Associations between curve severity and revised Scoliosis Research Society-22 and scoliosis Japanese Questionnaire-27 scores in female patients with adolescent idiopathic scoliosis: a multicenter, cross-sectional study.

BACKGROUND: Patient-reported outcome measures are widely utilized to assess health-related quality of life (HRQOL) in patients with adolescent idiopathic scoliosis (AIS). However, the association between HRQOL and curve severity is mostly unknown. The aim of this study is to clarify the association between HRQOL and curve severity, and to determine the optimal cutoff values of patient-reported outcomes for major curve severity in female patients with AIS. METHODS: Female patients with AIS treated conservatively were recruited. The patients' HRQOL outcomes were examined using the revised Scoliosis Research Society-22 (SRS-22r) and the Scoliosis Japanese Questionnaire-27 (SJ-27). The correlations of the SRS-22r and SJ-27 scores with the major Cobb angle were assessed using Spearman's correlation coefficient analysis. The association between HRQOL issues in the SJ-27 and the major Cobb angle was evaluated by calculating Akaike's Information Criterion (AIC). Furthermore, the optimal cutoff values of the SRS-22r and SJ-27 scores for the major Cobb angle were determined by AIC analysis. RESULTS: The study cohort comprised 306 female patients with AIS. The SRS-22r and SJ-27 scores were significantly correlated with the major Cobb angle. Questions in the SJ-27 regarding discomfort when wearing clothes showed a lower AIC value in patients with severe scoliosis. The optimal cutoff values were a SRS-22r score of 3.2 for the discrimination of severe scoliosis (Cobb angle ≥48°), and a SJ-27 score of 32 for the discrimination of moderate scoliosis (Cobb angle ≥33°). CONCLUSION: Discomfort when wearing clothes was the most important HRQOL problem caused by severe scoliosis. The SRS-22r and SJ-27 scores are useful for the discrimination of clinical status in female patients with severe scoliosis or moderate scoliosis.

Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial.

BACKGROUND: Lumbar traction is a treatment method traditionally used for chronic low back pain (CLBP) in many countries. However, its clinical effectiveness has not been proven in medical practice. The purpose is to conduct a multi-center, crossover, randomized controlled trial (RCT) to prove the efficacy and safety of traction on CLBP patients, using equipment capable of precise traction force control and of reproducibility of the condition based on the previous biomechanical and pre-clinical studies. METHODS: Ninety-five patients with non-specific CLBP from 28 clinics and hospitals were randomly assigned to either the intermittent traction with vibration (ITV) first group (A: sequence ITV to ITO) or the intermittent traction only (ITO) first group (B: sequence ITO to ITV); the former was treated with repeated traction and vibration force added to preload. All patients were followed up weekly for 2 periods after study-initiation. The primary outcome measures were disability level including pain and quality of life (based on Japan Low back pain Evaluation Questionnaire; JLEQ), and JLEQ was measured repeatedly. Statistical analysis was performed using linear mixed model. RESULTS: Comparing to pre-traction data, both traction modes significant improvement except the first intervention of ITO treatment. The differences in JLEQ scores over time showed significant improvements in the treatment to which vibrational force was added in contrast to the conventional traction treatment; Mean difference was significant to compare ITV treatment and ITO treatment (-1.75 (p = 0.001), 95% CI; -2.69 to -0.80). However, neither difference between the two sequences (p = 0.884) nor carryover effect (p = 0.527) was observed. CONCLUSIONS: Altogether, the results indicate that lumbar traction was able to improve the pain and functional status immediately in patients with CLBP. This study contributes to add some evidence of the efficacy of lumbar traction.

Effect and usability of anti-inflammatory drug plasters for knee osteoarthritis: A crossover, double-blind, repeated measures, randomized controlled trial.

BACKGROUND: The use of plasters is a well-accepted treatment with high adherence. However, the characteristics such as its cool feeling or extensibility favored by elderly have a possibility to contribute to clinical utility. The purpose is to examine the effect of anti-inflammatory drug plasters for knee osteoarthritis and the clinical preference of the patients for using plasters. We conducted a crossover, double-blind, randomized controlled trial (RCT) recruited 168 patients with knee osteoarthritis. METHODS: We included a "run-in-period" to evaluate the patients' preference among A (first-generation; methyl salicylate), B (second-generation; indomethacin), and N (base substrate for B) before the crossover sequence of two treatment periods with A and B plasters; four arms (N-A-B, A-A-B, N-B-A, and B-B-A) were made to compare the assessment of A, B, and N plasters. We used two measures: The Japanese Knee Osteoarthritis Measure (JKOM), for clinical functions, and the usability questionnaire to evaluate the clinical value of plasters. RESULTS: At baseline, there were no significant differences in characteristics. The subjects in groups A and B showed improved overall JKOM scores at the end of each intervention. Comparison of the change of the mean difference showed that A and B were statistically significant improvement over N (-2.40, (95%CI = -3.58 to -1.21), -2.52, (-3.65 to -1.40)) but no significant difference between A and B - 0.13, (-1.14 to 0.89)). In network analysis for usability, twelve items were independent of JKOM's network structure and consisted of two domains. The analysis of usability showed that N and B were preferred over A significantly. CONCLUSION: Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations. The patient is surely aware of the effect of the drug itself, but the two feelings are important in the preference.

Muscles Cooperation Analysis Using Akaike Information Criteria for Anterior Cruciate Ligament Injury Prevention.

In this paper, we propose the analysis method for finding out the similarity of the muscle force patterns to mine the risk factor of the anterior cruciate ligament (ACL) injury. Akaike information criteria (AIC) under the assumption of the auto-regression model is adapted to analyze the similarities of muscle force patterns in time-series. The difference of AIC values between 2 muscles is considered to be the distance between 2 muscle force patterns and the dexterity of the maneuver is expected to be discussed. We measured drop vertical jump (DVJ) and use the data around the contact timing of whom hadn't had ACL injury experiments. The results showed that we could successfully calculate AIC distance according to the similarity of the time-series data pattern and it can be useful to discuss one's dexterity of controlling body maneuvers soon after contact timing of DVJ motion.

Development of a patient-oriented outcome measure for patients with hand and elbow disorder: HandQ.

PURPOSE: The Disabilities of the Arm, Shoulder, and Hand (DASH) is the most widely used patient-oriented outcome measure for the upper extremities in the world, and high reliability and validity of it has already been confirmed. However, there are several problems with using the DASH, some of which are culturally related. We aimed to (1) develop a patient-oriented disease-specific outcome measure for patients with disorders of the hand and elbow, which we call the HandQ and (2) examine the practical applicability, reliability, and validity of the HandQ for any patient with disorders of the hand and elbow. METHODS: A total of 216 patients were surveyed with the HandQ, as well as the Hand20 and the DASH to assess psychometric characteristics. RESULTS: There were no considerable floor and ceiling effects regarding the total HandQ score. Test-retest reliability and internal consistency determined using the intraclass correlation coefficient (0.942) and Cronbach's α test (0.961) were excellent. The HandQ was well correlated with the Hand20 and the DASH scores. Scree plot showed unidimensionality of the HandQ, and the graphical model showed the questionnaire items of the HandQ had reasonable correlation among each item. CONCLUSIONS: The HandQ has a sufficient reliability and internal consistency, and an excellent validity, and was shown to be able to be practically applicable in all patients with hand and elbow disorders.

Optimal cutoff score for patient-reported outcome measures after anterior cruciate ligament reconstruction using load-displacement curve analysis.

To assess psychological components after anterior cruciate ligament (ACL) injury, we developed a new patient-reported outcome measure, the Japanese anterior cruciate ligament injury questionnaire 25 (JACL-25), and demonstrated that the JACL-25 is valid, reliable, and sufficiently responsive to evaluate psychological factors that are associated with outcomes in individuals with ACL injuries. The purpose of this study was to identify the optimum cutoff score for the JACL-25 that indicates successful clinical outcomes, combining with the graphical data obtained using the KT-2000. We studied 30 patients who underwent primary ACL reconstruction with a patella tendon or hamstring tendon autograft. On the same day of the JACL-25 evaluation, anterior knee laxity tests were performed using the KT-2000 arthrometer. ACL stiffness was calculated on the graphs of the hysteresis, which can be used to measure side-to-side differences in anterior translation. Akaike's information criterion (AIC) was used to determine the most appropriate cutoff level for the JACL-25 score for the stiffness reduction ratio and anterior-posterior (AP) translation. The average JACL-25 score was 23.8 (standard deviation (SD) 18.4). The average side-to-side displacement difference in AP translation was 2.4 (SD 4.2) mm. The average stiffness reduction ratio was 24.4% (SD 31.8). The smallest AIC values for the cutoff level for the JACL-25 score, the stiffness reduction ratio, and side-to-side differences of the anterior translation were 9, 27%, and 1.1 mm, respectively. We determined the optimal cutoff score for the JACL-25 that identifies successful clinical outcomes.

Relationship between X-ray findings of lumbar spondylosis and knee pain.

BACKGROUND: The aim of this study was to investigate the correlation between radiographic measurement in lumbar spine and clinical information including symptoms or results of functional testing using a baseline data of longitudinal cohort study. METHODS: A total of 314 elderly subjects were recruited from 5 orthopedic clinics or affiliated facilities. Data for the present investigation were collected via an interviewer-administered questionnaire, which included questions on past medical history, drug history, pain area. And also results of functional testing and X-ray imaging of the lumbar spine were collected. Analysis was carried out to determine any correlation between results of X-ray imaging of the lumbar spine and other collected data, and sorted regarding Akaike Information Criterion (AIC). The correlations among these variables and odds ratio were also analyzed. RESULTS: T12/L1% disc height showed a minimum AIC value with buttock pain (- 4.57) and history of vertebral fracture (- 4.05). The L1/L2, L2/L3, and L3/L4% disc height had a minimal AIC value with knee pain (- 4.11, - 13.3, - 3.15, respectively), and odds ratio of knee pain were 3.5, 3.8, and 2.7, respectively. CONCLUSIONS: Correlation was recognized between the T12/L1% disc height and both buttock pain and previous vertebral fractures, and the L1/L2, L2/L3, and L3/L4% disc height showed a correlation with knee pain. Especially the L2/L3% disc height and knee pain had a strong correlation. It was suggested that these findings may provide additional basis to the concept that lumbar spinal lesion associates with knee pain clinically.

Lumbar mechanical traction: a biomechanical assessment of change at the lumbar spine.

BACKGROUND: Lumbar traction is a traditional treatment modality for chronic low back pain (CLBP) in many countries. However, its effectiveness has not been demonstrated in clinical practice because of the following: (1) the lack of in vivo biomechanical confirmation of the mechanism of lumbar traction that occurs at the lumbar spine; (2) the lack of a precise delivery system for traction force and, subsequently, the lack of reproducibility; and (3) few randomized controlled trials proving its effectiveness and utility. METHODS: This study was planned as a preparatory experiment for a randomized clinical trial, and it aimed (1) to examine the biomechanical change at the lumbar area under lumbar traction and confirm its reproducibility and accuracy as a mechanical intervention, and (2) to reconfirm our clinical impression of the immediate effect of lumbar traction. One hundred thirty-three patients with non-specific CLBP were recruited from 28 orthopaedic clinics to undergo a biomechanical experiment and to assess and determine traction conditions for the next clinical trial. We used two types of traction devices, which are commercially available, and incorporated other measuring tools, such as an infrared range-finder and large extension strain gauge. The finite element method was used to analyze the real data of pelvic girdle movement at the lumbar spine level. Self-report assessments with representative two conditions were analyzed according to the qualitative coding method. RESULTS: Thirty-eight participants provided available biomechanical data. We could not measure directly what happened in the body, but we confirmed that the distraction force lineally correlated with the movement of traction unit at the pelvic girdle. After applying vibration force to preloading, the strain gauge showed proportional vibration of the shifting distance without a phase lag qualitatively. FEM simulation provided at least 3.0-mm shifting distance at the lumbar spine under 100 mm of body traction. Ninety-five participants provided a treatment diary and were classified as no pain, improved, unchanged, and worsened. Approximately 83.2% of participants reported a positive response. CONCLUSION: Lumbar traction can provide a distractive force at the lumbar spine, and patients who experience the application of such force show an immediate response after traction. TRIAL REGISTRATION: University Hospital Medical Information Network - Clinical Trial Registration: UMIN-CTR000024329 (October 13, 2016).

Reliability and validity of a novel quality of life questionnaire for female patients with adolescent idiopathic scoliosis: Scoliosis Japanese Questionnaire-27: a multicenter, cross-sectional study.

BACKGROUND: A progressive deformity associated with adolescent idiopathic scoliosis (AIS) negatively affects a patient's health-related quality of life (HRQOL). Although the Scoliosis Research Society-22 (SRS-22) is the standard measurement tool for assessing HRQOL in patients with AIS, it is partially suboptimal for evaluating HRQOL in Japanese patients with AIS because of cultural differences. The purpose of this study was to develop a novel patient-reported outcome measure for Japanese female patients with AIS and to evaluate the reliability and validity of this questionnaire in comparison with the SRS-22 tool. METHODS: We developed 27 questions based on the psychosocial problems in the daily life of young female patients with AIS in Japan, the Scoliosis Japanese Questionnaire-27 (SJ-27). To evaluate its reliability, the internal consistency was assessed using Cronbach's alpha coefficient. Concurrent validity was evaluated using Spearman's correlation coefficient between the SJ-27 and the SRS-22. To investigate the construct validity of the SJ-27, the correlation between the SJ-27 questions was assessed using Akaike's information criterion (AIC). RESULTS: We analyzed 384 female patients with AIS. Cronbach's alpha coefficients were 0.914 and 0.829 for the SJ-27 and the SRS-22, respectively. Spearman's correlation coefficient between the SJ-27 and the SRS-22 was 0.692 (p < 0.001). The AIC analysis indicated that the SJ-27 items are divided into five domains, indicating that the SJ-27 covered a wide range of health-related problems among female patients with AIS. CONCLUSIONS: The results suggest that the SJ-27 is a reliable and valid patient-reported outcome measure for evaluating HRQOL in female patients with AIS in Japan.

Characteristics of disability in activity of daily living in elderly people associated with locomotive disorders.

BACKGROUND: Ageing is associated with a decline of motor function and ability to perform daily activities. Locomotive disorders are one of the major disorders resulting in adverse health condition in elderly people. Concept of Locomotive syndrome (LoS) was proposed to tackle the problems and prolong healthy life expectancy of people with locomotive disorders. To develop intervention strategy for LoS it is mandatory to investigate impairments, functional disabilities which people with locomotive disorder experience and to examine relationships among these parameters. For this purpose we have developed Geriatric Locomotive Function Scale-25 (GLFS-25). Though several physical performance tests were reported for identification or monitoring the severity of LoS, there are few studies reported on characteristics of disability which people with locomotive disorders experience. The aim of this study was to report the characteristics of ADL disabilities in elderly people with locomotive disorders in terms of numbers and degree of activity limitations. METHODS: We organized a cohort study and recruited 314 participants aged 65 years and over from five orthopedic clinics or nursing care facilities. This was a cross-sectional study to use the baseline data of such cohort. ADL disabilities were assessed using GLFS-25 scale arranging the GLFS-25 scores in ordinal levels using "R language" program. Numbers and degrees of activity limitations were determined and compared among the levels. Frequency of limitation in activities regarding social activity, housework, locomotion, mobility and self-care was compared among across the disability level. RESULTS: The GLFS-25 score was mathematically categorized into 7 levels. The number of activity limitations and the degrees of each activity limitation were significantly greater in high GLFS-25 levels than in low levels. Difficulties in mobility appeared in less severe level, difficulties in domestic and social life appeared in moderately severe level, and difficulties in self-care appeared in advanced level. CONCLUSIONS: High GLFS-25 score represented high degree of disability on ADLs. Concordant increase of numbers of activity limitation and severity progression in activity limitation may contribute to progression of disability. Activity limitation may occur in the following order: sports activity, walking, transferring, and self-care.

Effect of elcatonin versus nonsteroidal anti-inflammatory medications for acute back pain in patients with osteoporotic vertebral fracture: a multiclinic randomized controlled trial.

The aim of this study was to compare the efficacy of elcatonin injections and oral nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with osteoporosis who have acute lumbar pain after experiencing new vertebral compression fractures. Two hundred twenty-eight Japanese female patients (mean age 77.3 years) with acute lumbar pain from osteoporotic vertebral fractures were randomly divided into two groups. Patients in one group were given an NSAID (NSAIDs group) and patients in the other group were given weekly intramuscular injections of 20 units of elcatonin (elcatonin group). All patients underwent follow-up examinations up to 6 weeks from the start of the trial. Outcome measures were the level of functional impairment according to the Japan Questionnaire for Osteoporotic Pain (JQ22), the Roland-Morris Disability Questionnaire (RDQ), and a visual analog scale (VAS) of pain intensity. Statistical analyses focused on (1) the time course of pain and functional level using linear mixed effects models to analyze the longitudinal data and (2) the effectiveness of elcatonin injection with mean difference values and 95 % confidence intervals. Significant differences were seen over time between the initial values and the postintervention values (4 and 6 weeks) in JQ22, RDQ, and VAS scores (effect size d > 0.4) in each group. The mean differences between the elcatonin group and the NSAIDs group in each measure at 4 and 6 weeks were -4.8 and -8.3 for the JQ22, -1.3 and -2.6 for the RDQ, and -11.3 and -11.5 for the VAS, shifted to elcatonin. Once weekly elcatonin injection was more effective than NSAIDs for treating acute lumbar pain and improving mobility in Japanese women with osteoporotic vertebral fractures.

Relationship between physician-judged functioning level and self-reported disabilities in elderly people with locomotive disorders.

PURPOSE: Locomotive disorders due to musculoskeletal involvement are one of the main causes requiring long-term care services in aging Japan. "Locomotive syndrome (LoS)" is a concept referring to the condition under which people require assistance from others or at risk in future. The object of this study is to examine the relationship between self-reported measure and physician-judged degrees on ADL disability in elder people with locomotive disorders. METHODS: In a cross-sectional study, 711 patients who were aged 65 years old or more were recruited from 49 outpatient clinics and hospitals. We investigated ADL disabilities by self-reported questionnaire (Geriatric Locomotive Function Scale-25: GLFS-25) and physician-judged grading (Locomotive Dysfunction Grade: LDG) and examined the relationship between these two. RESULTS: We classified the severity of locomotive disability by clinical phenotype into six grades: LDG Grade 1 (N = 77), Grade 2 (213), Grade 3 (139), Grade 4 (162), Grade 5 (78), and Grade 6 (42). The mean of GLFS-25 was 25.9. The mean of GLFS-25 was 5.68 for Grade 1, 14.33 for Grade 2, 22.34 for Grade 3, 35.40 for Grade 4, 43.25 for Grade 5, and 60.24 for Grade 6. Significant differences of GLFS-25 scores were found between adjacent LDGs. CONCLUSIONS: Physician-judged grade of locomotive dysfunction was significantly related to self-reported assessment scale on ADL disability. Physician-judged dysfunction grade is readily administered scale and useful to assess the severity of locomotive dysfunction. Self-reported scale provides precise information on ADL disabilities due to locomotive organ dysfunction and is useful to develop intervention programs.

Morbidity & Mortality Survey of Spinal Deformity Surgery in 2012-Report by the Japanese Scoliosis Society.

INTRODUCTION: The Japanese Scoliosis Society (JSS) planned to make a longitudinal survey of the mortality and morbidity (M&M) of spinal deformity surgery and established the M&M Committee in 2012. We reported the analysis of the surgical complication (M&M) survey in 2012. METHODS: A request to participate in this survey was mailed to all JSS members. Questionnaires were sent by email to members who agreed to cooperate, and their answers were obtained. Diagnosis was grouped into idiopathic scoliosis, congenital scoliosis, neuromuscular scoliosis, spondylolisthesis, pediatric kyphosis, and adult spinal deformity. Complications were grouped into death, blindness, neurological deficit, infection, massive bleeding, hematoma, pneumonia, cardiac failure, DVT/PE, gastrointestinal perforation, and instrumentation failure. RESULTS: A total of 2,906 patients were reported from sixty-eight hospitals: idiopathic 488, congenital 91, neuromuscular 82, others 214, spondylolisthesis 1,241, pediatric kyphosis 41, and adult spinal deformity 749. Complications were death in 3, neurological deficit in 49, early infection in 37, late infection in 14, massive bleeding in 91, hematoma in 18, pneumonia in 6, cardiac failure in 1, DVT/PE in 9, gastrointestinal perforation in 2, and instrumentation failure in 73. The complication rate of having a neurological deficit, massive bleeding, and instrumentation failure was 4.88%, 7.32%, and 4.88% respectively in patients with pediatric kyphosis, and 3.07%, 8.01%, and 5.21% respectively in patients with an adult spinal deformity. The complication rate of early infection was 4.88% in the patients with pediatric kyphosis. CONCLUSIONS: The complication rates of pediatric kyphosis and adult spinal deformity were high.

The usefulness of neutrophil CD64 expression for diagnosing infection after orthopaedic surgery in dialysis patients.

BACKGROUND: Dialysis patients undergoing orthopaedic surgery are at high risk for postoperative infection. Diagnosis of postoperative infection is difficult in dialysis patients due to presentation of signs and symptoms similar to infection, such as fever and elevated inflammatory marker levels. Neutrophil CD64 expression (CD64), a marker of infection, is upregulated by microbial wall components and several cytokines (interferon-γ and tumor necrosis factor-α). The purpose of this study is to evaluate the usefulness of CD64 for diagnosing postoperative infection in dialysis patients post orthopaedic surgery. PATIENTS AND METHODS: Between 2013 and 2014, we prospectively studied 36 dialysis patients (18 men, 18 women; mean age 65.9 years; 49 to 83) who underwent orthopaedic surgery. Dialysis patients were classified into three groups according to their postoperative course as follows; non-infected patients, infection suspected patients, and infected patients. Inflammatory markers such as white blood cell count (WBC), C-reactive protein (CRP) and CD64 were measured before operation and one week after surgery. Using the receiver-operating characteristic (ROC) curve and Akaike's Information Criterion (AIC), the cutoff value of CD64 and CRP was calculated leading to a determination of which inflammatory marker is best accurate for detecting postoperative infection. RESULTS: We found that postoperative CD64 and CRP levels presented a statistically significant difference between infected patients and non-infected patients (p < 0.05). Furthermore, comparison of the ROC curve and AIC value between postoperative CD64 and CRP levels exhibited that CD64 was more accurate infectious marker than CRP. CONCLUSION: CD64 is a useful marker for detecting postoperative infection after orthopaedic surgery in dialysis patients.

A novel patient-reported outcome measure for anterior cruciate ligament injury: evaluating the reliability, validity, and responsiveness of Japanese anterior cruciate ligament questionnaire 25.

PURPOSE: Despite objectively good results, up to 70 % of individuals may not return to their pre-injury level of sports activity after anterior cruciate ligament (ACL) reconstruction surgery. Although psychological responses have been shown to affect outcomes after ACL injury, an appropriate means of measuring their effects, in addition to functional status, has not been determined. The purpose of this study was to develop a patient-reported questionnaire for measuring psychological factors associated with outcomes after ACL injury and to evaluate its reliability, validity, and responsiveness. METHODS: After item analysis based on the results of two pilot studies and a short relevance assessment, 25 questionnaire items were selected for the Japanese Anterior Cruciate Ligament Injury Questionnaire 25 (JACL-25) and assessed for validity, reliability, and responsiveness in subjects with ACL injury. RESULTS: The JACL-25 had no floor or ceiling effects and no confounding factors. A Cronbach's alpha coefficient of 0.981 and a Guttman split-half coefficient of 0.983 indicated excellent reliability. Large standardized response means (1.30-1.62) and effect sizes (0.96-1.51) from the preoperative to postoperative period indicated good responsiveness. Construct structures were created, and these items were separated into three domains. Strong correlations between the JACL-25 and the International Knee Documentation Committee Subjective Knee Form (r s = -0.86), Lysholm Score (r s = -0.73), and Tegner Activity Scale (r s = -0.65) indicated good concurrent validity of the JACL-25. CONCLUSIONS: The present study demonstrated that the JACL-25 was valid, reliable, and responsive enough to evaluate psychological factors associated with outcomes in individuals with ACL injuries. LEVEL OF EVIDENCE: Diagnostic study, Level III.

Prevalence and risk factors of aortic aneurysm in patients with chronic obstructive pulmonary disease.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) manifest an excess of chronic co-morbidities and present a high prevalence of cardiovascular disease such as congestive heart failure and ischemic heart disease. Aortic aneurysm (AA) also shared the risks of those diseases and its rupture is an important cause of death. However, since AA progresses almost silently, the prevalence of AA in patients with COPD remains unclear. The aim of this study was to determine AA prevalence and risk factors in patients with COPD. METHODS: With computed tomography (CT) screening, we tested for AA in 231 COPD patients, and assessed emphysema by Goddard classification and aortic wall calcification in abdominal artery, respectively. We also evaluated that of thoracic artery using our original methods, which we assessed the extent of calcification in the thoracic artery as well as which defined as "aortic calcification index (ACI) in thoracic artery". RESULTS: In 231 patients with COPD, 27 (11.7%) had AA determined by CT imaging and another 6 patients with previously diagnosed AA and a history of repaired operation (2.6%). In this total of 33 patients (AA group), the age of 95% confidence interval (CI) was 75.8 to 80.1 years and the prevalence of AA in patients aged 76 to 80 years was 26.8%. A low attenuation area and aortic wall calcification were more severe in the AA group than in the non-AA group, but forced expiratory volume in 1 second (FEV1) was not significantly different in those patients. The Goddard score of nine and ACI in the thoracic artery of 25.0% were determined to identify the most appropriate cut-off levels for discriminating between AA and non-AA groups. CONCLUSIONS: Our analysis indicated that sizeable under-recognition of AA seems likely in COPD. Especially for patients with severe lung destruction and aortic calcification verifiable by chest CT, abdominal CT would be beneficial for detecting AA.

Tocilizumab, a proposed therapy for the cachexia of Interleukin6-expressing lung cancer.

BACKGROUND: We previously reported the role of IL-6 in a murine model of cancer cachexia and currently documented a patient in whom tocilizumab, anti-IL-6 receptor antibody, dramatically improved cachexia induced by IL-6 over-expressing lung cancer. Despite this potential to alleviate cancer cachexia, tocilizumab has not been approved for this clinical use. Therefore, preceding our planned clinical trial of tocilizumab, we designed the two studies described here to evaluate the levels of IL-6 in patients with lung cancer and the effect of tocilizumab in a murine model of human cancer cachexia. METHODS: First, we measured serum IL-6 levels in patients with lung cancer and analyzed its association with cachexia and survival. Next, we examined the effect of a rodent analog of tocilizumab (MR16-1) in the experimental cachexia model. RESULTS: Serum IL-6 levels were higher in patients with cachexia than those without cachexia. In patients with chemotherapy-resistant lung cancer, a high IL-6 serum level correlated strongly with survival, and the cut-off level for affecting their prognosis was 21 pg/mL. Meanwhile, transplantation of IL-6-expressing Lewis Lung Carcinoma cells caused cachexia in mice, which then received either MR16-1 or 0.9% saline. Tumor growth was similar in both groups; however, the MR16-1 group lost less weight, maintained better food and water intake and had milder cachectic features in blood. MR16-1 also prolonged the survival of LLC-IL6 transplanted mice (36.6 vs. 28.5 days, p = 0.016). CONCLUSION: Our clinical and experimental studies revealed that serum IL-6 is a surrogate marker for evaluating cachexia and the prognosis of patients with chemotherapy resistant metastatic lung cancer and that tocilizumab has the potential of improving prognosis and ameliorating the cachexia that so devastates their quality of life. This outcome greatly encourages our clinical trials to evaluate the safety and efficacy of tocilizumab treatment for patients with increased serum IL-6.

Determination of the optimal cutoff time to use when screening elderly people for locomotive syndrome using the one-leg standing test (with eyes open).

OBJECTIVE: To establish the cutoff time for the one-leg standing (OLS) test (with eyes open) to use when screening elderly people for locomotive syndrome. METHODS: Patients visiting orthopedic clinics and healthy volunteers, all ≥65 years old, were recruited. Participants were asked to complete the 25-question Geriatric Locomotive Function Scale (GLFS-25) and then underwent the OLS test. Using the previously determined GLFS-25 cutoff value, participants were divided into two groups: the locomotive and the non-locomotive syndrome groups (GLFS-25 scores of ≥16 and <16, respectively). Conventional receiver operating characteristic curve (ROC) analysis was used to calculate the optimal cutoff time for the OLS. RESULTS: Data from 880 individuals (261 men, 619 women; mean age (SD), 77 (6) years; range 65-96 years) were analyzed; 497 were in the locomotive syndrome group and 383 were in the non-locomotive syndrome group. A significant difference was seen between each group mean for individual average (IA) OLS times (IA-OLS: the average of the OLS times obtained for both legs of an individual). According to ROC analysis without age adjustment, when the IA-OLS time was ~9 s, the sum of the sensitivity and specificity of the test was highest. However, because of a statistically significant difference in IA-OLS time among the three age groups (aged ≤70, aged >70 and ≤75, and aged >75), we determined the optimal cutoff value for IA-OLS time for each of the three age groups using ROC analysis. According to additional ROC analysis, the optimal cutoff for IA-OLS time was 19 s for individuals aged ≤70, 10 s for individuals aged >70 and ≤75, and 6 s for individuals aged >75 when screening elderly persons for locomotive syndrome. CONCLUSIONS: We propose using a GLFS-25 score of 16 and/or a cutoff for the IA-OLS time of 19 s for individuals aged ≤70, 10 s for individuals aged >70 and ≤75, and 6 s for individuals aged >75 when screening elderly persons to determine who should receive medical intervention or undergoing training programs.

Efficacy and safety of low-dose sirolimus for treatment of lymphangioleiomyomatosis.

BACKGROUND: Lymphangioleiomyomatosis (LAM) is a rare disease caused by dysregulated activation of the mammalian target of rapamycin (mTOR). Sirolimus, an inhibitor of mTOR, has been reported to decrease the size of angiomyolipomas and stabilize pulmonary function in patients with LAM. However, the optimal dose for the treatment of LAM remains unclear. METHODS: We conducted a retrospective, observational study of 15 patients with LAM who underwent sirolimus therapy for more than 6 months. The efficacy was evaluated by reviewing the patients' clinical courses, pulmonary function and chest radiologic findings before and after the initiation of sirolimus treatment. RESULTS: All patients had blood trough levels of sirolimus lower than 5ng/mL. Sirolimus treatment improved the annual rates of change in FVC and FEV1 in the 9 patients who were free from chylous effusion (FVC, -101.0 vs. +190.0mL/y, p=0.046 and FEV1, -115.4 vs. +127.8mL/y, p=0.015). The remaining 7 patients had chylous effusion at the start of sirolimus treatment; the chylothorax resolved completely within 1-5 months of treatment in 6 of these cases. These results resembled those of previous studies in which blood trough levels of sirolimus ranged from 5 to 15ng/mL. CONCLUSIONS: Low-dose sirolimus (trough level, 5ng/mL or less) performed as well as the higher doses used previously for improving pulmonary function and decreasing chylous effusion in patients with LAM.

Effect of glucocorticoid monotherapy on pulmonary function and survival in Japanese patients with scleroderma-related interstitial lung disease.

BACKGROUND: Scleroderma-related interstitial lung disease (SSc-ILD) is a chronic, progressive condition that is characterized by a restrictive ventilator defect. Cyclophosphamide (CYC), with or without glucocorticoid, effectively alters the course of SSc-ILD. However, the effect of glucocorticoid monotherapy remains unclear. METHODS: Seventy-one patients with SSc-ILD were classified into 2 groups: 21 in the treatment group (glucocorticoid monotherapy [n=14] or immunosuppressive agents [n=7]) and 50 in the non-treatment group. Their backgrounds and prognoses were analyzed retrospectively. We also classified these patients into survival (n=55) and non-survival (n=16) groups to assess prognostic factors. RESULTS: The median follow-up period was 9.8 years. The treatment group had a greater proportion of patients with diffuse systemic sclerosis or respiratory symptoms than the non-treatment group. The treatment group's annual change in forced vital capacity (FVC) compared to baseline, which was 170.4mL (157.8mL for the glucocorticoid monotherapy subgroup and 191.3mL for the immunosuppressive agent subgroup), was better than that of the non-treatment group, -60.8mL (p<0.01). Still, in terms of 5- and 10-year survival, there was no statistically significant difference between these groups. No incidence of SSc renal crisis was reported in the treatment group. The non-survival group included more patients with pulmonary hypertension than the survival group, but multivariate analysis showed no other statistically significantly difference between these groups. CONCLUSIONS: Similar to CYC, glucocorticoid alone improved pulmonary function of Japanese SSc-ILD patients, suggesting that this monotherapy is a good alternative when CYC is contraindicated.