In Korea, a total of 556 chemical accidents occurred from 2012 to 2018 caused by adverse reactions of two or more chemicals, which required significant amounts of time to identify the causative chemicals. Rapid analysis is required for effective incident response and probing. In this study, a quantum transition time-of-flight mass spectrometer was used to identify the causative agents of chemical accidents caused by adverse reactions. The analyzer enabled fast real-time analysis without the need for sample collection and pretreatment. Quantitative and qualitative analysis of most volatile organic compounds with high hydrogen affinity was performed to investigate the cause of the chemical accidents. In fact, in the month of 201◯, methanol and toluene were detected as causative agents of the accident using a quantum transition time mass spectrometer, and were also the cause of the reported odor.
Objectives The purpose of this study is to evaluate the safety of Non-toxic bee venom (BV) and observe VAS change before and after Non-toxic BV treatment in pain patients. Methods We surveyed the clinical practitioners who treated with Non-toxic BV in pain patients who visited the Korean medical clinic. The questionnaire survey was conducted for clinical practitioners who agreed to participate after hearing the explanation for the purpose and characteristics of the questionnaire. Patients in the questionnaires were reviewed based on their medical records from July 1, 2016 to October 28, 2016. Results We received 445 cases and selected 403 cases finally. 2 cases, however, were not able to continue treatment for 3 weeks and were eliminated. Depending on when the pain occurred, we divided the 401 cases into three groups (Acute, Subacute, Chronic group). In all groups, VAS scores were significantly decreased after treatment. Adverse reactions following Non-toxic BV treatment had occurred was 16 cases (3.60%). Except for 3 cases with hives, most of adverse reactions were mild or moderate and were not in need of extra treatment. The total safety of treatment for 3 weeks was mostly safe. The number of cases discontinued treatment was 42 cases (9.44%). Most of these cases, treatment was stopped for personal reason unrelated to the Non-toxic BV treatment. Conclusions These results suggest that the Non-toxic BV treatment has no serious adverse reactions and is a relatively safe treatment. Further studies are needed to prove the efficacy and clinical safety of Non-toxic BV treatment.
Journal of the Korea Academia-Industrial cooperation Society
/
v.9
no.5
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pp.1386-1391
/
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.
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.
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.
Kim, Eun-Young;Seol, Jung Eun;Choi, Jae-Hyeog;Kim, Na-Yul;Shin, Jae-Gook
Translational and Clinical Pharmacology
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v.25
no.2
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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.
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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v.36
no.4
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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.
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.
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
/
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.
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