Positioning of Bristol Stool Form Scale type 3 in constipation treatment satisfaction: A multicenter study in Japan.

BACKGROUND AND AIM: Many patients are not satisfied with chronic constipation (CC) treatments. The aim of this study was to identify factors linked to CC treatment satisfaction or dissatisfaction. METHODS: Our study population included patients who received CC treatment at a clinic or hospital. CC was diagnosed by a physician based on the patient's complaint. Treatment satisfaction was evaluated using the 28th question of the Patient Assessment of Constipation Quality of Life questionnaire. RESULTS: We conducted this study at 28 facilities. We included 167 patients (mean age 66.7 ± 15.2 years, male:female ratio is 1:3.07). Sixty-eight (40.7%) of patients were satisfied with their constipation treatment. Treatment dissatisfaction of CC was significantly associated with frequency of bowel movement <3/week (odds ratio [OR] = 0.376, 95% confidence interval [CI]: 0.156-0.904, P = 0.029) or Bristol Stool Form Scale (BSFS) type 3 (OR = 0.401, 95% CI: 0.170-0.946, P = 0.037). CONCLUSIONS: Our study showed that CC patients with BSFS type3 were not satisfied with constipation treatment. In general, BSFS types 3-5 are defined as normal stools. Therefore, BSFS type 3 may be set as a treatment goal even though the patient is not satisfied. The pathophysiology of CC differs by region and patient background. Therefore, parameters used to define successful treatment will be different by patient or region. We should reconsider the positioning of BSFS type 3 to improve treatment satisfaction for CC.

Association of Takayasu arteritis with HLA-B 67:01 and two amino acids in HLA-B protein.

OBJECTIVE: Takayasu arteritis (TAK) is a rare autoimmune arteritis that affects large arteries. Although the association between TAK and HLA-B 52:01 is established, the other susceptibility HLA-B alleles are not fully known. We performed genetic association studies to determine independent HLA-B susceptibility alleles other than HLA-B 52:01 and to identify important amino acids of HLA-B protein in TAK susceptibility. METHODS: One hundred patients with TAK and 1000 unrelated healthy controls were genotyped for HLA-B alleles in the first set, followed by a replication set containing 73 patients with TAK and 1000 controls to compare the frequencies of HLA-B alleles. Step-up logistic regression analysis was performed to identify susceptibility amino acids of HLA-B protein. RESULTS: Strong associations of susceptibility to TAK with HLA-B 52:01 and HLA-B 67:01 were observed (P = 1.0 × 10(-16) and 9.5 × 10(-6), respectively). An independent susceptibility effect of HLA-B 67:01 from HLA-B 52:01 was also detected (P = 1.8 × 10(-7)). Amino acid residues of histidine at position 171 and phenylalanine at position 67, both of which are located in antigen binding grooves of the HLA-B protein, were associated with TAK susceptibility (P ≤ 3.8 × 10(-5)) with a significant difference from other amino acid variations (ΔAIC ≥ 9.65). CONCLUSION: HLA-B 67:01 is associated with TAK independently from HLA-B 52:01. Two amino acids in HLA-B protein are strongly associated with TAK susceptibility.

Clinical activity after 12 weeks of treatment with nonbiologics in early rheumatoid arthritis may predict articular destruction 2 years later.

OBJECTIVE: To investigate earlier prediction of future articular destruction in patients with early rheumatoid arthritis (RA). METHODS: We randomly allocated patients with RA with disease duration < 2 years to different nonbiologic disease modifying antirheumatic drug (DMARD) therapies in a double-blind trial. Progression of articular destruction over the 96-week treatment period was assessed using the modified Sharp method. RESULTS: Progression of articular destruction correlated more strongly with the American College of Rheumatology (ACR) core set measures after 12 weeks of treatment than with pretreatment values. Multiple regression analysis of data after 12 weeks yielded a correlation coefficient of 0.711. The sensitivity and specificity to predict articular destruction over the 75th percentile of the cohort were 78.6% and 84.6%, respectively. Patients who showed articular destruction over the 75th percentile of the cohort had low response to treatment at 12 weeks, and continued to have high clinical disease activity thereafter. Contrasting data were found in patients with slow progression of articular destruction. CONCLUSION: In patients with early RA, ACR core set measures after 12 weeks of nonbiologic DMARD treatment may predict articular destruction 2 years later. Low response to treatment at 12 weeks and continuing high disease activity thereafter were found in patients with rapid radiological progression. These data can be used to determine the appropriateness of treatment at 12 weeks and aid the decision to introduce biologic DMARD.

Therapeutic effects of the combination of methotrexate and bucillamine in early rheumatoid arthritis: a multicenter, double-blind, randomized controlled study.

Disease-modifying antirheumatic drug (DMARD) combination therapies are used widely, but there have been few reports clearly demonstrating that combination therapy is more effective than DMARD monotherapy. We conducted a multicenter, double-blind controlled trial in order to clarify that the combination of methotrexate and bucillamine is more effective than either alone. The subjects of this study were 71 patients with active rheumatoid arthritis within 2 years of onset. Dosages were 8 mg methotrexate with 5 mg folic acid per week (MTX group), 200 mg bucillamine per day (BUC group), or both MTX and BUC (combination group). Clinical effects and adverse reactions were observed for 96 weeks. The ACR 20 response rate was 79.2% in the combination group, significantly higher than the rates of 43.5% for the MTX group (P = 0.008) and 45.8% for the BUC group (P = 0.0178). The cumulative survival curve of maintaining the ACR 20 response was significantly higher in the combination group than in the MTX and BUC groups (P = 0.0123 and P = 0.0088, respectively). The mean increase in the total Sharp score over 96 weeks was 12.6 +/- 9.0 in the combination group, significantly lower (P = 0.0468) than the value of 28.0 +/- 28.3 for the single DMARD (combined MTX and BUC) group. The incidence of adverse reactions did not differ significantly between the three groups. It was concluded that the combination therapy with MTX and BUC showed significantly higher clinical efficacy than either of the single DMARD therapies.

[A multicenter cross-sectional study on the health related quality of life of patients with rheumatoid arthritis using a revised Japanese version of the arthritis impact measurement scales version 2 (AIMS 2), focusing on the medical care costs and their associative factors].

OBJECTIVE: To survey the actual conditions of medical care costs incurred by Japanese patients with rheumatoid arthritis, and to investigate impacts of health status, demographic and socioeconomic factors, clinical and laboratory measures, and medications on disease costs. METHODS: Self-reported health status questionnaires of the revised Japanese version of AIMS 2, and reports on out-of-pocket medical care costs were collected from 1471 patients with classical and definite rheumatoid arthritis recruited through the arthritis study group of Ministry of Public Health and Welfare consisting of eleven arthritis centers across the country during three months from September, 1994. Impacts of health status and other demographic and clinical factors on medical care costs were statistically analyzed by using chi-square tests for categorical variables and Spearman's rank correlation analysis for numerical variables. RESULTS: 1. Averaged out-of-pocket medical care costs for RA patients was estimated at yen 25,225 ($253.5) per person-month in 1994, in which direct medical care costs accounted for 53.9% and indirect medical care costs accounted for 46.1% of the total. Averaged substantial direct medical care costs including the costs covered by the public health insurance in addition to out-of-pocket costs was estimated at yen 512,000 ($5,140) per person-year based on the averaged 11.8% self-pay rate of the public health insurance in 1994. 2. The distribution curve of the total out-of-pocket medical care costs was highly skewed. Averaged total medical care costs in the 90th, 95th, and 100th percentiles were 4.5, 8.1, and 48 times as large as those in the median percentile, respectively. 3. Out-of-pocket direct medical care costs totaled in the top 1 and 5 percentiles reached 26.6%, and 57.6% of those in whole patients, respectively. 4. Variables most strongly related to the total out-of-pocket medical care costs were work disability in AIMS health status scales, followed by physical disability, rate of functional decline, pain, affect, daily dose of oral prednisolone, global assessment by physician, joint counts, blood levels of CRP, ESR, grip strength, blood concentrations of hemoglobin, age, Steinbrocker's class, sex, and medications, in this order. 5. There was a trend of increase in number of cases of male, middle aged, with lower levels of formal education and annual income, longer disease duration of 20 years or more, and single (male) or separated (female) in marital status, as the total out-of-pocket medical care costs increased. 6. The average rate of missed days due to illness to whole working days of RA patients was estimated at 21.9%. With increase in the rate of missed days, the annual income of RA patients decreased, indicating that the lower annual income of RA patents possibly resulted from their work disabilities. Based on the rate of missed days, the average earning loss due to the illness in RA patients was estimated approximately at yen 650,000 ($6,540) perperson-year, which was equivalent to 1.3 times the average direct medical care costs for RA per person-year. CONCLUSION: The costs of RA were strongly related to work disability and other health status as represented by AIMS-HRQOL scores. A small number of patents severely disabled shared a disproportionately large part of medical care costs. To reduce the costs, the measures to prevent the development of disability are most important.

Renal complications in a patient with A-to-G mutation of mitochondrial DNA at the 3243 position of leucine tRNA.

A 27-year-old woman with short stature, sensorineural deafness, and renal dysfunction was hospitalized for evaluation. The serum lactate and pyruvate concentrations were elevated. The analysis of her mitochondrial DNA revealed an A-to-G mutation of the tRNA(Leu (UUR)) gene at the 3243 position. Renal biopsy revealed many sclerotic glomeruli, advanced tubulointerstitial changes, and numerous swollen mitochondria of the tubular cells. It was concluded that the patient's mitochondrial gene mutation was etiologically related to her nephropathy. The clinicopathologic features of this patient, as contrasted to the previous reports, suggested that renal involvement due to this mitochondrial gene mutation can be heterogeneous.