1.The clinical outcomes analysis of drug-coated balloon de novo coronary lesions left with untreated dissection
Zhi-yuan CHENG ; Wen-rui MA ; Zi-lei PAN ; Chang-sheng NAI ; Shang CHANG ; Li LIANG ; Yao-jun ZHANG ; Qian LI
Chinese Journal of Interventional Cardiology 2025;33(10):568-573
Objective To investigate the clinical prognosis of untreated residual coronary artery dissection treated with drug coated balloon(DCB).Methods A retrospective analysis was conducted on the clinical and imaging data of patients with primary coronary artery lesions(2.5-4.0 mm)treated with DCB under angiography guidance at Xuzhou Cancer Hospital,Xuzhou New Health Geriatric Hospital,and Peixian Guotai Hospital from September 2017 to April 2023.According to the observation of coronary artery dissection through angiography,the patients were divided into a dissection group and a non dissection group.The main endpoint of this study was the major adverse cardiovascular event(MACE)during a 12-month follow-up.Results A total of 381 patients were enrolled in the three research centers,with 30 cases(30 lesions)in the dissection group and 351 cases(367 lesions)in the non dissection group.There was no significant difference between the two groups in terms of age,gender,hypertension,hyperlipidemia,diabetes,smoking,previous myocardial infarction,previous percutaneous coronary intervention,coronary artery bypass grafting and other baseline clinical characteristics(all P>0.05).Except for the reference vessel diameter(P=0.049)and DCB pressure(P=0.032),there was no statistically significant difference in the characteristics of coronary angiography lesions between the two groups of patients(both P>0.05).During a 12-month follow-up,there was no statistically significant difference(P>0.05)in the incidence of MACE between the dissection group and the non dissection group after DCB treatment for primary coronary artery lesions in situ.Conclusions Untreated residual dissection after DCB treatment of de novo coronary lesions does not lead to an increase in clinical MACE.
2.Bioequivalence of rivaroxabanpian in healthy Chinese subjects
Xu ZHU ; Xiao-ni WANG ; Chang LU ; Ran ZHANG ; Ning CHEN ; Jin-mei ZHOU ; Feng ZHANG ; Wen ZHANG ; Sheng-long ZHAO ; Shun-wang HUANG ; Huan ZHOU
Chinese Pharmacological Bulletin 2025;41(11):2194-2199
Aim To evaluate the bioequivalence of two oral preparations of rivaroxaban tablets(test preparation T and refe-rence preparation R)in fasting/postprandibular state in healthy Chinese subjects.Methods A randomized,open,single-dose,four-cycle,completely repeated crossover experiment was used in this study.A total of 70 healthy male and female subjects were enrolled,including 38 subjects in the fasting group and 32 sub-jects in the postprandial group.Rivaroxaban tablets(2.5 mg/tablet)were taken orally once per cycle and their reference preparations were tested.The plasma rivaroxaban concentration was determined by LC-MS/MS method.The pharmacokinetic parameters of rivaroxaban tablets were calculated by WinNonlin software,and the parameters were analyzed and processed.Re-sults The PK parameters of rivaroxaban tablets and reference preparations in fasting group were as follows:Cmax was(72.48±17.08)and(66.36±15.64)μg·L-1,respectively.AUC0-t were(383.49±101.06)and(370.43±102.16)h·ng·mL-1,and AUC0-inr were(389.58±102.28)and(375.84±103.01)h·μg·L-,respectively.Main PK parameters of subjects taking rivaroxaban tablets orally after meals:Cmax were(66.48±15.64 and 60.87±13.44)μg·L-1,AUC0-t were(404.44±72.58)and(381.80±79.93)h·μg·L-1,re-spectively.AUC0_inf was(410.88±73.55)and(393.64±69.71)h·μg·L-1,respectively.Under fasting and postmeal conditions,subjects took rivaroxaban test and reference prepara-tion orally,one tablet(2.5 mg/tablet)each time.The geometric mean of the main pharmacokinetic parameters of rivaroxaban in plasma(Cmax,AUC0-t,AUC0-inf)and their corresponding values had a 90%confidence interval ranging from 80.00%to 125.00%.No serious adverse events or unexpected adverse e-vents occurred in both groups.Conclusion Rivaroxaban tablets are bioequivalent and safe in vivo under fasting and postprandial conditions.
3.Water extract of Rehmannia glutinosa improves bleomycin-induced pulmonary fibrosis in mice and its metabolic mechanism
Zi-yu ZHANG ; Meng-nan ZENG ; Peng-li GUO ; Yu-han ZHANG ; Xiang-da LI ; Yan-xing WU ; Shuang-ying FU ; Zi-chang LIAN ; Wei-sheng FENG ; Xiao-ke ZHENG
Chinese Pharmacological Bulletin 2025;41(12):2315-2325
Aim To investigate the intervention effect of Rehmannia radix water extract on bleomycin(BLM)-induced pulmonary fibrosis in mice combined with metabolomics and to reveal the potential mechanism,in order to provide new ideas for clinical treatment of pul-monary fibrosis.Methods Male C57BL/6N mice were randomly divided into the control group,model group,pirfenidone group(positive control,PFD,270 mg·kg-1),and low dose(DH-L,4.55 g·kg-1)group,medium dose(DH-M,9.1 g·kg-1)group and high dose(DH-H,18.2 g·kg-1)group of Rehman-nia.Except for the control group,BLM(5 mg·kg-1)was instilled into the trachea to establish the model of pulmonary fibrosis in the other groups.The survival rate,lung index and blood oxygen saturation of mice in each group were evaluated.HE and Masson staining were used to observe the pathological changes of lung tissue.WBP was used to detect lung function.Flow cytometry was used to detect the apoptosis of primary lung cells,ROS and immune cells.ELISA was used to detect the levels of fibrosis markers and inflammatory factors(α-SMA,collagen Ⅰ,collagen Ⅲ,TGF-β1,TNF-α,IL-1 β,and IL-6).Biochemical method was employed to detect the contents of GSH-Px,T-SOD and MDA.Liquid chromatograph mass spectrometer(LC-MS)metabolomics was used to analyze the changes of serum metabolic profile.Results Water extract of Re-hmannia significantly increased the survival rate,oxy-gen saturation and lung function of mice with pulmona-ry fibrosis,reduced the lung coefficient,ameliorated pathological damage and collagen deposition in lung tissue,reduced the levels of apoptosis and oxidative stress,and down-regulated the levels of inflammatory factors in lung tissue.It regulated the levels of metabo-lites such as bile acid metabolism,sphingolipid metabo-lism,and unsaturated fatty acid metabolism.Conclu-sions Water extract of Rehmannia inhibits lung injury and collagen deposition in mice with pulmonary fibrosis by inhibiting inflammatory response,which may be a-chieved by regulating the levels of inflammatory factors through the metabolic pathways of bile acid and sphin-golipid.
4.In vivo effects of albendazole-glucan particles in the treatment of secondary Echinococcus metacestode infections in mice
Hai-shan YANG ; Sheng-xue LI ; Hai-xia ZHANG ; Hong-chang ZHAO ; Tong-chuan XING ; Xi-chen WU ; Xiang ZHANG ; Yan LIU
Chinese Journal of Zoonoses 2025;41(1):15-22
Albendazole-glucan particles(ABZ-GPS)and abendazole(ABZ)were used to treat secondary alveolar echinococ-cosis in mice.The therapeutic effects of ABZ-GPS on alveolar echinococcosis in vivo were evaluated,and the feasibility of using glucan particles as anti-hydatid drug carriers was further verified.Mice with echinococcosis were randomly divided into an ABZ group,glucan nanoparticle(GP)group,ABZ-GPS group,and control group.After four courses of administration with a final concentration of 50 mg/mL,the therapeutic effects of ABZ-GPS were evaluated on the basis of imaging,histopathological changes,ultrastructure,and immunology.After ABZ-GPS and ABZ administration,clear liver lesion tissue necrosis and large numbers of infiltrating lymphocytes were observed.Significant differences in the average cyst wet weight(t=7.83,P<0.05),were observed between the ABZ-GPS group and ABZ group.Imaging revealed that ABZ-GPs were targeted to liver tissue.Pa-thology and ultrastructure analyses demonstrated that the alveolar hydatid cells in the liver in the control group and GP group grew well,and the vesicles were large,filled with cystic fluid,and translucent or transparent;the cyst wall tension was high;no calcification was observed;the stratum corneum and germinal layer were clear;and more fertile capsules and different num-bers of protocephalospora were present in the liver.In the ABZ group,the capsular cavity collapsed,and showed partial necro-sis and lymphocyte infiltration.In the ABZ-GP group,the corneum and germinal layer of echinococcus vesicles were difficult to identify,and we observed bulbous necrosis,central calcification,fibrous tissue hyperplasia,inflammatory cell infiltration,coarser,shorter or absent microvilli of the germinal layer,nuclear shrinkage,dissolution or disappearance,clear expansion of cytoplasmic microtubules,and myelin-like or vacuole-like changes.Therefore,ABZ-GPs showed good targeting and killing ac-tivity in vivo in mice with secondary alveolar coccosis.
5.The clinical outcomes analysis of drug-coated balloon de novo coronary lesions left with untreated dissection
Zhi-yuan CHENG ; Wen-rui MA ; Zi-lei PAN ; Chang-sheng NAI ; Shang CHANG ; Li LIANG ; Yao-jun ZHANG ; Qian LI
Chinese Journal of Interventional Cardiology 2025;33(10):568-573
Objective To investigate the clinical prognosis of untreated residual coronary artery dissection treated with drug coated balloon(DCB).Methods A retrospective analysis was conducted on the clinical and imaging data of patients with primary coronary artery lesions(2.5-4.0 mm)treated with DCB under angiography guidance at Xuzhou Cancer Hospital,Xuzhou New Health Geriatric Hospital,and Peixian Guotai Hospital from September 2017 to April 2023.According to the observation of coronary artery dissection through angiography,the patients were divided into a dissection group and a non dissection group.The main endpoint of this study was the major adverse cardiovascular event(MACE)during a 12-month follow-up.Results A total of 381 patients were enrolled in the three research centers,with 30 cases(30 lesions)in the dissection group and 351 cases(367 lesions)in the non dissection group.There was no significant difference between the two groups in terms of age,gender,hypertension,hyperlipidemia,diabetes,smoking,previous myocardial infarction,previous percutaneous coronary intervention,coronary artery bypass grafting and other baseline clinical characteristics(all P>0.05).Except for the reference vessel diameter(P=0.049)and DCB pressure(P=0.032),there was no statistically significant difference in the characteristics of coronary angiography lesions between the two groups of patients(both P>0.05).During a 12-month follow-up,there was no statistically significant difference(P>0.05)in the incidence of MACE between the dissection group and the non dissection group after DCB treatment for primary coronary artery lesions in situ.Conclusions Untreated residual dissection after DCB treatment of de novo coronary lesions does not lead to an increase in clinical MACE.
6.Bioequivalence of rivaroxabanpian in healthy Chinese subjects
Xu ZHU ; Xiao-ni WANG ; Chang LU ; Ran ZHANG ; Ning CHEN ; Jin-mei ZHOU ; Feng ZHANG ; Wen ZHANG ; Sheng-long ZHAO ; Shun-wang HUANG ; Huan ZHOU
Chinese Pharmacological Bulletin 2025;41(11):2194-2199
Aim To evaluate the bioequivalence of two oral preparations of rivaroxaban tablets(test preparation T and refe-rence preparation R)in fasting/postprandibular state in healthy Chinese subjects.Methods A randomized,open,single-dose,four-cycle,completely repeated crossover experiment was used in this study.A total of 70 healthy male and female subjects were enrolled,including 38 subjects in the fasting group and 32 sub-jects in the postprandial group.Rivaroxaban tablets(2.5 mg/tablet)were taken orally once per cycle and their reference preparations were tested.The plasma rivaroxaban concentration was determined by LC-MS/MS method.The pharmacokinetic parameters of rivaroxaban tablets were calculated by WinNonlin software,and the parameters were analyzed and processed.Re-sults The PK parameters of rivaroxaban tablets and reference preparations in fasting group were as follows:Cmax was(72.48±17.08)and(66.36±15.64)μg·L-1,respectively.AUC0-t were(383.49±101.06)and(370.43±102.16)h·ng·mL-1,and AUC0-inr were(389.58±102.28)and(375.84±103.01)h·μg·L-,respectively.Main PK parameters of subjects taking rivaroxaban tablets orally after meals:Cmax were(66.48±15.64 and 60.87±13.44)μg·L-1,AUC0-t were(404.44±72.58)and(381.80±79.93)h·μg·L-1,re-spectively.AUC0_inf was(410.88±73.55)and(393.64±69.71)h·μg·L-1,respectively.Under fasting and postmeal conditions,subjects took rivaroxaban test and reference prepara-tion orally,one tablet(2.5 mg/tablet)each time.The geometric mean of the main pharmacokinetic parameters of rivaroxaban in plasma(Cmax,AUC0-t,AUC0-inf)and their corresponding values had a 90%confidence interval ranging from 80.00%to 125.00%.No serious adverse events or unexpected adverse e-vents occurred in both groups.Conclusion Rivaroxaban tablets are bioequivalent and safe in vivo under fasting and postprandial conditions.
7.In vivo effects of albendazole-glucan particles in the treatment of secondary Echinococcus metacestode infections in mice
Hai-shan YANG ; Sheng-xue LI ; Hai-xia ZHANG ; Hong-chang ZHAO ; Tong-chuan XING ; Xi-chen WU ; Xiang ZHANG ; Yan LIU
Chinese Journal of Zoonoses 2025;41(1):15-22
Albendazole-glucan particles(ABZ-GPS)and abendazole(ABZ)were used to treat secondary alveolar echinococ-cosis in mice.The therapeutic effects of ABZ-GPS on alveolar echinococcosis in vivo were evaluated,and the feasibility of using glucan particles as anti-hydatid drug carriers was further verified.Mice with echinococcosis were randomly divided into an ABZ group,glucan nanoparticle(GP)group,ABZ-GPS group,and control group.After four courses of administration with a final concentration of 50 mg/mL,the therapeutic effects of ABZ-GPS were evaluated on the basis of imaging,histopathological changes,ultrastructure,and immunology.After ABZ-GPS and ABZ administration,clear liver lesion tissue necrosis and large numbers of infiltrating lymphocytes were observed.Significant differences in the average cyst wet weight(t=7.83,P<0.05),were observed between the ABZ-GPS group and ABZ group.Imaging revealed that ABZ-GPs were targeted to liver tissue.Pa-thology and ultrastructure analyses demonstrated that the alveolar hydatid cells in the liver in the control group and GP group grew well,and the vesicles were large,filled with cystic fluid,and translucent or transparent;the cyst wall tension was high;no calcification was observed;the stratum corneum and germinal layer were clear;and more fertile capsules and different num-bers of protocephalospora were present in the liver.In the ABZ group,the capsular cavity collapsed,and showed partial necro-sis and lymphocyte infiltration.In the ABZ-GP group,the corneum and germinal layer of echinococcus vesicles were difficult to identify,and we observed bulbous necrosis,central calcification,fibrous tissue hyperplasia,inflammatory cell infiltration,coarser,shorter or absent microvilli of the germinal layer,nuclear shrinkage,dissolution or disappearance,clear expansion of cytoplasmic microtubules,and myelin-like or vacuole-like changes.Therefore,ABZ-GPs showed good targeting and killing ac-tivity in vivo in mice with secondary alveolar coccosis.
8.Water extract of Rehmannia glutinosa improves bleomycin-induced pulmonary fibrosis in mice and its metabolic mechanism
Zi-yu ZHANG ; Meng-nan ZENG ; Peng-li GUO ; Yu-han ZHANG ; Xiang-da LI ; Yan-xing WU ; Shuang-ying FU ; Zi-chang LIAN ; Wei-sheng FENG ; Xiao-ke ZHENG
Chinese Pharmacological Bulletin 2025;41(12):2315-2325
Aim To investigate the intervention effect of Rehmannia radix water extract on bleomycin(BLM)-induced pulmonary fibrosis in mice combined with metabolomics and to reveal the potential mechanism,in order to provide new ideas for clinical treatment of pul-monary fibrosis.Methods Male C57BL/6N mice were randomly divided into the control group,model group,pirfenidone group(positive control,PFD,270 mg·kg-1),and low dose(DH-L,4.55 g·kg-1)group,medium dose(DH-M,9.1 g·kg-1)group and high dose(DH-H,18.2 g·kg-1)group of Rehman-nia.Except for the control group,BLM(5 mg·kg-1)was instilled into the trachea to establish the model of pulmonary fibrosis in the other groups.The survival rate,lung index and blood oxygen saturation of mice in each group were evaluated.HE and Masson staining were used to observe the pathological changes of lung tissue.WBP was used to detect lung function.Flow cytometry was used to detect the apoptosis of primary lung cells,ROS and immune cells.ELISA was used to detect the levels of fibrosis markers and inflammatory factors(α-SMA,collagen Ⅰ,collagen Ⅲ,TGF-β1,TNF-α,IL-1 β,and IL-6).Biochemical method was employed to detect the contents of GSH-Px,T-SOD and MDA.Liquid chromatograph mass spectrometer(LC-MS)metabolomics was used to analyze the changes of serum metabolic profile.Results Water extract of Re-hmannia significantly increased the survival rate,oxy-gen saturation and lung function of mice with pulmona-ry fibrosis,reduced the lung coefficient,ameliorated pathological damage and collagen deposition in lung tissue,reduced the levels of apoptosis and oxidative stress,and down-regulated the levels of inflammatory factors in lung tissue.It regulated the levels of metabo-lites such as bile acid metabolism,sphingolipid metabo-lism,and unsaturated fatty acid metabolism.Conclu-sions Water extract of Rehmannia inhibits lung injury and collagen deposition in mice with pulmonary fibrosis by inhibiting inflammatory response,which may be a-chieved by regulating the levels of inflammatory factors through the metabolic pathways of bile acid and sphin-golipid.
9.Serotyping and drug resistance analysis of Salmonella from waterfowl in the Guangdong Region,2013-2023
Wan-jia LI ; Yin-sheng LIN ; Min-fang LIU ; Wen-chang XUE ; Wan-jun ZHU ; Ji-dang CHEN ; Ji-pei ZHANG
Chinese Journal of Zoonoses 2025;41(3):297-303
This study was aimed at understanding the prevalence and drug resistance status of Salmonella of waterfowl ori-gin in the Guangdong region in the past decade,to guide prevention and control efforts.The drug-sensitive paper slide method was used to conduct drug susceptibility testing on 314 waterfowl-originating Salmonella strains isolated from 238 waterfowl farms in the Guangdong region from 2013 to 2023.The isolated Salmonella strains were most resistant to penicillin,amoxicil-lin,cefradine,and cefazolin in the β-lactam group;sulphadoxine dimethylpyrimidine in the sulphonamide group;and tetracy-cline in the tetracycline group.The resistance rates ranged from 73.57%to 89.49%.The highest sensitivity was observed to amikacin,gentamicin,and kanamycin in the aminoglycoside group,and norfloxacin in the quinolone group,with susceptibility rates all exceeding 50%.The 280 strains of Salmonella showed multi-drug resistance to six classes of antimicrobial drugs and high resistance(as much as 60.83%)to five drug classes.Correlation analysis revealed the highest correlations for florfenicol with gentamicin,and for amoxicillin with penicillin(r=0.650 for both),followed by gentamicin with kanamycin(r=0.620).Salmonella resistance in waterfowl in Guangdong Province was generally severe and showed a complex pattern of drug resist-ance.Detection of waterfowl pathogens should be strengthened to prevent the spread of drug-resistant bacteria and support ra-tional use of antibiotics.This work provides a reference for Salmonella prevention and control in waterfowl farms.
10.Clinical observation of sulodexide in the treatment of proteinuria after renal transplantation
Linrui DAI ; Zhiyu ZOU ; Song CHEN ; Gang CHEN ; Weijie ZHANG ; Sheng CHANG
Chinese Journal of Organ Transplantation 2025;46(9):650-657
Objective:To evaluate the clinical efficacy and safety of sulodexide soft capsules in treating proteinuria after renal transplantation, as well as its impact on graft function.Methods:The clinical data from 80 recipients who developed proteinuria after renal transplantation and were treated with sulodexide soft capsules during regular follow-up at the outpatient department of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from March 1, 2019, to March 1, 2023, were retrospectively analyzed. Proteinuria levels, graft function, safety-related indicators (coagulation function), and adverse events were compared before treatment and at 1, 2, 3, 6, and 12 months after treatment. Based on efficacy, recipients were divided into a satisfactory efficacy group (67 cases) and a general efficacy group (13 cases). Univariate and multivariate logistic regression analyses were conducted to stratify baseline data and explore factors influencing efficacy.Results:Among the 80 recipients, 63 (78.75%) had mild proteinuria and 17 (21.25%) had moderate proteinuria. The overall treatment response rate was 91.25% (73/80). Drug-related adverse events occurred in 12 patients (15.0%). Median urinary protein excretion at 1, 2, 3, 6, and 12 months post-treatment was 0.35 (0.20, 0.55) g/24 h, 0.30 (0.17, 0.44) g/24 h, 0.23 (0.15, 0.39) g/24 h, 0.21 (0.13, 0.32) g/24 h, and 0.15 (0.10, 0.23) g/24 h, respectively, all significantly lower than the pre-treatment level of 0.52 (0.43, 0.90) g/24 h (all P<0.001). The median urinary albumin-to-creatinine ratios at the corresponding time points were 99.15 (45.33, 201.13) μg/mg, 77.20 (43.30, 176.20) μg/mg, 57.50 (31.35, 173.75) μg/mg, 53.55 (25.90, 142.00) μg/mg, and 39.05 (20.53, 103.60) μg/mg, also significantly reduced compared to the pre-treatment value of 152.05 (71.90, 271.23) μg/mg ( P=0.012, P=0.003, P<0.001, P<0.001, P<0.001, respectively). At 12 months post-treatment, the serum creatinine level (132.86±36.86 μmol/L) showed a statistically significant improvement compared to the pre-treatment level (146.60±48.42 μmol/L) ( P=0.045). Univariate analysis indicated that satisfactory efficacy was associated with the time of proteinuria onset post-transplantation, the interval between proteinuria onset and treatment initiation, and recipient age ( HR= 1.001, 95% CI: 1.001-1.020, P=0.043; HR = 1.034, 95% CI: 1.009-1.058, P=0.006; HR=1.058, 95% CI: 1.003-1.116, P=0.040). Stratified univariate analysis revealed that proteinuria onset within 2 years post-transplantation, treatment initiation within 2 years of proteinuria onset, and age younger than 45 years were significantly associated with satisfactory efficacy ( HR=5.524, 95% CI: 1.510-20.207, P=0.010; HR= 7.800, 95% CI: 2.104-28.920, P=0.002; HR=5.972, 95% CI: 1.497-23.822, P=0.011). Multivariate analysis identified the interval between proteinuria onset and treatment initiation as an independent factor influencing satisfactory efficacy ( HR=1.025, 95% CI: 1.010-1.093, P=0.015). Conclusions:Sulodexide effectively reduces proteinuria after renal transplantation, particularly in mild-to-moderate or early-onset cases, while maintaining stable allograft function without significant adverse effects

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