Effects of an individualized nutritional educational program in pregnant women: A randomized controlled trial in Japan.

AIM: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. METHODS: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30-min booklet-based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self-administered short dietary history questionnaire, and analyses of covariance and t tests were performed. RESULTS: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p = .051, 95% CI [-0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p = .040; F = 4.31; effect size = 0.36). CONCLUSIONS: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face-to-face interventions for pregnant women in Japan.

Anti-IL-10 antibody in systemic lupus erythematosus.

PURPOSE: IL-10 is a cytokine known to inhibit inflammatory cytokines. To determine its role in the pathogenesis of systemic lupus erythematosus (SLE), the presence of anti-IL-10 antibody is required to be examined. Although antibodies against cytokines are known to be present in SLE, no studies have determined the role of IL-10, particularly in Japanese patients. We assayed anti-IL-10 antibody in SLE and examined the clinical significance. PATIENTS AND METHODS: We performed a retrospective study of 80 Japanese patients with SLE. Sixteen scleroderma patients, 19 rheumatoid arthritis (RA) patients, 23 Behcet's disease patients, and 23 healthy subjects were selected as control groups. Clinical information was abstracted from medical records. Anti-IL-10 antibody level was determined with an ELISA. RESULTS: With the cutoff established as serum absorbance +2 SDs (OD 0.729) in healthy subjects, we defined any sample above this cutoff as anti-IL-10 antibody-positive. Fourteen patients with SLE (17.5%) were found to be anti-IL-10 antibody positive. Absorbance was significantly higher in serum from patients with SLE and RA than in healthy individuals. In SLE, patients with low complement values were significantly more common in the antibody-positive group. Serum IgG levels were significantly higher in the antibody-positive group. In multivariable analysis, high level of serum IgG is associated with anti-IL-10 antibody positive. CONCLUSION: The present study found that anti-IL-10 antibody is present in SLE and related to clinical parameters. These results suggest that the presence of anti-IL-10 antibody was associated with high level of serum IgG, but is not associated with disease activity in patients with SLE.

Low-dose rituximab as induction therapy for ANCA-associated vasculitis.

Administration of four once-weekly doses of 375 mg/m2 rituximab (RTX) is commonly used as remission induction therapy for ANCA-associated vasculitis (AAV). Low-dose RTX has been recently shown to produce closely similar results to conventional treatments in other autoimmune diseases. However, the therapeutic potential of this approach in AAV remains largely unknown. Here, we analyzed the efficacy and tolerability of high- and low-dose regimens of RTX in patients with AAV. We retrospectively examined AAV patients who met the classification algorithm of Watts et al. from 2006 to 2016. Patients were divided into high- (HD) and low-dose (LD) RTX groups. HD-RTX was the original regimen while LD-RTX consisted of two once-weekly doses of 375 mg/m2. Cumulative complete remission (CR) rates for 1 year were compared, and serial changes in peripheral B cell counts and serious adverse events were monitored. Apart from a higher percentage of elderly patients in the LD group (p < 0.01), the 17 patients with HD-RTX and 11 patients with LD-RTX showed no significant differences in clinical characteristics, including Birmingham Vasculitis Activity Score (BVAS), Vasculitis Damage Index (VDI), and the initial dose of glucocorticoid. On 1-year observation, cumulative CR rates did not significantly differ (p = 0.20). Further, peripheral B cell counts and incidence of serious adverse events also did not differ. Cumulative CR rate did not significantly differ between LD and HD groups. Further study is warranted to confirm these results.