1.A comparative study on efficacy and safety of generic and original ticagrelor in antiplatelet therapy
Shilei YANG ; Lu LI ; Yanna ZHU ; Xiaohan ZHAI ; Linlin LYU ; Yanwei CHEN ; Yan XI ; Jie LIU ; Xufeng TAO ; Shuai LI ; Jingya TANG ; Yunming LI ; Deshi DONG
Adverse Drug Reactions Journal 2023;25(3):145-151
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.
2.A comparative study on efficacy and safety of generic and original ticagrelor in antiplatelet therapy
Shilei YANG ; Lu LI ; Yanna ZHU ; Xiaohan ZHAI ; Linlin LYU ; Yanwei CHEN ; Yan XI ; Jie LIU ; Xufeng TAO ; Shuai LI ; Jingya TANG ; Yunming LI ; Deshi DONG
Adverse Drug Reactions Journal 2023;25(3):145-151
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.
3.Relationship between serum levels of PCT and neutrophil CD64 with effect of hormone therapy and complications in patients with nephrotic syndrome
Xinming HUANG ; Yangping ZHOU ; Rongrong ZHAI ; Lu WANG ; Xufeng GAO
International Journal of Laboratory Medicine 2017;38(16):2177-2178,2182
Objective To investigate the relationship between serum levels of PCT and neutrophil CD64 contents with the effect of hormone therapy and complications in the patients with primary nephrotic syndrome.Methods Sixty-five patients with primary nephrotic syndrome in our hospital from September 2015 to September 2016 were selected as the research subjects,all cases were treated with hormonal therapy,the serum levels of PCT and neutrophil CD64 were detected and their relationship with the curative effect and complications of nephrotic syndrome was analyzed.Results According to the PCT and neutrophil CD64 median levels,the cases were divided into the high level group and low level group,the results found that serum creatinine,serum protein,urine protein and pathological types had no statistical difference between the high level group and low level group.The hormone sensitivity had 15 cases in the patients with high PCT level,which was significantly lower than 21 cases in the patients with low PCT level;the hormone sensitivity had 14 cases in the patients with high neutrophil CD64 level,acute renal failure,infection and thrombus in the patients with high PCT level had 8,10,6 cases,which were significantly lower than those in the patients with low PCT level;acute renal failure,infection and thrombus in the patients with high neutrophil CD64 level had 7,11,6 cases,which were significantly higher than those in the patients with low neutrophil CD64 level (P<0.05).Conclusion The levels of serum PCT and neutrophil CD64 are significantly correlated with the therapeutic effect and clinical prognosis in the patients with nephrotic syndrome.
4.Determination of astragaloside Ⅳ in extract from Radix Astragali by TLC-Scanning
Xufeng ZHAI ; Fajin LIU ; Yongzhuang GUO ; Caizhe LIAO
Chinese Traditional Patent Medicine 1992;0(08):-
Objective: To determine the extract from Radix Astragali. Methods : Astragaloside IV in extract from Radix Astragali was determined by TLC-Scanning. Results : The linear relationship was at the rang of 0.78 ?g~ 4.68 ?g. The average recovery was 99.06% ( RSD=1.17% and n =5). Conclusion : The method is available with a good reproducibility. The pretreatment is simple and easy to operate.

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