• Journal of the Korea Academia-Industrial cooperation Society
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• 제9권5호
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• pp.1386-1391
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• 2008

The Korean Product Liability Act established the principle that a manufacturer has a duty to take care of a person who is not the customer who bought the product for him. In this instance, there is a duty to the patient for whom the product was purchased by the hospital from the pharmaceutical company. Therefore, the pharmaceutical company has the product liability for adverse reactions to the contrast medium. But the possibility for the patient to successfully sue the pharmaceutical company is quite low, because the patient needs to prove that a "defect" in the unsafe product was the cause of his injuries. And the physician or the radiological technologist can not reduce his liability risks based on the Product Liability Act. On the contrary, The has the product liability because diluting contrast medium belongs to the product category.

• Korean Journal of Clinical Pharmacy
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• 제26권1호
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• pp.40-45
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• 2016

Objective: The increasing use of imaging examinations such as computed tomography (CT) results in increased contrast media use, which increases contrast media-induced adverse reactions (AR). This study investigated the risk factors of ARs to nonionic iodinated contrast media. Methods: This study evaluated patients who were administered iodinated contrast media during CT scanning in Yeouido St. Mary's Hospital in Seoul, Korea in 2012. Among the subjects, those with contrast media-induced ARs were classified as the AR group. The control group included individuals without ARs who were selected through simple random sampling. The effects of sex, age, contrast media type and dose, CT region, previous contrast media administration, allergy history, and comorbidity were analyzed in the AR and control groups. Results: Multivariate logistic regression analyses were performed to evaluate the identified AR risk factors in 103 subjects in the AR group and 412 subjects in the control group. The results confirmed that the risk of developing ARs was significantly higher in females [odds ratio (OR): 2.206; 95% confidence interval (CI): 1.353-3.598], in individuals administered Iohexol (OR: 9.981; 95% CI: 2.361-42.193), in individuals with an allergy history (OR: 3.982; 95% CI: 1.742-9.101), and in individuals with comorbid asthma (OR: 6.619; 95% CI: 1.377-31.826). Most of the ARs were mild and immediate. Conclusion: In patients who were administered contrast media during CT scans, female gender, Iohexol use, allergy history, and asthma were risk factors for ARs. Therefore, special care is required for patients with such risk factors to prevent ARs.

• The Journal of Internal Korean Medicine
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• 제40권5호
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• pp.983-989
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• 2019

Objective: Many types of delayed adverse reactions, such as long-term numbness, occur after injecting contrast medium, but few clinical studies have reported effective treatments for these reactions. We report that herbal medicine can have a positive clinical effect in patients who have experienced long-term numbness after contrast medium injection. Method: A patient who had felt numbness in her head and whole limbs presented at Semyung University Korean Medicine hospital. Her numbness had first started 2 days after injection of contrast medium, and she had felt it constantly for almost 2 years. After admission at the hospital, she took "modified Samul-tang" herbal medicine (120 cc three times per day) from 29 January 2019 to 2 February 2019. We measured her numbness using a numeric rating scale (NRS) on 29 January and 2 February and we compared both scores to determine the degree of favorable and clinical effects of herbal medicine. Result: The NRS score for numbness was 5 for her head and limbs on the first day (29 January), but after 4 days (2 February), the NRS score decreased to 0 for her head and both arms and hands, and it decreased from 5 to 2 for both her legs and feet. Conclusion: Korean herbal medicine can have positive clinical effects on treating adverse reactions due to injection of contrast medium.

• Translational and Clinical Pharmacology
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• 제25권2호
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• pp.63-66
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• 2017

Allopurinol-induced severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome are reportedly associated with the $HLA-B^{\star}58:01$ genotype. Three patients who developed SCARs after allopurinol administration were subjected to HLA-B genotyping and lymphocyte activation test (LAT) to evaluate genetic risk and to detect the causative agent, respectively. All three patients given allopurinol to treat gout were diagnosed with DRESS syndrome. Symptom onset commenced 7-24 days after drug exposure; the patients took allopurinol (100-200 mg/d) for 2-30 days. HLA-B genotyping was performed using a polymerase chain reaction (PCR)-sequence-based typing (SBT) method. All patients had a single $HLA-B^{\star}58:01$ allele: $HLA-B^{\star}13:02/^{\star}58:01$ (a 63-year-old male), $HLA-B^{\star}48:01/^{\star}58:01$ (a 71-year-old female), and $HLA-B^{\star}44:03/^{\star}58:01$ (a 22-year-old male). Only the last patient yielded a positive LAT result, confirming that allopurinol was the causative agent. These findings suggest that patients with $HLA-B^{\star}58:01$ may develop SCARs upon allopurinol administration. Therefore, HLA-B genotyping could be helpful in preventing serious problems attributable to allopurinol treatment, although PCR-SBT HLA-B genotyping is time consuming. A simple genotyping test is required in practice. LAT may help to identify a causative agent.

• Journal of Korean Biological Nursing Science
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• 제23권4호
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• pp.318-329
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• 2021

Purpose: This study was conducted to identify factors affecting COVID-19 vaccination and associated side effects among health care workers in a small and medium-sized hospital. Methods: In May 2021, 301 workers out of a total of 670 working in a small and medium-sized hospital in Gyeonggi-do, were surveyed. The small and medium-sized hospital treats patients with COVID-19. Health care workers across different medical institutions responded with self-reported internet questionnaires. Factors influencing COVID-19 vaccination were analyzed via logistic regression. Results: Out of 301 subjects, 89.0% showed an intention to inoculate, and 85.7% were vaccinated against COVID-19. The most frequent reason for vaccination was responsibility as a medical worker. The fear of adverse reactions was the most frequent reason for non-vaccination. Adverse reactions after inoculation occurred in 70.9% of cases, and 30.6% were referred for treatment of adverse reactions. The factors ultimately influencing COVID-19 vaccination were vaccination intention, previous side effects from other vaccinations, occupation, and age. Conclusion: In order to improve the effectiveness of COVID-19 vaccination, a systematic approach is required to determine the risk factors associated with the young age of the administrative staff/personnel, subjects with a history of side effects associated with other vaccines, and health care workers who do not intend to be vaccinated. It is important to develop strategies to improve immunization. In addition, accurate and essential information regarding the side effects of vaccination is needed, along with appropriate education and publicity.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• 제36권4호
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• pp.51-69
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• 2023

Objectives : The purpose of this study is to assess the effect of using Boyanghwano-tang(BYHWT) for diabetic retinopathy. Methods : We searched randomized controlled trials(RCTs) that used BYHWT for diabetic retinopathy in 10 databases(RISS, KISS, ScienceON, KCI, OASIS, DBpia, CNKI, Wanfang Database, PubMed, Cochrane Library) on August 12, 2023. Outcome measurements included total effective rate(TER) and visual acuity as the primary outcome measurements, and the secondary outcome measurements included fasting blood glucose(FBG), 2hPG, HbA1c, ET-1, NO, etc. The indicator of stability included adverse reactions. A meta-analysis was conducted according to TER, visual acuity, FBG. Results : A total of 8 randomized control trials were selected. The treatment group which used BYHWT showed significant improvement effects in TER and visual acuity compared to the control group which used western medicine or chinese patent medicine alone. TER: (RR: 1.22, CI 1.14 to 1.31, P=<0.00001), visual acuity: (RR: 2.06, CI 1.40 to 3.03, P=0.0002). Secondary outcome measurements including FBG also showed improvement in the treatment group compared to the control group. FBG: (MD: -0.15, CI -0.43 to 0.31, P=0.28). Adverse reactions were only mentioned in one study, which showed that no adverse reactions occurred in both the treatment and control groups. Conclusions : This study suggests that BYHWT is effective for diabetic retinopathy. However these findings should be interpreted cautiously due to the insufficient number of studies and unknown or high risk of bias in the included trials.

• Korean Journal of Clinical Pharmacy
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• 제32권4호
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• pp.352-361
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• 2022

Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

• Korean Journal of Clinical Pharmacy
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• 제22권4호
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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.

• Journal of Korean Medicine Rehabilitation
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• 제34권2호
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• pp.165-172
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• 2024

Objectives This study aims to report current status and strategies of thread embedding acupuncture (TEA) on face through survey of Korean medicine doctors. Methods The survey was conducted online via e-mail to certified Korean medicine doctors. The questionnaire is developed by Korean medicine doctors in Kyung-Hee Korean Medicine Hospital at Gangdong. The survey mainly consisted with multiple-choice questions on the current status, cost, and adverse reactions. Results TEA was predominantly utilized for cosmetic purposes, and the billing cost was commonly determined based on the number of threads used. The reported incidence of adverse reactions during TEA was 69.9%. The most frequent self-resolving adverse reaction was bruising, while the most common adverse reaction requiring medical intervention or resulting in sequelae was the 'dimple phenomenon'. According to the questionnaire, the primary factor associated with adverse reactions was the treatment area. Conclusions This study provided insights into the practical use of TEA on face in Korean medical clinic.

• The Journal of Internal Korean Medicine
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• 제33권4호
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• pp.485-497
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• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.