1.Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility
Daham KIM ; Yoon Hee CHO ; Min Jeong KANG ; So Jeong LEE ; Soohyun LEE ; Bo Hyon YUN ; Hyunjin CHI ; Jeongsuk AN ; Kyungsun LEE ; Jaekyu HAN ; Susan CHI ; Moo Young SONG ; Sang-Hoon CHA ; Eun Jig LEE
Endocrinology and Metabolism 2025;40(1):146-155
Background:
Recombinant human follicle-stimulating hormone (rhFSH) is commonly used to treat female infertility, but its short half-life necessitates multiple doses. Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days. This study aimed to develop and evaluate a long-acting follicle-stimulating hormone (FSH) formulation using anti-serum albumin Fab-associated (SAFA) technology to avoid additional injections and enhance ovarian function.
Methods:
SAFA-FSH was synthesized using a Chinese hamster ovary expression system. Its biological efficacy was confirmed through assays measuring its ability to stimulate cyclic adenosine monophosphate (cAMP) production, estradiol synthesis, and the expression of human cytochrome P450 family 19 subfamily A member 1 (hCYP19α1) and human steroidogenic acute regulatory protein (hSTAR) in human ovarian granulosa (KGN) cells. To evaluate the effects of SAFA-FSH, we compared its impact on serum estradiol levels and ovarian weight increase with that of rhFSH in Sprague-Dawley (SD) rats using the modified Steelman-Pohley test.
Results:
The results indicated that SAFA-FSH induces cAMP synthesis in KGN cells and upregulates the expression of hCYP19α1 and hSTAR in a dose-dependent manner. Female SD rats, aged 21 days, receiving daily subcutaneous human chorionic gonadotropin injections for 5 days exhibited a significant increase in serum estradiol levels and ovarian weight when administered SAFA-FSH on the first day or when given nine injections of rhFSH over 5 days. Notably, the group receiving SAFA-FSH on the first and third days demonstrated an even greater rise in serum estradiol levels and ovarian weight.
Conclusion
These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts.
2.Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility
Daham KIM ; Yoon Hee CHO ; Min Jeong KANG ; So Jeong LEE ; Soohyun LEE ; Bo Hyon YUN ; Hyunjin CHI ; Jeongsuk AN ; Kyungsun LEE ; Jaekyu HAN ; Susan CHI ; Moo Young SONG ; Sang-Hoon CHA ; Eun Jig LEE
Endocrinology and Metabolism 2025;40(1):146-155
Background:
Recombinant human follicle-stimulating hormone (rhFSH) is commonly used to treat female infertility, but its short half-life necessitates multiple doses. Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days. This study aimed to develop and evaluate a long-acting follicle-stimulating hormone (FSH) formulation using anti-serum albumin Fab-associated (SAFA) technology to avoid additional injections and enhance ovarian function.
Methods:
SAFA-FSH was synthesized using a Chinese hamster ovary expression system. Its biological efficacy was confirmed through assays measuring its ability to stimulate cyclic adenosine monophosphate (cAMP) production, estradiol synthesis, and the expression of human cytochrome P450 family 19 subfamily A member 1 (hCYP19α1) and human steroidogenic acute regulatory protein (hSTAR) in human ovarian granulosa (KGN) cells. To evaluate the effects of SAFA-FSH, we compared its impact on serum estradiol levels and ovarian weight increase with that of rhFSH in Sprague-Dawley (SD) rats using the modified Steelman-Pohley test.
Results:
The results indicated that SAFA-FSH induces cAMP synthesis in KGN cells and upregulates the expression of hCYP19α1 and hSTAR in a dose-dependent manner. Female SD rats, aged 21 days, receiving daily subcutaneous human chorionic gonadotropin injections for 5 days exhibited a significant increase in serum estradiol levels and ovarian weight when administered SAFA-FSH on the first day or when given nine injections of rhFSH over 5 days. Notably, the group receiving SAFA-FSH on the first and third days demonstrated an even greater rise in serum estradiol levels and ovarian weight.
Conclusion
These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts.
3.Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility
Daham KIM ; Yoon Hee CHO ; Min Jeong KANG ; So Jeong LEE ; Soohyun LEE ; Bo Hyon YUN ; Hyunjin CHI ; Jeongsuk AN ; Kyungsun LEE ; Jaekyu HAN ; Susan CHI ; Moo Young SONG ; Sang-Hoon CHA ; Eun Jig LEE
Endocrinology and Metabolism 2025;40(1):146-155
Background:
Recombinant human follicle-stimulating hormone (rhFSH) is commonly used to treat female infertility, but its short half-life necessitates multiple doses. Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days. This study aimed to develop and evaluate a long-acting follicle-stimulating hormone (FSH) formulation using anti-serum albumin Fab-associated (SAFA) technology to avoid additional injections and enhance ovarian function.
Methods:
SAFA-FSH was synthesized using a Chinese hamster ovary expression system. Its biological efficacy was confirmed through assays measuring its ability to stimulate cyclic adenosine monophosphate (cAMP) production, estradiol synthesis, and the expression of human cytochrome P450 family 19 subfamily A member 1 (hCYP19α1) and human steroidogenic acute regulatory protein (hSTAR) in human ovarian granulosa (KGN) cells. To evaluate the effects of SAFA-FSH, we compared its impact on serum estradiol levels and ovarian weight increase with that of rhFSH in Sprague-Dawley (SD) rats using the modified Steelman-Pohley test.
Results:
The results indicated that SAFA-FSH induces cAMP synthesis in KGN cells and upregulates the expression of hCYP19α1 and hSTAR in a dose-dependent manner. Female SD rats, aged 21 days, receiving daily subcutaneous human chorionic gonadotropin injections for 5 days exhibited a significant increase in serum estradiol levels and ovarian weight when administered SAFA-FSH on the first day or when given nine injections of rhFSH over 5 days. Notably, the group receiving SAFA-FSH on the first and third days demonstrated an even greater rise in serum estradiol levels and ovarian weight.
Conclusion
These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts.
4.Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility
Daham KIM ; Yoon Hee CHO ; Min Jeong KANG ; So Jeong LEE ; Soohyun LEE ; Bo Hyon YUN ; Hyunjin CHI ; Jeongsuk AN ; Kyungsun LEE ; Jaekyu HAN ; Susan CHI ; Moo Young SONG ; Sang-Hoon CHA ; Eun Jig LEE
Endocrinology and Metabolism 2025;40(1):146-155
Background:
Recombinant human follicle-stimulating hormone (rhFSH) is commonly used to treat female infertility, but its short half-life necessitates multiple doses. Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days. This study aimed to develop and evaluate a long-acting follicle-stimulating hormone (FSH) formulation using anti-serum albumin Fab-associated (SAFA) technology to avoid additional injections and enhance ovarian function.
Methods:
SAFA-FSH was synthesized using a Chinese hamster ovary expression system. Its biological efficacy was confirmed through assays measuring its ability to stimulate cyclic adenosine monophosphate (cAMP) production, estradiol synthesis, and the expression of human cytochrome P450 family 19 subfamily A member 1 (hCYP19α1) and human steroidogenic acute regulatory protein (hSTAR) in human ovarian granulosa (KGN) cells. To evaluate the effects of SAFA-FSH, we compared its impact on serum estradiol levels and ovarian weight increase with that of rhFSH in Sprague-Dawley (SD) rats using the modified Steelman-Pohley test.
Results:
The results indicated that SAFA-FSH induces cAMP synthesis in KGN cells and upregulates the expression of hCYP19α1 and hSTAR in a dose-dependent manner. Female SD rats, aged 21 days, receiving daily subcutaneous human chorionic gonadotropin injections for 5 days exhibited a significant increase in serum estradiol levels and ovarian weight when administered SAFA-FSH on the first day or when given nine injections of rhFSH over 5 days. Notably, the group receiving SAFA-FSH on the first and third days demonstrated an even greater rise in serum estradiol levels and ovarian weight.
Conclusion
These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts.
5.Development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program: a nationwide project to improve surgical quality and patient safety
Jeong-Moo LEE ; In Woong HAN ; Oh Chul KWON ; Hye Rim SEO ; Jipmin JUNG ; So Jeong YOON ; Ahram HAN ; Juhan LEE ; Soo Young LEE ; Hoseok SEO ; Wooil KWON ; Bang Wool EOM ; In-Seob LEE ; Ji Won PARK ; Hae Won LEE ; Ho Kyoung HWANG ; Suk-Hwan LEE ; Eung Jin SHIN ; Woo Yong LEE
Annals of Surgical Treatment and Research 2024;107(6):305-314
Purpose:
Improvements in surgical quality and patient safety are critical components of the healthcare system. Despite excellent cancer survival rates in Korea, there is a lack of standardized postoperative complication management systems.To address this gap, the Korean Surgical Society initiated the development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program.
Methods:
K-QIPS was successfully launched in 87 general hospitals. This nationwide surgical quality improvement program covers 5 major surgical fields: gastric surgery, colorectal surgery, hepatectomy and liver transplantation, pancreatectomy, and kidney transplantation.
Results:
Common and surgery-specific complication platforms will be developed, and the program will work toward the implementation of an artificial intelligence-based complication prediction system and the provision of evidence-based feedback to participating institutions. K-QIPS represents a significant step toward improving surgical quality and patient safety in Korea.
Conclusion
This program aims to reduce postoperative complications, mortality, and medical costs by providing a standardized platform for complication management and prediction. The successful implementation of this nationwide project may provide a good model for other countries that are required to improve surgical outcomes and patient care.
6.Development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program: a nationwide project to improve surgical quality and patient safety
Jeong-Moo LEE ; In Woong HAN ; Oh Chul KWON ; Hye Rim SEO ; Jipmin JUNG ; So Jeong YOON ; Ahram HAN ; Juhan LEE ; Soo Young LEE ; Hoseok SEO ; Wooil KWON ; Bang Wool EOM ; In-Seob LEE ; Ji Won PARK ; Hae Won LEE ; Ho Kyoung HWANG ; Suk-Hwan LEE ; Eung Jin SHIN ; Woo Yong LEE
Annals of Surgical Treatment and Research 2024;107(6):305-314
Purpose:
Improvements in surgical quality and patient safety are critical components of the healthcare system. Despite excellent cancer survival rates in Korea, there is a lack of standardized postoperative complication management systems.To address this gap, the Korean Surgical Society initiated the development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program.
Methods:
K-QIPS was successfully launched in 87 general hospitals. This nationwide surgical quality improvement program covers 5 major surgical fields: gastric surgery, colorectal surgery, hepatectomy and liver transplantation, pancreatectomy, and kidney transplantation.
Results:
Common and surgery-specific complication platforms will be developed, and the program will work toward the implementation of an artificial intelligence-based complication prediction system and the provision of evidence-based feedback to participating institutions. K-QIPS represents a significant step toward improving surgical quality and patient safety in Korea.
Conclusion
This program aims to reduce postoperative complications, mortality, and medical costs by providing a standardized platform for complication management and prediction. The successful implementation of this nationwide project may provide a good model for other countries that are required to improve surgical outcomes and patient care.
7.Development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program: a nationwide project to improve surgical quality and patient safety
Jeong-Moo LEE ; In Woong HAN ; Oh Chul KWON ; Hye Rim SEO ; Jipmin JUNG ; So Jeong YOON ; Ahram HAN ; Juhan LEE ; Soo Young LEE ; Hoseok SEO ; Wooil KWON ; Bang Wool EOM ; In-Seob LEE ; Ji Won PARK ; Hae Won LEE ; Ho Kyoung HWANG ; Suk-Hwan LEE ; Eung Jin SHIN ; Woo Yong LEE
Annals of Surgical Treatment and Research 2024;107(6):305-314
Purpose:
Improvements in surgical quality and patient safety are critical components of the healthcare system. Despite excellent cancer survival rates in Korea, there is a lack of standardized postoperative complication management systems.To address this gap, the Korean Surgical Society initiated the development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program.
Methods:
K-QIPS was successfully launched in 87 general hospitals. This nationwide surgical quality improvement program covers 5 major surgical fields: gastric surgery, colorectal surgery, hepatectomy and liver transplantation, pancreatectomy, and kidney transplantation.
Results:
Common and surgery-specific complication platforms will be developed, and the program will work toward the implementation of an artificial intelligence-based complication prediction system and the provision of evidence-based feedback to participating institutions. K-QIPS represents a significant step toward improving surgical quality and patient safety in Korea.
Conclusion
This program aims to reduce postoperative complications, mortality, and medical costs by providing a standardized platform for complication management and prediction. The successful implementation of this nationwide project may provide a good model for other countries that are required to improve surgical outcomes and patient care.
8.Risk Stratification of Pancreatic Ductal Adenocarcinoma Patients Undergoing Curative-Intent Surgery after Neoadjuvant Therapy
Hyun Kyung YANG ; Mi-Suk PARK ; Kyunghwa HAN ; Geonsik EOM ; Yong Eun CHUNG ; Jin-Young CHOI ; Seungmin BANG ; Chang Moo KANG ; Jinsil SEONG ; Myeong-Jin KIM
Cancer Research and Treatment 2024;56(1):247-258
Purpose:
Clinical prognostic criteria using preoperative factors were not developed for post–neoadjuvant therapy (NAT) surgery of pancreatic ductal adenocarcinoma (PDAC). We aimed to identify preoperative factors associated with overall survival (OS) in PDAC patients who underwent post-NAT curative-intent surgery and develop risk stratification criteria.
Materials and Methods:
Consecutive PDAC patients who underwent post-NAT curative-intent surgeries between 2007 and 2020 were retrospectively analyzed. Demographic, laboratory, surgical, and histopathologic variables were collected. Baseline, preoperative, and interval changes of computed tomography (CT) findings proposed by the Society of Abdominal Radiology and the American Pancreatic Association were analyzed. Cox proportional hazard analysis was used to select preoperative variables associated with OS. We developed risk stratification criteria composed of the significant preoperative variables, i.e., post-NAT response criteria. We compared the discrimination performance of post-NAT response criteria with that of post-NAT pathological (yp) American Joint Cancer Committee TNM staging system.
Results:
One hundred forty-five PDAC patients were included. Stable or increased tumor size on CT (hazard ratio [HR], 2.58; 95% confidence interval [CI], 1.58 to 4.21; p < 0.001) and elevated preoperative carbohydrate antigen 19-9 (CA19-9) level (HR, 1.98; 95% CI, 1.11 to 3.55; p=0.021) were independent factors of OS. The OS of the patient groups stratified by post-NAT response criteria which combined changes in tumor size and CA19-9 showed significant difference (p < 0.001). Such stratification was comparable to ypTNM staging in discrimination performance (difference of C-index, 0.068; 95% CI, –0.012 to 0.142).
Conclusion
“Any degree of decrease in tumor size on CT” and CA19-9 normalization or staying normal were independent favorable factors of OS. The combination of the two factors discriminated OS comparably to ypTNM staging.
9.Prognostic Implication of Platelet Reactivity According to Left Ventricular Systolic Dysfunction Status in Patients Treated With Drug-Eluting Stent Implantation:Analysis of the PTRG-DES Consortium
Donghoon HAN ; Sun-Hwa KIM ; Dong Geum SHIN ; Min-Kyung KANG ; Seonghoon CHOI ; Namho LEE ; Byeong-Keuk KIM ; Hyung Joon JOO ; Kiyuk CHANG ; Yongwhi PARK ; Young Bin SONG ; Sung Gyun AHN ; Jung-Won SUH ; Sang Yeub LEE ; Ae-Young HER ; Young-Hoon JEONG ; Hyo-Soo KIM ; Moo Hyun KIM ; Do-Sun LIM ; Eun-Seok SHIN ; Jung Rae CHO ; For the PTRG Investigator
Journal of Korean Medical Science 2024;39(3):e27-
Background:
Coronary artery disease patients undergoing percutaneous coronary intervention (PCI) often exhibit reduced left ventricular ejection fraction (LVEF). However, the impact of LV dysfunction status in conjunction with platelet reactivity on clinical outcomes has not been previously investigated.
Methods:
From the multicenter PTRG-DES (Platelet function and genoType-Related long-term prognosis in DES-treated patients) consortium, the patients were classified as preserved-EF (PEF: LVEF ≥ 50%) and reduced-EF (REF: LVEF< 5 0%) group by echocardiography. Platelet reactivity was measured using VerifyNow P2Y 12 assay and high platelet reactivity (HPR) was defined as PRU ≥ 252. The major adverse cardiac and cerebrovascular events (MACCEs) were a composite of death, myocardial infarction, stent thrombosis and stroke at 5 years after PCI. Major bleeding was defined as Bleeding Academic Research Consortium bleeding types 3–5.
Results:
A total of 13,160 patients from PTRG-DES, 9,319 (79.6%) patients with the results of both PRU and LVEF were analyzed. The incidence of MACCE and major bleeding was higher in REF group as compared with PEF group (MACCEs: hazard ratio [HR] 2.17, P < 0.001, 95% confidence interval [CI] 1.85–2.55; major bleeding: HR 1.78, P < 0.001, 95% CI 1.39–2.78).The highest rate of MACCEs was found in patients with REF and HPR, and the difference between the groups was statistically significant (HR 3.14 in REF(+)/HPR(+) vs. PEF(+)/HPR(-) group,P <0.01, 95% CI 2.51–3.91). The frequency of major bleeding was not associated with the HPR in either group.
Conclusion
LV dysfunction was associated with an increased incidence of MACCEs and major bleeding in patients who underwent PCI. The HPR status further exhibited significant increase of MACCEs in patients with LV dysfunction in a large, real-world registry.Trial Registration: ClinicalTrials.gov Identifier: NCT04734028
10.Contemporary Statistics of Acute Ischemic Stroke and Transient Ischemic Attack in 2021: Insights From the CRCS-K-NIH Registry
Do Yeon KIM ; Tai Hwan PARK ; Yong-Jin CHO ; Jong-Moo PARK ; Kyungbok LEE ; Minwoo LEE ; Juneyoung LEE ; Sang Yoon BAE ; Da Young HONG ; Hannah JUNG ; Eunvin KO ; Hyung Seok GUK ; Beom Joon KIM ; Jun Yup KIM ; Jihoon KANG ; Moon-Ku HAN ; Sang-Soon PARK ; Keun-Sik HONG ; Hong-Kyun PARK ; Jeong-Yoon LEE ; Byung-Chul LEE ; Kyung-Ho YU ; Mi Sun OH ; Dong-Eog KIM ; Dong-Seok GWAK ; Soo Joo LEE ; Jae Guk KIM ; Jun LEE ; Doo Hyuk KWON ; Jae-Kwan CHA ; Dae-Hyun KIM ; Joon-Tae KIM ; Kang-Ho CHOI ; Hyunsoo KIM ; Jay Chol CHOI ; Joong-Goo KIM ; Chul-Hoo KANG ; Sung-il SOHN ; Jeong-Ho HONG ; Hyungjong PARK ; Sang-Hwa LEE ; Chulho KIM ; Dong-Ick SHIN ; Kyu Sun YUM ; Kyusik KANG ; Kwang-Yeol PARK ; Hae-Bong JEONG ; Chan-Young PARK ; Keon-Joo LEE ; Jee Hyun KWON ; Wook-Joo KIM ; Ji Sung LEE ; Hee-Joon BAE ;
Journal of Korean Medical Science 2024;39(34):e278-
This report presents the latest statistics on the stroke population in South Korea, sourced from the Clinical Research Collaborations for Stroke in Korea-National Institute for Health (CRCS-K-NIH), a comprehensive, nationwide, multicenter stroke registry. The Korean cohort, unlike western populations, shows a male-to-female ratio of 1.5, attributed to lower risk factors in Korean women. The average ages for men and women are 67 and 73 years, respectively.Hypertension is the most common risk factor (67%), consistent with global trends, but there is a higher prevalence of diabetes (35%) and smoking (21%). The prevalence of atrial fibrillation (19%) is lower than in western populations, suggesting effective prevention strategies in the general population. A high incidence of large artery atherosclerosis (38%) is observed, likely due to prevalent intracranial arterial disease in East Asians and advanced imaging techniques.There has been a decrease in intravenous thrombolysis rates, from 12% in 2017–2019 to 10% in 2021, with no improvements in door-to-needle and door-to-puncture times, worsened by the coronavirus disease 2019 pandemic. While the use of aspirin plus clopidogrel for noncardioembolic stroke and direct oral anticoagulants for atrial fibrillation is well-established, the application of direct oral anticoagulants for non-atrial fibrillation cardioembolic strokes in the acute phase requires further research. The incidence of early neurological deterioration (13%) and the cumulative incidence of recurrent stroke at 3 months (3%) align with global figures. Favorable outcomes at 3 months (63%) are comparable internationally, yet the lack of improvement in dependency at 3 months highlights the need for advancements in acute stroke care.

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