• The Journal of Korean Medicine
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• v.40 no.1
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• pp.124-152
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

• Journal of Rheumatic Diseases
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• v.24 no.4
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• pp.227-235
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• 2017

Objective. Failure of first-line anti-tumor necrosis factor (TNF) agents in in rheumatoid arthritis patients leads to decisions among second-line biologic agents. To better inform these decisions, the therapeutic effectiveness of rituximab is compared with other second-line biologic agents in this observational study. Methods. Between November 2011 and December 2014, study subjects were observed for 12 month periods. Patients with an inadequate response to initial anti-TNF agent received either rituximab or alternative anti-TNF agents (adalimumab/etanercept/infliximab) based on the preference of patients and physicians. The efficacy end point of this study was the change in 28-joint count Disease Activity Score (DAS28) at six and 12 months from baseline. Safety data were also collected. Results. Ninety patients were enrolled in the study. DAS28 at six months did not change significantly whether the patients were treated with rituximab or alternative anti-TNF agents in intention-to-treat analysis (n=34, $-1.63{\pm}0.30$ vs. n=31, $-2.05{\pm}0.34$) and standard population set analysis (n=31, $-1.51{\pm}0.29$ vs. n=24, $-2.21{\pm}0.34$). Similarly, the change in DAS28 at 12 months did not reach statistical significance ($-1.82{\pm}0.35$ in the rituximab vs. $-2.34{\pm}0.44$ in the alternative anti-TNF agents, p=0.2390). Furthermore, the incidences of adverse events were similar between two groups (23.5% for rituximab group vs. 25.8% for alternative anti-TNF agents group, p=0.7851). Conclusion. Despite the limitations of our study, switching to rituximab or alternative anti-TNF agents after failure of the initial TNF antagonist showed no significant therapeutic difference in DAS28 reduction.

• Journal of The Korean Society of Inherited Metabolic disease
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• v.20 no.2
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• pp.37-43
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• 2020

Phenylketonuria is the most prevalent disorder caused by an inborn error in aminoacid metabolism. It results from mutations in the phenylalanine hydroxylase (PAH) gene. If untreated or late treated, results in profound and irreversible mental disability. Newborn screening test identify patients with phenylketouria. The early initiation of a phenylalanine restricted diet very soon prevents most of the neuropsychiatric complications. However, the diet therapy is difficult to maintain and compliance is poor, especially in adolescents and adulthood. Since 2015, American Medical College of Medical Genetics and Genomics (ACMG) recommended more strong restrictive diet therapy for target blood level of phenylalanine (<360 umol/L). For over four decades the only treatment was a very restrictive low phenylalanine diet. This changed in 2007 with the approval of cofactor therapy (Tetrahydrobiopterin, BH4) which is effective in up to 30% of patients. Data from controlled clinical trials with sapropterin dihydrochloride indicate a similar occurrence of all-cause adverse events with this treatment and placebo. Large neutral aminoacids (LNAA) competes with phenylalanine for transport across the blood-brain-barrier and have a beneficial effect on executive functioning. A new therapy has just been approved that can be effective in most patients with PAH deficiency regardless of their degree of enzyme deficiency or the severity of their phenotype. Phenylalanine ammonia lyase (PAL-PEG) was approved in the USA by FDA in May of 2018 for adult patients with uncontrolled blood phenylalanine concentrations on current treatment. Nucleic acid therapy (therapeutic mRNA or gene therapy) is likely to provide longer term solutions with few side effects.

• Journal of Chest Surgery
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• v.54 no.2
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• pp.106-116
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• 2021

Background: We evaluated the mid-term outcomes and angiographic patency of redo coronary artery bypass grafting (CABG). Methods: Of 2,851 patients who underwent isolated CABG at Seoul National University Hospital from 2000 to 2017, 88 underwent redo CABG. Patients' mean age at redo CABG was 66.0±8.0 years. The mean interval between the first-time and redo CABG was 113.0±62.4 months. The mean follow-up duration was 86 months. Early and mid-term clinical outcomes were evaluated. Angiographic patency rates were evaluated early (1-2 days), 1 year, and 5 years after surgery. Comparative analyses between on-pump and off-pump CABG were also performed. Results: The culprits for reoperation were previous grafts (65.6%), native coronary vessels (17.8%), and both (16.7%). Off-pump CABG was performed in 75 cases (85.2%), and the mean number of distal anastomoses was 1.8±0.8. The saphenous vein (39.7%) was used most frequently, followed by the right internal thoracic artery (28.4%), right gastroepiploic artery (21.3%), left internal thoracic artery (7.8%), and radial artery (2.8%). Operative mortality was 1.1%. The overall survival, cumulative incidence of cardiac death, and cumulative incidence of major adverse cardiac events were 71.3%,12.0%, and 23.3% at 5 years after surgery, respectively. The overall angiographic patency rates were 95.7%, 90.1%, and 92.2% on early, 1-year, and 5-year angiograms, respectively. The angiographic patency rates of saphenous vein grafts were 93.1%, 85.6%, and 91.3% on early, 1-year, and 5-year angiograms, respectively. No significant differences in clinical outcomes or angiographic patency rates were observed between the on-pump (n=13) versus off-pump (n=75) groups. Multivariable analysis revealed that age (hazard ratio [HR], 1.07; p=0.005) and chronic kidney disease (HR, 3.85; p=0.001) were risk factors for all-cause mortality. Conclusion: Redo CABG could mostly be performed using the off-pump technique and did not show increased operative mortality and morbidities.

• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.44-52
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• 2021

Background: Post-transplant immunosuppression with calcineurin inhibitors (CNIs) is associated with kidney function impairment while mammalian target of rapamycin (mTOR) inhibitors, such as everolimus, can be used for its renal-sparing effects. In this study, we compared the efficacy and safety of everolimus with low dose tacrolimus (EVR+Low TAC) and conventional dose tacrolimus (TAC) in liver transplantation recipients. Methods: Medical records of recipients who received liver transplantation at Seoul National University Bundang Hospital from January 1st 2009 to December 31st 2018 were retrospectively reviewed. Cohort entry date was defined as the day everolimus was initiated and tacrolimus dosage was reduced. All patients were followed up for 1 year. Indicator of efficacy was the incidence of rejection and safety was evaluated by incidence of drug adverse events including renal function. Results: Among 118 patients, there were 40 patients (33.9%) in EVR+Low TAC group. Incidence of rejection, including both biopsy proven acute rejection and clinical rejection, was similar in two groups [7.5% (n=3) vs. 6.4% (n=5), p=1.000]. Renal dysfunction was less frequent in EVR+Low TAC [17.5% (n=7) vs. 35.9% (n=28), p=0.038]. However, incidence rates of dyslipidemia, oral ulcer were more frequent in EVR+Low TAC [45.0% (n=18) vs. 21.8% (n=17), p=0.009; 15.0% (n=6) vs. 1.3% (n=1), p=0.006]. Conclusions: In terms of prevention of rejection, EVR+Low TAC was as effective as TAC and had renal-sparing effect but was associated with increased risk of dyslipidemia and oral ulcer. This study demonstrates that EVR+Low TAC could be an alternative to liver transplant recipients with nephrotoxicity after administration of conventional dose tacrolimus.

• The Journal of Internal Korean Medicine
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• v.43 no.2
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• pp.166-174
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• 2022

Objective: The aim of this study is to report the effectiveness of Korean medicine for a patient with dizziness following anterior inferior cerebellar artery infarction. Methods: The patient was treated with traditional Korean methods including acupuncture, herbal therapy, moxibustion, and vestibular rehabilitation exercise during an admission period of seven days. The patient's dizziness was assessed using a numeric rating scale (NRS) and the Korean Dizziness Handicap Inventory (K-DHI), Korean Activities-specific Balance Confidence (K-ABC), Korean Vestibular Disorders Activities of Daily Living (K-VADL), the modified Rankin scale (mRS), and the Korean version of the Modified Barthel Index (K-MBI). Results: After seven days of combined treatment with traditional methods and vestibular rehabilitation, the patient's dizziness was reduced from NRS 6-7 to NRS 2. In addition, K-DHI decreased from 84 to 22; K-ABC improved from 52% to 78.125%; K-VADL reduced from 175 to 37; the mRS score changed from 4 to 1; and the K-MBI score increased from 86 to 98. No adverse events were observed during treatment. Conclusion: This study suggests that combined therapy of Korean medicine and vestibular rehabilitation can be effective treatment for anterior inferior cerebellar artery infarction patients.

• Pediatric Infection and Vaccine
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• v.29 no.1
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• pp.28-36
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• 2022

Purpose: To evaluate the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in children aged 5-11 years, a rapid systematic review was conducted on published clinical trials of COVID-19 vaccines and studies that analyzed real-world data on adverse events after COVID-19 vaccination. Methods: A systematic search was conducted on medical literature in international (Ovid-MEDLINE) and pre-published literature databases (medRxiv), followed by handsearching up to January 4, 2022. We used terms including COVID-19, severe acute respiratory syndrome coronavirus 2, and vaccines, and the certainty of evidence was graded using the GRADE approach. Results: A total of 1,675 studies were identified, of which five were finally selected. Among the five studies, four consisted of data from clinical trials of each of the four types of COVID-19 vaccines (BNT162b2, mRNA-1273, CoronaVac, and BBIBP-CorV). The remaining study consisted of real-world data on the safety of the BNT162b2 vaccine in children aged 5-11 years. This systematic review identified that COVID-19 vaccines in recipients aged 5-11 years produced a favorable immune response, and were vaccines were effective against COVID-19. The safety findings for the BNT162b2 vaccine in children and early adolescents aged 5-11 years were similar to those data noted in the clinical trial. Conclusions: There is limited data on COVID-19 vaccines in children aged 5-11 years. Consequently continuous and comprehensive monitoring is necessary for the evaluation of the safety and effectiveness of the COVID-19 vaccines.

• Pediatric Infection and Vaccine
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• v.29 no.1
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• pp.37-45
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• 2022

Purpose: During the coronavirus disease 2019 (COVID-19) pandemic, we conducted a Delphi survey that included the experts from the field of COVID-19 immunization in children aged 5-11 years. The aim was to organize collective expert opinions on COVID-19 vaccination in young children in the Republic of Korea, and so thus assist the vaccination policy. Methods: The panels included pediatric infectious disease specialists, preventive medicine experts, infectious disease physicians, and COVID-19 vaccine experts consulting the Ministry of Health and Welfare. The Delphi survey was conducted online using a questionnaire from February 14 to February 27, 2022. Results: The Delphi panels agreed that children were vulnerable to COVID-19, and the severity of illness was modest. Furthermore the panels reported that children with chronic illness were more susceptible to a worsening clinical course. There were generally positive opinions on the effectiveness of COVID-19 vaccination in children aged 5-11 years, and experts gathered a slightly positive opinion that the adverse events of pediatric COVID-19 were not numerous. The benefits of COVID-19 vaccination were evaluated at a level similar to the potential risks in children. Currently, the only approved mRNA platform vaccine in children seemed to be sustainable; however, the recombinant protein platform COVID-19 vaccines were evaluated as better options. Conclusions: Due to the surge of the Omicron variant and an increase in pediatric cases, the COVID-19 vaccination in young children may have to be considered. Panels had neutral opinions regarding the COVID-19 vaccination in children aged 5-11 years. Thus monitoring of the epidemiology and the data about the safety of COVID-19 vaccination should be continued.

• Nutrition Research and Practice
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• v.16 no.1
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• pp.60-73
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• 2022

BACKGROUND/OBJECTIVES: The extract from Dendropanax morbifera exhibited diverse therapeutic potentials. We aimed to evaluate the efficacy and safety of D. morbifera leaf extract for improving metabolic parameters in human. SUBJECTS/METHODS: A 12-week, double blind, placebo-controlled and randomized trial included a total of 74 adults, and they were assigned to the placebo group (n = 38) or 700 mg/day of D. morbifera group (n = 36). The efficacy endpoints were changes in glycemic, lipid, obesity, and blood pressure (BP) parameters, in addition to the prevalence of metabolic syndrome (MetS) and the numbers of MetS components. Safety was assessed by monitoring adverse events (AEs). RESULTS: After 12 weeks of treatment, the hemoglobin A1c (HbA1c) level significantly decreased in the D. morbifera group compared to that of the placebo group (difference: -0.13 ± 0.20% vs. 0.00 ± 0.28%, P = 0.031; % of change: -2.27 ± 3.63% vs. 0.10 ± 5.10%, P = 0.025). The homeostatic model assessment for insulin resistance level also decreased significantly from its baseline in the D. morbifera group. The systolic BP of D. morbifera group decreased significantly than that of placebo group (difference: -3.9 ± 9.8 mmHg vs. 3.3 ± 11.7 mmHg, P = 0.005; % of change: -2.8 ± 7.7% vs. 3.3 ± 10.2%, P = 0.005). However, the lipid parameters and body composition including body weight did not differ between the groups. The prevalence of MetS (36.8% vs. 13.9%, P = 0.022) and the incidence of MetS (10.5% vs. 13.9%, P = 0.027) at 12 weeks was significantly lower in the D. morbifera group than it was in the placebo group. No serious AEs occurred in either group. CONCLUSIONS: Supplementation with D. morbifera extracts over a 12-week period improved metabolic parameters such as HbA1c and BP and reduced the prevalence of MetS.

• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.801-815
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• 2022

Objective : To evaluate the stent apposition of a low-profile visualized intraluminal support (LVIS) device in distal internal carotid artery (ICA) aneurysms, examine its correlation with clinical and angiographic outcomes, and determine the predictive factors of ischemic adverse events (IAEs) related to stent-assisted coiling. Methods : We retrospectively analyzed a prospectively maintained database of 183 patients between January 2017 and February 2020. The carotid siphon from the cavernous ICA to the ICA terminus was divided into posterior, anterior, and superior bends. The anterior bends were categorized into angled (V) and non-angled (C, U, and S) types depending on the morphology and measured angles. Complete stent apposition (CSA) and incomplete stent apposition (ISA) were evaluated using unsubtracted angiography and flat-panel detector computed tomography. Dual antiplatelet therapy with aspirin 200 mg and clopidogrel 75 mg was administered. Clopidogrel resistance was defined as fewer responders (≥10%, <40%) and non-responders (<10%) based on the percent inhibition (%INH) of the VerifyNow system. These were counteracted by a dose escalation to 150 mg for fewer responders or substitution with cilostazol 200 mg for non-responders. IAEs included intraoperative in-stent thrombosis, transient ischemic attack, cerebral infarction, and delayed in-stent stenosis. A multivariate logistic regression analysis was used to determine the predictive factors for ISA and IAEs. Results : There were 33 ISAs (18.0%) and 27 IAEs (14.8%). The anterior bend angle was narrower in ISA (-4.16°±25.18°) than in CSA (23.52°±23.13°) (p<0.001). The V- and S-types were independently correlated with the ISA (p<0.001). However, treatment outcomes, including IAEs (15.3% vs. 12.1%), aneurysmal complete occlusion (91.3% vs. 88.6%), and recanalization (none of them), did not differ between CSA and ISA (p>0.05). The %INH of 27 IAEs (13.78%±14.78%) was significantly lower than that of 156 non-IAEs (26.82%±20.23%) (p<0.001). Non-responders to clopidogrel were the only significant predictive factor for IAEs (p=0.001). Conclusion : The angled and tortuous anatomical peculiarity of the carotid siphon caused ISA of the LVIS device; however, it did not affect clinical and angiographic outcomes, while the non-responders to clopidogrel affected the IAEs related to stent-assisted coiling.