1.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
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.
2.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
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.
3.Diagnosis of Prenatal MRI in Placenta Implantation Abnormality
Yonglu CHEN ; Ting SONG ; Yi LIU ; Jianwei HUANG ; Yongcai HE
Chinese Journal of Medical Imaging 2015;(6):470-473,477
Purpose To discuss the value of MRI in the diagnosis of placenta implantation abnormality, and to explore preliminarily the relationship between MRI signs and types of placenta implantation abnormality. Materials and Methods The clinical preoperative data and postnatal pathological findings of 54 women at high risk of placenta accreta were collected. All the patients undertook the conventional pelvic MRI examination. The scanning sequences mainly included: sagittal, coronal and axial T2-weighted imaging-turbo spin echo, balance fast field echo. The MRI images were observed and the areas which showed low signal in all the three directions on T2WI were measured. Then the correlation between the areas of low signal on T2WI in placental and the types of placenta implantation abnormality was analyzed. Results The incidence of placenta implantation abnormality was 64.8% in our research (35/54). The main MRI signs were low signal on T2WI (68.5%, 37/54) and heterogeneous signal in placenta (57.4%, 31/54); the main sign of placenta percreta was tenting bladder (75.0%, 6/8). The types of placenta implantation abnormality were positively correlated with the areas of low signal on T2WI (r=0.454, P<0.05). Conclusion Pregnant women at risk of placenta accreta should be evaluated with imaging examinations, particularly with MRI scanning, to improve disease detection rate. The typical indirect signs of placenta implantation abnormality are low signal on T2WI and heterogeneous signal in placenta. The larger size of low signal area on T2WI in placenta, the deeper implantation of placenta.
4.The role of brain natriuretic peptide in cardiac surgery
Yili MA ; Xijing ZHUANG ; Guanran LI ; Xuezhi HE ; Yongcai LIANG
Chinese Journal of Postgraduates of Medicine 2011;34(17):24-26
Objective To investigate the influence of brain natrluretic peptide(BNP) in the prognosis of cardiac surgery.Methods Selected 115 cases of pafients with the first cardiac surgery.Their BNP concentration was measured before operation. Observed the relationship between BNP and postoperative atrial fibrillation,mechanical ventilation time,hospital stay,and the mortality of 30 d.Results Whether the patients had hypertension,diabetes,myocardial infarction history,left main stem disease and hemoglobin level or not,showed no definite relationship with BNP (P>0.05).Preoperative lower left ventricular ejection fraction (LVEF)(P=0.002) and European system for cardiac operation risk evaluation [(5±3)scores](P=0.003) were associated with higher BNP level.Postoperative mechanical ventilation time was(15.0±5.4)h,hospital stay was (32±11) d,showed a clear relationship with BNP(P= 0.035,0.001),but postoperative mediastinal infection,atrial fibrillation and mortality of 30 d had no definite relationship with BNP(P>0.05).Conclusion BNP can be used to predict the risk after cardiac surgery.

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