Evaluation of belimumab in treatment of Chinese childhood-onset systemic lupus erythematosus: a prospective analysis from multicenter study.

OBJECTIVE: The aim of this study is to identify whether low lupus disease activity status (LLDAS) and clinical remission (CR) of belimumab plus standard of care (SoC) therapy are achievable goals in childhood-onset SLE (cSLE). METHODS: This multicentre, one arm pre-post intervention study was conducted at 15 centers in China. The primary end point was to describe the proportion of patients who achieved LLDAS and CR after 3, 6, and 12 months after treatment with belimumab plus SoC therapy. A multiple regression model was used to impute missing data. A Poisson regression model was used to calculate the effect of belimumab treatment on the reduced risk of serious diseases and the incidence of new damage. RESULT: 193 (92.2% female) with active cSLE from 15 centers were included. At 3, 6 and 12 months, the proportion of LLDAS (CR) was 12.4% (1.0%), 25.6% (4.5%) and 70.3% (29.7%), respectively. The mean SELENA-SLEDAI score decreased from 11.0 at baseline to 3.7, 2.9 and 1.7 at 3, 6, and 12 months. At baseline, all patients received steroids at a mean (SD) prednisone equivalent dose of 31.0 (18.2) mg/day, which decreased to 19.4 (10.8) mg/day at month 3, 12.6 (7.2) mg/day at month 6 and 6.7 (5.3) mg/day at month 12. The symptoms and immunological indicators were also significantly improved. CONCLUSION: This is the first and largest sample size prospective clinical intervention study of cSLE patients treated with belimumab in China. LLDAS and CR were attainable treat-to-target of belimumab plus SoC therapy in cSLE.

hsa-miR-607, lncRNA TUG1 and hsa_circ_0071106 can be combined as biomarkers in type 2 diabetes mellitus.

Type 2 diabetes mellitus (T2DM) is a multifactorial disorder that leads to alterations in gene regulation. ncRNAs have the characteristics of tissue specificity, disease specificity, timing specificity, high stability and post transcriptional regulation effect. These preconditions are more conducive to promote ncRNA to become a new biomarker for clinical diagnosis. Our study aims to explore the relationship between circRNA, lncRNA, miRNA and T2DM, and to evaluate their diagnostic value for T2DM. A total of 101 pairs of T2DM and controls were conducted in the study. QRT-PCR was used to study the differential expression of circRNAs, miRNAs and lncRNAs. ROC curve was used to estimate their diagnostic value in T2DM. Compared with healthy controls, the expression levels of hsa_circ_0071106, hsa_circ_0000284, hsa_circ_0071271, hsa-miR-29a-5p, hsa-miR-3690, hsa-miR-607, lncRNA MEG3 and lncRNA TUG1were higher in T2DM (all P < 0.05). The AUCs of hsa_circ_0071106, hsa-miR-607 and lncRNA TUG1 for diagnosis of T2DM were 0.563,0.645 and 0.642, respectively. The combined AUC of hsa-miR-607, lncRNA TUG1 and hsa_circ_0071106 was 0.798 ([0.720~0.875], P < 0.001). Moreover, the sensitivity of combined diagnosis was 75.2% and the specificity was 100.0%. The levels of lncRNA TUG1, hsa-miR-607 and hsa_circ_0071106 in peripheral blood have potential clinical diagnostic value for T2DM.

[Glucocorticoid combined with ulinastatin in treatment of Kawasaki disease in children: a non-randomized controlled clinical trial].

OBJECTIVE: To investigate the clinical efficacy of glucocorticoid combined with ulinastatin in the treatment of Kawasaki disease (KD) in children. METHODS: A total of 104 children who were admitted and diagnosed with typical KD between January 2011 and December 2013 were assigned to ulinastatin group (methylprednisolone+ulinastatin; n=46) and intravenous immunoglobulin (IVIG) group (n=58) according to the severity of KD and the willingness of their parents. Observations for the two groups were performed to compare the changes in coronary artery diameter before and at 1 week, 3 months, and 6 months after treatment, fever clearance time, retreatment condition, changes in white blood cells (WBC), platelets (PLT), hemoglobin (HB), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) at 1 week and 3 weeks after treatment, and total in-hospital cost. RESYLTS: There was no significant difference in the coronary artery diameter between the two groups before or at 1 week, 3 months or 6 months after treatment (P>0.05). All the patients (100%) in the ulinastatin group vs 83% in the IVIG group had a normal body temperature after 48 hours of treatment (P<0.01). Two patients (4%) in the ulinastatin group and 10 patients (17%) in the IVIG group received retreatment. Significant differences were observed in ESR, WBC, and HB between them (P<0.01). The total in-hospital cost in the ulinastatin group was significantly lower than that in the IVIG group (P<0.01). CONCLUSIONS: For children with KD, methylprednisolone combined with ulinastatin does not increase the risk of coronary artery aneurysm, decreases in-hospital costs, is superior in controlling laboratory markers and shortening the duration of fever during the acute phase compared with the IVIG therapy.