1.Epidemiological Characteristics and Outcome of Myocarditis and Pericarditis Temporally Associated With BNT162b2 COVID-19 Vaccine in Adolescents: Korean National Surveillance
Bin AHN ; Seung Hwan SHIN ; Myung-Jae HWANG ; HyoSug CHOI ; Sara NA ; Sangshin PARK ; Jue Seong LEE ; Young June CHOE ; Yoonsun YOON ; Kyoungsan SEO ; Jong Hee KIM ; Hyun Mi KANG
Journal of Korean Medical Science 2024;39(49):e317-
Background:
This study aimed to investigate the epidemiological characteristics and outcomes of myocarditis/pericarditis after BNT162b2 vaccination in Korean adolescents.
Methods:
This was a retrospective cohort analysis of adolescents aged 12–19 years old diagnosed with myocarditis/pericarditis within 42 days of BNT162b2 mRNA vaccination. All reported cases were investigated by city or government epidemiologists and the diagnostic certainty and causality was determined by the Korea Disease Control and Prevention Agency’s Adverse Event Following Immunization Expert Advisory Committee according to the modified version of Brighton Collaboration Myocarditis/Pericarditis Working group’s case definitions.
Results:
A total 3,709,063 adolescents aged 12–19 received 8,135,240 doses of the BNT162b2 vaccine in South Korea, and 184 cases met the Brighton criteria for the case definition of myocarditis and pericarditis with diagnostic certainty of possible and above. The median age was 17 years old (interquartile range [IQR], 15–18) and boys accounted for 81.5% (n = 150/184) of the cases. The overall incidence was 2.25 (95% confidence interval [CI], 1.94–2.60) cases per 100,000 doses and severe cases was 0.25 (95% CI, 0.15–3.80) cases per 100,000 doses.The highest incidence rate was observed in boys after the second dose, with 5.01 (95% CI, 4.12–6.17) cases per 100,000 doses. A total 89.1% (164/184) were classified as mild, and no deaths were reported.
Conclusion
The highest incidence of myocarditis/pericarditis after BNT162b2 immunization was observed in male adolescents after the second dose, with majority of the cases presenting with a mild clinical course and favorable outcome.
2.Epidemiological Characteristics and Outcome of Myocarditis and Pericarditis Temporally Associated With BNT162b2 COVID-19 Vaccine in Adolescents: Korean National Surveillance
Bin AHN ; Seung Hwan SHIN ; Myung-Jae HWANG ; HyoSug CHOI ; Sara NA ; Sangshin PARK ; Jue Seong LEE ; Young June CHOE ; Yoonsun YOON ; Kyoungsan SEO ; Jong Hee KIM ; Hyun Mi KANG
Journal of Korean Medical Science 2024;39(49):e317-
Background:
This study aimed to investigate the epidemiological characteristics and outcomes of myocarditis/pericarditis after BNT162b2 vaccination in Korean adolescents.
Methods:
This was a retrospective cohort analysis of adolescents aged 12–19 years old diagnosed with myocarditis/pericarditis within 42 days of BNT162b2 mRNA vaccination. All reported cases were investigated by city or government epidemiologists and the diagnostic certainty and causality was determined by the Korea Disease Control and Prevention Agency’s Adverse Event Following Immunization Expert Advisory Committee according to the modified version of Brighton Collaboration Myocarditis/Pericarditis Working group’s case definitions.
Results:
A total 3,709,063 adolescents aged 12–19 received 8,135,240 doses of the BNT162b2 vaccine in South Korea, and 184 cases met the Brighton criteria for the case definition of myocarditis and pericarditis with diagnostic certainty of possible and above. The median age was 17 years old (interquartile range [IQR], 15–18) and boys accounted for 81.5% (n = 150/184) of the cases. The overall incidence was 2.25 (95% confidence interval [CI], 1.94–2.60) cases per 100,000 doses and severe cases was 0.25 (95% CI, 0.15–3.80) cases per 100,000 doses.The highest incidence rate was observed in boys after the second dose, with 5.01 (95% CI, 4.12–6.17) cases per 100,000 doses. A total 89.1% (164/184) were classified as mild, and no deaths were reported.
Conclusion
The highest incidence of myocarditis/pericarditis after BNT162b2 immunization was observed in male adolescents after the second dose, with majority of the cases presenting with a mild clinical course and favorable outcome.
3.A Case of Tracheogastric Puncture Using Transnasal Esophagoscopy After Total Laryngopharyngoesophagectomy and Gastric Pull-Up Reconstruction
Sujin HAN ; Sin Jae KANG ; Jue Hee KIM ; Min Woo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2024;67(10):551-554
Voice rehabilitation after total laryngopharyngoesophagectomy is a significant challenge, especially when accompanied by gastric pull-up reconstruction. In 2021, a study revealed that tracheoesophageal puncture is also safe and feasible option for voice rehabilitation in patients who underwent gastric pull-up surgery. Here, we report for the first time in South Korea a case that represents an instance of voice prosthesis insertion after gastric pull-up surgery. The case demonstrates the feasibility and safety of voice prosthesis insertion in patients who undergo total laryngopharyngoesophagectomy and gastric pull-up surgery, providing evidence that voice prosthesis insertion is achievable and can be performed in the outpatient setting using transnasal esophagoscopy.
4.Two Cases of Diagnosis and Botulinum Toxin Treatment in Patients Who Were Unable to Burp
Jue Hee KIM ; Sujin HAN ; Sin Jae KANG ; Min Woo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2024;67(9):506-509
Retrograde cricopharyngeus dysfunction (R-CPD) is a new syndrome first described in 2019 by Bastian. It is characterized by an inability to belch, along with associated symptoms such as loud gurgling noises, chest and abdominal pain/distention, and excessive flatulence. The cause of R-CPD is not yet clearly understood, but it is believed to be related to the dysfunction of the cricopharyngeus muscle. In Korea, R-CPD is not well understood yet and consequently, there is no available treatment for this condition to date. Here, we aim to report two cases of diagnosing and treating patients with R-CPD for the first time in Korea using botulinum toxin injection under local anesthesia.
5.A Case of Tracheogastric Puncture Using Transnasal Esophagoscopy After Total Laryngopharyngoesophagectomy and Gastric Pull-Up Reconstruction
Sujin HAN ; Sin Jae KANG ; Jue Hee KIM ; Min Woo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2024;67(10):551-554
Voice rehabilitation after total laryngopharyngoesophagectomy is a significant challenge, especially when accompanied by gastric pull-up reconstruction. In 2021, a study revealed that tracheoesophageal puncture is also safe and feasible option for voice rehabilitation in patients who underwent gastric pull-up surgery. Here, we report for the first time in South Korea a case that represents an instance of voice prosthesis insertion after gastric pull-up surgery. The case demonstrates the feasibility and safety of voice prosthesis insertion in patients who undergo total laryngopharyngoesophagectomy and gastric pull-up surgery, providing evidence that voice prosthesis insertion is achievable and can be performed in the outpatient setting using transnasal esophagoscopy.
6.Two Cases of Diagnosis and Botulinum Toxin Treatment in Patients Who Were Unable to Burp
Jue Hee KIM ; Sujin HAN ; Sin Jae KANG ; Min Woo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2024;67(9):506-509
Retrograde cricopharyngeus dysfunction (R-CPD) is a new syndrome first described in 2019 by Bastian. It is characterized by an inability to belch, along with associated symptoms such as loud gurgling noises, chest and abdominal pain/distention, and excessive flatulence. The cause of R-CPD is not yet clearly understood, but it is believed to be related to the dysfunction of the cricopharyngeus muscle. In Korea, R-CPD is not well understood yet and consequently, there is no available treatment for this condition to date. Here, we aim to report two cases of diagnosing and treating patients with R-CPD for the first time in Korea using botulinum toxin injection under local anesthesia.
7.A Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer
Keun-Wook LEE ; Sae-Won HAN ; Tae Won KIM ; Joong Bae AHN ; Ji Yeon BAEK ; Sang Hee CHO ; Howard LEE ; Jin Won KIM ; Ji-Won KIM ; Tae-You KIM ; Yong Sang HONG ; Seung-Hoon BEOM ; Yongjun CHA ; Yoonjung CHOI ; Seonhui KIM ; Yung-Jue BANG
Cancer Research and Treatment 2024;56(2):590-601
Purpose:
GC1118 is a novel antibody targeting epidermal growth factor receptor (EGFR) with enhanced blocking activity against both low- and high-affinity EGFR ligands. A phase 1b/2a study was conducted to determine a recommended phase 2 dose (RP2D) of GC1118 in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) (phase 1b) and to assess the safety and efficacy of GC1118 plus FOLFIRI as a second-line therapy for recurrent/metastatic colorectal cancer (CRC) (phase 2a).
Materials and Methods:
Phase 1b was designed as a standard 3+3 dose-escalation study with a starting dose of GC1118 (3 mg/kg/week) in combination with biweekly FOLFIRI (irinotecan 180 mg/m2; leucovorin 400 mg/m2; 5-fluorouracil 400 mg/m2 bolus and 2,400 mg/m2 infusion over 46 hours) in patients with solid tumors refractory to standard treatments. The subsequent phase 2a part was conducted with objective response rate (ORR) as a primary endpoint. Patients with KRAS/NRAS/BRAF wild-type, EGFR-positive, recurrent/metastatic CRC resistant to the first-line treatment were enrolled in the phase 2a study.
Results:
RP2D of GC1118 was determined to be 3 mg/kg/wk in the phase 1b study (n=7). Common adverse drug reactions (ADRs) observed in the phase 2a study (n=24) were acneiform rash (95.8%), dry skin (66.7%), paronychia (58.3%), and stomatitis (50.0%). The most common ADR of ≥ grade 3 was neutropenia (33.3%). ORR was 42.5% (95% confidence interval [CI], 23.5 to 62.0), and median progression-free survival was 6.7 months (95% CI, 4.0-8.0).
Conclusion
GC1118 administered weekly at 3 mg/kg in combination with FOLFIRI appears as an effective and safe treatment option in recurrent/metastatic CRC.
8.A Case of Tracheogastric Puncture Using Transnasal Esophagoscopy After Total Laryngopharyngoesophagectomy and Gastric Pull-Up Reconstruction
Sujin HAN ; Sin Jae KANG ; Jue Hee KIM ; Min Woo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2024;67(10):551-554
Voice rehabilitation after total laryngopharyngoesophagectomy is a significant challenge, especially when accompanied by gastric pull-up reconstruction. In 2021, a study revealed that tracheoesophageal puncture is also safe and feasible option for voice rehabilitation in patients who underwent gastric pull-up surgery. Here, we report for the first time in South Korea a case that represents an instance of voice prosthesis insertion after gastric pull-up surgery. The case demonstrates the feasibility and safety of voice prosthesis insertion in patients who undergo total laryngopharyngoesophagectomy and gastric pull-up surgery, providing evidence that voice prosthesis insertion is achievable and can be performed in the outpatient setting using transnasal esophagoscopy.
9.Two Cases of Diagnosis and Botulinum Toxin Treatment in Patients Who Were Unable to Burp
Jue Hee KIM ; Sujin HAN ; Sin Jae KANG ; Min Woo PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2024;67(9):506-509
Retrograde cricopharyngeus dysfunction (R-CPD) is a new syndrome first described in 2019 by Bastian. It is characterized by an inability to belch, along with associated symptoms such as loud gurgling noises, chest and abdominal pain/distention, and excessive flatulence. The cause of R-CPD is not yet clearly understood, but it is believed to be related to the dysfunction of the cricopharyngeus muscle. In Korea, R-CPD is not well understood yet and consequently, there is no available treatment for this condition to date. Here, we aim to report two cases of diagnosing and treating patients with R-CPD for the first time in Korea using botulinum toxin injection under local anesthesia.
10.Epidemiological Characteristics and Outcome of Myocarditis and Pericarditis Temporally Associated With BNT162b2 COVID-19 Vaccine in Adolescents: Korean National Surveillance
Bin AHN ; Seung Hwan SHIN ; Myung-Jae HWANG ; HyoSug CHOI ; Sara NA ; Sangshin PARK ; Jue Seong LEE ; Young June CHOE ; Yoonsun YOON ; Kyoungsan SEO ; Jong Hee KIM ; Hyun Mi KANG
Journal of Korean Medical Science 2024;39(49):e317-
Background:
This study aimed to investigate the epidemiological characteristics and outcomes of myocarditis/pericarditis after BNT162b2 vaccination in Korean adolescents.
Methods:
This was a retrospective cohort analysis of adolescents aged 12–19 years old diagnosed with myocarditis/pericarditis within 42 days of BNT162b2 mRNA vaccination. All reported cases were investigated by city or government epidemiologists and the diagnostic certainty and causality was determined by the Korea Disease Control and Prevention Agency’s Adverse Event Following Immunization Expert Advisory Committee according to the modified version of Brighton Collaboration Myocarditis/Pericarditis Working group’s case definitions.
Results:
A total 3,709,063 adolescents aged 12–19 received 8,135,240 doses of the BNT162b2 vaccine in South Korea, and 184 cases met the Brighton criteria for the case definition of myocarditis and pericarditis with diagnostic certainty of possible and above. The median age was 17 years old (interquartile range [IQR], 15–18) and boys accounted for 81.5% (n = 150/184) of the cases. The overall incidence was 2.25 (95% confidence interval [CI], 1.94–2.60) cases per 100,000 doses and severe cases was 0.25 (95% CI, 0.15–3.80) cases per 100,000 doses.The highest incidence rate was observed in boys after the second dose, with 5.01 (95% CI, 4.12–6.17) cases per 100,000 doses. A total 89.1% (164/184) were classified as mild, and no deaths were reported.
Conclusion
The highest incidence of myocarditis/pericarditis after BNT162b2 immunization was observed in male adolescents after the second dose, with majority of the cases presenting with a mild clinical course and favorable outcome.

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