1.Bioequivalence study of dapoxetine hydrochloride tablets in Chinese healthy subjects
Gong-sheng XIAO ; Yu-hong SUN ; Na SHAN ; Yan-ni DANG ; Da-yong HUI ; Lin-lin MIAO ; Rui-xia LIU ; An-feng LOU ; Jia-hua GUO ; Feng LIU
The Chinese Journal of Clinical Pharmacology 2024;40(21):3153-3157
Objective To study the bioequivalence of generic and original dapoxetine hydrochloride tablets in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.Fasting and fed tests were performed on 36 subjects each.Single oral dose 60 mg of test and reference pre parations were taken under fasting and fed conditions,respectively.Plasma concentration of dapoxetine was determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic(PK)parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main PK parameters of the test and reference preparations of dapoxetine tablets in the fasting group were as follows:Cmax were(449.36±203.01)and(432.85±199.75)ng·mL-1;AUC0-t were(2 400.96±1 392.58)and(2 251.82±1 225.84)ng·mL-1·h;AUC0-∞ were(2 529.94±1 498.05)and(2 371.06±1 305.22)ng·mL-1·h.The main PK parameters of the test and reference preparations of dapoxetine tablets in the fed group were as follows:Cmax were(651.29±179.38)and(672.83±249.42)ng·mL-1;AUC0-t were(3 391.27±1 358.73)and(3 314.56±1 360.39)ng·mL-1·h;AUC0-∞ were(3 630.79±1 605.89)and(3 549.22±1 526.61)ng·mL-1·h.Under the fasting and fed conditions,the 90%confidence intervals of the main PK parameters of the test and reference preparations of dapoxetine tablets are 80.00%-125.00%.Conclusion Under the fasting and fed conditions,a single oral dose of generic and original dapoxetine hydrochloride tablets in Chinese healthy adult volunteers showed bioequivalence.
2.Remote Virtual Companion via Tactile Codes and Voices for The People With Visual Impairment
Song GE ; Xuan-Tuo HUANG ; Yan-Ni LIN ; Yan-Cheng LI ; Wen-Tian DONG ; Wei-Min DANG ; Jing-Jing XU ; Ming YI ; Sheng-Yong XU
Progress in Biochemistry and Biophysics 2024;51(1):158-176
ObjectiveExisting artificial vision devices can be divided into two types: implanted devices and extracorporeal devices, both of which have some disadvantages. The former requires surgical implantation, which may lead to irreversible trauma, while the latter has some defects such as relatively simple instructions, limited application scenarios and relying too much on the judgment of artificial intelligence (AI) to provide enough security. Here we propose a system that has voice interaction and can convert surrounding environment information into tactile commands on head and neck. Compared with existing extracorporeal devices, our device can provide a larger capacity of information and has advantages such as lower cost, lower risk, suitable for a variety of life and work scenarios. MethodsWith the latest remote wireless communication and chip technologies, microelectronic devices, cameras and sensors worn by the user, as well as the huge database and computing power in the cloud, the backend staff can get a full insight into the scenario, environmental parameters and status of the user remotely (for example, across the city) in real time. In the meanwhile, by comparing the cloud database and in-memory database and with the help of AI-assisted recognition and manual analysis, they can quickly develop the most reasonable action plan and send instructions to the user. In addition, the backend staff can provide humanistic care and emotional sustenance through voice dialogs. ResultsThis study originally proposes the concept of “remote virtual companion” and demonstrates the related hardware and software as well as test results. The system can not only achieve basic guide functions, for example, helping a person with visual impairment to shop in supermarkets, find seats at cafes, walk on the streets, construct complex puzzles, and play cards, but also can meet the demand for fast-paced daily tasks such as cycling. ConclusionExperimental results show that this “remote virtual companion” is applicable for various scenarios and demands. It can help blind people with their travels, shopping and entertainment, or accompany the elderlies with their trips, wilderness explorations, and travels.
3.Bioequivalence study of dapoxetine hydrochloride tablets in Chinese healthy subjects
Gong-sheng XIAO ; Yu-hong SUN ; Na SHAN ; Yan-ni DANG ; Da-yong HUI ; Lin-lin MIAO ; Rui-xia LIU ; An-feng LOU ; Jia-hua GUO ; Feng LIU
The Chinese Journal of Clinical Pharmacology 2024;40(21):3153-3157
Objective To study the bioequivalence of generic and original dapoxetine hydrochloride tablets in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.Fasting and fed tests were performed on 36 subjects each.Single oral dose 60 mg of test and reference pre parations were taken under fasting and fed conditions,respectively.Plasma concentration of dapoxetine was determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic(PK)parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main PK parameters of the test and reference preparations of dapoxetine tablets in the fasting group were as follows:Cmax were(449.36±203.01)and(432.85±199.75)ng·mL-1;AUC0-t were(2 400.96±1 392.58)and(2 251.82±1 225.84)ng·mL-1·h;AUC0-∞ were(2 529.94±1 498.05)and(2 371.06±1 305.22)ng·mL-1·h.The main PK parameters of the test and reference preparations of dapoxetine tablets in the fed group were as follows:Cmax were(651.29±179.38)and(672.83±249.42)ng·mL-1;AUC0-t were(3 391.27±1 358.73)and(3 314.56±1 360.39)ng·mL-1·h;AUC0-∞ were(3 630.79±1 605.89)and(3 549.22±1 526.61)ng·mL-1·h.Under the fasting and fed conditions,the 90%confidence intervals of the main PK parameters of the test and reference preparations of dapoxetine tablets are 80.00%-125.00%.Conclusion Under the fasting and fed conditions,a single oral dose of generic and original dapoxetine hydrochloride tablets in Chinese healthy adult volunteers showed bioequivalence.
4.Clinical treatment outcomes and their changes in extremely preterm twins: a multicenter retrospective study in Guangdong Province, China.
Bi-Jun SHI ; Ying LI ; Fan WU ; Zhou-Shan FENG ; Qi-Liang CUI ; Chuan-Zhong YANG ; Xiao-Tong YE ; Yi-Heng DAI ; Wei-Yi LIANG ; Xiu-Zhen YE ; Jing MO ; Lu DING ; Ben-Qing WU ; Hong-Xiang CHEN ; Chi-Wang LI ; Zhe ZHANG ; Xiao RONG ; Wei SHEN ; Wei-Min HUANG ; Bing-Yan YANG ; Jun-Feng LYU ; Hui-Wen HUANG ; Le-Ying HUO ; Hong-Ping RAO ; Wen-Kang YAN ; Xue-Jun REN ; Yong YANG ; Fang-Fang WANG ; Dong LIU ; Shi-Guang DIAO ; Xiao-Yan LIU ; Qiong MENG ; Yu WANG ; Bin WANG ; Li-Juan ZHANG ; Yu-Ge HUANG ; Dang AO ; Wei-Zhong LI ; Jie-Ling CHEN ; Yan-Ling CHEN ; Wei LI ; Zhi-Feng CHEN ; Yue-Qin DING ; Xiao-Yu LI ; Yue-Fang HUANG ; Ni-Yang LIN ; Yang-Fan CAI ; Sha-Sha HAN ; Ya JIN ; Guo-Sheng LIU ; Zhong-He WAN ; Yi BAN ; Bo BAI ; Guang-Hong LI ; Yue-Xiu YAN
Chinese Journal of Contemporary Pediatrics 2022;24(1):33-40
OBJECTIVES:
To investigate the clinical treatment outcomes and the changes of the outcomes over time in extremely preterm twins in Guangdong Province, China.
METHODS:
A retrospective analysis was performed for 269 pairs of extremely preterm twins with a gestational age of <28 weeks who were admitted to the department of neonatology in 26 grade A tertiary hospitals in Guangdong Province from January 2008 to December 2017. According to the admission time, they were divided into two groups: 2008-2012 and 2013-2017. Besides, each pair of twins was divided into the heavier infant and the lighter infant subgroups according to birth weight. The perinatal data of mothers and hospitalization data of neonates were collected. The survival rate of twins and the incidence rate of complications were compared between the 2008-2012 and 2013-2017 groups.
RESULTS:
Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of severe asphyxia and smaller head circumference at birth (P<0.05). The mortality rates of both of the twins, the heavier infant of the twins, and the lighter infant of the twins were lower in the 2013-2017 group compared with the 2008-2012 group (P<0.05). Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of pulmonary hemorrhage, patent ductus arteriosus (PDA), periventricular-intraventricular hemorrhage (P-IVH), and neonatal respiratory distress syndrome (NRDS) and a higher incidence rate of bronchopulmonary dysplasia (P<0.05).
CONCLUSIONS
There is a significant increase in the survival rate over time in extremely preterm twins with a gestational age of <28 weeks in the 26 grade A tertiary hospitals in Guangdong Province. The incidences of severe asphyxia, pulmonary hemorrhage, PDA, P-IVH, and NRDS decrease in both the heavier and lighter infants of the twins, but the incidence of bronchopulmonary dysplasia increases. With the improvement of diagnosis and treatment, the multidisciplinary collaboration between different fields of fetal medicine including prenatal diagnosis, obstetrics, and neonatology is needed in the future to jointly develop management strategies for twin pregnancy.
Bronchopulmonary Dysplasia/epidemiology*
;
Female
;
Gestational Age
;
Humans
;
Infant
;
Infant, Extremely Premature
;
Infant, Newborn
;
Pregnancy
;
Respiratory Distress Syndrome, Newborn/epidemiology*
;
Retrospective Studies
;
Treatment Outcome
5.Identification of gastric microbiota biomarker for gastric cancer.
Yi-Ni DANG ; Yu DONG ; Yan-Zhao MU ; Jin YAN ; Min LU ; Yong-Liang ZHU ; Guo-Xin ZHANG
Chinese Medical Journal 2020;133(22):2765-2767
6.Study on fingerprint of xiaochaihu granules sold in the market.
Lei YAN ; Long-Fei LIN ; Hui ZHANG ; Xiao-Fang DANG ; Jian NI
China Journal of Chinese Materia Medica 2013;38(20):3498-3501
To establish a fingerprint of Xiaochaihu granules sold in the market with HPLC method, and study fingerprints of Xiaochaihu granules produced by different manufacturers and in different batches of the same manufacturer. Seven major index components were identified for the first time. The established method provided an all-around analysis on the quality assessment of Xiaochaihu granules.
China
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Chromatography, High Pressure Liquid
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methods
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Drugs, Chinese Herbal
;
analysis
;
Quality Control
7.Interleukin-8 monoclonal antibody attenuates smooth muscle cell proliferation and balloon inflation-induced abdominal aorta stenosis in rabbits
Cun-Liang MENG ; Xiao-Yong QI ; Ying-Xiao LI ; Yi DANG ; Hui-Liang LIU ; Tian-Hong WANG ; Hua-Bing YUAN ; Yan-Hui NI ; Guang LIU ; Zhen-Chao WU ; Li-Hui GAO
Chinese Journal of Cardiology 2012;40(12):1056-1061
Objective To observe the effects of interleukin-8 monoclonal antibody on smooth muscle cell proliferation and balloon inflation-induced abdominal aorta stenosis in rabbits.Methods Thirtysix New Zealand white rabbits were randomly assigned to balloon inflation group (group A,n =12),intedeukin-8 monoclonal antibody pre-treated rabbits (2 mg/kg for 3 days before balloon inflation,group B,n =12) and sham-operated control group (group C,n =12).Peripheral blood was collected before experiment and at 4 h,1,3,7,14,and 28 days post balloon inflation or sham operation and the levels of IL-8 were measured by enzyme linked immunosorbent assay (ELISA).The ratio of positive and negative masculine cells in the high power microscopic field was determined in proliferating cell nuclear antigen (PCNA) stained slide.Histopathologic examination was performed in abdominal aorta and luminal area,intima and tunica media area were measured.Results Plasma interleukin-8 began to rise at 4 h and peaked at 1 day and remained increased up to 28 days after balloon inflation in rabbits of group A,plasma interleukin-8 level in group A was significantly higher than in group B and C at 4 h and thereafter post operation.The ratio of positive and negative masculine cells was significantly increased in group A compared to group C and was significantly lower in group B than in group A.Abdominal aorta stenosis,luminal area,intima and tunica media area were significantly reduced in group B than in group A.Correlation analysis indicated that there were positive relations between plasma IL-8 level and intima thickness,area of intima and tunica medias,respectively (r =0.894,0.783,0.801,0.912,all P <0.01).Conclusions Plasma IL-8 level is increased in this abdominal aorta stenosis model and is positively correlated to the severity of abdominal aorta stenosis.IL-8 monoclonal antibody could significantly reduce abdominal aorta stenosis in this abdominal aorta stenosis model.

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