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.

PURPOSE: This study aimed to determine the diagnostic value of the relative filtration fraction (RFF) assessed by dynamic ⁹⁹mTc-diethylenetriaminepentaacetic acid (⁹⁹mTc-DTPA) renal scintigraphy after angiotensin-converting enzyme (ACE) inhibition for renovascular hypertension (RVHT) diagnosis.METHODS: ⁹⁹mTc-DTPA captopril renal scintigraphy performed in adolescents or adults (≥ 10 years) with suspected RVHT was retrospectively reviewed. The RFF of the affected kidney was qualitatively assessed as the relative glomerular filtration rate during the 2 to 3-min period compared with the relative perfusion during the first 60 s (qualitative RFF) and scored from 1 (definitely same) to 5 (definitely decreased). The quantitative RFF of the affected kidney was obtained by dividing the percentage of glomerular filtration rate by the percentage of renal perfusion.RESULTS: Overall, 173 patients (high probability, n = 15; and low probability, n = 158) were included based on conventional captopril renal scintigraphic criteria. An abnormal qualitative RFF was observed in 12 patients with high probability, and the diagnostic sensitivity was 80.0% (95% CI, 51.9–95.7). The RFF was normal in 152 patients with low probability, and the diagnostic specificity was 96.2% (95% CI, 91.9–98.6). The RFF was lower in patients with high probability than in those with low probability (0.79 ± 0.15 vs. 1.02 ± 0.11, P < 0.0001).CONCLUSIONS: The RFF assessed by dynamic ⁹⁹mTc-DTPA renal scintigraphy after ACE inhibition can detect patients with high probability for RVHT. The RFF after ACE inhibition might be a useful diagnostic criterion especially when baseline scintigraphy is not available for evaluating ACE inhibition-induced changes.
Adolescent ; Adult ; Captopril ; Diagnosis ; Filtration ; Glomerular Filtration Rate ; Humans ; Hypertension, Renovascular ; Kidney ; Perfusion ; Radionuclide Imaging ; Retrospective Studies ; Sensitivity and Specificity

PURPOSE: This study aimed to determine the diagnostic value of the relative filtration fraction (RFF) assessed by dynamic ⁹⁹mTc-diethylenetriaminepentaacetic acid (⁹⁹mTc-DTPA) renal scintigraphy after angiotensin-converting enzyme (ACE) inhibition for renovascular hypertension (RVHT) diagnosis. METHODS: ⁹⁹mTc-DTPA captopril renal scintigraphy performed in adolescents or adults (≥ 10 years) with suspected RVHT was retrospectively reviewed. The RFF of the affected kidney was qualitatively assessed as the relative glomerular filtration rate during the 2 to 3-min period compared with the relative perfusion during the first 60 s (qualitative RFF) and scored from 1 (definitely same) to 5 (definitely decreased). The quantitative RFF of the affected kidney was obtained by dividing the percentage of glomerular filtration rate by the percentage of renal perfusion. RESULTS: Overall, 173 patients (high probability, n = 15; and low probability, n = 158) were included based on conventional captopril renal scintigraphic criteria. An abnormal qualitative RFF was observed in 12 patients with high probability, and the diagnostic sensitivity was 80.0% (95% CI, 51.9–95.7). The RFF was normal in 152 patients with low probability, and the diagnostic specificity was 96.2% (95% CI, 91.9–98.6). The RFF was lower in patients with high probability than in those with low probability (0.79 ± 0.15 vs. 1.02 ± 0.11, P < 0.0001). CONCLUSIONS The RFF assessed by dynamic ⁹⁹mTc-DTPA renal scintigraphy after ACE inhibition can detect patients with high probability for RVHT. The RFF after ACE inhibition might be a useful diagnostic criterion especially when baseline scintigraphy is not available for evaluating ACE inhibition-induced changes.

BACKGROUND: Occupational physicians (OPs) have complex relationships with employees, employers, and the general public. OPs may have simultaneous obligations towards third parties, which can lead to variable conflicts of interests. Among the various studies of ethical issues related to OPs, few have focused on the Korean OPs. The aim of the present survey was to investigate the ethical contexts, the practical resolutions, and the ethical principles for the Korean OPs. METHODS: An email with a self-administered questionnaire was sent to members of the Korean Society of Occupational and Environmental Medicine, comprising 150 specialists and 130 residents. The questionnaire was also distributed to 52 specialists and 46 residents who attended the annual meeting of the Korean Association of Occupational and Environmental Clinics in October 2015, and to 240 specialists by uploading the questionnaire to the online community ‘oem-doctors’ in February 2016. The responses to each question (perception of general ethical conflicts, recognition of various ethical codes for OPs, core professional values in ethics of occupational medicine, and a mock case study) were compared between specialists and residents by the chi-squared test and Fisher’s exact test. RESULTS: Responses were received from 80 specialists and 71 residents. Most participants had experienced ethical conflicts at work and felt the need for systematic education and training. OPs suffered the most ethical conflicts in decisions regarding occupational health examination and evaluation for work relatedness. Over 60% of total participants were unaware of the ethical codes of other countries. Participants thought ‘consideration of worker’s health and safety’ (26.0%) and ‘neutrality’ (24.7%) as the prominent ethical values in professionality ofoccupational medicine. In mock cases, participants chose beneficence and justice for fitness for work and confidential information acquired while on duty, and beneficence and respect for autonomy in pre-placement examinations. CONCLUSIONS: This study evaluated the current perception of and attitude toward ethical issues among the Korean OPs. These findings will facilitate the development of a code of ethics and the ethical decision-making program forthe Korean OPs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40557-017-0182-z) contains supplementary material, which is available to authorized users.
Beneficence ; Codes of Ethics ; Confidentiality ; Education ; Electronic Mail ; Environmental Medicine ; Ethics* ; Occupational Health ; Occupational Medicine ; Social Justice ; Specialization

No abstract available.
Environmental Health* ; Housing* ; Life Style*

BACKGROUND: Obstructive sleep apnea is a common sleep disorder that can cause excessive daytime sleepiness and impairment of cognition. These symptoms may lead to the occurrence of occupational accidents in workers with obstructive sleep apnea. CASE PRESENTATION: A 36-year-old man who worked as a dimensional control surveyor caused a vehicle accident while he was driving at the work site. Although he experienced loss of consciousness at the time of the accident, he had no other symptoms. His brain computed tomography and laboratory test did not show any specific findings. Medical tests were conducted to evaluate his fitness for work. Decreased sleep latency was observed on the electroencephalography image, which is suggestive of a sleep disorder. He frequently experienced daytime sleepiness and his Epworth sleepiness score was 13. The polysomnography showed a markedly increased apnea-hypopnea index of 84.3, which led to a diagnosis of severe obstructive sleep apnea. The patient was advised to return to work only when his obstructive sleep apnea improved through proper treatment. CONCLUSION: Proper screening for obstructive sleep apnea among workers is important for preventing workplace accidents caused by this disorder, but screening guidelines have not yet been established in Korea. An effort toward preparing practical guidelines for obstructive sleep apnea is needed.
Accidents, Occupational ; Adult ; Brain ; Cognition ; Diagnosis ; Electroencephalography ; Humans ; Korea ; Mass Screening ; Polysomnography ; Return to Work ; Sleep Apnea, Obstructive* ; Unconsciousness ; Workplace

PURPOSE: The Abbe flap procedure has been used to correct disharmony of the upper and lower lips as well as for making a philtrum for patients with secondary cleft lip deformities. But the Abbe flap procedure adds two scars in addition to the prior operative scar on the upper lip. This study was conducted to determine the treatment outcomes of esthetic subunit excision of the scar on the philtrum and Abbe flap coverage for correction of cleft lip deformities with photogrammetric analysis. METHODS: This study investigated a total of 11 patients with cleft lip deformities who underwent scar excision with Abbe flap coverage, and the patients were followed up for at least 6 months. Under general anesthesia, a mushroom- shaped Abbe flap was drawn on the lower lip with a width of 8 mm and a height 1~2mm longer than that of the philtral midline. The epidermis and dermis of the scar on the upper lip were excised. In the cases with alar base depression, the orbicularis oris muscle was split vertically and transposed to the alar base. The Abbe flap was harvested as a pedicled flap containing a small amount of muscle and this was rotated 180-degree to be inserted into the upper lip. Mucosa, muscle, subcutaneous tissue and skin were closed in layers. The flap was divided at the 7~14 postoperative day. The postoperative outcomes were evaluated by using photogrammetric analysis. Three indices were measured from the standard clinical photographs taken before and after the surgery. For anthroposcopic assessment, observers described the postoperative outcomes using an ordinary scale method. RESULTS: The postoperative values obtained in the photogrammetric analysis showed improvement as compared with the preoperative ones. Improved anthroposcopic outcomes were also noted. CONCLUSION: Scar excision and Abbe flap coverage were proven to be effective in improving protrusion and the height of the upper lip, the scar of the upper lip and the symmetry of Cupid's bow and the philtral column, as well as formation of the philtral dimple.
Anesthesia, General ; Cicatrix ; Cleft Lip ; Congenital Abnormalities ; Depression ; Dermis ; Epidermis ; Humans ; Lip ; Mucous Membrane ; Muscles ; Skin ; Subcutaneous Tissue ; Succinates ; Surgical Flaps

The aim of extremity reconstruction has focused on early wound coverage and functional recovery but rarely aesthetics. As the quality of life improves, however, the request for aesthetics has been growing. The authors has conducted retrospective reviews on the 86 cases that had extremity reconstruction using free flap, considering the characteristics of parts that had been assessed in primary operation between May 1996 and December 2010. Aesthetic grading was performed in four categories; color, texture, contour and marginal scar. Recipient sites were 42 hands, 19 feet, 14 lower extremities excluding feet and 10 upper extremities apart from the hand. Types of free flap were 16 latissimus dorsi free flaps, 13 anterolateral thigh free flaps, 12 dorsalis pedis free flaps, 8 transvers rectus abdominis free flaps, 7 gracillis free flaps, and 5 superficial temporal fascia free flaps. Total flap necrosis was seen in 8 cases(9.3%) and partial necrosis in 5 cases(5.8%). Secondary revision was done in 24 cases(27.9%) and the most common revision, debulking was done in 14 cases(16.3%). The authors has considered cosmetic aspects along with wound coverage and functional recovery in primary reconstruction. The results of aesthetic grading was 16.2 out of 20, and the secondary revision rate was reduced.
Cicatrix ; Cosmetics ; Esthetics ; Extremities ; Fascia ; Foot ; Free Tissue Flaps ; Hand ; Lower Extremity ; Necrosis ; Quality of Life ; Rectus Abdominis ; Retrospective Studies ; Thigh ; Upper Extremity

PURPOSE: Nasal bone fractures are often classified as minor injury. However, the incidence of posttraumatic nasal deformity remains alarmingly high. It is because of unnoticed septal fracture. This study was conducted to determine the necessity of septoplasty for patients with nasal bone fracture accompanying grade I septal fractures. METHODS: Among 105 patients with nasal bone fractures, 52 who had grade I septal fracture were diagnosed based on physical examination and computed tomography. Patients' age ranged from 14 to 65 years (mean 29.25 years), and 35 were male and 17 female. Patients were divided into 2 groups according to surgical treatment METHODS: patients who underwent closed reduction only (group 1, n=28) and those who underwent simultaneous closed reduction and septoplasty (group 2, n=24). The treatment outcomes were evaluated by comparing changes in nasal airway volume measured by acoustic rhinometry before the surgery, 3 months and 6 months after the surgery according to the timing of surgical repair and surgical treatment methods. RESULTS: Nasal airway volume increased after the surgery by 17.8% in 3 months after the surgery, 25.2% in 6 months in group 1 and by 22.7% in 3 months, 35.8% in 6 months in group 2. The increase in airway volume after the surgery by 26.3% in 3 months after the surgery, 34.2% in 6 months after the surgery in operation within 1 week after trauma and by 12.1% in 3 months, 22.2% in 6 months after the operation later 1 week after trauma. The difference was statistically significant. Three patients in group 1 complained of intermittent nasal obstruction, two of whom showed a decrease in nasal airway volume by acoustic rhinometry. CONCLUSION: Most patients with nasal bone fractures accompanying grade I septal fractures have been treated with closed reduction in clinical settings. However, the results of this study suggest that septoplasty be performed after a correct diagnosis of septal fracture is made through comprehensive physical examination and computed tomography. Septoplasty is important to obtain more favorable outcomes and reduce complication.
Acoustics ; Congenital Abnormalities ; Female ; Humans ; Incidence ; Male ; Nasal Bone ; Nasal Obstruction ; Physical Examination ; Rhinometry, Acoustic

PURPOSE: Complete septal extension grafts have been widely used in rhinoplasty for effective projection of the short retruded columella in Asian patients. Autologous septal cartilages and porous high-density polyethylene sheets are frequently used as septal extension grafts. This study was conducted to compare the postoperative results of porous polyethylene sheets and septal cartilages used for correction of unilateral cleft lip nasal deformities by using photogrammetric analysis. METHODS: This study investigated a total of 49 patients with cleft lip nasal deformities who underwent corrective surgery, and were followed up for at least 6 months. Septal cartilages were used in 39 patients, and porous polyethylene sheets were used in 10 patients. In all patients, through the open rhinoplasty, complete septal extension grafts were sutured to the caudal margin of the septal cartilage, and the alar cartilage was sutured with suspension. The cleft side alar cartilage was overcorrected by approximately 3 - 5 mm. Postoperative outcomes were evaluated by using photogrammetric analysis. Five indices and 4 angles were measured on their photographs taken before and after the surgery. In patients with unilateral cleft lip nasal deformities, symmetry was also evaluated by means of columellar length index. RESULTS: The postoperative values obtained in photogrammetric analysis showed improvements in comparison with the preoperative ones. The polyethylene group produced more improved outcomes than the septal cartilage group but also resulted in more complications at the same time. CONCLUSION: The results of this study indicates that complete septal extension grafts are efficient for the correction of unilateral cleft lip nasal deformities. However, since postoperative complications occur more frequently in the polyethylene group than in the septal cartilage group, caution is advised in using porous high-density polyethylene sheets in patients with cleft lip nasal deformities.
Asian Continental Ancestry Group ; Cartilage ; Cleft Lip ; Congenital Abnormalities ; Humans ; Nasal Cartilages ; Polyethylene ; Postoperative Complications ; Rhinoplasty ; Succinates ; Transplants