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.
4.Results of a Survey on Current Status and Demand for the Improvement of the Korean Journal of Pancreas and Biliary Tract
Tae Young PARK ; Jimin HAN ; Tae Hoon LEE ; Jae Kook YANG ; Hyeong Seok NAM ; Jun Hyuk SON ; Hoonsub SO ; Eaum Seok LEE ; Chi Hyuk OH ; Jun Hyung LEE ; Jong-Chan LEE ; Min Jae YANG ; Hee Seun LEE ; Seung Bae YOON ; Jae Hyuck CHANG
Korean Journal of Pancreas and Biliary Tract 2024;29(2):64-67
6.Accuracy and Clinical Outcomes of Fluoroscopy-Guided and Robotic-Assisted Percutaneous Pedicle Screw Fixation Performed by a Single Surgeon at a Single Center
Jong Hyeok LEE ; Dong Wuk SON ; Bu Kwang OH ; Jun Seok LEE ; Su Hun LEE ; Young Ha KIM ; Soon Ki SUNG ; Sang Weon LEE ; Geun Sung SONG ; Chang Hyeun KIM ; Chi Hyung LEE ; Seong YI
Journal of Minimally Invasive Spine Surgery and Technique 2024;9(1):61-68
Objective:
Fluoroscopy-guided percutaneous pedicle screw fixation (FGPSF) and its further development, robot-assisted percutaneous pedicle screw fixation (RAPSF), are minimally invasive spinal surgery (MISS) techniques. FGPSF is a standard technique at our hospital, and RAPSF incorporating artificial intelligence has been performed at our hospital since October 2021. This study compared these 2 techniques and analyzed their differences, accuracy, and clinical outcomes based on our experiences.
Methods:
This study conducted a detailed analysis of screw accuracy and the clinical outcomes of 2 MISS techniques, FGPSF, and RAPSF. Screw accuracy was evaluated using the Gertzbein and Robbins scale, categorizing placements into grades A–E, with grades A and B considered clinically acceptable. Accuracy was assessed using postoperative computed tomography images for FGPSF and intraoperative O-arm scan images for RAPSF. Clinical outcomes were compared by examining parameters, such as hospitalization duration, C-reactive protein (CRP) normalization period, estimated blood loss (EBL), and preoperative/postoperative visual analogue scale (VAS) scores. Screw-related complications were reviewed. Independent image evaluations by nonparticipating spine specialists ensured objective and reliable assessments.
Results:
Both FGPSF and RAPSF demonstrated high rates of clinically acceptable screw placement, with minimal breaches that required no repositioning. The clinically acceptable rates of FGPSF and RAPSF were similar (99.17% and 99.19%, respectively). Both groups also demonstrated similar clinical outcomes. The CRP normalization period, EBL, and ΔVAS (preoperative—postoperative) scores revealed no statistically significant differences between FGPSF and RAPSF. Neither group experienced screw-related complications; however, the RAPSF group exhibited a statistically significant shorter hospital stay than the FGPSF group.
Conclusion
This study compared the accuracy and clinical outcomes of FGPSF and RAPSF. Both methods demonstrated no significant differences in accuracy or clinical outcomes. Spine surgeons selected between the 2 methods based on individual patient needs, and additional research is required to fully understand the practical advantages of each technique in the clinical field.
7.Current Practice Patterns of Endoscopic Ultrasound-Guided Tissue Sampling for Pancreatic Solid Mass in Korea: Outcomes of a National Survey
Dong-Won AHN ; Hyung Ku CHON ; Sung-Hoon MOON ; Sang Wook PARK ; Woo Hyun PAIK ; Chang Nyol PAIK ; Byoung Kwan SON ; Tae Jun SONG ; Eaum Seok LEE ; Yun Nah LEE ; Yoon Suk LEE ; Jae Min LEE ; Tae Joo JEON ; Chang Hwan PARK ; Kwang Bum CHO ; Dong Wook LEE ; Hong Ja KIM ; Seung Bae YOON ; Kwang Hyun CHUNG ; Jin-Seok PARK
Gut and Liver 2023;17(2):328-336
Background/Aims:
Although endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) are widely used for tissue acquisition of pancreatic solid mass, the optimal strategy of this procedure has not been established yet. The aim of this nationwide study was to investigate the current practice patterns of EUS-FNA/FNB for pancreatic solid mass in Korea.
Methods:
The Policy-Quality Management of the Korean Pancreatobiliary Association (KPBA) developed a questionnaire containing 22 questions. An electronic survey consisting of the questionnaire was distributed by e-mail to members registered to the KPBA.
Results:
A total of 101 respondents completed the survey. Eighty respondents (79.2%) performed preoperative EUS-FNA/FNB for operable pancreatic solid mass. Acquire needles (60.4%) were used the most, followed by ProCore needles (47.5%). In terms of need size, most respondents (>80%) preferred 22-gauge needles regardless of the location of the mass. Negative suction with a 10-mL syringe (71.3%) as sampling technique was followed by stylet slow-pull (41.6%). More than three needle passes for EUS-FNA/FNB was performed by most respondents (>80%). The frequency of requiring repeated procedure was significantly higher in respondents with a low individual volume (<5 per month, p=0.001). Prophylactic antibiotics were routinely used in 39 respondents (38.6%); rapid on-site pathologic evaluation was used in 6.1%.
Conclusions
According to this survey, practices of EUS-FNA/FNB for pancreatic solid mass varied substantially, some of which differed considerably from the recommendations present in existing guidelines. These results suggest that the development of evidence-based quality guidelines fitting Korean clinical practice is needed to establish the optimal strategy for this procedure.
8.Location of Ulnar Nerve Branches to the Flexor Carpi Ulnaris during Surgery for Cubital Tunnel Syndrome
Won Seok LEE ; Hee-Jin YANG ; Sung Bae PARK ; Young Je SON ; Noah HONG ; Sang Hyung LEE
Journal of Korean Neurosurgical Society 2023;66(1):90-94
Objective:
: Cubital tunnel syndrome, the most common ulnar nerve entrapment neuropathy, is usually managed by simple decompression or anterior transposition. One of the concerns in transposition is damage to the nerve branches around the elbow. In this study, the location of ulnar nerve branches to the flexor carpi ulnaris (FCU) was assessed during operations for cubital tunnel syndrome to provide information to reduce operation-related complications.
Methods:
: A personal series (HJY) of cases operated for cubital tunnel syndrome was reviewed. Cases managed by transposition and location of branches to the FCU were selected for analysis. The function of the branches was confirmed by intraoperative nerve stimulation and the location of the branches was assessed by the distance from the center of medial epicondyle.
Results:
: There was a total of 61 cases of cubital tunnel syndrome, among which 31 were treated by transposition. Twenty-one cases with information on the location of branches were analyzed. The average number of ulnar nerve branches around the elbow was 1.8 (0 to 3), only one case showed no branches. Most of the cases had one branch to the medial head, and one other to the lateral head of the FCU. There were two cases having branches without FCU responses (one branch in one case, three branches in another). The location of the branches to the medial head was 16.3±8.6 mm distal to the medial epicondyle (16 branches; range, 0 to 35 mm), to the lateral head was 19.5±9.5 mm distal to the medial epicondyle (19 branches; range, -5 to 30 mm). Branches without FCU responses were found from 20 mm proximal to the medial condyle to 15 mm distal to the medial epicondyle (five branches). Most of the branches to the medial head were 15 to 20 mm (50% of cases), and most to the lateral head were 15 to 25 mm (58% of cases). There were no cases of discernable weakness of the FCU after operation.
Conclusion
: In most cases of cubital tunnel syndrome, there are ulnar nerve branches around the elbow. Although there might be some cases with branches without FCU responses, most branches are to the FCU, and are to be saved. The operator should be watchful for branches about 15 to 25 mm distal to the medial epicondyle, where most branches come out.
9.National Survey Regarding the Management of Difficult Bile Duct Stones in South Korea
Yoon Suk LEE ; Tae Joo JEON ; Woo Hyun PAIK ; Dong-Won AHN ; Kwang Hyun CHUNG ; Byoung Kwan SON ; Tae Jun SONG ; Sung-Hoon MOON ; Eaum Seok LEE ; Jae Min LEE ; Seung Bae YOON ; Chang Nyol PAIK ; Yun Nah LEE ; Jin-Seok PARK ; Dong Wook LEE ; Sang Wook PARK ; Hyung Ku CHON ; Kwang Bum CHO ; Chang Hwan PARK ;
Gut and Liver 2023;17(3):475-481
Background/Aims:
This study aimed to investigate the patterns of preferred endoscopic procedure types and techniques for managing difficult common bile duct (CBD) stones in South Korea.
Methods:
The Committee of Policy and Quality Management of Korean Pancreatobiliary Association (KPBA) conducted a survey containing 19 questions. Both paper and online surveys were carried out; with the paper survey being conducted during the 2019 Annual Congress of KPBA and the online survey being conducted through Google Forms from April 2020 to February 2021.
Results:
The response rate was approximately 41.3% (86/208). Sixty-two (73.0%) worked at tertiary hospitals or academic medical centers, and 60 (69.7%) had more than 5 years of endoscopic retrograde cholangiopancreatography experience. The preferred size criteria for large CBD stones were 15 mm (40.6%), 20 mm (31.3%), and 30 mm (4.6%). For managing of large CBD stones, endoscopic papillary large balloon dilation after endoscopic sphincterotomy was the most preferred technique (74.4%). When performing procedures in those with bleeding diathesis, 64 (74.4%) respondents favored endoscopic papillary balloon dilation (EPBD) alone or EPBD with small endoscopic sphincterotomy. Fifty-five respondents (63.9%) preferred the doubleguidewire technique when faced with difficult bile duct cannulation in patients with periampullary diverticulum. In surgically altered anatomies, cap-fitted forward viewing endoscopy (76.7%) and percutaneous transhepatic cholangioscopy (48.8%) were the preferred techniques for Billroth-II anastomosis and total gastrectomy with Roux-en-Y anastomosis, respectively.
Conclusions
Most respondents showed unifying trends for the management of difficult CBD stones. The current practice patterns could be used as basic data for clinical quality improvements in the management of difficult CBD stones.
10.Additive harmful effects of acute kidney injury and acute heart failure on mortality in hospitalized patients
Hyung Eun SON ; Jong Joo MOON ; Jeong-min PARK ; Ji Young RYU ; Eunji BAEK ; Jong Cheol JEONG ; Ho Jun CHIN ; Ki Young NA ; Dong-wan CHAE ; Seung Seok HAN ; Sejoong KIM
Kidney Research and Clinical Practice 2022;41(2):188-199
Organ crosstalk between the kidney and the heart has been suggested. Acute kidney injury (AKI) and acute heart failure (AHF) are well-known independent risk factors for mortality in hospitalized patients. This study aimed to investigate if these conditions have an additive effect on mortality in hospitalized patients, as this has not been explored in previous studies. Methods: We retrospectively reviewed the records of 101,804 hospitalized patients who visited two tertiary hospitals in the Republic of Korea over a period of 5 years. AKI was diagnosed using serum creatinine-based criteria, and AHF was classified using International Classification of Diseases codes within 2 weeks after admission. Patients were divided into four groups according to the two conditions. The primary outcome was all-cause mortality. Results: AKI occurred in 6.8% of all patients (n = 6,920) and AHF in 1.2% (n = 1,244). Three hundred thirty-one patients (0.3%) developed both conditions while AKI alone was present in 6,589 patients (6.5%) and AHF alone in 913 patients (0.9%). Among the 5,181 patients (5.1%) who died, 20.8% died within 1 month. The hazard ratio for 1-month mortality was 29.23 in patients with both conditions, 15.00 for AKI only, and 3.39 for AHF only. The relative excess risk of interaction was 11.85 (95% confidence interval, 2.43–21.27), and was more prominent in patients aged <75 years and those without chronic heart failure. Conclusion: AKI and AHF have a detrimental additive effect on short-term mortality in hospitalized patients.

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