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.Expression of CD151 and MT1-MMP in adenocarcinoma of esophagogastric junction and their significances
Jie MIAO ; Xiufang GUO ; Xin XU ; Dongying YAO ; Xiaoli LIU ; Lei QI ; Lin FU ; Yongcai LI
Chinese Journal of Clinical and Experimental Pathology 2015;(3):260-263
Purpose To investigate the expression of the protein of CD151 and MT1-MMP in adenocarcinoma of esophagogastric junc-tion tissues and to explore their relationship with the invasiveness and metastasis of the tumor. Methods CD151 and MT1-MMP pro-tein were detected by immunohistochemical staining respectively in 15 cases of paraneoplastic normal gastric mucosa tissue, 40 cases dysplasia and 172 cases of adenocarcinoma of esophagogastric junction tissues. Results All of the expression level of CD151 and MT1-MMP protein were increasing according to the order of normal-dysplsia-carcinoma. The expression rate of CD151 was 6. 67%, 20. 0% and 78. 3%, while the rate of MT1-MMP with 13. 3%, 22. 5% and 79. 1% in the normal, dysplasia and carcinoma subgroup. The expression rate of each protein were significant difference among the three goroups (P<0. 05). In the adenocarcinoma of esopha-gogastric junction tissues, the expression of them in the subgroup of poorly-differentiated with serosa invasion and lymph nodes metasta-sis was significantly higher than the other subgroup of well-differentiated with non serosa invasion or lymph nodes metastasis ( P <0. 05 ) . There was a positive correlation between the expression of CD151 and MT1-MMP protein in adenocarcinoma of esophagogastric junction tissues ( P<0. 05 ) . Conclusions CD151 and MT1-MMP assuredly and highly express in the adenocarcinoma of esopha-gogastric junction tissues and they have close relationships, which could involved in the invasiveness and metastasis synergistically in this tumor.
4.Research of ventricular late potentials detection based on approximate entropy analysis.
Chao GAO ; Yongcai GUO ; Xuanbing YANG
Journal of Biomedical Engineering 2007;24(3):526-529
We present an analysis method of electrocardiogram (ECG) to determine patients' ventricular late potentials (VLPs) characteristics by means of wavelet packet transform and entropy (ApEn). The results indicate that the patients with VLPs tend to have higher ApEn values than do those without. So ApEn can be used as an indicator and a BP neural network for distinguishing between the two patient groups. The experiment result shows that this method has higher distinguishability.
Electrocardiography
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methods
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Entropy
;
Heart Ventricles
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physiopathology
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Humans
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Neural Networks (Computer)
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Signal Processing, Computer-Assisted
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Ventricular Function

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