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.Developing standardized informed consent for hysterectomy and vulva cancer surgery
Soohyun OH ; Geonwoo LEE ; Kwang-Beom LEE ; Min-Sun KYUNG ; Myounghwan KIM ; Mi-Kyung KIM ; Jaeman BAE ; Min Jong SONG ; Heon Jong YOO ; Dae-Hyung LEE ; Sang-Hun LEE ; Ha Kyun CHANG ; Jae-Weon KIM ; Sang-Yoon PARK
Journal of Gynecologic Oncology 2025;36(6):e107-
Informed consent is a fundamental aspect of surgical care, designed to reinforce patient autonomy, promote shared decision-making, and potentially mitigate legal conflicts by ensuring the provision of comprehensive and consistent information in clinical practice. The Korean Society of Gynecologic Oncology (KSGO) previously published detailed informed consent documents for cervical, endometrial, and ovarian cancer surgery. However, standardized consent forms remain relatively lacking for laparoscopic-robotic hysterectomy performed for non-malignant indications, as well as for vulvar cancer surgery. Hence, the KSGO subcommittee collected, reviewed, and discussed consent forms from domestic medical institutions and subsequently developed informed consent for laparoscopic-robotic hysterectomy and vulvar cancer surgery, aiming to build patient trust and understanding.
3.Current status of treatment for esophagojejunostomy leakage after total gastrectomy in patients with gastric cancer: a multicenter retrospective study in Korea
Min-Chan KIM ; Mi Ran JUNG ; Jeong Ju NOH ; Sunghwa KANG ; Jae Hun CHUNG ; Ji-Ho PARK ; Tae-Han KIM ; Jae Kyun PARK ; Yoonhong KIM ; Sang Hyuk SEO ; Sung Eun KIM ; Oh Kyung KWON ; Ji Yeon PARK ; Ki Bum PARK ; Sun-Hwi HWANG ; SI-Hak LEE ; Young-Joon LEE ; Sang-Ho JEONG ; Tae-Yong JEON ; Dae Hwan KIM ; Chang In CHOI ; Ki Young YOON ; Kyung Won SEO ; Ki Hyun KIM ; Sang Hoon OH ; Kwang Hee KIM
Journal of Minimally Invasive Surgery 2025;28(4):184-192
Purpose:
Esophagojejunostomy leakage (EJL) remains one of the most critical complications following total gastrectomy for gastric cancer. This study aimed to evaluate the evolving therapeutic approaches and clinical outcomes of EJL using data from a large-scale multicenter retrospective cohort.
Methods:
Among 6,577 patients who underwent total gastrectomy or proximal gastrectomy with double tract reconstruction at nine institutions from 2003 to 2024, 196 (3.0%) developed EJL. Of these, 162 patients with comprehensive clinical data were included in the final analysis. The study examined treatment modalities, changes in management over time, patient characteristics, surgical variables, and clinical outcomes. Four groups were defined according to treatment approach: conservative, endoscopic, reoperation, and multimodal (combined) therapy.
Results:
Endoscopic therapy was first introduced in 2011 and has progressively supplanted reoperation, now comprising 32.5% of cases. The average time to EJL diagnosis was 8.4 days after surgery. Overall in-hospital mortality was 6.1% (10/162). When conservative management was excluded, endoscopic treatment demonstrated the highest rate of therapeutic success (94.3%, p = 0.004). Both the duration until diet resumption and length of hospital stay were notably reduced in the endoscopic and conservative groups compared with reoperation and multimodal therapy (p < 0.001). Moreover, although the highest post-leakage hospitalization costs were observed with multimodal treatment (p < 0.001), overall hospitalization expenses were significantly lower for patients managed conservatively or with endoscopic intervention (p < 0.001).
Conclusion
Over the past two decades, management of EJL has shifted toward endoscopic approaches. Endoscopic therapies yield superior clinical outcomes and should be considered a primary option for appropriate candidates.
4.Aortic valve sclerosis is not a benign finding but progressive disease associated with poor cardiovascular outcomes
Jeong Hun SEO ; Kwang Jin CHUN ; Bong‑Ki LEE ; Byung‑Ryul CHO ; Dong Ryeol RYU
Journal of Cardiovascular Imaging 2024;32(1):39-
Background:
Aortic valve sclerosis (AVS) shares risk factors with atherosclerosis. However, the relationship between AVS progression with cardiovascular (CV) risk has not been researched. This study investigates CV outcomes according to progression of AVS.
Methods:
This study included 2,901 patients with AVS (irregular leaflet thickening and peak aortic jet veloc‑ ity < 2 m/sec) who underwent serial echocardiograms at least 1 year apart during 2011–2020. The primary outcome was defined as CV death, myocardial infarction, stroke, or revascularization.
Results:
During a median follow-up period of 3.9 years, 439 of 2,901 AVS patients (15.1%) progressed to mild or greater aortic stenosis. Patients with progression were older and more likely to have atrial fibrillation than those without. In a stepwise regression, age (odds ratio [OR] per 1-year increase, 1.04; 95% confidence interval [CI], 1.01– 1.07), peripheral artery disease (OR, 9.07; 95% CI, 3.12–26.4), and left ventricular mass index (OR per 1-g/m 2 increase, 1.01; 95% CI, 1.00–1.02) were associated with AVS progression. Over a median of 6.3 years, the primary outcome occurred in 858 of 2,901 patients (29.6%). Patients with progression had higher frequency of CV death, myocardial infarction, stroke, or revascularization than those without progression (P < 0.0001). In Cox proportional hazards regres‑ sion, AVS progression (hazard ratio, 1.33; 95% CI, 1.10–1.61) was a significant determinant of CV mortality.
Conclusions
The progression to aortic stenosis in AVS patients is an independent risk factor for CV mortality. These findings suggest that patients with AVS progression may benefit from stricter CV risk monitoring.
5.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
6.Robotic-Assisted Spine Surgery: Role in Training the Next Generation of Spine Surgeons
Jun Seok LEE ; Dong Wuk SON ; Su Hun LEE ; Jong Hyeok LEE ; Young Ha KIM ; Sang Weon LEE ; Bu Kwang OH ; Soon Ki SUNG ; Geun Sung SONG ; Seong YI
Neurospine 2024;21(1):116-127
Objective:
This study aimed to assess the degree of interest in robot-assisted spine surgery (RASS) among residents and to investigate the learning curve for beginners performing robotic surgery.
Methods:
We conducted a survey to assess awareness and interest in RASS among young neurosurgery residents. Subsequently, we offered a hands-on training program using a dummy to educate one resident. After completing the program, the trained resident performed spinal fusion surgery with robotic assistance under the supervision of a mentor. The clinical outcomes and learning curve associated with robotic surgery were then analyzed.
Results:
Neurosurgical residents had limited opportunities to participate in spinal surgery during their training. Despite this, there was a significant interest in the emerging field of robotic surgery. A trained resident performed RASS under the supervision of a senior surgeon. A total of 166 screw insertions were attempted in 28 patients, with 2 screws failing due to skiving. According to the Gertzbein-Robbins classification, 85.54% of the screws were rated as grade A, 11.58% as grade B, 0.6% as grade C, and 1.2% as grade D. The clinical acceptance rate was approximately 96.99%, which is comparable to the results reported by senior experts and time per screw statistically significantly decreased as experience was gained.
Conclusion
RASS can be performed with high accuracy within a relatively short timeframe, if residents receive adequate training.
7.Clinical characteristics of toxoplasmosis patients in Korea: A retrospective study using health insurance review and assessment service data and electronic medical records
Do-Won HAM ; Bong-Kwang JUNG ; Ji-Hun SHIN ; Yong Joon KIM ; Kyoung Yul SEO ; Seung Mi LEE ; Jae Hyoung IM ; Jeong-Ran KWON ; Ho-Sung LEE ; Kyung-Won HWANG ; Eun-Hee SHIN
Parasites, Hosts and Diseases 2024;62(4):424-437
This study aimed to elucidate the clinical characteristics of patients diagnosed with toxoplasmosis in Korea. We collected and analyzed the specific research data of 5,917 patients from the Health Insurance Review and Assessment (HIRA; 2007–2020) and 533 electronic medical records (EMRs; 2003–2021) of Korean patients. The HIRA data showed that toxoplasmosis is an endemic disease that occurs constantly in Korea, with a large proportion of patients complaining of ocular symptoms. Of the 533 patients for whom EMR data were available, 54.6% were diagnosed with toxoplasmosis; ocular toxoplasmosis (35.7%), congenital toxoplasmosis (4.7%), cerebral toxoplasmosis (4.1%), pulmonary toxoplasmosis (0.4%), and toxoplasma hepatitis (0.6%), in order of frequency. In ocular cases, 54.4% of the patients had diverse ocular pathologies. Toxoplasmosis in Korea is characterized by a high frequency of ocular symptoms, most patients are adults, and 51.8% of patients with seropositivity were positive for IgG, suggesting prior infection. This study highlights that patients with ocular symptoms are included in the major diagnosis group for acquired toxoplasmosis in Korea.
8.Characteristics According to Frailty Status Among Older Korean Patients With Hypertension
Jung-Yeon CHOI ; Hae-Young LEE ; Ju-Hee LEE ; Youjin HONG ; Sue K. PARK ; Dong Ryeol RYU ; Jang Hoon LEE ; Seokjae HWANG ; Kye Hun KIM ; Sun Hwa LEE ; Song-Yi KIM ; Jae-Hyeong PARK ; Sang-Hyun KIM ; Hack-Lyoung KIM ; Jung Hyun CHOI ; Cheol-Ho KIM ; Myeong-Chan CHO ; Kwang-il KIM
Journal of Korean Medical Science 2024;39(10):e84-
Background:
As the prevalence of hypertension increases with age and the proportion of the older population is also on the rise, research on the characteristics of older hypertensive patients and the importance of frailty is necessary. This study aimed to identify clinical characteristics of older hypertension in Korea and to investigate these characteristics based on frailty status.
Methods:
The HOW to Optimize eLDerly systolic BP (HOWOLD-BP) is a prospective, multicenter, open-label, randomized clinical trial that aims to compare intensive (target systolic blood pressure [SBP] ≤ 130 mmHg) with standard (target SBP ≤ 140 mmHg) treatment to reduce cardiovascular events in older hypertensive Korean patients aged ≥ 65 years. Data were analyzed through a screening assessment of 2,085 patients recruited from 11 university hospitals. Demographic, functional (physical and cognitive), medical history, laboratory data, quality of life, and medication history of antihypertensive drugs were assessed.
Results:
The mean age was 73.2 years (standard deviation ± 5.60), and 48.0% (n = 1,001) were male. Prevalent conditions included dyslipidemia (66.5%), obesity (body mass index ≥ 25 kg/m 2 , 53.6%), and diabetes (28.9%). Dizziness and orthostatic hypotension were self-reported by 1.6% (n = 33) and 1.2% (n = 24), respectively. The majority of patients were on two antihypertensive drugs (48.4%), while 27.5% (n = 574) and 20.8% (n = 433) were on 1 and 3 antihypertensive medications, respectively. Frail to pre-frail patients were older and also tended to have dependent instrumental activities of daily living, slower gait speed, weaker grip strength, lower quality of life, and lower cognitive function. The frail to pre-frail group reported more dizziness (2.6% vs. 1.2%, P < 0.001) and had concerning clinical factors, including lower glomerular filtration rate, more comorbidities such as diabetes, stroke, and a history of admission. Frail to pre-frail older hypertensive patients used slightly more antihypertensive medications than robust older hypertensive patients (1.95 vs. 2.06, P = 0.003). Pre-frail to frail patients often chose beta-blockers as a third medication over diuretics.
Conclusion
This study described the general clinical characteristics of older hypertensive patients in Korea. Frail hypertensive patients face challenges in achieving positive clinical outcomes because of multifactorial causes: they are older, have more morbidities, decreased function, lower quality of life and cognitive function, and take more antihypertensive medications. Therefore, it is essential to comprehensively evaluate and monitor diseaserelated or drug-related adverse events more frequently during regular check-ups, which is necessary for pre-frail to frail older patients with hypertension.
9.Sex Differences in Chronic Cough Epidemiology: The Korean Cough Study Group
Jiyeon KANG ; Woo Jung SEO ; Jieun KANG ; Jung Gon KIM ; Sung Jun CHUNG ; Hyung Koo KANG ; Sung-Soon LEE ; Tai Joon AN ; Hyonsoo JOO ; Hyun LEE ; Youlim KIM ; Ina JEONG ; Jinkyeong PARK ; Sung-Kyoung KIM ; Jong-Wook SHIN ; Chin Kook RHEE ; Yee Hyung KIM ; Kyung Hoon MIN ; Ji-Yong MOON ; Deog Kyeom KIM ; Seung Hun JANG ; Kwang Ha YOO ; Jin Woo KIM ; Hyoung Kyu YOON ; Hyeon-Kyoung KOO
Journal of Korean Medical Science 2024;39(38):e273-
Background:
Chronic cough is a common symptom encountered by healthcare practitioners.The global prevalence of chronic cough is 9.6%, with a female predominance. The aim of our study is to reveal the sex differences in prevalence and severity of chronic cough in South Korea, stratified by age and etiology.
Methods:
This study included adult patients with chronic cough who were recruited from 19 respiratory centers in South Korea. Patients completed the cough numeric rating scale (NRS) and COugh Assessment Test (COAT) questionnaire to assess the severity and multidimensional impact of cough.
Results:
Among the 625 patients, 419 (67.0%) were females, with a male-to-female ratio of 1:2.03. The mean age was 49.4 years, and the median duration of cough was 12 weeks. The mean NRS and COAT scores were 5.5 ± 1.8 and 9.5 ± 3.6, respectively. Female patients were older (45.3 ± 15.4 vs. 51.6 ± 15.2, P < 0.001) and more likely to have asthma/cough variant asthma (CVA) (26.7% vs. 40.8%, P = 0.001) than male patients. There was no difference in the duration or severity of cough between sexes, regardless of the cause. The male-tofemale ratio was lower for upper airway cough syndrome (UACS), asthma/CVA, and gastroesophageal reflux disease (GERD), but not for eosinophilic bronchitis (EB) or unexplained cough. The mean age of female patients was higher in UACS and asthma/CVA, but not in EB, GERD, or unexplained cough. The majority (24.2%) fell within the age category of 50s. The proportion of females with cough increased with age, with a significant rise in the 50s, 60s, and 70–89 age groups. The severity of cough decreased in the 50s, 60s, and 70–89 age groups, with no significant sex differences within the same age group.
Conclusion
The sex disparities in prevalence and severity of cough varied significantly depending on the age category and etiology. Understanding the specific sex-based difference could enhance comprehension of cough-related pathophysiology and treatment strategies.
10.A Single-Center Experience of Robotic-Assisted Spine Surgery in Korea : Analysis of Screw Accuracy, Potential Risk Factor of Screw Malposition and Learning Curve
Bu Kwang OH ; Dong Wuk SON ; Jun Seok LEE ; Su Hun LEE ; Young Ha KIM ; Soon Ki SUNG ; Sang Weon LEE ; Geun Sung SONG ; Seong YI
Journal of Korean Neurosurgical Society 2024;67(1):60-72
Objective:
: Recently, robotic-assisted spine surgery (RASS) has been considered a minimally invasive and relatively accurate method. In total, 495 robotic-assisted pedicle screw fixation (RAPSF) procedures were attempted on 100 patients during a 14-month period. The current study aimed to analyze the accuracy, potential risk factors, and learning curve of RAPSF.
Methods:
: This retrospective study evaluated the position of RAPSF using the Gertzbein and Robbins scale (GRS). The accuracy was analyzed using the ratio of the clinically acceptable group (GRS grades A and B), the dissatisfying group (GRS grades C, D, and E), and the Surgical Evaluation Assistant program. The RAPSF was divided into the no-breached group (GRS grade A) and breached group (GRS grades B, C, D, and E), and the potential risk factors of RAPSF were evaluated. The learning curve was analyzed by changes in robot-used time per screw and the occurrence tendency of breached and failed screws according to case accumulation.
Results:
: The clinically acceptable group in RAPSF was 98.12%. In the analysis using the Surgical Evaluation Assistant program, the tip offset was 2.37±1.89 mm, the tail offset was 3.09±1.90 mm, and the angular offset was 3.72°±2.72°. In the analysis of potential risk factors, the difference in screw fixation level (p=0.009) and segmental distance between the tracker and the instrumented level (p=0.001) between the no-breached and breached group were statistically significant, but not for the other factors. The mean difference between the no-breach and breach groups was statistically significant in terms of pedicle width (p<0.001) and tail offset (p=0.042). In the learning curve analysis, the occurrence of breached and failed screws and the robot-used time per screw screws showed a significant decreasing trend.
Conclusion
: In the current study, RAPSF was highly accurate and the specific potential risk factors were not identified. However, pedicle width was presumed to be related to breached screw. Meanwhile, the robot-used time per screw and the incidence of breached and failed screws decreased with the learning curve.

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