An exploratory clinical trial to evaluate the safety and efficacy of combination therapy of REGROTH® and Cytrans® granules for severe periodontitis with intrabony defects.

Introduction: Currently, flap operation (FOP) using REGROTH® (0.3% basic fibroblast growth factor [FGF-2]) is the standard treatment for periodontal regenerative therapy in Japan. However, the periodontal tissue regenerative effect with REGROTH® monotherapy is inadequate for severe alveolar bone defects. Therefore, in this study, we evaluated the safety and effectiveness of periodontal regenerative therapy for patients with severe periodontitis using REGROTH® (test medicine) combined with Cytrans® Granules (test device: carbonated apatite granules), which is a new artificial bone. Methods: The study participants included 10 patients with severe periodontitis (mean age: 47.4 years). All participants provided written informed consents. In each patient, the intrabony defect site (mean bone defect depth: 5.7 mm) was defined as the test site. FOP was performed for the test site after the baseline investigation; moreover, the test medicine and test device were administered simultaneously. Furthermore, the observation of subjects' general condition and test sites was conducted and the blood, urine, and periodontal tissue tests were performed up to 36 weeks after FOP. The rate of bone increase (%), clinical attachment level (CAL), probing pocket depth (PPD), bleeding on probing (BOP), tooth mobility (Mo), width of keratinized gingiva (KG), gingival recession (REC), gingival index (GI), and plaque index (PlI) were evaluated during the periodontal tissue investigation. Results: As the primary endpoint, no adverse events related to the test medicine and test device occurred during the entire observation period of this study. Regarding the secondary endpoints, there was a significant increase in new alveolar bone (p = 0.003) and CAL acquisition (p = 0.001) as well as decrease in PPD (p = 0.002) and BOP (p = 0.016) at 36 weeks after administration of the test medicine and test device compared with the preoperative values. Furthermore, at 36 weeks after surgery, the Mo, GI, and PlI decreased to preoperative levels at 40%, 60%, and 30% of sites, respectively. However, at 36 weeks after surgery, there was no difference in KG and REC compared with their preoperative values. Conclusions: The safety of periodontal regenerative therapy using the test medicine in combination with the abovementioned test device was confirmed. In addition, it was suggested that this periodontal regenerative therapy is effective for tissue regeneration in severe alveolar bone defects.This clinical trial was conducted after registering and publicizing as a specified clinical trial in the Japan registry of clinical trials (jRCTs051190045).

SAPHO syndrome and pustulotic arthro-osteitis.

Synovitis-Acne-Pustulosis-Hyperostosis-Osteitis (SAPHO) syndrome is a rare inflammatory osteoarticular disorder, which encompassed many diseases, including pustulotic arthro-osteitis (PAO). Musculoskeletal manifestations, including osteitis, synovitis, and hyperostosis, are the hallmarks of the SAPHO syndrome and affect a variety of regions of the body. Recent survey indicated that more than 80% of cases of SAPHO syndrome in Japan were PAO, originally proposed by Sonozaki et al. in 1981, whereas severe acne was the most commonly reported skin ailment amongst participants with SAPHO syndrome in Israel. Prevalence of SAPHO syndrome remains unavailable, whereas the prevalence of palmoplantar pustulosis (PPP) was reported to be 0.12% in Japan, and 10-30% of patients with PPP had PAO. SAPHO syndrome and PAO are predominantly found in patients in the third through fifth decades of life, and a female predominance is seen in both groups. The diagnosis is typically made by a rheumatologist or dermatologist. Identification of a variety of the clinical, radiological, and laboratory features outlined, as well as diagnostic criteria, are used to make the diagnosis. Goals of treatment seek to maximize health-related quality of life, preventing structural changes and destruction, and normalizing physical function and social participation. Finally, we review the non-pharmacological and pharmacological managements.

Population Pharmacokinetics of Teicoplanin and Its Dosing Recommendations for Neutropenic Patients With Augmented Renal Clearance for Hematological Malignancies.

BACKGROUND: Plasma teicoplanin concentrations do not reach the therapeutic range in several patients with hematological malignancies. Nevertheless, the characteristics of the population pharmacokinetic (PPK) models have not been clarified for malignancy. The decrease in the teicoplanin concentration in patients with cancer has been attributed to augmented renal clearance (ARC). It is essential to identify the causative factors of ARC to construct a PPK model to optimize the administration method. The authors aimed to establish a PPK model and develop an appropriate dosing regimen for teicoplanin in patients with hematological malignancies. METHODS: PPK analysis was performed using therapeutic drug monitoring (TDM) data from 119 patients with hematological malignancies. The developed model was verified by predictive performance. RESULTS: The covariates affecting systemic clearance were serum creatinine, presence or absence of neutropenia (<500/µL), and body size descriptor. Patients with hematologic malignancies and neutropenia showed a 25% increase in clearance compared with those with a normal neutrophil count. The PPK model was constructed based on the presence or absence of neutropenia. This model allowed the selection of the most appropriate dosage regimen out of those recommended by the TDM guidelines for patients with eGFR of >60 mL/min/1.73 m2. The PPK model predicted a dosing regimen for achieving a 10% improvement in the coverage probability of the target concentration range during the loading and maintenance phases. CONCLUSIONS: The PPK model may help optimize dose regimens and evaluate dosing methods, using comparative simulations, in patients with hematological malignancies.

Polypharmacy among older advanced lung cancer patients taking EGFR tyrosine kinase inhibitors.

OBJECTIVE: Polypharmacy (PP) is a common problem among the older adults and has a potential effect on health-related problems. However, the significance of PP in older advanced non-small cell lung cancer (NSCLC) patients and those on oral molecular-targeted anticancer agents is unclear. MATERIALS AND METHODS: This retrospective, nonrandomized study reviewed the records of 334 advanced NSCLC patients who underwent epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treatment. PP was defined as ≥ 5 concomitant medications. Potentially inappropriate medication (PIM) use was measured using the updated screening tool of older people's prescriptions (STOPP) ver. 2 criteria. We also estimated survival distributions using the Kaplan-Meier method, compared between-group differences using the log-rank test, explored potential predictors of survival using Cox regression, and performed cluster analysis to identify factors affecting multiple-medication use. RESULTS: The PP and PIM use prevalence was 38.4% and 31.9%, respectively. The median overall survival (OS) for PP(+) and PP(-) patients was 19.4 and 27.3 months, respectively. Multivariate analysis revealed a significant correlation between PP and OS. The frequency of unexpected hospitalization during EGFR-TKI treatment was higher in PP(+) patients compared to PP(-) patients (49.4% vs. 29.4%; odds ratio = 2.34). CONCLUSION: PP is an independent prognostic factor in older advanced NSCLC patients taking EGFR-TKIs. PP can be used as a simple indicator of such patients' comorbidities and symptoms or as a predictive marker of unexpected hospitalization during treatment.

The Diagnosis and Treatment of Adult Patients with SAPHO Syndrome: Controversies Revealed in a Multidisciplinary International Survey of Physicians.

INTRODUCTION: This study aimed to investigate the current practice in the diagnosis and treatment of SAPHO syndrome among the international rheumatology and dermatology communities. METHODS: We conducted an electronic survey among the members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the Japan Spondyloarthritis, and Israeli Societies of Rheumatology. RESULTS: A total of 78 physicians participated in the survey: rheumatologists (83%, n = 65), dermatologists (11.5%, n = 9), and orthopedics (3.8%, n = 3). SAPHO was considered a subtype of spondyloarthritis by 48.7% (n = 38), a subtype of psoriatic arthritis by 19.2% (n = 15), a separate entity by 25.6% (n = 20), and a subtype of reactive arthritis by 6.4% (n = 5). Palmoplantar pustulosis was the most prevalent cutaneous manifestation (n = 44, 56.4%) and anterior chest pain-the most prevalent osteoarticular manifestation (n = 66, 84.6%). The majority (84.6%, n = 66) voted for the update of the present diagnostic criteria by Khan 1994. Magnetic resonance imaging was considered the preferred imaging modality for the diagnosis of SAPHO by 41% (n = 32). Conduction of bone biopsy for diagnosis of non-infectious osteitis was supported only by 10.3% (n = 8). Patient-reported outcomes were considered the most appropriate measure for the assessment of disease activity by 47.4% (n = 37). The treatment approach was overall similar among the rheumatology and dermatology communities, including non-steroidal anti-inflammatory drugs, bisphosphonates, conventional disease-modifying anti-inflammatory drugs, and biologics. CONCLUSIONS: Our study underlines the controversy on diagnosis and treatment of SAPHO syndrome among specialists in rheumatology and dermatology and emphasizes an unmet need for update and validation of diagnostic criteria and treatment approach.

Associations of Ambient Air Pollutant Concentrations With Respiratory Symptoms and Perceived Health Status in Japanese Adults With and Without Chronic Respiratory Diseases: A Panel Study.

OBJECTIVES: In recent years, transboundary air pollution from mainland East Asia has led to growing concerns about air pollution in Japan. Air pollution is reportedly associated with the exacerbation of respiratory diseases. In this study, we assessed the effects of air pollution on respiratory symptoms and the health status of participants with and without chronic respiratory diseases. METHODS: Participants (n=2753) with and without chronic respiratory diseases who visited healthcare facilities in Japan during February from 2010 to 2015 filled out a self-report questionnaire regarding their symptoms and perceived health status. Participants were followed up during April-May and June-July. RESULTS: Oxidant concentrations were associated with respiratory symptoms, overall health, and quality of life (QoL). Suspended particulate matter (SPM) and particulate matter <2.5 µm levels were associated with physical fitness; SPM was also associated with QoL. Recent experience of an Asian sand dust event had a significant effect on allergic symptoms, change in health, and QoL. CONCLUSIONS: Respiratory symptoms were more strongly affected by oxidants than by other pollutants. Significant associations of air pollutants were found with a comprehensive range of items related to perceived health status, including overall health and QoL. Although the effects of air pollutants on respiratory symptoms and health status were more apparent among patients with respiratory diseases, the adverse effects of air pollutants were significant even among participants without such conditions.

Relationships between perceived health status and ambient air quality parameters in healthy Japanese: a panel study.

BACKGROUND: There has been growing global concern about air pollution due to its great risk to public health. In Japan, although industrial- and traffic-related air pollution has been decreasing, concerns about particulate matter air pollution has been growing in recent years. In this study, we examined the effects of air pollution on symptoms and the health status of healthy subjects in Japan. METHODS: Participants (n = 2887) who visited healthcare centers in Kumamoto or Niigata prefectures in February from 2010 to 2015 were asked to fill out a questionnaire, which was a self-completed booklet containing questions on the characteristics of participants, their respiratory symptoms, and questionnaires on their health status in February, May, and July. Generalized estimating equation analyses were performed to predict the factors associated with the symptoms and health status using two-week averages of air quality parameters obtained from 49 monitoring stations as independent variables. RESULTS: Only allergy was associated with air quality in both areas. Prevalence of the other respiratory symptoms were correlated with air quality only in Kumamoto. The health statuses including the 'physical fitness', 'daily activities', and 'social activities' domains were related only to time spent outdoors. The 'overall health' was associated with time spent outdoors and concentrations of nitrogen dioxide and suspended particulate matters (SPM) in Kumamoto, and with temperatures and SPM in Niigata. The 'pain' score was correlated with temperature and carbon monoxide concentration only in Kumamoto. In Kumamoto, the 'quality of life (QoL)' was worse in those who spent shorter hours outdoors, were exposed to lower humidity, higher concentrations of oxidants, SPM, and PM2.5, and who experienced more Asian sand dust (ASD) events. In Niigata, a worsened 'QoL' was associated with time spent outdoors, temperature, and SPM. CONCLUSIONS: The associations between air quality and the health status was found mainly in the comprehensive domain of the health status such as 'overall health' and 'QoL'. The effect of short-term exposure to larger particles, such as SPM, on health status was observed when compared to smaller particles such as PM2.5 and gaseous pollutants.

The Impact of Air Pollution, Including Asian Sand Dust, on Respiratory Symptoms and Health-related Quality of Life in Outpatients With Chronic Respiratory Disease in Korea: A Panel Study.

OBJECTIVES: Air pollution is a growing concern in Korea because of transboundary air pollution from mainland China. A panel study was conducted to clarify the effects of air pollution on respiratory symptoms and health-related quality of life (HR-QoL) in outpatients with and without chronic obstructive pulmonary disease (COPD) in Korea. METHODS: Patients filled out a questionnaire including self-reported HR-QoL in February and were followed up in May and July. The study was conducted from 2013 to 2015, with different participants each year. Air quality parameters were applied in a generalized estimating equation as independent variables to predict factors affecting HR-QoL. RESULTS: Lower physical fitness scores were associated with Asian sand dust events. Daily activity scores were worse when there were high concentrations of particulate matter (PM) less than 10 µm in diameter (PM10). Lower social functioning scores were associated with high PM less than 2.5 µm in diameter and nitrogen dioxide (NO2) concentrations. High NO2 concentrations also showed a significant association with mental health scores. Weather-related cough was prevalent when PM10, NO2, or ozone (O3) concentrations were high, regardless of COPD severity. High PM10 concentrations were associated with worsened wheezing, particularly in COPD patients. CONCLUSIONS: The results suggest that PM, NO2, and O3 cause respiratory symptoms leading to HR-QoL deterioration. While some adverse effects of air pollution appeared to occur regardless of COPD, others occurred more often and more intensely in COPD patients. The public sector, therefore, needs to consider tailoring air pollution countermeasures to people with different conditions to minimize adverse health effects.

Atypical perioperative management for duodenal obstruction in an infant with heterotaxy syndrome: a case report.

BACKGROUND: Heterotaxy syndrome (HS) is characterized by a wide variety of cardiac and extra-cardiac malformations, including pulmonary valve stenosis, interruption of the inferior vena cava, total anomalous pulmonary venous connection (TAPVC), asplenia, polysplenia, intestinal malrotation, and preduodenal portal vein (PDPV). We report the case of a heterotaxic infant with an infracardiac TAPVC and preduodenal portal vein who experienced repetitive hemodynamic instability during urgent laparotomy for duodenal obstruction. CASE PRESENTATION: A 3-day-old boy with HS was planned to undergo urgent laparotomy for duodenal atresia. Echocardiogram showed an interrupted inferior vena cava, single right ventricle, pulmonary valve stenosis, and infracardiac TAPVC. On exploratory laparotomy, intestinal malrotation characterized by Ladd's band was found. During further exploration, repetitive severe hypotension and hypoxia occurred. Thorough examination revealed a greatly dilated PDPV crossing over and compressing the proximal duodenum externally. Finally, we considered the possibility that surgical manipulation directly compressed the dilated PDPV into which the TAPVC had pulmonary venous drainage, leading to repetitive pulmonary venous obstruction (PVO). Computed tomography, which was examined after laparotomy, indicated that the vertical vein from pulmonary venous confluence drained into the portal vein. CONCLUSION: PDPV is a rare anomaly associated with HS. In case of intestinal malrotation and duodenal obstruction in HS with infracardiac TAPVC, both the presence of PDPV and the possibility of pulmonary venous drainage into the PDPV should be considered by pediatric surgeons and anesthesiologists performing laparotomy to avoid catastrophic PVO.

Effects of air pollution and seasons on health-related quality of life of Mongolian adults living in Ulaanbaatar: cross-sectional studies.

BACKGROUND: Ulaanbaatar, Mongolia, is known as severely air-polluted city in the world due to increased coal consumption in the cold season. The health effects of air pollution in Mongolia such as mortality, morbidity and symptoms have been previously reported. However, the concept of health-related quality of life (HR-QoL), which refers to the individual's perception of well-being, should also be included as an adverse health outcome of air pollution. METHODS: Surveys on the Mongolian people living in Ulaanbaatar were performed in the warm and cold seasons. Self-completed questionnaires on the subjects' HR-QoL, data from health checkups and pulmonary function tests by respiratory specialists were collected for Mongolian adults aged 40-79 years (n = 666). Ambient PM2.5 and PM10 were concurrently sampled and the components were analyzed to estimate the source of air pollution. RESULTS: In logistic regression analyses, respiratory symptoms and smoke-rich fuels were associated with reduced HR-QoL (> 50th percentile vs. ≤ 50th percentile). PM 2.5 levels were much higher in the cold season (median 86.4 µg/m3 (IQR: 58.7-121.0)) than in the warm season (12.2 µg/m3 (8.9-21.2). The receptor model revealed that the high PM2.5 concentration in the cold season could be attributed to solid fuel combustion. The difference in HR-QoL between subjects with and without ventilatory impairment was assessed after the stratification of the subjects by season and household fuel type. There were no significant differences in HR-QoL between subjects with and without ventilatory impairment regardless of household fuel type in the warm season. In contrast, subjects with ventilatory impairment who used smoke-rich fuel in the cold season had a significantly lower HR-QoL. CONCLUSIONS: Our study showed that air pollution in Ulaanbaatar worsened in the cold season and was estimated to be contributed by solid fuel combustion. Various aspects of HR-QoL in subjects with ventilatory impairment using smoke-rich fuels deteriorated only in the cold season while those with normal lung function did not. These results suggest that countermeasures or interventions by the policymakers to reduce coal usage would improve HR-QoL of the residents of Ulaanbaatar, especially for those with ventilatory impairment in the winter months.

Congruence between Preferred and Actual Participation Roles Increases Satisfaction with Treatment Decision Making among Japanese Women with Breast Cancer

Objective: This study investigated the correlation between participation in the treatment decision-making process and satisfaction with the process among Japanese women with breast cancer. The influence of sociodemographic and clinical characteristics on satisfaction with the treatment decision-making process was also examined. Methods: We conducted a cross-sectional, self-administered internet survey of 650 Japanese women with breast cancer in March 2016. Decisional role (active, collaborative, passive) in the treatment decision-making was elicited using the Japanese version of the Control Preference Scale. Satisfaction with the decision-making process was assessed. Result: About half of the participants preferred to play a collaborative role, while half of the participants perceived that they played an active role. Satisfaction among the participants who made their treatment choice collaboratively with their physicians was significantly higher than that of participants who made the choice by themselves or entrusted their physicians to make the decision. However, two-way ANOVA demonstrated that satisfaction level was associated with the congruence between the participants' preferred and actual decisional roles, but not with the actual decisional roles that they played. This association had no interaction with sociodemographic and clinical status, except for education level. A majority of the participants who participated in the roles they preferred in choosing their treatment option indicated that they would participate in the same role if they were to face a similar decision-making situation in the future. Conclusion: Regardless of their role played in the cancer treatment decision-making process, and irrespective of their sociodemographic and clinical status, Japanese women with breast cancer are more satisfied with the treatment decision-making process when their participation in the process matches their preferred role in the process.

Prevalence and risk factors of airflow limitation in a Mongolian population in Ulaanbaatar: Cross-sectional studies.

The burden of chronic obstructive pulmonary disease (COPD) is expected to increase in the coming decades. In Ulaanbaatar, Mongolia, air pollution, which has been suggested to correlate with COPD, is a growing concern. However, the COPD prevalence in Ulaanbaatar is currently unknown. This study aims to estimate the prevalence of airflow limitation and investigate the association between airflow limitation and putative risk factors in the Mongolian population. Five cross-sectional studies were carried out in Ulaanbaatar. Administration of a self-completed questionnaire, body measurements, and medical examination including spirometry were performed in 746 subjects aged 40 to 79 years living in Ulaanbaatar. The age- and sex-standardized prevalence of airflow limitation in Ulaanbaatar varied widely from 4.0 to 10.9% depending on the criteria for asthma. Age, body mass index (BMI), and smoking habit were independent predictors for airflow limitation while residential area and household fuel type were not significant. In conclusion, prevalence of putative COPD was 10.0% when subjects with physician-diagnosed asthma were excluded from COPD. Older age, lower BMI, and current smoking status were putative risk factors for airflow limitation. This prevalence was consistent with reports from Asian countries.

Effects of air pollution and seasonality on the respiratory symptoms and health-related quality of life (HR-QoL) of outpatients with chronic respiratory disease in Ulaanbaatar: pilot study for the comparison of the cold and warm seasons.

BACKGROUND: This study was performed to investigate the effects of air pollution and seasonality on the respiratory symptoms and health-related quality of life (HR-QoL) of outpatients with respiratory diseases in Ulaanbaatar, Mongolia. Subjects were outpatients who visited the hospital with chronic obstructive pulmonary diseases (COPD) or bronchial asthma (BA) in March. Their symptoms and HR-QoL were evaluated using a questionnaire including the SF-36v2 and COOP/WONCA charts in March, May and July. PM2.5 was sampled in March and July in Ulaanbaatar, and its composition was analyzed. RESULTS: Patients with COPD or BA showed higher prevalence of respiratory symptoms than the control subjects in each month. For HR-QoL, all subscales worsened in the patients than in the control group in March. Although the HR-QoL of the COPD and control groups were not significantly changed through the surveys, some subscales of the BA group showed remarkable improvement in July as compared to March. Daily means of PM2.5 in March were significantly higher than those in July. Carbon and ionic component concentrations, except for magnesium and calcium ions, were significantly higher in March than July. Mass concentrations of some metallic components were also significantly higher in March than July. The percentage of nitrate ion in PM2.5 was significantly higher in March when compared to that in July. CONCLUSIONS: These results suggested that the symptoms in the COPD and BA groups were caused by the disease, and the association with air pollution or seasonality remained unclear. However, the effects of air pollution and seasonality on the HR-QoL were significant in the patients with BA.

Validation of the Mongolian version of the SF-36v2 questionnaire for health status assessment of Mongolian adults.

BACKGROUND: Ulaanbaatar, Mongolia, is one of the world's worst air-polluted cities, but effects of this air pollution on the population health status have not yet been evaluated. Therefore, we developed a Mongolian version of the SF-36v2 questionnaire to investigate the health status of Mongolian population. METHODS: Health checkups were conducted in Ulaanbaatar and the health status was measured using a Mongolian translated version of the SF-36v2 questionnaire. The reliability and validity of the Mongolian SF-36v2 questionnaire, and the relationship between health status and respiratory condition were examined. RESULTS: Factor analysis of the Mongolian SF-36v2 questionnaire showed that the "Role-physical" and "Role-emotional" were classified into a single subscale. The "Mental health" and "Vitality" were each divided into two subscales. Cronbach's alpha and intraclass correlation coefficient (ICC) for reproducibility were >0.7, except for "General health perceptions" (Cronbach's alpha and ICC < 0.7), "Social functioning" (Cronbach's alpha < 0.7), and "Vitality" (ICC < 0.7). The SF-36v2 subscales and the corresponding items of the COOP/WONCA charts were correlated, and subjects with respiratory symptoms showed lower SF-36v2 scores compared to normal subjects, suggesting external validity. Subjects with respiratory symptoms showed significantly lower scores for the majority of the SF-36v2 subscales than those with normal lung function. In subjects with combined ventilatory impairment, "Physical functioning", "Role-physical", "Bodily pain", and "Vitality" scores were significantly lower than those with normal lung function. CONCLUSIONS: The Mongolian version of the SF-36v2 questionnaire provides substantial reliability and validity, and is useful for evaluating the health status of Mongolian adults with ventilatory impairment. Health status measured by SF-36v2 was significantly aggravated by combined ventilatory impairment when compared with normal lung function.

Psychological impacts from expectation of worsening conditions and obstacles to life planning are affected by glycemic control, self-reported symptoms, and drug therapy in patients with type 2 diabetes mellitus.

INTRODUCTION/AIMS: It is important to reduce psychological stresses for glycemic control in diabetes. We investigated the factors affecting psychological impact, which was involved in the disease conditions in 378 patients with type 2 diabetes mellitus. MATERIALS AND METHODS: Patients' self-assessed symptoms and four subscales of psychological impacts on diabetes - impact from diabetes (S1), anxiety from having a chronic disease (S2), expectation of worsening conditions (S3) and obstacles to life planning (S4) - were analyzed. RESULTS: Significant odds ratios (ORs) were found for sex and age in S1, age and glycemic control in S2, glycemic control in S3, disease duration and glycemic control in S4, and number of symptoms in S1-S4. Scores of S1 and S2 in women were lower than those in men, and decreased age-dependently. Significant ORs for the number of symptoms in S3 and S4 were greater than in S1 and S2. ORs increased markedly for patients under oral hypoglycemic agent therapy in S4 and insulin therapy in S1-S4 when compared with ORs for lifestyle therapy alone. CONCLUSIONS: The psychological impact of type 2 diabetes involved a priori factors dependent on sex and aging in the subscales of current anxieties and impact, and a posteriori factors, such as disease duration, glycemic control and treatment methods, in the subscales of expectation of worsening conditions and obstacles to life planning.

Degradation of Jatropha curcas phorbol esters derived from Jatropha oil cake and their tumor-promoting activity.

Large amount of oil cake is generated during biodiesel production from Jatropha seeds. Although Jatropha oil cake is rich in plant nutrients, presence of toxic phorbol esters restricts the usage of oil cake as a fertilizer. The objective of this study is to evaluate the components and tumor promoting activity of phorbol esters in Jatropha oil cake-supplemented soil and plants grown in the treated soil. Contents and their biological activity of Jatropha phorbol esters in soil and plants were sequentially analyzed by high-performance liquid chromatography (HPLC) and in vitro cell transformation assay, respectively. Disappearance of Jatropha phorbol-ester-specific peaks were followed with HPLC during incubation of Jatropha oil cake with soil for five weeks. Along with the degradation of Jatropha phorbol ester in soil, tumor-promoting activity in the sample was also attenuated and ultimately disappeared. Jatropha phorbol esters and tumor promoting activity were not detected from mustard spinach grown in the Jatropha oil cake-supplemented soil. In addition, the esterase KM109 degrades DHPB (see definition below; Jatropha phorbol ester) and reduced its tumor-promoting activity. From these data, we conclude: (1) components and tumor promoting activity of Jatropha phorbol esters in the oil cake disappeared completely by incubation with soil for five-week, (2) Jatropha phorbol esters did not transfer into plants grown in the Jatropha oil cake-supplemented soil, and (3) DHPB can be degraded by esterase from soil bacterium. These observations are useful for utilization of Jatropha oil cake as a fertilizer.

Biomechanical analysis of articular-sided partial-thickness rotator cuff tear and repair.

BACKGROUND: Articular-sided partial-thickness rotator cuff tears are common injuries in throwing athletes. The superior shoulder capsule beneath the supraspinatus and infraspinatus tendons works as a stabilizer of the glenohumeral joint. PURPOSE: To assess the effect of articular-sided partial-thickness rotator cuff tear and repair on shoulder biomechanics. The hypothesis was that shoulder laxity might be changed because of superior capsular plication in transtendon repair of articular-sided partial-thickness rotator cuff tears. STUDY DESIGN: Controlled laboratory study. METHODS: Nine fresh-frozen cadaveric shoulders were tested by using a custom shoulder-testing system at the simulated late-cocking phase and acceleration phase of throwing motion. Maximum glenohumeral external rotation angle, anterior translation, position of the humeral head apex with respect to the glenoid, internal impingement area, and glenohumeral and subacromial contact pressures were measured. Each specimen underwent 3 stages of testing: stage 1, with the intact shoulder; stage 2, after creation of articular-sided partial-thickness tears of the supraspinatus and infraspinatus tendons; and stage 3, after transtendon repair of the torn tendons by using 2 suture anchors. RESULTS: Articular-sided partial-thickness tears did not significantly change any of the shoulder biomechanical measurements. In the simulated late-cocking phase, transtendon rotator cuff repair resulted in decreased maximum external rotation angle by 4.2° (P = .03), posterior shift of the humeral head (1.1-mm shift; P = .02), decreased glenohumeral contact pressure by 1.7 MPa (56%; P = .004), and decreased internal impingement area by 26.4 mm(2) (65%; P < .001) compared with values in the torn shoulder. In the acceleration phase, the humeral head shifted inferiorly (1.2-mm shift; P = .03 vs torn shoulder), and glenohumeral anterior translation (1.5-mm decrease; P = .03 vs torn shoulder) and subacromial contact pressure (32% decrease; P = .004 vs intact shoulder) decreased significantly after transtendon repair. CONCLUSION: Transtendon repair of articular-sided partial-thickness supraspinatus and infraspinatus tears decreased glenohumeral and subacromial contact pressures at time zero; these changes might lead to reduced secondary subacromial and internal impingements and consequently progression to full-thickness rotator cuff tear. However, repair of the tendons decreased anterior translation and external rotation and changed the positional relationship between the humeral head and the glenoid. CLINICAL RELEVANCE: Careful attention should be paid to shoulder laxity and range of motion when transtendon repair is chosen to treat articular-sided partial-thickness rotator cuff tears, specifically in throwing athletes.

Development of a novel, short, self-completed questionnaire on empowerment for patients with type 2 diabetes mellitus and an analysis of factors affecting patient empowerment.

BACKGROUND: Patient empowerment has recently been proposed as an important concept in self-management for effective glycemic control. A concise self-completed questionnaire for patients with type 2 diabetes mellitus was created to comprehensively evaluate their empowerment on the basis of self-managed dietary/exercise behaviors, psychological impact, and family support. The reliability and validity of this short questionnaire were tested and factors relating to patient empowerment were analyzed. METHODS: The self-completed empowerment questionnaire was based on questionnaires for self-managed dietary and exercise behaviors, the Appraisal of Diabetes Scale, and the Diabetes Family Behavior Checklist. The questionnaire was trialed on 338 male and female patients with type 2 diabetes mellitus who lived with family. The validity and reliability of the questionnaire were investigated and stepwise multiple linear regression analysis was used to identify factors that affect patient empowerment. RESULTS: The self-completed patient empowerment questionnaire included 13 questions on background data (e.g., age, gender, and HbA1c) and 18 questions within five scales to assess self-managed dietary behaviors, self-managed exercise behaviors, and psychological impact of diabetes, as well as positive and negative feedback in patient-family communication. The questionnaire showed sufficient internal consistency, construct validity, reproducibility, factorial construct validity, and concurrent validity. The results were generally satisfactory, and the questionnaire reflected the particular characteristics of treatment methods. Multiple linear regression analysis showed that patient empowerment was strongly affected by the number of disease-related symptoms, age, and gender. CONCLUSIONS: The results suggest that the concise self-completed empowerment questionnaire developed here is useful for measuring the empowerment of individual patients and evaluating the impact of symptoms and therapies on empowerment.