Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

BACKGROUND: Intensive phototherapy (IPT) and exchange transfusion (ET) are the main treatments for extreme hyperbilirubinemia. However, there is no reliable evidence on determining the thresholds for these treatments. This multicenter study compared the effectiveness and complications of IPT and ET in the treatment of extreme hyperbilirubinemia. METHODS: This retrospective cohort study was conducted in seven centers from January 2015 to January 2018. Patients with extreme hyperbilirubinemia that met the criteria of ET were included. Patients were divided into three subgroups (low-, medium-, and high- risk) according to gestational week and risk factors. Propensity score matching (PSM) was performed to balance the data before treatment. Study outcomes included the development of bilirubin encephalopathy, duration of hospitalization, expenses, and complications. Mortality, auditory complications, seizures, enamel dysplasia, ocular motility disorders, athetosis, motor, and language development were evaluated during follow-up at age of 3 years. RESULTS: A total of 1164 patients were included in this study. After PSM, 296 patients in the IPT only group and 296 patients in the IPT plus ET group were further divided into the low-, medium-, and high-risk subgroups with 188, 364, and 40 matched patients, respectively. No significant differences were found between the IPT only and IPT plus ET groups in terms of morbidity, complications, and sequelae. Hospitalization duration and expenses were lower in the low- and medium-risk subgroups in the IPT only group. CONCLUSIONS In this study, our results suggest that IPT is a safe and effective treatment for extreme hyperbilirubinemia. The indication of ET for patients with hyperbilirubinemia could be stricter. However, it is necessary to have a contingency plan for emergency ET as soon as IPT is commenced especially for infants with risk factors. If IPT can be guaranteed and proved to be therapeutic, ET should be avoided as much as possible.
Child, Preschool ; Exchange Transfusion, Whole Blood/adverse effects* ; Humans ; Hyperbilirubinemia, Neonatal/therapy* ; Infant ; Infant, Newborn ; Kernicterus/therapy* ; Phototherapy/methods* ; Retrospective Studies

Objective:To investigate the effects of Porphyromonas gingivalis lipopolysaccharide (Pg-LPS) of type Ⅰand Ⅳ fimA on the proliferation and migration of human umbilical artery smooth muscle cells (HUASMC) under co-culture conditions and to explore the biological basis and possible mechanisms of the relationship between periodontitis and atherosclerosis (As). Methods:Type Ⅰ and Ⅳ fimA Pg were anaerobically cultured and the Pg-LPS was extracted, purified and identified. Human umbilical vein endothelial cells (HUVEC) and HUASMC were cultured in vitro and the HUVEC-HUASMC co-cultured cell model was established using rat tail type Ⅰ collagen. The experiment was divided into three groups: group T1 (co-cultured cells were stimulated with type Ⅰ fimA Pg-LPS at the mass concentrations of 0.5, 1.0, 2.0, 5.0, 10.0 mg/L), group T2 (co-cultured cells were stimulated with type Ⅳ fimA Pg-LPS at the mass concentrations of 0.5, 1.0, 2.0, 5.0, 10.0 mg/L), and negative control group (without LPS). Cell counting kit-8 (CCK-8) was used to detect the proliferation ability of HUASMC and the migration ability of HUASMC was observed by using the Transwell migration chamber. Comparasons of the changes in the proliferation and migration ability of HUASMC after 2, 8, 24 and 48 h of Pg-LPS stimulated co-cultured cells with various mass concentrations of Pg-LPS were conducted. Results:For the co-cultured cells under the action of type Ⅰ and Ⅳ fimA Pg-LPS, at 24 and 48 h, in each mass concentration group of the two types of Pg-LPS (0.5, 1.0, 2.0, 5.0, 10.0 mg/L), HUASMC′s A values were significantly up-regulated compared to the negative control group ( P<0.05) and for the co-cultured cells after the stimulation of type Ⅳ fimA Pg-LPS at concentrations of 5 and 10 mg/L at 48 h, the A values (1.386±0.044, 1.455±0.058) of HUASMC were significantly higher than that of HUASMC (1.168±0.064, 1.204±0.088) in the same concentrations of type Ⅰ fimA Pg-LPS ( P<0.05). In addition, the A values of HUASMC in stimulated co-cultured cells under concentrations of 5.0 and 10.0 mg/L of type Ⅳ fimA Pg-LPS at 48 h were significantly higher than that in stimulated co-culture cells under the concentrations of 0.5 and 1.0 mg/L of type Ⅳ fimA Pg-LPS (1.170±0.082, 1.239±0.089) ( P<0.05). The migration results of HUASMC showed that at 8, 24, and 48 h, the numbers of migration of HUASMC in each mass concentration group of type Ⅰ and Ⅳ fimA Pgas-LPS were significantly higher than that of HUASMC under the same Pg-LPS mass concentration at 2 h in the same group ( P<0.05). The migration quantities of HUASMC in the other Pg-LPS mass concentration groups at 48 h were significantly higher than that of HUASMC under the same Pg-LPS mass concentration at 24 h in the same group ( P<0.05), except for 10.0 mg/L type Ⅳ fimA Pg-LPS. The numbers of HUASMC migration in 2.0 mg/L type Ⅳ fimA Pg-LPS stimulated co-cultured cells at 48 h (204.00±20.98) were significantly higher than that in type Ⅰ fimA Pg-LPS stimulated co-culture cells at the same concentration (141.89±18.28) ( P<0.05). Further more, at the same observation time point, the higher the Pg-LPS concentration, the greater the number of HUASMC migration ( P<0.05). Conclusions:Both Ⅰ and Ⅳ fimA Pg-LPS could enhance the proliferation and migration ability of HUASMC in the co-culture system, and the virulence of Pg-LPS might be related to the fimA genotype. Ⅳ fimA Pg-LPS showed a more significant stimulating effect and more likely to cause HUASMC dysfunction than Ⅰ fimA Pg-LPS, which provided part of the basis for the progression of As in severe periodontitis.

Objective:To assess the correlation of high mobility group box 1 (HMGB-1) with Organoleptic rating(OR),dental plaque index(PLI) and halitosis with chronic periodontitis.Methods:Serum samples from 20 halitosis patients,20 chronic periodontitis patients with oral malodor and 8 healthy controls were collected.The level of HMGB-1 in the serum was detected by ELISA.The OR and PLI were estimated by organoleptic method and periodontal examination respectively.The data were analyzed with SPSS 17.0.Results:The levels of HMGB1 in the serum from 2 groups of patients was significantly higher than that of the controls(P ＜0.01).The level of HMGB-1 in the patients of halitosis with chronic periodontitis was significantly higher than that of the halitosis patients(P ＜ 0.01).There was no statistical difference of OR between the 2 groups of patients(P ＞ 0.05).The PLI of the chronic periodontitis patients with oral malodor was significantly higher than that of halitosis patients (P ＜ 0.01).The correlation of HMGB1 with OR and PLI of 2 groups of patients were positively correlated(P ＜ 0.05 and 0.01 respectively),the OR of halitosis patients showed no relevant(P ＞0.05).Conclusion:HMGB-1 may be one of the important factors that result in chronic periodontal inflammation and stubborn bad breath.