1.Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial
Do Seon SONG ; Won KIM ; Sang Hoon AHN ; Hyung Joon YIM ; Jae Young JANG ; Young Oh KWEON ; Yong Kyun CHO ; Yoon Jun KIM ; Gun Young HONG ; Dong Joon KIM ; Young Kul JUNG ; Joo Hyun SOHN ; Jin-Woo LEE ; Sung Jae PARK ; Byung Seok LEE ; Ju Hyun KIM ; Hong Soo KIM ; Seung Kew YOON ; Moon Young KIM ; Kwan Sik LEE ; Young Suk LIM ; Wan Sik LEE ; Jin Mo YANG ; Kyun-Hwan KIM ; Kwang-Hyub HAN ; Soon Ho UM
Clinical and Molecular Hepatology 2021;27(2):346-359
Background/Aims:
Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.
Methods:
Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).
Results:
Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.
Conclusions
BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).
2.Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial
Do Seon SONG ; Won KIM ; Sang Hoon AHN ; Hyung Joon YIM ; Jae Young JANG ; Young Oh KWEON ; Yong Kyun CHO ; Yoon Jun KIM ; Gun Young HONG ; Dong Joon KIM ; Young Kul JUNG ; Joo Hyun SOHN ; Jin-Woo LEE ; Sung Jae PARK ; Byung Seok LEE ; Ju Hyun KIM ; Hong Soo KIM ; Seung Kew YOON ; Moon Young KIM ; Kwan Sik LEE ; Young Suk LIM ; Wan Sik LEE ; Jin Mo YANG ; Kyun-Hwan KIM ; Kwang-Hyub HAN ; Soon Ho UM
Clinical and Molecular Hepatology 2021;27(2):346-359
Background/Aims:
Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.
Methods:
Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).
Results:
Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.
Conclusions
BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).
3.Incidentally Detected Asymptomatic Perianal Abscess in an Adolescent during Crohn's Disease Diagnosis: Is Routine Pelvic Imaging Required in Korean Pediatric Patients at Diagnosis?
Soo Hyun UM ; Sang Woo LEE ; Ki Hwan SONG ; So Mi LEE ; Byung-Ho CHOE ; Yoo Min LEE ; Ben KANG
Pediatric Gastroenterology, Hepatology & Nutrition 2021;24(6):564-570
Perianal fistulizing diseases, namely perianal fistulas and/or abscesses, are well-known complications of Crohn's disease (CD). These are known to develop more frequently in Asian children with CD, especially in the early stages of the disease course. Approximately half of the pediatric CD cases in Korea present with perianal fistulizing diseases at diagnosis. We report a rare case of a 12-year-old boy with CD with an incidental discovery of a perianal abscess on pelvic magnetic resonance imaging during CD diagnosis. No symptoms or signs of perianal fistulizing disease were identified. The early diagnosis of the perianal abscess enabled timely and effective treatment. Considering the high incidence of concomitant perianal CD in Korean children at diagnosis, perianal imaging may be useful and should be considered during diagnostic evaluation, even in patients with no subjective or objective findings indicating perianal CD.
4.Korean Clinical Practice Guideline for the Diagnosis and Treatment of Insomnia in Adults
Hayun CHOI ; Soyoung YOUN ; Yoo Hyun UM ; Tae Won KIM ; Gawon JU ; Hyuk Joo LEE ; Chungsuk LEE ; Sang Don LEE ; Kyungyeol BAE ; Seong Jae KIM ; Ji Hyun LEE ; Tae KIM ; Seockhoon CHUNG
Psychiatry Investigation 2020;17(11):1048-1059
Objective:
We aim to present a clinical guideline for the diagnosis and treatment of insomnia in adults by reviewing and integrating existing clinical guidelines. The purpose of this guideline is to assist clinicians who perform evidence-based insomnia treatment.
Methods:
We selected literature that may be appropriate for use in guideline development from evidence-based practice guidelines that have been issued by an academic or governmental institution within the last five years. The core question of this guideline was made in sentence form including Patient/Problem, Intervention, Comparison, Outcome (PICO) elements. After searching PubMed, EMBASE, and medical guideline issuing agencies, three guidelines were judged to be the most appropriately reviewed, up-to-date, and from trusted sources.
Results:
The Appraisal of Guidelines for Research and Evaluation (AGREE) II tool was used to evaluate the quality of the three clinical guidelines. The final outcome of the guideline development process is a total of 15 recommendations that report the strength of the recommendation, the quality of evidence, a summary of content, and considerations in applying the recommendation.
Conclusion
It is vital for clinical guidelines for insomnia to be developed and continually updated in order to provide more accurate evidence-based treatments to patients.
5.Protection of Surgical Team from COVID-19 during Bipolar Hemiarthroplasty in an Infected Elderly Patient
Sang Hyun UM ; Du-Han KIM ; Moon-Yul YOUN ; Chul-Hyun CHO ; Hyun-Ah KIM ; Byung-Woo MIN ; Ki-Cheor BAE ; Kyung-Jae LEE
Clinics in Orthopedic Surgery 2020;12(3):286-290
The novel coronavirus disease 2019 (COVID-19), which began in Wuhan, China, has rapidly flared up all over the world, evolving into a pandemic. During these critical times, we should give emphasis on infection prevention for the health care staff as well as appropriate patient management in order to maintain the health care system. We report our experience in protecting a surgical team from COVID-19 infection during a bipolar hemiarthroplasty in an infected patient. This case highlights the importance of appropriate protection of the health care staff and education in minimizing the risk of transmission of the infection and maintaining the health care system.
6.Evaluation of Treatment Response after Endoscopic Variceal Obturation with Abdominal Computed Tomography
Han Ah LEE ; Hyun Gil GOH ; Tae Hyung KIM ; Young-Sun LEE ; Sang Jun SUH ; Young Kul JUNG ; Hyuk Soon CHOI ; Eun Sun KIM ; Ji Hoon KIM ; Hyunggin AN ; Yeon Seok SEO ; Hyung Joon YIM ; Sung Bum CHO ; Yoon Tae JEEN ; Jong Eun YEON ; Hoon Jai CHUN ; Kwan Soo BYUN ; Soon Ho UM ; Chang Duck KIM
Gut and Liver 2020;14(1):117-124
Background:
s/Aims: Rebleeding of gastric varices (GVs) after endoscopic variceal obturation (EVO) can be fatal. This study was performed to evaluate the usefulness of computed tomography (CT) for the prediction of rebleeding after EVO GV bleeding.
Methods:
Patients who were treated with EVO for GV bleeding and underwent CT before and after EVO were included. CT images of the portal phase showing pretreatment GVs and feeding vessels, and nonenhanced images showing posttreatment cyanoacrylate impaction were reviewed.
Results:
Fifty-three patients were included. Their mean age was 60.6±11.6 years, and 40 patients (75.5%) were men. Alcoholic liver disease was the most frequent underlying liver disease (45.3%). Complete impaction of cyanoacrylate in GVs and feeding vessels were achieved in 40 (75.5%) and 24 (45.3%) of patients, respectively. During the follow-up, GV rebleeding occurred in nine patients, and the cumulative incidences of GV rebleeding at 3, 6, and 12 months were 11.8%, 18.9%, and 18.9%, respectively. The GV rebleeding rate did not differ significantly according to the complete cyanoacrylate impaction in the GV, while it differed significantly according to complete cyanoacrylate impaction in the feeding vessels. The cumulative incidences of GV rebleeding at 3, 6, and 12 months were 22.3%, 35.2%, and 35.2%, respectively, in patients with incomplete impaction in feeding vessels, and there was no rebleeding during the follow-up period in patients with complete impaction in the feeding vessels (p=0.002).
Conclusions
Abdominal CT is useful in the evaluation of the treatment response after EVO for GV bleeding. Incomplete cyanoacrylate impaction in feeding vessels is a risk factor for GV rebleeding.
7.Postoperative Rehabilitation after Hip Fracture:A Literature Review
Kyung-Jae LEE ; Sang-Hyun UM ; Young-Hun KIM
Hip & Pelvis 2020;32(3):125-131
As the proportion of elderly individuals within the population grows, the incidence of hip fractures increases.Traditionally, orthopedic surgeons used to focus on surgical treatment of hip fractures; however, the field’s appreciation for the importance of postoperative rehabilitation has been increasing recently. Many studies have shown that proper rehabilitation after hip fracture surgery can shorten hospital stays and improve clinical outcomes.However, such studies use different methods and published rehabilitation protocols address varying aspects that do not always overlap. Here, we review and summarize the latest guidelines and studies on postoperative rehabilitation of elderly patients with hip fractures.
8.Associations of COL2A1 Gene Polymorphisms and Ankylosing Spondylitis in the Korean Population
Eun-Seok SON ; Sang-Hyun UM ; Moon-Yul YOUN
Journal of Korean Society of Spine Surgery 2020;27(1):1-8
Objectives:
The aim of this study was to investigate whether single nucleotide polymorphisms (SNPs) of COL2A1 affect the development of ankylosing spondylitis (AS).Summary of Literature Review: Many factors have been reported to be involved in the etiology of AS. Human leukocyte antigen (HLA)-B27 has been established as a genetic factor involved in the development of AS; however, it has been reported in recent studies that various genetic polymorphisms may be related to the development of AS. The collagen, type II, alpha 1 gene (COL2A1 ) plays a role in cartilage formation and maintaining the vitreous humor in the eye. Several previous studies have investigated the associations of COL2A1 with spinal degenerative diseases, but no case-control comparative study has yet investigated the effect of COL2A1 variants on the development of AS.
Materials and Methods:
The study was planned with 96 AS patients in the study group and 330 healthy individuals in the control group. We searched the gene region of the COL2A1 gene in the NCBI SNP database (http://www.ncbi.nlm.nih.gov/snp), and 3 SNPs (rs3803183, rs2070739 and rs1793949) were found using sequencing to be significantly different between the AS and control groups. Multiple logistic regression models for genetic analysis were applied
Results:
Three SNPs (rs3803183, rs2070739 and rs1793949) of COL2A1 showed significant associations with AS patients compared to control subjects (p<0.05).
Conclusions
SNPs of COL2A1 may be associated with the development of AS in the Korean population.
9.The Development of Evidence-Based Guideline for Diagnosis and Management of Headache in Korea
Sun Mi KIM ; Young Hoon KO ; Seoyoung YOON ; Won Sub KANG ; Hye Geum KIM ; Hye Youn PARK ; Cheolmin SHIN ; Yoo Hyun UM ; Soyoung YOUN ; Jae Hon LEE ; Seung Ho JANG ; Sang Won JEON ; Hong Jun JEON ; Seockhoon CHUNG ; Jae Won CHOI ; Kyu Man HAN ; Sang Yeol LEE
Psychiatry Investigation 2019;16(3):199-205
OBJECTIVE: We aimed to develop the clinical guideline for headache by the systematic review and synthesis of existing evidence-based guidelines. The purpose of developing the guideline was to improve the appropriateness of diagnosis and treatment of headache disorder, and consequently, to improve patients’ pain control and quality of life. The guideline broadly covers the differential diagnosis and treatment of tension-type headache, migraine, cluster headache, and medication-overuse headache. METHODS: This is a methodological study based on the ADAPTE methodology, including a systematic review of the literature, quality assessment of the guidelines using the Appraisal of Clinical Guidelines for REsearch & Evaluation II (AGREE II) Instrument, as well as an external review using a Delphi technique. The inclusion criteria for systematic search were as follows: topic-relevant, up-to-date guidelines including evidence from within 5 years, evidence-based guidelines, guidelines written in English or Korean, and guidelines issued by academic institutions or government agencies. RESULTS: We selected five guidelines and conducted their quality assessment using the AGREE II Instrument. As a result, one guideline was found to be eligible for adaptation. For 13 key questions, a total of 39 recommendations were proposed with the grading system and revised using the nominal group technique. CONCLUSION: Recommendations should be applied to actual clinical sites to achieve the ultimate goal of this guideline; therefore, follow-up activities, such as monitoring of guideline usage and assessment of applicability of the recommendations, should be performed in the future. Further assessment of the effectiveness of the guideline in Korea is needed.
Cluster Headache
;
Delphi Technique
;
Diagnosis
;
Diagnosis, Differential
;
Follow-Up Studies
;
Government Agencies
;
Headache Disorders
;
Headache
;
Korea
;
Methods
;
Migraine Disorders
;
Quality of Life
;
Tension-Type Headache
10.Total Ankylosis by Heterotopic Ossification in an Adolescent Anterior Trans-olecranon Fracture Dislocation: A Case Report
Beom Soo KIM ; Kwang Soon SONG ; Ki Cheor BAE ; Si Wook LEE ; Sang Hyun UM ; Chul Hyun CHO
Journal of the Korean Shoulder and Elbow Society 2019;22(3):154-158
The incidence of heterotopic ossification in adolescents appears to be lower than in adults. There exist very few reports of heterotopic ossification with total bony ankylosis in child or adolescent populations. We describe a case of total bony ankylosis of the elbow secondary to heterotopic ossification, in a 14-year-old female. Total ankylosis of the elbow at 45 degrees of flexion was noted 6 months post-surgery, and complete surgical excision of the heterotopic mass was performed. After an additional one-time dose of radiation therapy and nonsteroidal anti-inflammatory drug medication, full range of motion was obtained without any recurrence or other complications, up to the last follow-up of 30 months.
Adolescent
;
Adult
;
Ankylosis
;
Child
;
Dislocations
;
Elbow
;
Female
;
Follow-Up Studies
;
Fractures, Bone
;
Humans
;
Incidence
;
Ossification, Heterotopic
;
Range of Motion, Articular
;
Recurrence

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