1.Efficacy and safety of secukinumab in Chinese patients with psoriasis: Update of six-year real-world data and a meta-analysis.
He HUANG ; Yaohua ZHANG ; Caihong ZHU ; Zhengwei ZHU ; Yujun SHENG ; Min LI ; Huayang TANG ; Jinping GAO ; Dawei DUAN ; Hequn HUANG ; Weiran LI ; Tingting ZHU ; Yantao DING ; Wenjun WANG ; Yang LI ; Xianfa TANG ; Liangdan SUN ; Yanhua LIANG ; Xuejun ZHANG ; Yong CUI ; Bo ZHANG
Chinese Medical Journal 2025;138(23):3198-3200
2.Study on initial weight-bearing stability after internal fixation of femoral intertrochanteric fracture
Xiaomeng ZHANG ; Yanhua WANG ; Yun JI ; Yichong ZHANG ; Zhentao DING ; Xiaofeng CHEN ; Chen XIONG ; Yilin WANG ; Miaotian TANG ; Dianying ZHANG
Chinese Journal of Orthopaedics 2024;44(7):492-498
Objective:To investigate the effect of internal fixation of medial support and lateral wall on initial weight-bearing stability of femoral intertrochanteric fracture after reconstruction of intertrochanteric fracture.Methods:Based on the digital model of Sawbones femur, intertrochanteric fracture models with different medial support and lateral wall states were constructed. Combined with various intramedullary and extramedullary fixation methods, the mechanical models after fixation were simplified, and seven mechanical simplified models were obtained. The individual body weight load (70 kg) was simulated by applying concentrated force (700 N) to the end nodes of the femoral head. Through the analysis and calculation of each model in StrucMaster software, the axial force, shear force, bending moment, displacement deformation, and support reaction force of each bar in each mechanical model were obtained, and the results were output through the supporting SMConsole.Results:The median bending moment of model 1 was 11.55(5.57, 18.00) N·m, and the median bending moment was 2.89(2.81, 2.94) rad. The median bending moment of model 2 was 13.72(9.30, 20.05) N·m, and the median bending moment was 2.93(2.77, 3.05) rad. The median bending moment of model 3 was 19.65(10.23, 26.11) N·m, and the median bending moment was 2.93 (2.77, 3.05) rad. The median bending moment of model 4 was 25.95(25.14, 36.70) N·m, and the median bending moment was 4.38(3.16, 5.15) rad. The median bending moment of model 5 was 13.66(7.99, 25.62) N·m, and the median bending moment was 3.50(3.32, 3.56) rad. The median bending moment of model 6 was 24.60(9.33, 29.37) N·m, and the median bending moment was 3.90(3.69, 4.10) rad. The median bending moment of model 7 was 41.14(0.16, 41.30) N·m, and the median bending moment was 5.50(5.50, 7.05) rad. The mechanical properties of model 1 were better than those of the other six models.Conclusion:The simplified mechanical model and its mechanical calculation analysis based on the lever reconstruction balance theory can be used to preliminarily reveal the mechanical characteristics of femoral intertrochanteric fractures after internal fixation. The internal fixation methods of the medial support and lateral wall of femoral intertrochanteric fracture reconstruction can improve the initial stability of the weight bearing after internal fixation of femoral intertrochanteric fractures and have guiding significance for the functional rehabilitation of early postoperative weight bearing.
3.Effect of Coronavirus Disease 2019 infection on B-cell non-Hodgkin lymphoma
Xuanlu WU ; Xin DING ; Yanhua ZHENG ; Xiaoxue WANG
Journal of Clinical Medicine in Practice 2024;28(22):137-142
Coronavirus Disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with B-cell lymphoma may experience immunodeficiency due to the disease itself and its treatment, making them a high-risk group for susceptibility and severe outcomes of COVID-19. Therefore, it is crucial to analyze the baseline characteristics of B-cell non-Hodgkin lymphoma patients diagnosed with COVID-19, investigate common risk factors, evaluate the efficacy of vaccination and assess the immune deficiencies induced by immunotherapy, particularly CD20 monoclonal antibodies. For B-cell NHL patients with COVID-19, an individualized assessment of risk factors is necessary. This review discussed the immune response of lymphoma patients to COVID-19, summarized the characteristics of lymphoma patients following COVID-19, analyzed the vaccine effectiveness in this population, and explored the impact of COVID-19 on the onset and anti-tumor treatment of B-cell non-Hodgkin lymphoma, along with associated risk factors, aiming to provide recommendations for formulating treatment strategies and clinical management.
4.Serotypes and drug resistance of salmonella in commercial food in Pudong New Area from 2020 to 2022
Yanru LIANG ; Nuo CHEN ; Bowen YANG ; Xiao WANG ; Jin DING ; Yanhua GUI ; Huifang QIU ; Lipeng HAO ; Lifeng PAN
Shanghai Journal of Preventive Medicine 2023;35(4):374-379
ObjectiveTo understand the serotype distribution and drug resistance of salmonella contaminated in commercially available food. MethodsSalmonella detection, including the serotypes, was conducted in food products sold in Pudong New Area from 2020 to 2022. The antimicrobial susceptibility test of 15 antibiotics was conducted by the broth microassay. ResultsA total of 118 salmonella strains were detected in 2 497 pieces of food, with a total detection rate of 4.7%. The dominant detection categories were poultry meat, livestock meat and aquatic products. The 118 salmonella strains could be divided into 24 serotypes, Salmonella enteritidis (26.4%), Salmonella Typhimurium (16.2%) and Salmonella delpy (14.4%) were the main dominant types. Salmonella had the highest resistance rate to ampicillin (63.6%), followed by tetracycline, chloramphenicol, cotrimoxazole and nalidixic acid. Among the three dominant serotypes, the multidrug resistance rate of Salmonella typhimurium was the highest (89.5%), followed by Salmonella delpy (70.6%) and Salmonella enteritidis (61.3%). ConclusionLivestock, poultry meat, and aquatic products are seriously contaminated by salmonella with diverse serotypes. The livestock meat is mainly contaminated by Salmonella typhimurium and Salmonella delpy, and the poultry meat is mainly contaminated by Salmonella enteritidis. The drug resistance spectrum is wide and the multi-drug resistance rate is high. Different from the livestock and aquatic isolates, poultry meat-derived strains have high tolerance to ampicillin, nalidixic acid and polymyxin, and carry certain potential food safety risks.
5.Effect of electroacupuncture at Baihui ameliorated neurologic deficit and hemodynamic stability in rat model of post-cardiac arrest syndrome
Ruifeng ZENG ; Yuejia ZHONG ; Yanhua WU ; Peng WANG ; Chengzhi LAI ; Xiangqi LIU ; Yunbiao DUAN ; Zunjiang LI ; Tao YU ; Banghan DING
Chinese Critical Care Medicine 2022;34(12):1285-1290
Objective:To observe the results of electroacupuncture (EA) on the resuscitation of a rat model of asphyxia cardiac arrest (CA). And to explore its effect on the neurologic deficits and hemodynamic instability of post-cardiac arrest syndrome (PCAS).Methods:A total of 107 male SD rats were randomly divided into sham, CA, and EA groups. Each group received arterial catheterization and tracheal intubation. The sham group was not induced asphyxia. Asphyxial cardiac arrest was established by endotracheal tube clamping. Rats in the CA group received basic respiratory support and fluid resuscitation in return of spontaneous circulation (ROSC) and rats in the EA group received EA at Baihui based on the treatment of CA group after ROSC, with a dense-dispersed wave at frequencies of 4-20 Hz, while the current intensity was adjusted minimum to induce a twitch of the scalp, the course of treatment was 30 minutes. The baseline data, hemodynamics after ROSC, neurological deficit score (NDS), pathological changes of brain tissue, and levels of serum biomarker were recorded and compared among the three groups. The 72-hour survival of rats was analyzed by Kaplan-Meier survival curve. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of necrotic neurons in the hippocampal CA1 region of rat brain. Meanwhile, Nissl staining and TdT-mediated dUTP nick-end labeling (TUNEL) were used to detect cell apoptosis and injury.Results:Compared with the CA group, the mean arterial pressure (MAP) in the EA group increased significantly at 15 minutes after ROSC [mmHg (1 mmHg≈0.133 kPa): 125.00 (94.00, 136.25) vs. 92.00 (72.00, 122.50), P < 0.05]. There was no significant difference in the NDS score between the EA group and the sham group. Still, the NDS score of the rats in the CA group at 6 hours after ROSC were significantly lower than that in the sham group (46.00±10.61 vs. 80.00±0.00, P < 0.05). Kaplan-Meier survival curve analysis showed that EA did not improve the 72-hour survival rate of rats (100% in the sham group, 25% in the CA group, and 30% in the EA group, P > 0.05). The analysis by TUNEL showed that the apoptosis rate of neurons in CA1 region of the hippocampus in EA group at 6 hours after ROSC was significantly lower than that in CA group [(62.84±2.67)% vs. (71.29±3.70)%, P < 0.05]. Compared with the CA group, the level of serum S100 calcium binding protein B (S100B) in the EA group at 6 hours after ROSC was significantly lower (ng/L: 19.30±13.87 vs. 132.28±31.67, P < 0.05), but there were no significant differences in the levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) between these two groups. Conclusions:In the present study, EA at Baihui can stabilize the hemodynamic, moreover, it has a particular neuroprotective effect on PCAS rats. Still, EA at Baihui does not reduce the systemic inflammatory response and improve the survival rate of rats, and its mechanism remains to be verified in further research.
6.Clinical studies of new antiviral drugs for chronic hepatitis B
Hong ZHANG ; Xiaoxue ZHU ; Jiajia MAI ; Hong CHEN ; Jing ZHOU ; Yue HU ; Jia XU ; Yanhua DING
Journal of Clinical Hepatology 2021;37(5):1006-1010.
Hepatitis B virus (HBV) infection is a major global public health issue. Clinical cure (also known as functional cure) of chronic hepatitis B (CHB) is the ideal therapeutic goal recommended by the latest guidelines for the prevention and treatment of CHB in China and globally. Optimized treatment regimens with direct-acting antiviral agents [e.g., nucleos(t)ide analogues] or immunomodulators (e.g., pegylated interferon-α) sequentially or in combination tend to have low cure rates. Rapid development has been achieved in the research and development of drugs for the treatment of CHB. This article reviews the clinical study of new antiviral drugs for CHB, including the selection of subjects, study design, dosage, dose escalation, adverse events, and efficacy evaluation. It is necessary to introduce the knowledge of quantitative pharmacology to analyze the association of drug exposure in body with efficacy and adverse reactions, and exploratory indicators should be incorporated for comprehensive analysis. This review provides related experience and new ideas for the clinical research and development of new anti-HBV drugs.
7.Effects of mindfulness training on clinical efficacy in patients with nitrous oxide addiction
Jie XU ; Pei SUN ; Jie LI ; Yu LIU ; Lu YIN ; Lianyong DU ; Jihuan XIA ; Hui DING ; Junyong XUE ; Yanhua LU
Chinese Journal of Behavioral Medicine and Brain Science 2021;30(4):305-309
Objective:To study the effect of mindfulness-based training intervention on clinical efficacy in patients with nitrous oxide(laughing gas) addiction.Methods:From June 2019 to June 2020, sixty-six patients with nitrous oxide addiction in Beijing Gaoxin Hospital were selected and randomly divided into experimental group( n=33) and control group( n=33). The control group received Taijiquan training and physical training, while the experimental group added mindfulness-based training intervention on the basis of Taijiquan training and physical training.Symptom checklist 90 (SCL-90) scores and visual analog scales (VAS) craving scores were compared between the two groups at admission and 8 weeks after treatment.SPSS 22.0 software was used for statistical analysis.Independent sample t test and paired sample t test were used to compare the differences between groups and within groups. Results:(1)Before treatment, there were no significant differences in subscale scores of SCL-90 between the two groups except for depression factor((2.45±0.86), (2.03±0.46), t=2.474, P<0.05). After treatment, the subscale scores of somatization((1.38±0.35), (1.68±0.34), t=-3.656, P<0.05), phobic anxiety((1.49±0.37), (1.81±0.30), t=-3.993, P<0.05), paranoid ideation((1.50±0.47), (1.88±0.31), t=-3.898, P<0.05) and psychotism((1.34±0.54), (1.55±0.27), t=-3.094, P<0.05) of SCL-90 in the experimental group were significantly lower than those in the control group.(2)Before treatment, there was no significant difference in VAS craving score between the two groups( t=0.857, P=0.395). After treatment, the score of VAS in the experimental group was significantly lower than that in the control group( t=27.427, P<0.05). Conclusion:Mindfulness training intervention can effectively improve the clinical symptoms of patients with nitrous oxide addiction, which is worthy of clinical application.
8.The effect of ozone water on repairing articular cartilage of knee osteoarthritis and its influence on NF-κB signaling pathway
Mingyue TIAN ; Xiaofen DING ; Songchen HAN ; Zhimeng YANG ; Yanhua LI ; Mengya JIA ; Youlong ZHOU
Chinese Journal of Orthopaedics 2021;41(23):1717-1725
Objective:To observe the repairing effect of ozone water injection in the articular cavity for the treatment of knee osteoarthritis (KOA) on articular cartilage and to explore its repair mechanism.Methods:48 rats were randomly divided into fourgroups, the normal, model, normal saline and ozone water group, each group had 12 rats. The rats were injectied into the joint cavity with papain to establish a KOA model other than the normal group. After confirming the success of the model, the ozone water group and normal saline group was treated with ozone water and normal saline injection into the joint cavity once a week for a total of 3 treatments, the normal group and the model group are all raised routinely. Before and after the treatment, the ratknee joint behavioral score MG score was conducted; after the treatment articular cartilage surface gross score, hematoxylin and eosin (HE) staining and modified Mankin score of articular cartilage pathological changes was measured, and Western blot and Rt-PCR to measure the level of protein and mRNA expression of NF-κB p65, IKKβ and IκBα in articular cartilage tissues.Results:Compared with before the treatment, the rat knee joint behavioral score of the ozone water group was significantly lower (all P<0.05); after the treatment, the gross articular cartilage surface score and the modified Mankin score of the ozone water group were significantly reduced compared with the model and normal saline group (all P<0.05); Compared with the model and normal saline group, the protein and mRNA expression levels of NF-κB p65 and IKKβ in the ozone water group are significantly lower (all P<0.05), and the levels of IκBα are significantly higher (all P<0.05). Conclusion:Ozone water injection in the articular cavity can effectively repair damaged articular cartilage. The repair mechanism may be achieved by inhibiting the activation of NF-κB signaling pathway.
9.Tolerance and pharmacokinetics of coblopasvir hydrochloride capsules in patients with hepatitis C virus infection
Jinfeng LOU ; Hong ZHANG ; Huan WANG ; Jifeng SHI ; Yanhua DING ; Junqi NIU ; Xiaoxue ZHU
Journal of Clinical Hepatology 2021;37(6):1304-1308
ObjectiveTo investigate the tolerance, pharmacokinetics, and antiviral activity of coblopasvir hydrochloride capsules in patients with hepatitis C. MethodsA total of 36 patients with hepatitis C who were admitted to The First Hospital of Jilin University from November 2016 to January 2017 were enrolled as subjects, and four dose groups (30 mg, 60 mg, 90 mg, and 120 mg) and one placebo group were established. The subjects were administered once daily for 3 consecutive days; tolerance was evaluated on D2 and D6, and follow-up was performed on D8 and D10. The subjects were enrolled based on single dose escalation, and a multiple-dose study was conducted under the premise of good tolerance to single dose. Liquid chromatography-tandem mass spectrometry was used to measure the plasma concentration of coblopasvir hydrochloride in human body, and WinNonlin 6.4 software was used to calculate main pharmacokinetic parameters. HCV RNA load was used to evaluate antiviral activity at different time points; a one-way analysis of variance was used for comparison between multiple groups, and the LSD t-test was used for further comparison between two groups. ResultsAfter coblopasvir hydrochloride capsules were administered orally once a day at a dose of 30-120 mg, the plasma concentration and exposure of coblopasvir hydrochloride increased with the increase in dose. There were no significant differences in plasma concentration and exposure between multiple-dose administration and single-dose administration in a fasting state, without accumulation in human body. After the oral administration of coblopasvir hydrochloride capsules once a day, the subjects with HCV genotype 1b had a reduction in HCV RNA load since baseline, with the lowest level at 120 hours, and there was a significant difference in antiviral activity between different dose groups (F=14.621, P<0.000 1), among which the 60 mg group had a significantly greater reduction than the 30 mg group (P=0.025), while there was no significant difference between the 60 mg group and the 90/120 mg group (P>0.05). There was no significant difference in HCV RNA load between different groups of patients with HCV genotype 2a (P>0.05). Of all 36 subjects, 20 reported 34 cases of treatment-emergent adverse events, among which 19 cases were associated with coblopasvir hydrochloride, and no significant adverse events or serious adverse events were observed. ConclusionOral administration of coblopasvir hydrochloride capsules in a fasting state at a dose of 30-120 mg/d (for 3 consecutive days) has good safety and antiviral activity. Therefore, it has good application prospect in the treatment of HCV infection and provides a basis for dose selection in phrase 2 study.
10.Clinical considerations in the design of clinical trial for innovative hepatitis B drugs
Junqi NIU ; Hong ZHANG ; Hong YOU ; Yanhua DING ; Ruihua DONG ; Jinlin HOU ; Jidong JIA
Chinese Journal of Hepatology 2020;28(8):654-657
The research and development of chronic hepatitis B (CHB) therapeutic drugs has been undergoing rapid development in recent years in order to achieve the World Health Organization's goal of eliminating viral hepatitis as a major public health threat by 2030. The focus of early stage clinical trials (including the first human trial) is the selection of subjects, study design, dose selection, administration method, dose escalation, monitoring, observation and reporting procedures for adverse events/reactions (tolerability evaluation), and criteria for subjects to continue and discontinue administration. Therefore, quantitative pharmacology knowledge is required to analyze the relationship between in vivo drug exposure, efficacy and adverse reactions, and the inclusion of exploratory indicators such as HBV RNA, hepatitis B virus core-related antigen (HBcrAg), etc., to analyze the mechanism and target of innovative drugs and the efficacy of cccDNA in anti-hepatocytes. On the other hand, Phase II-III clinical trials prioritize the optimal dose, efficacy and safety indicators to verify the efficacy and safety of new drugs in a wider range of subjects. This paper refers to the relevant domestic and foreign literature, combined with the author's practical experience in early clinical research, and then briefly introduces the clinical issues that should be paid attention to in the design of clinical trials of CHB innovative drugs.


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