1.Bioequivalence study of desloratadine tablets in healthy Chinese subjects
Peng-fei XIE ; Yuan-lu CHEN ; Hong-di CUI ; Hui LONG ; Yong-gang ZHAO ; Qi-shan HUANG ; Peng YANG ; Yan ZHOU ; Yong-dong ZHANG
The Chinese Journal of Clinical Pharmacology 2025;41(2):220-224
Objective To explore the pharmacokinetic(PK)characteristics of desloratadine tablets and reference drugs in healthy subjects,and evaluate their bioequivalence and safety.Methods The random,open,two-period,cross-over pharmacokinetic study method was adopted,each subject received a single oral dose of desloratadine tablets test drug(T)or reference drug(R)for 5 mg.The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS);and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.Results The main PK parameters of T and R of desloratadine were as follows:the fasting condition Cmax were respectively(3 809.82±1 016.54)and(3 642.36±777.07)pg·mL-1;AUC0-120h were respectively(5.75 ×104±5.03 ×104)and(5.51 × 104±4.00 × 104)pg·h·mL-1;AUC0-∞ were respectively(6.85× 104±1.03× 104)and(6.37 × 104±7.92 × 104)pg·h·mL-1.The fed condition Cmax were respectively(4 398.98±1 191.22)and(4 744.4±1 511.97)pg·mL-1;AUC0-120h were respectively(5.25 × 104±1.82 × 104)and(5.55 × 104±1.98 × 104)pg·h·mL-1;AUC0-∞ were respectively(5.37 × 104±1.86 × 104)and(5.68 × 104±2.04 × 104)pg·h·mL-1.The 90%confidence interval of Cmax,AUC0-t and AUC0-∞ of desloratadine were all within 80.00%~125.00%.Conclusion There was no significant difference in the main PK parameters between T tablets and R under fasting or high-fat postprandial conditions,and desloratadine tablets were bioequivalent,safe and well tolerated.
2.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
3.Design and realization of training device for flight crew plateau normobaric low-oxygen acclimatization
Chen WANG ; Yu-fei QIN ; Da-long GUO ; Zhen TIAN ; Ting-ting CUI ; La-mei SHANG ; Zhong-tian WANG ; Yu-bin ZHOU
Chinese Medical Equipment Journal 2025;46(8):18-24
Objective To design a training device of the flight crew for plateau normobaric low-oxygen acclimatization so as to enhance the flight crew's ability to adapt to the low oxygen environment after rushing into the plateau and reduce the incidence of acute plateau reaction.Methods The training device comprised a plateau environment simulation controller,a multimodal physiological acquisition system and hypoxia exercise training evaluation software.The plateau environment simulation controller was composed of an environment monitor for plateau acclimatization,two composite sensor sets,a control valve and an alarm device;the multimodal physiological acquisition system was made up of 20 groups of vital signs acquisi-tion devices,with a wearable dynamic ECG and respiration recorder,a wrist oximeter and an arm sphygmomano-meter included in each group.The hypoxia exercise training evaluation software was developed with a B/S architecture,Java language and JetBrains 2020.3.Results The training device proved to have the simulation altitude ranging from 0 to 6 000 m and facilitated simultaneous training of 20 persons for normobaric low-oxygen acclimatization,screening for hypoxia endurance,real-time monitoring of physiological parameters and assessment of training effect,with none of the trainees having acute plateau reaction.Conclusion The training device assists the flight crew for plateau normobaric low-oxygen acclimatization,and can be used for acclimatization training before plateau missions.[Chinese Medical Equipment Journal,2025,46(8):18-24]
4.Predictive value of CHE and sST2 for short-term death in patients with myocardial infarction and heart failure
Peng-fei ZHOU ; Fan CAO ; Cheng-long YIN
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(4):492-497
Objective:To investigate the predictive value of serum cholinesterase(CHE)and soluble growth stimula-tion gene 2 protein(sST2)for short-term death in patients with myocardial infarction and heart failure.Methods:A total of 100 patients with myocardial infarction and heart failure admitted in Nanjing Benq Hospital between March 2021 and March 2023 were screened.After 6-month follow-up,patients were grouped according to pres-ence of death.Multivariate Cox regression was used to analyze the factors associated with death during 6-month follow-up in patients with myocardial infarction and heart failure.The predictive value of CHE,sST2 and their combined detection for short-term death in patients with myocardial infarction and heart failure was analyzed by receiver operating characteristic(ROC)curve.Kaplan-Meier survival curve was used to compare short-term sur-vival rate between myocardial infarction and heart failure patients with different CHE and sST2 levels.Results:During 6-month follow-up,46 cases died.Compared to those in survival group,patients in death group had sig-nificant higher heart rate(HR)[(82.20±8.09)beats/min vs.(71.54±6.97)beats/min],mean arterial pressure(MAP)[(126.58±5.38)mmHg vs.(104.79±4.94)mmHg]and sST2[(76.48±4.82)ng/ml vs.(40.62±4.96)ng/ml],and significant lower CHE[(3.47±0.26)IU/L vs.(5.07±0.80)IU/L](P<0.001 all).Multivariate Cox regression showed that HR(HR 1.046,95%CI 1.002~1.092,P=0.040),MAP(HR 1.988,95%CI 1.298~2.455,P<0.001),and sST2(HR 1.068,95%CI 1.014~1.125,P=0.013)were independent risk factors for short-term death in patients with myocardial infarction and heart failure,while CHE was its independent protec-tive factor(HR=0.252,95%CI 0.145~0.561,P=0.023).ROC curve analysis indicated that the area under the curve(AUC)of CHE,sST2 and their combination for diagnosing short-term death in patients with myocardial in-farction and heart failure was 0.609(95%0.504~0.707),0.630(95%0.525~0.726)and 0.939(95%0.871~0.977)respectively,and the diagnostic efficacy of combined detection was significantly higher than CHE and sST2 alone(Z=5.814,5.524,P<0.001 all).Kaplan-Meier survival curve showed that the survival rate of patients with low CHE level was significantly lower than that of patients with high CHE level,and the survival rate of pa-tients with high sST2 level was significantly lower than that of patients with low sST2 level(Log-rank x2=2.415,2.354,P<0.001 all).Conclusion:CHE and sST2 were independent influencing factors for death during 6-month follow-up in patients with myocardial infarction and heart failure;their combined detection had good predictive value for short-term death in these patients.
5.Design and realization of training device for flight crew plateau normobaric low-oxygen acclimatization
Chen WANG ; Yu-fei QIN ; Da-long GUO ; Zhen TIAN ; Ting-ting CUI ; La-mei SHANG ; Zhong-tian WANG ; Yu-bin ZHOU
Chinese Medical Equipment Journal 2025;46(8):18-24
Objective To design a training device of the flight crew for plateau normobaric low-oxygen acclimatization so as to enhance the flight crew's ability to adapt to the low oxygen environment after rushing into the plateau and reduce the incidence of acute plateau reaction.Methods The training device comprised a plateau environment simulation controller,a multimodal physiological acquisition system and hypoxia exercise training evaluation software.The plateau environment simulation controller was composed of an environment monitor for plateau acclimatization,two composite sensor sets,a control valve and an alarm device;the multimodal physiological acquisition system was made up of 20 groups of vital signs acquisi-tion devices,with a wearable dynamic ECG and respiration recorder,a wrist oximeter and an arm sphygmomano-meter included in each group.The hypoxia exercise training evaluation software was developed with a B/S architecture,Java language and JetBrains 2020.3.Results The training device proved to have the simulation altitude ranging from 0 to 6 000 m and facilitated simultaneous training of 20 persons for normobaric low-oxygen acclimatization,screening for hypoxia endurance,real-time monitoring of physiological parameters and assessment of training effect,with none of the trainees having acute plateau reaction.Conclusion The training device assists the flight crew for plateau normobaric low-oxygen acclimatization,and can be used for acclimatization training before plateau missions.[Chinese Medical Equipment Journal,2025,46(8):18-24]
6.Bioequivalence study of desloratadine tablets in healthy Chinese subjects
Peng-fei XIE ; Yuan-lu CHEN ; Hong-di CUI ; Hui LONG ; Yong-gang ZHAO ; Qi-shan HUANG ; Peng YANG ; Yan ZHOU ; Yong-dong ZHANG
The Chinese Journal of Clinical Pharmacology 2025;41(2):220-224
Objective To explore the pharmacokinetic(PK)characteristics of desloratadine tablets and reference drugs in healthy subjects,and evaluate their bioequivalence and safety.Methods The random,open,two-period,cross-over pharmacokinetic study method was adopted,each subject received a single oral dose of desloratadine tablets test drug(T)or reference drug(R)for 5 mg.The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS);and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.Results The main PK parameters of T and R of desloratadine were as follows:the fasting condition Cmax were respectively(3 809.82±1 016.54)and(3 642.36±777.07)pg·mL-1;AUC0-120h were respectively(5.75 ×104±5.03 ×104)and(5.51 × 104±4.00 × 104)pg·h·mL-1;AUC0-∞ were respectively(6.85× 104±1.03× 104)and(6.37 × 104±7.92 × 104)pg·h·mL-1.The fed condition Cmax were respectively(4 398.98±1 191.22)and(4 744.4±1 511.97)pg·mL-1;AUC0-120h were respectively(5.25 × 104±1.82 × 104)and(5.55 × 104±1.98 × 104)pg·h·mL-1;AUC0-∞ were respectively(5.37 × 104±1.86 × 104)and(5.68 × 104±2.04 × 104)pg·h·mL-1.The 90%confidence interval of Cmax,AUC0-t and AUC0-∞ of desloratadine were all within 80.00%~125.00%.Conclusion There was no significant difference in the main PK parameters between T tablets and R under fasting or high-fat postprandial conditions,and desloratadine tablets were bioequivalent,safe and well tolerated.
7.Predictive value of CHE and sST2 for short-term death in patients with myocardial infarction and heart failure
Peng-fei ZHOU ; Fan CAO ; Cheng-long YIN
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(4):492-497
Objective:To investigate the predictive value of serum cholinesterase(CHE)and soluble growth stimula-tion gene 2 protein(sST2)for short-term death in patients with myocardial infarction and heart failure.Methods:A total of 100 patients with myocardial infarction and heart failure admitted in Nanjing Benq Hospital between March 2021 and March 2023 were screened.After 6-month follow-up,patients were grouped according to pres-ence of death.Multivariate Cox regression was used to analyze the factors associated with death during 6-month follow-up in patients with myocardial infarction and heart failure.The predictive value of CHE,sST2 and their combined detection for short-term death in patients with myocardial infarction and heart failure was analyzed by receiver operating characteristic(ROC)curve.Kaplan-Meier survival curve was used to compare short-term sur-vival rate between myocardial infarction and heart failure patients with different CHE and sST2 levels.Results:During 6-month follow-up,46 cases died.Compared to those in survival group,patients in death group had sig-nificant higher heart rate(HR)[(82.20±8.09)beats/min vs.(71.54±6.97)beats/min],mean arterial pressure(MAP)[(126.58±5.38)mmHg vs.(104.79±4.94)mmHg]and sST2[(76.48±4.82)ng/ml vs.(40.62±4.96)ng/ml],and significant lower CHE[(3.47±0.26)IU/L vs.(5.07±0.80)IU/L](P<0.001 all).Multivariate Cox regression showed that HR(HR 1.046,95%CI 1.002~1.092,P=0.040),MAP(HR 1.988,95%CI 1.298~2.455,P<0.001),and sST2(HR 1.068,95%CI 1.014~1.125,P=0.013)were independent risk factors for short-term death in patients with myocardial infarction and heart failure,while CHE was its independent protec-tive factor(HR=0.252,95%CI 0.145~0.561,P=0.023).ROC curve analysis indicated that the area under the curve(AUC)of CHE,sST2 and their combination for diagnosing short-term death in patients with myocardial in-farction and heart failure was 0.609(95%0.504~0.707),0.630(95%0.525~0.726)and 0.939(95%0.871~0.977)respectively,and the diagnostic efficacy of combined detection was significantly higher than CHE and sST2 alone(Z=5.814,5.524,P<0.001 all).Kaplan-Meier survival curve showed that the survival rate of patients with low CHE level was significantly lower than that of patients with high CHE level,and the survival rate of pa-tients with high sST2 level was significantly lower than that of patients with low sST2 level(Log-rank x2=2.415,2.354,P<0.001 all).Conclusion:CHE and sST2 were independent influencing factors for death during 6-month follow-up in patients with myocardial infarction and heart failure;their combined detection had good predictive value for short-term death in these patients.
8.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
9.Design of GIS-based 3D playback system for flight human-plane data
La-Mei SHANG ; Yu-Fei QIN ; Wen WANG ; Wan-Qi LI ; Da-Long GUO ; Xiao-Chao GUO ; Juan LIU ; Zhen TIAN ; Ting-Ting CUI ; Yu-Bin ZHOU
Chinese Medical Equipment Journal 2024;45(10):14-19
Objective To develop a GIS-based 3D playback system for the flight human-plane data to realize the fusion of pilots'airborne flight data and physiological data.Methods The 3D playback system was developed with the Browser/Server(B/S)architecture,micro-server model,Java language and Spring Cloud technology framework,which was composed of three functional modules for flight process reproduction,physiological situational awareness and critical event calibration analysis.Results The system developed achieved time synchronization and data fusion of airborne flight data and physiological data with a time synchronization frequency of 1 Hz and a refresh rate of not less than 120 frames/s.Conclusion The system developed with high safety,stability,reliability and accuracy facilitates pilot in-flight physiological monitoring and fusion and simultaneous display of airborne flight data and physiological data,which can be used as an important platform for decision-making support in flight training.[Chinese Medical Equipment Journal,2024,45(10):14-19]
10.Efficacy and Safety of Thermal Ablation for Solitary Low-Risk T2N0M0 Papillary Thyroid Carcinoma
Yu-Lin FEI ; Ying WEI ; Zhen-Long ZHAO ; Li-Li PENG ; Yan LI ; Shi-Liang CAO ; Jie WU ; Hui-Di ZHOU ; Ming-An YU
Korean Journal of Radiology 2024;25(8):756-766
Objective:
To evaluate the efficacy and safety of thermal ablation in treating solitary low-risk T2N0M0 papillary thyroid cancer (PTC) and compare the outcomes of microwave ablation (MWA) and radiofrequency ablation (RFA).
Materials and Methods:
This retrospective, single center study involved 34 patients (age: 40.0 ± 13.9 years; 28 female) who had low-risk T2N0M0 PTC with a maximum diameter >2 cm and ≤4 cm and underwent MWA (n = 15) or RFA (n = 19) from November 2016 to April 2023. The primary outcomes were the cumulative rate of disease progression and delayed surgery rates.In contrast, the secondary outcomes included changes in tumor size, cumulative rate of complete tumor disappearance, and complication rates.
Results:
The median follow-up period was 18.0 months (interquartile range [IQR]: 9.0–40.0 months). At 12 months, the median volume reduction rate of the ablation zone was 74.2% (IQR: 53.7%–86.0%). Disease progression was noted in two patients within 1 year, including one patient with local tumor progression post-RFA and one with a new tumor post-MWA, resulting in a constant cumulative disease progression rate of 8.8% (95% confidence interval [CI]: 0%–19.8%) throughout the remaining follow-up period. Both patients were subsequently treated with additional ablation and did not require surgery. The cumulative rates of complete tumor disappearance at 1, 3, and 5 years were 4.0% (95% CI: 0%–11.4%), 26.8% (95% CI: 2.7%– 44.9%), and 51.2% (95% CI: 0%–79.1%), respectively. No significant differences were observed in the disease progression (P = 0.829) or complete tumor disappearance (P = 0.633) rates between the MWA and RFA groups. Complications occurred in 14.7% (5/34) of patients presenting with transient hoarseness. RFA had a higher but not statistically significant complication rate than MWA did (21.1% [4/19] vs. 6.7% [1/15]; P = 0.355).
Conclusion
Both MWA and RFA demonstrated promising short-term outcomes in terms of efficacy and safety in treating solitary low-risk T2N0M0 PTC, with no significant differences.

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