• Title/Summary/Keyword: Adverse Factors

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Analysis of Renal Adverse Reaction Caused by Amphotericin B (Amphotericin B 투여에 의한 신장 유해반응 분석)

  • Lee, Song Bin;Kim, Tae Kyung;Ko, Jong Hee;Ahn, Ji Hyune;Kim, Sung Eun;Seok, Hyun Ju;Kim, Hyunah
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.4
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    • pp.340-346
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    • 2012
  • Background: Amphotericin B is a mainstay in the treatment of many systemic fungal infections due to its wide antifungal spectrum and low incidence of resistance. However, the use of amphotericin B is limited by its nephrotoxicity. Objectives: The objective of this study was to evaluate the incidence and risk factors of renal adverse drug reactions (ADRs) of conventional amphotericin B (Fungizone$^{(R)}$). In addition, we compared the changes of serum creatinine (SCr) between patients who remained conventional amphotericin B and patients who were switched to liposomal amphotericin B after occurrence of renal adverse reactions. Methods: Adult hospitalized patients who reported renal adverse reactions caused by conventional amphotericin B from January 2011 to July 2012 at pharmacovigilance center in Yonsei University Healthcare System included in this study. ADRs scored as 'doubtful' in Naranjo probability ADR scale were excluded. We retrospectively analyzed patients' basic clinical characteristics, concurrent diseases or nephrotoxic drugs in order to find variables that can correlate with occurrence of renal ADRs. Changes in SCr were compared between conventional amphotericin B group and liposomal amphotericin B group. Results: A total of 231 ADRs after administration of conventional amphotericin B in 75 patients were reported to pharmacovigilance center and assessed their severities as 'possible', 'probable', or 'definite'. Renal adverse reaction was the most common ADR with incidence rate of 42% (96 of 231 ADRs). Mean change in SCr from baseline was 0.26 mg/dL (change % 37.8) and statistically significant (p=0.000). Simple correlations analysis revealed that the number of concurrent diseases and number of nephrotoxic drugs were positively correlated with changes in SCr, but these results were not statistically significant. Among 43 patients who remained amphotericin B after occurrence of renal ADRs, 27 patients was administered conventional amphotericin B and 16 patients changed to liposomal amphotericin B. Mean change in SCr in amphotericin B group was 0.23 mg/dL (32.75%), whereas mean change in SCr in liposomal amphotericin B group were -0.28 mg/dL (19.38%) and difference between two groups was statistically significant (p=0.003). The numbers of patient with SCr elevation more than 30% were 9 (33.3%) in amphotericin B group and 2 (12.5%) in liposomal amphotericin B group (Odd Ratio=3.50, 95% Confidence Interval 0.65-18.85; p=0.130). Conclusion: An analysis of ADRs due to amphotericin B administration revealed significant mean changes in SCr from baseline. Switching to liposomal amphotericin B showed significant decrease in SCr compared with conventional amphotericin B.

Efficacy and Adverse Events of Bangpungtongseong-san(Bofutsusho-san) and Bangkihwangki-tang(Boiogiot-tang) by Oriental Obesity Pattern Identification on Obese Subjects : Randomized, Double Blind, Placebo-controlled Trial (비만 환자에서 한방 비만 변증에 따른 방풍통성산과 방기황기탕의 치료효과 및 부작용 비교 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Lee, Myeong-Jong;Kim, Ho-Jun;Hong, Sun-woo;Lee, Dong-Ki;Yoo, Jae-Wook;Choi, Sun-Mi;Moon, Jin-Seok;Lim, Chi-Yeon;Lee, Jung-bok
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.2
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    • pp.265-278
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    • 2011
  • Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

Adverse Effect of Exposure to Ambient Particular Matter on Neuropsychiatric Disorder (미세먼지노출이 신경정신장애에 미치는 영향)

  • Lim, Myung Ho;Kim, Jong-Hun;Kwon, Ho Jang;Cheong, Hae-Kwan
    • Anxiety and mood
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    • v.16 no.2
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    • pp.57-75
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    • 2020
  • Particular matter is steadily increasing due to environmental factors at domestic and abroad such as industry and economy. Recently, the exposure particular matters has been reported to increase the risk not only for morbidity and mortality, but also for diseases of the respiratory system, cardiovascular system and central nervous system/neuropsychiatric disorder. Although the causes of neuropsychiatric diseases are genetic and environmental factors, it is necessary to pay more attention to environmental factors in terms of prevention. We mainly describe environmental factors that affect neuropsychiatric disorders, mainly on particular matter, which is one of harmful environmental substances. In the current study, we reviewed evidence for the presence of particular matter or particular matter related harmful air pollutants-O3, SO2, NO2/NOx, traffic related air pollution, that may represent risk factors for the development of neuropsychiatric disorder.

Development of Stress-tolerant Crop Plants

  • Park, Hyung-In;Kang, Jung-Youn;Sohn, Hee-Kyung;Kim, Soo-Young
    • Journal of Plant Biotechnology
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    • v.4 no.2
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    • pp.53-58
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    • 2002
  • Adverse environmental conditions such as drought, high salt and cold/freezing are major factors that reduces crop productivity worldwide. According to a survey, 50-80% of the maximum potential yield is lost by these "environmental or abiotic stresses", which is approximately ten times higher than the loss by biotic stresses. Thus, improving stress-tolerance of crop plants is an important way to improve agricultural productivity, In order to develop such stress-tolerant crop plants, we set out to identify key stress signaling components that can be used to develop commercially viable crop varieties with enhanced stress tolerance. Our primary focus so far has been on the identification of transcription factors that regulate stress responsive gene expression, especially those involved in ABA-mediated stress response. Be sessile, plants have the unique capability to adapt themselves to the abiotic stresses. This adaptive capability is largely dependent on the plant hormone abscisic acid (ABA), whose level increases under various stress conditions, triggering adaptive response. Central to the response is ABA-regulated gene expression, which ultimately leads to physiological changes at the whole plant level. Thus, once identified, it would be possible to enhance stress tolerance of crop plants by manipulating the expression of the factors that mediate ABA-dependent stress response. Here, we present our work on the isolation and functional characterization of the transcription factors.n factors.

A Longitudinal Investigation of the Moderating Effect of Social Support on Job Strain Developing Non-Specific Neck Pain in Office Workers

  • Jun, Deokhoon
    • The Journal of Korean Physical Therapy
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    • v.31 no.4
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    • pp.254-259
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    • 2019
  • Purpose: This study examined the interactions between the job strain and social support in the workplace on the development of workrelated neck pain in office workers. Methods: The participants included 62 office workers without neck pain over the last twelve months. A battery of measures evaluating the potential workplace risk factors in office settings were conducted at the baseline, and at the 12 month incidence of work-related neck pain was reported via monthly questionnaires. Survival analysis evaluated the interaction effect between job strain and social support on the development of work-related neck pain. Results: The incidence of work-related neck pain was 1.91 (95% CI: 1.06 - 3.45) per 100 person months. The interaction effect between job strain and social support found that job strain may increase the risk of developing new work-related neck pain when lower social support existed in the workplace. On the other hand, the adverse effects of job strain on the development of neck pain were not significant when workers had higher social support from their colleagues and supervisors. Conclusion: An investigation of the moderating effects of risk factors on neck pain might reveal the unexplained relationship between the risk factors for the development of neck pain in office workers. Therefore, the interest in prevention plans and treatments should involve a comprehensive understanding of the risk factors at workplace.

Clinical Trial of Taeeumjowui-Tang(Taiyintiaowei-tang) on Obese Patients - Randomized, Double Blind, Placebo-Controlled Study - (비만 환자에 대한 태음조위탕(太陰調胃湯) 임상연구 - 무작위배정, 이중맹검, 위약·대조군 임상시험 -)

  • Li, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.4
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    • pp.197-213
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    • 2010
  • Objectives : The clinical trial was designed to investigate the safety and effects of Taeeumjowui-tang(Taiyintiaowei-tang) extracts on the change of the weight, body compositions, serum in obese patients. Methods : This was a 12-weeks, randomized, double blind, placebo-controlled clinical trial. Patients with a body mass index of either greater than $30kg/m^2$ or between 27 and $30kg/m^2$ with controlled hypertension, diabetes, hyperlipidemia were considered eligible. Participants of 41 obese patients were randomized either to Taeeumjowui-tang(Taiyintiaowei-tang)(23) or placebo(18). After 12 weeks of treatment, we measured anthropometric factors(weight, height, waist circumference, BMI(body mass index) etc.), abdominal fat area by CT(computed tomography)scanning, serum lipid(total cholesterol, tryglyceride, HDL-cholesterol, LDL-cholesterol), blood lever of variety(AST, ALT, BUN, creatinine etc.). Adverse events also evaluated. Results : After 12 weeks of treatment mean weight, waist-circumference, total cholesterol, LDL-cholesterol and score of KEAT-26 were significant changed in Taeeumjowui-tang(Taiyintiaowei-tang). There were no serious adverse events in either groups. Conclusions : There were limited in this study that is conducted within a short period of 12 weeks. but its weight and WC(waist circumference), WHR(waist hip ratio), total cholesterol, LDL-cholesterol and score of KEAT-26 loss effect was significant and it had few adverse events.

Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients (비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험)

  • Lee, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine for Obesity Research
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    • v.10 no.1
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

A Review of Herbal Medicinal Products Associated with Toxic Events in Korea (최근 독성 문제가 제기된 한약재에 대한 고찰)

  • Jang, In-Soo;Yang, Chang-Sop;Han, Chang-Ho
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.1-10
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    • 2007
  • Background : There has been renewed interest in complementary alternative medicine around the world far a decade. On the other hand, the issue of safety of herbal medicine in Korea has been continuously questioned. Issues raised have included not only chemical residue or heavy metals caused by pollution, but also the toxicity of herbal medicine itself. Objectives : The purpose of this study was to review some herbal medicines subject to controversy of toxicity and figure out what kind of problems they evidence. Methods : In this review, PubMed was used to search medical journals. Keywords such as 'herb, or herbal medicine', 'safety, or adverse events, or adverse effect, or toxicity, or liver injury' were applied. Journals were selected by four inclusion criteria, as objectives should be human, researchers should be medical doctors, literature written in the English language, and types of journals should be meta-analysis or practice guideline or reviews. Finally, 9 cases from 60 journals were included in this review. Results : We reviewed 13 herbal medicines for controversy of toxicity such as ephedra(Mahuang), Arisolochia fangchi, Aristolochia manshuriensis, licorice, skullcap , germander, Syo-saiko-to(Xiao-chai-hu-tang), Chelidonium majus, mistletoe, Dictamnus dasycarpus and madder. Conclusions : It suggested that 'who it is prescribed for' is one of the most important factors to identify the causes of toxicity in herbal medicine and dietary supplements, under specific conditions in Korea.

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The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD): A Korean Chronic Kidney Disease Cohort

  • Oh, Kook-Hwan;Park, Sue K.;Kim, Jayoun;Ahn, Curie
    • Journal of Preventive Medicine and Public Health
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    • v.55 no.4
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    • pp.313-320
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    • 2022
  • The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) was launched in 2011 with the support of the Korea Disease Control and Prevention Agency. The study was designed with the aim of exploring the various clinical features and characteristics of chronic kidney disease (CKD) in Koreans, and elucidating the risk factors for CKD progression and adverse outcomes of CKD. For the cohort study, nephrologists at 9 tertiary university-affiliated hospitals participated in patient recruitment and follow-up. Biostatisticians and epidemiologists also participated in the basic design and structuring of the study. From 2011 until 2016, the KNOW-CKD Phase I recruited 2238 adult patients with CKD from stages G1 to G5, who were not receiving renal replacement therapy. The KNOW-CKD Phase II recruitment was started in 2019, with an enrollment target of 1500 subjects, focused on diabetic nephropathy and hypertensive kidney diseases in patients with reduced kidney function who are presumed to be at a higher risk of adverse outcomes. As of 2021, the KNOW-CKD investigators have published articles in the fields of socioeconomics, quality of life, nutrition, physical activity, renal progression, cardiovascular disease and outcomes, anemia, mineral bone disease, serum and urine biomarkers, and international and inter-ethnic comparisons. The KNOW-CKD researchers will elaborate a prediction model for various outcomes of CKD such as the development of end-stage kidney disease, major adverse cardiovascular events, and death.

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
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.3
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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.