1.Pharmacokinetics study of single and multiple doses of azvudine in healthy young and elderly subjects
Yu ZHANG ; Xiao-Jian LIU ; Hao-Shuang JU ; Bin-Yuan HE ; Yuan-Hao WAN ; Li-Wei CHAI ; Le-Yang REN ; Min LÜ ; Ya-Qiang JIA ; Wei ZHANG ; Ping XU
The Chinese Journal of Clinical Pharmacology 2024;40(9):1316-1320
Objective To evaluate the pharmacokinetic characteristics and safety of single and multiple oral azvudine tablets in healthy young and elderly Chinese subjects.Methods This was a open-label and parallel-group study.The trial consisted of two groups:healthy young subjects group and healthy elderly subjects group,with 12 subjects in each group.Enrolled subjects were first given a single dose,fasting oral azvudine tablet 5 mg,after a 3-day cleansing period entered the multiple dose phase,fasting oral azvudine tablet 5 mg·d-1 for 7 days.Results After a single dose of azvudine 5 mg,Cmax and AUC0-∞ were(4.76±2.12)ng·mL-1,(6.53±2.20)ng·mL-1·h,and Tmax,t1/2 were 0.75,1.87 h in young subjects;Cmax and AUC0-∞ were(6.40±3.25)ng·mL-1,(9.50±3.70)ng·mL-1·h,and Tmax,t1/2 were 0.63,2.66 h in elderly subjects.After a multiple dose of azvudine 5 mg·d-1 for 7 d,Cmax and AUC0-∞ were(3.26±1.61)ng·mL-1,(5.38±2.19)ng·mL-1·h,and Tmax,ss,t1/2,ss were 0.88,2.13 h in young subjects;Cmax,ss and AUC0-∞,ss were(3.97±2.09)ng·mL-1,(6.71±3.26)ng·mL-1·h,and Tmax,ss,t1/2,ss were 0.75,2.56 h in elderly subjects.Elderly/young geometric mean ratios and 90%CIs were 128.37%(88.23%-186.76%),139.93%(105.42%-185.72%),140.03%(106.33%-184.41%)for azvudine Cmax,AUC0-t,AUC0-∞ after a single dose,and were 118.66%(80.83%-174.20%),118.41%(83.60%-167.69%),118.95%(84.78%-166.89%)for azvudine Cmax,AUC0-t,AUC0_∞ after a multiple dose of azvudine 5 mg·d-1 for 7 d.Conclusion After single and multiple oral administration of azvudine tablets,systemic exposure to azvudine was higher in healthy elderly subjects compared with healthy young subjects.After taking azvudine tablets,the types,severity and incidence of adverse events and adverse drug reactions in healthy elderly people were not significantly different from those in healthy young subjects.Azvudine was found to be safe and well tolerated in healthy elderly subjects.
2.A single-center study on the safety and effectiveness of a novel non-implant interatrial shunt device
San-Shuai CHANG ; Xin-Min LIU ; Zheng-Ming JIANG ; Yu-Tong KE ; Qian ZHANG ; Qiang LÜ ; Xin DU ; Jian-Zeng DONG ; Guang-Yuan SONG
Chinese Journal of Interventional Cardiology 2024;32(8):425-433
Objective To preliminarily evaluate the safety and effectiveness of a novel non-implantable atrial shunt device based on radiofrequency ablation for the treatment of chronic heart failure(CHF).Methods This was a prospective single-arm study.From January 2023 to December 2023,five eligible CHF patients were consecutively enrolled at Beijing Anzhen Hospital,Capital Medical University,and underwent inter-atrial shunt using Shenzhen Betterway atrial shunt device.Pulmonary capillary wedge pressure(PCWP),right atrial pressure(RAP),pulmonary artery pressure(PAP),total pulmonary resistance(TPR),pulmonary vascular resistance(PVR),and pulmonary/systemic blood flow ratio(Qp/Qs)were measured using right heart catheterization before and immediately after procedure.Patients were followed up for 90 days,and echocardiography,right heart catheterization,and cardiac functional indicators were evaluated.The primary endpoint was procedural success.Secondary endpoints included clinical success,echocardiographic changes,6-minute walk distance(6MWD)changes,New York Heart Association(NYHA)class changes,Kansas city cardiomyopathy questionnaire(KCCQ)score changes,and amino-terminal probrain natriuretic peptide(NT-proBNP)level changes at 90 days.The safety endpoint was major cardiovascular and cerebrovascular adverse events and device-related adverse events.Results All five patients successfully achieved left-to-right atrial shunt.Compared with baseline,PCWP decreased significantly immediately after procedure in all five patients,with a procedural success rate of 100%.There were no significant changes in RAP,PAP,TPR,and PVR before and immediately after procedure.After 90 days follow-up,four patients had persistent left-to-right atrial shunt,and PCWP was significantly lower than baseline,with a clinical success rate of 80%.Compared with baseline,LVEF increased,left ventricular end-diastolic diameter decreased,and tricuspid annular plane systolic excursion and right ventricular fractional area change were not impaired in all five patients at 90 days.KCCQ scores and 6MWT improved,NT-proBNP decreased,and NYHA class did not change significantly.There were no deaths,rehospitalizations for heart failure,stroke-related adverse events,or device-related adverse events during the follow-up.Conclusions The novel non-implantable atrial shunt catheter can safely and effectively improve hemodynamic,echocardiographic,and cardiac functional indicators in patients with heart failure.However,larger-scale clinical studies are still needed to validate its long-term clinical effectiveness.
3.Analysis of risk factors for recurrence after unilateral biportal endoscopy in patients with lumbar disc herniation
Qiang LÜ ; Rui LIU ; Shenpeng LIU
China Journal of Endoscopy 2024;30(3):47-51
Objective To explore the risk factors for recurrence after unilateral biportal endoscopy in patients with lumbar disc herniation.Methods Clinical data of 156 patients with lumbar disc herniation were retrospectively analyzed.All the patients underwent unilateral biportal endoscopy treatment.Follow up for 2 years after surgery,and the recurrence rate of all patients was recorded.The clinical characteristics of patients in the recurrent and non recurrent groups were compared,the factors influencing postoperative recurrence were analyzed by multivariate Logistic regression.Results After a 2-year follow-up,a total of 22 patients experienced recurrence,with a recurrence rate of 14.10%(22/156).The results of multivariate Logistic analysis showed that,the age>60 years old,fiber ring break>5 mm,incomplete nucleus pulposus removal,and postoperative intervertebral motion>10 ° were independent risk factors for recurrence after unilateral biportal endoscopy in patients with lumbar disc herniation(P<0.05).Conclusion Age>60 years old,fiber ring break>5 mm,incomplete removal of the nucleus pulposus,and postoperative intervertebral motion>10 ° were independent risk factors for recurrence after unilateral biportal endoscopy in patients with lumbar disc herniation,and prevention should be strengthened.
4.Analysis of the mechanisms of Guanxinning Tablet for antithrombotic and microthrombotic effects caused by COVID-19 based on network pharmacology
Pei-yu GONG ; Guang-xu XIAO ; Wen-jun LI ; Guan-wei FAN ; Ming LÜ ; Jin-qiang ZHU
Acta Pharmaceutica Sinica 2024;59(9):2545-2555
Thrombosis is a key factor that increases the mortality rate of COVID-19 patients and causes long COVID sequelae. Guanxinning Tablet (GXNT), which is composed of
5.The Action Effect of Two Kinds of Lumbar Massage Obliquity Manipulation with Different Lumbar Degeneration Degrees: A Comparative Study
Duoduo WANG ; Yanha ZHANG ; Panjing GUO ; Jie LÜ ; Jun XU ; Lijun DING ; Nan ZHOU ; Qiang LÜ
Journal of Medical Biomechanics 2023;38(1):E059-E064
Objective To compare the action effect of traditional and modified lumbar massage obliquity manipulation with different degrees of lumbar degeneration. Methods The biomechanical model of quality-spring-damping system lumbar spine was established and massage forces from professional massage doctors were collected. The force was used as input of the model, and lumbar degeneration was simulated by increasing elastic coefficient of the spring and damping coefficient of the damping in the model. By using MATLAB/ Simulink simulation technology, the effects of massage obliquity manipulation ( the maximum relative displacement and maximum acceleration) with different degrees of lumbar degeneration were obtained for comparative analysis.Results When the lumbar spine was degenerative, the maximum relative displacement and maximum acceleration of each segment were obtained under two manipulations. With the increase of lumbar degenerationdegree, the maximum relative displacement and maximum acceleration of each segment under two manipulations showed a downward trend, and the attenuation rate of the maximum relative displacement and maximum acceleration of each segment under two manipulations was obtained. Conclusions When degenerative changes in the spine do not occur, the effectiveness of traditional lumbar massage obliquity manipulation is slightly better than that of modified lumbar massage obliquity manipulation, but the safety of modified lumbar massage obliquity manipulation is obviously better than that of the traditional lumbar massage obliquity manipulation, so the modified lumbar massage obliquity manipulation should be used. With the aggravation of lumbar degeneration, the action effects of two manipulations are attenuated in a power function. The attenuation rate of effectiveness of modified lumbar massage obliquity manipulation is significantly faster than that of traditional lumbar massage obliquity manipulation, indicating that the modified lumbar massage obliquity manipulation should not be used in the caseof lumbar degeneration.
6.Clinical observation on Yi Jin Jing(Sinew-transforming Qigong Exercises)in improving anxiety for asymptomatic patients with COVID-19 infection during quarantine
Hua XING ; Xiaojie SU ; Xuqiu SUN ; Sheng SHAO ; Yiming SHAN ; Yazhou LI ; Chao ZHOU ; Weicong ZHENG ; Fanchao MENG ; Qiang LÜ ; Wuquan SUN ; Li GONG ; Fuqing ZHANG
Journal of Acupuncture and Tuina Science 2023;21(4):285-293
Objective:To observe the effect of Yi Jin Jing(Sinew-transforming Qigong Exercises)intervention on anxiety in asymptomatic patients with Corona Virus Disease 2019(COVID-19)infection during quarantine.Methods:A total of 160 asymptomatic patients with COVID-19 infection were stratified by gender and divided into an observation group and a control group by the stratified randomization method,with 80 cases in each group.The control group was given basic nursing in the cabin,and the observation group was given additional Yi Jin Jing exercises once a day,20 min each time,and trained continuously until 1 d before leaving the cabin.The Hamilton anxiety scale(HAMA)score was compared between the two groups.Results:A total of 154 cases were included for data analysis in this study,including 74 cases in the observation group and 80 cases in the control group.After intervention,the HAMA scores in both groups increased(P<0.05),while the score in the observation group was lower than that in the control group(P<0.05).In the control group,the HAMA score of females after intervention was higher than that of males.The scores of mental anxiety and somatic anxiety in both groups were higher than those before intervention,while the score of mental anxiety in the observation group was significantly lower than that in the control(P<0.05).However,there was no statistical difference in the somatic score between the two groups(P>0.05).Conclusion:Patients with COVID-19 infection will get anxious during quarantine.Yi Jin Jing exercise can effectively reduce the aggravation of anxiety in asymptomatic patients with COVID-19 infection during concentrated quarantine.
7.Introduction to revision of Technical Specification for Occupational Health Surveillance
Chen YU ; Dehong LI ; Daoyuan SUN ; Zubing WANG ; Chaoqiang JIANG ; Xunmiao ZHANG ; Yongjian YAN ; Weiming YUAN ; Yiqun XUAN ; Xin QIAO ; Yujing XIA ; Qiuhong ZHU ; Qiang HOU ; Hong WANG ; Yiwen JIANG ; Xuetao ZHANG ; Fang QI ; Xiangpei LÜ ; Huanqiang WANG
China Occupational Medicine 2023;50(2):209-216
To revise GBZ 188 Technical Specification for Occupational Health Surveillance based on national laws, regulations, standards, specifications and legal documents of occupational disease, and combination with the actual situation in China. The main modifications are as follows: the occupational health surveillance for workers exposed to toluene (xylene may implement by reference), bromopropane, methyl iodide, ethylene oxide, chloroacetic acid, indium and its compounds, coal tar, coal tarasphalt, asphalt, β-naphthylamine, dust of metal and its compounds(tin, iron, antimony, barium and its compounds), hard metal dust, erionite dust, low temperature, laser, tick-borne encephalitis virus, Borrelia burgdorferi, and human immunodeficiency virus, for scraper or grind operators, and underground workers using squatting or kneeling position, crawling position, side-lying position, or shoulder position for a long period of time are included. The emergency health screening for workers exposed to arsenic, fluorine and its inorganic compounds, and acrylamide are included. The occupational medical examination (OME) for workers exposed to amino and nitro compounds of benzene, phosgene, monomethylamine, organic fluorine and dimethyl sulfate has been adjusted and made mandatory, with corresponding assessments required upon leaving the job. The special occupational health surveillance for workers exposed to mycobacterium tuberculosis and hepatitis virus is removed. The OME conclusion of reexamination is removed, and standardize recheck/additional inspection requirements. The optional items in OME performed before, during and after leaving post are removed, but the optional items in emergency medical examination are retained. Additional OME items are added. The Guideline for OME Summary Reports is added as informative appendix, and so on. The revised GBZ 188 Technical Specification for Occupational Health Surveillance is more scientific and practical.
9.Baseline characteristics of the Chinese health quantitative CT big data program in 2018—2019
Kaiping ZHAO ; Jian ZHAI ; Limei RAN ; Yongli LI ; Shuang CHEN ; Yan WU ; Guobin HONG ; Yong LU ; Yuqin ZHANG ; Xiao MA ; Jing LU ; Xigang XIAO ; Xiangyang GONG ; Zehong YANG ; Wei CHEN ; Lü YINGRU ; Jianbo GAO ; Shaolin LI ; Yuehua LI ; Xiaojuan ZHA ; Zhiping GUO ; Qiang ZENG ; Zhenlin LI ; Jing WU ; Xiaoguang CHENG
Chinese Journal of Health Management 2022;16(9):596-603
Objective:To describe the baseline characteristics of the subjects enrolled in the China Quantitative CT (QCT) big data program in 2018—2019.Methods:Based on baseline data from the Chinese health big data project from January 2018 to December 2019 from the eligible enrolled population, measurements of bone mineral density (BMD) and visceral adipose tissue (VAT) were performed using Mindways′ QCT Pro Model 4 system. The baseline data of age, gender, regional distribution, height, weight, abdominal circumference, blood pressure, blood routine and blood biochemical tests were analyzed. And the single factor analysis of variance (ANOVA) was used to check the age related trend of BMD and VAT in both genders.Results:After screening the inclusion exclusion criteria and outliers of the main indicators, 86 113 people were enrolled in the project. The enrollment rate was 92.47%, including 35 431 (41.1%) women and 50 682 (58.9%) men, and the ratio of men to women was 1.43. The mean age was (50.3±12.7) years in all the subjects, and it was (50.2±12.8) years and (50.4±12.5) years in men and women, respectively, and there was no statistical difference between the two genders ( P>0.05). Total of 43 833 people were enrolled in east China, it was the largest group by region (50.90%), it was followed by central China (16 434 people, 19.08%), and the number of people enrolled in Northeast China was the lowest (2 914 people, 3.38%). The rate of completing of health information indicators related to the main outcome of the study were all above 70%, and there were significant differences between men and women (all P<0.05). The mean BMD was (139.33±46.76) mg/cm 3 in women, (135.90±36.48) mg/cm 3 in men, which showed a decreasing trend with age in both gender (both P<0.001); the mean intra-abdominal fat area was (116.39±56.23) cm 2 in women, (191.67±77.07) cm 2 in men, and there was an increasing trend with age in both men and women (both P<0.001). Conclusions:There are gender differences in BMD and VAT measured by QCT with different age tendency, and there are gender differences in health information index. Regional factors should also be taken into account for regional differences in the inclusion of data.
10.Normal reference and regional variation of spinal bone mineral density under the quantitative CT in Chinese male population
Liuping CHEN ; Jian ZHAI ; Limei RAN ; Yongli LI ; Lü YINGRU ; Yan WU ; Shaolin LI ; Hanqi WANG ; Yaling PAN ; Tongtong CHEN ; Lü HAIYING ; Kaiping ZHAO ; Yuqin ZHANG ; Xiao MA ; Jing LU ; Xigang XIAO ; Xiangyang GONG ; Zehong YANG ; Wei CHEN ; Jianbo GAO ; Yuehua LI ; Xia DU ; Zhenlin LI ; Qiang ZENG ; Xiaoguang CHENG ; Shuang CHEN ; Jing WU ; Yong LU
Chinese Journal of Health Management 2022;16(9):604-609
Objective:To investigate the normal reference values of spinal bone mineral density measured by quantitative computed tomography (QCT) and the differences of bone mineral density (BMD) in different regions of in Chinese adult males.Methods:Men who underwent low-dose CT lung scan for cancer screening in regions of Northeast, North, East, South, Central and Southwest of China from January 2018 to December 2019 were selected. And the lumbar vertebrae BMD values in the male subjects were measured by the QCT system (Mindways Software, Inc.). The mean BMD values and their decline rates were calculated at an age interval of 10 years, and the prevalence of osteoporosis was calculated according to the American College of Radiology spine QCT osteoporosis diagnostic criteria.Results:A total of 50 682 males with a mean age of (50.22±12.79) years (ranged 20 to 98 years) were included in this study. The peak BMD of (173.11±28.56) mg/cm 3 in the healthy Chinese adult male population appeared in the age group of 20 to 29 years and then declined with age. Before the age of 70 years, the BMD was relatively higher in males in South China, and it was lower in Central China and Southwest China, and it was intermediate in Northeast, North and East of China, with statistically significant differences. There was no significant differences in BMD in the males in the two age groups of 70 to 79 years and 80 and older among the regions in China. The overall decline rate of spinal BMD in Chinese males under QCT was about 46.92% over the lifetime, and it declined obviouslyin the 40-49 age group. The overall prevalence of osteoporosis in Chinese male population aged 50 years and above was approximately 11.42%, with the highest prevalence in Southwest China and Central China (14.72% and 13.87%, respectively) and the lowest in North China and South China (8.53% and 7.71%, respectively). Conclusions:A reference of lumbar spine BMD values for healthy males in China based on QCT is established. BMD values were highest in South China and Lowest in Central China.

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