1.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
2.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
3.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
4.Risk factors of hypotension during cesarean section with spinal anesthesia in parturients with COVID-19: a retrospective study in comparison with pregnant women without COVID-19
Si Ra BANG ; Gunn Hee KIM ; Sung Jun CHO ; Mi Jung YOON
Anesthesia and Pain Medicine 2024;19(4):326-332
The incidence of hypotension in parturients with coronavirus disease (COVID-19) undergoing regional anesthesia remains controversial. This study aimed to investigate the incidence of hypotension during spinal anesthesia in parturients infected with COVID-19, as well as to identify associated risk factors. Methods: This retrospective study compared COVID-19-positive parturients who underwent cesarean section under spinal anesthesia (COVID-19 group) with a control group between January 2017 and June 2022. We reviewed the medical records and collected the following information: basic patient characteristics, spinal anesthesia, and newborn-related data. Results: Compared with the control group, the COVID-19 group did not show any significant differences in terms of hypotension occurrence and vasopressor usage. A positive correlation was noted in the COVID-19 group between heart rate and duration of hospital stay (P < 0.001, Spearman’s rho = 0.422). In subgroup analysis of the COVID-19 group, group with a baseline heart rate ≥ 100 (group H) had lower Apgar scores at 1 min, longer hospital stays, and more severe COVID-19 symptoms than the with a baseline heart rate < 100 (group L). Moreover, in group H, there was a positive correlation between the heart rate and the lowest systolic blood pressure after spinal anesthesia (P = 0.012, Spearman’s rho = 0.528). Conclusions: Parturients with COVID-19 do not appear to have a higher risk of hypotension during cesarean section under spinal anesthesia than those without COVID-19. Given the close association between preoperative heart rate and extent of hypotension in parturients with COVID-19 undergoing spinal anesthesia, vigilant monitoring of vital signs by anesthesiologists is crucial during the perioperative period.
5.Risk factors of hypotension during cesarean section with spinal anesthesia in parturients with COVID-19: a retrospective study in comparison with pregnant women without COVID-19
Si Ra BANG ; Gunn Hee KIM ; Sung Jun CHO ; Mi Jung YOON
Anesthesia and Pain Medicine 2024;19(4):326-332
The incidence of hypotension in parturients with coronavirus disease (COVID-19) undergoing regional anesthesia remains controversial. This study aimed to investigate the incidence of hypotension during spinal anesthesia in parturients infected with COVID-19, as well as to identify associated risk factors. Methods: This retrospective study compared COVID-19-positive parturients who underwent cesarean section under spinal anesthesia (COVID-19 group) with a control group between January 2017 and June 2022. We reviewed the medical records and collected the following information: basic patient characteristics, spinal anesthesia, and newborn-related data. Results: Compared with the control group, the COVID-19 group did not show any significant differences in terms of hypotension occurrence and vasopressor usage. A positive correlation was noted in the COVID-19 group between heart rate and duration of hospital stay (P < 0.001, Spearman’s rho = 0.422). In subgroup analysis of the COVID-19 group, group with a baseline heart rate ≥ 100 (group H) had lower Apgar scores at 1 min, longer hospital stays, and more severe COVID-19 symptoms than the with a baseline heart rate < 100 (group L). Moreover, in group H, there was a positive correlation between the heart rate and the lowest systolic blood pressure after spinal anesthesia (P = 0.012, Spearman’s rho = 0.528). Conclusions: Parturients with COVID-19 do not appear to have a higher risk of hypotension during cesarean section under spinal anesthesia than those without COVID-19. Given the close association between preoperative heart rate and extent of hypotension in parturients with COVID-19 undergoing spinal anesthesia, vigilant monitoring of vital signs by anesthesiologists is crucial during the perioperative period.
6.Risk factors of hypotension during cesarean section with spinal anesthesia in parturients with COVID-19: a retrospective study in comparison with pregnant women without COVID-19
Si Ra BANG ; Gunn Hee KIM ; Sung Jun CHO ; Mi Jung YOON
Anesthesia and Pain Medicine 2024;19(4):326-332
The incidence of hypotension in parturients with coronavirus disease (COVID-19) undergoing regional anesthesia remains controversial. This study aimed to investigate the incidence of hypotension during spinal anesthesia in parturients infected with COVID-19, as well as to identify associated risk factors. Methods: This retrospective study compared COVID-19-positive parturients who underwent cesarean section under spinal anesthesia (COVID-19 group) with a control group between January 2017 and June 2022. We reviewed the medical records and collected the following information: basic patient characteristics, spinal anesthesia, and newborn-related data. Results: Compared with the control group, the COVID-19 group did not show any significant differences in terms of hypotension occurrence and vasopressor usage. A positive correlation was noted in the COVID-19 group between heart rate and duration of hospital stay (P < 0.001, Spearman’s rho = 0.422). In subgroup analysis of the COVID-19 group, group with a baseline heart rate ≥ 100 (group H) had lower Apgar scores at 1 min, longer hospital stays, and more severe COVID-19 symptoms than the with a baseline heart rate < 100 (group L). Moreover, in group H, there was a positive correlation between the heart rate and the lowest systolic blood pressure after spinal anesthesia (P = 0.012, Spearman’s rho = 0.528). Conclusions: Parturients with COVID-19 do not appear to have a higher risk of hypotension during cesarean section under spinal anesthesia than those without COVID-19. Given the close association between preoperative heart rate and extent of hypotension in parturients with COVID-19 undergoing spinal anesthesia, vigilant monitoring of vital signs by anesthesiologists is crucial during the perioperative period.
7.Risk factors of hypotension during cesarean section with spinal anesthesia in parturients with COVID-19: a retrospective study in comparison with pregnant women without COVID-19
Si Ra BANG ; Gunn Hee KIM ; Sung Jun CHO ; Mi Jung YOON
Anesthesia and Pain Medicine 2024;19(4):326-332
The incidence of hypotension in parturients with coronavirus disease (COVID-19) undergoing regional anesthesia remains controversial. This study aimed to investigate the incidence of hypotension during spinal anesthesia in parturients infected with COVID-19, as well as to identify associated risk factors. Methods: This retrospective study compared COVID-19-positive parturients who underwent cesarean section under spinal anesthesia (COVID-19 group) with a control group between January 2017 and June 2022. We reviewed the medical records and collected the following information: basic patient characteristics, spinal anesthesia, and newborn-related data. Results: Compared with the control group, the COVID-19 group did not show any significant differences in terms of hypotension occurrence and vasopressor usage. A positive correlation was noted in the COVID-19 group between heart rate and duration of hospital stay (P < 0.001, Spearman’s rho = 0.422). In subgroup analysis of the COVID-19 group, group with a baseline heart rate ≥ 100 (group H) had lower Apgar scores at 1 min, longer hospital stays, and more severe COVID-19 symptoms than the with a baseline heart rate < 100 (group L). Moreover, in group H, there was a positive correlation between the heart rate and the lowest systolic blood pressure after spinal anesthesia (P = 0.012, Spearman’s rho = 0.528). Conclusions: Parturients with COVID-19 do not appear to have a higher risk of hypotension during cesarean section under spinal anesthesia than those without COVID-19. Given the close association between preoperative heart rate and extent of hypotension in parturients with COVID-19 undergoing spinal anesthesia, vigilant monitoring of vital signs by anesthesiologists is crucial during the perioperative period.
8.Risk factors of hypotension during cesarean section with spinal anesthesia in parturients with COVID-19: a retrospective study in comparison with pregnant women without COVID-19
Si Ra BANG ; Gunn Hee KIM ; Sung Jun CHO ; Mi Jung YOON
Anesthesia and Pain Medicine 2024;19(4):326-332
The incidence of hypotension in parturients with coronavirus disease (COVID-19) undergoing regional anesthesia remains controversial. This study aimed to investigate the incidence of hypotension during spinal anesthesia in parturients infected with COVID-19, as well as to identify associated risk factors. Methods: This retrospective study compared COVID-19-positive parturients who underwent cesarean section under spinal anesthesia (COVID-19 group) with a control group between January 2017 and June 2022. We reviewed the medical records and collected the following information: basic patient characteristics, spinal anesthesia, and newborn-related data. Results: Compared with the control group, the COVID-19 group did not show any significant differences in terms of hypotension occurrence and vasopressor usage. A positive correlation was noted in the COVID-19 group between heart rate and duration of hospital stay (P < 0.001, Spearman’s rho = 0.422). In subgroup analysis of the COVID-19 group, group with a baseline heart rate ≥ 100 (group H) had lower Apgar scores at 1 min, longer hospital stays, and more severe COVID-19 symptoms than the with a baseline heart rate < 100 (group L). Moreover, in group H, there was a positive correlation between the heart rate and the lowest systolic blood pressure after spinal anesthesia (P = 0.012, Spearman’s rho = 0.528). Conclusions: Parturients with COVID-19 do not appear to have a higher risk of hypotension during cesarean section under spinal anesthesia than those without COVID-19. Given the close association between preoperative heart rate and extent of hypotension in parturients with COVID-19 undergoing spinal anesthesia, vigilant monitoring of vital signs by anesthesiologists is crucial during the perioperative period.
9.Simulator-based training method in gastrointestinal endoscopy training and currently available simulators
Yuri KIM ; Jeong Hoon LEE ; Gin Hyug LEE ; Ga Hee KIM ; Gunn HUH ; Seung Wook HONG ; Hwoon-Yong JUNG
Clinical Endoscopy 2023;56(1):1-13
The apprenticeship-based training method (ABTM) is highly effective for gastrointestinal (GI) endoscopic training. However, the conventional ABTM has significant issues. Although many supplementary training methods (TMs) have been developed and utilized, they cannot entirely replace the ABTM, which remains the major TM strategy. Currently, new TM construction is crucial and necessary due to financial constraints, difficulty of obtaining sufficient training time due to patient safety-related regulations, and catastrophic damage caused by disasters such as the coronavirus disease 2019 pandemic. The simulator-based TM (SBTM) is widely accepted as an alternative to the ABTM, owing to the SBTM’s advantages. Since the 1960s, many GI endoscopy training simulators have been developed and numerous studies have been published on their effectiveness. While previous studies have focused on the simulator’s validity, this review focused on the accessibility of simulators that were introduced by the end of 2021. Although the current SBTM is effective in GI endoscopic education, extensive improvements are needed to replace the ABTM. Incorporating simulator-incorporated TMs into an improved ABTM is an attempt to overcome the incompleteness of the current SBTM. Until a new simulator is developed to replace the ABTM, it is desirable to operate a simulator-integrated and well-coordinated TM that is suitable for each country and institution.
10.The sniffing position facilitated easier light wand guided endotracheal intubation compared with the neutral position with chin-lift
Gunn Hee KIM ; Eun Jae JUNG ; Yun Jae HAN ; Mi Jung YUN
Anesthesia and Pain Medicine 2023;18(4):431-438
Traditionally, the patient's head is placed in a neutral position with a chin-lift to facilitate light wand guided endotracheal intubation. However, our study found that the sniffing position was more effective. In this study, we aimed to compare the two positions of light wand guided endotracheal intubation. Methods: Sixty adult patients were included in the study, after obtaining informed consent, and were randomly assigned to one of two groups: a control group in a neutral position with a chin-lift (group C, n = 30) and a sniffing position group (group S, n = 30). In group C, the anesthesiologist inserted a light wand after lifting the patient's mandible using the thumb of their non-dominant hand inside the patient's mouth. In group S, a light wand was inserted after the patient's head was flexed with the neck extended. We assessed variables such as light-search time, number of intubation attempts, time to achieve intubation, and side effects including blood tinge on the endotracheal tube, hoarseness, sore throat, and anesthesiologist satisfaction. Results: The light-search and intubation times were shorter in group S than in group C. The incidence of blood tinge on the endotracheal tube was higher in group C than in group S. Anesthesiologist satisfaction was higher in group S than in group C. Conclusions: The sniffing position was more effective in facilitating light wand guided endotracheal intubation than the neutral position with a chin-lift.

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