• Title/Summary/Keyword: Adverse Event

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The Intoxication of Beta Blocker with Psychiatric Drugs Focused on the Cardiovascular Adverse Effects (베타차단제를 포함한 정신과적 약물 중독: 심혈관계 영향을 중심으로)

  • Joo, Sung Woo;Min, Young-Gi;Choi, Sang-Cheon;Park, Eun Jung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.14 no.2
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    • pp.100-106
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    • 2016
  • Purpose: Beta blocker (BB) has been prescribed for anxiety and panic disorder. Patients intoxicated by psychiatric drugs have often been exposed to BB. Moreover, BB overdose has adverse effects including cardiovascular effects, which can be life-threatening. This study was conducted to identify the characteristics of BB intoxication with psychiatric drugs and the adverse effects on the cardiovascular system. Methods: A single center, retrospective study was performed from January 2010 to December 2015. A total of 4,192 patients visited the emergency department (ED) with intoxication, and 69 with BB intoxication were enrolled. Results: Overall, 64 patients (92.8%) of enrolled patients were intoxicated with drugs prescribed for the purpose of psychiatric disorders. Propranolol was the most common BB (62 cases, 96.2%), and the median dose was 140.0 mg (25%-75% 80.0-260.0). Twenty-four patients (37.5%) had experienced cardiovascular events, and these patients tended to have decreased mentality, hypotension and coingestion with quetiapine. An initial mean arterial pressure (MAP) below 65 mmHg (odds ratio 10.069, 95% confidence interval 1.572-64.481, p=0.015) was identified as a factor of cardiovascular event upon multiple logistic regression analysis. Conclusion: Initial MAP below 65 mmHg was a factor of cardiovascular adverse effect in patients of BB intoxication with psychiatric drugs.

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.

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

  • Yoon, Sang-Hoon;Lee, Eunji;Jo, Hyunjung;Han, Yeji;Kim, Hyunho;Yun, Younghee;Choi, Ye-yong;Park, Jongseung;Leem, Jungtae
    • Journal of Korean Medicine for Obesity Research
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    • v.20 no.1
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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.

A review of pathophysiological mechanism of Bisphosphonate-related osteonecrosis of the jaw (임상가를 위한 특집 1 - 비스포스포네이트 관련 골괴사의 병태생리학적 기전에 대한 검토)

  • Kwon, Tae-Geon
    • The Journal of the Korean dental association
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    • v.52 no.4
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    • pp.192-202
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    • 2014
  • Bisphosphonate(BP) significantly influence the hone remodeling process. Increasing number of patients with osteoporosis and metastatic bone disease need high dose or long term bisphosphonate therapy. Major adverse effect is jaw bone necrosis and now the bisphosphonate-related necrosis of the jaw(BRONJ) is the major concern of dental practitioner. This study intended to perform the review of the current understandings concerning the pathophysiology of BRONJ. Even though pathophysiological mechanism of BRONJ is not clearly elucidated but now suggested as largely two different concepts; so-called "inside-out" or "outside-in" theory. Inside-out theory emphasize the osteonecrosis of the jaw is the initial major event and subsequent infection and inflammation is the second event that accompanies bone exposure and death of overlying mucosa. However, in "outside-in" theory, infection or inflammation initiated by traumatized oral epithelium is the major event of BRONJ. Both theory would be partially explain BRONJ. Recent research reveals the immune modulating effect and influence of microcrack accumulation by BP. These findings and those of others might explain the missing part of outside-in theory.

The Impact of COVID-19 Pandemic on Stock Prices: An Empirical Study of State-Owned Enterprises in Indonesia Stock Exchange

  • MANGINDAAN, Joanne Valesca;MANOSSOH, Hendrik;WALANGITAN, Olivia Fransiske Christine
    • The Journal of Asian Finance, Economics and Business
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    • v.9 no.3
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    • pp.337-346
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    • 2022
  • This study explores the impact of the COVID-19 pandemic on the stock prices of state-owned enterprises listed on the Indonesia Stock exchange. The impact of the pandemic is analyzed based on different pandemic phases and the corresponding government pandemic interventions to curb the disease. This study analyzes 6 pandemic event dates, covering the time period from January 2020 to February 2021. A total of 20 state-owned enterprises are included as the sample of this study. Test of difference is employed to compare the stock prices of the state-owned enterprises before and after each pandemic event date. In general, this study confirms the adverse impact of the COVID-19 pandemic on the stock prices, especially the event in 2020, although some variations do exist. The results of the study reveal a significant decrease in the stock prices of the state-owned enterprises after the announcement of the first confirmed COVID-19 cases, the announcement of COVID-19 as a global pandemic, the imposing of Large Scale Social Restriction (PSBB I and PSBB II). In contrast, the stock prices increase after the imposing of a new normal policy and the imposing of Public Activity Restriction (PPKM). This study also documents that the effect of the pandemic may vary based on the pandemic phase.

The Influence of adversity quotient on organizational socialization among dental hygienists (치과위생사의 역경지수가 조직사회화에 미치는 영향)

  • Kim, Young-Sun;Lee, Jung-Hwa
    • Journal of Korean Dental Hygiene Science
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    • v.3 no.2
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    • pp.9-18
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    • 2020
  • This study analyzed 183 for dental hygienists working at dental hospitals and clinics in Daegu to survey organizational socialization of them. The adversity index of the study subjects averaged 58.60±9.16 points out of a total score of 100, with the highest individual initiative of 16.58±3.09 points, and a low of 13.86±3.66 points for continuity of the situation. Organizational socialization averaged 123.40±12.82 points out of 190, with the highest personal characteristics of 30.37±3.71 points, and the lowest occupational identity of 10.34±1.94. The adversity index of the participants was significantly higher in graduate school or higher (F=3.112, p=0.047), the lower the intensity of their work (F=2.860, p=0.060), and the more often the degree of turnover (F=5.196, p<0.006). In organizational socialization, age (F=9.290, p<0.001), educational background (F=8.655, p<0.001), and higher position (F=5.425, p=0.005) were significantly higher when working in hospitals (F=4.534, p=0.012). The higher the position (F=5.425, p=0.005), the higher the work experience (F=5.320, p=0.002), the lower the turnover (F=22.935, p<0.001), and the highrer the intensity of the work(F=7.02, p<0.001). The study subjects' organizational socialization showed a significant correlation with the adverse event index (r=0.395, p<0.000). The regression analysis using organizational socialization as a dependent variable showed that the degree of turnover (β=0.300, p<0.001) had a significant effect on organizational socialization. The total explanatory power of this variable was 41.6%, with significant effects on individual initiative (β=0.255, p<0.000) and personal control (β=0.180, p<0.009) among the adverse events index. The above findings confirmed that a high adverse event index of dental hygienists has the effect of increasing organizational socialization. Dental hygienists' adversity index is average, meaning they live a smooth life in smooth conditions, however, when major adversity arises, organizational socialization is highly necessary. In addition, to strengthen the organizational socialization of new dental hygienists, as well as experienced dental hygienists, a customized program should be administered to raise the adverse index of dental hygienists, and provide a human management tool through regular confirmation of the program.

Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease

  • Hwang, Hyunjung;Shin, Ji Young;Park, Kyu Ree;Shin, Jae Ouk;Song, Kyoung-hwan;Park, Joonhyung;Park, Jeong Woong
    • Tuberculosis and Respiratory Diseases
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    • v.78 no.4
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    • pp.321-325
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    • 2015
  • Background: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasing a few weeks later to $500{\mu}g$ daily. Methods: We retrospectively investigated 85 patients with COPD who had taken either $500{\mu}g$ roflumilast, or a starting dose of $250{\mu}g$ and then increased to $500{\mu}g$. We analyzed all adverse events and assessed differences between patients who continued taking the drug after dose escalation and those who had stopped. Results: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea (10.6%). Of the 52 patients who had increased from a starting dose of $250{\mu}g$ roflumilast to $500{\mu}g$, 43 (82.7%) successfully maintained the $500{\mu}g$ roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detected between the dose-escalated and the discontinued groups. Of the 26 patients who started with the $500{\mu}g$ roflumilast regimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference in discontinuation rate between the dose-escalated and the control groups (p=0.22). Conclusion: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to the full dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-term and larger-scale studies are needed to support the full benefit of a dose escalation strategy.

Effect of Triple Compared to Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Percutaneous Coronary Intervention (관상동맥 약물 용출 스텐트 삽입 후 항혈소판제제 3제요법과 2제요법의 임상적 효과 비교)

  • Ye, Kyong-Nam;Kim, Jeong-Tae;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.2
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    • pp.113-122
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    • 2012
  • ACC/AHA/SCAI Guideline recommends for administration dual antiplatelet therapy after drug-eluting stent (DES) to prevent restenosis and stent thrombosis in patients with percutaneous coronary intervention (PCI). Recently triple antiplatelet therapy including cilostazol is known to reduce restenosis and stent thrombosis significantly after DES implantation. However, there is lack of data providing the efficacy of triple antiplatelet therapy. The purpose of this study is to evaluate the clinical effects of the triple therapy after DES implantation compared with the dual therapy. This retrospective study collected data from medical charts of 251 patients who received DES implantation between Jul 2006 and Jun 2008. They received either dual antiplatelet therapy (N = 154 clopidogrel and aspirin; Dual group) or triple antiplatelet therapy (N = 97 cliostazol, clopidogrel and aspirin; Triple group). Major adverse cardiac event rates (MACE, included total death, myocardial infarction, target lesion revascularization) at 12 months, 24 months, stent thrombosis, rates of bleeding complications and adverse drug reactions were compared between these two groups. Compared with the dual group, the triple group had a similar incidence of the MACE rates at 24months (12.3% vs. 12.4%, p = 0.99). There is no difference in overall stent thrombosis between two groups (Dual group 2.6% vs. Triple group 4.1%, p = 0.5). Subgroup analysis showed that diabetic patients got more benefit in reducing MACE rates but, there is no statistical difference. Bleeding complications and adverse drug effects were not different significantly. As compared with dual antiplatelet therapy, triple antiplatelet therapy did not reduce the 12-months, 24-months MACE rates and stent thrombosis. Bleeding complications and adverse drug effects were not different.

Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors and Incidence of Adverse Events in Patients with Type 2 Diabetes (제2형 당뇨병 환자에서 Dapagliflozin이 혈당과 심혈관계질환 위험인자에 미치는 영향 및 안전성)

  • Lee, Hye Jin;Geum, Min Jung;Kim, Jae Song;Kim, Soo Hyun;Son, Eun Sun
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.4
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    • pp.214-220
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    • 2017
  • Background: Dapagliflozin is an oral selective inhibitor of sodium-glucose cotransporter 2(SGLT2), the kidney transporter chiefly responsible for glucose reabsorption from the glomerular filtrate. Because this mechanism does not require the action of insulin, dapagliflozin rarely causes hypoglycemia. Dapagliflozin may affect blood glucose control as well as blood pressure and the body weight which are one of the cardiovascular disease risk factors. However, dehydration and ketoacidosis are reported as the side effects of the dapagliflozin treatment and the safety issues have been occurred. The aim of this study is to analyze the effectiveness and adverse events of dapagliflozin in Korean patients. Methods: From December 2014 to August 2015, we retrospectively reviewed the electronic medical records of type 2 diabetes patients who were prescribed dapagliflozin at Severance Hospital. Results: A total of 202 Korean patients were enrolled in this study. The effectiveness in the reduction of blood glucose was statistically significant(p<0.001). Dapagliflozin decreased 0.74% of HbA1c after 24 weeks. Significantly more participants achieved the target HbA1c level(HbA1c<7%) after 24 weeks(n=42, 35.3%) than before taking dapagliflozin(n=21, 17.6%). Blood pressure decreased 5.7 mmHg systolic blood pressure(SBP), 1.9 mmHg diastolic blood pressure(DBP) after 24 weeks. More than one quarter of participants(n=35, 29.4%) experienced weight loss. Most common adverse event was genitourinary symptoms. Conclusion: In this study, the effectiveness of dapagliflozin in improving glycemic control, blood pressure control, and weight loss was statistically significant. However, elderly and female patients, who have higher incidence of adverse events, should use dapagliflozin cautiously.

Simultaneous Comparison of Efficacy and Adverse Events of Interventions for Patients with Esophageal Cancer: Protocol for a Systematic Review and Bayesian Network Meta-analysis

  • Doosti-Irani, Amin;Mansournia, Mohammad Ali;Rahimi-Foroushani, Abbas;Cheraghi, Zahra;Holakouie-Naieni, Kourosh
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.2
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    • pp.867-872
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    • 2016
  • Background: Esophageal cancer is one of the most serious malignancies. Due to the aggressive nature of this cancer, the prognosis is poor. A network meta-analysis with simultaneous comparison of multiple treatments can help determine better treatment options that have higher effects on overall survival of patients with lower adverse events. The aim of this review is to simultaneously compare efficacy and adverse events of treatment interventions for esophageal cancer. Materials and Methods: In this review, only randomized control trials (RCT) will be considered for network meta-analysis. All international electronic databases including Medline, Web of Sciences, Scopus, Cochran's library, EMBASE and Cancerlit will be searched to find randomized control trials which compared two or more treatment interventions for esophageal cancer. A network plot will be drawn for visual representation of all available treatment interventions. Bayesian approach will be used to combine the direct and indirect evidence. Treatment effects (e.g. hazard ratio for time to event outcomes, risk ratio for binary outcomes, and rate ratio for count outcomes with 95% credible interval) will be reported. Moreover, cumulative probability of the treatment ranks will be reported using the surface under the cumulative ranking (SUCRA) graphs. Consistency assumption will be assessed by the loop-specific and design-by-treatment interaction approaches. Conclusions: The results of this study may be helpful for the patients, clinicians and health policy makers in selecting treatments that have the best effect on survival and lowest adverse events.