• Title/Summary/Keyword: adverse drug events

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The Efficacy of Inhaled Corticosteroid on Chronic Idiopathic Cough (만성 특발성 기침에 대한 흡입 스테로이드의 치료 효과)

  • Han, Boram;Jang, Seung Hun;Kim, Yu Jin;Park, Sunghoon;Hwang, Yong Il;Kim, Dong-Gyu;Kim, Cheol-Hong;Hyun, In-Gyu;Jung, Ki-Suck
    • Tuberculosis and Respiratory Diseases
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    • v.67 no.5
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    • pp.422-429
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    • 2009
  • Background: The discomfort caused by chronic cough, that is persistent for more than 3 weeks, causes a number of patients to seek medical attention. However, the underlying disorder often remains undetermined despite thorough examinations, and is considered to be idiopathic. This study compared the efficacy of inhaled corticosteroid with conventional cough suppressants on chronic idiopathic cough. Methods: Eligible patients with chronic idiopathic cough were randomly assigned to either the inhaled fluticasone group or the codeine plus levodropropizine oral administration group. The subjects in each group took their planned medication for 2 weeks. After the trial, comparative analyses of outcomes were performed in terms of the remnant cough (%) at the end of treatment, drug compliance, and adverse drug events. Results: Seventy-seven patients were enrolled in this randomized trial; 38 to the inhaled fluticasone group and 39 to the codeine plus levodropropizine group. The remnant cough was 41.0${\pm}$35.8% in the inhaled fluticasone group, and 32.4${\pm}$32.0% in the codeine+levodropropizine group (p=0.288). Drug compliance was 95.4${\pm}$7.4% and 81.8${\pm}$18.6% in the inhaled fluticasone and the codeine+levodropropizine group, respectively (p<0.001). Nine patients had adverse drug events in the codeine+levodropropizine group compared to one in the inhaled fluticasone group (p<0.001). Conclusion: Short-term inhaled corticosteroid is not inferior to conventional antitussive agents in controlling chronic idiopathic cough without significant adverse events.

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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    • v.20 no.1
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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.

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

  • Yang, Jinmo;Ko, Dong Ryul;Kong, Taeyoung;Joo, Young Seon;You, Je Sung;Chung, Sung Phil
    • Journal of The Korean Society of Clinical Toxicology
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    • v.13 no.2
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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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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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    • v.42 no.4
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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.

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

  • Kim, Eun-Young;Kang, Won-Ku;Kwon, Kwang-Il
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.383-389
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    • 2011
  • CSS for identifying ADEs are sufficiently developed for broad use and they are much more accurate than spontaneous reporting and more time- and cost-effective than manual chart review. Also computer alert systems can be used to identify opportunities to prevent or reduce patient injury associated with a broad range of ADEs. This CSS can be used to identify opportunities to prevent or reduce patient injury associated with preventable ADEs and increase patient safety, increase quality of drug therapy and decrease the extra-cost of the treatment for ADEs. In the future, increasing utilization of this concurrent CSS should have an enormous beneficial impact on the quality of medical care.

Potential Drug Interactions in Cancer Patients on Oral Kinase Inhibitors (경구용 활성효소 억제제 복용 암환자의 잠재적 약물상호작용 연구)

  • Jung, Eun-Hee;Bang, Joon Seok;Lee, Yu Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.2
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    • pp.129-136
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    • 2013
  • Objectives: Among many new drugs that are under investigation with intent to treat cancer, oral kinase inhibitors are proven to be effective in numerous clinical trials and easy to administer. Due to these advantages the use of oral kinase inhibitors is increasing. Oral kinase inhibitors are metabolized by CYP450 which can result either increase of adverse effect or decrease of drug effect by drug interaction when used concurrently with other agents. In this research, the medication records of patients on oral kinase inhibitors from Oct. 2010 to Nov. 2011 were reviewed to investigate potential drug interactions. Methods: From Oct. 2010 to Nov. 2011, cancer patients in Inha University Hospital who took oral kinase inhibitors more than once were included. The patients' medication records were reviewed to list out concurrent medications that have interaction potential with oral kinase inhibitors, the frequency of concurrent use, and the severity of interaction result using Micromedex$^{(R)}$ and Lexicomp-online$^{(R)}$ as references. Results: As a result, 90 cases of drug with interaction potential were prescribed by Micromedex$^{(R)}$ and 179 cases by Lexicomp-online$^{(R)}$ data. In case of severity, 33.3% by Micromedex$^{(R)}$ and 26.3% by Lexicomp-online$^{(R)}$ were categorized as Major and 65.6% by Micromedex$^{(R)}$ and 72.6% by Lexicomp-online$^{(R)}$ as Moderate. The number of adverse events was 92 cases which 58.7% were on skin and 19.6% on Gastro-intestinal tract. Conclusions: Considerable number of drug with interaction potential was used though each oral kinase inhibitors showed differences in extent. Hence there exists the risk of drug interaction in patients taking oral kinase inhibitors with other drugs.

Predictive Factors of Major Adverse Cardiac Events after Drug-Eluting Balloon Angioplasty for In-Stent Restenosis Lesion (스텐트 내 재협착 병변에서 약물용출 풍선확장술 후 주요 심장사건 발생의 예측인자)

  • Lee, Doo Hwan;Kim, In Soo;Kong, Chang gi;Han, Jae Bok
    • Journal of the Korean Society of Radiology
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    • v.14 no.2
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    • pp.179-191
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    • 2020
  • The aim of this study was to investigate the predictors of major adverse cardiac events (MACE) in patients with drug-eluting balloon (DEB) for in-stent restenosis (ISR) lesion. Total of 257 patients who developed ISR on follow-up coronary angiography (66.1 ± 10.1years, 172 males) in Chonnam National University Hospital between October 2012 and January 2017 were enrolled. We divided the patients into two groups; group I (MACE group; n= 35) and group II (No MACE group; n= 222). A multivariate logistic regression analysis revealed that type IV ISR (HR=4.179, 95% C.I.=1.851-9.437 p= 0.001), lesion length > 25 mm (HR=8.773, 95% C.I.=1.898-40.546 p=0.005), number of ISR recurrence > 2 (HR=4.693, 95% C.I.=1.259-17.490 p= 0.021) were independent factors for MACE after DEB in ISR lesions.

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 (WHO VigiAccess에 수록된 식물성 독성주의한약재 관련 이상사례 보고 현황)

  • Mikyung Kim
    • The Journal of Korean Medicine
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    • v.45 no.1
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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.

Monitoring and Safety of Azathioprine Therapy in Inflammatory Bowel Disease

  • Kim, Mi Jin;Choe, Yon Ho
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.16 no.2
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    • pp.65-70
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    • 2013
  • Azathioprine is the most common drug used to maintain clinical remission in inflammatory bowel disease. This drug is also important as a steroid-sparing agent in steroid-dependent and chronically active inflammatory bowel disease. Nevertheless, many questions remain concerning the optimal treatment regimens of azathioprine. The dose of azathioprine has to be reduced or the therapy has to be discontinued frequently because of drug-induced toxicity. In this review, we discuss monitoring of thiopurines, adverse events, malignant complications and how to use azathioprine safely and usefully.

Toxicogenomics and Cell-based Assays for Toxicology

  • Tong, Weida;Fang, Hong;Mendrick, Donna
    • Interdisciplinary Bio Central
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    • v.1 no.3
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    • pp.10.1-10.5
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    • 2009
  • Toxicity is usually investigated using a set of standardized animal-based studies which, unfortunately, fail to detect all compounds that induce human adverse events and do not provide detailed mechanistic information of observed toxicity. As an alternative to conventional toxicology, toxicogenomics takes advantage of currently advanced technologies in genomics, proteomics, metabolomics, and bioinformatics to gain a molecular level understanding of toxicity and to enhance the predictive power of toxicity testing in drug development and risk/safety assessment. In addition, there has been a renewed interest, particularly in various government agencies, to prioritize and/or supplement animal testing with a battery of mechanistically informative in vitro assays. This article provides a brief summary of the issues, challenges and lessons learned in these fields and discuss the ways forward to further advance toxicology using these technologies.