-L1 therapy, has been proposed as a new response pattern associated with deleterious prognosis. Anti-PD-1/PD-L1 therapy can also cause a unique pattern of adverse events termed immune-related adverse events, sometimes leading to treatment discontinuation and fatal outcomes. Investigations have been carried out to predict and monitor treatment outcomes using peripheral blood as an alternative to tissue biopsy. This review summarizes recent studies utilizing peripheral blood immune cells to predict various outcomes in cancer patients treated with anti-PD-1/PD-L1 therapy.

Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial

  • Song, Sang-Wook;Kim, Ha-Na;Shim, Jae-Yong;Yoo, Byeong-Yeon;Kim, Dae-Hyun;Lee, Sang-Hyun;Park, Joo-Sung;Kim, Moon-Jong;Yoo, Jun-Hyun;Cho, BeLong;Kang, Hee-Cheol;Kim, Kwang-Min;Kim, Sung-Soo;Kim, Kyung-Soo
    • Journal of Ginseng Research
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    • 제42권4호
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    • pp.571-576
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    • 2018
  • Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

WHO VigiAccess에 수록된 식물성 독성주의한약재 관련 이상사례 보고 현황 (Status of reports of adverse events related to botanical herbal medicines with toxic precautions officially managed by Korean government: A descriptive analysis from WHO VigiAccess)

  • 김미경
    • 대한한의학회지
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    • 제45권1호
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    • pp.165-181
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    • 2024
  • Objectives: This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea. Methods: This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO's global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed. Results: Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death. Conclusions: This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.

클로자핀 투약시 나타나는 발열의 원인 (A Review on the Cause of Fever During Clozapine Treatment)

  • 송지혜;제성석;이재종;이승윤;이승훈;이은영;소형석;최하연;최진희
    • 정신신체의학
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    • 제30권2호
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    • pp.66-72
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    • 2022
  • 클로자핀은 치료 저항성 조현병 약물치료의 "최적 표준(gold standard)"으로 받아들여지고 있다. 클로자핀은 다른 항정신병약물에서 흔히 나타나는 추체외로 증후군, 지연이상 운동증을 거의 일으키지 않고 고프로락틴의 일시적인 상승만 보이는 한편, 발열 등의 약물 이상반응이 흔하게 나타난다. 치료 시작 시기에 드물게 무과립구증, 신경이완제 악성증후군과 같은 치명적인 부작용과 연관된 발열이 발생할 수 있으며, 이 경우 클로자핀을 즉시 중단해야 한다. 그러나 발열의 양성 원인은 생명을 위협하는 부작용보다 훨씬 빈번하므로 치료 시작 시기에 발열을 보이는 경우 무조건 클로자핀을 중단하는 것은 타당하지 않다. 또한, 치료 유지 시기에도 언제든지 발열은 발생할 수 있다. 특히 폐렴의 위험은 시간이 지남에 따라 감소하지 않으며, 클로자핀은 다른 항정신병약물 보다 폐렴의 위험이 높으므로 항상 이를 염두에 두고 치료제 모니터링을 통하여 약물 용량을 결정하는것이 권장된다.

Apoptosis of MCF7 Cells Treated with PKC Inhibitors and Daunorubicin

  • Park, Won-Chul;Son, Joo-Young;Chung, Sook-Hyun;An, Woon-Gun
    • Preventive Nutrition and Food Science
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    • 제7권2호
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    • pp.128-132
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    • 2002
  • The present study was performed to observe the role of protein kinase C (PKC) inhibitors (H-7, staurosporine) and daunorubicin in the cell death process of MCF7 cells; and examined whether or not the type of induced cell death was apoptosis. The usefulness of the combined therapy of PKC inhibitors and daunorubicin to improve the adverse effect of daunorubicin was also investigated. Cell death was induced by treatment with PKC inhibitors or daunorubicin. Characteristic morphologic features of cell shrinkage, chromatic condensation, and cytoplasmic vacuolization were observed. These treatments also stimulated the cleavage of poly-(ADP-ribose) polymerase (PARP), an early event in apoptosis. With slight differences in the percentage of apoptosis-induced cells, staurosporine, H-7 and daunorubicin effectively induced apoptosis in MCF7 cells. Furthermore, combined treatment of PKC inhibitors and daunorubicin significantly drove the cells into an apoptotic state. Hence, our results revealed the possible therapeutic value of combined therapy for the prevention of drug resistance and adverse side effects.

급성 칼슘통로차단제 중독에서 고용량 인슐린/정상혈당치료의 효과: 체계적 고찰 (Effect of High Dose Insulin/Euglycemia Therapy for Acute Calcium Channel Blocker Intoxication: A Systematic Review)

  • 양진모;고동률;공태영;주영선;유제성;정성필
    • 대한임상독성학회지
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    • 제13권2호
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    • pp.103-110
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    • 2015
  • Purpose: The purpose of this study is to evaluate the effectiveness and the adverse events of high dose insulin/euglycemia therapy in acute calcium channel blocker (CCB) poisoning. Methods: We developed a systematic search strategy and applied it to 4 electronic reference databases. We searched medical journals as well as the bibliographies of relevant articles. All forms of literature relevant to human use of high dose insulin for acute CCB poisoning were included. The literature search was conducted by two investigators in August, 2015 with publication language restricted to English and Korean. Case reports were divided between CCB overdose alone and multi-drug overdose including CCB. The effect and adverse event of high dose insulin and clinical outcome of each case were analyzed. Results: Among 55 searched studies, 20 studies were included. A prospective study, a retrospective study, a systematic review study, and 17 case reports were identified. Case reports consisted of 11 CCB alone and 12 multidrug overdose cases including CCB. Although most cases described significant clinical improvements, one of them showed no beneficial effect. Several adverse events including hypoglycemia and hypokalemia were reported. No significant sequalae from adverse events was reported. Conclusion: Although there were many case reports demonstrating successful use of high dose insulin for CCB poisoning, the effect cannot be estimated due to a possibility of publication bias. Therefore, high dose insulin/euglycemia therapy might be considered adjunctive therapy in cases of CCB intoxication refractory for standard therapy.

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정상 간기능을 가진 방광암환자에서 간효소 수치를 올리는 Tosufloxacin Tosylate: 증례보고 (Tosufloxacin Tosylate Increased the Liver Enzyme Levels in a Bladder Cancer Patient with Normal Liver Functions: a Case Report)

  • 최은주;송인자;유기연;윤현옥
    • 한국임상약학회지
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    • 제25권1호
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    • pp.56-58
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    • 2015
  • Summary: We report the first hepatic adverse effect of tosufloxacin tosylate in a muscle invasive bladder cancer patient with normal liver functions and with scheduling to undergo a surgical operation for a neobladder. Tosufloxacin tosylate 150 mg was administered to a 57-year-old man who maintained transurethral resection of bladder tumor (TUR-BT) postoperative multiple medications. His labs presented significant increases in alanine amino transferase (ALT) and aspartate amino transferase (AST) levels with 2-week compliance of 150 mg tablet three times a day. After discontinuing tosufloxacin tosylate, the levels slowly decreased and completely returned to normal ranges without any intervention in a few weeks. The Naranjo Causality Algorithm indicates a probable relationship between increased ALT and tosufloxacin. The patient was to have the second surgical operation as scheduled after getting normal range of ATL level. Therefore, tosufloxacin should be avoided in patients at risk for having liver dysfunctions or diseases if the patients have a schedule for any operation. Background: Tosufloxacin tosylate has been shown to have favorable benefits as an antibiotic. Tosufloxacin tosylate may be considered to have the adverse effects such as nauseas, vomiting, diarrhea, abdominal pain, stomatitis, tendonitis, tendon rupture, headache, dizziness, drowsiness, insomnia, weakness, agitation including hemolysis in the event of glucose-6-phosphate dehydrogenase deficiency as other fluoroquinolones. More severe adverse reactions of tosufloxacin tosylate over the above common adverse effects of fluoroquinolones were thrombocytopenia and nephritis. It also is not well known that tosufloxacin can cause hepatic problem. Here the study reports the first hepatic reaction from tosufloxacin and might arouse heath care providers' attention to appropriate drug choice for patients.