Effectiveness of Repetitive Hyperbaric Oxygen Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Lower extremity artery disease is strongly associated with morbidity and is typically addressed through revascularization interventions. We assessed the clinical outcomes of patients with chronic limb-threatening ischemia (CLTI) without revascularization who did and did not undergo repetitive hyperbaric oxygen therapy (HBOT). METHODS: Between April 2002 and March 2017, the records of 58 patients with CLTI (Rutherford classification 4 in 19% and 5 in 81%) were evaluated retrospectively. HBOT was performed at 2.8 atm of oxygen (HBOT group). The control group included those who could not continue HBOT and historical controls. Patients in poor general health or with an indication for revascularization therapy were excluded. We examined major adverse events (MAEs) and limb salvage rates. Independent predictors and risk stratification were analyzed using a multivariate regression analysis. RESULTS: The mean age was 71±13 years. Of all patients, 67% had diabetes and 43% were undergoing hemodialysis. The mean follow-up period was 4.3±0.8 years. The overall survival rate was 84.5% and 81.0% at 1 and 3 years, respectively. The Cox regression analysis indicated that high body mass index (odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.76-0.97; p=0.01), well-nourished (OR: 1.21; 95% CI: 1.01-1.45), and HBOT (OR: 0.05; 95% CI: 0.01-0.26; p<0.001) independently predicted absence of MAEs. For major limb amputation, the ankle-brachial index (OR: 0.2; 95% CI: 0.05-0.86; p=0.03) and HBOT (OR: 0.04; 95% CI: 0.004-0.32; p=0.003) were independent predictors. CONCLUSIONS: Repetitive, stand-alone HBOT was associated with MAE-free survival and limb salvage in patients with CLTI.

The effect of mechanical feedback on outcome in self-care support tool based on solution-focused brief therapy.

Little is known about the impact of mechanical feedback in self-care support tools. Technically, natural language processing and machine learning can provide mechanical feedback in self-care support tools. This study compared the differences between mechanical feedback and no feedback conditions in a self-care support tool based on solution-focused brief therapy. In the feedback condition, feedback was provided by mechanically determining the probability that the goal answered in goal setting was concrete or realistic.A total of 501 participants were recruited and randomly assigned to either the feedback (n = 268) or no feedback (n = 233) condition.The results showed that the mechanical feedback increased the probability of problem-solving. In contrast, solution-building, positive and negative affect, and the probability of living an ideal life increased when using the self-care support tool based on solution-focused brief therapy, regardless of the feedback. In addition, the higher the probability of goal concreteness and reality, the greater the improvement in solution-building and positive affect.This study suggests that self-care support tools based on solution-focused brief therapy with feedback are more effective than those without feedback. Self-care support tools based on solution-focused brief therapy with feedback can be used as an easily accessible tool to maintain and promote mental health.

Clinical utility of 67 Gallium-SPECT/CT for determining osteotomy indication in patients with lower-limb osteomyelitis.

Standard non-invasive methods for diagnosing and selecting the best treatment for osteomyelitis in patients with multiple chronic conditions remain to be established. We aimed to evaluate the ability of quantitative 67 Ga-citrate single-photon emission computed tomography (67 Ga-SPECT/CT) to determine the indication for either non-surgical treatment or osteotomy in patients with lower-limb osteomyelitis (LLOM) associated with diabetes mellitus and lower-extremity ischemia, based on monitoring of inflammatory activity in bone tissue. This single-centre prospective study conducted from January 2012 to July 2017 included 90 consecutive patients with suspected LLOM. Regions of interest were drawn on SPECT images during quantification of Ga accumulation. Subsequently, the inflammation-to-background ratio (IBR) was calculated by dividing the maximal accumulated lesion number by the mean number for the distal femur bone marrow of the unaffected side. Osteotomy was performed in 28 of 90 patients (31%). The osteotomy rate was higher for patients with IBR >8.4 (71.4%) than for those with IBR ≤8.4 (5.5%) (p < 0.001, sensitivity: 0.89, specificity: 0.84). In the multivariate Cox regression analysis, IBR >8.4 was an independent risk factor for osteotomy (hazard ratio [HR]: 19.0, 95% confident interval [CI]: 5.6-63.9, p < 0.001). Transcutaneous oxygen tension (TcPO2 ) was identified as an independent risk factor for lower-limb amputation (HR: 0.96, 95% CI: 0.92-0.99, p = 0.01). The current results indicate that quantitative 67 Ga-SPECT/CT is useful for distinguishing patients with LLOM likely to require osteotomy.

Multisensory perceptual distortion including auditory distortions in Alice in Wonderland syndrome: a case report.

Alice in Wonderland syndrome (AIWS) is a rare perceptual disorder characterized mainly by perceptual distortions of visual objects and one's own body. While there are many case reports of visual and somatosensory distortions associated with AIWS, little is known about auditory distortion. Therefore, we present the case of a 22-year-old right-handed woman who described having auditory as well as visual and somatosensory distortion experiences and a family history of AIWS. The subject reported experiencing multisensory perceptual distortions, where she sees other people's faces as larger and hears their voices as louder at the same time. This particular case suggests that auditory distortion - which contributes to constructing the perception of the surrounding space and the body - may also be characterized as a perceptual symptom of AIWS.

Diagnostic performance of quantitative Ga-SPECT/CT for patients with lower-limb osteomyelitis.

BACKGROUND: Patients with lower-limb osteomyelitis (LLOM) may experience major adverse events, such as lower-leg amputations or death; therefore, early diagnosis and risk stratification are essential to improve outcomes. Ga-scintigraphy is commonly used for diagnosing inflammatory diseases. Although the diagnostic performance of planar and SPECT imaging for localized lesions is limited, SPECT/CT, which simultaneously acquires functional and anatomical definition, has resulted in significant improvements to diagnostic confidence. While quantitative Ga-SPECT/CT is an emerging approach to improve diagnoses, its diagnostic performance has not been sufficiently evaluated to date. Therefore, this study aimed to evaluate the diagnostic performance of Ga-SPECT/CT with quantitative analyses for patients with LLOM. METHODS: A total of 103 consecutive patients suspected of LLOM between April 2012 and October 2016 were analyzed. All patients underwent Ga-scintigraphy with SPECT/CT imaging. Findings were assessed visually, with higher than background accumulation considered positive, and quantitatively, using Ga-SPECT/CT images to calculate the lesion-to-background ratio (LBR), the maximum standardized uptake value (SUVmax), and total lesion uptake (TLU). Diagnoses were confirmed using pathological examinations and patient outcomes, and diagnostic performances of planar, SPECT, and SPECT/CT images were compared. To evaluate prognostic performance, all patients were observed for 5 years for occurrences of major adverse events (MAE), defined as recurrence of osteomyelitis, major leg amputation, or fatal event. Multivariate Cox regression was performed to evaluate outcome factors. RESULTS: The overall diagnoses indicated that 54 out of 103 patients had LLOM. LBR, SUVmax, and TLU were significantly higher in patients with LLOM (12.23 vs. 1.00, 4.85 vs. 1.34, and 68.77 vs. 8.63, respectively; p < 0.001). Sensitivity and specificity were 91% and 96% for SPECT/CT with LBR, 89% and 94% for SPECT/CT with SUVmax, and 91% and 92% for SPECT/CT with TLU, respectively. MAE occurred in 23 of 54 LLOM patients (43%). TLU was found to be an independent prognostic factor (p = 0.047). CONCLUSIONS: Ga-SPECT/CT using quantitative parameters, namely LBR and TLU, had better diagnostic and prognostic performances for patients with LLOM compared to conventional imaging. The results suggest that Ga-SPECT/CT is a good alternative for diagnosing LLOM in countries where FDG-PET/CT is not commonly available.

Fear of COVID-19 infection and related factors in Japan: A comparison of college students, pregnant women, hospital nurses and the general public.

The fear of COVID-19 has become a social problem during the pandemic. The present study compares the fear of COVID-19 among members of the general public, college students, pregnant women, and hospital nurses. It also examines various factors associated with the fear of COVID-19. In this study, we conducted a survey of the general public on fear of infection and related factors and compared from previous studies of college students, pregnant women, and hospital nurses. A crowdsourced survey was administered to 450 members of the general public, who were asked about their fear of COVID-19 infection. Data from college students, nurses, and pregnant women were recruited from a May-June 2020 survey on fear of COVID-19. An analysis of variance was used to compare the fear of infection among different attribution. The results showed that more pregnant women and fewer college students feared infection, as did equal numbers of hospital nurses and members of the general public. The multiple regression analysis revealed that college students and pregnant women associated the fear of infection with their key source of information, while hospital nurses associated the fear of infection with living with an older person. These results suggest that pregnant women have a significant fear of infection, which is further defined by the risk of serious illness in cases of infection. Although the fear of infection is relatively low among hospital nurses, they fear becoming a source of infection. These results reveal the groups in Japan that fear infection and the reasons for their concern. The present study may help to provide psychological support to counteract the fear of infection in vulnerable groups.

The Association Between COVID-19 Information Sources and Stigma Against Health Care Workers Among College Students: Cross-sectional, Observational Study.

BACKGROUND: The COVID-19 pandemic has triggered stigmatic attitudes against health care workers. Some forms of social media may play a role in disseminating stigmatizing messages. OBJECTIVE: We aimed to investigate the association between COVID-19 information sources and stigma against health care workers among college students during the pandemic. METHODS: A cross-sectional, observational study was conducted using a web-based platform in the Tohoku region of Japan. College students aged ≥20 years were asked to complete the questionnaire between August 18 and October 31, 2020. Stigma against health care workers was evaluated using a modified Japanese version of the Social Distance Scale. Participants were also asked to rate their perceived vulnerability to infection using the Japanese version of the Perceived Vulnerability to Disease scale. RESULTS: A total of 281 students from 8 colleges completed the web-based survey. There were 139 (49.5%) participants who used Twitter, 187 (66.5%) who used news websites, and 46 (16.4%) who used the websites of public health agencies as COVID-19 information sources. After adjusting for age, sex, department, and Perceived Vulnerability to Disease scores, the level of stigma did not differ between students who used Twitter and those who did not. Students who used the websites of public health agencies showed a significantly less stigmatic attitude than those who did not. CONCLUSIONS: Fact-checking and directing visitors to credible information sources from public health agencies may have prevented the formation of stigmatic attitudes toward health care workers. An effective strategy to enable easy access to information provided by public agencies should be integrated into widespread web-based platforms.

The relationship between family variables and family social problems during the COVID-19 pandemic.

This study examined the relationship between variables about family members co-residing during the COVID-19 pandemic and anxiety about COVID-19, domestic violence from spouse, child abuse anxiety, internet addiction, and mental health as social problems related to the COVID-19 pandemic. A total of 220 parents (70 male and 150 female, age; M = 41.6, SD = 34.4) were included in the analysis. Stepwise hierarchical multiple regression analysis was conducted with dependent variables of fear of COVID-19, spousal violence, anxiety regarding perpetrating child abuse, internet addiction, and mental health. The independent variables were basic variables related to family members such as family composition. The results demonstrated that parents with preschool children were anxious about the possibility that they might abuse their children (ß = .203, p < .01). Subjects who smoked were associated with anxiety about being the victim of domestic violence by their spouse (ß = .154, p < .05). Those whose income had decreased due to the COVID-19 pandemic, those who were employed, and those with few rooms in their house were more likely to be dependent on the Internet (in order, ß = .189, p < .01; ß = .196, p < .01; ß = -.140, p < .05). Finally, mental health was impaired among those whose income was reduced by the COVID-19 pandemic (ß = .134, p < .05) and among those who had conflicting opinions in their families regarding the pandemic (ß = .206, p < .01). These results indicate that family variables are associated with family social problems. Additionally, we assume these have been exacerbated by the COVID-19 pandemic. While further research is required to determine the causal relationships among the variables, the findings can be used as an indicator of support that should be provided to families.

The impact of clarifying the long-term solution picture through solution-focused interventions on positive attitude towards life.

Solution-focused brief therapy is a psychotherapeutic model. The purpose of this study was to examine the effects of clarity of long-term solutions on positive attitude towards life. In order to examine the effects of the long-term solution image, the conditions for clarifying the long-term and short-term solution images, and not seeking clarification of the solution image were set and randomly assigned. A total of 94 participants who responded to all questions were included in the analysis. The results of this study indicate that clarity of the long-term solution enhances time-oriented attitude. In addition, the clarity of short-term solutions increases the reality of their goals. Furthermore, solution-building and, positive, and ideal levels of life were shown to increase after implementation, regardless of the condition. These results indicate that clarification of the long-term solution expands the positive attitude of valuing limited time.

Depression and anxiety among nursing students during the COVID-19 pandemic in Tohoku region, Japan: A cross-sectional survey.

AIM: Restrictions such as physical distancing and online learning for college students were implemented due to the COVID-19 pandemic. Owing to this, students may experience psychological distress from social isolation and loneliness. Nursing students are subjected to an exacerbated level of distress during the pandemic due to their role as health professionals. Therefore, the present study aimed to investigate the level of anxiety and depression among Japanese nursing students, according to their perceived vulnerability to COVID-19. METHODS: A total of 281 college students (104 nursing students and 177 other college students) responded to a web-based anonymous questionnaire survey from 18 August to 31 October 2020. The Hospital Anxiety and Depression Scale was used to evaluate anxiety (HADS-A) and depression (HADS-D). Perceived vulnerability to COVID-19 was assessed using the Perceived Vulnerability to Disease Scale. RESULTS: In both groups of students, the prevalence of both anxiety (30.5% in nursing students; 69.5% in others) and depressive symptoms (31.1% in nursing students; 68.9% in others) were remarkably high. There were no significant differences in anxiety and depression between nursing and other students after adjusting for perceived vulnerability to COVID-19 plus socio-demographic characteristics and stress coping styles. Perceived vulnerability and its interactions with nursing did not show a significant association with either depression or anxiety. CONCLUSION: This study highlights the need for greater support and preventive strategies for mental health problems for college students during the COVID-19 pandemic regardless of perceived vulnerability.

Cardiac Troponin Is Elevated in Patients with Thyrotoxicosis and Decreases as Thyroid Function Improves and Brain Natriuretic Peptide Levels Decrease.

INTRODUCTION: High-sensitive cardiac troponin reflects micro-myocardial injury in the absence of overt myocardial infarction. OBJECTIVE: This study aimed to clarify how thyrotoxicosis affects cardiac troponin. METHODS: This was a prospective observational study in Japan. Untreated patients with thyrotoxicosis who visited Ito Hospital were enrolled, and medical treatment was initiated for hyperthyroidism. Thyroid function, high-sensitive troponin I (hsTnI), and brain natriuretic peptide (BNP) were measured at baseline and then every 3 months for 1 year. RESULTS: Data from a total of 143 patients (median age, 42 years; 32 men and 111 women) were investigated. At baseline, median hsTnI was 1.9 pg/mL and ranged from 0 to 69.6 pg/mL. Five patients (3.5%) had a high hsTnI value that exceeded 26.2 pg/mL, which is used as the cutoff for diagnosis of myocardial infarction, and 22 patients (15.4%) had an intermediate value between 5.0 and 26.2 pg/mL. Multivariable regression analysis showed that significant predictors of the hsTnI value were age (ß = 0.20, p = 0.01) and BNP (ß = 0.43, p < 0.0001) (R2 = 0.27, F = 26.0, p < 0.0001), and significant predictors of the BNP value were age (ß = 0.23, p = 0.001), hemoglobin (ß = -0.43, p < 0.0001), free T4 (FT4) (ß = 0.23, p = 0.001), and hsTnI (ß = 0.27, p < 0.0001) (R2 = 0.49, F = 33.8, p < 0.0001). Correlations were found between a decrease in hsTnI and BNP in the first 3 months (ρ = 0.49, p < 0.0001). A decrease in FT4 in the first 3 months was weakly correlated with decreases in hsTnI (ρ = 0.32, p = 0.0004) and BNP (ρ = 0.32; p = 0.0003). Of the 27 patients with elevated hsTnI (≥5.0 pg/mL), the hsTnI level was normalized in 20 patients within a year. CONCLUSIONS: In thyrotoxicosis, the myocardial biomarker hsTnI is elevated in about 20% of patients; hsTnI levels decrease as thyroid function improves and BNP decreases.

Principles of Disinfectant Use and Safety Operation in Medical Facilities During Coronavirus Disease 2019 (COVID-19) Outbreak.

Medical collapse became a major concern under coronavirus disease 2019 (COVID-19) outbreak; prevention of medical accidents is essential during disinfection either. The objective of this review is to enhance the awareness regarding the safety aspects towards infection prevention practices and to offer solutions for safe patient care practices including side effects of disinfectants and precaution in specific medical facilities especially in hemodialysis rooms, intensive care unit, hyperbaric oxygen therapy (HBO) chambers, or patient transport vehicle. Literature was researched that was obtained from studies of human coronavirus infections, including the severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS), and created a summary of the characteristics of these disinfectants. This review is not intended to replace infection prevention policies and procedures established by hospitals, and manufacturers, but to provide some update confidence in the safety measures that each medical facility already uses and to offer additional input that should optimally reduce the risk of infection.

Enhanced Sternal Healing Through Platelet-Rich Plasma and Biodegradable Gelatin Hydrogel.

Platelet-rich plasma (PRP) contains numerous growth factors and promotes bone fracture healing. The aim of this study was to evaluate the effectiveness of the controlled release of PRP from biodegradable gelatin hydrogel for promoting healing in a rabbit ischemic sternal model. PRP was prepared from the whole blood of a Japanese white rabbit. Sixteen rabbits were randomized into four groups (each n = 4) and all underwent median sternotomy and bilateral internal thoracic artery removal. Before the sternum was closed, the following solutions were applied between the sternum incisions in three of the groups: 30 mg of gelatin hydrogel incorporating 300 µL of phosphate-buffered saline, 300 µL of a solution form of PRP, or 30 mg of gelatin hydrogel incorporating 300 µL of PRP (PRP + Gel). The fourth group acted as a control. Sternal healing was evaluated by histology and microcomputed tomography 7 days after the intervention. The PRP + Gel group showed a significantly higher proportion of fibrosis within the fracture area (an indicator of sternal healing) than the other groups and a significantly higher mean intensity of osteocalcin. These results indicate that the controlled release of PRP from locally applied gelatin hydrogel was markedly effective in enhancing sternal healing in the early postoperative period. This novel therapy could potentially help prevent complications, such as deep sternal wound infection and could result in early postoperative ambulation after median sternotomy.

Endothelial dysfunction may promote keloid growth.

Keloid is a cutaneous fibroproliferative disorder. It results from impaired wound healing that generates persistent inflammation and extensive deposition of collagen fibers in the wound/scar. Keloids tend to be worse in hypertensive patients. The present prospective cross-sectional study assessed whether endothelial dysfunction, which occurs in hypertension, associates with keloid formation and progression. This study included randomly selected patients with keloids who were assessed for surgical keloid treatment in 2013-2014. A series of nonkeloid patients admitted to the hospital was also recruited during this period. To measure endothelial function, all patients underwent digital reactive hyperemia peripheral arterial tonometry. Test results were expressed as reactive hyperemia index (RHI) and augmentation index (AI). In total, 57 patients with keloids and 19 nonkeloid controls were recruited. Keloid patients did not differ from the controls in terms of demographic or clinical variables, but had significantly worse RHI and AI values. Moreover, poor RHI and AI values associated with keloid development on binomial logistic regression. The keloid patients were then divided into four groups depending on whether their keloids started at age 0-12, 13-18, 19-29, or ≥30 years. Patients whose keloids arose before and well after puberty tended to have lower RHI than the controls, but these differences did not achieve statistical significance. However, these two groups did have significantly poorer AI values than the controls. Thus, endothelial dysfunction could cause keloid formation and/or aggravation. This indicates that vascular endothelial cells are important for wound healing.

Prognostic value of lower limb perfusion single-photon emission computed tomography-computed tomography in patients with lower limb atherosclerotic peripheral artery disease.

PURPOSE: The purpose of this study was to estimate the severity of the participants' lower limb ischemia by calculating the lower limb muscle-to-background ratio (LMBR) using lower limb perfusion single-photon emission computed tomography-computed tomography (SPECT/CT) and to evaluate the prognostic value of LMBR in peripheral artery disease (PAD) patients. MATERIALS AND METHODS: This retrospective study consists of 38 patients with PAD (70 ± 12 years) and observed over 1 year who were included in the analysis. All participants underwent lower limb perfusion SPECT/CT. LMBR was calculated by dividing counts/volume in lower limb muscle by mean counts/volume of background. All patients were divided into two groups based on their LMBR value and observed for the occurrence of a major adverse event (MAE). RESULTS: The high and low LMBR groups consisted of 26 and 12 patients, respectively. The median LMBR in the high group was 9.59 (6.11-11.87) while that in the low group was 4.35 (3.85-4.99). A significantly higher number of patients in the low LMBR group experienced MAE than in the high LMBR group (7 of 12 vs. 1 of 26, p < 0.001). CONCLUSION: This study demonstrated that the LMBR derived from lower limb perfusion SPECT/CT may have a high prognostic value in patients with PAD.

Imaging Angiogenesis Using 99mTc-Macroaggregated Albumin Scintigraphy in Patients with Peripheral Artery Disease.

UNLABELLED: One problem of vascular angiogenesis therapy is the lack of reliable methods for evaluating blood flow in the microcirculation. We aimed to assess whether (99m)Tc-macroaggregated albumin perfusion scintigraphy ((99m)Tc-MAA) predicts quantitated blood flow after therapeutic angiogenesis in patients with peripheral artery disease. METHODS: Forty-six patients with peripheral artery disease were treated with bone marrow mononuclear cell implantation (BMCI). Before and 4 wk after BMCI, blood flow was evaluated via transcutaneous oxygen tension (TcPO2), ankle-brachial index, intravenous (99m)Tc-tetrofosmin perfusion scintigraphy ((99m)Tc-TF), and intraaortic (99m)Tc-MAA. RESULTS: Four weeks after BMCI, TcPO2 improved significantly (20.4 ± 14.4 to 36.0 ± 20.0 mm Hg, P < 0.01), but ankle-brachial index did not (0.65 ± 0.30 to 0.76 ± 0.24, P = 0.07). Improvement in (99m)Tc-TF count (0.60 ± 0.23 to 0.77 ± 0.29 count ratio/pixel, P < 0.01) and (99m)Tc-MAA count (5.21 ± 3.56 to 10.33 ± 7.18 count ratio/pixel, P = 0.02) was observed in the foot region but not the lower limb region, using both methods. When these data were normalized by subtracting the pixel count of the untreated side, the improvements in (99m)Tc-TF count (-0.04 ± 0.26 to 0.08 ± 0.32 count ratio/pixel, P = 0.04) and (99m)Tc-MAA count (1.49 ± 3.64 to 5.59 ± 4.84 count ratio/pixel, P = 0.03) in the foot remained significant. (99m)Tc-MAA indicated that the newly developed arteries were approximately 25 µm in diameter. CONCLUSION: BMCI induced angiogenesis in the foot, which was detected using (99m)Tc-TF and (99m)Tc-MAA. (99m)Tc-MAA is a useful method to quantitate blood flow, estimate vascular size, and evaluate flow distribution after therapeutic angiogenesis.

Beraprost Sodium Protects Against Diabetic Nephropathy in Patients with Arteriosclerosis Obliterans: A Prospective, Randomized, Open-label Study.

BACKGROUND: Inhibition of the renin-angiotensin system (RAS) has been used to treat diabetic nephropathy. However, RAS inhibition increases the risk of renal complications. In this study, we evaluated the effect of combining RAS inhibitor treatment with beraprost sodium (BPS), a prostaglandin I2 analog, in diabetic nephropathy with arteriosclerosis obliterans. METHODS: This study was a prospective, randomized, open-label study. Twenty-six Japanese patients (age >30 years) with diabetic nephropathy and arteriosclerosis obliterans were randomly assigned to the BPS group (n=13), which received the combination of an RAS inhibitor and BPS (120 µg/day) therapy, or the control group (n=13), which received only an RAS inhibitor. Patients were followed up for 1 year. The primary endpoint was the effect of BPS on renal function. RESULTS: In the control group, serum creatinine (1.64±0.87 to 2.34±1.53 mg/dL, p<0.001), 1/creatinine (0.82±0.47 to 0.65±0.47, p=0.003) cystatin C (1.77±0.61 to 2.18±0.86 mg/L, p<0.001), and the estimated glomerular filtration rate (43.9±26.1 to 34.0±24.6 mL/min/1.73 m(2), p=0.004) were significantly worsened 48 weeks after the start of treatment. Conversely, in the BPS group, serum creatinine (1.71±0.75 to 1.66±0.81 mg/dL, p=0.850), 1/creatinine (0.66±0.19 to 0.71±0.25, p=0.577), cystatin C (1.79±0.55 to 1.80±0.57 mg/L, p=0.999), and the estimated glomerular filtration rate (35.8±10.8 to 38.7±14.4 mL/min/1.73 m(2), p=0.613) were unchanged. CONCLUSIONS: Combination treatment with BPS and an RAS inhibitor prevented the progression of diabetic nephropathy. These observations should be confirmed in large-scale studies with long-term follow-up.