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Purpose@#This study evaluated whether an addition of simvastatin to chemotherapy improves survival in ever-smokers with extensive disease (ED)–small cell lung cancer (SCLC). @*Materials and Methods@#This is an open-label randomized phase II study conducted in National Cancer Center (Goyang, Korea). Chemonaive patients with ED-SCLC, smoking history (≥ 100 cigarettes lifetime), and Eastern Cooperative Oncology Group performance status of ≤ 2 were eligible. Patients were randomized to receive irinotecan plus cisplatin alone or with simvastatin (40 mg once daily orally) for a maximum of six cycles. Primary endpoint was the the 1-year survival rate. @*Results@#Between September 16, 2011, and September 9, 2021, 125 patients were randomly assigned to the simvastatin (n=62) or control (n=63) groups. The median smoking pack year was 40 years. There was no significant difference in the 1-year survival rate between the simvastatin and control groups (53.2% vs. 58.7%, p=0.535). The median progression-free survival and overall survival between the simvastatin arm vs. the control groups were 6.3 months vs. 6.4 months (p=0.686), and 14.4 months vs. 15.2 months, respectively (p=0.749). The incidence of grade 3-4 adverse events was 62.9% in the simvastatin group and 61.9% in the control group. In the exploratory analysis of lipid profiles, patients with hypertriglyceridemia had significantly higher 1-year survival rates than those with normal triglyceride levels (80.0% vs. 52.7%, p=0.046). @*Conclusion@#Addition of simvastatin to chemotherapy provided no survival benefit in ever-smokers with ED-SCLC. Hypertriglyceridemia may be associated with better prognosis in these patient population.
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Objective@#To compare the outcomes of digital breast tomosynthesis (DBT) screening combined with ultrasound (US) with those of digital mammography (DM) combined with US in women with dense breasts. @*Materials and Methods@#A retrospective database search identified consecutive asymptomatic women with dense breasts who underwent breast cancer screening with DBT or DM and whole-breast US simultaneously between June 2016 and July 2019. Women who underwent DBT + US (DBT cohort) and DM + US (DM cohort) were matched using 1:2 ratio according to mammographic density, age, menopausal status, hormone replacement therapy, and a family history of breast cancer. The cancer detection rate (CDR) per 1000 screening examinations, abnormal interpretation rate (AIR), sensitivity, and specificity were compared. @*Results@#A total of 863 women in the DBT cohort were matched with 1726 women in the DM cohort (median age, 53 years; interquartile range, 40–78 years) and 26 breast cancers (9 in the DBT cohort and 17 in the DM cohort) were identified. The DBT and DM cohorts showed comparable CDR (10.4 [9 of 863; 95% confidence interval {CI}: 4.8–19.7] vs. 9.8 [17 of 1726;95% CI: 5.7–15.7] per 1000 examinations, respectively; P = 0.889). DBT cohort showed a higher AIR than the DM cohort (31.6% [273 of 863; 95% CI: 28.5%–34.9%] vs. 22.4% [387 of 1726; 95% CI: 20.5%–24.5%]; P < 0.001). The sensitivity for both cohorts was 100%. In women with negative findings on DBT or DM, supplemental US yielded similar CDRs in both DBT and DM cohorts (4.0 vs. 3.3 per 1000 examinations, respectively; P = 0.803) and higher AIR in the DBT cohort (24.8% [188 of 758; 95% CI: 21.8%–28.0%] vs. 16.9% [257 of 1516; 95% CI: 15.1%–18.9%; P < 0.001). @*Conclusion@#DBT screening combined with US showed comparable CDR but lower specificity than DM screening combined with US in women with dense breasts.
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Objective@#The purpose of this nationwide age- and sex- matched longitudinal study was to determine the pyogenic spondylitis (PS) increases the incidence of ischemic stroke (IS) in Korea. @*Methods@#From the National Health Insurance Service (NHIS), we collected the patient data for the period from January 1, 2004 to December 31, 2015. PS was classified according to the International Classification of Disease codes M46.2-M46.8, M49.2, and M49.3. By using a 1:5 age- and sex- stratified matching, a total of 628 patients and 3140 control subjects were included in the study. The IS incidence rates in PS and control group was calculated by using the Kaplan-Meier method. The outcome of hazard ratio of IS was estimated by Cox proportional hazards regression analyses. This study did not exclude PS as a result of postoperative complications. @*Results@#According to the study, 51 patients (8.12%) in the PS group and 201 patients (6.4%) in the control group experienced IS. The adjusted hazard ratio of IS in the PS group was 3.419 (95% CI: 2.473-4.729) after adjusting individual medical condition and demographics. Following the results of subgroup analysis, the risk ratio of IS was greater in most of the subgroup categories (male, female, age 65, non-diabetic, hypertensive, non-hypertensive, dyslipidemic and non-dyslipidemic subgroup). However, the risk of IS did not differ significantly in diabetic subgroup (95% CI: 0.953-4.360). @*Conclusions@#The risk rate of IS increased in patient with pyogenic spondylitis.
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Objectives@# Based on the results from the Korean Total Diet Study (KTDS), the sodium (Na) and potassium (K) intake of Koreans were estimated and compared with intake estimates from the Food & Nutrient Database (FNDB), as in the Korea National Health and Nutrition Examination Survey (KNHANES) to verify the validity of these estimates. @*Methods@# One hundred and thirty-four representative foods (RFs) covering 92.5% of the total food intake of Koreans were selected, and 228 pairs of corresponding ‘RF x representative cooking method’ were derived by reflecting the methods used mainly in terms of frequency and quantity in their cooking.RF samples were collected from three cities with a larger population size in three regions (nine cities) nationwide, and six composite samples were made for each RF, considering its regional and/or seasonal characteristics. One thousand three hundred and sixty-eight ‘RF x representative cooking method’ pair samples were prepared, and the Na and K contents were assessed using inductively coupled plasma atomic emission spectrometry (ICP-MS). The Na and K intake of the Korean population was estimated by linking the content with the food intake data from the 7th KNHANES. @*Results@# The mean Na and K intake of Koreans were 2,807.4 mg and 2,335.0 mg per person per day, respectively. A comparison with the Na and K intake from KNHANES, including only RFs of KTDS, showed comparable results with less than 5% variation. While the contribution and ranking of food items to Na intake were similar between KNHANES and KTDS, there were differences in K intake.This was attributed to the large discrepancies in the K content of rice and coffee between KTDS results and the values in the 9th Revision of the National Food Composition Table used in KNHANES. @*Conclusions@# The Na and K intake of Koreans estimated based on the KTDS, which performed nutrient analysis on samples prepared to a ‘table-ready’ state using foods of the representative collection, was similar and comparable with that of KNHANES. This supports the validity and usefulness of FNDB-based nutrient intake estimation at the population level. The list of nutrients studied in KTDS is expected to be expanded, allowing for intake estimation of nutrients with currently insufficient or absent information in the FNDBs in use.
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Purpose@#To identify the imaging features indicative of sarcoid-like reactions in patients with intrathoracic lymphadenopathy after complete remission of malignancies. @*Materials and Methods@#This study enrolled five patients with histopathologically confirmed sarcoid-like reactions that developed after cancer remission. The clinical features and findings of CT and 18F-fluorodeoxyglucose (FDG) PET/CT were assessed. @*Results@#The underlying malignancies included breast, nasopharyngeal, colon, and endometrial cancer and lymphoma. The time intervals between complete remission of malignancy and the diagnosis of sarcoid-like reaction ranged from 6 to 78 months. CT findings of sarcoid-like reaction included bilateral hilar and mediastinal lymphadenopathies (n = 5), pulmonary nodules (1–15 mm) with peribronchovascular, fissural, or subpleural distribution, and interlobular interstitial thickening in the lungs (n = 4). 18F-FDG PET/CT revealed hypermetabolic uptake in the mediastinal and hilar lymph nodes and both lungs in the absence of extrathoracic uptake (n = 3). The sarcoid-like reactions resolved in all patients after corticosteroid treatment. @*Conclusion@#In patients with complete remission of malignancies, newly developed bilateral hilar and mediastinal lymphadenopathies with or without pulmonary nodules of perilymphatic distribution, in the absence of recurrence at the primary tumor site and extrathoracic metastasis, may suggest a sarcoid-like reaction. Such cases warrant histologic evaluation of the lymph nodes to prevent unnecessary systemic chemotherapy.
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Purpose@#To identify the imaging features indicative of sarcoid-like reactions in patients with intrathoracic lymphadenopathy after complete remission of malignancies. @*Materials and Methods@#This study enrolled five patients with histopathologically confirmed sarcoid-like reactions that developed after cancer remission. The clinical features and findings of CT and 18F-fluorodeoxyglucose (FDG) PET/CT were assessed. @*Results@#The underlying malignancies included breast, nasopharyngeal, colon, and endometrial cancer and lymphoma. The time intervals between complete remission of malignancy and the diagnosis of sarcoid-like reaction ranged from 6 to 78 months. CT findings of sarcoid-like reaction included bilateral hilar and mediastinal lymphadenopathies (n = 5), pulmonary nodules (1–15 mm) with peribronchovascular, fissural, or subpleural distribution, and interlobular interstitial thickening in the lungs (n = 4). 18F-FDG PET/CT revealed hypermetabolic uptake in the mediastinal and hilar lymph nodes and both lungs in the absence of extrathoracic uptake (n = 3). The sarcoid-like reactions resolved in all patients after corticosteroid treatment. @*Conclusion@#In patients with complete remission of malignancies, newly developed bilateral hilar and mediastinal lymphadenopathies with or without pulmonary nodules of perilymphatic distribution, in the absence of recurrence at the primary tumor site and extrathoracic metastasis, may suggest a sarcoid-like reaction. Such cases warrant histologic evaluation of the lymph nodes to prevent unnecessary systemic chemotherapy.
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Purpose@#Squamous cell carcinomas (SqCC) of the lung often express high levels of thymidylate synthase (TS), which is associated with primary resistance to pemetrexed. We explored the efficacy of pemetrexed in a selected population of patients with lung SqCC with low TS expression. @*Materials and Methods@#In this single-arm phase II trial, we enrolled 32 previously-treated patients with advanced lung SqCC exhibiting low immunohistochemical staining for TS (i.e., in 10% or less of tumor cells). The primary endpoint was 12-week progression-free survival (PFS) rate. @*Results@#Of 32 patients, eight patients (25%) had an Eastern Cooperative Oncology Group performance status of 2, and seven patients (22%) had previously received three or more lines of chemotherapy. The disease control rate from pemetrexed treatment was 30%, and no objective response was observed. The 12-week PFS rate was 24.5% (95% confidence interval [CI], 13.0 to 46.1). Median PFS was 1.3 months (95% CI, 1.3 to 2.7), and median overall survival was 11.8 months (95% CI, 8.1 to not applicable). Most of adverse events were grade 1 or 2. @*Conclusion@#Pemetrexed demonstrated modest activity as a salvage chemotherapy in patients with advanced lung SqCC with low TS expression, although its toxicity was generally manageable.
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Objective@#The disabled are in a blind spot for obtaining information on drugs, and the pharmacies’ counseling on drug use is centered on non-disabled people. Few studies have investigated the current statuses of drug use by type of disability. The purpose of this study is to understand the drug use by type of disability and by life cycle of visually impaired and hearing impaired in Korea. @*Methods@#The study participants consisted of 16 people with visually impairments, 12 people with hearing impairments. One indepth interview was conducted per participant, and each interview was recorded and documented. @*Results@#Common barriers against safe medication and medical service uses across disability types are ‘lack of consideration and service for the disabled, limited access to medical facilities due to disability, limited access to information regarding medication use, psychological anxiety about drug use and side effects, and inconvenience regarding COVID-19 epidemic. The specific factors were ‘difficulties in identifying proper medicines and following prescribed dosages’ in the case of visually impaired, and ‘problems with sign language interpretation system’ for the hearing impaired. @*Conclusion@#Disabled people are hindered from using medicines properly due to various factors. Based on the content derived from this study, it is necessary to eliminate the inhibition factors and devise specific measures for the safety of each type of disorder such as developing a method for medication counseling considering disabilities and establishing communication support systems.
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Iatrogenic esophageal perforation is a rare condition in children, but occasionally occurs in premature infants due to repeated intubation or nasogastric tube insertion. Esophageal perforation is common in pneumothorax and interstitial emphysema, but rarely occurs in the absence of pneumothorax. Although complications, such as mediastinitis, after esophageal perforation are rare, they can be fatal. Therefore, rapid and accurate diagnosis and appropriate treatment are important. The authors report a case of huge retrocardiac pneumomediastinum and subcutaneous emphysema suspected to be caused by esophageal perforation after repeated intubation.
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OBJECTIVE: To compare the diagnostic performance and interobserver variability of strain ratio obtained from one or two regions of interest (ROI) on breast elastography.MATERIALS AND METHODS: From April to May 2016, 140 breast masses in 140 patients who underwent conventional ultrasonography (US) with strain elastography followed by US-guided biopsy were evaluated. Three experienced breast radiologists reviewed recorded US and elastography images, measured strain ratios, and categorized them according to the American College of Radiology breast imaging reporting and data system lexicon. Strain ratio was obtained using the 1-ROI method (one ROI drawn on the target mass), and the 2-ROI method (one ROI in the target mass and another in reference fat tissue). The diagnostic performance of the three radiologists among datasets and optimal cut-off values for strain ratios were evaluated. Interobserver variability of strain ratio for each ROI method was assessed using intraclass correlation coefficient values, Bland–Altman plots, and coefficients of variation.RESULTS: Compared to US alone, US combined with the strain ratio measured using either ROI method significantly improved specificity, positive predictive value, accuracy, and area under the receiver operating characteristic curve (AUC) (all p values < 0.05). Strain ratio obtained using the 1-ROI method showed higher interobserver agreement between the three radiologists without a significant difference in AUC for differentiating breast cancer when the optimal strain ratio cut-off value was used, compared with the 2-ROI method (AUC: 0.788 vs. 0.783, 0.693 vs. 0.715, and 0.691 vs. 0.686, respectively, all p values > 0.05).CONCLUSION: Strain ratios obtained using the 1-ROI method showed higher interobserver agreement without a significant difference in AUC, compared to those obtained using the 2-ROI method. Considering that the 1-ROI method can reduce performers' efforts, it could have an important role in improving the diagnostic performance of breast US by enabling consistent management of breast lesions.
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BACKGROUND@#AND PURPOSE: This study aimed to determine the effects of lamotrigine (LTG) on language unction, including problem-solving abilities, in newly diagnosed pediatric epileptic patients.@*METHODS@#This study included 112 newly diagnosed epileptic patients treated with LTG [69 males and 43 females aged 9.6±2.7 years (mean±SD)]. Repeated neurologic examinations, electroencephalography, neuroimaging studies, and standard language tests including the Test of Problem Solving (TOPS), mean length of utterance in words (MLU-w), Receptive and Expressive Vocabulary Test (REVT), and Urimal Test of Articulation and Phonology were performed before and after initiating LTG treatment. The starting LTG dosage was 1 mg/kg/day (maximum: 25 mg/day) for the first 14 days, which was increased to 2 mg/kg/day for the subsequent 14 days and then up to 7 mg/kg/day (or 200 mg/day) for maintenance.@*RESULTS@#Problem-solving skills as assessed by TOPS scores significantly improved after initiating LTG treatment (33.5±14.5 vs. 35.7±14.25, p < 0.01). Scores in the “determining causes†category (11.9±4.7 vs. 12.9±4.8, p < 0.01), “making inferences†category (12.9±6.2 vs. 13.6±6.0, p < 0.05), and “predicting†category (8.9±5.4 vs. 9.7±5.6, p < 0.01) significantly improved after LTG treatment. The MLU-w score did not decrease after LTG treatment (4.7±1.9 vs. 5.0±2.1). There was a significant improvement in receptive language function as assessed using the REVT score (9.4±3.4 years vs. 9.9±3.3 years, p < 0.01). Precise articulation also improved after initiating LTG treatment (97.8% vs. 98.5%).@*CONCLUSIONS@#Language function including problem-solving skills improved after LTG treatment, suggesting that LTG can be administered without causing significant negative effects on language function in pediatric patients.
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Pseudoaneurysm formation in the profunda femoris artery (PFA) is a rare complication of femur shaft fractures or, more usually, a consequence of operative repair. Over the past few years, percutaneous transcatheter arterial embolization (TAE) has increasingly been considered the most effective treatment for pseudoaneurysms of the PFA. We report two cases with pseudoaneurysms of the PFA that were caused by femur shaft fractures and were successfully treated using TAE with n-butyl cyanoacrylate (NBCA). When a pseudoaneurysm of the PFA occurs due to a femur shaft fracture, early recognition and prompt radiologic intervention may prevent severe vascular injury without the need for additional surgery. The advent of TAE using NBCA enables minimally invasive treatment to be undertaken and it is effective for managing pseudoaneurysms of the PFA.
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OBJECTIVE: To compare digital breast tomosynthesis (DBT) and conventional full-field digital mammography (FFDM) in the detectability of breast cancers in patients with dense breast tissue, and to determine the influencing factors in the detection of breast cancers using the two techniques. MATERIALS AND METHODS: Three blinded radiologists independently graded cancer detectability of 300 breast cancers (288 women with dense breasts) on DBT and conventional FFDM images, retrospectively. Hormone status, histologic grade, T stage, and breast cancer subtype were recorded to identify factors affecting cancer detectability. The Wilcoxon signed-rank test was used to compare cancer detectability by DBT and conventional FFDM. Fisher's exact tests were used to determine differences in cancer characteristics between detectability groups. Kruskal-Wallis tests were used to determine whether the detectability score differed according to cancer characteristics. RESULTS: Forty breast cancers (13.3%) were detectable only with DBT; 191 (63.7%) breast cancers were detected with both FFDM and DBT, and 69 (23%) were not detected with either. Cancer detectability scores were significantly higher for DBT than for conventional FFDM (median score, 6; range, 0–6; p < 0.001). The DBT-only cancer group had more invasive lobular-type breast cancers (22.5%) than the other two groups (i.e., cancer detected on both types of image [both-detected group], 5.2%; cancer not detected on either type of image [both-non-detected group], 7.3%), and less detectability of ductal carcinoma in situ (5% vs. 16.8% [both-detected group] vs. 27.5% [both-non-detected group]). Low-grade cancers were more often detected in the DBT-only group than in the both-detected group (22.5% vs. 10%, p = 0.026). Human epidermal growth factor receptor-2 (HER-2)-negative cancers were more often detected in the DBT-only group than in the both-detected group (92.3% vs. 70.5%, p = 0.004). Cancers surrounded by mostly glandular tissue were detected less often in the DBT only group than in the both-non-detected group (10% vs. 31.9%, p = 0.016). DBT cancer detectability scores were significantly associated with cancer type (p = 0.012), histologic grade (p = 0.013), T and N stage (p = 0.001, p = 0.024), proportion of glandular tissue surrounding lesions (p = 0.013), and lesion type (p < 0.001). CONCLUSION: Invasive lobular, low-grade, or HER-2-negative cancer is more detectable with DBT than with conventional FFDM in patients with dense breasts, but cancers surrounded by mostly glandular tissue might be missed with both techniques.
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Feminino , Humanos , Neoplasias da Mama , Mama , Carcinoma Intraductal não Infiltrante , Fator de Crescimento Epidérmico , Mamografia , Estudos RetrospectivosRESUMO
BACKGROUND: Neurotrophin-3 (NT-3), a member of the NT family, has only been considered an ancillary compound that provides anti-apoptotic benefits by inactivating tropomyosin receptor kinase C (TrkC)-induced apoptotic signals. However, little is known about the clinical relevance of NT-3 expression itself in neuroblastoma. The purpose of this study was to assess NT-3 expression in patients with neuroblastoma and its relevance to clinicopathologic findings and treatment outcomes. METHODS: In this study, expression of NT-3 and TrkC was analyzed using immunohistochemistry in 240 patients with newly diagnosed neuroblastoma. RESULTS: The results of the study revealed that NT-3 expression was associated with older age at diagnosis, localized tumors, and more differentiated tumors but was not associated with early treatment response (degree of residual tumor volume after three cycles of chemotherapy) and progression-free survival (PFS). However, when analysis was confined to patients with MYCN amplified tumors, NT-3 expression was associated with better early treatment response with borderline significance (P = 0.092) and higher PFS (86.9% vs. 58.2%; P = 0.044). In multivariate analysis in patients with MYCN amplified tumors, NT-3 was independent prognostic factor (hazard ratio, 0.246; 95% confidence interval, 0.061–0.997; P = 0.050). In another subgroup analysis, the early treatment response was better if NT-3 was expressed in patients without TrkC expression (P = 0.053) while it was poorer in patients with TrkC expression (P = 0.023). CONCLUSION: This study suggests that NT-3 expression in neuroblastoma has its own clinical significance independent of TrkC expression, and its prognostic significance differs depending on the status of MYCN amplification and/or TrkC expression.
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Humanos , Diagnóstico , Intervalo Livre de Doença , Imuno-Histoquímica , Análise Multivariada , Neoplasia Residual , Neuroblastoma , Fosfotransferases , TropomiosinaRESUMO
BACKGROUND: Intraoperative indocyanine green (ICG) lymphography can effectively detect functioning lymph vessels in edematous limbs. However, it is sometimes difficult to clearly identify their course in later-stage edematous limbs. For this reason, many surgeons rely on experience when they decide where to make the skin incision to locate the lymphatic vessels. The purpose of this study was to elucidate lymphatic vessel flow patterns in healthy upper extremities in a Korean population and to use these findings as a reference for lymphedema treatment. METHODS: ICG fluorescence lymphography was performed by injecting 1 mL of ICG into the second web space of the hand. After 4 hours, fluorescence images of lymphatic vessels were obtained with a near-infrared camera, and the lymphatic vessels were marked. Three landmarks were designated: the radial styloid process, the mid-portion of the cubital fossa, and the lower border of the deltopectoral groove. A straight line connecting the points was drawn, and the distance between the connected lines and the marked lymphatic vessels was measured at 8 points. RESULTS: There were 30 healthy upper extremities (15 right and 15 left). The average course of the main lymph vessels passed 26.0±11.6 mm dorsal to the styloid process, 5.7±40.7 mm medial to the mid-cubital fossa, and 31.3±26.1 mm medial to the three-quarters point of the upper landmark line. CONCLUSIONS: The main functioning lymphatic vessel follows the course of the cephalic vein at the forearm level, crosses the mid-cubital point, and travels medially toward the mid-axilla.
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Extremidades , Fluorescência , Antebraço , Mãos , Verde de Indocianina , Vasos Linfáticos , Linfedema , Linfografia , Pele , Cirurgiões , Extremidade Superior , VeiasRESUMO
BACKGROUND: Although distal radius fractures (DRF) are common fractures, intra-articular comminuted DRF with volar free fragments are uncommon. There is considerable difficulty in the fixation of free fragments beyond the watershed line using the existing volar locking plate. We aimed to examine the efficacy and potential complications associated with the use of juxta-articular volar plates in intra-articular DRF accompanied by free fragments beyond the watershed line. METHODS: The patients were enrolled in a consecutive manner between 2007 and 2016. In cases of DRF with free fragments beyond the watershed line, we employed a 2.4-mm small fragment juxta-articular volar locking compression plate using a volar Henry approach. A total of 32 patients were included in this study. There were 15 males and 17 females with a mean age of 52.3 years (range, 33 to 69 years). The mean follow-up period was 14.5 months (range, 10 to 24 months). Preoperative radiographs and three-dimensional computed tomography images were used to analyze fracture patterns and assess the free fragments beyond the watershed line. The mean number of free fracture fragments beyond the watershed line was 2.33. Plain radiographs of immediate postoperative and last follow-up were used to confirm fracture union, incongruence, radial height, volar tilt, radial inclination, and arthritic changes. For functional assessment, we measured grip strength, range of motion (ROM), modified Mayo wrist score (MMWS) and determined Disabilities of Arm, Shoulder and Hand (DASH) scores at the last follow-up. Postoperative complications were monitored during the follow-up period. RESULTS: All patients obtained sound union without significant complications. At the last follow-up, 16 cases presented with an articular step-off of more than 1 mm (mean, 1.10 mm). The mean MMWS was 76.3 (range, 55 to 90), mean DASH score was 15.38 (range, 9 to 22), mean visual analogue scale score for pain was 1.2 and mean grip strength was 75.5% of the opposite side. The mean ROM was 74.3° for volar flexion and 71.5° for dorsiflexion. CONCLUSIONS: In cases of intra-articular DRF with free fragments beyond the watershed line, a volar approach with use of a juxtaarticular plate provided favorable outcomes without significant complications.
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Feminino , Humanos , Masculino , Braço , Seguimentos , Mãos , Força da Mão , Fraturas Intra-Articulares , Complicações Pós-Operatórias , Fraturas do Rádio , Rádio (Anatomia) , Amplitude de Movimento Articular , Ombro , Punho , Articulação do PunhoRESUMO
PURPOSE: Because of growing concerns about lung cancer in female never smokers, chest low-dose computed tomography (LDCT) screening is often performed although it has never shown clinical benefits. We examinewhether or not female never smokers really need annual LDCT screening when the initial LDCT showed negative findings. MATERIALS AND METHODS: This retrospective cohort study included 4,365 female never smokers aged 40 to 79 years who performed initial LDCT from Aug 2002 to Dec 2007. Lung cancer diagnosis was identified from the Korea Central Cancer Registry Database registered until December 31, 2013. We calculated the incidence, cumulative probability, and standardized incidence ratio (SIR) of lung cancer by Lung Imaging Reporting and Data System (Lung-RADS) categories showed on initial LDCT. RESULTS: After median follow-up of 9.69 years, 22 (0.5%) had lung cancer. Lung cancer incidence for Lung-RADS category 4 was 1,848.4 (95% confidence interval [CI], 1,132.4 to 3,017.2) per 100,000 person-years and 16.4 (95% CI, 7.4 to 36.4) for categories 1, 2, and 3 combined. The cumulative probability of lung cancer for category 4 was 10.6% at 5 years and 14.8% at 10 years while they were 0.07% and 0.17% when categories 1, 2, and 3 were combined. The SIR for subjects with category 4 was 43.80 (95% CI, 25.03 to 71.14), which was much higher than 0.47 (95% CI, 0.17 to 1.02) for categories 1, 2, and 3 combined. CONCLUSION: Considering the low risk of lung cancer development in female never smokers, it seems unnecessary to repeat annual LDCT screening for at least 5 years or even longer unless the initial LDCT showed Lung-RADS category 4 findings.
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Feminino , Humanos , Estudos de Coortes , Diagnóstico , Seguimentos , Incidência , Sistemas de Informação , Coreia (Geográfico) , Neoplasias Pulmonares , Pulmão , Programas de Rastreamento , Estudos Retrospectivos , Tórax , Tomografia Computadorizada por Raios XRESUMO
PURPOSE: This phase II study examined whether the addition of simvastatin to afatinib provides a clinical benefit compared with afatinib monotherapy in previously treated patients with nonadenocarcinomatous non-small cell lung cancer (NA-NSCLC). MATERIALS AND METHODS: Patients with advanced NA-NSCLC who progressed after one or two chemotherapy regimens were randomly assigned to a simvastatin (40 mg/day) plus afatinib (40 mg/day) (AS) arm or to an afatinib (A) arm. The primary endpoint was response rate (RR). RESULTS: Sixty-eight patients were enrolled (36 in the AS arm and 32 in the A arm). The RR was 5.7% (95% confidence interval [CI], 0.7 to 19.2) for AS and 9.4% (95% CI, 2.0 to 25.0) for A (p=0.440). In arms AS and A, the median progression-free survival (PFS) was 1.0 versus 3.6 months (p=0.240) and the overall survival was 10.0 months versus 7.0 months (p=0.930), respectively. Skin rash, stomatitis, and diarrhea were the most common adverse events in both arms. More grade 3 or 4 diarrhea was observed in arm A (18.8% vs. 5.6% in arm AS). In all patients, the median PFS for treatment including afatinib was not correlated with the status of epidermal growth factor receptor (EGFR) mutation (p=0.122), EGFR fluorescence in situ hybridization (p=0.944), or EGFR immunohistochemistry (p=0.976). However, skin rash severity was significantly related to the risk of progression for afatinib (hazard ratio for skin rash grade ≥ 2 vs. grade < 2, 0.44; 95% CI, 0.25 to 0.78; p=0.005). CONCLUSION: There were no significant differences in the efficacy between AS and A arms in patients with NA-NSCLC.
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Humanos , Braço , Carcinoma Pulmonar de Células não Pequenas , Carcinoma de Células Escamosas , Diarreia , Intervalo Livre de Doença , Tratamento Farmacológico , Exantema , Fluorescência , Inibidores de Hidroximetilglutaril-CoA Redutases , Imuno-Histoquímica , Hibridização In Situ , Receptores ErbB , Sinvastatina , EstomatiteRESUMO
OBJECTIVE: Rebampide is a gastroprotective agent used to treat gastritis. It possesses anti-inflammatory and anti-arthritis effects, but the mechanisms of these effects are not well understood. The objective of this study was to explore mechanisms underlying the therapeutic effects of rebamipide in inflammatory arthritis. METHODS: Collagen-induced arthritis (CIA) was induced in DBA/1J mice. DBA/1J mice were immunized with chicken type II collagen, then treated intraperitoneally with rebamipide (10 mg/kg or 30 mg/kg) or vehicle (10% carboxymethylcellulose solution) alone. Seven weeks later, plasma samples were collected. Plasma metabolic profiles were analyzed using ultra performance liquid chromatography/quadrupole time-of-flight mass spectrometry-based metabolomics study and metabolite biomarkers were identified through multivariate data analysis. RESULTS: Low dose rebamipide treatment reduced the clinical arthritis score compared with vehicle treatment, whereas high dose rebamipide in CIA aggravated arthritis severity. Based on multivariate analysis, 17 metabolites were identified. The plasma levels of metabolites associated with fatty acids and phospholipid metabolism were significantly lower with rebamipide treatment than with vehicle. The levels of 15-deoxy-Δ¹²,¹⁴ prostaglandin J2 and thromboxane B3 decreased only in high dose-treated groups. Certain peptide molecules, including enterostatin (VPDPR) enterostatin and bradykinin dramatically increased in rebamipide-treated groups at both doses. Additionally, corticosterone increased in the low dose-treated group and decreased in the high dose-treated group. CONCLUSION: Metabolomics analysis revealed the anti-inflammatory effects of rebamipide and suggested the potential of the drug repositioning in metabolism- and lipid-associated diseases.
Assuntos
Animais , Camundongos , Artrite , Artrite Experimental , Biomarcadores , Bradicinina , Carboximetilcelulose Sódica , Galinhas , Colágeno Tipo II , Corticosterona , Reposicionamento de Medicamentos , Ácidos Graxos , Gastrite , Espectrometria de Massas , Metabolismo , Metaboloma , Metabolômica , Análise Multivariada , Plasma , Estatística como Assunto , Usos TerapêuticosRESUMO
PURPOSE: We examined the efficacy of poziotinib, a second-generation epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor (TKI) in patients with lung adenocarcinoma with activating EGFR mutations, who developed acquired resistance (AR) to EGFR-TKIs. MATERIALS AND METHODS: This single-arm phase II study included EGFR-mutant lung adenocarcinoma with AR to erlotinib or gefitinib based on the Jackman criteria. Patients received poziotinib 16 mg orally once daily in a 28-day cycle. The primary endpoint was progression-free survival (PFS). Prestudy tumor biopsies and blood samples were obtained to determine resistance mechanisms. RESULTS: Thirty-nine patients were treated. Tumor genotyping was determined in 37 patients; 19 EGFR T790M mutations and two PIK3CA mutations were detected in the prestudy tumors, and seven T790M mutations were detected in the plasma assay. Three (8%; 95% confidence interval [CI], 2 to 21) and 17 (44%; 95% CI, 28 to 60) patients had partial response and stable disease, respectively. The median PFS and overall survival were 2.7 months (95% CI, 1.8 to 3.7) and 15.0 months (95% CI, 9.5 to not estimable), respectively. A longer PFS was observed for patients without T790M or PIK3CA mutations in tumor or plasma compared to those with these mutations (5.5 months vs. 1.8 months, p=0.003). The most frequent grade 3 adverse events were rash (59%), mucosal inflammation (26%), and stomatitis (18%). Most patients required one (n=15) or two (n=15) dose reductions. CONCLUSION: Low activity of poziotinib was detected in patients with EGFR-mutant non-small cell lung cancer who developed AR to gefitinib or erlotinib, potentially because of severe-toxicityimposed dose limitation.