1.A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
Hyun-Woong CHO ; Sohyeon JEONG ; Seung Hun SONG ; Young Tae KIM ; Jae-Weon KIM ; Chi-Heum CHO ; Soo Young HUR ; Suk-Joon CHANG ; Yong Man KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2024;35(4):e52-
		                        		
		                        			 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. 
		                        		
		                        		
		                        		
		                        	
2.A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
Hyun-Woong CHO ; Sohyeon JEONG ; Seung Hun SONG ; Young Tae KIM ; Jae-Weon KIM ; Chi-Heum CHO ; Soo Young HUR ; Suk-Joon CHANG ; Yong Man KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2024;35(4):e52-
		                        		
		                        			 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. 
		                        		
		                        		
		                        		
		                        	
3.A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the RKP00156 vaginal tablet in healthy women and patients with cervical intraepithelial neoplasia 2
Hyun-Woong CHO ; Sohyeon JEONG ; Seung Hun SONG ; Young Tae KIM ; Jae-Weon KIM ; Chi-Heum CHO ; Soo Young HUR ; Suk-Joon CHANG ; Yong Man KIM ; Jae Kwan LEE
Journal of Gynecologic Oncology 2024;35(4):e52-
		                        		
		                        			 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. 
		                        		
		                        		
		                        		
		                        	
4.Painful eccrine spiradenoma containing nerve fibers in the forearm: a case report
Tae Hyun KIM ; Seong Heum JEONG ; Hyun Jeong HA ; Chung Hun KIM
Archives of hand and microsurgery 2024;29(1):60-63
		                        		
		                        			
		                        			 Eccrine spiradenomas are rare benign adnexal tumors that originate from the eccrine glands. They mainly arise in the head, neck, and upper trunk of young adults and are sometimes accompanied by pain and tenderness. Although spontaneous pain is a typical symptom of eccrine spiradenoma, the underlying mechanism remains unclear. We report the case of a patient who had a spiradenoma in the subcutaneous tissue of the left forearm that was accompanied by agonizing pain triggered by pressure. A 42-year-old man who had undergone surgical excision of a left forearm mass 5 years ago presented for relapsed pain and a palpable mass at the previous excision site. The agonizing pain had been triggered a few days ago, in response to even a slight touch. The mass measured approximately 0.8×0.8 mm, and ther e were no changes visible around the scar. Irregularly shaped masses, each measuring approximately 5 mm, were removed with a 2-mm safety margin from the subcutaneous fat. A histopathologic examination revealed the resected nodules were surrounded by delicate fibrous capsules, some parts of which contained blood vessels and prominent thickened nerve fibers. By the time of the 6-month follow-up, the masses had not recurred, and the biopsy site was well maintained without pain. We describe the surgical and histopathologic findings of an isolated eccrine spiradenoma accompanied by recurrent agonizing pain. The peculiar microscopic arrangement of the thickened nerve fibers encasing the nodule of eccrine spiradenoma may correlate with its pain mechanism. 
		                        		
		                        		
		                        		
		                        	
5.Pleomorphic Adenoma of the Upper Lip: A Case Report
Tae Hyun KIM ; Seong Heum JEONG ; Chung Hun KIM
Korean Journal of Head and Neck Oncology 2024;40(1):33-36
		                        		
		                        			
		                        			 Pleomorphic adenoma (PA) is a commonly occurring benign tumor originating in the salivary glands. The incidence is mostly in the parotid glands (85%) followed by minor salivary glands (10%). Pleomorphic adenoma from minor salivary glands of the lips is a rare neoplasm. Here, we present a case of a patient with PA in the upper lip, reporting a common neoplasm in a rare site. A 82-year-old male with a slowly progressing swelling that occurred 20years ago on the upper white lip. This tumor is not associated with pain and tenderness. The mass was about 1.5x1.5cm sized, circumscribed, sessile and firm on the external upper lip without oral side bulging (Fig. 1). The tumor was removed completely with a elliptical incision under local anesthesia. The encapsulated mass was measured 0.9x0.9x0.6cm. On histology, a well-circumscribed growth was seen comprising epithelial and stromal components. The epithelial component formed glandular structures lined by round-to oval cells having small nuclei, pink cytoplasm and myoepithelial basal cell layer while the stroma had a fibromyxoid appearance(Fig. 2). Postoperatively wound was well healed without recurrence after 6months. Pleomorphic adenoma of the upper lip is a rare neoplasm, especially not intraoral growth. For aesthetic good result, the mass was removed without hesitation. It is required a high index of suspicion and a long-term follow-up because it could recur and rarely be transformed into malignancy. 
		                        		
		                        		
		                        		
		                        	
6.Effectiveness of a postoperative continuous irrigation system via a catheter following implant-based breast reconstruction
Hyun Jeong HA ; Seong Heum JEONG ; Tae Hyun KIM ; Hee Chang AHN ; Euna HWANG
Archives of Aesthetic Plastic Surgery 2023;29(1):35-40
		                        		
		                        			 Background:
		                        			Implant-based breast reconstruction is a technique frequently used for breast reconstruction. Infection and inflammation are considered to be the most troublesome complications of implant-based breast reconstruction and can lead to capsular contracture or implant failure. To date, however, only a few methods have been proposed to prevent these complications. Therefore, the authors introduce a simple irrigation system using indwelling drain catheters to decrease postoperative inflammation. 
		                        		
		                        			Methods:
		                        			Continuous saline irrigation was performed once per day for 3 days immediately after prosthesis-based breast reconstruction. Normal saline (500 mL) was inserted into the implant pocket through a superomedial-oriented drain catheter and drained through an inferolateral-oriented drain catheter using a suction device. Inflammatory indicators, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), white blood cell count (WBC), and postoperative complications were compared between the non-irrigation and irrigation groups. 
		                        		
		                        			Results:
		                        			This study included 37 patients divided into two groups (20 non-irrigation and 17 irrigation). An analysis of inflammatory indicators revealed that the peak CRP level in the irrigation group was significantly lower than that in the non-irrigation group, while no statistically significant differences were found for the other mediators (ESR and WBC). In the immediate postoperative period, continuous irrigation effectively washed out tissue debris and blood clots within the implant pocket, which helped maintain the function of the drain catheter and decrease pro-inflammatory mediators. 
		                        		
		                        			Conclusions
		                        			This irrigation method was simple and cost-effective for decreasing inflammation within the breast pocket. Furthermore, it can also be applied to infected breast pockets in combination with antibiotics. 
		                        		
		                        		
		                        		
		                        	
7.Does the dominant hand’s use affect the complication rates in prosthetic breast reconstruction?
Seong Heum JEONG ; Euna HWANG ; Hyun Jeong HA ; Tae Hyun KIM ; Deok-Yeol KIM ; Chung Hun KIM ; Suk Wha KIM ; Hee Chang AHN
Archives of Aesthetic Plastic Surgery 2023;29(4):201-206
		                        		
		                        			 Background:
		                        			Numerous studies have investigated risk factors for unfavorable outcomes in prosthetic breast reconstruction, such as obesity, perioperative radiotherapy, and acellular dermal matrix use. However, no reports have explored whether the use of the dominant hand influences complications in breast reconstruction. To address this gap in the literature, analyzed complication rates between the dominant and non-dominant sides after reconstruction. 
		                        		
		                        			Methods:
		                        			We retrospectively reviewed the charts of 160 patients (170 breasts) who underwent breast reconstruction from February 2017 to March 2022. We analyzed the complications between beasts on the dominant and non-dominant sides according to the reconstruction method. 
		                        		
		                        			Results:
		                        			During prosthetic breast reconstruction, the drainage volume and duration on the dominant side exceeded those on the non-dominant side after reconstruction (duration: 9.79 days on the dominant side vs. 9.12 days on the non-dominant side, P=0.196; volume: 771.1 mL on the dominant side vs. 654.3 mL on the non-dominant side, P=0.027). The incidence of complications such as wound dehiscence, mastectomy flap necrosis, and infection was significantly higher in the dominant hand group (infection: 6 vs. 0, P=0.014; dehiscence: 15 vs. 4, P=0.009; flap necrosis: 13 vs. 4, P=0.024). 
		                        		
		                        			Conclusions
		                        			Complications including seroma, infection, and mastectomy skin flap necrosis following prosthetic reconstruction were common in breasts on the dominant-hand side. Therefore, meticulous management and restriction of shoulder movement can aid in preventing seroma-related complications in prosthetic breast reconstruction, especially on the side of the dominant hand. 
		                        		
		                        		
		                        		
		                        	
8.Efficacy Analysis of Suprapapillary versus Transpapillary Self-Expandable Metal Stents According to the Level of Obstruction in Malignant Extrahepatic Biliary Obstruction
Sung Yong HAN ; Tae Hoon LEE ; Sung Ill JANG ; Dong Uk KIM ; Jae Kook YANG ; Jae Hee CHO ; Min Je SUNG ; Chang-Il KWON ; Jin-Seok PARK ; Seok JEONG ; Don Haeng LEE ; Sang-Heum PARK ; Dong Ki LEE
Gut and Liver 2023;17(5):806-813
		                        		
		                        			 Background/Aims:
		                        			The use of a self-expandable metal stent (SEMS) is recommended for unresectable malignant biliary obstruction (MBO). Stent-related adverse events might differ according to the position of the stent through the ampulla of Vater (AOV). We retrospectively evaluated SEMS patency and adverse events according to the position of the SEMS. 
		                        		
		                        			Methods:
		                        			In total, 280 patients who underwent endoscopic SEMS placement due to malignant distal biliary obstruction were analyzed retrospectively. Suprapapillary and transpapillary SEMS insertions were performed on 51 patients and 229 patients, respectively. 
		                        		
		                        			Results:
		                        			Between the suprapapillary group (SPG) and transpapillary group (TPG), the stent patency period was not significantly different (median [95% confidence interval]: 107 days [82.3 to 131.7] vs 120 days [99.3 to 140.7], p=0.559). There was also no significant difference in the rate of adverse events. In subgroup analysis, the stent patency for an MBO located within 2 cm from the AOV was found to be significantly shorter than that for an MBO located more than 2 cm from the AOV in the SPG (64 days [0 to 160.4] vs 127 days [82.0 to 171.9], p<0.001) and TPG (87 days [52.5 to 121.5] vs 130 [97.0 to 162.9], p<0.001). Patients with an MBO located within 2 cm from the AOV in both groups had a higher percentage of duodenal invasion (SPG: 40.0% vs 4.9%, p=0.002; TPG: 28.6% vs 2.9%, p<0.001) than patients with an MBO located more than 2 cm from the AOV. 
		                        		
		                        			Conclusions
		                        			The SPG and TPG showed similar results in terms of stent patency and rate of adverse events. However, patients with an MBO located within 2 cm from the AOV had a higher percentage of duodenal invasion with shorter stent patency than those with an MBO located more than 2 cm from the AOV, regardless of stent position. 
		                        		
		                        		
		                        		
		                        	
9.The Two Cases of Multifocal Fixed Drug Eruption Caused by Diclofenac
Ho Jung LEE ; Jeong Yeon HONG ; Tae Heum PARK ; Sung Yul LEE ; Jong Suk LEE ; Euy Hyun CHUNG ; Sang Hoon LEE ; Jung Eun KIM
Korean Journal of Dermatology 2020;58(6):411-415
		                        		
		                        			
		                        			 Fixed drug eruption (FDE) is a drug-induced disorder that may appear as patches or bullae. It recurs at the same sites as those involved in exposure to the same drug (causative drug). We encountered two cases of generalized FDE, and both patients had a history of diclofenac exposure before the onset of skin lesions. In the first case, an 82-year-old female patient presented with multiple erythematous patches on the trunk and lower extremities. In the second case, a 71-year-old male patient developed multiple bullae on violaceous patches on the trunk and extremities. The findings of histopathologic examinations were indicative of the diagnosis of FDEs. Although diclofenac is commonly used as a non-steroidal inflammatory drug, diclofenac-induced generalized FDE occurs rarely and has not been reported in Korea. With reuse of causative drugs, the size and number of lesions tend to increase. Therefore, early diagnosis of FDE is important, and avoidance of repeated exposure to drugs should be educated. 
		                        		
		                        		
		                        		
		                        	
10.Effect of Weight Changes on the Development of Erosive Esophagitis
Tae-Heum CHUNG ; Jiho LEE ; In-Du JEONG ; Kun-Chul LEE
Korean Journal of Family Medicine 2020;41(1):14-19
		                        		
		                        			 Background:
		                        			Gastroesophageal reflux disease is highly prevalent among overweight and obese individuals. This study aimed to investigate the effect of weight change on the development of erosive esophagitis (EE). 
		                        		
		                        			Methods:
		                        			A retrospective review of medical records from a university hospital in South Korea identified 7,123 subjects who underwent routine health checkups in 2012 and 2014. We excluded participants with EE in 2012. Body mass index (BMI) changes were classified as loss, stable, mild gain, or moderate gain. 
		                        		
		                        			Results:
		                        			Mild and moderate weight gain increased the odds of EE development (odds ratio [OR], 1.39; 95% confidence interval [CI], 1.06–1.84 and OR, 2.80; 95% CI, 1.87–4.21, respectively) relative to weight stability. Weight loss decreased the odds of EE development (OR, 0.58; 95% CI, 0.38–0.90) relative to weight stability. After stratifying subjects into three groups by baseline BMI, those with mild and moderate weight gain in the obese group and moderate gain in the overweight group showed increased odds of EE development relative to members of those groups whose weights remained stable (OR, 2.08; 95% CI, 1.29–3.36; OR, 3.92; 95% CI, 1.99–7.73 in obese group, and OR, 3.30; 95% CI, 1.64–6.64 in overweight group, respectively). In comparison, weight loss in the normal weight group decreased the odds of EE development relative to weight stability (OR, 0.38; 95% CI, 0.15–0.97). 
		                        		
		                        			Conclusion
		                        			Weight gain was positively associated with EE development in overweight or obese individuals. Weight loss was negatively associated with EE development in normal-weight individuals. 
		                        		
		                        		
		                        		
		                        	
            
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