1.Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study
Hyung Seok SON ; Min Kyung SHIN ; Jong Hun LEE ; Moon Bum KIM ; Kwang Ho YOO ; Sun Young CHOI ; Hye Sung HAN ; Joon SEOK ; Beom Joon KIM ; Yang Won LEE
Annals of Dermatology 2026;38(1):33-41
Background:
A novel botulinum toxin type A (Protoxin; Protox Inc.) has been developed.
Objective:
To evaluate the efficacy and safety of the newly developed Protoxin compared to the approved drug onabotulinumtoxinA (OBoNT) in moderate to severe glabellar lines.
Methods:
Adults with a glabellar line Facial Wrinkle Scale (FWS) score of 2 (moderate) or 3 (severe) were enrolled in the study. Subjects were randomized in a 1:1 ratio to receive either Protoxin or OBoNT. A total of 20 units of botulinum toxin was injected at five sites in the glabellar region (4 units at each site). FWS scores were assessed at baseline and at weeks 4, 8, 12, and 16 post-injection. The primary endpoint was the proportion of subjects at week 4 who had a reduction of 2 or more points in FWS and a final score of 0 (none) or 1 (mild).
Results:
A total of 274 subjects were randomized, of whom 78.1% were female. At week 4 post-treatment, the improvement rate of glabellar lines was 62.22% in the Protoxin group and 62.96% in the OBoNT group. The lower limit of the two-sided 95% confidence interval (−12.24%) exceeded the −15% margin, confirming the non-inferiority of the new drug. Safety profiles were comparable between the two groups.
Conclusion
Protoxin demonstrated efficacy and safety profiles comparable to those of OBoNT in the treatment of moderate to severe glabellar lines.
2.Detection Ability of Quality of Life Changes and Responsiveness of the KOQUSS-40 and the EORTC QLQ-C30/STO22 in Patients Who Underwent Gastrectomy: A Prospective Comparative Study
Bang Wool EOM ; Keun Won RYU ; Ji Yeong AN ; Yun-Suhk SUH ; In CHO ; Sung Geun KIM ; Ji-Ho PARK ; Hoon HUR ; Hyung-Ho KIM ; Sang-Hoon AHN ; Sun-Hwi HWANG ; Hong Man YOON ; Ki Bum PARK ; Hyoung-Il KIM ; In-Gyu KWON ; Han-Kwang YANG ; Byoung-Jo SUH ; Sang-Ho JEONG ; Tae-Han KIM ; Oh Kyoung KWON ; Hye-Seong AHN ; Ji Yeon PARK ; Ki Young YOON ; Myoung Won SON ; Seong-Ho KONG ; Young-Gil SON ; Geum Jong SONG ; Jong Hyuk YUN ; Jung-Min BAE ; Do Joong PARK ; Sol LEE ; Jun-Young YANG ; Kyung Won SEO ; You-Jin JANG ; So Hyun KANG ; Joongyub LEE ; Hyuk-Joon LEE ;
Cancer Research and Treatment 2026;58(1):221-231
Purpose:
The aim of this study is to compare the detection ability of quality of life (QoL) changes and responsiveness of the KOrean QUality of life in Stomach cancer patients Study group (KOQUSS)-40 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ).
Materials and Methods:
A multicenter prospective observational study was conducted to evaluate QoL changes after various gastrectomies between January 2021 and April 2022. Participants were instructed to complete the KOQUSS-40 and EORTC QLQ-C30/STO22 preoperatively and at 1, 3, 6, and 12 months postoperatively. QoL changes over time and QoL responsiveness were assessed for each questionnaire.
Results:
Data from 491 patients who underwent curative gastrectomy for gastric cancer at 22 institutions were analyzed. The summary scores of the KOQUSS-40 and EORTC QLQ-STO22 showed significant differences between the total and proximal gastrectomy groups (p=0.044 and p=0.038, respectively), but no difference was observed for the EORTC QLQ-C30. Dysphagia on the KOQUSS-40 was significantly different between the total and proximal gastrectomy groups (p=0.031); however, dysphagia on the EORTC QLQ-STO22 did not differ. The responsiveness of the KOQUSS-40 was similar to that of the EORTC QLQ in patients who experienced ≥ 10% body weight loss, but approximately 10% less in patients receiving adjuvant chemotherapy than the EORTC QLQ.
Conclusion
KOQUSS-40 has several advantages over EORTC QLQ-C30/STO22 when comparing QoL between the total and proximal gastrectomy groups. The findings provide information for researchers investigating the QoL of patients who have undergone curative gastrectomy for gastric cancer.
3.Ulcerative colitis-associated colorectal neoplasm is increasing as a surgical indication in the biologics era:a retrospective observational study of 20 years of experience in a single tertiary center
Hyo Jun KIM ; Seung-Bum RYOO ; Jin Sun CHOI ; Han-Ki LIM ; Min Jung KIM ; Ji Won PARK ; Seung-Yong JEONG ; Kyu Joo PARK
Annals of Surgical Treatment and Research 2025;108(3):150-157
Purpose:
We aimed to identify changes in surgical indications in patients with ulcerative colitis (UC) in the biologics era in a single tertiary center.
Methods:
In this retrospective observational study, 108 patients with UC who underwent abdominal surgery for UC at Seoul National University Hospital from 2000 to 2021 were included. We compared the total number of patients undergoing UC before and after the introduction of biologic therapy.
Results:
Of the 108 patients with UC (male, 59 and female, 49; mean age, 46.8 years), 30 (27.8%) underwent surgery for neoplasms and 78 (72.2%) for medical intractability without neoplasms. The duration between diagnosis and surgery varied significantly (126.00 months vs. 60.50 months, P = 0.001). A significant difference was also noted in the surgical indications according to time (P = 0.02). Between 2000 and 2010, 12 patients (19.4%) underwent surgery for UC with neoplasms and 50 (80.6%) for UC without neoplasms, while between 2011 and 2021, 18 (39.1%) and 28 patients (60.9%) underwent surgery for UC with and without neoplasms, respectively.
Conclusion
Since 2011, when biological agents were covered by insurance in South Korea, there has been a relative increase in the incidence of surgical indications for neoplasia cases. Focusing on closely monitoring individuals with longterm UC for neoplasms is necessary.
4.Ulcerative colitis-associated colorectal neoplasm is increasing as a surgical indication in the biologics era:a retrospective observational study of 20 years of experience in a single tertiary center
Hyo Jun KIM ; Seung-Bum RYOO ; Jin Sun CHOI ; Han-Ki LIM ; Min Jung KIM ; Ji Won PARK ; Seung-Yong JEONG ; Kyu Joo PARK
Annals of Surgical Treatment and Research 2025;108(3):150-157
Purpose:
We aimed to identify changes in surgical indications in patients with ulcerative colitis (UC) in the biologics era in a single tertiary center.
Methods:
In this retrospective observational study, 108 patients with UC who underwent abdominal surgery for UC at Seoul National University Hospital from 2000 to 2021 were included. We compared the total number of patients undergoing UC before and after the introduction of biologic therapy.
Results:
Of the 108 patients with UC (male, 59 and female, 49; mean age, 46.8 years), 30 (27.8%) underwent surgery for neoplasms and 78 (72.2%) for medical intractability without neoplasms. The duration between diagnosis and surgery varied significantly (126.00 months vs. 60.50 months, P = 0.001). A significant difference was also noted in the surgical indications according to time (P = 0.02). Between 2000 and 2010, 12 patients (19.4%) underwent surgery for UC with neoplasms and 50 (80.6%) for UC without neoplasms, while between 2011 and 2021, 18 (39.1%) and 28 patients (60.9%) underwent surgery for UC with and without neoplasms, respectively.
Conclusion
Since 2011, when biological agents were covered by insurance in South Korea, there has been a relative increase in the incidence of surgical indications for neoplasia cases. Focusing on closely monitoring individuals with longterm UC for neoplasms is necessary.
5.Analysis of Incidence and Risk Factors for Periprosthetic Fracture after Total Knee Arthroplasty in South Korea from 2010 to 2020Based on National Registry Data
Jisu PARK ; Tae Woo KIM ; Min Ki KIM ; Jiyu SUN ; Kee Jeong BAE ; Moon Jong CHANG ; Chong Bum CHANG ; Seung-Baik KANG
Clinics in Orthopedic Surgery 2025;17(3):408-416
Background:
Periprosthetic fracture (PPF) is a troublesome complication as it utilizes substantial healthcare resources. Recent studies about the epidemiology of PPF after total knee arthroplasty (TKA) are still lacking, and there is limited national-level analysis focusing on the comorbid chronic conditions as risk factors of PPF. This study used national registry data from South Korea and aimed to investigate the epidemiology of PPF following TKA between 2010 and 2020 and identify which comorbidities contributed to the risk of PPF.
Methods:
Using Health Insurance Review and Assessment (HIRA) service data in South Korea, the incidence of PPF after TKA between 2010 and 2020 was evaluated and stratified by age and sex. Medical comorbidities were evaluated as possible risk factors for PPF using Cox regression analysis.
Results:
PPF occurred in 14,429 patients, accounting for 2.37% of total TKA patients. The prevalence of PPF by sex was 2.50% in women and 1.64% in men. The PPF rate was 2.82% in under 60 years, 2.25% in 60 to 69 years, 2.42% in 70 to 79 years, 2.29% in 80 to 89 years, and 2.12% in over 90 years. Among 17 analyzed comorbidities, 11 were found to be associated with PPF after TKA. Severe liver disease (hazard ratio [HR], 1.303), hemiplegia (HR, 1.244), and dementia (HR, 1.206) were the top 3 risk factors.Although osteoporosis, pulmonary disease, peptic ulcer, and diabetes showed relatively low HRs than these top 3 factors, the incidence rates were higher.
Conclusions
PPF occurred in 2.37% of TKA patients in South Korea from 2010 to 2020. PPF rate was higher in women. To prevent PPF after TKA, proper patient management and education should be emphasized, particularly in patients with severe liver disease, hemiplegia, and dementia.
6.Prospective Multicenter Observational Study on Postoperative Quality of Life According to Type of Gastrectomy for Gastric Cancer
Sung Eun OH ; Yun-Suhk SUH ; Ji Yeong AN ; Keun Won RYU ; In CHO ; Sung Geun KIM ; Ji-Ho PARK ; Hoon HUR ; Hyung-Ho KIM ; Sang-Hoon AHN ; Sun-Hwi HWANG ; Hong Man YOON ; Ki Bum PARK ; Hyoung-Il KIM ; In Gyu KWON ; Han-Kwang YANG ; Byoung-Jo SUH ; Sang-Ho JEONG ; Tae-Han KIM ; Oh Kyoung KWON ; Hye Seong AHN ; Ji Yeon PARK ; Ki Young YOON ; Myoung Won SON ; Seong-Ho KONG ; Young-Gil SON ; Geum Jong SONG ; Jong Hyuk YUN ; Jung-Min BAE ; Do Joong PARK ; Sol LEE ; Jun-Young YANG ; Kyung Won SEO ; You-Jin JANG ; So Hyun KANG ; Bang Wool EOM ; Joongyub LEE ; Hyuk-Joon LEE ;
Journal of Gastric Cancer 2025;25(2):382-399
Purpose:
This study evaluated the postoperative quality of life (QoL) after various types of gastrectomy for gastric cancer.
Materials and Methods:
A multicenter prospective observational study was conducted in Korea using the Korean Quality of Life in Stomach Cancer Patients Study (KOQUSS)-40, a new QoL assessment tool focusing on postgastrectomy syndrome. Overall, 496 patients with gastric cancer were enrolled, and QoL was assessed at 5 time points: preoperatively and at 1, 3, 6, and 12 months after surgery.
Results:
Distal gastrectomy (DG) and pylorus-preserving gastrectomy (PPG) showed significantly better outcomes than total gastrectomy (TG) and proximal gastrectomy (PG) with regard to total score, indigestion, and dysphagia. DG, PPG, and TG also showed significantly better outcomes than PG in terms of dumping syndrome and worry about cancer. Postoperative QoL did not differ significantly according to anastomosis type in DG, except for Billroth I anastomosis, which achieved better bowel habit change scores than the others. No domains differed significantly when comparing double tract reconstruction and esophagogastrostomy after PG. The total QoL score correlated significantly with postoperative body weight loss (more than 10%) and extent of resection (P<0.05 for both).Reflux as assessed by KOQUSS-40 did not correlate significantly with reflux observed on gastroscopy 1 year postoperatively (P=0.064).
Conclusions
Our prospective observation using KOQUSS-40 revealed that DG and PPG lead to better QoL than TG and PG. Further study is needed to compare postoperative QoL according to anastomosis type in DG and PG.
7.Comparison of Treatment Outcomes: Screw Fixation versus Suture-Button Fixation in Distal Tibiofibular Syndesmosis Diastasis Combined with Ankle Fractures
Baegyun KIM ; Bum Soo KIM ; Seong-Tae KIM ; Hyung min SUN
Journal of Korean Foot and Ankle Society 2025;29(1):27-33
Purpose:
This study compared the treatment outcomes between fixation using screws and suture buttons for addressing distal tibiofibular syndesmosis diastasis combined with ankle fractures.
Materials and Methods:
A retrospective study was conducted involving 20 patients with ankle fractures treated with screws and 21 patients treated with suture buttons for distal tibiofibular syndesmosis diastasis. The postoperative clinical outcomes were assessed using the American Orthopedic Foot and Ankle Society (AOFAS) score, while the radiological outcomes were determined by measuring the tibiofibular clear space, tibiofibular overlap, and medial clear space on the pre- and post-operative radiographs. In addition, factors such as the need for internal fixation removal surgery and the incidence of internal fixation damage were investigated.
Results:
One-year post-surgery, the average AOFAS score showed no significant difference between the screw and suture button surgery groups. Initially, measurements of the tibiofibular clear space, tibiofibular overlap, and medial clear space did not exhibit significant differences between the two groups. On the other hand, significant differences were observed one-year post-surgery. All patients in the screw surgery group underwent screw removal surgery. Within this group, two cases of screw breakage and one case of surgical wound infection were recorded.
Conclusion
When treating distal tibiofibular syndesmosis diastasis, the screw surgery group and the suture button surgery group showed similar clinical outcomes measured by AOFAS one year after surgery, but the suture button surgery group had better results in radiological evaluation and complication frequency.
8.Analysis of Incidence and Risk Factors for Periprosthetic Fracture after Total Knee Arthroplasty in South Korea from 2010 to 2020Based on National Registry Data
Jisu PARK ; Tae Woo KIM ; Min Ki KIM ; Jiyu SUN ; Kee Jeong BAE ; Moon Jong CHANG ; Chong Bum CHANG ; Seung-Baik KANG
Clinics in Orthopedic Surgery 2025;17(3):408-416
Background:
Periprosthetic fracture (PPF) is a troublesome complication as it utilizes substantial healthcare resources. Recent studies about the epidemiology of PPF after total knee arthroplasty (TKA) are still lacking, and there is limited national-level analysis focusing on the comorbid chronic conditions as risk factors of PPF. This study used national registry data from South Korea and aimed to investigate the epidemiology of PPF following TKA between 2010 and 2020 and identify which comorbidities contributed to the risk of PPF.
Methods:
Using Health Insurance Review and Assessment (HIRA) service data in South Korea, the incidence of PPF after TKA between 2010 and 2020 was evaluated and stratified by age and sex. Medical comorbidities were evaluated as possible risk factors for PPF using Cox regression analysis.
Results:
PPF occurred in 14,429 patients, accounting for 2.37% of total TKA patients. The prevalence of PPF by sex was 2.50% in women and 1.64% in men. The PPF rate was 2.82% in under 60 years, 2.25% in 60 to 69 years, 2.42% in 70 to 79 years, 2.29% in 80 to 89 years, and 2.12% in over 90 years. Among 17 analyzed comorbidities, 11 were found to be associated with PPF after TKA. Severe liver disease (hazard ratio [HR], 1.303), hemiplegia (HR, 1.244), and dementia (HR, 1.206) were the top 3 risk factors.Although osteoporosis, pulmonary disease, peptic ulcer, and diabetes showed relatively low HRs than these top 3 factors, the incidence rates were higher.
Conclusions
PPF occurred in 2.37% of TKA patients in South Korea from 2010 to 2020. PPF rate was higher in women. To prevent PPF after TKA, proper patient management and education should be emphasized, particularly in patients with severe liver disease, hemiplegia, and dementia.
9.Comparison of Treatment Outcomes: Screw Fixation versus Suture-Button Fixation in Distal Tibiofibular Syndesmosis Diastasis Combined with Ankle Fractures
Baegyun KIM ; Bum Soo KIM ; Seong-Tae KIM ; Hyung min SUN
Journal of Korean Foot and Ankle Society 2025;29(1):27-33
Purpose:
This study compared the treatment outcomes between fixation using screws and suture buttons for addressing distal tibiofibular syndesmosis diastasis combined with ankle fractures.
Materials and Methods:
A retrospective study was conducted involving 20 patients with ankle fractures treated with screws and 21 patients treated with suture buttons for distal tibiofibular syndesmosis diastasis. The postoperative clinical outcomes were assessed using the American Orthopedic Foot and Ankle Society (AOFAS) score, while the radiological outcomes were determined by measuring the tibiofibular clear space, tibiofibular overlap, and medial clear space on the pre- and post-operative radiographs. In addition, factors such as the need for internal fixation removal surgery and the incidence of internal fixation damage were investigated.
Results:
One-year post-surgery, the average AOFAS score showed no significant difference between the screw and suture button surgery groups. Initially, measurements of the tibiofibular clear space, tibiofibular overlap, and medial clear space did not exhibit significant differences between the two groups. On the other hand, significant differences were observed one-year post-surgery. All patients in the screw surgery group underwent screw removal surgery. Within this group, two cases of screw breakage and one case of surgical wound infection were recorded.
Conclusion
When treating distal tibiofibular syndesmosis diastasis, the screw surgery group and the suture button surgery group showed similar clinical outcomes measured by AOFAS one year after surgery, but the suture button surgery group had better results in radiological evaluation and complication frequency.
10.Comparison of Treatment Outcomes: Screw Fixation versus Suture-Button Fixation in Distal Tibiofibular Syndesmosis Diastasis Combined with Ankle Fractures
Baegyun KIM ; Bum Soo KIM ; Seong-Tae KIM ; Hyung min SUN
Journal of Korean Foot and Ankle Society 2025;29(1):27-33
Purpose:
This study compared the treatment outcomes between fixation using screws and suture buttons for addressing distal tibiofibular syndesmosis diastasis combined with ankle fractures.
Materials and Methods:
A retrospective study was conducted involving 20 patients with ankle fractures treated with screws and 21 patients treated with suture buttons for distal tibiofibular syndesmosis diastasis. The postoperative clinical outcomes were assessed using the American Orthopedic Foot and Ankle Society (AOFAS) score, while the radiological outcomes were determined by measuring the tibiofibular clear space, tibiofibular overlap, and medial clear space on the pre- and post-operative radiographs. In addition, factors such as the need for internal fixation removal surgery and the incidence of internal fixation damage were investigated.
Results:
One-year post-surgery, the average AOFAS score showed no significant difference between the screw and suture button surgery groups. Initially, measurements of the tibiofibular clear space, tibiofibular overlap, and medial clear space did not exhibit significant differences between the two groups. On the other hand, significant differences were observed one-year post-surgery. All patients in the screw surgery group underwent screw removal surgery. Within this group, two cases of screw breakage and one case of surgical wound infection were recorded.
Conclusion
When treating distal tibiofibular syndesmosis diastasis, the screw surgery group and the suture button surgery group showed similar clinical outcomes measured by AOFAS one year after surgery, but the suture button surgery group had better results in radiological evaluation and complication frequency.

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