1.Experience of the use of cerebral embolic protection device during transcatheter aortic valve replacement.
Lan ZHANG ; Xinmin LIU ; Ziwei XI ; Fei YUAN ; Jing YAO ; Zhengming JIANG ; Yunfeng YAN ; Guangyuan SONG
Journal of Zhejiang University. Medical sciences 2025;54(4):541-548
OBJECTIVES:
To evaluate the feasibility, efficacy and safety of Sentinel cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR). This study is a subgroup analysis of the China Moderate to Severe Valvular Heart Disease Registry, which has been registered at the Chinese Clinical Trial Registry (ChiCTR2300075006).
METHODS:
Patients undergoing TAVR with the Sentinel CEPD from October 2023 to September 2024 were retrospectively enrolled. A total of 80 patients were included, with a median age of 72 (68, 76) years, including 52 males (65.0%) and 28 females (35.0%); 62 patients (77.5%) with tricuspid valves, and 18 patients (22.5%) with bicuspid valves; 34 patients (42.5%) with type Ⅰ aortic arch, 24 patients (30.0%) with type Ⅱ aortic arch, 12 patients (15.0%) with type Ⅲ aortic arch, and 10 patients (12.5%) with bovine-type aortic arch. Clinical data of the patients were summarized and analyzed. The primary endpoints were success rate of Sentinel CEPD implantation, as well as all-cause death, symptomatic stroke, transient ischemic attack, and Sentinel CEPD access vessel complications during hospitalization and within 30 days postoperatively.
RESULTS:
In the 80 patients, self-expanding valves were used in 68 cases (85.0%) and balloon-expandable valves in 12 cases (15.0%). Seventy-nine patients (98.8%) successfully underwent TAVR with Sentinel CEPD deployment. Macroscopically visible debris was captured in 92.5% (74/80) by filters of Sentinel CEPD. Although the procedure time for Sentinel CEPD placement was slightly longer in patients with bovine-type aortic arch, there was no statistically significant difference in deployment time among different aortic arch types (P>0.05). During hospitalization and within 30 days postoperatively, only one case of transient ischemic attack occurred, and there was no all-cause mortality, symptomatic stroke, or access-site vascular complications related to the Sentinel CEPD observed.
CONCLUSIONS
The Sentinel CEPD demonstrates high feasibility across aortic arch types, potential efficacy in embolic capture, and excellent safety in TAVR.
Humans
;
Transcatheter Aortic Valve Replacement/adverse effects*
;
Male
;
Female
;
Aged
;
Embolic Protection Devices
;
Retrospective Studies
;
Intracranial Embolism/prevention & control*
;
Aged, 80 and over
;
Aortic Valve Stenosis/surgery*
;
Aortic Valve/surgery*
2.Progress on structural abnormalities in the cerebral cortex in children with attention deficit/hyperactivity disorder
Haixia YUAN ; Xinmin HAN ; Tianyi CHEN ; Yuchen SONG
The Journal of Practical Medicine 2024;40(10):1455-1459
Neuroimaging is increasingly widely used in the field of ADHD research,and more and more studies have shown that ADHD patients have structural abnormalities such as reduced cortical volume,thinning thickness,and reduced surface area,which are related to complex clinical symptoms and abnormal brain function in patients.However,the use of neuroimaging to identify biomarkers as an objective diagnostic tool for ADHD still faces many challenges.Multimodal studies can be used to explore the relationship between the structure and function of different brain regions in ADHD patients,and to use neuroimaging to reveal the mechanism of the evolution of clinical symptoms in the whole life cycle of ADHD patients.
3.Early Identification and Successful Thrombectomy in a Patient With Acute Cerebral Infarction Following Transcatheter Aortic Valve Replacement
Fei YUAN ; Qiang LI ; Xinmin LIU ; Lifeng WANG ; Jing YAO ; Taiyang LUO ; Zhengming JIANG ; Guangyuan SONG
Chinese Circulation Journal 2024;39(8):813-815
Transcatheter aortic valve replacement(TAVR)is one of the most important guideline-recommended procedures for severe symptomatic aortic stenosis.Acute cerebral infarction is a serious complication after TAVR,with a high incidence rate and may significantly affect patient prognosis and quality of life.Thrombolysis and mechanical thrombectomy are standard treatments for acute cerebral infarction recommended by guidelines,but evidence of their efficacy and safety in patients undergoing TAVR is limited.We report a patient with acute cerebral infarction after TAVR,who were treated with emergency cerebral angiography and successful transcatheter thrombectomy.
4.TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children
Xi MING ; Liqun WU ; Ziwei WANG ; Bo WANG ; Jialin ZHENG ; Jingwei HUO ; Mei HAN ; Xiaochun FENG ; Baoqing ZHANG ; Xia ZHAO ; Mengqing WANG ; Zheng XUE ; Ke CHANG ; Youpeng WANG ; Yanhong QIN ; Bin YUAN ; Hua CHEN ; Lining WANG ; Xianqing REN ; Hua XU ; Liping SUN ; Zhenqi WU ; Yun ZHAO ; Xinmin LI ; Min LI ; Jian CHEN ; Junhong WANG ; Yonghong JIANG ; Yongbin YAN ; Hengmiao GAO ; Hongmin FU ; Yongkun HUANG ; Jinghui YANG ; Zhu CHEN ; Lei XIONG
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(7):722-732
Following the principles of evidence-based medicine,in accordance with the structure and drafting rules of standardized documents,based on literature research,according to the characteristics of chronic cough in children and issues that need to form a consensus,the TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children was formulated based on the Delphi method,expert discussion meetings,and public solicitation of opinions.The guideline includes scope of application,terms and definitions,eti-ology and diagnosis,auxiliary examination,treatment,prevention and care.The aim is to clarify the optimal treatment plan of Chinese medicine in the diagnosis and treatment of this disease,and to provide guidance for improving the clinical diagnosis and treatment of chronic cough in children with Chinese medicine.
5.Bibliometric analysis of active surveillance of post-marketing drug safety
Conghui WANG ; Ziming YANG ; Zhenxing WANG ; Wei SHI ; Hua ALATENG ; Chengwei XI ; Songning PI ; Xinmin YUAN ; Siyan ZHAN
Chinese Journal of Pharmacoepidemiology 2024;33(9):1054-1063
Objective To conduct bibliometric visualization analyses of the literature domestic and overseas on active surveillance of post-marketing safety of drugs,aiming to display the current status and trend of hotspots in this field and to provide references for future research and the improvement of the Chinese management system of active surveillance.Methods The English and Chinese literature on active surveillance of post-marketing safety of drugs were searched in Web of Science and CNKI respectively and imported into CiteSpace 6.3.R2 software for the analysis of the number of publications,authors,institutions,and national cooperative networks,and the analysis of keyword co-occurrence,clustering and emergence.Results 415 Chinese and 676 English literature were included,with an overall increasing trend in annual publication volume.The author collaboration network of Chinese literature was smaller than that of English literature,and the partnership network was sparse,with no strong centralized institution.Domestic drug regulatory agencies played an important role in the field,while drug companies'monitoring research on their own products was still relatively scarce.The research topic covered active surveillance systems,technical method research,and drug safety active surveillance practice research for specific drugs and diseases.Conclusion Countries worldwide have widely considered active surveillance of post-marketing drug safety.The heat of research activities in China has shown a significant growth trend.However,there is still a significant gap compared with the international frontiers.Further cooperation needs to be strengthened to promote the improvement of the active surveillance management system in China.
6.Randomized, Double-blind, Single-simulation, Placebo-controlled, Multicenter Clinical Trial of An'erning Granules in Reducing Use of Antibiotics for Children's Community-acquired Pneumonia
Ruili WEI ; Jian LYU ; Xinmin LI ; Farong YUAN ; Lianxin WANG ; Liqun WU ; Ying DING ; Mengqing WANG ; Baoqing ZHANG ; Zheng XUE ; Yongsheng XU ; Jingxiao ZHANG ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(19):105-114
ObjectiveTo evaluate the efficacy and safety of An'erning granules in the treatment of community-acquired pneumonia in children. MethodA randomized, double-blind, single-simulation, placebo-controlled trial was designed in this study. The children were randomly assigned into an observation group (An'erning granules combined with ceftriaxone sodium) and a control group (An'erning granules placebo combined with ceftriaxone sodium) according to the ratio of 2∶1. The disease cure rate was taken as the main indicator of efficacy, and the safety of An'erning granules was observed. ResultA total of 206 children (137 in the observation group and 69 in the control group) were included in this study. Before treatment, the age, sex, body height, body weight, diagnosis time of pneumonia, and symptom and sign scores had no significant differences between the two groups. After 8 days of continuous medication, the observation group[70.80%(97/137)] had higher cure rate than the control group[56.52%(39/69)](χ2=4.17,P<0.05) and total effective rate of chest X-ray [97.98%(97/99)] than the control group[86.27%(44/51)] (χ2=12.98,P<0.01). The observation group was superior to the control group in the alleviation of TCM syndrome under the condition of 0-3 g dose stratification on day 3 of medication (P<0.01). The recovery time, time to complete fever abatement, time to fever abatement and expectoration alleviation, rate of conversion to severe case, and reduction in the frequency of antibiotic use showed no significant differences between the two groups. In terms of safety, 13 and 7 adverse events occurred in the observation group and control group, respectively, which were relieved or disappeared after drug withdrawal or symptomatic treatment and showed no significant difference between the two groups. ConclusionIntravenous drip of ceftriaxone sodium combined with An'erning granules is effective in the treatment of community-acquired pneumonia in children. It can accelerate the absorption of pulmonary inflammation, alleviate the clinical symptoms in a short time for young children or the children with mild symptoms, and is safe in clinical application.
7.Cardiac rehabilitation for patients with aortic stenosis undergoing transcatheter aortic valve replacement
Ran LIU ; Tingting YAN ; Qi CHEN ; Jing YAO ; Xinmin LIU ; Taiyang LUO ; Fei YUAN ; Wenhui WU ; Chengqian YIN ; Zhinan LU ; Guangyuan SONG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(12):1567-1573
Aortic stenosis (AS) is the most common primary valve lesion requiring surgery or transcatheter intervention in modern era. Its prevalence is rising rapidly as a consequence of the aging population. Transcatheter aortic valve replacement (TAVR) as a therapy option for older high-risk symptomatic severe AS patients has emerged and is currently extending its indications towards surgery intermediate- and low-risk subjects. Considering the common characteristics of frailty and high comorbidity among AS patients, cardiac rehabilitation (CR) has been proven to improve not only survival but also quality of life in previous reports. CR as a classⅠ recommendation in guidelines for the prevention and treatment of cardiovascular disease has been widely used in clinical practice. The purpose of this article is to sort out the current CR programs for TAVR patients in global medical management, and explore the CR optimization program fit for China medical model in post COVID-19 pandemic era.
8.Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients (version 2022)
Tao SUI ; Jian CHEN ; Zhenfei HUANG ; Zhiyi HU ; Weihua CAI ; Lipeng YU ; Xiaojian CAO ; Wei ZHOU ; Qingqing LI ; Jin FAN ; Qian WANG ; Pengyu TANG ; Shujie ZHAO ; Lin CHEN ; Zhiming CUI ; Wenyuan DING ; Shiqing FENG ; Xinmin FENG ; Yanzheng GAO ; Baorong HE ; Jianzhong HUO ; Haijun LI ; Jun LIU ; Fei LUO ; Chao MA ; Zhijun QIAO ; Qiang WANG ; Shouguo WANG ; Xiaotao WU ; Nanwei XU ; Jinglong YAN ; Zhaoming YE ; Feng YUAN ; Jishan YUAN ; Jie ZHAO ; Xiaozhong ZHOU ; Mengyuan WU ; Yongxin REN ; Guoyong YIN
Chinese Journal of Trauma 2022;38(12):1057-1066
Osteoporotic thoracolumbar fracture in the elderly will seriously reduce their quality of life and life expectancy. For osteoporotic thoracolumbar fracture in the elderly, spinal reconstruction is necessary, which should comprehensively consider factors such as the physical condition, fracture type, clinical characteristics and osteoporosis degree. While there lacks relevant clinical norms or guidelines on selection of spinal reconstruction strategies. In order to standardize the concept of spinal reconstruction for osteoporotic thoracolumbar fracture in the elderly, based on the principles of scientificity, practicality and progressiveness, the authors formulated the Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients ( version 2022), in which suggestions based on evidence of evidence-based medicine were put forward upon 10 important issues related to the fracture classification, non-operative treatment strategies and surgical treatment strategies in spinal reconstruction after osteoporosis thoracolumbar fracture in the elderly, hoping to provide a reference for clinical treatment.
9.Effects of allicin on the biological behavior of vascular endothelial cells and epidural scar
Yujie ZHANG ; Jiandong YANG ; Jingcheng WANG ; Jun CAI ; Xinmin FENG ; Shoulei ZHU ; Yuan TIAN
Chinese Journal of Orthopaedics 2021;41(10):633-643
Objective:To investigate the effects of allicin on the proliferation, migration and angiogenesis of rat vascular endothelial cells (RVES), and to explore the influencing mechanism of allicin on epidural fibrosis.Methods:According to the results of preliminary experiments, RVECs were divided into control group (0 mg/L), low concentration group (25 mg/L), medium concentration group (50 mg/L) and high concentration group (100 mg/L). The morphology, viability, migration rate, cell cycle, apoptosis rate and cell lumen formation ability were measured using fluorescence microscope, AnnexinV-FITC double staining, PI/RN-asestaining, scratch assay and Transwell experiments test. Western Blot was used to measure the protein expression level of JAK2, STAT3, p-STAT3, PCNA, Bax and Bcl-2 protein. Using random number method, 36 adult male SD rats were divided into sham operation group, saline group and allicin group, with 12 rats in each group. Hematoxylin-eosin (HE) staining, Masson staining and immunohistochemical staining were used to analysis the epidural fibrosis in each group.Results:With the increase of concentration of allicin, cell viability, cell migration and lumen formation ability significantly lower than that of control group ( P<0.05). With the increase of allicin concentration, the percentage of cells in the G1 and S phases gradually decreased ( P<0.05), the percentage of cells in the G2 phase and the apoptosis rate gradually increased ( P<0.05), and the cells were blocked in the G2/M phase. With the increase of allicin concentration, the protein expression levels of JAK2, STAT3, p-STAT3, PCNA and Bcl-2 were gradually down-regulated ( P<0.05), while the protein expression level of Bax was gradually up-regulated ( P<0.05), the ratio of p-STAT3/STAT3 was decreased ( P<0.05), and the ratio of Bax/Bcl-2 was increased ( P<0.05). There was no death, infection or abnormal gait in all the experimental animals. Dense scar tissue could be observed in the extradural area of the sham operation group and the epidural area of the control group, but there was obvious space between the epidural scar and the dura mater in the allicin group, and the density of collagen, the number of blood vessels, and the protein density of p-STAT3 were significantly lower than those in the control group ( P<0.05). Conclusion:Allicin inhibits angiogenesis and the severity of epidural scar after laminectomy, and the mechanism may be through inhibiting the JAK2/STAT3 signaling pathway of vascular endothelial cells.
10. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin in Asian adult patients with chronic HCV genotype 1b infection and compensated cirrhosis
Lai WEI ; Guiqiang WANG ; Kopecky-Bromberg SARAH ; Jun CHENG ; Qing XIE ; Maorong WANG ; Min XU ; Zhongping DUAN ; Jinlin HOU ; Mingxiang ZHANG ; Yuexin ZHANG ; Hong TANG ; Wei ZHAO ; Shumei LIN ; Zhansheng JIA ; Junqi NIU ; Zhiliang GAO ; Hong YUAN ; Minghua LIN ; Xinmin ZHOU ; Yan LUO ; Fredrick LINDA ; Mobashery NILOUFAR ; Ye WANG ; Jidong JIA
Chinese Journal of Hepatology 2018;26(5):353-358
Objective:
To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis.
Methods:
An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs.
Results:
A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal.
Conclusion
Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.

Result Analysis
Print
Save
E-mail