Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

Purpose: To assess patient radiation doses during diagnostic and therapeutic neurointerventional procedures from multiple centers and propose dose reference level (RL). Materials and Methods: Consecutive neurointerventional procedures, performed in 22 hospitals from December 2020 to June 2021, were retrospectively studied. We collected data from a sample of 429 diagnostic and 731 therapeutic procedures. Parameters including dose-area product (DAP), cumulative air kerma (CAK), fluoroscopic time (FT), and total number of image frames (NI) were obtained. RL were calculated as the 3rd quartiles of the distribution. Results: Analysis of 1160 procedures from 22 hospitals confirmed the large variability in patient dose for similar procedures. RLs in terms of DAP, CAK, FT, and NI were 101.6 Gy·cm2, 711.3 mGy, 13.3 minutes, and 637 frames for cerebral angiography, 199.9 Gy·cm2, 3,458.7 mGy, 57.3 minutes, and 1,000 frames for aneurysm coiling, 225.1 Gy·cm2, 1,590 mGy, 44.7 minutes, and 800 frames for stroke thrombolysis, 412.3 Gy·cm2, 4,447.8 mGy, 99.3 minutes, and 1,621.3 frames for arteriovenous malformation (AVM) embolization, respectively. For all procedures, the results were comparable to most of those already published. Statistical analysis showed male and presence of procedural complications were significant factors in aneurysmal coiling. Male, number of passages, and procedural combined technique were significant factors in stroke thrombolysis. In AVM embolization, a significantly higher radiation dose was found in the definitive endovascular cure group. Conclusion Various RLs introduced in this study promote the optimization of patient doses in diagnostic and therapeutic interventional neuroradiology procedures. Proposed 3rd quartile DAP (Gy·cm2) values were 101.6 for diagnostic cerebral angiography, 199.9 for aneurysm coiling, 225.1 for stroke thrombolysis, and 412.3 for AVM embolization. Continual evolution of practices and technologies requires regular updates of RLs.

PURPOSE: To assess patient radiation doses during cerebral angiography and embolization of intracranial aneurysms across multi-centers and propose a diagnostic reference level (DRL). MATERIALS AND METHODS: We studied a sample of 490 diagnostic and 371 therapeutic procedures for intracranial aneurysms, which were performed at 23 hospitals in Korea in 2015. Parameters including dose-area product (DAP), cumulative air kerma (CAK), fluoroscopic time and total angiographic image frames were obtained and analyzed. RESULTS: Total mean DAP, CAK, fluoroscopy time, and total angiographic image frames were 106.2 ± 66.4 Gy-cm2, 697.1 ± 473.7 mGy, 9.7 ± 6.5 minutes, 241.5 ± 116.6 frames for diagnostic procedures, 218.8 ± 164.3 Gy-cm², 3365.7 ± 2205.8 mGy, 51.5 ± 31.1 minutes, 443.5 ± 270.7 frames for therapeutic procedures, respectively. For diagnostic procedure, the third quartiles for DRLs were 144.2 Gy-cm² for DAP, 921.1 mGy for CAK, 12.2 minutes for fluoroscopy times and 286.5 for number of image frames, respectively. For therapeutic procedures, the third quartiles for DRLs were 271.0 Gy-cm² for DAP, 4471.3 mGy for CAK, 64.7 minutes for fluoroscopy times and 567.3 for number of image frames, respectively. On average, rotational angiography was used 1.5 ± 0.7 times/session (range, 0-4; n=490) for diagnostic procedures and 1.6 ± 1.2 times/session (range, 0-4; n=368) for therapeutic procedures, respectively. CONCLUSION: Radiation dose as measured by DAP, fluoroscopy time and image frames were lower in our patients compared to another study regarding cerebral angiography, and DAP was lower with fewer angiographic image frames for therapeutic procedures. Proposed DRLs can be used for quality assurance and patient safety in diagnostic and therapeutic procedures.
Angiography ; Cerebral Angiography ; Fluoroscopy ; Humans ; Intracranial Aneurysm* ; Korea ; Patient Safety ; Radiation Exposure*

Biliary plastic stent induced life-threatening hemobilia is very rare. In this case, hemobilia seriously worsened following removal of a biliary stent, which had been placed for treatment of a postoperative bile leak in a patient who had undergone lateral liver segmentectomy for abdominal trauma. Following placement of the biliary stent, the bile leak improved, but hemobilia and cholangitis developed five days later. To manage the stent malfunction, we removed the biliary stent. However, life-threatening hemobilia developed immediately after removal. Endoscopic hemostasis was impossible; therefore, emergency angiographic embolization and stent graft were performed successfully. In such cases, angiographic embolization and stent-graft placement are effective diagnostic and therapeutic alternatives. When a patient develops hemobilia or cholangitis after biliary stent placement, endoscopists should pay special attention to remove the stent, which might exacerbate hemobilia.
Angiography ; Bile* ; Blood Vessel Prosthesis ; Cholangitis ; Emergencies ; Hemobilia* ; Hemostasis, Endoscopic ; Humans ; Liver ; Mastectomy, Segmental ; Plastics ; Stents*

The Asian Society of Gynecologic Oncology International Workshop 2014 on gynecologic oncology was held in Asan Medical Center, Seoul, Korea on the 23rd to 24th August 2014. A total of 179 participants from 17 countries participated in the workshop, and the up-to-date findings on the management of gynecologic cancers were presented and discussed. This meeting focused on the new trends in the management of cervical cancer, fertility-sparing management of gynecologic cancers, surgical management of gynecologic cancers, and recent advances in translational research on gynecologic cancers.
Female ; Fertility Preservation/methods ; Genital Neoplasms, Female/*therapy ; Humans ; Ovarian Neoplasms/therapy ; Translational Medical Research/methods ; Uterine Cervical Neoplasms/therapy

A 71-year-old woman who had suffered from pulmonary thromboembolism with deep vein thrombosis for 12 years presented the hospital with a huge thoracic aortic aneurysm. During thoracic endovascular therapy, she had a sudden coronary artery occlusion without having organized stenosis or plaque rupture even under the dual antiplatelet treatment and heparinization. She turned out to be having a protein S deficiency. A procedure related thrombotic adverse event in patient with protein S deficiency is very rare, so we report a case with literature review.
Aged ; Aortic Aneurysm, Thoracic ; Constriction, Pathologic ; Coronary Thrombosis* ; Coronary Vessels ; Endovascular Procedures ; Female ; Heparin ; Humans ; Protein S Deficiency* ; Pulmonary Embolism ; Rupture ; Venous Thrombosis

BACKGROUND: Reduction of nasal bone fracture can be performed under general or local anesthesia. The aim of this study was to compare general anesthesia (GA) and monitored anesthetic care (MAC) with dexmedetomidine based on intraoperative vital signs, comfort of patients, surgeons and nurses and the adverse effects after closed reduction of nasal bone fractures. METHODS: Sixty patients with American Society of Anesthesiologists physical status I or II were divided into a GA group (n = 30) or MAC group (n = 30). Standard monitorings were applied. In the GA group, general anesthesia was carried out with propofol-sevoflurane-N2O. In the MAC group, dexmedetomidine and local anesthetics were administered for sedation and analgesia. Intraoperative vital signs, postoperative pain scores by visual analog scale and postoperative nausea and vomiting (PONV) were compared between the groups. RESULTS: Intraoperatively, systolic blood pressures were significantly higher, and heart rates were lower in the MAC group compared to the GA group. There were no differences between the groups in the patient, nurse and surgeon's satisfaction, postoperative pain scores and incidence of PONV. CONCLUSIONS: MAC with dexmedetomidine resulted in comparable satisfaction in the patients, nurses and surgeons compared to general anesthesia. The incidence of postoperative adverse effects and severity of postoperative pain were also similar between the two groups. Therefore, both anesthetic techniques can be used during the reduction of nasal bone fractures based on a patient%s preference and medical condition.
Analgesia ; Anesthesia, General ; Anesthesia, Local ; Anesthetics, Local ; Dexmedetomidine ; Heart Rate ; Humans ; Incidence ; Nasal Bone ; Pain, Postoperative ; Postoperative Nausea and Vomiting ; Vital Signs

BACKGROUND: It is important to know the current level of primary care performance in order to evaluate and plan for desirable health policy. We tried to compare patient's assessment of primary (family physician, general practitioner, internist, pediatrician, and general surgeon) and non-primary (the other specialties) care physicians. METHODS: Study subjects were physicians of primary care clinics in Seoul. The study subject evaluators were Seoul citizens who were selected by a list-assisted random digit dialing sampling method and who had visited their primary care clinic on six or more occasions over a period of more than 6 months as a usual source of care. The modified version of the Korean Primary Care Assessment Tool was used for the evaluation of primary care performance. The data were collected with the aid of a computer-assisted telephone interview system from June 29 to July 22, 2009. RESULTS: The data on 260 individuals were used for analysis. The mean scores of primary and non-primary care physician group were respectively 1.19 and 0.85 in the comprehensiveness domain, 1.00 and 0.83 in the coordination domain, 1.54 and 1.31 in the family/community orientation, and 1.24 and 0.99 as an average of 3 domains above. The scores in the comprehensiveness domain and the average of 3 domains were significantly higher in the primary than in the nonprimary care physician group. CONCLUSION: Primary care physicians showed superior performance compared to non-primary care physicians in comprehensiveness domain and in the average of comprehensiveness, coordination, and family/community orientation domains.
General Practitioners ; Health Policy ; Humans ; Interviews as Topic ; Orientation ; Patient Satisfaction ; Physicians, Primary Care ; Primary Health Care ; Republic of Korea