1.Application analysis of breast ultrasound structured report in clinical teaching of standardized residency training of ultrasonography
Yanxiang ZHOU ; Sheng CAO ; Jinling CHEN ; Qing ZHOU ; Bo HU ; Nan JIANG
Chinese Journal of Medical Education Research 2024;23(6):846-850
Objective:To explore the application value of breast ultrasound structured report in the clinical teaching of standardized residency training of ultrasonography.Methods:Forty-eight residents from the Department of Ultrasonography in Renmin Hospital of Wuhan University were selected as the research objects, and were randomly divided into experimental group and control group in average. The experimental group used structured report template to write the breast ultrasound report, while the control group used free text. After 1 month of clinical teaching, the teachers who were not clear about the grouping assessed and analyzed the differences between the two groups of residents in grasping the characteristics of lesions and reporting content. At the same time, the students were asked to fill in a questionnaire for self-evaluation to analyze the learning situation of the two groups of students. SPSS 21.0 statistical analysis software was used for t-test and Chi-square test. Results:In terms of teacher evaluation, the scores of residents in the experimental group were higher than those in the control group in terms of completeness of report content, accuracy of description of peripheral conditions of lesions, standardization of professional terms and practicality of differential diagnosis (all P<0.001). There was no significant difference in the accuracy of lesion description between the two groups ( P=0.342). In terms of self-evaluation of residents in the standardized residency training, the evaluations of residents in the experimental group on the degree of mastery of knowledge points, clinical thinking cultivation and satisfaction of teaching mode were significantly higher than those of residents in the control group ( P=0.006, 0.012, <0.001, respectively). There were no significant differences between the two groups in learning interest and operation convenience ( P=0.186, 0.065, respectively). Conclusions:The structured report of breast ultrasound is helpful for the residents to master the characteristics of lesions and write a complete and professional report. It is also helpful for them to improve the standardization of operation and clinical thinking ability.
2.Study on bioequivalence evaluation of Pemirolast potassium tablets in Chinese healthy volunteers on an empty stomach/after meals
Yi-Ming MA ; Wang HU ; Feng ZHANG ; Wen ZHANG ; Sheng-Long ZHAO ; Yang CAO ; Jing XIE ; Huan ZHOU ; Shun-Wang HUANG
Chinese Pharmacological Bulletin 2024;40(6):1075-1081
Aim To compare the pharmacokinetics of pemirolast potassium tablets in healthy subjects in Chi-na under single fasting and postprandial conditions,and to evaluate the bioequivalence of the test prepara-tion(T)and the reference preparation(R).Methods A randomized,open-ended,single-dose,two-cycle,double-cross bioequivalence trial design was adopted,and 26 and 30 subjects were enrolled in the fasting group and the postprandial group,respectively,and 10 mg of the test preparation and the reference preparation were taken in the fasting or postprandial state each cy-cle,and venous blood was collected at the designed time points before and after the administration cycle.The concentration of pemirolast potassium in plasma was determined by LC-MS/MS method,and the phar-macokinetic parameters were calculated with PhoenixTM WinNonlin ?(8.3)software,and the bioequivalence analysis of the two preparations was performed.Re-sults The t1/2 of the test preparation and the reference preparation was(4.44±0.91)h and(4.49±0.93)h,respectively;the median tmax was(1.96±1.29)h and(2.18±1.25)h,respectively;the Cmax was(867.12±205.56)μg·L-1 and(863.35±172.03)μg·L-1,respectively;the AUC0-t was(5 513.23±1463.67)h·μg·L-1 and(5 661.32±1 628.65)h·μg·L-1,respectively;AUC0_∞ was(5 699.81±1477.68)h·μg·L-1 and(5 849.44±1 644.75)h·μg·L-1,respectively.The statistical results of the 90%confidence intervals of the main pharmacokinetic parameters Cmax,AUC0-t,and AUC0-∞ was 92.49%~107.53%,94.71%~100.67%and 95.28%~100.27%,respectively,all of which were within the range of 80.00%~125.00%,and the safety of the tested preparation and the reference preparation was good when taken orally on an empty stomach.The t1/2 of single oral administration after prandial administra-tion of the tested preparation and the reference prepara-tion was(4.46±0.78)and(4.51±0.84)h,respec-tively;the median tmax was(3.08±1.36)h and(3.28±1.28)h,respectively;the Cmax was(683.83±111.87)μg·L-1 and(689.77±110.24)μg·L-1,respectively;the AUC0-t was(5 695.99±1566.05)h·μg·L-1 and(5 773.60±1 551.04)h·μg·L-1,respectively;the AUC0-∞ was(5 914.06±1 551.86)h·μg·L-1 and(5 967.30±1552.89)h·μg·L-1,respectively.The 90%confi-dence interval of Cmax,AUC0-t,and AUC0-∞ was 93.56%~104.69%,96.43%~100.83%,and 97.29%~101.14%,respectively,which was in the range of 80.00%~125.00%,and the safety of the tested preparation and the reference preparation was good after meals.Conclusion In the state of fasting and postprandial single oral administration,the two kinds of pemirolast potassium tablets have good bio-equivalence.
3.Expressions of zinc homeostasis proteins,GPR39 and ANO1 mRNA in the sperm of asthenozoospermia patients and their clinical significance
Chun HE ; Fang-Fang DAI ; Jun-Sheng LIU ; Ya-Song GENG ; Jun-Xia ZHOU ; Yi-Zhen HU ; Bo ZHENG ; Shu-Song WANG
National Journal of Andrology 2024;30(1):18-25
Objective:To explore the expressions of zinc homeostasis-related proteins,G protein-coupled receptor 39(GPR39)and ANO1 mRNA in the sperm of patients with asthenozoospermia(AS),and analyze their correlation with sperm motility.Methods:We collected semen samples from 82 male subjects with PR+NP<40%,PR<32%and sperm concentration>15 × 106/ml(the AS group,n=40)or PR+NP≥40%,PR≥32%and sperm concentration>15 × 106/ml(the normal control group,n=42).We analyzed the routine semen parameters and measured the zinc content in the seminal plasma using the computer-assisted sperm analysis system,detected the expressions of zinc transporters(ZIP13,ZIP8 and ZNT10),metallothioneins(MT1G,MT1 and MTF),GPR39,and calcium-dependent chloride channel protein(ANO1)in the sperm by real-time quantitative PCR(RT qPCR),examined free zinc distribution in the sperm by laser confocal microscopy,and determined the expressions of GPR39 and MT1 proteins in the sperm by immunofluorescence staining,followed by Spearman rank correlation analysis of their correlation with semen parameters.Results:There was no statistically significant difference in the zinc concentration in the seminal plasma between the AS and normal control groups(P>0.05).Compared with the controls,the AS patients showed a significantly reduced free zinc level(P<0.05),relative expressions of MT1G,MTF,ZIP13,GPR39 and ANO1 mRNA(P<0.05),and that of the GPR39 protein in the AS group(P<0.05).No statistically significant differences were observed in the relative expression levels of ZIP8,ZNT10 and MT1 mRNA between the two groups(P>0.05).The relative expression levels of GPR39,ANO1,MT1G and MTF mRNA were positively correlated with sperm motility and the percentage of progressively motile sperm(P<0.05).Conclusion:The expressions of zinc homeostasis proteins(MT1G,MTF and ZIP13),GPR39 and ANO1 mRNA are downregulated in the sperm of asthenozoospermia pa-tients,and positively correlated with sperm motility.
4.Design,numerical simulation and experimental study of novel oxygenator
Ming-Hao YUE ; Shi-Yao ZHANG ; Ji-Nian LI ; Hui-Chao LIU ; Zi-Hua SU ; Ya-Wei WANG ; Zeng-Sheng CHEN ; Shi-Hang LIN ; Jin-Yu LI ; Ya-Ke CHENG ; Yong-Fei HU ; Cun-Ding JIA ; Ming-Zhou XU
Chinese Medical Equipment Journal 2024;45(3):23-28
Objective To design a novel oxygenator to solve the existing problems of extracorporeal membrane oxygenation(ECMO)machine in high transmembrane pressure difference,low efficiency of blood oxygen exchange and susceptibility to thrombosis.Methods The main body of the oxygenator vascular access flow field was gifted with a flat cylindrical shape.The topology of the vascular access was modeled in three dimensions,and the whole flow field was cut into a blood inlet section,an inlet buffer,a heat exchange zone,a blood oxygen exchange zone,an outlet buffer and a blood outlet section.The oxygenator was compared with Quadrox oxygenator by means of ANSYS FLUENT-based simulation and prototype experiments.Results Simulation calculations showed the oxygenator designed was comparable to the clinically used ones in general,and gained advantages in transmembrane pressure difference,blood oxygen exchange and flow uniformity.Experimental results indicated that the oxygenator behaved better than Quadrox oxygenator in transmembrane pressure difference and blood oxygen exchange.Conclusion The oxygenator has advantages in transmem-brane pressure difference,temperature change,blood oxygen ex-change and low probability of thrombosis.[Chinese Medical Equipment Journal,2024,45(3):23-28]
5.A trinity strategy for the treatment of multiple orthopedic trauma and assessment of its clinical application
Xiao CHEN ; Guangchao WANG ; Hao ZHANG ; Kaiyang LYV ; Qirong ZHOU ; Yunfei NIU ; Yan HU ; Yuanwei ZHANG ; Zuhao LI ; Hao SHEN ; Jin CUI ; Sicheng WANG ; Zhengrong GU ; Zhen GENG ; Dongliang WANG ; Zhehao FAN ; Shihao SHENG ; Chongru HE ; Jun FEI ; Yunfeng CHEN ; Haodong LIN ; Guohui LIU ; Zhiyong HOU ; Jiacan SU
Chinese Journal of Trauma 2024;40(10):888-896
Objective:To explore the clinical value of a trinity strategy for the treatment of multiple orthopedic trauma.Methods:A retrospective case series study was conducted to analyze the clinical data of 1 267 patients with multiple orthopedic trauma admitted to Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and the First Affiliated Hospital of Navy Medical University from June 2013 to May 2023, including 862 males and 405 females, aged 18-93 years [(55.2±19.8)years]. Associated injuries included hemorrhagic shock in 632 patients, traumatic wet lung in 274, cranial injuries in 135, abdominal and pelvic bleeding in 116, pneumothorax in 89, urinary injury in 13, and vesical rupture in 8. All the patients were treated with the trinity strategy and the treatment process was divided into the phases of first aid, remodeling, and rehabilitation. The first aid phase focused on stabilizing symptoms and saving lives; the remodeling phase centered on restoring the anatomical structure and alignment; the rehabilitation phase aimed for functional recovery through the integration of both Western and traditional Chinese medicine. The all-cause mortality within 30 days after surgery and fracture healing time were calculated; the excellent and good rates of Constant-Murley shoulder score, Mayo elbow score, Gartland-Werley wrist score, Harris hip score, Hospital for Special Surgery (HSS) knee score and the American Orthopedic Foot & Ankle Society (AOFAS) ankle-hindfoot score at the last follow-up and the overall excellent and good rate of all joint function scores were measured. The short form health survey (SF-36) scores were collected preoperatively and at 6 months postoperatively, including 8 aspects such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The incidence of postoperative complications was recorded.Results:All the patients were followed up for 6-18 months [(10.2±4.2)months]. The mortality rate during the acute phase (within 30 days after surgery) was 2.37% with 12 deaths due to hemorrhagic shock, 10 due to traumatic brain injury, 6 due to multiple organ dysfunction syndrome (MODS), and 2 due to pulmonary infection. The average fracture healing time averaged 3.8-18 months [(11.5±4.2)months], with 89.49% of the patients having bone union within 12 months after surgery, 8.93% having bone union within 18 months after surgery, and 1.58% undergoing reoperation. For the patients with internal fixation failure and nonunion, the average healing time was extended to (10.2±2.2)months and (13.7±3.3)months respectively. At the last follow-up, the excellent and good rates of Constant-Murley shoulder score, Mayo elbow score, Gartland-Werley wrist score, Harris hip score, HSS knee score, and AOFAS ankle-hindfoot score were 83.93%, 90.24%, 94.12%, 85.57%, 88.46%, and 92.31% respectively, with an overall excellent and good rate of 89.11%. At 6 months after surgery, the SF-36 scores of all the patients in the eight dimensions,including the physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health were (74.4±8.6)points, (44.7±14.4)points, (77.4±10.9)points, (68.4±18.2)points, (72.5±16.0)points, (76.8±8.7)points, (49.9±17.6)points, and (72.8±17.9)points, significantly improved compared with those before operation [(63.4±12.7)points, (30.9±17.4)points, (56.4±18.0)points, (55.4±24.7)points, (53.5±21.0)points, (55.8±24.3)points, (36.9±24.0)points, (58.8±21.6)points] ( P<0.01). Complications of different degrees occurred in 214 patients (16.89%), including lung infections in 118 patients (9.31%), lower extremity deep vein thrombosis in 50(3.95%), pressure injuries in 26(2.05%), internal fixation failure in 12(0.95%), and nonunion in 8(0.63%). Conclusions:The trinity strategy provides whole-process management, personalized treatment, and overall rehabilitation for multiple orthopedic trauma. It can decrease mortality, shorten fracture healing time, improve joint function and quality of life, and reduce the incidence of complications.
6.Predictive value of atrial volume and strain parameters for disease progression in patients with different types of atrial fibrillation
Liuqing WANG ; Hongning SONG ; Sheng CAO ; Bo HU ; Tuantuan TAN ; Qing ZHOU ; Jinling CHEN
Chinese Journal of Ultrasonography 2024;33(1):49-56
Objective:To evaluate the cardiac morphological and functional parameters of patients with persistent atrial fibrillation (per-AF) and paroxysmal atrial fibrillation (PAF) using two-dimensional speckle tracking echocardiography (2D-STE) and real-time three-dimensional echocardiography (RT-3DE), and to explore their predictive value for the occurrence and progression of atrial fibrillation.Methods:A retrospective study was conducted on 30 per-AF patients (per-AF group), 30 PAF patients (PAF group) and 25 non-AF subjects (control group) who underwent echocardiography at Wuhan University People′s Hospital from May 2022 to May 2023. The left/right atrial longitudinal strain of reservoir, conduct and contraction (LASr/RASr, LAScd/RAScd, LASct/RASct), and calculated left atrial stiffness (LASI) were assessed by 2D-STE. Three-dimensional left and right atrial maximum volume index (LAVImax/RAVImax), minimum volume index (LAVImin/RAVImin) and emptying fraction (LAEF/RAEF) were obtained by RT-3DE. Then, patients with atrial fibrillation were divided into the normal LAVI group and enlarged LAVI group, and the differences of atrial strain among each group were compared. ROC curve was used to evaluate the overall diagnostic efficiency and cutoff values of ultrasonic parameters in patients with normal volume of atrial fibrillation. Finally, a multivariate Logistic regression model was established to identify the ultrasonic parameters associated with the occurrence and progression of different types of atrial fibrillation.Results:①Structurally, LAD, RAD and RAVImin in control, PAF and per-AF groups increased gradually, while LAEF and RAEF decreased gradually (all P<0.05). ②In terms of strain, LASr in control, PAF and per-AF groups decreased gradually (all P<0.05); Compared with the control group, LAScd, RASr and RAScd in PAF and per-AF groups were significantly decreased, and LASct and RASct in PAF group were significantly decreased (all P<0.05). ③Compared with the normal LAVI group, the LASr, LAScd and LASct in the enlarged LAVI group were significantly decreased, while LASI was significantly increased (all P<0.05); Compared with control group, the left and right atrial strain parameters in LAVI normal group were decreased, and LASI was increased (all P<0.05). The atrial strain parameter ROC was constructed in all subjects with normal left atrial volume, and RASr was the most sensitive indicator.④Multi-factor Logistic regression analysis showed that LAVImin and RASr were the influence factors of PAF ( OR=1.521, 0.907; 95% CI=1.173-1.972, 0.825-0.998; P=0.002, 0.044), LASr was the influence factor of pre-AF ( OR=0.858, 95% CI=0.802-0.917, P<0.001). Conclusions:2D-STE and RT-3DE can be used to evaluate the structural and functional changes of both atria, especially LAVImin, LASr and RASr, which have certain predictive value for the occurrence and progression of atrial fibrillation.
7.Influence of gestational weight gain and preconception body mass index on overweight and obesity of school-age children
Caixia HU ; Tianfeng WU ; Hua CHEN ; Sen WANG ; Yichen CHEN ; Jiayi SHENG ; Lianghong SUN ; Xiaobin QU ; Yi ZHOU ; Pinqing BAI
Chinese Journal of Child Health Care 2024;32(3):248-254
【Objective】 To understand the prevalence of overweight/obesity among school-age children in Pudong New Area of Shanghai, and to explore the influence of gestational weight gain and pre-pregnancy body mass index (BMI) on weight status of school-age children. 【Methods】 From November to December 2020,a stratified cluster sampling method was adopted to select first-grade students from 13 primary schools in Pudong New Area of Shanghai.After matching with the birth monitoring database, 755 students with complete birth information were selected as the study subjects.The relevant information of mothers before and during pregnancy was retrospectively collected, and the effects of pregnancy weight gain combined with pre-pregnancy BMI on overweight/obesity in school-age children were analyzed. 【Results】 1) The prevalence rates of overweight and obesity of first-grade children were 15.89% and 18.41%, respectively.2) Maternal excessive weight gain during pregnancy (OR=1.678) and overweight/obesity before pregnancy (OR=2.315,2.412) were risk factors for overweight/obesity of the offspring at school age(P<0.05).3) For mothers who were underweight before pregnancy, excessive weight gain during pregnancy was associated with overweight/obesity in school-age children in their offspring (OR=7.436, 95%CI: 1.489 - 37.143,P<0.05).4) Excessive weight gain during pregnancy combined with overweight/obesity before pregnancy significantly increased the risk of overweight/obesity in offspring (OR=3.606, 95%CI: 2.030 - 6.405, P<0.05). Mothers who gained a moderate amount of weight during pregnancy and were emaciated before pregnancy had a significantly lower risk of overweight/obesity in their school-age children (OR=0.217, 95%CI: 0.049 - 0.967, P<0.05). 【Conclusion】 Excessive weight gain during pregnancy increases the risk of overweight/obesity in school-age children in their offspring, strengthening pregnancy health education and perinatal care to help pregnant women maintain appropriate weight gain during pregnancy may be an important and novel strategy to prevent childhood obesity.
8.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
9.Preparation of soluble microneedle patch with fusion protein nanoparticles secreted by Mycobacterium tuberculosis and application of tuberculosis skin test
Fan CHEN ; Rong-sheng ZHU ; Jing ZHOU ; Yue HU ; Yun XUE ; Jian-hua KANG ; Wei WANG
Acta Pharmaceutica Sinica 2024;59(6):1804-1811
Rapid epidemiological screening for tuberculosis (TB) usually uses tuberculin pure protein derivative (PPD) skin test, which has limitations such as low specificity and high side effects. ESAT-6 and CFP-10 are secreted proteins of
10.Efficacy, safety, and pharmacokinetics of capsid assembly modulator linvencorvir plus standard of care in chronic hepatitis B patients
Jinlin HOU ; Edward GANE ; Rozalina BALABANSKA ; Wenhong ZHANG ; Jiming ZHANG ; Tien Huey LIM ; Qing XIE ; Chau-Ting YEH ; Sheng-Shun YANG ; Xieer LIANG ; Piyawat KOMOLMIT ; Apinya LEERAPUN ; Zenghui XUE ; Ethan CHEN ; Yuchen ZHANG ; Qiaoqiao XIE ; Ting-Tsung CHANG ; Tsung-Hui HU ; Seng Gee LIM ; Wan-Long CHUANG ; Barbara LEGGETT ; Qingyan BO ; Xue ZHOU ; Miriam TRIYATNI ; Wen ZHANG ; Man-Fung YUEN
Clinical and Molecular Hepatology 2024;30(2):191-205
Background/Aims:
Four-week treatment of linvencorvir (RO7049389) was generally safe and well tolerated, and showed anti-viral activity in chronic hepatitis B (CHB) patients. This study evaluated the efficacy, safety, and pharmacokinetics of 48-week treatment with linvencorvir plus standard of care (SoC) in CHB patients.
Methods:
This was a multicentre, non-randomized, non-controlled, open-label phase 2 study enrolling three cohorts: nucleos(t)ide analogue (NUC)-suppressed patients received linvencorvir plus NUC (Cohort A, n=32); treatment-naïve patients received linvencorvir plus NUC without (Cohort B, n=10) or with (Cohort C, n=30) pegylated interferon-α (Peg-IFN-α). Treatment duration was 48 weeks, followed by NUC alone for 24 weeks.
Results:
68 patients completed the study. No patient achieved functional cure (sustained HBsAg loss and unquantifiable HBV DNA). By Week 48, 89% of treatment-naïve patients (10/10 Cohort B; 24/28 Cohort C) reached unquantifiable HBV DNA. Unquantifiable HBV RNA was achieved in 92% of patients with quantifiable baseline HBV RNA (14/15 Cohort A, 8/8 Cohort B, 22/25 Cohort C) at Week 48 along with partially sustained HBV RNA responses in treatment-naïve patients during follow-up period. Pronounced reductions in HBeAg and HBcrAg were observed in treatment-naïve patients, while HBsAg decline was only observed in Cohort C. Most adverse events were grade 1–2, and no linvencorvir-related serious adverse events were reported.
Conclusions
48-week linvencorvir plus SoC was generally safe and well tolerated, and resulted in potent HBV DNA and RNA suppression. However, 48-week linvencorvir plus NUC with or without Peg-IFN did not result in the achievement of functional cure in any patient.

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