Objective:To compare the efficacy and safety of vildagliptin tablets (the generic drug) manufactured by Qilu Pharmaceutical Co., Ltd. and vildagliptin tablets (the original drug) manufactured by Novartis Pharmaceutical Co., Ltd. in the treatment of type 2 diabetes mellitus (T2DM) in third round of national centralized volume-based procurement.Methods:The study design was a multicenter retrospective cohort study. The study subjects were T2DM patients treated with vildagliptin tablets at the Outpatient Department of Zhuhai People′s Hospital, Zhongshan City People′s Hospital, Jiangmen Central Hospital, and General Hospital of Southern Theater Command of PLA from January 2020 to December 2021. Using the hospital electronic medical record system, medical records in outpatients who met the inclusion criteria were collected, and relevant clinical data were extracted. The patients were divided into generic drug group and original drug group. To exclude the interference of confounding factors, the propensity score matching method was used. The efficacy evaluation index was the magnitude of hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reductions within one year after administration. Generalized linear regression model was used to analyze the influencing factors for the magnitude of HbA1c and FPG reduction. The safety evaluation index was the incidence of adverse events within one year of drug use.Results:A total of 4 511 patients with T2DM who were treated with vildagliptin tablets were collected from 4 hospitals, including 3 039 in the generic drug group and 1 472 in the original drug group. After treatment, the HbA1c and FPG in patients of the 2 groups decreased compared with those before treatment. The magnitude of HbA1c and FPG reductions in patients of the generic drug group were not significantly different from those in the original drug group [0.50 (0.05, 2.30)% vs. 0.90 (-0.10, 1.70)%, Z=0.235, P=0.814; 0.59 (-0.40, 2.20) mmol/L vs. 1.00 (-0.61, 2.32) mmol/L, Z=0.421, P=0.674]. The results of generalized linear regression model analysis showed that the therapeutic drugs did not affect the magnitude of HbA1c and FPG reductions ( P=0.627, P=0.478). Compared with the original drug group, the incidences of adverse events and hypoglycemia in the generic drug group were not statistically significant [1.6‰ (5/3 039) vs. 2.7‰ (4/1 472), P=0.721; 0.7 ‰ (2/3 039) vs. 0.7 ‰ (1/1 472), P=1.000]. Conclusion:The efficacy and safety of generic vildagliptin tablets manufactured by Qilu Pharmaceutical Co., Ltd. were generally consistent with those of the original drug in the treatment of T2DM.

Objective:To compare the efficacy and safety of vildagliptin tablets (the generic drug) manufactured by Qilu Pharmaceutical Co., Ltd. and vildagliptin tablets (the original drug) manufactured by Novartis Pharmaceutical Co., Ltd. in the treatment of type 2 diabetes mellitus (T2DM) in third round of national centralized volume-based procurement.Methods:The study design was a multicenter retrospective cohort study. The study subjects were T2DM patients treated with vildagliptin tablets at the Outpatient Department of Zhuhai People′s Hospital, Zhongshan City People′s Hospital, Jiangmen Central Hospital, and General Hospital of Southern Theater Command of PLA from January 2020 to December 2021. Using the hospital electronic medical record system, medical records in outpatients who met the inclusion criteria were collected, and relevant clinical data were extracted. The patients were divided into generic drug group and original drug group. To exclude the interference of confounding factors, the propensity score matching method was used. The efficacy evaluation index was the magnitude of hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reductions within one year after administration. Generalized linear regression model was used to analyze the influencing factors for the magnitude of HbA1c and FPG reduction. The safety evaluation index was the incidence of adverse events within one year of drug use.Results:A total of 4 511 patients with T2DM who were treated with vildagliptin tablets were collected from 4 hospitals, including 3 039 in the generic drug group and 1 472 in the original drug group. After treatment, the HbA1c and FPG in patients of the 2 groups decreased compared with those before treatment. The magnitude of HbA1c and FPG reductions in patients of the generic drug group were not significantly different from those in the original drug group [0.50 (0.05, 2.30)% vs. 0.90 (-0.10, 1.70)%, Z=0.235, P=0.814; 0.59 (-0.40, 2.20) mmol/L vs. 1.00 (-0.61, 2.32) mmol/L, Z=0.421, P=0.674]. The results of generalized linear regression model analysis showed that the therapeutic drugs did not affect the magnitude of HbA1c and FPG reductions ( P=0.627, P=0.478). Compared with the original drug group, the incidences of adverse events and hypoglycemia in the generic drug group were not statistically significant [1.6‰ (5/3 039) vs. 2.7‰ (4/1 472), P=0.721; 0.7 ‰ (2/3 039) vs. 0.7 ‰ (1/1 472), P=1.000]. Conclusion:The efficacy and safety of generic vildagliptin tablets manufactured by Qilu Pharmaceutical Co., Ltd. were generally consistent with those of the original drug in the treatment of T2DM.

OBJECTIVE:To provide reference for improving the clopidogrel rational use in cerebral infarction secondary preven-tion. METHODS:Medical cases of 471 patients with acute cerebral infarction in neurology department in a hospital from 2013 to 2014 were retrospective surveyed to collect the utilization rate of clopidogrel and the combination of clopidogrel with proton pump inhibitors(PPIs)and aspirin,and the rationality was analyzed. RESULTS:The utilization rate of clopidogrel in cerebral infarction secondary prevention was 93.84%;the combination rate with PPIs was 52.49%,of which,51.72% had no drug selection or com-bined treatment basis;the combination rate with aspirin was 40.72%,cardiogenic cerebral infarction accounted for only 3.9%, non-cardiogenic cerebral infarction accounted for 96.1%,and recurrence of cerebral infarction in high-risk patients accounted for 31.11%. CONCLUSIONS:Clopidogrel in patients with cerebral infarction secondary prevention is widely used in the hospital,has high combination rate with PPIs and aspirin and low guide compliance rate. Clopidogrel should be enhanced pharmacy services, comply with evidence based medicine and improve the rationality of medication.

The transcriptional repressor RE1 silencer transcription factor(NRSF/REST) is an important factor that restricts some neuronal traits in neurons.Since these traits are also present in pancreatic islet cells,NRSF-regulated genes involved in islet function are searched.A NRSE-like motif was analysed in human insulin promoter.The role of NRSE was evaluated by generating a model of insulin-secreting cells that firmly express NRSF.The presence of NRSF led to a decrease in activity of human insulin promoter by stable or transient transfection with human insulin-promoter luciferase.The predicted NRSE-like motif also confers NRSF-dependent transcriptional repression in the context of a surrogate gene promoter.Specific binding activity of NRSF/REST to the NRSE-like motif was confirmed by EMSA.Moreover,the binding activity is competed by consensus NRSE sequence.These data showed that human insulin promoter is regulated by the transcriptional repressor NRSF/REST via the NRSE-like motif.

Objective To study the effect of the intervention mode of MTP on use of antibacterials in upper respiratory infection.Methods Adopt retrospective method to select randomly prescriptions of upper respiratory infection from July to September in 2006 for baseline investigation in Outpatient Clinic of Respiratory Department of the First People's Hospital of the city of Zhuhai in Guangdong province.Then aim physicians was interfered by MTP and investigation of post-interference was carried out after a month.The process of intervention and investigation was carried out repeatedly until June in 2007.The ratio of antibacterials use,injection use percentage and average drug fee was observed in pre/post-interference.Results The ratio of antibacterials use in upper respiratory infection in our hospital was decreased from 81.33% to 0,and the ratio percentage of injection use and average drug fee decreased by 81.69% and 35.47% respectively after four MTP circulations.Conclusion The intervention mode of MTP is feasible and effective on promoting the rational use of antibacterials on upper respiratory infection in Outpatient Clinic of Respiratory Department of our hospital.

OBJECTIVE:To study the main factors affecting in vitro dissolubility of total puerariae flavones(TPF)bioad?hesive tablets.METHODS:Using HPMC,Carbopol(CP934NP)as bioadhesive and base materials,lactose as porogenic agent to prepare bioadhesive tablets;Basket-rotating method was adopted to determine the dissolubility while0.1mol/L HCl was used as dissolution medium,Rotational speed was100r/min.The accumulated dissolution was detected and the influence of the amount of HPMC,CP,kind of porogenic agent,amount of lactose,size of granules in pressed tablets and medium pH on dissolubility was observed.RESULTS&CONCLUSION:The amount of HPMC,CP and lactose,kind of porogenic agent,size of granules in tablets and medium pH can affect the dissolubility of bioadhesive tablets.