• Title/Summary/Keyword: Drug-associated

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Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System (의약품부작용보고시스템을 이용한 바레니클린의 이상사례 실마리정보 도출)

  • Jang, Min-Gyo;Gu, Hyun-Jin;Kim, Junwoo;Shin, Kwang-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.1
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    • pp.1-7
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    • 2022
  • Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

In-silico Studies of Boerhavia diffusa (Purnarnava) Phytoconstituents as ACE II Inhibitor: Strategies to Combat COVID-19 and Associated Diseases

  • Rahul Maurya;Thirupataiah Boini;Lakshminarayana Misro;Thulasi Radhakrishnan
    • Natural Product Sciences
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    • v.29 no.2
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    • pp.104-112
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    • 2023
  • COVID-19 caused a catastrophe in human health. People infected with COVID-19 also suffer from various clinical illnesses during and after the infection. The Boerhavia diffusa plant is well known for its antihypertensive activity. ACE-II inhibitors and calcium channel blockers are reported as mechanisms for the antihypertensive activity of B. diffusa phytoconstituents. Various studies have said ACE-II is the virus's binding site to attack host cells. COVID-19 treatment commonly employs a variety of synthetic antiviral and steroidal drugs. As a result, other clinical illnesses, such as hypertension and hyperglycemia, emerge as serious complications. Safe and effective drug delivery is a prime objective of the drug development process. COVID-19 is treated with various herbal treatments; however, they are not widely used due to their low potency. Many herbal plants and formulations are used to treat COVID-19 infection, in which B. diffusa is the most widely used plant. The current study relies on discovering active phytoconstituents with ACE-II inhibitory activity in the B. diffusa plant. As a result, it can be used as a treatment option for patients with COVID-19 and related diseases. Different phytoconstituents of the B. diffusa plant were selected from the reported literature. The activity of phytoconstituents against ACE-II proteins has been studied. Molecular docking and ligand-protein interaction computation tools are used in the in-silico experiment. Physicochemical, drug-likeness, water solubility, lipophilicity, and pharmacokinetic parameters are used to evaluate phytoconstituents. Liriodenine has the best drug-likeness, bioactivity, and binding score characteristics among the selected ligands. The in-silico study aims to find the therapeutic potential of B. diffusa phytoconstituents against ACE-II. Targeting ACE-II also shows an effect against SARS-CoV-2. It can serve as a rationale for designing a drug for patient infected with COVID-19 and associated diseases.

Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS) (의약품부작용보고시스템을 이용한 메토클로프라미드의 이상사례 실마리정보 도출)

  • Min-Gyo Jang;Yeonghwa Lee;Hyunsuk Jeong;Kwang-Hee Shin
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.2
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    • pp.122-127
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    • 2023
  • Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

Factors Associated with Mortality in Elderly Patients Admitted to Intensive Care Unit due to Acute Drug Intoxication from Suicide Attempts (중환자실에 급성약물중독으로 입실한 자살시도 노인의 사망 관련요인)

  • Kim, Kyung-Eun;Moon, Sun-Hee;Song, Chieun;An, Minjeong
    • Journal of Korean Critical Care Nursing
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    • v.17 no.2
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    • pp.1-11
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    • 2024
  • Purpose : This study aimed to determine the mortality rate among elderly patients admitted to the intensive care unit (ICU) for acute drug intoxication resulting from suicide attempts. It also compared the characteristics of survivors and decedents to identify factors associated with mortality. Methods : This retrospective descriptive study included 150 patients aged 65 years or older who were admitted to the ICU of a tertiary university hospital in Gwangju due to acute drug intoxication, with the period spanning January 1, 2018 to December 31, 2020. The collected data were analyzed using descriptive statistics, independent t-tests, Chi-squared tests, Fisher's exact test, and multiple logistic regression analysis. Results : The mortality rate among elderly individuals admitted to the ICU for acute drug intoxication was 19.3%. The likelihood of death was significantly higher in patients with an acute physiology and chronic health examination (APACHE) III score of 70 or above (OR=23.75, 95% CI=3.78-149.46, p<.001) and those with metabolic acidosis on initial acid-base results (OR=3.73, 95% CI=1.12-12.43, p=.032). Conclusion : These findings underscore the need for developing and implementing systematic education and targeted nursing interventions for ICU nurses caring for acutely drug-intoxicated elderly adults, particularly considering the APACHE III score and the presence of metabolic acidosis.

Establishment of Analytical Method for Residues of Ethychlozate, a Plant Growth Regulator, in Brown Rice, Mandarin, Pepper, Potato, and Soybean Using HPLC/FLD

  • Kim, Jae-Young;Lee, Jin Hwan;Lee, Sang-Mok;Chae, Young-Sik;Rhee, Gyu-Seek;Chang, Moon-Ik
    • Korean Journal of Environmental Agriculture
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    • v.34 no.2
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    • pp.111-119
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    • 2015
  • BACKGROUND: Ethychlozate (ECZ) is a plant growth regulator of synthetic auxin for agricultural commodities (ACs). Accurate and sensitive method to determine ECZ in diverse ACs on global official purpose is required to legal residue regulation. As the current official method is confined to the limited type of crops with poor validation, this study was conducted to improve and extend the ECZ method using high-performance liquid chromatography (HPLC) in all the registered crops with method verification. METHODS AND RESULTS: ECZ and its acidic metabolite (ECZA) were both extracted from acidified samples with acetone and briefly purified by dichloromethane partition. ECZ was hydrolyzed to form ECZA and the combined ECZA was finally purified by ion-associated partition including hexane-washing. The instrumental quantitation was performed using HPLC/ FLD under ion-suppression of ECZA with no interference by sample co-extractives. The average recoveries of intra- and inter-day experiment ranged from 82.0 to 105.2% and 81.7 to 102.8%, respectively. The repeatability and reproducibility for intra- and inter-day measurements expressed as a relative standard deviation was less than 8.7% and 7.4%, respectively. CONCLUSION: Established analytical method for ECZ residue in ACs was applicable to the nation-wide pesticide residues monitoring program with the acceptable level of sensitivity, repeatability and reproducibility.

Gene Expression Analysis for Statin-induced Cytotoxicity from Rat Primary Hepatocytes

  • Ko, Moon-Jeong;Ahn, Joon-Ik;Shin, Hee-Jung;Kim, Hye-Soo;Chung, Hye-Joo;Jeong, Ho-Sang
    • Genomics & Informatics
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    • v.8 no.1
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    • pp.41-49
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    • 2010
  • Statins are competitive inhibitors of hydroxy-3-methyl glutaryl coenzyme A (HMG-CoA) reductase and used most frequently to reduce plasma cholesterol levels and to decrease cardiovascular events. However, statins also have been reported to have undesirable side effects such as myotoxicity and hepatotoxicity associated with their intrinsic efficacy mechanisms. Clinical studies recurrently reported that statin therapy elevated the level of liver enzymes such as ALT and AST in patients suggesting possible liver toxicity due to statins. This observation has been drawn great attention since statins are the most prescribed drugs and statin-therapy was extended to a larger number of high-risk patients. Here we employed rat primary hepatocytes and microarray technique to understand underlying mechanism responsible for statin-induced liver toxicity on cell level. We isolated genes whose expressions were commonly modulated by statin treatments and examined their biological functions. It is of interest that those genes have function related to response to stress in particular immunity and defense in cells. Our study provided the basic information on cellular mechanism of statin-induced cytotoxicity and may serve for finding indicator genes of statin -induced toxicity in rat primary hepatocytes.

Synthetic Cannabinoid-Induced Immunosuppression Augments Cerebellar Dysfunction in Tetanus-Toxin Treated Mice

  • Yun, Jaesuk;Gu, Sun Mi;Lee, Tac-hyung;Song, Yun Jeong;Seong, Seonhwa;Kim, Young-Hoon;Cha, Hye Jin;Han, Kyoung Moon;Shin, Jisoon;Oh, Hokyung;Jung, Kikyung;Ahn, Chiyoung;Park, Hye-Kyung;Kim, Hyung Soo
    • Biomolecules & Therapeutics
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    • v.25 no.3
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    • pp.266-271
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    • 2017
  • Synthetic cannabinoids are one of most abused new psychoactive substances. The recreational use of abused drug has aroused serious concerns about the consequences of these drugs on infection. However, the effects of synthetic cannabinoid on resistance to tetanus toxin are not fully understood yet. In the present study, we aimed to determine if the administration of synthetic cannabinoids increase the susceptibility to tetanus toxin-induced motor behavioral deficit and functional changes in cerebellar neurons in mice. Furthermore, we measured T lymphocytes marker levels, such as CD8 and CD4 which against tetanus toxin. JWH-210 administration decreased expression levels of T cell activators including cluster of differentiation (CD) $3{\varepsilon}$, $CD3{\gamma}$, CD74p31, and CD74p41. In addition, we demonstrated that JWH-210 induced motor impairment and decrement of vesicle-associated membrane proteins 2 levels in the cerebellum of mice treated with tetanus toxin. Furthermore, cerebellar glutamatergic neuronal homeostasis was hampered by JWH-210 administration, as evidenced by increased glutamate concentration levels in the cerebellum. These results suggest that JWH-210 may increase the vulnerability to tetanus toxin via the regulation of immune function.

Autoimmune hepatitis and thyroiditis associated with antituberculous medications : A case report (항결핵약으로 유발되고 갑상선염이 동반된 자가면역간염 1례)

  • Yu, Seong Keun;Kim, Sara;Moon, Jin Soo;Kim, Han Seong
    • Clinical and Experimental Pediatrics
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    • v.51 no.5
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    • pp.528-532
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    • 2008
  • Drug-induced toxic hepatitis is a relatively common hepatic disease in children, and it is usually self-limiting upon cessation of the offending drugs. Antituberculous drugs are well known for inducing hepatitis. Some cases of drug-induced hepatitis with autoimmune features have been reported; in these cases, the offending drugs were usually methyldopa, nitrofurantoin, minocycline, and interferon. The authors report the first case in Korea of drug-induced autoimmune hepatitis associated with thyroiditis and multiple autoantibodies that was induced by the antituberculous drugs isoniazid and rifampin.

Medication use among adults in Korea: focusing on prescription drugs and lifestyle drugs (우리나라 성인의 의약품 사용 양상 : 외래처방의약품과 라이프스타일 의약품을 중심으로)

  • Byeon, Jinok;Jung, Youn;Chung, Haejoo
    • Health Policy and Management
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    • v.22 no.4
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    • pp.579-596
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    • 2012
  • The purpose of the study is to examine the use of medication among adults by comparing the pattern of outpatient prescription drug use with the pattern of long term taking lifestyle drug use. Furthermore, the study investigates factors associated with the use of medication, particularity focusing on socioeconomic factors. Korea Health Panel data of 2008 was used to conduct the study analysis. By performing four different logistic regression models, the study noticed different patterns of the medication use between prescription drugs and lifestyle drugs. More specifically, the study showed that adults with lower education level tend to more frequently receive prescriptions while adults with higher education as well as income level tend to more use lifestyle drugs than their counterparts. Furthermore, other control factors such as age and gender were statistically significant for the use of both prescription and lifestyle drugs in different patterns. The study findings expect that reimbursement structure of drugs may be significantly associated with the different patterns and accordingly the accessability of medicine in particularly vulnerable population. Therefore, these policy factors should be considered in future study to more comprehensively understand about the diverse patterns in the medication use.

Dewormer drug fenbendazole has antiviral effects on BoHV-1 productive infection in cell cultures

  • Chang, Long;Zhu, Liqian
    • Journal of Veterinary Science
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    • v.21 no.5
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    • pp.72.1-72.10
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    • 2020
  • Background: Fenbendazole, a dewormer drug, is used widely in the clinical treatment of parasite infections in animals. Recent studies have shown that fenbendazole has substantial effects on tumor growth, immune responses, and inflammatory responses, suggesting that fenbendazole is a pluripotent drug. Nevertheless, the antiviral effects have not been reported. Fenbendazole can disrupt microtubules, which are essential for multiple viruses infections, suggesting that fenbendazole might have antiviral effects. Objectives: This study examined whether fenbendazole could inhibit bovine herpesvirus 1 (BoHV-1) productive infection in cell cultures. Methods: The effects of fenbendazole on viral production, transcription of the immediate early (IE) genes, viron-associated protein expression, and the cellular signaling PLC-γ1/Akt pathway were assessed using distinct methods. Results: Fenbendazole could inhibit BoHV-1 productive infections significantly in MDBK cells in a dose-dependent manner. A time-of-addition assay indicated that fenbendazole affected both the early and late stages in the virus replication cycles. The transcription of IE genes, including BoHV-1 infected cell protein 0 (bICP0), bICP4, and bICP22, as well as the synthesis of viron-associated proteins, were disrupted differentially by the fenbendazole treatment. The treatment did not affect the cellular signaling pathway of PLC-γ1/Akt, a known cascade playing important roles in virus infection. Conclusions: Overall, fenbendazole has antiviral effects on BoHV-1 replication.