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.

Background/Aims: We evaluated the feasibility and long-term efficacy of the combination of cytarabine, idarubicin, and all-trans retinoic acid (ATRA) for treating patients with newly diagnosed acute promyelocytic leukemia (APL). Methods: We included 87 patients with newly diagnosed acute myeloid leukemia and a t(15;17) or promyelocytic leukemia/retinoic acid receptor alpha (PML-RARα) mutation. Patients received 12 mg/m2/day idarubicin intravenously for 3 days and 100 mg/m2/day cytarabine for 7 days, plus 45 mg/m2/day ATRA. Clinical outcomes included complete remission (CR), relapse-free survival (RFS), overall survival (OS), and the secondary malignancy incidence during a 20-year follow-up. Results: The CR, 10-year RFS, and 10-year OS rates were 89.7%, 94.1%, and 73.8%, respectively, for all patients. The 10-year OS rate was 100% for patients that achieved CR. Subjects were classified according to the white blood cell (WBC) count in peripheral blood at diagnosis (low-risk, WBC < 10,000/mm3; high-risk, WBC ≥ 10,000/mm3). The low-risk group had significantly higher RFS and OS rates than the high-risk group, but the outcomes were not superior to the current standard treatment (arsenic trioxide plus ATRA). Toxicities were similar to those observed with anthracycline plus ATRA, and higher than those observed with arsenic trioxide plus ATRA. The secondary malignancy incidence after APL treatment was 2.7%, among the 75 patients that achieved CR, and 5.0% among the 40 patients that survived more than 5 years after the APL diagnosis. Conclusions Adding cytarabine to anthracycline plus ATRA was not inferior to anthracycline plus ATRA alone, but it was not comparable to arsenic trioxide plus ATRA. The probability of secondary malignancy was low.

Since laparoscopic liver resection was first introduced in 2001, Korean surgeons have chosen a laparoscopic procedure as one of the treatment options for benign or malignant liver disease. We distributed and analyzed a nationwide questionnaire to members of the Korean Laparoscopic Liver Surgery Study Group (KLLSG) in order to evaluate the current status of laparoscopic liver resection in Korea. Questionnaires were sent to 24 centers of KLLSG. The questionnaire consisted of operative procedure, histological diagnosis of liver lesions, indications for resection, causes of conversion to open surgery, and postoperative outcomes. A laparoscopic liver resection was performed in 416 patients from 2001 to 2008. Of 416 patients, 59.6% had malignant tumors, and 40.4% had benign diseases. A total laparoscopic approach was performed in 88.7%. Anatomical laparoscopic liver resection was more commonly performed than non-anatomical resection (59.9% vs 40.1%). The anatomical laparoscopic liver resection procedures consisted of a left lateral sectionectomy (29.3%), left hemihepatectomy (19.2%), right hemihepatectomy (6%), right posterior sectionectomy (4.3%), central bisectionectomy (0.5%), and caudate lobectomy (0.5%). Laparoscopy-related serious complications occurred in 12 (2.8%) patients. The present study findings provide data in terms of indication, type and method of liver resection, and current status of laparoscopic liver resection in Korea.
*Hepatectomy/statistics & numerical data ; Humans ; *Laparoscopy/statistics & numerical data ; Liver/*surgery ; Liver Diseases/pathology/surgery ; Liver Neoplasms/pathology/surgery ; Postoperative Complications/epidemiology ; Questionnaires ; Republic of Korea

The aims of the study were to evaluate the effect of epinephrine-containing local anesthetics on pulpal blood flow (PBF) and to investigate its effect on cavity preparation-induced PBF change. PBF was recorded using a laser Doppler flowmeter (Perimed Co., Sweden) from canines of nine cats under general anesthesia before and after injection of local anesthetics and after cavity preparation. 2% lidocaine hydrochloride with 1 : 100,000 epinephrine was administered by local infiltration given apical to the mandibular canine at the vestibular area and the same volume of isotonic saline was injected on the contralateral tooth as a control. A round carbide bur was operated at slow speed with isotonic saline flushing to grind spherical cavities with increasing depth through the enamel and into the dentin on both teeth. The obtained data was analyzed with paired t-test. Cavity preparation caused significant increase of PBF (n = 9, p < 0.05). Local infiltration of lidocaine with epinephrine resulted in decreases of PBF (n = 9, p < 0.05), whereas there was no significant change of PBF with the physiologic saline as a control. Cavity preparation on tooth anesthetized with lidocaine with epinephrine caused significantly less increase of PBF than in control tooth (p < 0.05). Therefore, the result of the present study demonstrates that local infiltration of 2% lidocaine with 1 : 100,000 epinephrine effectively reduces PBF increase caused by cavity preparation.
Anesthesia, General ; Anesthesia, Local* ; Anesthetics, Local ; Animals ; Cats ; Dental Enamel ; Dentin ; Epinephrine ; Flowmeters ; Flushing ; Lidocaine ; Neurogenic Inflammation ; Tooth*

PURPOSE: We planned to determine the diagnostic capability of focused assessment with sonography for trauma (FAST) in cases of blunt abdominal injury (BAI). METHODS: A retrospective analysis of FAST sheets was performed from April 2002 to December 2004. During the study period, 135 BAI patients were evaluated with FAST at the Emergency Department of Bundang CHA Hospital. Of this group, twenty-eight patients were excluded, leaving 107 patients for analysis. Abdomen CT (computerized tomography) or exploratory laparotomy confirmed the presence of hemoperitoneum. At the secondary survey, patients underwent a three-view FAST examination (LogicQ; General Electric, Waukesha, USA) by an emergency physician, followed within 2 hours by an abdomen CT or exploratory laparotomy. The FAST examination was considered positive if it demonstrated evidence of free intra-abdominal fluid. RESULTS: There were 45 true-positive FAST examination, 57 true-negatives, 1 false-positive, and 4 false negatives (sensitivity 91.8%, specificity 98.3%, positive predictive value 97.8%, negative predictive value 93.4%). The area under the ROC curve was 0.951 for the FAST examination. CONCLUSION: FAST is a highly reliable method for screening patients suspected of having BAI for the presence or absence of hemoperitoneum.
Abdomen ; Abdominal Injuries ; Emergencies ; Emergency Service, Hospital ; Hemoperitoneum ; Humans ; Laparotomy ; Mass Screening ; Retrospective Studies ; ROC Curve ; Sensitivity and Specificity ; Tomography, X-Ray Computed

PURPOSE: We planned to determine the diagnostic capability of focused assessment with sonography for trauma (FAST) in cases of blunt abdominal injury (BAI). METHODS: A retrospective analysis of FAST sheets was performed from April 2002 to December 2004. During the study period, 135 BAI patients were evaluated with FAST at the Emergency Department of Bundang CHA Hospital. Of this group, twenty-eight patients were excluded, leaving 107 patients for analysis. Abdomen CT (computerized tomography) or exploratory laparotomy confirmed the presence of hemoperitoneum. At the secondary survey, patients underwent a three-view FAST examination (LogicQ; General Electric, Waukesha, USA) by an emergency physician, followed within 2 hours by an abdomen CT or exploratory laparotomy. The FAST examination was considered positive if it demonstrated evidence of free intra-abdominal fluid. RESULTS: There were 45 true-positive FAST examination, 57 true-negatives, 1 false-positive, and 4 false negatives (sensitivity 91.8%, specificity 98.3%, positive predictive value 97.8%, negative predictive value 93.4%). The area under the ROC curve was 0.951 for the FAST examination. CONCLUSION: FAST is a highly reliable method for screening patients suspected of having BAI for the presence or absence of hemoperitoneum.
Abdomen ; Abdominal Injuries ; Emergencies ; Emergency Service, Hospital ; Hemoperitoneum ; Humans ; Laparotomy ; Mass Screening ; Retrospective Studies ; ROC Curve ; Sensitivity and Specificity ; Tomography, X-Ray Computed

PURPOSE: This study was performed to determine whether the anion gap, the base excess, the lactate, and the strong ion gap obtained in the emergency department correlate with the prognosis and whether the strong ion gap is the most useful marker compared to the prognostic ability of the anion gap, the base excess, and the lactate. METHODS: We reviewed the records of 106 patients admitted to the intensive care unit via the emergency department. We measured the anion gap, the base excess, and the lactate and we calculated strong anion gap by using a formula. We divided the patients into survivors and nonsurvivors and compared the prognostic abilities of the four variables by using the Student's t-test and receiver operator characteristic curves. RESULTS: The mean age of the patients was 67+/-14, and the numbers of males and females were similar (58 males vs 48 females). The number of survivors was 92 (86.7%), and that of nonsurvivors was 14 (3.2%). The anion gap ( 24.8+/-8.8 vs. 16.4+/-4.8 mmol/L, p value=0.000), the base excess (-11.9+/-8.7 vs. -3.49+/-6.5 mmol/L, p value = 0.001), the lactate (9.1+/-7.7 vs. 4.5+/-3.1 mmol/L, p value = 0.011 ) and the strong ion gap (16.6+/-3.6 vs. 10.9+/-3.7, p value=0.000) of the nonsurvivors were higher. All of the four varibles were associated with the prognosis, but among them, the strong ion gap discriminated most strongly with an area under the receiver operator characteristic curve of 0.866 (95% confidence interval, 0.787 to 0.92). CONCLUSION: The initial emergency-department acid-base variables, the anion gap, the base excess, the lactate and the strong ion gap have prognostic abilities, but the strong ion gap is the variable that most strongly predicts of mortality.
Acid-Base Equilibrium ; Critical Illness* ; Emergencies* ; Emergency Service, Hospital* ; Female ; Humans ; Intensive Care Units ; Lactic Acid ; Male ; Mortality ; Prognosis ; Survivors

PURPOSE: This retrospective study was performed to investigate epidemiological characteristics in terms of the ageand the sex-specific incidences in patients with perforated or nonperforated appendicitis. METHOD: The study population comprised 314 patients who underwent appendectomies for suspected acute appendicitis between March 2002 and August 2003. This study used the student t-test, the coefficient of correlation, and the Cochran-Mantel-Haenszel Chi-square statistics. RESULTS: The incidence of nonperforated appendicitis was higher. Perforated appendicitis occurred at almost the same incidence in both sexes. However, the incidence of perforated appendicitis was high in small children and the elderly. The statistics of this study proved that the incidence of perforated appendicitis of the elderly was considerable. CONCLUSIONS: We suggest that the elderly need careful examination and rapid evaluation. Also, we suggest that since perforated appendicitis has a long duration of treatment, diagnostic accuracy is needed.
Aged ; Appendectomy ; Appendicitis* ; Child ; Humans ; Incidence* ; Retrospective Studies

The purpose of this study was to investigate the influence of NK1 receptor antagonists on the pulpal blood flow (PBF) when applied iontophoretically through the dentinal cavity of the teeth in order to understand whether iontophoretically applied NK1 receptor antagonists can control the pulpal inflammation. Eleven cats were anesthetized with alpha-chloralose and urethane, and substance P (SP) was administered to the dental pulp through the catheterized lingual artery in doses that caused PBF change without the influence of systemic blood pressure. NK1 receptor antagonists were applied iontophoretically to the prepared dentinal cavity of ipsilateral canine teeth of the drug administration, and PBF was monitored. Data were analyzed statistically with paired t-test. PBF increase after iontophoretic application of the NK1 receptor antagonists followed by the intra-arterial administration of SP was significantly less than PBF increase after iontophoretic application of the 0.9% saline followed by the intra-arterial administration of SP as a control (p < 0.05). Iontophoretic application of the NK1 receptor antagonists (0.2~3.4 mM) following the intra-arterial administration of SP resulted in less increase of PBF than the iontophoretic application of the 0.9% saline following the intra-arterial administration of SP as a control (p < 0.05). Therefore, the results of the present study provide evidences that the iontophoretic application is an effective method to deliver drugs to the dental pulp, and that iontophoretically applied NK1 receptor antagonists block SP-induced vasodilation effectively. The above results show the possibility that the iontophoretical application of NK1 receptor antagonists can control the neurogenic inflammation in the dental pulp.
Animals ; Arteries ; Blood Pressure ; Catheters ; Cats* ; Chloralose ; Cuspid ; Dental Pulp ; Dentin ; Inflammation ; Iontophoresis ; Neurogenic Inflammation ; Substance P ; Tooth ; Urethane ; Vasodilation

Cytomegalovirus (CMV) infections are commonly reported in severely immunocompromised hosts and ulcers of the alimentary tract are frequently observed in systemic CMV infections. However, invasive and ulcerative disease of the gastrointestinal (GI) tract caused by CMV has also been reported in healthy adults. Many reports show that a CMV infection can produce localized ulcerations in the esophagus, stomach, small intestine, and colon in nonimmunocompromised individuals. The most common site of involvement by CMV infection in the GI tract is the colon followed by the upper GI tract and the least common site is the small intestine. Although GI bleeding is one of the major presenting symptoms of patients with CMV infections of the GI tract, lower GI bleeding due to CMV ileal ulcers in immunocompetent patients, to our knowledge, has not been reported in the English literature. Recently, we experienced a case of lower GI bleeding due to CMV ileal ulcers in a 57-year-old man who had no evidence of immunocompromise. This case suggests that small intestinal ulcers due to CMV infection should be included in the differential diagnosis of lower GI bleeding even in immunocompetent hosts.
Case Report ; Cytomegalovirus Infections/complications* ; Gastrointestinal Hemorrhage/etiology* ; Human ; Ileal Diseases/complications* ; Male ; Middle Age ; Ulcer/complications*