1.Analysis of a case of regulatory violations by an occupational health examination institution
Chanchan QI ; Ruiyan HUANG ; Chaoting ZHAO ; Leyi XU ; Jianyong LU ; Xiaoyi LI ; Jiabin CHEN
China Occupational Medicine 2025;52(1):106-109
Objective To analyze a case of violations by an occupational medical examination (OME) institution and to explore the key control points for the supervision and management of OME institutions, as well as the core role of quality assessment in this context. Methods An OME institution suspected of illegal activities was used as the study subject. Retrospective analysis was conducted. Clues of suspected violations were identified by an on-site quality assessment. After investigation and verification by the local health authorities, legal action was taken against the institution for its violations. Results During an on-site quality assessment, the Guangdong Province OME quality control expert group discovered that the OME institution violated regulations, including unqualified personnel file, exceeding the scope of services category, issuing false reports, failing to report suspected occupational diseases on time, and failing to notify workers about suspected occupational diseases as required. The evidence was then submitted to the Guangdong Province OME Quality Control Center, which subsequently forwarded the case to local health administration department for filing and investigation. After the investigation, penalties were imposed on the OME institution for its illegal activities. Conclusion The key supervision and inspection points in the quality assessment of OME institutions include personnel file configuration, the quality control management system and its implementation, the quality of OME reports, and information reporting. Quality assessment plays a pivotal role in ensuring the legal and compliant practice of OME institutions, safeguarding the health rights and interests of workers, and enhancing the overall standard of the OME industry.
2.Correlation between serum GDNF level and neuroimaging changes and cognitive impairment in patients with cerebral small vessel disease
Fangli YANG ; Hao LIU ; Fan WANG ; Qing LI ; Xiyan CHEN ; Ruiyan CAI ; Qingwu WU ; Jian ZHANG ; Sibei JI ; Chengbiao LU ; Shaomin LI ; Jianhua ZHAO
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(9):809-815
Objective:To investigate the relationship between serum glial cell line-derived neurotrophic factor (GDNF) levels and neuroimaging changes and cognitive impairment in patients with cerebral small vascular disease (CSVD).Methods:135 patients with CSVD recruited from the Department of Neurology of the First Affiliated Hospital of Xinxiang Medical University from September 2021 to July 2022 were assessed by cranial multimodal magnetic resonance imaging and Montreal cognitive function assessment (MoCA), and the basic data were analyzed at the same time.The serum GDNF concentration of all patients was detected by enzyme-linked immunosorbent assay (ELISA). According to the median GDNF concentration, the patients were divided into low GDNF group and high GDNF group. The baseline data, MoCA score and imaging markers of the two groups were compared by Mann-Whitney U test, chi-square test, logistic regression, Kruskal-Wallis H test and Jonckheere-Terpstra trend test, and the correlation between serum GDNF level and imaging markers and cognitive function of patients with CSVD was analyzed. Results:The median serum GDNF concentration of all CSVD patients was 16.66 pg/mL. Multivariate logistic regression analysis showed that low serum GDNF level was a risk factor for white matter hyperintensity and total image load in patients with CSVD. Serum GDNF level was a protective factor of cognitive impairment in patients with CSVD in multiple logistic regression analysis. The area under the curve of ROC curve analysis of cognitive impairment after CSVD predicted by serum GDNF level was 0.735, the sensitivity was 66.4%, and the specificity was 71.4%. The level of serum GDNF was positively related with visual space and executive function, attention and computational power, delayed recall and orientation( r=0.267, 0.187, 0.219, 0.215, all P<0.05). Conclusion:The serum GDNF level is related to white matter hyperintensities, total imaging load and cognitive impairment in patients with CSVD. Serum GDNF level may play a predictive role in CSVD and cognitive impairment.
3.Identification and expression analysis of WRKY gene family in eukaryotic algae.
Yanan SONG ; Tao LUO ; Chunchao ZHAO ; Chunli JI ; Chunhui ZHANG ; Ruiyan MA ; Hongli CUI ; Runzhi LI
Chinese Journal of Biotechnology 2022;38(5):1965-1980
WRKY is a superfamily of plant-specific transcription factors, playing a critical regulatory role in multiple biological processes such as plant growth and development, metabolism, and responses to biotic and abiotic stresses. Although WRKY genes have been characterized in a variety of higher plants, little is known about them in eukaryotic algae, which are close to higher plants in evolution. To fully characterize algal WRKY family members, we carried out multiple sequence alignment, phylogenetic analysis, and conserved domain prediction to identify the WRKY genes in the genomes of 30 algal species. A total of 24 WRKY members were identified in Chlorophyta, whereas no WRKY member was detected in Rhodophyta, Glaucophyta, or Bacillariophyta. The 24 WRKY members were classified into Ⅰ, Ⅱa, Ⅱb and R groups, with a conserved heptapeptide domain WRKYGQ(E/A/H/N)K and a zinc finger motif C-X4-5-C-X22-23-H-X-H. Haematococcus pluvialis, a high producer of natural astaxanthin, contained two WRKY members (HaeWRKY-1 and HaeWRKY-2). Furthermore, the coding sequences of HaeWRKY-1 and HaeWRKY-2 genes were cloned and then inserted into prokaryotic expression vector. The recombinant vectors were induced to express in Escherichia coli BL21(DE3) cells and the fusion proteins were purified by Ni-NTA affinity chromatography. HaeWRKY-1 had significantly higher expression level than HaeWRKY-2 in H. pluvialis cultured under normal conditions. High light stress significantly up-regulated the expression of HaeWRKY-1 while down-regulated that of HaeWRKY-2. The promoters of HaeWRKY genes contained multiple cis-elements responsive to light, ethylene, ABA, and stresses. Particularly, the promoter of HaeWRKY-2 contained no W-box specific for WRKY binding. However, the W-box was detected in the promoters of HaeWRKY-1 and the key enzyme genes HaeBKT (β-carotene ketolase) and HaePSY (phytoene synthase) responsible for astaxanthin biosynthesis. Considering these findings and the research progress in the related fields, we hypothesized that the low expression of HaeWRKY-2 under high light stress may lead to the up-regulation of HaeWRKY-1 expression. HaeWRKY-1 may then up-regulate the expression of the key genes (HaeBKT, HaePSY, etc.) for astaxanthin biosynthesis, consequently promoting astaxanthin enrichment in algal cells. The findings provide new insights into further analysis of the regulatory mechanism of astaxanthin biosynthesis and high light stress response of H. pluvialis.
Eukaryota
;
Gene Expression Regulation, Plant
;
Phylogeny
;
Plant Proteins/metabolism*
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Plants/metabolism*
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Stress, Physiological/genetics*
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Transcription Factors/metabolism*
4.Correlation between serum VEGF level and white matter hyperintensity and cognitive dysfunction in patients with cerebral small vessel disease
Jin WANG ; Jianhua ZHAO ; Hao LIU ; Junli LIU ; Fangli YANG ; Qiong LI ; Minghua WANG ; Panpan ZHAO ; Fan WANG ; Qing LI ; Zhixiu XU ; Junyan YUE ; Jian ZHANG ; Sibei JI ; Ruiyan CAI ; Shaomin LI
Chinese Journal of Behavioral Medicine and Brain Science 2022;31(4):333-340
Objective:To investigate the relationship between serum vascular endothelial growth factor (VEGF) levels and white matter high signal and non-dementia vascular cognitive dysfunction in patients with cerebral small vascular disease (CSVD).Methods:Total 106 patients with CSVD who were admitted to the Department of Neurology of the First Affiliated Hospital of Xinxiang Medical College from April 2019 to December 2020 were enrolled.They were divided into vascular cognitive impairment no dementia group (VCIND group, n=47) and no vascular cognitive impairment group (N-VCI group, n=59)according to mini-mental assessment scale (MMSE), Montreal cognitive assessment (MoCA) scale and activity of daily living scale (ADL). Serum VEGF levels were detected by enzyme-linked immunosorbent assay (ELISA). The baseline data, serum VEGF levels, MoCA score and Fazekas score were compared between the two groups.The correlation between serum VEGF level and white matter high signal and cognitive function was analyzed.SPSS 19.0 software was used for data processing.The statistical methods were t-test, Chi square test, nonparametric test, Logistic regression analysis, Pearson correlation analysis and Spearman correlation analysis. Results:There were significant differences in serum VEGF level((464.18±114.58)pg/mL, (414.17±45.80)pg/mL, F=22.880), MoCA score((13.07±6.48), (20.17±4.06), F=17.920) and Fazekas score (4(3, 5), 3(1, 3), Z=-4.189)between the two groups (all P<0.05). The level of VEGF( β=0.008, OR=1.008, 95% CI=1.001-1.015, P<0.05) was the influencing factor of cognitive function in patients with CSVD .The level of VEGF was negatively correlated with the total score of MoCA, attention and calculation power, and orientation ability ( r=-0.345, -0.373, -0.445, all P<0.05) and it was positively correlated with the total Fazekas score and the Fazekas score of paraventricular and deep white matter ( r=0.392, 0.495, 0.302, all P<0.05). There was a linear trend between the high signal grade of paraventricular and deep white matter and VCIND (both P<0.05). Conclusion:Serum VEGF level is correlated with cognitive function and white matter hyperintensity in patients with CSVD.The increase of VEGF level may be a factor reflecting cognitive dysfunction.In addition, with the increase of white matter hyperintensity level, the risk of VCIND in CSVD is increased.
5.Neonatal and long-term outcomes of selective fetal growth restricted fetuses
Ruiyan SHANG ; Yuan WEI ; Jing YANG ; Yangyu ZHAO ; Jinfang YUAN ; Tianchen WU ; Xiaoyan YOU ; Pengbo YUAN ; Li LI
Chinese Journal of Perinatal Medicine 2022;25(12):933-941
Objective:To investigate the short- and long-term outcomes of fetuses with selective fetal growth restriction (sFGR).Methods:A retrospective study was conducted on monochorionic diamniotic (MCDA) twins with sFGR admitted to the Neonatal Intensive Care Unit of Peking University Third Hospital from September 2017 to December 2019. MCDA neonates delivered during the same period without significant complications were selected as the control group. MCDA twins with sFGR were divided into type Ⅰ, Ⅱ, and Ⅲ groups and then further divided into the larger and the smaller fetus subgroups according to the birth weight. These children were followed up by telephone at 2-3 years old. Height-for-age and weight-for-age Z-scores were calculated. Ages and Stages Questionnaire-Third Edition (ASQ-3) was used to determine comprehensive development. Independent sample t-test, one-way analysis of variance, non-parameter test, and Chi-square test (or rank-sum test) were used for statistical analysis. Results:(1) A total of 116 pregnant women with sFGR (232 neonates) were enrolled in this study. There were 43, 40, and 33 mothers and 86, 80, and 66 newborns in type Ⅰ, Ⅱ, and Ⅲ groups, respectively. The control group included 31 pregnant women and 62 neonates. The gestational age at onset of sFGR was younger in the type Ⅱ and Ⅲ groups than in type Ⅰ group [(23.8±4.8) and (24.1±3.1) vs (27.0±6.1) weeks, F=5.19, P<0.05; all P<0.017 during pairwise comparisons]. (2) The incidence of sepsis and treatment abandonment/death in neonates in type Ⅱ and Ⅲ groups were higher than those in type Ⅰ and control groups [neonatal sepsis: 11.3% (9/80) and 6.1% (4/66) vs 2.3% (2/86) and 0.0% (0/62), χ2=6.30, P=0.001; death or treatment abandonment rate:13.8% (11/80) and 10.6% (7/66) vs 3.5% (3/86) and 0.0% (0/62), χ2=4.68, P=0.003; all P<0.017 during pairwise comparisons]. In cases with type Ⅱ or type Ⅲ sFGR, the risk of digestive system diseases was significantly higher in the smaller fetus group than in the larger fetus group [type Ⅱ: 46.2% (37/80) vs 38.7% (31/80), χ2=16.72; type Ⅲ: 47.0% (31/66) vs 34.8% (23/66), χ2=39.69; both P<0.001], while the rate of respiratory system diseases was lower in the smaller fetus group [type Ⅱ: 35.0% (28/80) vs 45.0% (36/80), χ2=36.85; type Ⅲ: 37.9% (25/66) vs 45.4% (30/66), χ2=12.55; both P<0.001]. The incidence of neonatal sepsis in smaller fetuses was higher than that in larger ones in type Ⅱ sFGR [7.5% (6/80) vs 3.7% (3/80), χ2=4.68, P=0.034]. The incidence of neurological complications in larger fetuses was higher than that in smaller ones in type Ⅲ sFGR [15.1% (10/66) vs 4.5% (3/66), χ2=5.72, P<0.001]. (3) In type Ⅱ group, seven neonates died (one case of cerebral hemorrhage, two cases of gastrointestinal perforation, two cases of septic shock, and two cases of necrotizing enterocolitis), and four cases withdrew the treatment. In type Ⅲ group, four neonates died (two cases of necrotizing enterocolitis, one case of gastrointestinal perforation, and one case of cerebral hemorrhage), and three cases withdrew from the treatment. (4) Totally, 71 children in type Ⅰ, 61 in type Ⅱ, and 58 in type Ⅲ group were followed up at the age of 2-3. Children with type Ⅱ or type Ⅲ sFGR lagged behind those in type Ⅰ group and control group in physical growth [ M ( P25- P75), Z-scores:-0.46 (-0.87-0.42),-0.35 (-0.62-0.71), 0.05 (-0.61-0.51), and 0.14 (-0.57-0.75); H=6.20, P=0.001]. In type Ⅱ and Ⅲ groups, the smaller fetuses lagged the larger fetuses in physical growth at 2-3 years of age. ASQ-3 scores in communication, gross motor, fine motor, problem-solving and personal-social areas were all lower in type Ⅱ and Ⅲ groups than in type Ⅰ and control groups. ASQ-3 scores in the five dimensions of the smaller fetuses in the type Ⅱ group were lower than those of the larger fetuses. In the type Ⅲ group, the smaller fetuses had lower ASQ-3 scores in communication and gross motor than the larger ones [communication ability: (42.6±18.8) vs (56.4±9.4) scores, t=19.63, P<0.001; gross motor: (45.5±19.7) vs (54.5±9.7) scores, t=12.64, P=0.003]. Conclusion:The neonatal morbidity is significantly increased in type Ⅱ and Ⅲ sFGR, and babies lagged others in height, weight, and ASQ-3 score at 2-3, which is worthy of early attention.
6.Correlation between serum matrix metalloproteinase-9 level and location and severity of bleeding in patients with cerebral microbleeds
Xue PENG ; Lifang MENG ; Hao LIU ; Jin WANG ; Junli LIU ; Xianglei JIA ; Panpan ZHAO ; Fan WANG ; Chaowei WANG ; Junyan YUE ; Jian ZHANG ; Sibei JI ; Bin YUAN ; Ruiyan CAI ; Shaomin LI ; Jianhua ZHAO
Chinese Journal of Behavioral Medicine and Brain Science 2021;30(3):244-249
Objective:To investigate the relationship between serum matrix metalloproteinase-9 (MMP-9) level and the location and severity of bleeding in patients with cerebral microbleeds(CMBs).Methods:A total of 60 CMBs patients admitted to the Department of Neurology of the First Affiliated Hospital of the Xinxiang Medical University from January 2019 to August 2020 were selected as subjects as the CMBs group, and 60 healthy controls without nervous system diseases in outpatient physical examination during the same period were selected as the control group. The clinical data and biochemical indicators of the two groups were collected. Serum MMP-9 levels were measured by enzyme linked immunosorbent assay (ELISA). According to susceptibility weighted imaging (SWI), CMBs patients were divided into grade 1 group ( n=24), grade 2 group ( n=19) and grade 3 group ( n=17), and according to the micro analytical rating scale (MARS), the CMBs patients were divided into the lobar group ( n=19), the deep or infratentorial group ( n=17) and the mixed group ( n=24).The relationship between serum MMP-9 level and the location and severity of CMBs was analyzed. SPSS 19.0 software was used for data statistical analysis.One-way ANOVA, t-test and rank sum test were used for comparison. Logistic regression analysis was used to analyze the influencing factors. Pearson correlation analysis and Spearman correlation analysis were used for correlation analysis. Results:The level of MMP-9 in CMBs group was significantly higher than that in control group (208.13(142.25, 285.88) μg/L, 149.50(93.40, 186.51)μg/L), and the difference was statistically significant ( P<0.05). Serum MMP-9 level was a risk factor of CMBs ( β=1.322, OR=3.750, 95% CI=2.038-7.997, P=0.002). The difference of level of MMP-9 in different severity of CMBs was statistically significant (147.55(109.25, 266.47)μg/L, 242.12(147.55, 288.80)μg/L, 270.42(203.43, 364.27)μg/L, P=0.017). Serum MMP-9 level was positively correlated with the number of CMBs ( r=0.371, P=0.003). The difference of MMP-9 level of CMBs in different locations were statistically significant (249.77(158.43, 338.46)μg/L, 188.83(138.52, 243.15)μg/L, 210.65(144.25, 255.78)μg/L, P=0.013). The increased serum MMP-9 level was a risk factor for CMBs( β=0.401, OR=1.122, 95% CI=1.004-1.204, P=0.036). Conclusion:The increased level of serum MMP-9 may be a risk factor of CMBs, especially for CMBs in cerebral lobesand, and the level of MMP-9 is positively correlated with the severity of CMBs.
7. Impact of hypertensive disorder complicating pregnancy on neonatal mortality and major complications in preterm infants
Meiyu WANG ; Xiangyong KONG ; Zhichun FENG ; Fengdan XU ; Hongyan LYU ; Lihong YANG ; Sujing WU ; Rong JU ; Jin WANG ; Li PENG ; Zhankui LI ; Xiaolin ZHAO ; Shujuan ZENG ; Huixian QIU ; Weixi WEN ; Hui WU ; Ying LI ; Nan LI ; Xuefeng ZHANG ; Wenzheng JIA ; Guo GUO ; Weipeng LIU ; Feng WANG ; Gaimei LI ; Fang LIU ; Wei LI ; Xiao-ying ZHAO ; Hongbin CHENG ; Yunbo XU ; Wenchao CHEN ; Huan YIN ; Yanjie DING ; Xiaoliang WANG ; Ruiyan SHAN ; Ping XU ; Meiying HAN ; Chunyan YANG ; Tieqiang CHEN ; Xiaomei TONG ; Shaojun LIU ; Ziyuan LIU
Chinese Journal of Applied Clinical Pediatrics 2018;33(14):1065-1070
Objective:
To investigate the effect of hypertensive disorder complicating pregnancy (HDCP) on the mortality and early complications of premature infants.
Methods:
The general clinical data of preterm infants with gestational age 24-36+ 6 weeks were collected from the cooperative units in the task group from January 1, 2013 to December 31, 2014.According to the severity of HDCP, the infants were divided into 4 groups: HDCP group, preeclampsia group, eclampsia group and non HDCP group, the mortality and major complications of preterm infants were compared, and the influencing factors were analyzed.
Results:
The mortality rate of preterm in the HDCP group was significantly higher than that of non HDCP group, and there was statistical significance (
8.Predictive value of lipoprotein-associated phospholipase A2 on perioperative myocardial injury in patients with stable angina after percutaneous coronary intervention
Yanchun CHEN ; Yunjie YIN ; Liang XU ; Xianghai ZHAO ; Song YANG ; Jinchuan YAN ; Ruiyan ZHANG
Journal of Interventional Radiology 2017;26(12):1073-1077
Objective To explore the correlation between lipoprotein-associated phospholipase A2 (Lp-PLA2) and perioperative myocardial injury (PMI),and to discuss the predictive value of Lp-PLA2 in patients with stable angina after percutaneous coronary intervention (PCI).Methods A total of 222 consecutive patients with stable angina,who were admitted to Yixing Municipal People's Hospital,Jiangsu Province,China to receive PCI during the period from June 2015 to March 2017,were enrolled in this study.The patients' baseline data as well as the distribution pattern of coronary lesions,were recorded.According to the paclitaxel-PCI and the surgical cooperative study (SYNTAX) score,the severity of target vascular lesions was assessed,which was classified into low score group (0 to 22 points),middle score group (23 to 32 points) and high score group (≥33 points).The preoperative blood lipid level and renal function,both preoperative and postoperative Troponin T (cTnT),high sensitive C reactive protein(hs-CRP),as well as the postoperative Lp-PLA2 were tested.Results After the procedure,the Lp-PLA2 levels in patients with normal cTnT value (n=155) and in patients with elevated cTnT value (n=67) were(122.21±43.80) ng/ml and (224.53±65.00) ng/ml respectively (P<0.05).SYNTAX score analysis showed that low score group had 120 patients,middle score group had 78 patients and high score group had 24 patients,the Lp-PLA2 levels of the above three groups were (119.51±51.96) ng/ml,(178.67±61.49) ng/ml and (233.16±61.32) ng/ml respectively,the differences were statistically significant between each other among the three groups (P<0.05).Pearson correlation analysis indicated that a parallel correlation existed between Lp-PLA2 levels and postoperative cTnT values (R=0.492,P<0.05).Logistic regression analysis revealed that Lp-PLA2 was the independent risk factor for elevated cTnT value during the perioperative period of PCI (OR=7.377,95%CI=3.368-16.156,P<0.05).The area under ROC curve of Lp-PLA2 was 0.896 (95%CI=0.874-0.945,P<0.001),the best cut-off point was 179 ng/ml,and the sensitivity and specificity for the diagnosis of PMI were 92.2% and 66.7%,respectively.Conclusion Lp-PLA2 levels are closely correlated with the increased cTnT values after PCI,and the preoperative high level of Lp-PLA2 is the independent risk factor for PMI after PCI.
9.Correlation between plasma homocysteine levels and behavioral and psychological symptoms in patients with mild to moderate vascular dementia
Fang LI ; Xiuying LI ; Dongyu WANG ; Ruiyan ZHAO
Chinese Journal of Behavioral Medicine and Brain Science 2015;24(9):800-804
Objective To explore the correlation between serum homocysteine(Hcy) levels and behavioral and psychological symptoms dementia (BPSD) in patients with mild to moderate vascular dementia (VaD).Methods Two hundred and ninety-three patients with mild to moderate vascular dementia (aged 40 or over) admitted to the department of neurology of the First Affiliated Hospital of Liaoning Medical College from January 2012 to January 2015.Patients were diagnosed with dementia by NINDS-AIREN criteria,MMSE scores ≤26,Hachinski ischemic scale(≥4) and clinical dementia rating(1≤ C DR ≤ 2).VaD patients were divided into high Hcy(HHcy) group (Hcy≥ 15 μ,mol/L,n=188) and control group(Hcy<15 μmol/L,n=105).The total scores and the scores of 12 functional domains of behavioral and psychological symptoms in NPI were analyzed by using comparative statistical methods.Results Prevalence of high homocysteine was 64.16% (n=188) among mild to moderate VaD (n=293).The incidence of BPSD in HHcy group(80.9%) was significantly higher than that in the control group (57.1%),the difference was statistically significant (x2=18.932,P<0.01).HHcy patients (27.95±5.04) had a significantly higher total score of NPI compared with control patients (16.87± 1.87),the difference was statistically significant (t=3.753,P<0.01).In terms of scores in 12 functional domains in NPI,the scores in sleep disorders (2.99± 1.40),high (2.10±0.53),irritability/mood swings (2.64± 1.43),abnormal behavior (1.74±0.52),disinhibition (1.40±0.43),agitation (2.02±0.74) were higher than those in control groups (1.85±0.37,0.21±0.05,1.80 ±0.56,0.36±0.09,0.45±0.07,0.68±0.23),all the difference were significant(t=2.327,t=2.012,t=2.136,t=2.066,t=2.050,t=2.007,all P<0.05).Binary logistic regression analysis showed that there were positive correlation between scores of NPI and plasma Hcy levels (OR=1.164,95% CI:1.052-1.288,P=0.003).Compared with HHcy group and control group,there were no statistical significance in regard to infarcted brain focus including the frontal lobe,parietal lobe,temporal lobe,occipital lobe,basal ganglia,brain stem and cerebellum (x2=0.528,x2=0.043,x2=0.630,x2=0.166,x2=0.657,x2=1.010,x2=0.019,allP>0.05).Conclusion High homocysteine levels are correlated with behavioral and psychological symptoms in patients with mild to moderate VaD,including performance of sleep disorders,high,irritability/mood swings,abnormal behavior,disinhibition and agitation.Moreover,the severity of BPSD is positively associated with homocysteine levels.The higher the homocysteine level,the more severe the BPSD.The serum homocysteine levels are no correlated with infarcted brain focus.
10.Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the TARGET II trial.
Bo XU ; Yelin ZHAO ; Yuejin YANG ; Ruiyan ZHANG ; Hui LI ; Changsheng MA ; Shaoliang CHEN ; Jianan WANG ; Yong HUO ; Martin B LEON ; Runlin GAO
Chinese Medical Journal 2014;127(6):1027-1032
BACKGROUNDIn the TARGET I randomized controlled trial, the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions. This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population (including patients with small vessels, long lesions and multi-vessels), and at validating the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent.
METHODSTARGET II was a prospective, multicenter, single-arm study with primary outcome of 12-month target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (TLR). Stent thrombosis was defined according to the Academic Research Consortium (ARC) definition. Patients were grouped by tertiles of SS (≤6, >6 to ≤12, and >12). All patients were exclusively treated with the FIREHAWK stent and were followed up at 1, 6, and 12 months, and annually thereafter up to five years.
RESULTSA total of 730 patients were included in this registry study. The 12-month incidence of TLF was 4.4% and the incidence of TLF components were, cardiac death 0.5%, TV-MI 3.2%, and TLR 2.2%. One definite/probable stent thrombosis was observed at 12-month follow-up. Mean SS was 10.87±6.87. Patients in the SS >12 tertile had significantly higher TLF (P = 0.02) and TLR (P < 0.01) rates than those in lower SS groups. In COX proportional-hazards regression analyses, TLF incidence was strongly related to lesion length (long lesion vs. non-long lesion patients; HR 3.416, 95% CI, 1.622-7.195), but unrelated to diabetic, small vessel, and multivessel subgroups.
CONCLUSIONSThe low TLF incidence in this study indicates that FIREHAWK is safe and effective in the treatment of moderately complex coronary disease. SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients.
Adolescent ; Adult ; Aged ; Biocompatible Materials ; chemistry ; Cardiovascular Agents ; therapeutic use ; Coronary Stenosis ; drug therapy ; therapy ; Coronary Vessels ; pathology ; Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; Polymers ; Proportional Hazards Models ; Sirolimus ; therapeutic use ; Young Adult

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