1.Short-term Clinical Outcomes of Ranibizumab Biosimilar SB11 Therapy in Neovascular Age-related Macular Degeneration
Dong Gyu NA ; Chul Gu KIM ; Jong Woo KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2025;66(5):224-232
Purpose:
To investigate the short-term outcomes of intravitreal injections of the ranibizumab biosimilar SB11 in patients with neovascular age-related macular degeneration (AMD).
Methods:
This retrospective comparative study assessed changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients diagnosed with neovascular AMD who received three monthly injections of SB11. The outcomes were compared to those of patients who received the same treatment using the ranibizumab originator. Within the SB11 group, comparisons were made between BCVA and CRT at diagnosis and after three injections. The proportion of patients with resolved subretinal fluid/intraretinal fluid was also evaluated.
Results:
The study included 46 eyes. In the SB11 group (n = 23), the average BCVA improved significantly from a baseline of logarithm of minimal angle of resolution 0.54 ± 0.42 to 0.40 ± 0.32 after three injections (p = 0.008). The average CRT decreased significantly from 447.4 ± 167.7 µm at baseline to 267.9 ± 66.9 µm after treatment (p < 0.001). Complete resolution of macular edema was observed in 19 eyes (82.7%). No significant differences were found in the degree of change in BCVA (p = 0.883) and CRT (p = 0.629) when compared to the ranibizumab originator group (n = 23). No complications such as intraocular inflammation or retinal detachment were noted.
Conclusions
Treatment with SB11 loading injections in neovascular AMD led to significant improvements in vision and reductions in macular thickness. The extent of improvement was comparable to that achieved with the ranibizumab originator and no severe complications were observed.
2.Short-term Clinical Outcomes of Ranibizumab Biosimilar SB11 Therapy in Neovascular Age-related Macular Degeneration
Dong Gyu NA ; Chul Gu KIM ; Jong Woo KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2025;66(5):224-232
Purpose:
To investigate the short-term outcomes of intravitreal injections of the ranibizumab biosimilar SB11 in patients with neovascular age-related macular degeneration (AMD).
Methods:
This retrospective comparative study assessed changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients diagnosed with neovascular AMD who received three monthly injections of SB11. The outcomes were compared to those of patients who received the same treatment using the ranibizumab originator. Within the SB11 group, comparisons were made between BCVA and CRT at diagnosis and after three injections. The proportion of patients with resolved subretinal fluid/intraretinal fluid was also evaluated.
Results:
The study included 46 eyes. In the SB11 group (n = 23), the average BCVA improved significantly from a baseline of logarithm of minimal angle of resolution 0.54 ± 0.42 to 0.40 ± 0.32 after three injections (p = 0.008). The average CRT decreased significantly from 447.4 ± 167.7 µm at baseline to 267.9 ± 66.9 µm after treatment (p < 0.001). Complete resolution of macular edema was observed in 19 eyes (82.7%). No significant differences were found in the degree of change in BCVA (p = 0.883) and CRT (p = 0.629) when compared to the ranibizumab originator group (n = 23). No complications such as intraocular inflammation or retinal detachment were noted.
Conclusions
Treatment with SB11 loading injections in neovascular AMD led to significant improvements in vision and reductions in macular thickness. The extent of improvement was comparable to that achieved with the ranibizumab originator and no severe complications were observed.
3.Short-term Clinical Outcomes of Ranibizumab Biosimilar SB11 Therapy in Neovascular Age-related Macular Degeneration
Dong Gyu NA ; Chul Gu KIM ; Jong Woo KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2025;66(5):224-232
Purpose:
To investigate the short-term outcomes of intravitreal injections of the ranibizumab biosimilar SB11 in patients with neovascular age-related macular degeneration (AMD).
Methods:
This retrospective comparative study assessed changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients diagnosed with neovascular AMD who received three monthly injections of SB11. The outcomes were compared to those of patients who received the same treatment using the ranibizumab originator. Within the SB11 group, comparisons were made between BCVA and CRT at diagnosis and after three injections. The proportion of patients with resolved subretinal fluid/intraretinal fluid was also evaluated.
Results:
The study included 46 eyes. In the SB11 group (n = 23), the average BCVA improved significantly from a baseline of logarithm of minimal angle of resolution 0.54 ± 0.42 to 0.40 ± 0.32 after three injections (p = 0.008). The average CRT decreased significantly from 447.4 ± 167.7 µm at baseline to 267.9 ± 66.9 µm after treatment (p < 0.001). Complete resolution of macular edema was observed in 19 eyes (82.7%). No significant differences were found in the degree of change in BCVA (p = 0.883) and CRT (p = 0.629) when compared to the ranibizumab originator group (n = 23). No complications such as intraocular inflammation or retinal detachment were noted.
Conclusions
Treatment with SB11 loading injections in neovascular AMD led to significant improvements in vision and reductions in macular thickness. The extent of improvement was comparable to that achieved with the ranibizumab originator and no severe complications were observed.
4.The effect of the sera from severe preeclamptic patients on endothelial cell viability and endothelin-1 in cultured human umbilical vein endothelial cells.
Yong Yook KIM ; Wook Yull NA ; Jong Kun LEE ; Young LEE ; Eun Jeong BAIK ; Jong Gu RHA ; Sa Jin KIM ; Hyung Gun LEE ; Jong Chul SHIN ; Soo Pyung KIM
Korean Journal of Obstetrics and Gynecology 2000;43(7):1162-1167
OBJECTIVES: In order to assess the effects of sera from severe preeclamptic patients on endothelial cell viability in vitro and endothelin-1 synthesis in cultured human umbilical vein endothelial cells. METHODS: The cultured human umbilical vein endothelial cells were incubated with media containing 10% sera from women with either preeclamptic patients or normal pregnancies for 24 hours or 48 hours. After then, their viability was measured by colorimetric MTT{3-(4,5-dimethylthiazol-2yl)2,5-diphenyl tetrazolium bromide} assay and their production of endothelin-1 was measured. We also measured the serum levels of endothelin-1 level in sera obtained from the normal and severe preeclamptic pregnancies. RESULTS: The calorimetric MTT assay revealed that after 24 hours, the absorbances in the media treated with normal pregnancies and severe preeclampsia sera were 0.0718+/-0.0078 and 0.0837+/-0.0129, respectively and after 48 hours, they were 0.1133+/-0.0103 and 0.1268+/-0.0186, respectively. Serum obtained from severe preeclampsia did not affect endothelial cell viability. 2. The serum mean levels of endothelin-1 in normal and severe preeclamptic pregnancies were 22.66+/-8.6 fmol/ml and 48.98+/-25.27 fmol/ml. The mean level in preeclamptic sera was significantly higher than that of normal pregnant women. (P<0.05) 3. After 24 hours, the mean amount of endothelin-1 stimulated by normal pregnant and severe preeclamptic sera were 37.52+/-18.41 fmol/ml and 97.58+/-53.64 fmol/ml, respectively. The mean amount of endothelin-1 in preeclamptic sera-treated cells was significantly higher than that of normal pregnant sera-treated cells. (P<0.05). CONCLUSION: The sera from severe preeclamptic women do not affect cell viability but act selectively on specific activation of their function such as endothelin-1 production. And it is necessary that the identification and isolation of the putative serum factor(s) will be performed to resolve the pathogenesis in future.
Cell Survival
;
Endothelial Cells*
;
Endothelin-1*
;
Female
;
Human Umbilical Vein Endothelial Cells*
;
Humans
;
Humans*
;
Pre-Eclampsia
;
Pregnancy
;
Pregnant Women
5.Development of Multiplex Reverse Transcription Polymerase Chain Reaction for Detection and Typing of Parainfluenza Viruses.
Gu Choul SHIN ; Chan PARK ; Joo Yeon LEE ; Byoung Kuk NA ; Jong Won PARK ; Chun KANG ; Jee Hee KIM ; Woo Joo KIM ; Chul Yong SONG
Journal of Bacteriology and Virology 2001;31(2):199-206
No abstract available.
Paramyxoviridae Infections*
;
Polymerase Chain Reaction*
;
Reverse Transcription*
6.Diagnostic Usefulness of Korean Standard on Heavy Drinking for the DSM-5 Alcohol Use Disorder.
Seong Gu KIM ; Jong Sung KIM ; Han Ju PACK ; Han Na SUNG
Korean Journal of Health Promotion 2017;17(2):91-98
BACKGROUND: This research investigated the usefulness of heavy drinking standards of ‘guidelines for moderate alcohol drinking amount for Koreans’ for diagnosis of Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) alcohol use disorder. METHODS: This retrospective study was conducted with 976 adults who visited an health screening center in Daejeon for health check-up in 2015. Daily drinking amount, drinking frequency per week, and weekly drinking amount were investigated. Using the heavy drinking criteria of Korean guideline, participants were grouped by age and gender and classified as normal or heavy drinkers. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), Positive likelihood ratio (LR+), Negative likelihood ratio (LR-), odds ratio (OR) and Youden's Index of heavy drinking according to Korean guideline for diagnosis of DSM-5 alcohol use disorder were calculated. RESULTS: The Area under the receiver operating characteristic (ROC) curve of a model screening DSM-5 alcohol use disorder by weekly drinking amount were 0.812 in males up to age 65 years and 0.931 in males over age 65 years and females respectively. The sensitivity, specificity, PPV and NPV of Korean guideline heavy drinking group for diagnosis of DSM-5 alcohol use disorder were 61.0%, 89.7%, 67.0%, and 87.05% respectively. The LR+, LR-, OR and Youden's Index of those were 5.917 (4.704-7.435), 0.434 (0.379-0.497), 13.623 (9.607-19.317), and 0.507 respectively. CONCLUSIONS: This research shows the Korean heavy drinking standard is useful for diagnosis of DSM-5 alcohol use disorder in Korean people.
Adult
;
Alcohol Drinking
;
Diagnosis
;
Diagnostic and Statistical Manual of Mental Disorders
;
Drinking*
;
Female
;
Humans
;
Male
;
Mass Screening
;
Odds Ratio
;
Retrospective Studies
;
ROC Curve
;
Sensitivity and Specificity
7.Usefulness of Heavy Drinking and Binge Drinking for the Diagnosis of Alcohol Use Disorder.
Seong Gu KIM ; Jong Sung KIM ; Han Ju PACK ; Han Na SUNG
Korean Journal of Family Medicine 2016;37(4):214-220
BACKGROUND: This research investigated the sensitivity and specificity of heavy and binge drinking for screening of alcohol use disorder. METHODS: This retrospective study was conducted with 976 adults who visited the Sun Health Screening Center for health screenings in 2015. Daily drinking amount, drinking frequency per week, and weekly drinking amount were investigated. Using criteria from the National Institute on Alcohol Abuse and Alcoholism, participants were classified as normal drinkers, heavy drinkers, or binge drinkers, and grouped by age and sex. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of heavy and binge drinking were compared for the diagnosis of alcohol abuse and alcohol dependence using the Diagnostic and Statistical Manual of Mental Disorders (DSM) 4th edition-text revision and alcohol use disorder using the DSM 5th edition. RESULTS: The sensitivity of heavy and binge drinking for the diagnosis of alcohol abuse, alcohol dependence, and alcohol use disorder were 51.7%, 43.8%, and 35.3%, and 69.0%, 62.5%, and 48.2%, respectively. The specificity of these were 90.1%, 91.7%, and 95.5%, and 84.3%, 86.8%, and 91.2%, respectively. The PPV of these were 24.8%, 40.5%, and 72.7%, and 21.7%, 38.0%, and 65.2%, respectively. The NPV of these were 96.7%, 92.6%, and 81.2%, and 97.8%, 94.7%, and 83.7%, respectively. CONCLUSION: Heavy and binge drinking did not show enough diagnostic power to screen DSM alcohol use disorder although they did show high specificity and NPV.
Adult
;
Alcoholism
;
Alcohol Drinking
;
Binge Drinking*
;
Diagnosis*
;
Diagnostic and Statistical Manual of Mental Disorders
;
Humans
;
Mass Screening
;
National Institute on Alcohol Abuse and Alcoholism (U.S.)
;
Retrospective Studies
;
Sensitivity and Specificity
8.Growth Characteristics and Physiological Functionality of Yeasts in Pear Marc Extracts.
In Taek JANG ; Min Gu KANG ; Kwang Chul NA ; Jong Soo LEE
Mycobiology 2011;39(3):170-173
Kluyveromyces fragilis KCTC 7260 and Saccharomyces cerevisiae KCTC 7904, which both grew well in pear marc extract, were selected and their growth profiles and physiological functionalities were determined. Both of the selected yeasts established maximal growth by 20 hr of cultivation at 30degrees C in pear marc extract. The cell-free extracts showed high antihypertensive angiotensin I-converting enzyme inhibitory activity of 68.9% and 52.1%, respectively. The extracts also displayed 9.2 U/mL and 12.0 U/mL of protease activity, respectively.
Kluyveromyces
;
Peptidyl-Dipeptidase A
;
Pyrus
;
Saccharomyces cerevisiae
;
Yeasts
9.The hyperexpressions of putative stem cells in the eutopic endometrium of patients with advanced endometriosis.
Jong Ryeol CHOI ; Jong Kil JOO ; Yong Jin NA ; Kyung Rae KO ; Hong Gu LEE ; Kyu Sup LEE ; Yong Taek LIM
Korean Journal of Obstetrics and Gynecology 2010;53(3):264-273
OBJECTIVE: Recently it has been proposed that stem cells may be associated with the pathogenesis of endometriosis. The purposes of this study are to investigate whether the eutopic endometrial cells of women with or without endometriosis show the characteristics of stem cells in vitro and have a difference of the expressions of the undifferentiated stem cell markers as OCT-4 and CXCR4. METHODS: A total of 6 women with advanced endometriosis and a total of 10 women without endometriosis, adenomyosis or leiomyoma were included in this study. The eutopic endometrial cells, which were obtained from the menstrual blood at menstrual cycle day 2 to 4, were cultured in vitro for approximately 2 weeks, subsequently the putative very small stem cells were separated by Percoll density gradient method and were cultured. The expressions of OCT-4 and CXCR4 were analyzed by real time RT-PCR. RESULTS: The eutopic endometrial cells of the group of endometriosis compared with the control group showed the different morphological characteristics in vitro; more commonly heterogeneous supportive cells, very small round cells less than 3 micrometer and 5~15 micrometer sized hyperchromatic round cells. After the separation of very small round cells by Percoll density gradient method, these cells showed the several characteristics of stem cells; self-renewal, asymmetric cell division, colony formation and embryoid body-like formation. Also These cells showed the similar characteristics of very small embryonic-like stem cells; the mobile cells smaller than erythrocyte, the cell migration or adhesion to supportive cells, the sphere formation by cell aggregation and the formation of new differentiated cell by cell fusion. The expressions of OCT-4 and CXCR4 in the group of endometriosis are respectively 5.66 times and 17.69 times as high as the control group (P<0.05). CONCLUSION: The very small round cells less than 3 micrometer and 5~15 micrometer sized hyperchromatic round cells, which showed the several characteristics of stem cells in vitro, were more common in eutopic endometrial cells of patients with endometriosis and the expressions of OCT-4 and CXCR4 were significantly higher. This study suggests that stem cells might play a key role in the pathogenesis of endometriosis and OCT-4 and CXCR4 might be used as a tool for diagnosis or follow-up.
Adenomyosis
;
Asymmetric Cell Division
;
Cell Aggregation
;
Cell Fusion
;
Cell Movement
;
Endometriosis
;
Endometrium
;
Erythrocytes
;
Female
;
Humans
;
Leiomyoma
;
Menstrual Cycle
;
Povidone
;
Silicon Dioxide
;
Stem Cells
10.A clinical study of torsion of ovarian tumors in pregnancy.
Ye Hoon CHOI ; Chul Hun PARK ; Gui SeRa LEE ; Sa Jin KIM ; Jong Chul SIN ; Jong Gu NA ; Soo Pyung KIM
Korean Journal of Obstetrics and Gynecology 2002;45(12):2250-2253
OBJECTIVE: To evaluate optimal management of an ovarian tumor in pregnancy METHODS: This study includes 89 cases of an ovarian tumor in pregnancy that required surgery at Catholic Medical Center, Kangnam St. Mary's hospital, Holy Family hospital of the Catholic University Medical College from January, 1990 to December, 2001. We collected 36 cases from 48 pregnant women who underwent emergency operation. And 53 cases were pregnant women who underwent elective operation. The student t-test and x2 test were used for statistical analysis. A P value of <0.05 was considered significant. RESULTS: The most common size of torsion of an ovarian tumor during pregnancy was 6-10 cm and the incidence was the most frequent during the first trimester of pregnancy. Pregnant women with torsion of an ovarian tumor who underwent emergency operation compared with those who underwent elective operation, the risk of preterm delivery were significant. But there were no fetal deaths reported, also there were no difference in the birth weight or the method of delivery. CONCLUSION: The torsion of an ovarian tumor dose not have a serious affect on the overall pregnancy. If the early diagnosis of the ovarian tumor is made and the malignancy is ruled out, it seems likely that the conservative care is better than the invasive method of operation during the second trimester of pregnancy just to prevent from preterm labor due to emergency operation of ovarian tumor.
Birth Weight
;
Early Diagnosis
;
Emergencies
;
Female
;
Fetal Death
;
Humans
;
Incidence
;
Obstetric Labor, Premature
;
Pregnancy Trimester, First
;
Pregnancy Trimester, Second
;
Pregnancy*
;
Pregnant Women