1.Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5–24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study
Lu WANG ; Ying-Jie DAI ; Yu CUI ; Hong ZHANG ; Chang-Hao JIANG ; Ying-Jie DUAN ; Yong ZHAO ; Ye-Fang FENG ; Shi-Mei GENG ; Zai-Hui ZHANG ; Jiang LU ; Ping ZHANG ; Li-Wei ZHAO ; Hang ZHAO ; Yu-Tong MA ; Cheng-Guang SONG ; Yi ZHANG ; Hui-Sheng CHEN
Journal of Stroke 2023;25(3):371-377
Background:
and Purpose Intravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset.
Methods:
In this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5–24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0–1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH).
Results:
Of the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46–2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0–2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group.
Conclusion
This phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5–24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.
2.Association of FokI rs2228570 and TMPRSS6 rs855791 polymorphisms with cow's milk protein allergy in children.
Ye ZHANG ; Yong GUO ; Jian MA ; Xu-Zai LU ; Xian-Qiong LUO
Chinese Journal of Contemporary Pediatrics 2018;20(8):641-646
OBJECTIVETo study the association of polymorphisms of FokI rs2228570 in the vitamin D receptor (VDR) gene and TMPRSS6 rs855791 with cow's milk protein allergy (CMPA) in children.
METHODSQuantitative real-time PCR was used to analyze the single nucleotide polymorphisms of FokI rs2228570 in the VDR gene and TMPRSS6 rs855791 in 100 children with CMPA and 100 healthy children (control group). The multivariate logistic regression model was used to identify the risk factors for CMPA.
RESULTSThere were significant differences in the frequencies of CC, CT, and TT genotypes of TMPRSS6 rs855791 between the CMPA and control groups (P=0.008), and the CMPA group had a significantly higher frequency of TT genotype. The multivariate logistic regression analysis showed that the children with TT genotype of rs855791 had an increased risk of CMPA (OR=3.473, P=0.011). However, there was no significant difference in the genotype distribution of FokI rs2228570 in the VDR gene between the two groups (P=0.686).
CONCLUSIONSTMPRSS6 rs855791 polymorphism is associated with CMPA in children, and TT genotype may be the susceptible genotype of CMPA. FokI rs2228570 polymorphism is not associated with CMPA.
3.Efficacy and Safety of the WATCHMAN Left Atrial Appendage System for Stroke Prevention in Chinese Patients with Nonvalvular Atrial Fibrillation: A Single-center, Prospective, Observational Study.
Wei-Ping HUANG ; Yong-Hua ZHANG ; Lei HE ; Xi SU ; Xin-Wei YANG ; Zai-Xiong GUO
Chinese Medical Journal 2017;130(4):434-438
BACKGROUNDIn patients with nonvalvular atrial fibrillation (NVAF), embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. The WATCHMAN LAA Occlusion Device has been shown to be noninferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with NVAF. This study aimed to evaluate the procedural feasibility, safety and 12-month outcomes of the WATCHMAN LAA Occlusion Device in NVAF patients with high risk for stroke in China.
METHODSThe clinical data of 106 NVAF patients, who were consecutively underwent LAA closure with the WATCHMAN Device between April 2014 and May 2015, were collected. Patients were followed up at 1, 3, 6, and 12 months after discharge. A transesophageal echocardiograph was performed at 45 days after implantation and repeated in case of an unexpected event during the follow-up period.
RESULTSThis study included 106 NVAF patients with a mean age of 64.2 ± 8.6 years (ranging from 50 to 88 years), and the mean CHA2DS2-VASc score of all patients was 3.6 ± 1.6 (ranging from 2 to 9). Among those 106 NVAF patients, 100 (94.3%) patients were implanted with the device successfully. The procedural success rate was 94.3% (100/106), and the occlusion rate was 100.0% (100/100). There were one tamponade, one ischemic stroke, and eight minor pericardial effusions during hospitalization. During 12-month follow-up period, two patients developed a thrombus layer on the device that resolved with additional anticoagulation: one with visible device-thrombus experienced transient ischemic stroke, and one had a hemorrhagic stroke. There were no deaths in this study. The overall survival rate was 100.0%, and nonmajor adverse event rate was 95.0% (95/100). In this study, the expected annual rate of ischemic stroke risk in these patients according to the CHA2DS2-VASc score was 4.0%, while the observed ischemic stroke rate was 2.0% per year.
CONCLUSIONSLAA closure with the WATCHMAN Device was feasible, efficient, and safe for NVAF to prevent the accidence of stroke in Chinese patients. During the 12-month follow-up period, the observed ischemic stroke rate (2.0% per year) in our study was lower than the predicted annual stroke risk (4.0%) using the CHA2DS2-VASc score.
Aged ; Aged, 80 and over ; Atrial Appendage ; surgery ; Atrial Fibrillation ; complications ; Cardiac Surgical Procedures ; methods ; China ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Prosthesis Implantation ; adverse effects ; methods ; Stroke ; prevention & control
4.Impacts of the regional cooperative chest pain center on the therapeutic time and the short term outcome of patients with ST segment elevated myocardial infarction
qin Guo CHEN ; hao Jian LI ; zhu Wen ZHANG ; yong Jia LIANG ; yong Zai ZHANG ; dong Han LEI ; cai Ming SONG
Chinese Journal of Interventional Cardiology 2017;25(10):579-583
Objective To investigate the impact of the regional cooperative chest pain center (CPC) on therapeutic time and short term outcome after primary percutaneous coronary intervention (PCI) of patients with ST segment elevated myocardial infarction.Methods 372 patients with ST segment elevated myocardial infarction were enrolled in the study who had received were operated primary PCI 18 months before and after the regional cooperative CPC was set up.There were 156 patients in the green channel group before the setup of CPC and 216 patients in the CPC group.Total ischemia time,first medical contact (FMC) time,FML-to-balloon (FMC2B) time,door-to-balloon (D2B) time,hospital mortality rates,cardiac failure rates on the next day after PCI,length of CCU stays and hospital stays were compared between the two groups.Results Compared to the green channel group,total ischemia time[(281.0±102.7)min vs.(365.2±115.6)min,P<0.05],FMC time [(174.3±97.5) min vs.(225.4±104.6) min,P<0.05],FMC2B time [(106.7±61.2) min vs.(139.8±75.7) min,P<0.05] and D2B time [(75.2±45.4) min vs.(102.4±53.7) min,P<0.05] of the CPC group were significant shorter.The rates of reaching the standard of FMC2B time (70.83% vs.34.62%,P<0.001) and D2B time (75.93% vs.40.38%,P<0.001)were significantly higher in the CPC group.Cardiac failure rates on the next day after PCI was lower in the CPC group (14.35% vs.23.72%,P=0.021),and CCU stays was shorter [(64.3±13.72)h vs.(92.6±15.65)h,P=0.043].Conclusions Establishment of a standardized regional cooperative CPC requires combination and consideration of the characteristics of local resources FMC2B time and D2B time of STEMI patients can be shorten by a standardized CPC lending to further shortening of total ischemia time and improvement in cardiac function.
5.Studies on flavonoids from Derris eriocarpa.
Lun-xing WANG ; Hong-guo WU ; Hua ZHANG ; Hua-yong LOU ; Guang-yi LIANG ; Wen-wen JIANG ; Zai-chang YANG ; Wei-dong PAN
China Journal of Chinese Materia Medica 2015;40(15):3009-3012
Derris eriocarpa, a traditional Chinese medicine belonging to the family of Leguminosae, is widely distributed mainly over Yunnan, Guangxi and Guizhou of China. Modern pharmacological researches on this herb showed that it had extensive bioactivities, such as promoting urination, removing dampness and cough and reducing inspissated mucus and other biological activities. The extensive studies on the chemical constituents of this plant have resulted in the isolation of triterpenoids, steroids, fatty acid and others, but the flavone compounds haven't reported before. In our further research on the ethyl acetate of this plant, nine flavone compounds were obtained by column chromatography on silica gel, Sephadex LH-20, semi-prep HPLC, polyamide column chromatography and recrystallization for separation and purification. The structures were determined on the basis of extensive spectroscopic analysis, including MS, NMR experiments and comparison with spectroscopic data in the literature, respectively, as diosmetin (1), 3, 3'-di-O-methylquercetin (2), afromosin (3), 6, 3'-dihydroxy-7, 4'-dimethoxyisoflavone (4), odoratin (5), 7, 3'-dihydroxy-8, 4'-dimethoxyisoflavone (6), 6, 4'-dihydroxy-7, 3'-dimethoxyisoflavone (7), 5, 7, 4'-trihydroxy-3, 3', 5'-trimethoxyflavone (8), and alpinumisoflavone (9). All these compounds were isolated from Derris eriocarpa How for the first time. And the in vitro assays showed that compound 2 possessed moderate inhibitory activity against human cancer cells K562 and HEL.
Derris
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chemistry
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Flavonoids
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chemistry
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isolation & purification
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pharmacology
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Humans
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K562 Cells
6.Multilayer stents, a new progress in the endovascular treatment of aneurysms.
Yong-xue ZHANG ; Qing-sheng LU ; Zai-ping JING
Chinese Medical Journal 2013;126(3):536-541
OBJECTIVETo review the recent progress of multilayer stents in treating arterial aneurysms and to draw an initial conclusion about its paradigm.
DATA SOURCESPubMed database and ELSEVIER database were searched with the keywords "cardiatis" or "multilayer stent" for relevant articles from January 2008 to September 2012. Relevant websites (provided by Cardiatis) were also involved in the review process.
STUDY SELECTIONWell-controlled, relatively large-scale, retrospective studies as well as meaningful individual cases were all selected as materials.
RESULTSA total of 23 articles were involved in this review. The newly introduced Cardiatis multilayer stent aims at creating an active flow-modulating barrier between normal blood flow and aneurismal sac, which can induce thrombosis within aneurismal sac and preserve collateral circulation at the same time. Currently, it has been applied for complicated aneurysms located in different segments of the arterial system.
CONCLUSIONThis new concept of multilayer uncovered stent offers a promising alterative in the treatment of arterial aneurysms. However, a further large-scale clinical and hemodynamic study is required to evaluate the long-term effects.
Aneurysm ; physiopathology ; therapy ; Databases, Factual ; Hemodynamics ; physiology ; Humans ; Retrospective Studies ; Stents
7.Acceptability of pre-exposure prophylaxis among female sex workers in Xinjiang.
Zhen ZHAO ; Yong SUN ; Qian XUE ; Fan-liang MENG ; Ting ZHAO ; Yinuer ZAI ; Hong-fang ZHOU ; Ying-hua ZHANG ; Jiang-hong DAI ; Ai-long HUANG
Journal of Zhejiang University. Medical sciences 2011;40(3):281-285
OBJECTIVETo assess the acceptability of pre-exposure prophylaxis (Pr-EP) among the female sex workers in Xinjiang.
METHODSA volunteer-based, anonymous and one-to-one questionnaire survey was conducted in 762 female sex workers (FSW) in Urumqi and Kelamayi of Xinjiang Uyghur Autonomous Region.
RESULTAmong 762 FSW surveyed, 673 (88.32%) was not aware of pre-exposure prophylaxis with an awareness rate of 11.55%. The awareness rate of FSWs working in high-end entertainment venues was higher than that of FSWs working in medium-low end entertainment venues(P<0.001). Five hundred and twenty eight FSWs (69.29%) were willing to take Pr-EP, 145 (19.03%) were unwilling to take the medicine and 89 (11.68%) were possible to use the Pr-EP. There was no significant difference in willingness of using Pr-EP among FSWs working in high and medium-low end entertainment venuew (P=0.285). The subjects who were willing to take Pr-EP mainly concerned of the drug security, effectiveness and cost. The main reasons for not willing to take Pr-EP were: not having risk of infecting HIV, suspecting effectiveness of Pr-EP and worrying about side effects.
CONCLUSIONThe acceptability to use Pr-EP in female sex workers of Xinjiang is relatively high and the drug security, effectiveness and cost will influence the promotion and application of Pr-EP in the future.
Adult ; Chemoprevention ; China ; Female ; HIV Infections ; prevention & control ; Health Knowledge, Attitudes, Practice ; Humans ; Patient Acceptance of Health Care ; Sex Work ; Surveys and Questionnaires ; Young Adult
8.Clinical characteristics and outcome comparison between young (≤ 45 years) female and male patients with coronary artery disease undergoing percutaneous coronary intervention
Jing-Han HUANG ; Shu-Bin QIAO ; Bo XU ; Jian-Jun LI ; Jue CHEN ; Hai-Bo LIU ; Yue-Jin YANG ; Min YAO ; Yong-Jian WU ; Jin-Qing YUAN ; Xue-Wen QIN ; Yuan WU ; Jun DAI ; Shi-Jie YOU ; Feng-Huan HU ; Wei-Hua MA ; Jie QIAN ; Pei ZHANG ; Ke-Fei DOU ; Ji-Lin CHEN ; Zai-Jia CHEN ; Run-Lin GAO
Chinese Journal of Cardiology 2010;38(3):248-251
Objective To compare the clinical characteristics and clinical outcomes in young (≤45 years) female and male coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). Methods Angiographic and clinical data from 124 premenopausal female patients who underwent elective PCI from April 2004 to February 2008 were compared to age-matched 430 male patients who underwent elective PCI between 2006 and 2007 in our department. All patients were treated according to guidelines and coronary angiography was repeated after 6 months. One year clinical follow-up were performed in all patients. Results Incidences of dyslipidemia, the history of myocardial infarction and smoking were significantly lower in female patients than in male patients (all P < 0.01 ). Left main, left anterior descending and bifurcation lesions were more common while type C lesion and right coronary lesion were less common in young female CAD group compared to young male CAD group (P <0. 01 -0. 05). The average lesion length in female patients was significantly longer than that in male patients [ (20. 36±13.37)mm vs.( 23.04±13.86) mm, P < 0. 05 ]. The in-hospital and follow-up incidences of major adverse cardiac events,stent thrombosis and in-stent restenosis were similar between young female and male CAD patients.Conclusions CAD risk factors were less and vessel lesions were more likely to be found at left main, left anterior descending and bifurcation in young female CAD patients compared to young male CAD patients.The clinical outcomes were similar between young female and male CAD patients.
9.Production of human papillomavirus type 16 virus-like particles and its immunogenicity.
Min-Xi WEI ; Shao-Wei LI ; Bo HUANG ; Wen-Tong SHEN ; Yong-Zai SU ; Chun-Hua ZHANG ; Ying GU ; Hai-Lian DU ; Jun ZHANG ; Ning-Shao XIA
Chinese Journal of Virology 2009;25(4):245-250
HPV16 L1 gene was amplified from HPV16 positive vaginal secretion sample by PCR, and inserted into pTO-T7 to obtain the recombinant expression vector pTO-T7-HPV16-L1. Then, the pTO-T7-HPV16-L1 was transformed into E. coil strain ER2566 and the recombinant protein HPV16 L1 was expressed in soluble form. After purification by ammonium sulfate precipitation, ion-exchange chromatography, and hydrophobic interaction chromatography, the recombinant protein HPV16 L1 had a purity of more than 98%. By removing DTT, purified HPV16 L1 proteins self-assembled in vitro into VLPs with the diameter of 50 nm. The vaccination experiments on experimental animals showed the VLPs could elicit high titer of neutralizing antibodies against HPV 16. HPV16 VLPs with high immunogenicity and high purity can be produced easily and effectively from an E. coli expression system in the study, and thus can be used in structure investigation and HPV16 vaccine development.
Animals
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Antibodies, Viral
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immunology
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ultrastructure
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Capsid Proteins
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genetics
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immunology
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isolation & purification
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Goats
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Human papillomavirus 16
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genetics
;
immunology
;
ultrastructure
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Humans
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Male
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Oncogene Proteins, Viral
;
genetics
;
immunology
;
isolation & purification
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Papillomavirus Infections
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immunology
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virology
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Rabbits
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Recombinant Proteins
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genetics
;
immunology
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Vaccination
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Virion
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genetics
;
immunology
10.The cryosurgery of central lung cancer by rigid bronchoscopy.
Yan-chu TIAN ; De-ruo LIU ; Yong-qing GUO ; Zhen-rong ZHANG ; Zai-yong WANG ; Jing-yu CHEN ; Bing-sheng GE
Chinese Journal of Surgery 2009;47(24):1876-1878
OBJECTIVETo evaluate the method and effectiveness of rigid-bronchoscopic cryosurgery for advanced central lung cancer.
METHODSForty-eight patients were enrolled in this study from June 2002 to December 2008, including 33 male and 15 female. The average age was 70 years (ranged from 45 to 83 years old). For the 48 patients, 38 cases were patients with advanced central lung cancer who were not suitable for surgery, and the remaining 10 cases were patients with local recurrence in trachea or main bronchus postoperatively. Cryosurgery was performed 120 times for all patients, 2.5 times per patient on average. The trachea or bronchus station, symptom such as dyspnea, hemoptysis, respiratory function and quality of life were observed.
RESULTSThe unblocked ratio of trachea and bronchi was 97%. All patients got satisfied improvement ratio of symptoms, 87.5% for dyspnea, 72.9% for cough, 93.8% for hemoptysis and 62.5% for chest pain. Respiratory function tests showed that both the mean forced expiratory volume in first second and forced vital capacity got an improvement from (1.03+/-0.05) L to (1.85+/-0.13) L and from (1.69+/-0.18) L to (2.96+/-0.14) L respectively (P<0.01). Karnofsky score also got no less than 20 scores improvement. The Follow-up time was 6 to 62 months. The longest survival was 62 months. The median survival time was 20 months. There was no severe perioperative complications and mortality except for 3 cases of moderate exeduation.
CONCLUSIONSCryosurgery is easy to perform with minimal complications. Not only could it provide an effective and rapid control of symptoms caused by central lung cancer, it could also unobstructed bronchus promptly and improve patients' quality of life.
Aged ; Aged, 80 and over ; Bronchoscopy ; Cryosurgery ; methods ; Female ; Humans ; Lung Neoplasms ; surgery ; Male ; Middle Aged ; Treatment Outcome

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