• Title/Summary/Keyword: drug-related side effects

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Changing Gadolinium-Based Contrast Agents to Prevent Recurrent Acute Adverse Drug Reactions: 6-Year Cohort Study Using Propensity Score Matching

  • Min Woo Han;Chong Hyun Suh;Pyeong Hwa Kim;Seonok Kim;Ah Young Kim;Kyung-Hyun Do;Jeong Hyun Lee;Dong-Il Gwon;Ah Young Jung;Choong Wook Lee
    • Korean Journal of Radiology
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    • v.25 no.9
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    • pp.824-832
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    • 2024
  • Objective: To determine the preventive effect of changing gadolinium-based contrast agents (GBCAs) to reduce the recurrence of GBCA-associated acute adverse drug reactions (ADRs). Materials and Methods: This retrospective, observational, single-center study-conducted between January 2016 and December 2021-included 238743 consecutive GBCA-enhanced MRI examinations. We focused on a subgroup of patients who experienced acute GBCA-associated ADRs during any of these examinations and subsequently underwent follow-up GBCA-enhanced MRI examinations up until July 2023. The follow-up examinations involved either the same (non-change group) or different (change group) GBCAs compared to the ones that initially caused the acute ADR. Baseline participant characteristics, generic profile of the GBCAs, administration of premedication, history of prior ADR to iodinated contrast media, and symptoms of GBCA-associated acute ADRs were retrospectively analyzed. Multivariable logistic regression with generalized estimating equations and propensity score matching were used. Results: A total of 1042 instances of acute ADRs (0.44%; 95% confidence interval [CI]: 0.41%-0.46%) were reported. Three-hundred and seventy-three patients underwent GBCA-enhanced MRI examinations after experiencing GBCA-associated acute ADRs within the study period; 31.9% (119/373) reexperienced acute ADRs at any of the follow-up examinations. The ADR recurrence was significantly lower in the GBCA change group than in the non-change group according to multivariable logistic regression (adjusted odds ratio [OR]: 0.35; 95% CI: 0.13-0.90; P = 0.03) and analysis with propensity score matching (14.3% [6/42] vs. 36.9% [31/84], respectively; OR: 0.32, 95% CI: 0.11-0.94; P = 0.04). A history of an ADR to iodinated contrast media (OR: 1.14, 95% CI: 0.68-1.90; P = 0.62) and premedication (adjusted OR: 2.09, 95% CI: 0.93-4.68; P = 0.07) were not significantly associated with GBCA-associated acute ADR recurrence. A separate analysis for recurrent allergic-like hypersensitivity reactions demonstrated similar results (adjusted OR: 0.20, 95% CI: 0.06-0.65; P < 0.01). Conclusion: Changing GBCAs may reduce the risk of GBCA-associated acute ADR recurrence.

Research Direction for Functional Foods Safety (건강기능식품 안전관리 연구방향)

  • Jung, Ki-Hwa
    • Journal of Food Hygiene and Safety
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    • v.25 no.4
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    • pp.410-417
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    • 2010
  • Various functional foods, marketing health and functional effects, have been distributed in the market. These products, being in forms of foods, tablets, and capsules, are likely to be mistaken as drugs. In addition, non-experts may sell these as foods, or use these for therapy. Efforts for creating health food regulations or building regulatory system for improving the current status of functional foods have been made, but these have not been communicated to consumers yet. As a result, problems of circulating functional foods for therapy or adding illegal medical to such products have persisted, which has become worse by internet media. The cause of this problem can be categorized into (1) product itself and (2) its use, but in either case, one possible cause is lack of communications with consumers. Potential problems that can be caused by functional foods include illegal substances, hazardous substances, allergic reactions, considerations when administered to patients, drug interactions, ingredients with purity or concentrations too low to be detected, products with metabolic activations, health risks from over- or under-dose of vitamin and minerals, and products with alkaloids. (Journal of Health Science, 56, Supplement (2010)). The reason why side effects related to functional foods have been increasing is that under-qualified functional food companies are exaggerating the functionality for marketing purposes. KFDA has been informing consumers, through its web pages, to address the above mentioned issues related to functional foods, but there still is room for improvement, to promote proper use of functional foods and avoid drug interactions. Specifically, to address these issues, institutionalizing to collect information on approved products and their side effects, settling reevaluation systems, and standardizing preclinical tests and clinical tests are becoming urgent. Also to provide crucial information, unified database systems, seamlessly aggregating heterogeneous data in different domains, with user interfaces enabling effective one-stop search, are crucial.

Drug Evaluation of Ursodeoxycholic Acid Use for Treatment of Cholestasis Associated with TPN Therapy in Neonate (신생아의 TPN 요법 시 발생되는 Cholestasis 치료를 위한 Ursodeoxycholic Acid의 약물사용 평가)

  • Lee, Jung-Ok;Song, Tae-Beom;Lee, Myung-Koo;Lim, Sung-Cil
    • YAKHAK HOEJI
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    • v.54 no.4
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    • pp.270-281
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    • 2010
  • Total parenteral nutrition (TPN) is necessary to neonates in neonatal intensive care unit (NICU) for survival and growth because of impossible of enteral feeding. Long-term TPN can be associated with a broad spectrum of hepatobiliary disorder, ranging from mild hepatic dysfunction to severe end-stage liver disease. Cholestasis developed most commonly in neonate, ursodeoxycholic acid (UDCA) is widely used in adult with cholestatic and non-cholestatic liver diseases but there have been limited data on the effects in neonate with PNAC. This study was performed retrospectively to review all medical histories of the total 30 neonates with was administrated UDCA for treatment to parenteral nutrition associated cholestasis (PNAC) at Chungbuk National University Hospital NICU from April 2002 to December 2008. UDCA was administrated at bilirubin is over 2 mg/dl. The criterias for drug evaluation were included hepatic biochemical marker such as direct bilirubin, total bilirubin, AST, ALT, ALP and GGT, TPN therapy period, cholestasis development period, UDCA treatment period, UDCA dosage and adverse effect. In the results, Post-UDCA treatment significant was decreased direct bilirubin, total bilirubin, AST and ALP (p<0.05), and was decreased GGT (p>0.05) and slightly was increased ALT (p>0.05). Reffective timect biDCA was appear at mean $10.5{\pm}1.3$ days, iDCA administration period was mean $64.4{\pm}5.9$ days, cholestasis period was mean $71.9{\pm}6.4$ days and UDCA dosage was mean $22.9{\pm}0.9$ mg/kg/day. Common adverse effects is diarrhea, 5 patients arised mild diarrhea but it possible also related with increased enteral feeding. In conclusion, iDCA can decrease direct bilirubin that major parameter t bcholestasis and oher hepatic biochemical makers. UDCA is effective on PNAC without any serious side effect and cost-effective. Although no greatly shortening cholestasis period, but can protect to develop into severe liver disease and other complication or death. Based on these result, UDCA is recommended for treatment of cholestasis at direct bilirubin is over 2 mg/dl.

A Study on the Skin Disease of Sanghanron 《傷寒論》 and Geumgweyoryak 《金匱要略》 (《상한론(傷寒論)》, 《김궤요략(金匱要略)》의 피부증상(皮膚症狀) 및 질환(疾患)에 대한 연구(硏究))

  • Kang, Na-Ru;Han, Jung-Min;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.25 no.1
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    • pp.55-74
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    • 2012
  • Objective : The purpose of this study is to investigate the skin disease in Sanghanron"傷寒論" and Geumgweyoryak"金匱要略". Methods : We conducted a study on the original text paragraphs of Sanghanron and Geumgweyoryak containing the skin disease and analysis of Woo, Oh, Sung, Zhang, etc. We drew a parallel between skin disease from Sanghanron and Geumgweyoryak and matching diagnoses from western medicine. Results : The results were as follows. 1. In Sanghanron and Geumgweyoryak pruritus was related to psychogenic pruritus and similar to skin disease caused by decrease of sweating, dry skin in cholinergic urticaria, atopic dermatitis and eczema, etc. in western medicine. 2. In Geumgweyoryak ichthyosis was caused by woman's disease, after menopause, chronic disease and malnutrition and related to winter itch and xerotic eczema in western medicine. 3. In Sanghanron Goose bumps, keratosis follicularis, acute and chronic urticaria and cold urticaria were occurred because of poorly managed fever care and side effect of antibiotic. 4. In Geumgweyoryak red face was similar to face flushing and side effects, which is after drug and laser treatment on face, in western medicine. 5. In Geumgweyoryak urticaria was, in a broad sense, skin disease with pruritus and secondary infection resulted from scratch. Skin diseases with pruritus are similar to urticaria, dermatitis herpetiformis, lichen planus, atopic dermatitis, contact dermatitis, psoriasis, nummular eczema, lichen simplex chronicus, prurigo nodularis, neurodermatitis and internal disease with pruritus in western medicine. 6. In Geumgweyoryak spots in the skin were caused by fever and similar to allergic purpura and SLE symptom in western medicine. 7. In Geumgweyoryak bullous disease with yellowish discharge was similar to eczema, pustule, atopic eczema, etc. in western medicine. 8. In Geumgweyoryak repeated inflammation of oral cavity, genitals, eyes and skin was similar to Behcet's disease in western medicine. 9. In Sanghanron and Geumgweyoryak boil was similar to abscess and acute lymphadenitis in western medicine caused by oily foods and infections. 10. In Geumgweyoryak swelling and boil were occurred in a poor health. Damage from metalic material could cause a convulsion and was similar to tetanus in western medicine. Conclusion : We analyzed the original text paragraphs of Sanghanron and Geumgweyoryak and explanations about skin disease. As a results, we found out etiology, pathogenesis, treatments of the skin disease in Sanghanron and Geumgweyoryak. Further we compared with western medicine to develop better understanding of the skin disease.

PHARMACOLOGICAL TREATMENT IN PERVASIVE DEVELOPMENTAL DISORDERS (전반적발달장애의 약물치료)

  • Choi, Jin-Sook
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.4 no.1
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    • pp.27-38
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    • 1993
  • Pervasive developmental disorder is one of the most severe clinical disorder in child psychiatry and is associated with deviancies in multiple areas of development. Medication does not cure pervasive developmental disorder and its effectiveness is generally nonspecific. But psychopharmacological treatment can be important for some children with pervasive developmental disorder and can make many young autistics more amenable to behavior modification and education. Haloperidol, the most widely studied antipsychotics, was statistically and clinically superior to placebo, and furthermore, was known to facilitate the positive functioning such as, discrimination learning and imitative communication, without side effects. However, administration of haloperidol is associated with drug related dyskinesia, and it warrants the introduction and use of the other novel drugs. Several biochemical studies suggest that subgroups of children with pervasive developmental disorder show hyperserotonemia and increased endogenous opioid level as compared with controls. Psychopharmacological trials were conducted according to these findings(ex : fenfluramine, naltrexone), with mixed results till now. These and another drugs that have been used in children with pervasive developmental disorder and their effectiveness are reviewed.

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Blockade of Kv1.5 by paroxetine, an antidepressant drug

  • Lee, Hyang Mi;Hahn, Sang June;Choi, Bok Hee
    • The Korean Journal of Physiology and Pharmacology
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    • v.20 no.1
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    • pp.75-82
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    • 2016
  • Paroxetine, a selective serotonin reuptake inhibitor (SSRI), has been reported to have an effect on several ion channels including human ether-a-go-go-related gene in a SSRI-independent manner. These results suggest that paroxetine may cause side effects on cardiac system. In this study, we investigated the effect of paroxetine on Kv1.5, which is one of cardiac ion channels. The action of paroxetine on the cloned neuronal rat Kv1.5 channels stably expressed in Chinese hamster ovary cells was investigated using the whole-cell patch-clamp technique. Paroxetine reduced Kv1.5 whole-cell currents in a reversible concentration-dependent manner, with an $IC_{50}$ value and a Hill coefficient of $4.11{\mu}M$ and 0.98, respectively. Paroxetine accelerated the decay rate of inactivation of Kv1.5 currents without modifying the kinetics of current activation. The inhibition increased steeply between -30 and 0 mV, which corresponded with the voltage range for channel opening. In the voltage range positive to 0 mV, inhibition displayed a weak voltage dependence, consistent with an electrical distance ${\delta}$ of 0.32. The binding ($k_{+1}$) and unbinding ($k_{-1}$) rate constants for paroxetine-induced block of Kv1.5 were $4.9{\mu}M^{-1}s^{-1}$ and $16.1s^{-1}$, respectively. The theoretical $K_D$ value derived by $k_{-1}/k_{+1}$ yielded $3.3{\mu}M$. Paroxetine slowed the deactivation time course, resulting in a tail crossover phenomenon when the tail currents, recorded in the presence and absence of paroxetine, were superimposed. Inhibition of Kv1.5 by paroxetine was use-dependent. The present results suggest that paroxetine acts on Kv1.5 currents as an open-channel blocker.

A Survey on Weight Control and Eating Behavior in Reproductive Women by BMI (가임여성의 비만도에 따른 체중조절 실태 및 식습관)

  • Lee, Eun-Jung;Kim, Mi-Hyun;Kim, Wha-Young;Cho, Mi-Sook
    • Journal of the Korean Society of Food Culture
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    • v.18 no.2
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    • pp.172-180
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    • 2003
  • This study was performed to document the weight loss diet practice and dietary habit related to weight control in child-bearing Korean women. The subjects were 1,434 women aged 17-39 years. The subjects were classified into 3 groups based on BMI: low weight(LW) BMI < 18.5; normal weight(NW), 18.5 BMI 22.9; and overweight(OW), 23.0 BMI. Anthropometric, general characteristics, weight control practice, and the quality of diet were assessed by a questionnaire. LW group had higher rate of smoking and drinking. They also complained more subjective symptom of anemia and used less nutritional supplementation. Weight loss diet had been practiced by about 40% of subjects and the percent was increased with increasing BMI. The reason of weight loss diet were significantly different by BMI groups(p<0.05); LW to keep body in shape, OW for health. Low BMI group had experienced more side effects after weight loss diet(p<0.05). LW group usually used inappropriate method to control weight such as skipping meals and some of OW group reported using drug to lose weight. All subjects have been skipped their meals of 3.9 times per week, especially 4.3 times in LW group. By mini dietary assessment, most of the subjects did not have regular meals. LW group tended to eat what they like and OW group preferred fried food. This study showed that child-bearing aged women make a ceaseless effort apart from their weight, and LW group have a matter of grave concern because of their dietary habit and weight control practice. Additional research should be necessary to assess the relation of health and weight loss diet in young women.

Effects of Hospital-based Home Care Demonstration Project on Physical and Emotional Problems and Cost - effectiveness of Patients having Arthritis (병원중심 가정간호 사업의 평가 연구 -외래 관절염 환자를 대상으로 -)

  • Lim, Nan-Young;Kim, Seong-Yoon;Lee, Eun-Ok;Lee, In-Sook
    • Journal of muscle and joint health
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    • v.3 no.1
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    • pp.4-22
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    • 1996
  • Purposes of this study were to identify a hospital-based home care model and to improve the physical, emotional and economical effectiveness of arthritic patients through medical and nursing team approach. The design in nonequivalent control group pretest-posttest design with matched samples in terms of age, sex and disease severity. Fifty two patients in each group were assigned in Seoul, Kyunggi, Kangwon and Kwangju. Before and after 6-month period of home care, level of pain, duration of morning stiffness, Richie Index, ADL, self efficacy, depression, cost expenditure were measured. Nine patients were excluded from the control group in the period of study because of denial of participation. Contents of home care provided to the experimental group include mainly distribution of prescribed drugs, 'assessment of patients' condition and side-reactions of drug. All of the information related to the home care patient were reported to the physician. On the bases of these data, the physician prescribe the specific drugs to each patient. Each patient visited the physician every 2 or 3 month for laboratory test. Patients assigned to the control group visited the outpatient clinic once a month as usual. Null hypotheses were selected because physicians concerned about the ineffective change of patients' conditions due to indirect communication with patients through nurses. Level of pain, Richie index, ADL, self-efficacy, depression, duration of morning stiffness and direct medical cost were the home care provided to them. If a family member accompany in a home care group can save 10,676 Won/month in Seoul, 34,000 Won/month in other districts. Other in-direct cost for transportation and meal can also be saved. In conclusion, those patients with low level of ADL, high level of pain and Richie index, living in the remote area definitely need the home care.

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Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group (의약품부작용보고시스템 데이터베이스를 이용한 고강도 statin과 중·저강도 statin 관련 이상사례 비교 분석)

  • Lee, Sera;Ock, Miyoung;Kim, Hyunah
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.293-299
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    • 2018
  • Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.

Antipsychotics for patients with pain

  • Shin, Sang Wook;Lee, Jin Seong;Abdi, Salahadin;Lee, Su Jung;Kim, Kyung Hoon
    • The Korean Journal of Pain
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    • v.32 no.1
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    • pp.3-11
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    • 2019
  • Going back to basics prior to mentioning the use of antipsychotics in patients with pain, the International Association for the Study of Pain (IASP) definition of pain can be summarized as an unpleasant experience, composed of sensory experience caused by actual tissue damage and/or emotional experience caused by potential tissue damage. Less used than antidepressants, antipsychotics have also been used for treating this unpleasant experience as adjuvant analgesics without sufficient evidence from research. Because recently developed atypical antipsychotics reduce the adverse reactions of extrapyramidal symptoms, such as acute dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia caused by typical antipsychotics, they are expected to be used more frequently in various painful conditions, while increasing the risk of metabolic syndromes (weight gain, diabetes, and dyslipidemia). Various antipsychotics have different neurotransmitter receptor affinities for dopamine (D), 5-hydroxytryptamine (5-HT), adrenergic (${\alpha}$), histamine (H), and muscarinic (M) receptors. Atypical antipsychotics antagonize transient, weak $D_2$ receptor bindings with strong binding to the $5-HT_{2A}$ receptor, while typical antipsychotics block long-lasting, tight $D_2$ receptor binding. On the contrary, antidepressants in the field of pain management also block the reuptake of similar receptors, mainly on the 5-HT and, next, on the norepinephrine, but rarely on the D receptors. Antipsychotics have been used for treating positive symptoms, such as delusion, hallucination, disorganized thought and behavior, perception disturbance, and inappropriate emotion, rather than the negative, cognitive, and affective symptoms of psychosis. Therefore, an antipsychotic may be prescribed in pain patients with positive symptoms of psychosis during or after controlling all sensory components.