1.Establishing an Active Vaccine Safety Surveillance System Using Large Scale Databases in Korea: Lessons and Scalable Insights for Global Application
Jin Gu YOON ; Eliel NHAM ; Yu Jung CHOI ; Min Joo CHOI ; Won Suk CHOI ; Young Kyung YOON ; Yu Bin SEO ; Hakjun HYUN ; Jung Yeon HEO ; Jin-Soo LEE ; Chung-Jong KIM ; Ji Yun NOH ; Joon Young SONG ; Hee Jin CHEONG
Journal of Korean Medical Science 2026;41(1):e47-
Vaccines are highly effective, but rare or delayed adverse events following immunization (AEFIs) require post-licensure surveillance beyond clinical trials. Korea lacks a comprehensive, active, database-based framework, yet key assets exist: nationwide claims databases (National Health Insurance Service/Health Insurance Review and Assessment Service), the national immunization registry (Korea Disease Control and Prevention Agency’s Immunization Registry Information System) for National Immunization Program (NIP) and non-NIP vaccines, and increasingly standardized hospital electronic health records.We propose a federated, code to data architecture with data linkages between these data.Implementation should adopt a common data model (CDM), standardized case definitions, latency accounting, and transparent public reporting under strong privacy governance. Major challenges include multi step administrative approvals for data linkage, incomplete capture of adult non-NIP vaccinations, heterogeneous hospital data structures, and strict data protection constraints. Strategic priorities are to streamline statutory and administrative processes for public health use, mandate or enable claims-based capture of adult vaccinations, enhance CDM based interoperability, and develop secure hubs for aggregated outputs. With these measures, Korea will be well positioned to establish a scalable active surveillance system capable of detecting rare AEFIs, supporting transparent and evidence-based communication, and ensuring equitable injury compensation grounded in domestic data.
2.Incidence, Risk Factors, and Outcomes of Chronic AntibioticRefractory Pouchitis in Korean Patients with Ulcerative Colitis
Ji Eun BAEK ; Jung-Bin PARK ; June Hwa BAE ; Min Hyun KIM ; Seung Wook HONG ; Sung Wook HWANG ; Jong Lyul LEE ; Yong Sik YOON ; Dong-Hoon YANG ; Byong Duk YE ; Jeong-Sik BYEON ; Seung-Jae MYUNG ; Chang Sik YU ; Suk-Kyun YANG ; Sang Hyoung PARK
Gut and Liver 2025;19(3):388-397
Background/Aims:
The study investigated the incidence, risk factors, and clinical outcomes of chronic antibiotic-refractory pouchitis (CARP) in Korean patients with ulcerative colitis (UC).
Methods:
This single-center retrospective study included patients with UC who underwent total proctocolectomy with ileal pouch-anal anastomosis at the Asan Medical Center in Korea between January 1987 and December 2022. The primary outcomes were endoscopic remission and pouch failure. The Cox’s proportional hazard model was used to identify the risk factors for CARP.
Results:
The clinical data of 232 patients were analyzed. The most common cause of surgery was steroid refractoriness (50.9%), followed by dysplasia/colorectal cancer (26.7%). Among 74 patients (31.9%) with chronic pouchitis (CP), 31 (13.4%) had CARP, and 43 (18.5%) had chronic antibiotic-dependent pouchitis (CADP). The most frequent endoscopic phenotype was focal inflammation of the pouch (CP, 47.3%; CARP, 35.5%; CADP, 55.8%). Patients with CARP were less likely to use concomitant probiotics than patients with CADP (29.0% vs 72.1%, p<0.01). The endoscopic remission rate of CP, CARP, and CADP was 14.9%, 9.7%, and 18.6%, respectively.The pouch failure rate associated with CP, CARP, and CADP was 13.5%, 16.1%, and 11.6%, respectively. Current smoking status (adjusted hazard ratio [aHR], 2.96; 95% confidence interval [CI], 1.27 to 6.90; p=0.01) and previous use of biologics/small molecules (aHR, 2.40; 95% CI, 1.05 to 5.53; p=0.04) were significantly associated with CARP development.
Conclusions
UC patients who were current smokers and previously used biologics/small molecules had a higher risk of developing CARP. Concomitant use of probiotics was less likely to be associated with CARP development.
3.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
4.Characteristics and outcomes of portal vein thrombosis in patients with inflammatory bowel disease in Korea
Ki Jin KIM ; Su-Bin SONG ; Jung-Bin PARK ; June Hwa BAE ; Ji Eun BAEK ; Ga Hee KIM ; Min-Jun KIM ; Seung Wook HONG ; Sung Wook HWANG ; Dong-Hoon YANG ; Byong Duk YE ; Jeong-Sik BYEON ; Seung-Jae MYUNG ; Suk-Kyun YANG ; Chang Sik YU ; Yong-Sik YOON ; Jong-Lyul LEE ; Min Hyun KIM ; Ho-Su LEE ; Sang Hyoung PARK
The Korean Journal of Internal Medicine 2025;40(2):243-250
Background/Aims:
Portal vein thrombosis (PVT) frequently occurs in patients with inflammatory bowel disease (IBD), particularly when influenced by factors such as abdominal infections, IBD flare-ups, or surgical procedures. The implications of PVT range from immediate issues such as intestinal ischemia to long-term concerns including portal hypertension and its complications. However, there is a notable gap in comprehensive studies on PVT in IBD, especially with the increasing incidence of IBD in Asia. This research aimed to evaluate the clinical features and outcomes of PVT in patients with IBD at a leading hospital in South Korea.
Methods:
This retrospective analysis reviewed adult patients diagnosed with both IBD and PVT from 1989 to 2021 at a renowned South Korean medical center. The study focused on patient characteristics, specifics of PVT, administered treatments, and outcomes, all confirmed through enhanced CT scans.
Results:
A total of 78 patients met the study’s criteria. Notably, only 20.5% (16/78) were treated with oral anticoagulants; however, a vast majority (96.2%; 75/78) achieved complete radiographic resolution (CRR). When comparing patients receiving anticoagulants to those who did not, a significant preference for anticoagulant use was observed in cases where the main portal vein was affected, as opposed to just the left or right veins (p = 0.006). However, multivariable analysis indicated that neither anticoagulant use nor previous surgeries significantly impacted CRR.
Conclusions
Patients with IBD and PVT generally had favorable outcomes, regardless of anticoagulant use.
5.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
6.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
7.Incidence, Risk Factors, and Outcomes of Chronic AntibioticRefractory Pouchitis in Korean Patients with Ulcerative Colitis
Ji Eun BAEK ; Jung-Bin PARK ; June Hwa BAE ; Min Hyun KIM ; Seung Wook HONG ; Sung Wook HWANG ; Jong Lyul LEE ; Yong Sik YOON ; Dong-Hoon YANG ; Byong Duk YE ; Jeong-Sik BYEON ; Seung-Jae MYUNG ; Chang Sik YU ; Suk-Kyun YANG ; Sang Hyoung PARK
Gut and Liver 2025;19(3):388-397
Background/Aims:
The study investigated the incidence, risk factors, and clinical outcomes of chronic antibiotic-refractory pouchitis (CARP) in Korean patients with ulcerative colitis (UC).
Methods:
This single-center retrospective study included patients with UC who underwent total proctocolectomy with ileal pouch-anal anastomosis at the Asan Medical Center in Korea between January 1987 and December 2022. The primary outcomes were endoscopic remission and pouch failure. The Cox’s proportional hazard model was used to identify the risk factors for CARP.
Results:
The clinical data of 232 patients were analyzed. The most common cause of surgery was steroid refractoriness (50.9%), followed by dysplasia/colorectal cancer (26.7%). Among 74 patients (31.9%) with chronic pouchitis (CP), 31 (13.4%) had CARP, and 43 (18.5%) had chronic antibiotic-dependent pouchitis (CADP). The most frequent endoscopic phenotype was focal inflammation of the pouch (CP, 47.3%; CARP, 35.5%; CADP, 55.8%). Patients with CARP were less likely to use concomitant probiotics than patients with CADP (29.0% vs 72.1%, p<0.01). The endoscopic remission rate of CP, CARP, and CADP was 14.9%, 9.7%, and 18.6%, respectively.The pouch failure rate associated with CP, CARP, and CADP was 13.5%, 16.1%, and 11.6%, respectively. Current smoking status (adjusted hazard ratio [aHR], 2.96; 95% confidence interval [CI], 1.27 to 6.90; p=0.01) and previous use of biologics/small molecules (aHR, 2.40; 95% CI, 1.05 to 5.53; p=0.04) were significantly associated with CARP development.
Conclusions
UC patients who were current smokers and previously used biologics/small molecules had a higher risk of developing CARP. Concomitant use of probiotics was less likely to be associated with CARP development.
8.Analysis of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ
Bin YANG ; Shengqiang GAO ; Min YU ; Genjun MAO ; Jiansheng LUO ; Shian YU
Chinese Journal of Hepatobiliary Surgery 2025;31(5):337-340
Objective:To study the feasibility and safety of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ.Methods:Clinical data of 60 patients with liver tumors treated at Jinhua Central Hospita from January 2018 to September 2022 were retrospectively collected, including 40 males and 20 females, aged (51.5±4.5) years. Perioperative data on operative time, intraoperative blood loss, postoperative time of ambulation, postoperative time to flatulate, duration of hospital stay, pathological type, complications (bile leakage, pleural effusion, etc.) were analyzed. Postoperative follow-ups were conducted through telephone reviews, outpatient visits.Results:Of 57 patients (95.0%) successfully underwent the surgery, while three cases (5.0%) were converted to open surgery due to excessive intraoperative bleeding. The operative time was (210.5±20.5) min. The intraoperative blood loss was (220.5±50.5) ml. The postoperative time of ambulation was (1.5±0.5) d, and the postoperative time to flatulate was (2.0±0.8) d. The postoperative hospital stay was (7.2±1.5) d. Bile leakage occurred in four cases (6.7%) after surgery, which was managed by conservative treatment, and pleural effusion occurred in eight cases (13.3%), which recovered after puncture and drainage. Postoperative pathology included 40 cases (66.7%) of hepatocellular carcinoma, three cases (5.0%) of intrahepatic cholangiocarcinoma, five cases (8.3%) of liver metastases, seven cases (11.7%) of hepatic hemangioma, two case (3.3%) of angiomyolipoma, and three case (5.0%) of focal hepatic nodular hyperplasia. No tumor recurrence was observed during follow-up (median 26 months; range 18-40 months).Conclusion:The application of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ is safe and feasible.
9.Characteristics and outcomes of portal vein thrombosis in patients with inflammatory bowel disease in Korea
Ki Jin KIM ; Su-Bin SONG ; Jung-Bin PARK ; June Hwa BAE ; Ji Eun BAEK ; Ga Hee KIM ; Min-Jun KIM ; Seung Wook HONG ; Sung Wook HWANG ; Dong-Hoon YANG ; Byong Duk YE ; Jeong-Sik BYEON ; Seung-Jae MYUNG ; Suk-Kyun YANG ; Chang Sik YU ; Yong-Sik YOON ; Jong-Lyul LEE ; Min Hyun KIM ; Ho-Su LEE ; Sang Hyoung PARK
The Korean Journal of Internal Medicine 2025;40(2):243-250
Background/Aims:
Portal vein thrombosis (PVT) frequently occurs in patients with inflammatory bowel disease (IBD), particularly when influenced by factors such as abdominal infections, IBD flare-ups, or surgical procedures. The implications of PVT range from immediate issues such as intestinal ischemia to long-term concerns including portal hypertension and its complications. However, there is a notable gap in comprehensive studies on PVT in IBD, especially with the increasing incidence of IBD in Asia. This research aimed to evaluate the clinical features and outcomes of PVT in patients with IBD at a leading hospital in South Korea.
Methods:
This retrospective analysis reviewed adult patients diagnosed with both IBD and PVT from 1989 to 2021 at a renowned South Korean medical center. The study focused on patient characteristics, specifics of PVT, administered treatments, and outcomes, all confirmed through enhanced CT scans.
Results:
A total of 78 patients met the study’s criteria. Notably, only 20.5% (16/78) were treated with oral anticoagulants; however, a vast majority (96.2%; 75/78) achieved complete radiographic resolution (CRR). When comparing patients receiving anticoagulants to those who did not, a significant preference for anticoagulant use was observed in cases where the main portal vein was affected, as opposed to just the left or right veins (p = 0.006). However, multivariable analysis indicated that neither anticoagulant use nor previous surgeries significantly impacted CRR.
Conclusions
Patients with IBD and PVT generally had favorable outcomes, regardless of anticoagulant use.
10.Incidence, Risk Factors, and Outcomes of Chronic AntibioticRefractory Pouchitis in Korean Patients with Ulcerative Colitis
Ji Eun BAEK ; Jung-Bin PARK ; June Hwa BAE ; Min Hyun KIM ; Seung Wook HONG ; Sung Wook HWANG ; Jong Lyul LEE ; Yong Sik YOON ; Dong-Hoon YANG ; Byong Duk YE ; Jeong-Sik BYEON ; Seung-Jae MYUNG ; Chang Sik YU ; Suk-Kyun YANG ; Sang Hyoung PARK
Gut and Liver 2025;19(3):388-397
Background/Aims:
The study investigated the incidence, risk factors, and clinical outcomes of chronic antibiotic-refractory pouchitis (CARP) in Korean patients with ulcerative colitis (UC).
Methods:
This single-center retrospective study included patients with UC who underwent total proctocolectomy with ileal pouch-anal anastomosis at the Asan Medical Center in Korea between January 1987 and December 2022. The primary outcomes were endoscopic remission and pouch failure. The Cox’s proportional hazard model was used to identify the risk factors for CARP.
Results:
The clinical data of 232 patients were analyzed. The most common cause of surgery was steroid refractoriness (50.9%), followed by dysplasia/colorectal cancer (26.7%). Among 74 patients (31.9%) with chronic pouchitis (CP), 31 (13.4%) had CARP, and 43 (18.5%) had chronic antibiotic-dependent pouchitis (CADP). The most frequent endoscopic phenotype was focal inflammation of the pouch (CP, 47.3%; CARP, 35.5%; CADP, 55.8%). Patients with CARP were less likely to use concomitant probiotics than patients with CADP (29.0% vs 72.1%, p<0.01). The endoscopic remission rate of CP, CARP, and CADP was 14.9%, 9.7%, and 18.6%, respectively.The pouch failure rate associated with CP, CARP, and CADP was 13.5%, 16.1%, and 11.6%, respectively. Current smoking status (adjusted hazard ratio [aHR], 2.96; 95% confidence interval [CI], 1.27 to 6.90; p=0.01) and previous use of biologics/small molecules (aHR, 2.40; 95% CI, 1.05 to 5.53; p=0.04) were significantly associated with CARP development.
Conclusions
UC patients who were current smokers and previously used biologics/small molecules had a higher risk of developing CARP. Concomitant use of probiotics was less likely to be associated with CARP development.

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