• Journal of Environmental Health Sciences
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• v.50 no.2
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• pp.113-124
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• 2024

Background: The increasing need to minimize animal testing has sparked interest in alternative methods with more humane, cost-effective, and time-saving attributes. In particular, in silico-based computational toxicology is gaining prominence. Adverse outcome pathway (AOP) is a biological map depicting toxicological mechanisms, composed of molecular initiating events (MIEs), key events (KEs), and adverse outcomes (AOs). To understand toxicological mechanisms, predictive models are essential for AOP components in computational toxicology, including molecular structures. Objectives: This study reviewed the literature and investigated previous research cases related to AOP and in silico methodologies. We describe the results obtained from the analysis, including predictive techniques and approaches that can be used for future in silico-based alternative methods to animal testing using AOP. Methods: We analyzed in silico methods and databases used in the literature to identify trends in research on in silico prediction models. Results: We reviewed 26 studies related to AOP and in silico methodologies. The ToxCast/Tox21 database was commonly used for toxicity studies, and MIE was the most frequently used predictive factor among the AOP components. Machine learning was most widely used among prediction techniques, and various in silico methods, such as deep learning, molecular docking, and molecular dynamics, were also utilized. Conclusions: We analyzed the current research trends regarding in silico-based alternative methods for animal testing using AOPs. Developing predictive techniques that reflect toxicological mechanisms will be essential to replace animal testing with in silico methods. In the future, since the applicability of various predictive techniques is increasing, it will be necessary to continue monitoring the trend of predictive techniques and in silico-based approaches.

• The Korean Journal of Health Service Management
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• v.11 no.1
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• pp.159-169
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• 2017

Objectives : The purpose of this descriptive observational study was to identify the factors influencing the nutritional status of patients with liver cancer receiving transarterial chemoembolization(TACE) Methods : A total of 100 participants were enrolled in this study. Data were collected and descriptive statistics and logistic regression were performed. Results : Among participants, 41.0% had a risk of malnutrition and 59.0% had a normal nutritional status. Statistically significant differences between the normal and risk groups were found for the following factors: occupation; economical status; regular exercise; underlying disease; adverse events right after TACE; current adverse events; duration after TACE; depression; and self-care performance. Underlying disease(OR=5.134, p=.005) and self-care performance(OR=0.931, p=.032) had statistically associated with nutritional status. Conclusions : The findings suggest that underlying disease and self-care performance influence the nutritional status among liver cancer patients receiving transcatheter arterial chemoembolization(TACE).

• International journal of thyroidology
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• v.11 no.2
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• pp.71-74
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• 2018

Adverse events such as hemoptysis and gastrointestinal hemorrhage during tyrosine kinase inhibitor treatment are relatively rare, but the severity of the bleeding can be higher than other common adverse events. It is necessary to educate patients about its possibility so that they can be found early. In this case report of radioiodine refractory thyroid cancer patient, hemoptysis and gastrointestinal bleeding has occurred following lenvatinib administration. Drug interruption and dose modification and dose interruption were required in addition to management for bleeding itself. It is necessary to confirm the high risk of bleeding before the administration of tyrosine kinase inhibitors, and to appropriately control the follow-up interval and drug dosage accordingly.

• 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.

• 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.

• The Journal of Internal Korean Medicine
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• v.38 no.1
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• pp.72-80
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• 2017

Objective: The purpose of this study is to report the case of a patient with recurring non-small cell lung carcinoma (NSCLC) taking Samchilchoongcho-Jung with Afatinib. Methods: An NSCLC patient diagnosed with multiple bone and pulmonary metastasis was taking Afatinib (20 mg/day) and suffering from stomatitis caused by the Afatinib. The patient was treated with Samchilchoongcho-Jung (1,500 mg/ day) for 3 months. The tumor size was measured with computed tomography, and laboratory findings, including tumor markers (CEA, Cyfra 21-1), were also followed up. Stomatitis was measured by a numeric rating scale, and adverse events were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0. Results: After combined treatment, stable disease was shown on computed tomography. The tumor marker levels of CEA and Cyfra 21-1 were decreased, and the stomatitis significantly improved. NCI-CTCAE 4.0 showed no adverse events. Conclusion: This case study suggests that Samchilchoongcho-Jung may have a synergic effect, in conjunction with Afatinib, on the treatment of patients with recurring NSCLC.

• Journal of Acupuncture Research
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• v.35 no.2
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• pp.75-80
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• 2018

Background: The aim of this study was to assess the feasibility of conducting a clinical study of using acupuncture for chronic pain in patients with osteoporotic thoracolumbar vertebral compression fractures (VCFs) in the outpatient setting. Methods: A prospective case-series attempting to recruit 20 participants was performed from February 11, 2016, to December 31, 2016. We provided Manual and electrical acupuncture was provided one 1 to three 3 times a week, for 6 weeks, up to 18 sessions. The primary clinical outcome was the average pain intensity as measured by the visual analog scale (VAS) at 6 weeks. Secondary outcomes included back-specific dysfunction (Oswestry disability index), quality of life (quality of life questionnaire-26), patient-reported improvement, use of other healthcare resources, and adverse events at 6 weeks. Use of healthcare resources and adverse events were additionally followed-up at 12 weeks by telephone. Results: Of 33 patients screened, a total of 7 were enrolled in the study. Manual and electrical acupuncture was provided 1 to 3 times a week, for 6 weeks, up to 18 sessions. We observed reduced pain intensity at 6 weeks in all participants. The change in the quality of life and back-specific dysfunction was inconsistent among participants. Mild, temporary adverse events were observed in three patients. Conclusion: In our clinical setting, it was not feasible to recruit sufficient participants and to assess the efficacy of acupuncture for chronic pain after osteoporotic thoracolumbar VCFs under a year. Strategies to improve recruitment and to identify barriers to participation are required for future clinical trials.

• Korean Journal of Acupuncture
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• v.32 no.4
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• pp.177-189
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• 2015

Objectives : To develop and validate a survey form for adverse events(AEs) associated with acupuncture and moxibustion treatment. Methods : The 1st version of a survey form consisting of 9 categories was developed and modified based on the analysis of questionnaires from previous studies on AEs. To evaluate content validity of the 1st version, a Delphi survey where experts in acupuncture and moxibustion, and research methodology were invited, was conducted alongside a separate content validity questionnaire. The content validity indices for each item and total scale were calculated as the proportion of the number of experts judging each item or scale valid to the number of total experts. Results : After the Delphi round 1, the content validity of 2 items and total scale was rated as inadequate. The 1st version was modified accordingly, and the 2nd version of the survey form was developed. The content validity of the 2nd version was assessed in the Delphi round 2 and the final version was completed after incorporating the expert comments. The final version consists of 13 questions regarding practitioner/patient information, condition/disease, intervention, treated body parts, safety issue and AE occurrence related with practitioner's behavior or instruments, AEs associated with treatment and emergency actions taken if necessary, time to AE occurrence, outcomes, serious AEs or death, and time to AE disappearance. Conclusions : This newly developed and validated survey form will serve to collect AEs associated with acupuncture and moxibustion treatments in Korea and contribute to establishing the evidence on safety of Korean acupuncture treatment.

• The Journal of Pediatrics of Korean Medicine
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• v.34 no.3
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• pp.1-17
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• 2020

Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in refractory nephrotic syndrome (RNS). Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on RNS from the Pubmed, CNKI, OASIS, NDSL, J-stage, and CiNii. The demographic data, duration of illness, intervention, treatment period, outcome, adverse events, and composition of herbal medicine were analyzed for this study. Results 11 RCT studies were selected and analyzed. The children in the control group were given western medicine therapy, and the treatment group was given herbal medicine along with the same western medicine of the control group. The most commonly used herbal medicines were the prescriptions to treat 'Kidney Deficiency with Blood Stasis (腎虛兼瘀血)' which composed of 'Promoting blood circulation (化瘀)', 'Diuresis-inducing (利水)', or 'Heating Yang (溫陽)' medicine based on 'Replenishing Kidney or Spleen (補腎, 補脾)' medicine. In the treatment group, proteinuria and serum lipid was significantly decreased, serum albumin was significantly increased, and total effective rate was significantly higher than the control group. Hypercoagulation and relapse rate was also significantly reduced. Adverse events were significantly lower in the treatment group. Conclusions Herbal medicine treatment on pediatric RNS can be suggested as a new treatment for children who have less response to the conventional therapy. It can also supplement the limitations of the western medicine by reducing adverse events from the steroids and immuno-suppressive agents, and lower the relapse rate as well.

• Biomolecules & Therapeutics
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• v.14 no.1
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• pp.56-65
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• 2006

Adverse drug events (ADEs) are the most common type of adverse events in medical practice. Hospital admissions related to ADEs cost high and should be monitored to prevent them. While concerns about the ADEs are increasing, the frequency and characteristics of admissions related to ADEs have not been reported in Korea. The objective of the study was to assess the rate of hospital admission related to ADEs and their characteristics through ADE signal-based retrospective reviews of medical records. As results, a total of 1,420 patients had ADE signals suggesting potential ADEs from 3,494 patients who discharged from an academic medical center over one month period. Six pharmacists independently assessed the presence of ADEs after the review of patients' medical records. Among the 3,494 discharges, 62 admissions (1.8%) were found to be realted to ADEs. Of admissions with ADEs, 83.9% were moderate (category F by the NCC MERP classification), 37.2% were preventable, and 85.5% were type A reaction. The most frequent suspected drugs causing ADEs were antineoplastics (48.9%), and the most frequent ADE signal detecting hospital admissions related to ADEs was white blood cell count (24.2%). Hospital admissions related to ADEs were found through screening the ADE signals. The ADE signal-based retrospective review could be a practical approach for identifying hospital admissions related to ADEs.