1.Bioequivalence study of etoricoxib tablets in healthy Chinese subjects
Zhen-Zhen JIAO ; Li XU ; Man LIU ; Tian-Ze HU ; Dan SONG ; Xiao-Juan WANG ; Zhi-Jing ZHAO ; Hui-Chen LIU
The Chinese Journal of Clinical Pharmacology 2024;40(5):718-722
Objective To study the pharmacokinetic characteristics of etoricoxib tablets in healthy Chinese subjects and to evaluate the bioequivalence and safety of the test and reference formulations.Methods In a randomised,single-dose,two-period,two-sequence crossover trial,28 healthy subjects were enrolled under the fasting and fed conditions,respectively,who received a single oral dose of 60 mg of etoricoxib tablets in the test or reference formulation.The concentration of etoricoxib in plasma was detected by LC-MS/MS,and the main pharmacokinetic parameters were calculated to evaluate bioequivalence and using WinNonlin 8.2 software.Results The main pharmacokinetic parameters of the test and reference preparations were as follows:The fasting condition Cmax of etoricoxib were(1 176.96±287.95)and(1 164.93±189.65)ng·mL-1;AUC0-t were(18 651.95±6 100.27)and(19 241.39±6 107.48)ng·h·mL-1;and AUC0-∞ were(19 939.15±7 553.27)and(20 536.31±7 223.40)ng·h·mL-1.The fed condition Cmax of etoricoxib were(913.50±184.72)and(878.59±164.35)ng·mL-1;and AUC0-t were(19 085.22±5 155.01)and(18 669.54±4 508.21)ng·h·mL-1;AUC0-∞ were(20 103.77±5 567.02)and(19 528.05±4 989.74)ng·h·mL-1.The 90%confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters in the fasting and fed conditions fell between 80.00%and 125.00%.The incidence of adverse events in the fasting and fed conditions were 28.57%and 21.43%,respectively.Conclusion Two kinds of etoricoxib tablets are bioequivalent,and have similar safety in healthy Chinese subjects.
2.Based on LC-MS technology explored the metabolomics of Agrimonia pilosa intervening in non-small cell lung cancer A549 cells
Ze-hua TONG ; Wen-jun GUO ; Han-rui ZOU ; Li-wei XU ; Ya-juan XU ; Wei-fang WANG
Acta Pharmaceutica Sinica 2024;59(3):704-712
The objective of this study was to analyze the effects on cell viability, apoptosis, and cell cycle of non-small cell lung cancer (NSCLC) A549 cells after intervention with
3.Infections and epidemiological characteristics of viral myocarditis in Wuxi Region
Ze XU ; Ting LI ; Wenting CAO
Journal of Public Health and Preventive Medicine 2024;35(3):107-110
Objective To analyze the epidemic situation and pathological characteristics of viral myocarditis in Wuxi region, laying the foundation for epidemiological research on viral myocarditis. Method A total of 8 000 patients with viral myocarditis from 2013 to 2022 were included. The basic data and infection status of patients diagnosed with viral myocarditis within 10 years were statistically analyzed, and the serum of the patients was tested for Coxsackie B virus nucleic acid. Results Viral myocarditis is mainly caused by Coxsackie B virus infection, with a confirmed positive rate of 69.24%. The main types of infected viruses are B3 and B4, with 29.31% and 33.87%, respectively. The infection of viral myocarditis varies with age, and the positive rate in children is higher at 69.29%, with statistical differences among different age groups(χ2=1210.344 , P<0.001). The infection rate of Coxsackie B virus was 38.21% in males and 31.03% in females, with a statistically significant difference(χ2=155.032 , P<0.001). Conclusion In the past 10 years, the infection rate of suspected viral myocarditis in children in Wuxi region has been higher than that in adults, and the incidence of COVID-19 B group virus infection is higher in men, with B3 and B4 being the main cases. It is necessary to increase prevention efforts in children and young men.
4.A Case Report of Multidisciplinary Diagnosis and Treatment of a Patient with Tuberous Sclerosis Complex and Multi-Organ Involvement
Hua ZHENG ; Yunfei ZHI ; Lujing YING ; Lan ZHU ; Mingliang JI ; Ze LIANG ; Jiangshan WANG ; Haifeng SHI ; Weihong ZHANG ; Mengsu XIAO ; Yushi ZHANG ; Kaifeng XU ; Zhaohui LU ; Yaping LIU ; Ruiyi XU ; Huijuan ZHU ; Li WEN ; Yan ZHANG ; Gang CHEN ; Limeng CHEN
JOURNAL OF RARE DISEASES 2024;3(1):79-86
Tuberous sclerosis complex(TSC)is a rare genetic disease that can lead to benign dysplasia in multiple organs such as the skin, brain, eyes, oral cavity, heart, lungs, kidneys, liver, and bones. Its main symptoms include epilepsy, intellectual disabilities, skin depigmentation, and facial angiofibromas, whilst incidence is approximately 1 in 10 000 to 1 in 6000 newborns. This case presents a middle-aged woman who initially manifested with epilepsy and nodular depigmentation. Later, she developed a lower abdominal mass, elevated creatinine, and severe anemia. Based on clinical features and whole exome sequencing, the primary diagnosis was confirmed as TSC. Laboratory and imaging examinations revealed that the lower abdominal mass originated from the uterus. CT-guided biopsy pathology and surgical pathology suggested a combination of leiomyoma and abscess. With the involvement of multiple organs and various complications beyond the main diagnosis, the diagnostic and therapeutic process for this patient highlights the importance of rigorous clinical thinking and multidisciplinary collaboration in the diagnosis and treatment of rare and challenging diseases.
5.Variation rules of main secondary metabolites in Hedysari Radix before and after rubbing strip
Xu-Dong LUO ; Xin-Rong LI ; Cheng-Yi LI ; Peng QI ; Ting-Ting LIANG ; Shu-Bin LIU ; Zheng-Ze QIANG ; Jun-Gang HE ; Xu LI ; Xiao-Cheng WEI ; Xiao-Li FENG ; Ming-Wei WANG
Chinese Traditional Patent Medicine 2024;46(3):747-754
AIM To investigate the variation rules of main secondary metabolites in Hedysari Radix before and after rubbing strip.METHODS UPLC-MS/MS was adopted in the content determination of formononetin,ononin,calycosin,calycosin-7-glucoside,medicarpin,genistein,luteolin,liquiritigenin,isoliquiritigenin,vanillic acid,ferulic acid,γ-aminobutyric acid,adenosine and betaine,after which cluster analysis,principal component analysis and orthogonal partial least squares discriminant analysis were used for chemical pattern recognition to explore differential components.RESULTS After rubbing strip,formononetin,calycosin,liquiritigenin and γ-aminobutynic acid demonstrated increased contents,along with decreased contents of ononin,calycosin-7-glucoside and vanillic acid.The samples with and without rubbing strip were clustered into two types,calycosin-7-glucoside,formononetin,γ-aminobutynic acid,vanillic acid,calycosin-7-glucoside and formononetin were differential components.CONCLUSION This experiment clarifies the differences of chemical constituents in Hedysari Radix before and after rubbing strip,which can provide a reference for the research on rubbing strip mechanism of other medicinal materials.
6.Quantitative Evaluation of Latent Fingerprints Developed by Fluorescent Methods Based on Python
Zhuo-Hong YU ; Zhi-Ze XU ; Meng WANG ; Wen-Zhuo FAN ; Jie LI ; Ming LI ; Chuan-Jun YUAN
Chinese Journal of Analytical Chemistry 2024;52(7):964-974,中插1-中插12
A serious of rare earth luminescent micro/nano-materials with various properties were synthesized via chemical method for fluorescent development of latent fingerprints(LFPs).Three evaluation indexes namely contrast,sensitivity and selectivity were introduced to evaluate the effects of LFP development.Quantitative formulas for calculating the contrast,sensitivity and selectivity were further put forward,and a quality evaluation system based on Python was thus established.In addition,the objective evaluation value was finally confirmed to be consistent with the subjective visual judgment.The reproducibility of this evaluation method was finally confirmed.The effects of luminescence intensity and color of developing materials on the contrast,particle size of developing materials on the sensitivity,and micromorphology and surface property of developing materials on the selectivity were discussed in detail.Five effective ways were also proposed to promote the quality of LFP development,such as increasing the luminescence intensity,tuning the luminescence color,decreasing the particle size,adjusting the micromorphology,and modifying the surface property.This quality evaluation system based on Python could evaluate the effects of LFP development objectively,accurately and comprehensively,exhibiting easy operability,high efficiency,sensitive response,accurate and reliable results,and wide applicability,which would provide beneficial references for the reasonable selection of LFP development methods as well as objective evaluation of evidence value.
7.Study on fatigue vibration evaluation of ultrasonic knife tip based on Q factor
Ke-Sheng WANG ; Ze-Kai LI ; Pei LIU ; Jing-Sheng SUN ; Xu-Guang PENG ; Shuang-Shuang LI ; Qian-Hong HE ; Zhen LIU
Chinese Medical Equipment Journal 2024;45(6):17-22
Objective To propose a Q factor-based fatigue vibration evaluation method of the ultrasonic knife tip.Methods Firstly,an ultrasonic cutter fatigue testing table was established to realize repeated cutting,which was composed of a power supply module,a three-axis moving module,an ultrasonic cutter clamping module and a control module.Secondly,10 ultrasonic knives of some brand underwent fatigue testing with the table,during which non-contact measurement of the ultrasonic knife tip vibration was carried out and the Q factors were calculated at the five periods of the fatigue test,including the periods before cutting,after 500 times of cutting,after 1 000 times of cutting,after 2 000 times of cutting and after 3 000 times of cutting.Finally,the average cutting speed and burst pressure for coagulated vessels were computed at each period to validata the effectiveness of the method proposed.Results It's indicated that Q factor could effectively reflect the fatigue degradation of the ultrasonic knife tip,while the average cutting speed and burst pressure for coagulated vessels were difficult to efficiently evaluate the fatigue degradation level of the ultrasonic knife tip due to the uncertainty factors in the measurement process.Conclusion The proposed Q factor-based evaluation method can directly evaluate fatigue vibration of the ultrasonic knife tip in an accurate and quantitative manner.[Chinese Medical Equipment Journal,2024,45(6):17-22]
8.Accurate quantitative evaluation of MRI scanning noise based on laser vibrometry technology
Ke-Sheng WANG ; Pei-Jia XU ; Pei LIU ; Jing-Sheng SUN ; Ze-Kai LI ; Xu-Guang PENG ; Shuang-Shuang LI ; Qian-Hong HE ; Zhen LIU
Chinese Medical Equipment Journal 2024;45(10):20-24
Objective To carry out accurate quantative evaluation of MRI scanning noise based on laser vibrometry technology.Methods Skull and spine MRI was performed with mute and conventional sequences.A laser vibrometry device was used to sample the surface vibration noise at the outer edge of the inspection hole of MRI system according to GB/T 16539-1996 Acoustics—Determination of sound power levels of noise sources using vibration velocity—Measurement for seal machinery,and the indicators of sound power level,sound pressure level and perceived noise level obtained by the three calculation methods(LPN1,LPN2 and LPN3)were analyzed with some dedicated MRI noise analysis software.Results The peak sound pressure levels for conventional and mute sequences of skull scanning were 81 and 63 dB(A),respectively,and mute sequence reduced the noise level significantly;the peak sound pressure levels for conventional and mute sequences of spine scanning were 79 and 75 dB(A),respectively,and the noise reduction level was significantly lower than that of skull scanning.Significant differences in noise reduction were not found in spine scanning sequences,while were found in skull scanning sequences.During spine and skull scanning LPN1,LPN2 and LPN3 obtained by the three calculation methods of conventional and mute sequences were all higher than the overall sound power and overall pressure levels obviously.Conclusion Mute sequence can not realize linear noise reduction for the whole frequency band,the perceived noise of the human ear during MRI scanning is related directly to the scanning sequence,and there may be some bias when only one physical indicator is involved in the noise evaluation of MRI system.[Chinese Medical Equipment Journal,2024,45(10):20-24]
9.Analysis of efficacy and safety of neoadjuvant therapy combined with bevacizumab for locally advanced rectal cancer
Xu ZHANG ; Qing ZHANG ; Shuai GUO ; Mu LI ; Yuanfa WANG ; Ze LI
Chinese Journal of General Surgery 2024;33(10):1623-1632
Background and Aims:Currently,surgery remains the primary treatment for colorectal cancer,while neoadjuvant therapy can transform initially unresectable lesions into resectable ones,improving patient prognosis.Bevacizumab combined with chemotherapy has shown promising efficacy for advanced metastatic colorectal cancer;however,the routine use of bevacizumab in neoadjuvant therapy for potentially resectable metastatic colorectal cancer patients remains controversial.Therefore,this study was performed to investigate the efficacy and safety of bevacizumab combined neoadjuvant therapy in patients with locally advanced rectal cancer(LARC). Methods:The clinical data of LARC patients who received bevacizumab-combined neoadjuvant therapy in the Department of Colorectal and Gastrointestinal Oncology,Jilin Cancer Hospital,from 2021 to 2022,were retrospectively analyzed. Results:A total of 45 patients were included,of whom 26 received the XELOX(oxaliplatin combined with capecitabine)+bevacizumab neoadjuvant regimen(chemotherapy plus bevacizumab group),and 19 received radiotherapy concurrent with XELOX and sequential bevacizumab neoadjuvant treatment(chemoradiotherapy plus bevacizumab group).Preoperative imaging evaluations showed tumor response rates of 84.61%and 94.74%,respectively,with a disease control rate of 100.0%in both groups.The CEA and CA19-9 levels significantly decreased compared to their pre-treatment levels in both groups(both P<0.05).In the chemotherapy plus bevacizumab group,all patients underwent Dixion resection with D2 lymphadenectomy,with 10 patients receiving preventive ileostomy.Postoperative pathology showed an average of 18.3 lymph nodes removed,with 2.1 metastatic nodes;tumor regression grade(TRG)was 0 in 2 cases(7.69%),1 in 8 cases(30.77%),2 in 10 cases(38.46%),and 3 in 6 cases(23.08%).In the chemoradiotherapy plus bevacizumab group,15 patients underwent Dixion resection with D2 lymphadenectomy,2 patients underwent Miles surgery,1 patient was unable to undergo surgery due to severe pelvic adhesions,and another was unable to have resection due to pelvic floor adhesions found during surgery.Preventive ileostomy was performed in all 15 patients who had Dixion surgery.Postoperative pathology showed an average of 18.5 lymph nodes removed,with 1.6 metastatic nodes;TRG was 0 in 2 cases(10.53%),1 in 7 cases(36.84%),2 in 6 cases(31.58%),and 3 in 2 cases(10.53%).Surgical specimens in both groups showed negative proximal and distal margins,with no tumor residuals.A total of 55 neoadjuvant therapy-related adverse events occurred,all graded 1-2,without affecting subsequent treatment. Conclusion:For LARC patients,bevacizumab-combined neoadjuvant therapy is safe and effective.Bevacizumab combined with chemotherapy can be selected,with radiotherapy as an option based on tumor location,to increase the probability of radical resection and sphincter-preserving opportunities.
10.Immunological characteristics of the PhoP protein of two-component system in Mycobacterium tuberculosis
Xue LI ; Huan-Huan NING ; Jian KANG ; Ming-Ze XU ; Ruo-Nan CUI ; Ting DAI ; Yan-Zhi LU ; Sa XUE ; Yin-Lan BAI
Chinese Journal of Zoonoses 2024;40(4):352-358
In this study,the immunological characteristics of the PhoP protein were explored with a two-component system of Mycobacterium tuberculosis(Mtb).Bioinformatics was used to predict the B and T cell epitopes of the PhoP protein.A re-combinant expression plasmid was constructed by PCR analysis of the phoP sequence and cloning into the prokaryotic expres-sion vector pET-28a(+).Competent Escherichia coli BL21 cells were transformed with the recombinant plasmid and expres-sion was induced with IPTG.The recombinant PhoP protein was purified by affinity chromatography.Serum levels of PhoP-specific antibodies in Mtb-infected mice and tuberculosis(TB)patients were analyzed with an ELISA.BALB/c mice were im-munized with the PhoP recombinant protein by intramuscular injection.Sera of mice were collected and antibody titers were detected with an ELISA and specificity was assessed by West-ern blot analysis.Mouse splenocytes were isolated and the pro-portions of IFN-y-positive cells and cytokine levels were detec-ted with an ELISpot and ELISA,respectively.Bioinformatics i-dentified 24 B cell and 11 T cell epitopes of the PhoP protein.A prokaryotic recombinant vector of PhoP was successfully con-structed and the recombinant PhoP protein was obtained by purification.Specific antibody levels to PhoP in sera of Mtb in-fected mice and TB patients increased significantly,with preci-sion of 99.9%and 82.5%,and specificity of 100%,respectively.PhoP protein immunization successfully induced production of specific antibodies in mice.Stimulated by antigens in vitro,IL-2 and IFN-γ levels were significantly increased in the splenocytes of immunized mice.Immunization with the PhoP protein induce a humoral immune response and Thl-dominated cellular immu-nity,indicating that the PhoP protein was immunogenic with diagnostic efficacy for TB.These results lay a foundation to clari-fy the role of PhoP in Mtb infection and application for diagnosis and prevention of TB.


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