Objective:To compare the efficacy and safety of ticagrelor tablets produced by Zhejiang Hisun Pharmaceutical Co., Ltd. (the generic drug) and ticagrelor tablets produced by AstraZeneca Pharmaceutical Co., Ltd. (the original drug) in antiplatelet therapy.Methods:The study design was a retrospective cohort study. The subjects were patients who underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and postoperative antiplatelet therapy with ticagrelor tablets at First Affiliated Hospital of Dalian Medical University during January 2020 to July 2021. Through the hospital electronic medical record system, relevant clinical data of patients (age, gender, comorbidities, blood lipid level on admission, PCI indications, antiplatelet treatment regimen, efficacy and safety assessment endpoint events within 12 months of treatment, etc.) were collected. The patients were divided into the generic drug group and the original drug group. To exclude confounders, propensity score matching (PSM) method was used. The efficacy evaluation index was the incidence of the primary endpoint events (cardiogenic death, stroke, target revascularization, recurrent infarction) and secondary endpoint events (all-cause mortality, peripheral artery occlusion, stent thrombosis, angina attacks) within 12 months of treatment. The safety evaluation index was the incidence of bleeding event within 12 months of treatment.Results:A total of 1 486 patients were included in this study, including 734 in the generic drug group and 752 in the original drug group. The proportion of women and unstable angina, and the level of high-density lipoprotein cholesterol were higher than those in the original drug group (all P<0.05). The proportion of patients with hyperlipidemia and ST-segment elevation myocardial infarction were lower than those in the original drug group (both P<0.05). After PSM, 690 patients were enrolled in the generic drug group and 690 patients in the original drug group (all P>0.05). No differences in the comparison of clinical features between the 2 groups was significant (all P>0.05). No differences in the incidences of primary endpoints, secondary endpoints, and bleeding events between the 2 groups was significant before and after PSM [before PSM: 12.1%(89/734) vs. 10.9%(82/752), 10.8%(79/734) vs. 8.4%(63/752), 0.3%(2/734) vs. 0.5%(4/752); after PSM: 12.6%(87/690) vs. 12.3%(85/690), 11.0%(76/690) vs. 8.3%(57/690), 0.3%(2/690) vs. 0.4%(3/690); all P>0.05]. No death occurred in patients of both groups. Bleeding is predominantly characterized by epistaxis and subcutaneous petechiae, which did not lead to interruption of antiplatelet therapy. Conclusion:The efficacy and safety of ticagrelor tablets produced by Zhejiang Hisun Pharmaceutical Co., Ltd. for antiplatelet therapy in ACS patients after PCI surgery were basically the same as those of the original drug.

Objective:To compare the efficacy and safety of ticagrelor tablets produced by Zhejiang Hisun Pharmaceutical Co., Ltd. (the generic drug) and ticagrelor tablets produced by AstraZeneca Pharmaceutical Co., Ltd. (the original drug) in antiplatelet therapy.Methods:The study design was a retrospective cohort study. The subjects were patients who underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and postoperative antiplatelet therapy with ticagrelor tablets at First Affiliated Hospital of Dalian Medical University during January 2020 to July 2021. Through the hospital electronic medical record system, relevant clinical data of patients (age, gender, comorbidities, blood lipid level on admission, PCI indications, antiplatelet treatment regimen, efficacy and safety assessment endpoint events within 12 months of treatment, etc.) were collected. The patients were divided into the generic drug group and the original drug group. To exclude confounders, propensity score matching (PSM) method was used. The efficacy evaluation index was the incidence of the primary endpoint events (cardiogenic death, stroke, target revascularization, recurrent infarction) and secondary endpoint events (all-cause mortality, peripheral artery occlusion, stent thrombosis, angina attacks) within 12 months of treatment. The safety evaluation index was the incidence of bleeding event within 12 months of treatment.Results:A total of 1 486 patients were included in this study, including 734 in the generic drug group and 752 in the original drug group. The proportion of women and unstable angina, and the level of high-density lipoprotein cholesterol were higher than those in the original drug group (all P<0.05). The proportion of patients with hyperlipidemia and ST-segment elevation myocardial infarction were lower than those in the original drug group (both P<0.05). After PSM, 690 patients were enrolled in the generic drug group and 690 patients in the original drug group (all P>0.05). No differences in the comparison of clinical features between the 2 groups was significant (all P>0.05). No differences in the incidences of primary endpoints, secondary endpoints, and bleeding events between the 2 groups was significant before and after PSM [before PSM: 12.1%(89/734) vs. 10.9%(82/752), 10.8%(79/734) vs. 8.4%(63/752), 0.3%(2/734) vs. 0.5%(4/752); after PSM: 12.6%(87/690) vs. 12.3%(85/690), 11.0%(76/690) vs. 8.3%(57/690), 0.3%(2/690) vs. 0.4%(3/690); all P>0.05]. No death occurred in patients of both groups. Bleeding is predominantly characterized by epistaxis and subcutaneous petechiae, which did not lead to interruption of antiplatelet therapy. Conclusion:The efficacy and safety of ticagrelor tablets produced by Zhejiang Hisun Pharmaceutical Co., Ltd. for antiplatelet therapy in ACS patients after PCI surgery were basically the same as those of the original drug.

Objective:To evaluate the dental biofilm penetration efficiency of a novel stabilized stannous-containing sodium fluoride dentifric(EXP) and its lipopolysaccharide (LPS) neutralization efficiency.Methods:A controlled,randomized,examiner-blind in situ clinical trial was conducted with the treatment of PBS(control),EXP and a marketed stannous-containing sodium fluoride dentifrice (MKD).Fluorescent dye,fluorescent probe and fluorescence colocalization were used for sample examination and analysis.Results:EXP offered better stannous penetration into the biofilm than MKD and PBS(P ＜0.05),as well as greater LPS neutralization efficiency(P ＜0.05).There was a 96.52％ overlap of stannous ions and bounded LPS at the same sites treated by EXP.Conclusion:EXP is more effective than MKD in the delivery of stannous into the biofilm and in the neutralization of LPS.

Objective Xenografts have poor biocompatibilities,the aim of this study was to improve the biocompatibilities of decellular xenografts via heparin/dihydroxy-iron complex multilayeres (HDCMs) nanomodification.Methods A novel thrombo-resistant surface for decellular xenograft had been developed by alternating linkage of dihydroxy-iron and heparin to decellular bovine jugular vein (DC-BJV),and surface characterization and biocompatibility of HDCMs nanomodified BJV (HDCMs-BJV) were detected.Results Toluidine blue colorimetric method showed the amount of linked heparin was about (808 ±86) μg/cm2 per assembly-cycle.SEM images proved HDCMs were uniformly linked to and formed nanoscale films around the fibrils of DC-BJV.Washing test proved HDCMs were firmly linked to BJV and sustainedly released heparin for a long time.Tensile test showed that biomechanical stability was increased.Antithrombogenicity test showed that the activated partial thrombin time (APTT) and prothrombin time (PT) of all trial groups were above the normal reference ranges.Platelet adhesion test evaluated mean platelet count per 10 000 μm2 area was 8 ±4 for HDCMs-BJV vs.48 ± 16 for DC-BJV.Endothelial cells (ECs) proliferation test showed the number and activity of ECs on luminal surface of HDCMs-BJV were very similar to DC-BJV at 7-day incubation.Calcium content assay evaluated mean calcium content was ( 8.5 ± 1.9 ) μg/mg dry weight for HDCMs-BJV vs.(26.6 ± 3.7) μg/mg dry weight for DC-BJV at 4 weeks and (21.5 ± 6.8 ) μg/mg dry weight for HDCMsBJV vs.( 112.6 ± 16.9) μg/mg dry weight for DC-BJVs at 8 weeks,respectively.Conclusion These results demonstrate HDCMs were firmly linked to BJV and formed nanoscale thrombo-resistant films,and HDCMs nanomodification improves biocompatibilities of decellular xenograft.

OBJECTIVE: To improve the hemocompatibility of decellular vascular matrix via heparin-iron complex multilayers (HICMs) nanomodification. METHODS: A novel thrombo-resistant surface for decellular xenograft was developed by alternating linkage of dihydroxy-iron and heparin to decellular bovine jugular vein (DC-BJV), and its surface characterization, biomechanical stability and hemocompatibility were detected by scanning electron microscopy, tensile test and hemocompatibility evaluation, respectively. RESULTS: A toluidine blue colorimetric method indicated the amount of linked heparin was about (808±86) μg/cm2 per assembly-cycle. Scanning electron microscopic (SEM) images proved that HICMs were uniformly linked to and formed nanoscale films around the fibrils of DC-BJV. Toluidine blue staining histologic images showed that HICMs were linked mainly to DC-BJV surfaces. Washing test showed that the release of heparin was (281±43), (422 ± 60), (729±81), (1053±116), (1317±157), (1618±187) and (1945 ± 268 ) μg/cm(2) at 1 day, 1, 2, 3, 4, 6 and 8 week washing, respectively. Tensile tests showed an increased biomechanical stability. Hemocompatibility evaluations showed that PT and APTT of all the trial groups were above the normal reference ranges and that mean platelet count per 10000 μm2 area was 8±4 for HICMs layer-by-layer modified BJV (LBL-BJV) vs 48±16 for DC-BJV. CONCLUSION HICMs are firmly linked to DC-BJV, and can form nanoscale thrombo-resistant films, which yield a sustained release of heparin. HICMs nanomodification improves the hemocompatibility of decellular xenograft.
Animals ; Biocompatible Materials ; Blood Vessel Prosthesis ; Cattle ; Cell-Free System ; Coated Materials, Biocompatible ; chemical synthesis ; chemistry ; pharmacology ; Heparin ; administration & dosage ; chemistry ; Iron ; administration & dosage ; chemistry ; Jugular Veins ; Nanostructures ; chemistry ; ultrastructure ; Surface Properties ; Tissue Scaffolds ; Transplantation, Heterologous

Objective To investigate the short term effect of gastric bypass surgery for the treatment of nonobese type 2 diabetes mellitus and possible mechanisms. Methods The clinical data of 58 patients with nonobese type 2 diabetes mellitus who received gastric bypass surgery from March to August, 2009 were retrospectively analyzed. The levels of fasting plasms glucose (FPG), 2-hour postprandial plasma glucose (2h PG) and glycosylated hemoglobin (HbA1c) were dynamically monitored, and the insulin resistance index (HOMA-IR) and body mass index ( BMI) were calculated. All data were analyzed using variance of analysis and LSD test. Results Of the 58 patients, 48 (83% ) met the requirement of complete response criteria and stopped administration of hypoglycemic agents; 7( 12% ) had to use hypoglycemic agents, but the dose of the agents was lowered by 50% compared to that before surgery. The surgery was ineffective in 3 patients (5% ). The levels of FPG, 2h PG, HbAlc and HOMA-IR of the 58 patients showed a significant decreasing trend after surgery when compared to those before surgery (F = 67. 867, 50. 885, 78. 278, 572. 757, P <0.05), while there was no significant change of the BMI after surgery ( F = 3. 503, P > 0. 05 ). Conclusions Gastric bypass surgery has a good effect on nonobese patients with type 2 diabetes mellitus whose BMI was less than 25 kg/m2. The improvement of insulin resistance after the surgery might be the main reason.