1.Pharmacokinetic Characteristics of Ibandronate and Tolerability of DP-R206 (150 mg Ibandronate/24,000 IU Vitamin D3) Compared to the Ibandronate (150 mg) Monotherapy in Healthy Adults.
Hee Youn CHOI ; Mi Jo KIM ; Yo Han KIM ; Yook Hwan NOH ; Jae Won LEE ; Tae Won LEE ; Min Gul KIM ; Kyun Seop BAE
Translational and Clinical Pharmacology 2014;22(1):22-29
Ibandronate (a bisphosphonate) is commonly used as an treatment of osteoporosis in combination with vitamin D. Monthly DP-R206-a novel, fixed-dose combination tablet (150 mg ibandronate/24,000 IU vitamin D3)-was recently developed to enhance patient compliance. This open, randomized, two-period crossover study was conducted to compare the pharmacokinetics of ibandronate when administered as DP-R206 or 150 mg ibandronate to healthy adult volunteers. Each volunteer was randomly allocated to receive single-dose DP-R206 or ibandronate with a 28-day washout period between treatments. Blood samples were assessed using pharmacokinetic analysis. Plasma ibandronate concentrations were determined using liquid chromatography-tandem mass spectrometry. Safety and tolerability assessments were performed throughout the study. In total, 103 participants received the study drugs and 72 participants completed the study. The geometric mean ratios (DP-R206/ibandronate) of the maximum concentration (C(max)) and the area under the plasma concentration time curve from time zero to the last concentration (AUC(last)) values were 0.959 (90% CI: 0.820-1.120) and 0.924 (90% CI: 0.805-1.060), respectively. The frequencies of adverse events (AEs) and drug reactions were similar between treatment groups, and all AEs were recovered without sequalae. Ibandronate pharmacokinetics, tolerability, and safety are comparable when administered to healthy individuals, regardless if administered as DP-R206 or ibandronate.
Adult*
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Cross-Over Studies
;
Humans
;
Mass Spectrometry
;
Osteoporosis
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Patient Compliance
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Pharmacokinetics
;
Plasma
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Vitamin D
;
Vitamins*
;
Volunteers
2.Echinococcal Cyst: A Case Report.
Hee Chan LEE ; Byoung Jo KWON ; Young Yo PARK ; Sung Won KWON ; Woon Sup HAN
Korean Journal of Urology 1988;29(3):511-514
Echinococcal cyst is a rare disease in Korea. A 33 year old man who had lower abdominal discomfort for 4 months, and multiple cysts in intraperitoneal and retroperitoneal cavity on abdominal CT. scan. On abdominal exploration, the multiple were diagnosed for Echinococcal cyst. Thin case is the first documented case of multiple Echinococcal cysts among Koreans reported in the literature.
Adult
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Humans
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Korea
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Rare Diseases
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Tomography, X-Ray Computed
3.Prolotherapy with Very Fine Needle and Low Concentration of Glucose in a Patient with Chronic Lateral Elbow Pain
Jun Seog LEE ; Yo Han SEO ; Won Yeong JO ; Taeha RYU ; So Young LEE ; Jin Yong JUNG
Keimyung Medical Journal 2022;41(2):114-117
Prolotherapy is a non-surgical injection treatment method that repeatedly injects small amounts of proliferators into damaged ligaments, tendon, joints and surrounding tissues. The most common proliferator is a high concentration of glucose solution. Glucose solutions with a concentration of 10-25% are commonly used. Prolotherapy using glucose solution has few serious adverse events, but common side effects include post injection pain, stiffness, edema, and mild bleeding. There are many cases of complaining of pain caused by injection during or after prolotherapy. Some patients give up treatment if the pain is severe. A 43-year-old male patient visited the hospital with both elbow pain and left wrist pain, and prolotherapy was performed. In order to minimize pain during procedure and post injection pain of the patient, 10% glucose solution with 0.5% lidocaine was injected using a very fine needle of 30 G. The total number of treatments was eight. The patient did not complain of pain caused by needle insertion during procedure and post-injection pain. Chronic pain that lasted for two years after treatment almost disappeared. The patient was very satisfied with this treatment method and result.
4.Association Between Low Anti-spike Antibody Levels After the Third Dose of SARS-CoV-2 Vaccination and Hospitalization due to Symptomatic Breakthrough Infection in Kidney Transplant Recipients
Ahram HAN ; Sangil MIN ; Eun-Ah JO ; Hajeong LEE ; Yong Chul KIM ; Seung Seok HAN ; Hee Gyung KANG ; Yo Han AHN ; Inseong OH ; Eun Young SONG ; Jongwon HA
Annals of Laboratory Medicine 2024;44(1):64-73
Background:
Whether anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody levels post-third coronavirus disease (COVID-19) vaccination correlate with worse outcomes due to breakthrough infection is unclear. We evaluated the association between anti-SARS-CoV-2 antibody levels and symptomatic breakthrough infection or hospitalization during the Omicron surge in kidney transplant recipients.
Methods:
In total, 287 kidney transplant recipients expected to receive a third vaccination were enrolled between November 2021 and February 2022. The Abbott SARS-CoV-2 IgG II Quant test (Abbott, Chicago, IL, USA) was performed within three weeks before and four weeks after the third vaccination. The incidence of symptomatic breakthrough infection and hospitalization from two weeks to four months post-third vaccination was recorded.
Results:
After the third vaccination, the seropositive rate and median antibody titer of the 287 patients increased from 57.1% to 82.2% and from 71.7 (interquartile range [IQR] 7.2– 402.8) to 1,612.1 (IQR 153.9–5,489.1) AU/mL, respectively. Sixty-four (22.3%) patients had symptomatic breakthrough infections, of whom 12 required hospitalization. Lower anti-receptor-binding domain (RBD) IgG levels ( < 400 AU/mL) post-third vaccination were a risk factor for symptomatic breakthrough infection (hazard ratio [HR] = 3.46, P < 0.001).Anti-RBD IgG levels < 200 AU/mL were a critical risk factor for hospitalization (HR = 36.4, P = 0.007).
Conclusions
Low anti-spike IgG levels after third vaccination in kidney transplant recipients were associated with symptomatic breakthrough infection and, particularly, with hospitalization during the Omicron surge. These data can be used to identify patients requiring additional protective measures, such as passive immunization using monoclonal antibodies.
5.Analysis of Role of Peripheral Vestibular Receptors on Orthostatic Tolerance using Heart Rate Variability in Rats.
Seong Wook PARK ; Han Saem LEE ; Seung Hoi LEE ; Hak Seung LEE ; Bong Kee CHOI ; Yo Sik KIM ; Kwang Ho JO ; Min Sun KIM ; Byung Rim PARK
Journal of the Korean Neurological Association 2002;20(6):652-659
BACKGROUND: There is substantial evidence that the vestibular system is involved in the regulation of blood pressure. Heart rate variability (HRV) is useful to investigate the role of the peripheral vestibular receptors and the baroreceptors in the orthostatic tolerance. METHODS: EKG was recorded during postural changes with the head up either after sinoaortic denervation or after bilateral labyrinthectomies in Sprague-Dawley rats. HRV, including mean, standard deviation, coefficient of variation (CV), and power spectrum, were analyzed from R-R intervals of EKG. RESULTS: Phenylephrine increased low frequency region and sodium nitroprusside increased high frequency region in the power spectral analysis of HRV in anesthetized rats. Postural changes decreased blood pressure transiently and then increased blood pressure gradually in control rats, but the depression of blood pressure induced by postural change was greater in rats with both sinoaortic denervation and bilateral labyrinthectomies. The increase of CV of HRV just after sinoaortic denervation or bilateral labyrinthectomies represents an unstable heart rate in resting position, however, CV of HRV was increased markedly by postural change 7 days after bilateral labyrinthectomies. Postural change with sinoaortic denervation increased low-frequency region representing sympathetic activity, whereas bilateral labyrinthectomies increased highfrequency region representing parasympathetic activity in power spectral analysis. CONCLUSIONS: These results suggest that both the peripheral vestibular receptors and the baroreceptors have subsidiary action in orthostatic tolerance and the peripheral vestibular receptors regulate blood pressure during postural change through the sympathetic nervous system.
Animals
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Blood Pressure
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Denervation
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Depression
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Electrocardiography
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Head
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Heart Rate*
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Heart*
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Nitroprusside
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Phenylephrine
;
Pressoreceptors
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Rats*
;
Rats, Sprague-Dawley
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Sympathetic Nervous System
6.Clinical Significance of Lymph Node Ratio in Stage III Colorectal Cancer.
Yo Han PARK ; Jae Im LEE ; Jong Kyung PARK ; Hang Ju JO ; Won Kyung KANG ; Chang Hyeok AN
Journal of the Korean Society of Coloproctology 2011;27(5):260-265
PURPOSE: Recent literature has shown that lymph node ratio is superior to the absolute number of metastatic lymph nodes in predicting the prognosis in several malignances other than colorectal cancer. The aim of this study was to evaluate the prognostic significance of the lymph node ratio (LNR) in patients with stage III colorectal cancer. METHODS: We included 186 stage III colorectal cancer patients who underwent a curative resection over a 10-year period in one hospital. The cutoff point of LNR was chosen as 0.07 because there was significant survival difference at that LNR. The Kaplan-Meier and the Cox proportional hazard models were used to evaluate the prognostic effect according to LNR. RESULTS: There was statistically significant longer overall survival in the group of LNR > 0.07 than in the group of LNR < or = 7 (P = 0.008). Especially, there was a survival difference for the N1 patients group (LN < 4) according to LNR (5-year survival of N1 patients was lower in the group of LNR > 0.07, P = 0.025), but there was no survival difference for the N2 group (4 > or = LN) according to LNR. The multivariate analysis showed that the LNR is an independent prognostic factor. CONCLUSIONS: LNR can be considered as a more accurate and potent modality for prognostic stratifications in patients with stage III colorectal cancer.
Colorectal Neoplasms
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Humans
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Lymph Nodes
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Multivariate Analysis
;
Prognosis
;
Proportional Hazards Models
7.Bioequivalence of HCP1104, a New Fixed Dose Combination Drug and Co-administration of Eperisone 50 mg and Aceclofenac 100 mg: A Partial Replicated Crossover Study Design to Estimate the Pharmacokinetics of Highly Variable Drugs.
Mi Jo KIM ; Yo Han KIM ; Hee Youn CHOI ; Hae Sun JEON ; Yook Hwan NOH ; Hyeong Seok LIM ; Kyun Seop BAE
Journal of Korean Society for Clinical Pharmacology and Therapeutics 2013;21(2):120-129
BACKGROUND: This clinical study was conducted to compare pharmacokinetics of eperisone and aceclofenac of HCP1104, a new fixed dose combination drug with those in co-administration of eperisone 50 mg and aceclofenac 100 mg. The study used a partial replicated study design to characterize intra-subject variability of eperisone when co-administrated with aceclofenac. METHODS: A partial replicated crossover design was employed in 30 subjects. Each subject received a single dose of co-administration of eperisone 50 mg and aceclofenac 100 mg on two occasions and a single dose of 1 capsule of HCP1104. Blood samples were obtained for 24 hrs after dosing, and plasma was assayed for eperisone and aceclofenac by Liquid chromatography-electrospray ionization-mass spectrometry. RESULTS: Using an average bioequivalence criterion, the 90 % confidence limits for Ln-transformed Cmax and AUClast for aceclofenac fell wihin the acceptable range of 80 - 125 %. Point estimates of eperisone AUClast and Cmax were 1.0152 and 1.0490, respectively and the 90 % confidence interval for Cmax was 0.8499 - 1.3025. The within-subject coefficient of variation of Cmax for the reference was 50.198 %. Acceptance range for eperisone Cmax based on new bioequivalence guidance for highly variable drugs was extended to 0.6984 - 1.4319. CONCLUSION: The extent of exposure and rate of absorption of both eperisone and aceclofenac with a single dose of HCP1104 capsule were equivalent to those with co-administration of a marketed eperisone 50 mg tablet and a marketed aceclofenac 100 mg tablet under fasting conditions in healthy adult males.
Absorption
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Adult
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Cross-Over Studies*
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Fasting
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Humans
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Male
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Pharmacokinetics*
;
Plasma
;
Spectrum Analysis
;
Therapeutic Equivalency*
8.PMK-S005 Alleviates Age-Related Gastric Acid Secretion, Inflammation, and Oxidative Status in the Rat Stomach.
Yoon Jeong CHOI ; Nayoung KIM ; Ju Yup LEE ; Ryoung Hee NAM ; Ji Hyung SUH ; Sun Min LEE ; Min Hee HAM ; Hyun Jin JO ; Young Kwang SHIM ; Yo Han PARK ; Jong Chan LEE ; Yoon Jin CHOI ; Hye Seung LEE ; Dong Ho LEE
Gut and Liver 2016;10(5):749-756
BACKGROUND/AIMS: The aim of this study was to evaluate the effect of the synthetic S-allyl-l-cysteine (SAC) PMK-S005 on gastric acid secretion, inflammation, and antioxidant enzymes in aging rats. METHODS: The rats were divided into four groups at 31 weeks of age and were continuously fed a diet containing a vehicle control, PMK-S005 (5 or 10 mg/kg), or lansoprazole (5 mg/kg). Gastric acid secretion and connective tissue thickness of the lamina propria were evaluated at 74 weeks and 2 years of age. Tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and COX-2 levels were measured by using enzyme-linked immunosorbent assays (ELISAs) or Western blot assays. Levels of antioxidant enzymes, including heme oxyganase 1 (HO-1) and NAD(P)H:quinone oxidoreductase 1 (NQO-1), were also measured. RESULTS: As the rats aged, gastric acid secretion significantly decreased, and the connective tissue of the lamina propria increased. However, 74-week-old rats in the PMK-S005 group exhibited greater levels of gastric acid secretion than those of the control and lansoprazole groups. The increase of TNF-α, IL-1β, and COX-2 expression in 74-week and 2-year-old control rats were inhibited by PMK-S005. In addition, the decrease in HO-1 and NQO-1 protein expression that occurred with aging was inhibited by PMK-S005 in the 74-week-old rats. CONCLUSIONS: These results suggest that PMK-S005 has therapeutic potential as an antiaging agent to ameliorate age-related gastric acid secretion, inflammation, and oxidative stress in the stomach.
Aging
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Animals
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Antioxidants
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Blotting, Western
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Child, Preschool
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Connective Tissue
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Diet
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Enzyme-Linked Immunosorbent Assay
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Gastric Acid*
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Heme
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Humans
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Inflammation*
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Interleukins
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Lansoprazole
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Mucous Membrane
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Oxidative Stress
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Rats*
;
Stomach*
;
Tumor Necrosis Factor-alpha
9.An Analysis of Treatment Results of Lymphoblastic Lymphoma in Adults According to the Chemotherapy Regimens.
Dong wan KIM ; Jong Mu SUN ; Jung Hye KWON ; Do Youn OH ; Jae Jin LEE ; Yo Han JO ; Tae You KIM ; Sung Soo YOON ; Dae Seog HEO ; Yung Jue BANG ; Seonyang PARK ; Byoung Kook KIM ; Neo Kyeong KIM
Korean Journal of Hematology 2003;38(1):32-39
BACKGROUND: This study was done to analyze the treatment outcomes of adult lymphoblastic lymphoma patients according to the risk groups and the treatment regimens. METHODS: The analysis was performed on twenty patients histologically diagnosed as lymphoblastic lymphoma at Seoul National University Hospital. The high-risk group was defined as patients with Ann Arbor stage IV with bone marrow, central nervous system (CNS) involvement or initial serum lactate dehydrogenase level more than 1.5 times upper normal limits. Twelve patients received dose-intensive Stanford/Northern California Oncology Group (NCOG) regimen consisted of four phase of induction, CNS prophylaxis, consolidation, and maintenance. Eight patients received conventional dose regimen, either six courses of vincristine, bleomycin, cyclophosphamide, doxorubicin, prednisolone, procarbazine (COPBLAM-V) or cyclophosphamide, vincristine, doxorubicin, prednisolone, L-asparaginase (CHOP/L-ASP) with CNS prophylaxis. We analyzed the response rate and the survival rate according to the risk groups and treatment regimens. RESULTS: The overall response rate was 90% (75% complete response). In low-risk group, the complete response (CR) rate was 100% irrespective of treatment regimen. In high-risk group, conventional dose regimen did not produce CR. Four of the six high-risk patients receiving dose-intensive regimen achieved CR. The 5-year overall survival (OS) rate was 52% in total patients. The 5-year OS rate were 77% and 30% for low- and high-risk group, respectively (P=0.242). In low-risk group, conventional dose regimen showed similar survival outcomes compared with that of dose intensive regimen. Toxicity profile was more favorable in the patients with conventional dose regimens. CONCLUSION: For low-risk patients, conventional dose regimen showed similar effect in comparison with dose-intensive regimen. However, for high-risk patients, CR was observed only with dose-intensive regimen. Multi-center clinical trials are necessary to confirm our observation.
Adult
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Male
;
Female
;
Humans