1.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
Background:
Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods:
An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results:
During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion
This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
2.History of Acquired Immune Deficiency Syndrome in Korea
June Myung KIM ; Nam Joong KIM ; Jun Yong CHOI ; Bum Sik CHIN
Infection and Chemotherapy 2020;52(2):234-244
The first human immunodeficiency virus (HIV) infection was reported in Korea in 1985. The number of HIV-infected persons domestically increased in the 1990s showing epidemic indigenousization. Since then, the number of new infections gradually increased every year, and recently more than 1,000 newly infected cases were reported per year. A total of 12,522 infected individuals have been reported up to 2015, of which 2,020 died. The male to female ratio was 15.4:1, and 34.2% of them were under 30 years old. The infection route was homosexual and bisexual contact in 60.1% of cases and heterosexual contact in 34.6% of cases. Candidiasis, Pneumocystis pneumonia, tuberculosis were common as a AIDS (acquired immune deficiency syndrome)-defining illness. But with the introduction of antiretroviral therapy in the late 1990s, non-AIDS defining illnesses such as metabolic complications, cardiovascular diseases, bone diseases, and neuropsychiatric disorders such as neurocognitive dysfunction, depression, and anxiety are emerging as new health problems. The management policy switched its focus from regulating and monitoring of HIV-infected persons to ensuring access to treatment and promotion of voluntary HIV testing in high-risk groups. Also as the age of the infected persons increases, a need for various supports such as social rehabilitation, life counseling, and welfare has emerged.
3.The Current Status of Intervention for Intermediate Coronary Stenosis in the Korean Percutaneous Coronary Intervention (K-PCI) Registry
Jin Ho KIM ; Woonggil CHOI ; Ki Chang KIM ; Chang Wook NAM ; Bum Kee HONG ; June Hong KIM ; Doo Soo JEON ; Jang Whan BAE ; Sang Hyun KIM ; Keon Woong MOON ; Byung Ryul CHO ; Doo Il KIM ; Jae Sik JANG
Korean Circulation Journal 2019;49(11):1022-1032
BACKGROUND AND OBJECTIVES: Intermediate coronary lesion that can be under- or over-estimated by visual estimation frequently results in stenting of functionally nonsignificant lesions or deferral of percutaneous coronary intervention (PCI) of significant lesions inappropriately. We evaluated current status of PCI for intermediate lesions from a standardized database in Korea. METHODS: We analyzed the Korean percutaneous coronary intervention (K-PCI) registry data which collected a standardized PCI database of the participating hospitals throughout the country from January 1, 2014, through December 31, 2014. Intermediate lesion was defined as a luminal narrowing between 50% and 70% by visual estimation and then compared whether the invasive physiologic or imaging study was performed or not. RESULTS: Physiology-guided PCI for intermediate lesions was performed in 16.8% for left anterior descending artery (LAD), 9.8% for left circumflex artery (LCX), 13.2% for right coronary artery (RCA). PCI was more frequently performed using intravascular ultrasound (IVUS) than using fractional flow reserve (FFR) for coronary artery segments (27.7% vs. 13.9% for LAD, 32.9% vs. 8.1% for LCX, and 33.8% vs. 10.8% for RCA). In accordance with or without FFR, PCI for intermediate lesions was more frequently performed in the hospitals with available FFR device than without FFR, especially in left main artery (LM), proximal LAD lesion (40.9% vs. 5.9% for LM, 24.6% vs 7.6% for proximal LAD). CONCLUSIONS: These data provide the current PCI practice pattern with the use of FFR and IVUS in intermediate lesion. More common use of FFR for intermediate lesion should be encouraged.
Arteries
;
Coronary Artery Disease
;
Coronary Stenosis
;
Coronary Vessels
;
Fractional Flow Reserve, Myocardial
;
Korea
;
Percutaneous Coronary Intervention
;
Phenobarbital
;
Stents
;
Ultrasonography
4.The Current Status of Intervention for Intermediate Coronary Stenosis in the Korean Percutaneous Coronary Intervention (K-PCI) Registry
Jin Ho KIM ; Woonggil CHOI ; Ki Chang KIM ; Chang Wook NAM ; Bum Kee HONG ; June Hong KIM ; Doo Soo JEON ; Jang Whan BAE ; Sang Hyun KIM ; Keon Woong MOON ; Byung Ryul CHO ; Doo Il KIM ; Jae Sik JANG
Korean Circulation Journal 2019;49(11):1022-1032
BACKGROUND AND OBJECTIVES:
Intermediate coronary lesion that can be under- or over-estimated by visual estimation frequently results in stenting of functionally nonsignificant lesions or deferral of percutaneous coronary intervention (PCI) of significant lesions inappropriately. We evaluated current status of PCI for intermediate lesions from a standardized database in Korea.
METHODS:
We analyzed the Korean percutaneous coronary intervention (K-PCI) registry data which collected a standardized PCI database of the participating hospitals throughout the country from January 1, 2014, through December 31, 2014. Intermediate lesion was defined as a luminal narrowing between 50% and 70% by visual estimation and then compared whether the invasive physiologic or imaging study was performed or not.
RESULTS:
Physiology-guided PCI for intermediate lesions was performed in 16.8% for left anterior descending artery (LAD), 9.8% for left circumflex artery (LCX), 13.2% for right coronary artery (RCA). PCI was more frequently performed using intravascular ultrasound (IVUS) than using fractional flow reserve (FFR) for coronary artery segments (27.7% vs. 13.9% for LAD, 32.9% vs. 8.1% for LCX, and 33.8% vs. 10.8% for RCA). In accordance with or without FFR, PCI for intermediate lesions was more frequently performed in the hospitals with available FFR device than without FFR, especially in left main artery (LM), proximal LAD lesion (40.9% vs. 5.9% for LM, 24.6% vs 7.6% for proximal LAD).
CONCLUSIONS
These data provide the current PCI practice pattern with the use of FFR and IVUS in intermediate lesion. More common use of FFR for intermediate lesion should be encouraged.
5.Irritated Subtype of Seborrheic Keratosis in the External Auditory Canal.
June Kyu PARK ; Kyung Sik KIM ; Seung Hong KIM ; Jun CHOI ; Jeong Yeol YANG ; Jeong Ju LEE
Archives of Plastic Surgery 2017;44(6):570-572
No abstract available.
Ear Canal*
;
Keratosis, Seborrheic*
6.Analysis of Effect of Eggshell Membrane Patching for Moderate-to-Large Traumatic Tympanic Membrane Perforation.
Jong Yoon JUNG ; Hee Chul YUN ; Tae Min KIM ; Jae Woo JOO ; In Sik SONG ; Yoon Chan RAH ; Jiwon CHANG ; Gi Jung IM ; June CHOI
Journal of Audiology & Otology 2017;21(1):39-43
BACKGROUND AND OBJECTIVES: To evaluate the effect of eggshell membrane (ESM) patching for tympanic membrane (TM) perforation, and to investigate correlations between healing time and age, gender, patching time, perforation size, and perforation location. SUBJECTS AND METHODS: One hundred and seventy-five patients diagnosed with traumatic TM perforation at the Department of Otorhinolaryngology-Head and Neck Surgery, Korea University Ansan Hospital, between January 2008 and October 2013. Patients were divided into two groups, according to perforation edge approximation or ESM patching treatment. Healing time was compared between the group that received perforation edge approximation and the group that received ESM patching. Perforation grade, age, onset, and location were also compared between the two groups. RESULTS: ESM patching significantly improved healing time compared to spontaneous healing, especially in patients with moderate or large traumatic TM perforations (≥grade II). However, patient age, gender, perforation location, and especially timing of procedure, did not significantly affect healing time. CONCLUSIONS: ESM patching can be a good treatment choice to promote tympanic membrane healing in large traumatic TM perforations.
Gyeonggi-do
;
Humans
;
Korea
;
Membranes*
;
Neck
;
Tympanic Membrane Perforation*
;
Tympanic Membrane*
7.Reconstruction of a Traumatic Cleft Earlobe Using a Combination of the Inverted V-Shaped Excision Technique and Vertical Mattress Suture Method.
June Kyu PARK ; Kyung Sik KIM ; Seung Hong KIM ; Jun CHOI ; Jeong Yeol YANG
Archives of Craniofacial Surgery 2017;18(4):277-281
Traumatic cleft earlobes are a common problem encountered by plastic and reconstructive surgeons. Various techniques have been reported for the repair of traumatic cleft earlobes. Usually, the techniques of split earlobe repair are divided into two categories, namely straight- and broken-line repairs. Straight-line repair is simple and easy, but scar contracture frequently results in notching of the inferior border of the lobule. It can be avoided by the broken-line repair such as Z-plasty, L-plasty, or a V-shaped flap. Between April 2016 and February 2017, six patients who presented with traumatic cleft earlobe underwent surgical correction using a combination of the inverted V-shaped excision technique and vertical mattress suture method. All the patients were female and had a unilateral complete cleft earlobe. No postoperative notching of the inferior border the lobule occurred during 6–16 months of follow-up. Without the use of a broken-line repair, both the patients and the operators attained aesthetically satisfactory results. Therefore, the combination of the inverted V-shaped excision technique and vertical mattress suture method is considered useful in the treatment of traumatic cleft earlobes.
Cicatrix
;
Contracture
;
Ear
;
Female
;
Follow-Up Studies
;
Humans
;
Methods*
;
Plastics
;
Surgeons
;
Suture Techniques
;
Sutures*
8.Reconstruction of a Traumatic Cleft Earlobe Using a Combination of the Inverted V-Shaped Excision Technique and Vertical Mattress Suture Method.
June Kyu PARK ; Kyung Sik KIM ; Seung Hong KIM ; Jun CHOI ; Jeong Yeol YANG
Archives of Craniofacial Surgery 2017;18(4):277-281
Traumatic cleft earlobes are a common problem encountered by plastic and reconstructive surgeons. Various techniques have been reported for the repair of traumatic cleft earlobes. Usually, the techniques of split earlobe repair are divided into two categories, namely straight- and broken-line repairs. Straight-line repair is simple and easy, but scar contracture frequently results in notching of the inferior border of the lobule. It can be avoided by the broken-line repair such as Z-plasty, L-plasty, or a V-shaped flap. Between April 2016 and February 2017, six patients who presented with traumatic cleft earlobe underwent surgical correction using a combination of the inverted V-shaped excision technique and vertical mattress suture method. All the patients were female and had a unilateral complete cleft earlobe. No postoperative notching of the inferior border the lobule occurred during 6–16 months of follow-up. Without the use of a broken-line repair, both the patients and the operators attained aesthetically satisfactory results. Therefore, the combination of the inverted V-shaped excision technique and vertical mattress suture method is considered useful in the treatment of traumatic cleft earlobes.
Cicatrix
;
Contracture
;
Ear
;
Female
;
Follow-Up Studies
;
Humans
;
Methods*
;
Plastics
;
Surgeons
;
Suture Techniques
;
Sutures*
9.Prognosis of Pregnancy-Associated Gastric Cancer: An Age-, Sex-, and Stage-Matched Case-Control Study.
Min Jeong SONG ; Young Soo PARK ; Ho June SONG ; Se Jeong PARK ; Ji Yong AHN ; Kee Don CHOI ; Gin Hyug LEE ; Hwoon Yong JUNG ; Jeong Hwan YOOK ; Byung Sik KIM
Gut and Liver 2016;10(5):731-738
BACKGROUND/AIMS: Pregnancy-associated gastric cancer is a rare condition. This case-control study was performed to identify the clinicopathological features and prognostic factors of pregnancy-associated gastric cancer. METHODS: All consecutive patients who presented to our tertiary referral hospital with pregnancy-associated gastric cancer from 1991 to 2012 were identified. Two age-, sex-, and stage-matched controls for each case were also identified from the records. Clinicopathological, gynecological, and oncological outcomes were recorded. Immunohistochemical staining was performed for estrogen receptor, progesterone receptor, epidermal growth factor receptor, human epidermal growth factor receptor, and E-cadherin. Fluorescence in situ hybridization was performed for fibroblast growth factor receptor 2. RESULTS: The median overall survival rates of the pregnancy-associated gastric cancer and control groups were 7.0 months and 15.0 months, respectively (p=0.189). Poor prognostic factors included advanced stage and tumor location in the corpus or the entire stomach but not pregnancy status or loss of E-cadherin. Pregnancy-associated gastric cancer was associated with a longer time from diagnosis to treatment (21 days vs 7 days, p=0.021). The two groups did not differ in the expression of the receptors or E-cadherin. CONCLUSIONS: The dismal prognosis of pregnancy-associated gastric cancer may related to the tumor stage and location rather than to pregnancy itself.
Cadherins
;
Case-Control Studies*
;
Diagnosis
;
Estrogens
;
Fluorescence
;
Humans
;
In Situ Hybridization
;
Pregnancy
;
Prognosis*
;
Receptor, Epidermal Growth Factor
;
Receptor, Fibroblast Growth Factor, Type 2
;
Receptors, Progesterone
;
Stomach
;
Stomach Neoplasms*
;
Survival Rate
;
Tertiary Care Centers
10.Intraoperative neuromonitoring of the external branch of the superior laryngeal nerve during robotic thyroid surgery: a preliminary prospective study.
Su Jin KIM ; Kyu Eun LEE ; Byung Mo OH ; Eun Mee OH ; Dong Sik BAE ; June Young CHOI ; Jun Pyo MYONG ; Yeo Kyu YOUN
Annals of Surgical Treatment and Research 2015;89(5):233-239
PURPOSE: The aim of this study was to evaluate the feasibility of monitoring external branch of the superior laryngeal nerve (EBSLN) during robotic thyroid surgery. METHODS: A total of 10 patients undergoing bilateral axillo-breast approach (BABA) robotic thyroid surgery were enrolled. The nerve integrity monitor (NIM Response 2.0 System) was used for EBSLN monitoring. We performed voice assessments preoperatively and at 1 and 3 months postoperatively using Voice Handicap Index-10 (VHI-10), maximal phonation time (MPT), phonation efficient index (PEI), and laryngeal electromyography (EMG). RESULTS: A total of 19 EBSLNs were at risk and 14 EBSLNs (73.7%) were identified using neuromonitoring. VHI-10 showed a change of voice over time (0.1 vs. 3.6 vs. 1.3); however, this was not statistically significant. VHI-10 scores normalized at 3 months postoperatively compared to the preoperative scores. MPT (a) (16.0 vs. 15.6 vs. 15.4), and MPT (e) (20.1 vs. 15.4 vs. 18.5) showed no significant differences preoperatively compared to the values obtained 1 and 3 months postoperatively. There was a significant change of PEI over time (4.8 vs. 1.1 vs. 4.6) (P = 0.036); however, the values normalized at 3 months postoperatively. Laryngeal EMG results showed 4 cases (21.2%) of neuropathy of EBSLNs at 1 month postoperatively, and electrodiagnostic studies revealed nearly complete recovery of the function of EBSLNs in 4 patients at 3 months postoperatively CONCLUSION: It is suggested that neuromonitoring of EBSLNs during BABA robotic thyroid surgery is feasible and might be helpful to preserve voice quality.
Electromyography
;
Humans
;
Intraoperative Neurophysiological Monitoring
;
Laryngeal Nerves*
;
Phonation
;
Prospective Studies*
;
Thyroid Gland*
;
Thyroidectomy
;
Voice
;
Voice Quality

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