1.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.
2.A study on enhancing the ability of faculty in the department of radiology in teaching radiological image interpretation during residency training using a "sandwich" feedback method based on the PDCA cycle
Qiafeng CHEN ; Yubin XIAO ; Danmiao SUN ; Huanpeng WANG ; Lipeng HUANG ; Weisong CHEN ; Wei MEI ; Ruibin HUANG
Chinese Journal of Medical Education Research 2025;24(11):1546-1553
Objective:To explore the value of the "sandwich" feedback method based on the PDCA (plan, do, check, action) cycle in improving the ability of faculty in the department of radiology in teaching clinical radiological image interpretation during standardized residency training.Methods:The study involved six faculty members engaged in standardized residency training in the department of radiology from January 2023 to January 2024. The "sandwich" feedback method based on PDCA cycle was adopted to improve their ability in teaching clinical radiological image interpretation quarterly. The teaching ability was evaluated by residents and peer faculty members. A survey on teaching satisfaction was carried out.Results:Comparison of the teaching ability between PDCA cycles demonstrated a progressive increase in scores as rated by both residents and peer faculty members (scores from quarter 1 to quarter 4 were (77.00±2.53)/(80.33±3.26), (79.16±2.04)/(82.83±2.86), (81.83±1.17)/(85.16±1.17), (83.00±1.41)/(86.00±1.41). ANOVA of repeated measures indicated that quarter had a significant impact on both peer faculty member and resident evaluations ( P<0.001), and the results remained significant after Greenhouse-Geisser correction (G-G) and Huynh-Feldt correction (H-F). Moreover, a steady increase was observed in the scores of common deficiencies. The questionnaire survey showed that 88.88% (24/27) of the faculty members were "satisfied" or "very satisfied" with the feedback model. There were no significant differences in the scores of teaching feedback is necessary and aids in standardized teaching activities, creating an atmosphere before feedback is essential and effective "sandwich" feedback is helpful in improving the ability of faculty in teaching radiological image interpretation, and "sandwich" feedback can promote teaching reflection among faculty" between resident and peer faculty member evaluations ( P>0.05). Conclusions:The "sandwich" feedback method based on the PDCA cycle can effectively improve the ability of faculty in teaching clinical radiological image interpretation in the department of radiology and provide new ideas for achieving teaching homogeneity.
3.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.
4.A study on enhancing the ability of faculty in the department of radiology in teaching radiological image interpretation during residency training using a "sandwich" feedback method based on the PDCA cycle
Qiafeng CHEN ; Yubin XIAO ; Danmiao SUN ; Huanpeng WANG ; Lipeng HUANG ; Weisong CHEN ; Wei MEI ; Ruibin HUANG
Chinese Journal of Medical Education Research 2025;24(11):1546-1553
Objective:To explore the value of the "sandwich" feedback method based on the PDCA (plan, do, check, action) cycle in improving the ability of faculty in the department of radiology in teaching clinical radiological image interpretation during standardized residency training.Methods:The study involved six faculty members engaged in standardized residency training in the department of radiology from January 2023 to January 2024. The "sandwich" feedback method based on PDCA cycle was adopted to improve their ability in teaching clinical radiological image interpretation quarterly. The teaching ability was evaluated by residents and peer faculty members. A survey on teaching satisfaction was carried out.Results:Comparison of the teaching ability between PDCA cycles demonstrated a progressive increase in scores as rated by both residents and peer faculty members (scores from quarter 1 to quarter 4 were (77.00±2.53)/(80.33±3.26), (79.16±2.04)/(82.83±2.86), (81.83±1.17)/(85.16±1.17), (83.00±1.41)/(86.00±1.41). ANOVA of repeated measures indicated that quarter had a significant impact on both peer faculty member and resident evaluations ( P<0.001), and the results remained significant after Greenhouse-Geisser correction (G-G) and Huynh-Feldt correction (H-F). Moreover, a steady increase was observed in the scores of common deficiencies. The questionnaire survey showed that 88.88% (24/27) of the faculty members were "satisfied" or "very satisfied" with the feedback model. There were no significant differences in the scores of teaching feedback is necessary and aids in standardized teaching activities, creating an atmosphere before feedback is essential and effective "sandwich" feedback is helpful in improving the ability of faculty in teaching radiological image interpretation, and "sandwich" feedback can promote teaching reflection among faculty" between resident and peer faculty member evaluations ( P>0.05). Conclusions:The "sandwich" feedback method based on the PDCA cycle can effectively improve the ability of faculty in teaching clinical radiological image interpretation in the department of radiology and provide new ideas for achieving teaching homogeneity.
5.Design and application of foot pad for arch support after plantar skin extraction
Xiao-sheng JIANG ; Hai-ying CHEN ; Ping-dong LIN ; Shu-run HUANG ; Mei-ping ZHUANG ; Ting-ting WANG
Chinese Medical Equipment Journal 2025;46(3):115-117
Objective To develop a foot pad for arch support after plantar skin grafting and evaluate its rehabilitation effect on scar tissue in the arch area of postoperative patients.Methods The foot pad for arch support after plantar skin grafting was fabricated from medical-grade silicone and comprised a pad body and an arch support component.The pad body featured shock-absorbing convex patterns on its surface,precision-cut grooves in the metatarsal region and an upwardly convex arch section;the arch support component consisted of an arch-supporting portion with heel reinforcement and a heel-supporting portion,both peripherally integrated with vibration-damping through-holes.Totally 82 burn patients undergoing grafting using plantar skin were selected and divided equally into a control group and an experimental group with the random number table method.In the control group,anti-scarring care such as applying silicone gel and pressure therapy by rehabilitation nurses was carried out immediately after the healing of the plantar skin removal site.In the experimental group,the foot pad was used for rehabilitation care besides the routine treatment in the control group.The two groups were compared in terms of scarring and adverse reactions at the plantar skin removal site.SPSS 25.0 software was used for statistical analysis.Results Within 1 week after healing,the number of patients in the experimental group who had subcutaneous bruising and rupture was less than that in the control group,and the difference was statistically significant(P<0.05).At 3 months after healing,the experimental group behaved better than the control group in scarring,and the difference was statistically significant(P<0.05).Conclusion The foot pad developed with simple structure and easy operation can be used for rehabilitation exercise of patients after plantar skinning.[Chinese Medical Equipment Journal,2025,46(3):115-117]
6.The anti-heart failure mechanism of N-acetylcysteine in diabetic cardiomyopathy via ERK1/2 path-way
Jian JI ; Ya-hong HUANG ; Ying-min LU ; Dong-mei YUE ; Xiao-hui ZHENG ; Jin-chun ZHANG ; Zhao-xia WANG
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(4):543-547
Objective:To investigate the anti-heart failure mechanism of N-acetylcysteine(NAC)in diabetic cardiomyop-athy independent from coronary artery factors.Methods:A total of 40 diabetic mice after heart failure model construction were randomly divided into two groups,NAC group(n=20,NAC 100mg·kg-1·d-1)and control group(n=20,Saline 100 mg·kg-1·d-1).Echocardiography was performed to detect left ventricular end-diastolic volume(LVEDV),left ventricular end-systolic volume(LVESV),left ventricular ejection fraction(LVEF),mitral left ventricular early-dias-tolic peak flow velocity/left ventricular late-diastolic peak flow velocity(E/A),isovolumic relaxation time(IVRT)and cardiac output(CO)after 4 weeks.Terminal uridine nick-end labeling(TUNEL)was performed to detect apoptosis in-dex,and Western Blot was performed to detect the expression of extracellular regulated protein kinases(ERK)1/2 after 6 weeks in two groups.Results:Compared to those in control group,mice in NAC group had significant higher LVEF[(40.5±3.4)%vs.(36.9±3.2)%],E/A[(1.5±0.1)vs.(1.4±0.1)]and CO[(10.3±0.6)ml/min vs.(9.9±0.5)ml/min](P<0.05 or<0.01);and significant lower LVESV[(23.1±1.3)μl vs.(24.7±1.5)μl],apoptosis index[(31.2±0.5)%vs.(45.1±0.9)%]and the expression of ERK1/2[(2.2±0.2)vs.(3.9±0.1)](P<0.001 all).Conclusion:NAC exerts anti-heart failure effect by attenuating apoptosis of cardiomyocytes via regulating ERK1/2 pathway.
7.Development of A High-performance Rectangular Ion Trap for Multi-reflection Time-of-Flight Mass Spectrometer
Xiao-Xia CHEN ; Yi REN ; Qi HUANG ; Da-Jun XIANG ; Chang-Wei LI ; Yi HONG ; Lei LI ; Zheng-Xu HUANG ; Mei LI ; Jing-Wei XU ; Zhen ZHOU
Chinese Journal of Analytical Chemistry 2025;53(1):38-46
As a new generation of time-of-flight mass spectrometry,multiple-reflection time-of-flight mass spectrometry(MR-TOF-MS)has been increasingly applied in the fields such as nuclear physics,chemistry,and biology due to its ultra-high resolution and rapid analysis capabilities.However,the analytical performance of MR-TOF-MS largely depends on the ion bunch state entering the mass analyzer.In this study,a rectangular ion trap(RIT)was developed,designed and processed using printed circuit board technology,as an ion accumulating and focusing device for MR-TOF mass analyzer.Compared to traditional ion traps composed of two sets of planar electrodes,this RIT had higher voltage utilization efficiency,resulting in more efficient ion collection and focusing.The ions were cooled to a sufficiently small bunch for precise mass measurement with MR-TOF-MS mass spectrometry in only 1 ms of cooling time in the RIT,then orthogonally ejected to the MR-TOF mass spectrometer for mass analysis.Experimental results indicated that the working cycle,ion flux,and ion focusing state of the RIT fully met the requirements of the MR-TOF mass analyzer.When coupled with the MR-TOF mass analyzer,the RIT enabled MR-TOF-MS to achieve a mass resolution of 1.5×105.
8.Synthesis and Identification of Saturated Arsenic-containing Hydrocarbons
Jia-Jia CHEN ; Ying-Xiong ZHONG ; Xin-Huang KANG ; Chun-Mei DENG ; Bing-Bing SONG ; Xiao-Fei LIU ; Zhuo WANG ; Rui LI ; Jian-Ping CHEN ; Xue-Jing JIA ; Sai-Yi ZHONG
Chinese Journal of Analytical Chemistry 2025;53(3):472-480
Arsenic is a semi-metal,and lipid-soluble arsenic compounds are one of the widespread forms in the environment and food chain,but there is a lack of standards for lipid-soluble arsenic compounds,which is one of the bottlenecks in the current analytical detection and toxicological studies of organic arsenic.In this study,four saturated arsenic-containing hydrocarbons,AsHC 318,AsHC 332,AsHC 346,and AsHC 374(The number is relative molecular mass),were successfully synthesized in three steps by using dimethylarsinic acid,potassium iodide,sodium hydroxide,and four brominated alkanes(1-Bromotetradecane,1-bromopentadecane,1-bromohexadecane,and 1-bromooctadecane)as raw materials.The structures of these four saturated arsenic-containing hydrocarbons were characterized by proton nuclear magnetic resonance(1H NMR)spectroscopy,13C nuclear magnetic resonance(13C NMR)spectroscopy,and high-resolution mass spectrometry(HR-MS).The yields of the method were 8%-10%,and the synthesized compounds could be used in subsequent toxicity evaluation experiments to assess the toxic effects and mechanisms of action of arsenic-containing hydrocarbons.This study provided an effective method for synthesis of arsenic-containing hydrocarbons,enriching the synthesis methods of arsenic-containing hydrocarbons,and provided raw materials for the subsequent toxicological studies of arsenic-containing hydrocarbons.
9.Effect of endometrial thickness on obstetric and neonatal outcomes of monoparous pregnancy in fresh cleavage-embryo transfer
Li-juan SUN ; Jia-ping PAN ; Shan-shan LIANG ; Mei-yuan HUANG ; Kai-li ZHU ; Xiao-ming TENG ; Hai-xia WU
Fudan University Journal of Medical Sciences 2025;52(1):63-70
Objective To investigate the association of endometrial thickness(EMT)with obstetric and neonatal outcomes of monoparous pregnancy in fresh cleavage embryos transfer.Methods A total of 1 845 patients of monoparous pregnancy after fresh cleavage embryos transfer cycles from Jan 2016 to Mar 2022 at Shanghai First Maternity and Infant Hospital,Tongji Universtiy were analyzed retrospectively.Patients were categorized into three groups by EMT on transferation day:≤8 mm(group A),8-14 mm(group B)and≥14 mm(group C).The primary outcomes were preterm birth(PTB),birth weight and birth weight z-score,small-for-gestation age,large-for-gestation age,very low birth weight,low birth weight and macrosomia.The second outcomes were pregnancy and perinatal complications.The relationship between EMT and adverse neonatal outcomes was estimated by Logistic regression analysis.Results The rate of ectopic pregnancy was increased significantly in group A.No significant differences were found among the three groups in gestation age,birth weight,birth weight z-score,PTB,small for gestation age,large for gestation age,low birth weight,very low birth weight and macrosomia.Compared with group B,the odds of adverse neonatal outcomes did not show significant differences before and after adjustment in both group A and group C by Logistic regression analysis.Conclusion Thinner EMT in fresh cleavage embryos transfer is associated with higher rate of ectopic pregnancy,while it is not independently associated with adverse perinatal outcomes.
10.Effect of endometrial thickness on obstetric and neonatal outcomes of monoparous pregnancy in fresh cleavage-embryo transfer
Li-juan SUN ; Jia-ping PAN ; Shan-shan LIANG ; Mei-yuan HUANG ; Kai-li ZHU ; Xiao-ming TENG ; Hai-xia WU
Fudan University Journal of Medical Sciences 2025;52(1):63-70
Objective To investigate the association of endometrial thickness(EMT)with obstetric and neonatal outcomes of monoparous pregnancy in fresh cleavage embryos transfer.Methods A total of 1 845 patients of monoparous pregnancy after fresh cleavage embryos transfer cycles from Jan 2016 to Mar 2022 at Shanghai First Maternity and Infant Hospital,Tongji Universtiy were analyzed retrospectively.Patients were categorized into three groups by EMT on transferation day:≤8 mm(group A),8-14 mm(group B)and≥14 mm(group C).The primary outcomes were preterm birth(PTB),birth weight and birth weight z-score,small-for-gestation age,large-for-gestation age,very low birth weight,low birth weight and macrosomia.The second outcomes were pregnancy and perinatal complications.The relationship between EMT and adverse neonatal outcomes was estimated by Logistic regression analysis.Results The rate of ectopic pregnancy was increased significantly in group A.No significant differences were found among the three groups in gestation age,birth weight,birth weight z-score,PTB,small for gestation age,large for gestation age,low birth weight,very low birth weight and macrosomia.Compared with group B,the odds of adverse neonatal outcomes did not show significant differences before and after adjustment in both group A and group C by Logistic regression analysis.Conclusion Thinner EMT in fresh cleavage embryos transfer is associated with higher rate of ectopic pregnancy,while it is not independently associated with adverse perinatal outcomes.

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