1.A Multi-Center, Double-Blind Randomized Controlled Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802 (Tenofovir Disoproxil Orotate) and Viread (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients
Hyung Joon KIM ; Ju Hyun KIM ; Jong Eun YEON ; Yeon Seok SEO ; Jeong Won JANG ; Yong Kyun CHO ; Byoung Kuk JANG ; Byung Hoon HAN ; Changhyeong LEE ; Joon Hyeok LEE ; Jung-Hwan YOON ; Kang Mo KIM ; Moon Young KIM ; Do Young KIM ; Neung Hwa PARK ; Eun Young CHO ; June Sung LEE ; Jin-Woo LEE ; In Hee KIM ; Byung-Cheol SONG ; Byung-Seok LEE ; Oh Sang KWON
Journal of Korean Medical Science 2022;37(11):e92-
Background:
Tenofovir disoproxil fumarate (TDF, Viread® ) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF.
Methods:
The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated.
Results:
A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was −5.13 ± 1.40 in the DA-2802 group and −4.97 ± 1.40 log 10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity.
Conclusion
DA-2802 is considered an effective and safe treatment for patients with CHB.
2.Erratum to “2020 Korean Guidelines for Cardiopulmonary Resuscitation. Part 4. Adult advanced life support”
Jaehoon OH ; Kyoung-Chul CHA ; Jong-Hwan LEE ; Seungmin PARK ; Dong-Hyeok KIM ; Byung Kook LEE ; Jung Soo PARK ; Sung Phil CHUNG ; Young-Min KIM ; June Dong PARK ; Han-Suk KIM ; Mi Jin LEE ; Sang-Hoon NA ; Gyu Chong CHO ; Ai-Rhan Ellen KIM ; Sung Oh HWANG ;
Clinical and Experimental Emergency Medicine 2022;9(2):162-163
3.Guidelines for Cancer Care during the COVID-19 Pandemic in South Korea
Jii Bum LEE ; Minkyu JUNG ; June Hyuk KIM ; Bo Hyun KIM ; Yeol KIM ; Young Seok KIM ; Byung Chang KIM ; Jin KIM ; Sung Ho MOON ; Keon-Uk PARK ; Meerim PARK ; Hyeon Jin PARK ; Sung Hoon SIM ; Hong Man YOON ; Soo Jung LEE ; Eunyoung LEE ; June Young CHUN ; Youn Kyung CHUNG ; So-Youn JUNG ; Jinsoo CHUNG ; Eun Sook LEE ; Hyun Cheol CHUNG ; Tak YUN ; Sun Young RHA
Cancer Research and Treatment 2021;53(2):323-329
At the end of 2019, the cause of pneumonia outbreaks in Wuhan, China, was identified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In February 2020, the World Health Organization named the disease cause by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). In response to the pandemic, the Korean Cancer Association formed the COVID-19 task force to develop practice guidelines. This special article introduces the clinical practice guidelines for cancer patients which will help oncologists best manage cancer patients during the COVID-19 pandemic.
4.2020 Korean Guidelines for Cardiopulmonary Resuscitation. Part 4. Adult advanced life support
Jaehoon OH ; Kyoung-Chul CHA ; Jong-Hwan LEE ; Seungmin PARK ; Dong-Hyeok KIM ; Byung Kook LEE ; Jung Soo PARK ; Woo Jin JUNG ; Dong Keon LEE ; Young Il ROH ; Tae Youn KIM ; Sung Phil CHUNG ; Young-Min KIM ; June Dong PARK ; Han-Suk KIM ; Mi Jin LEE ; Sang-Hoon NA ; Gyu Chong CHO ; Ai-Rhan Ellen KIM ; Sung Oh HWANG ;
Clinical and Experimental Emergency Medicine 2021;8(S):S26-S40
5.Guidelines for Cancer Care during the COVID-19 Pandemic in South Korea
Jii Bum LEE ; Minkyu JUNG ; June Hyuk KIM ; Bo Hyun KIM ; Yeol KIM ; Young Seok KIM ; Byung Chang KIM ; Jin KIM ; Sung Ho MOON ; Keon-Uk PARK ; Meerim PARK ; Hyeon Jin PARK ; Sung Hoon SIM ; Hong Man YOON ; Soo Jung LEE ; Eunyoung LEE ; June Young CHUN ; Youn Kyung CHUNG ; So-Youn JUNG ; Jinsoo CHUNG ; Eun Sook LEE ; Hyun Cheol CHUNG ; Tak YUN ; Sun Young RHA
Cancer Research and Treatment 2021;53(2):323-329
At the end of 2019, the cause of pneumonia outbreaks in Wuhan, China, was identified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In February 2020, the World Health Organization named the disease cause by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). In response to the pandemic, the Korean Cancer Association formed the COVID-19 task force to develop practice guidelines. This special article introduces the clinical practice guidelines for cancer patients which will help oncologists best manage cancer patients during the COVID-19 pandemic.
6.2020 Korean Guidelines for Cardiopulmonary Resuscitation. Part 4. Adult advanced life support
Jaehoon OH ; Kyoung-Chul CHA ; Jong-Hwan LEE ; Seungmin PARK ; Dong-Hyeok KIM ; Byung Kook LEE ; Jung Soo PARK ; Woo Jin JUNG ; Dong Keon LEE ; Young Il ROH ; Tae Youn KIM ; Sung Phil CHUNG ; Young-Min KIM ; June Dong PARK ; Han-Suk KIM ; Mi Jin LEE ; Sang-Hoon NA ; Gyu Chong CHO ; Ai-Rhan Ellen KIM ; Sung Oh HWANG ;
Clinical and Experimental Emergency Medicine 2021;8(S):S26-S40
8.Current Status of Pediatric Critical Care in Korea: Results of 2015 National Survey.
Jong seo YOON ; Won Kyoung JHANG ; Yu Hyeon CHOI ; Bongjin LEE ; Yoon Hee KIM ; Hwa Jin CHO ; Byung Wook EUN ; Jintae KIM ; Kyung Won KIM ; Joongbum CHO ; Hong Ju SHIN ; Jeong Min RYU ; Jae Hee CHUNG ; Young YOO ; June HUH ; Seong Jong PARK ; June Dong PARK
Journal of Korean Medical Science 2018;33(49):e308-
BACKGROUND: The aim of this study was to describe the structure, organization, management, and staffing of pediatric critical care (PCC) in Korea. METHODS: We directed a questionnaire survey for all Upper Grade General Hospitals (n = 43) in Korea in 2015. The first questionnaire was mainly about structure, organization, and staffing and responses were obtained from 32 hospitals. The second questionnaire was mainly about patients and management. Responses to second questionnaire were obtained from 18 hospitals. RESULTS: Twelve from 32 Upper Grade General Hospitals had pediatric intensive care units (PICUs) and 11 of them had the PICU which was exclusive for children. Total number of PICU beds in Korea was 113. The ratio of the number of PICU beds to the number of children was 1:77,460 in Korea and this ratio is lower than that of other developed countries. The mean number of beds in the PICUs was 9.4 ± 9.3 (range, 2–30). There were 16 medical doctors who were assigned for PCC and only 5 of them were full time pediatric intensivists. In the 18 Upper Grade General Hospitals that responded to the second questionnaire survey, there were 97 patients in the PICUs with an average number of 5.7 ± 7.2 (range, 0–22) on the survey day. The mean age of the patients was 3.4 ± 5.6 years. The mean length of hospital stay was 82 ± 271 days. The mean Pediatric Risk of Mortality score III was 9.4 ± 7.8 at the time of admission to the PICUs. CONCLUSION: There is a considerable shortage of PICU beds compared to those in developed countries. In addition, the proportion of PICUs with PCC specialists is much lower than those in the US and European countries.
Child
;
Critical Care*
;
Developed Countries
;
Hospitals, General
;
Humans
;
Intensive Care Units, Pediatric
;
Korea*
;
Length of Stay
;
Mortality
;
Specialization
9.Rupture of Right Ventricular Free Wall Following Ventricular Septal Rupture in Takotsubo Cardiomyopathy with Right Ventricular Involvement.
June Min SUNG ; Sung Jin HONG ; In Hyun CHUNG ; Hye Young LEE ; Jae Hoon LEE ; Hyun Jung KIM ; Young Sup BYUN ; Byung Ok KIM ; Kun Joo RHEE
Yonsei Medical Journal 2017;58(1):248-251
Most patients diagnosed with takotsubo cardiomyopathies are expected to almost completely recover, and their prognosis is excellent. However, complications can occur in the acute phase. We present a case of a woman with takotsubo cardiomyopathy with right ventricular involvement who developed a rupture of the right ventricular free wall following ventricular septal rupture, as a consequence of an acute increase in right ventricular afterload by left-to-right shunt. Our case report illustrates that takotsubo cardiomyopathy can be life threatening in the acute phase. Ventricular septal rupture in biventricular takotsubo cardiomyopathy may be a harbinger of cardiac tamponade by right ventricular rupture.
Acute Disease
;
Aged
;
Female
;
Heart Ventricles/injuries
;
Humans
;
Prognosis
;
Takotsubo Cardiomyopathy/*complications
;
Ventricular Septal Rupture/*etiology
10.Alpha-Blocker Treatment Response in Men With Lower Urinary Tract Symptoms Based on Sympathetic Activity: Prospective, Multicenter, Open-Labeled, Observational Study.
Sung Gon PARK ; Byung Ha CHUNG ; Sung Won LEE ; Jong Kwan PARK ; Kwangsung PARK ; Jun CHEON ; Kyung Seop LEE ; Hyung Jee KIM ; Do Hwan SEONG ; Seung June OH ; Sae Woong KIM ; Ji Youl LEE ; Seol Ho CHOO ; Jong Bo CHOI
International Neurourology Journal 2015;19(2):107-112
PURPOSE: In this study, we compared the treatment outcomes for an alpha-blocker between 2 groups of men, one with high sympathetic activity (HSA) and another with low sympathetic activity (LSA) or normal sympathetic activity. METHODS: A total of 159 men (> or =50 years of age) with lower urinary tract symptoms resulting from benign prostatic hyperplasia were analyzed. We assigned patients to groups according to their sympathetic activity, which was evaluated by heart ratevariability measurements. HSA was defined as a low frequency/high frequency ratio greater than 1.6. All patients received 10mg of alfuzosin once a day for 12 weeks. The primary end point was a change in the total International Prostate SymptomScore (IPSS) at 12 weeks from baseline. RESULTS: Sixty-seven men were assigned to the HSA group and 92 men were assigned to the LSA group. The baseline characteristics were not significantly different between the 2 groups, and the response to alfuzosin was good in both groups. Themean total IPSS change was not different between the groups. Both groups were not significantly different with respect to the changes in maximal flow rate, IPSS voiding or storage symptom subscores, quality of life, and rates of adverse drug events. TheHSA group showed a similar willingness to continue treatment compared to the LSA group, although their treatment satisfaction rating was lower. CONCLUSIONS: The therapeutic effects of alfuzosin did not differ in regards to the differences in sympathetic activity, but treatment satisfaction ratings were lower in the HSA group.
Drug-Related Side Effects and Adverse Reactions
;
Heart
;
Heart Rate
;
Humans
;
Lower Urinary Tract Symptoms*
;
Male
;
Observational Study*
;
Prospective Studies*
;
Prostate
;
Prostatic Hyperplasia
;
Quality of Life
;
Sympathetic Nervous System

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