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1.
The Association of Longitudinal Serum Uric Acid and All-Cause Mortality in Incident Peritoneal Dialysis Patients.
Chang, W, Zhang, W, Wang, X, Liu, Y, Han, Y, Tu, Y, Uchida, S
Blood purification. 2019;(1-3):185-192
Abstract
BACKGROUND Time-averaged uric acid (TA-UA) value was calculated to investigate the association of longitudinal UA and all-cause mortality in incident peritoneal dialysis (PD) patients. METHODS Three hundred PD patients were divided into 3 groups based on the serum TA-UA level (Group 1: < 6 mg/dL; Group 2: 6-8 mg/dL; Group 3: ≥8 mg/dL). Hazards ratio (HR) of all-cause mortality was calculated. Logistic regression was conducted to identify the associated clinical factors of lower and higher TA-UA level. RESULTS Increased HRs for death existed in Group 1 and Group 3 compared with Group 2 (HR 3.24, 95% CI 1.25-8.39, p = 0.016; HR 4.69, 95% CI 1.24-17.72, p = 0.023). Lower residual renal function, lower albumin, and higher high-density lipoprotein cholesterol were related to the lower serum TA-UA. Higher body mass index and higher C-reactive protein were associated with higher serum TA-UA in PD patients. CONCLUSION Both TA-UA < 6 and ≥8 mg/dL increased the all-cause mortality in incident PD patients.
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2.
Effects of different doses of magnesium sulfate on pneumoperitoneum-related hemodynamic changes in patients undergoing gastrointestinal laparoscopy: a randomized, double-blind, controlled trial.
Tan, W, Qian, DC, Zheng, MM, Lu, X, Han, Y, Qi, DY
BMC anesthesiology. 2019;(1):237
Abstract
BACKGROUND The infusion of magnesium sulfate is well known to reduce arterial pressure and attenuate hemodynamic response to pneumoperitoneum. This study aimed to investigate whether different doses of magnesium sulfate can effectively attenuate the pneumoperitoneum-related hemodynamic changes and the release of vasopressin in patients undergoing laparoscopic gastrointestinal surgery. METHODS Sixty-nine patients undergoing laparoscopic partial gastrectomy were randomized into three groups: group L received magnesium sulfate 30 mg/kg loading dose and 15 mg/kg/h continuous maintenance infusion for 1 h; group H received magnesium sulfate 50 mg/kg followed by 30 mg/kg/h for 1 h; and group S (control group) received same volume 0.9% saline infusion, immediately before the induction of pneumoperitoneum. Systemic vascular resistance (SVR), cardiac output (CO), mean arterial pressure (MAP), heart rate (HR), central venous pressure (CVP), serum vasopressin and magnesium concentrations were measured. The extubation time, visual analogue scale were also assessed. The primary outcome is the difference in SVR between different groups. The secondary outcome is the differences of other indicators between groups, such as CO, MAP, HR, CVP, vasopressin and postoperative pain score. RESULTS Pneumoperitoneum instantly resulted in a significant reduction of cardiac output and an increase in mean arterial pressure, systemic vascular resistance, central venous pressure and heart rate in the control group (P < 0.01). The mean arterial pressure (T2 - T4), systemic vascular resistance (T2 - T3), central venous pressure(T3-T5) and the level of serum vasopressin were significantly lower (P < 0.05) and the cardiac output (T2 - T3) was significantly higher (P < 0.05) in group H than those in the control group. The mean arterial pressure (T4), systemic vascular resistance (T2), and central venous pressure(T3-T4) were significantly lower in group H than those in group L (P < 0.05). Furthermore, the visual analog scales at 5 min and 20 min, the level of vasopressin, and the dose of remifentanil were significantly decreased in group H compared to the control group and group L (P < 0.01). CONCLUSION Magnesium sulfate could safely and effectively attenuate the pneumoperitoneum-related hemodynamic instability during gastrointestinal laparoscopy and improve postoperative pain at serum magnesium concentrations above 2 mmol/L. TRIAL REGISTRATION The study was retrospectively registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IPD-17011145, principal investigator: D.Y. Q., date of registration: April 13, 2017.
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3.
Differential efficacy of methylcobalamin and alpha-lipoic acid treatment on symptoms of diabetic peripheral neuropathy.
Han, Y, Wang, M, Shen, J, Zhang, Z, Zhao, M, Huang, J, Chen, Y, Chen, Z, Hu, Y, Wang, Y
Minerva endocrinologica. 2018;(1):11-18
Abstract
BACKGROUND Diabetic hyperglycemia damages peripheral nerves by triggering ischemia, oxidative stress, and inflammation. Alpha-lipoic acid (ALA) and methylcobalamin (MC) are known to improve signs of diabetic peripheral neuropathy (DPN), possibly by enhancing neural and vascular endothelial cell metabolism and antioxidant capacity. We evaluated differences in efficacy following short-term MC or ALA treatment on DPN symptoms to guide clinical drug selection. METHODS Forty DPN patients were randomly divided into MC and ALA treatment groups (both N.=20) and assessed by the Toronto Clinical Neuropathy Scoring System (TCSS), total symptom score (TSS), visual analog scale (VAS) of positive symptoms, and easy sensory test (EST) for negative symptoms before and after 2 weeks of treatment. Serum malondialdehyde (MDA) and superoxide dismutase (SOD) were also measured. RESULTS Neuropathy as measured by TCSS, TSS, and VAS scores was significantly reduced by both treatments (P<0.05) but magnitude varied by symptom. The VAS score reductions for burning and pain were significantly greater following ALA (P<0.01), while MC reduced numbness and paresthesia VAS scores to a slightly greater extent than ALA (P>0.05). Numbers of abnormal (low-response) points for pressure and pinprick sensation were reduced by MC but not by ALA, while both treatments induced a significant reduction in vibratory perception threshold (P<0.01). Neither MC nor ALA improved temperature sensation or tendon reflexes (P>0.05). Alpha-lipoic acid, increased SOD and reduced MDA (P<0.05), indicating enhanced antioxidant capacity, while MC had no effect. CONCLUSIONS Due to differences in efficacy, MC or ALA should be chosen according to the symptoms of individual patients.
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4.
A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents.
Han, Y, Xu, B, Fu, G, Wang, X, Xu, K, Jin, C, Tao, L, Li, L, Hou, Y, Su, X, et al
JACC. Cardiovascular interventions. 2018;(3):260-272
Abstract
OBJECTIVES The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents. BACKGROUND BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating. METHODS Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients. RESULTS The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07). CONCLUSIONS The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).
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5.
Randomized comparison of novel biodegradable polymer and durable polymer-coated cobalt-chromium sirolimus-eluting stents: Three-Year Outcomes of the I-LOVE-IT 2 Trial.
Song, L, Li, J, Guan, C, Jing, Q, Lu, S, Yang, L, Xu, K, Yang, Y, Xu, B, Han, Y, et al
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2018;(S1):608-616
Abstract
OBJECTIVES We aimed to compare the long-term outcomes of the novel biodegradable polymer cobalt-chromium sirolimus-eluting stent (BP-SES) versus the durable polymer sirolimus-eluting stent (DP-SES) in the I-LOVE-IT2 trial. BACKGROUNDS Comparisons of the long-term safety and efficiency of the BP-DES versus the DP-DES are limited. METHODS A total of 2,737 patients eligible for coronary stenting were randomized to the BP-SES or DP-SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization. RESULTS A three-year clinical follow-up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient-oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP-SES and DP-SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1-3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms. CONCLUSIONS In this prospective randomized trial, the BP-SES showed similar clinical results versus the DP-SES in terms of safety and efficacy outcomes over a 3-year follow-up period.
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6.
A randomised comparison of biodegradable polymer- and permanent polymer-coated platinum-chromium everolimus-eluting coronary stents in China: the EVOLVE China study.
Han, Y, Liu, H, Yang, Y, Zhang, J, Xu, K, Fu, G, Su, X, Jiang, T, Pang, W, Chen, J, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017;(10):1210-1217
Abstract
AIMS: The EVOLVE China randomised study sought to evaluate the clinical safety and effectiveness of the SYNERGY bioabsorbable polymer-coated everolimus-eluting stent (EES) for the treatment of patients with coronary heart disease in China. METHODS AND RESULTS Eligible patients with de novo native coronary artery lesions were randomised (1:1) to receive the SYNERGY or PROMUS Element Plus stent. The primary endpoint was in-stent late loss at nine months. Secondary endpoints included death, MI, revascularisation, and stent thrombosis up to 12 months. A total of 412 subjects were randomised (205 SYNERGY; 207 PROMUS Element Plus) at 14 sites in China from October 2013 to July 2014. SYNERGY was non-inferior to PROMUS Element Plus for the primary endpoint of nine-month in-stent late loss: SYNERGY 0.20±0.33 mm vs. PROMUS Element Plus 0.17±0.38 mm with an upper one-sided 97.5% confidence interval of the difference (0.10 mm), significantly less than the non-inferiority margin (0.15 mm; p<0.0008). Clinical adverse event rates were low and not significantly different between groups at nine and 12 months (all p>0.05). CONCLUSIONS In the EVOLVE China trial, the SYNERGY bioabsorbable polymer-coated EES was noninferior to the PROMUS Element Plus permanent polymer-coated EES for the primary endpoint of late loss at nine months.
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7.
PLATINUM China: a prospective, randomized investigation of the platinum chromium everolimus-eluting stent in de novo coronary artery lesions.
Gao, R, Han, Y, Yang, Y, Zhang, J, Hou, Y, Wang, H, Li, H, Fang, Q, Yu, B, Xu, B, et al
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2015;:716-23
Abstract
OBJECTIVES The PLATINUM China clinical trial evaluated the safety and effectiveness of the thin-strut, everolimus-eluting, platinum-chromium PROMUS™ Element™ stent (PtCr-EES) (Boston Scientific, Marlborough, MA) for the treatment of patients in China. BACKGROUND Clinical outcomes from the PtCr-EES have not been evaluated in patients from China, nor has it been directly compared with the second-generation stainless steel paclitaxel-eluting TAXUS Liberté stent (PES) in a randomized head-to-head trial. Methods In this prospective, multicenter, single-blind, superiority trial, patients with a single de novo atherosclerotic coronary artery lesion were randomized 1:3 to receive either the PES or PtCr-EES. The primary endpoint was in-stent late loss at 9 months. RESULTS Among 127 PES and 373 PtCr-EES patients (71.2% male; mean age 57.3 years), the primary endpoint of 9-month in-stent late loss was 0.40 ± 0.45 mm for PES versus 0.11 ± 0.36 mm for PtCr-EES (P < 0.001). In-stent % diameter stenosis was 22.20 ± 16.00% for PES versus 11.06 ± 13.86% for PtCr-EES (P < 0.001) at 9 months. The 1-year rate of death/MI was 1.6% (2/127) for PES versus 0% (0/371) for PtCr-EES (P = 0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr-EES (P = 0.26). No stent thromboses occurred at 12 months in either group. CONCLUSIONS In the largest prospective angiographic evaluation conducted to date with this stent, the PROMUS Element PtCr-EES was superior to the TAXUS Liberté PES for the primary endpoint of late loss at 9 months, with low rates of clinical events at 1 year. Clinical follow-up will continue to 2 years.
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8.
A randomized comparison of novel biodegradable polymer- and durable polymer-coated cobalt-chromium sirolimus-eluting stents.
Han, Y, Xu, B, Jing, Q, Lu, S, Yang, L, Xu, K, Li, Y, Li, J, Guan, C, Kirtane, AJ, et al
JACC. Cardiovascular interventions. 2014;(12):1352-60
Abstract
OBJECTIVES The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES. BACKGROUND No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type. METHODS In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis. RESULTS At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: -1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55). CONCLUSIONS In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381).
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9.
Microtensile bond strength of one- and two-step self-etching adhesives on sclerotic dentin: the effects of thermocycling.
Xie, C, Han, Y, Zhao, XY, Wang, ZY, He, HM
Operative dentistry. 2010;(5):547-55
Abstract
This study evaluated the effects of thermocycling on the microtensile bond strength (microTBS) of one- and two-step self-etch adhesives (SEAs) to sclerotic dentin. Two adhesives, Clearfil S3 Bond (S3), a one-step self-etch adhesive (1-SEA), and Clearfil SE Bond (SE), a two-step self-etch adhesive (2-SEA), were applied on cervical lesions in human premolars with sclerotic or normal dentin. After adhesive application, the lesions were restored and built up using a resin composite (Clearfil AP-X). After 24 hours in water storage, the restored teeth were sectioned into 0.7 x 0.7 mm composite-dentin beams. The beams were then aged with 0, 5,000 or 10,000 thermocycles. The use of two adhesives, two substrate types and three thermocycling regimens yielded 12 experimental groups of 14-19 beams each. The beams were subsequently subjected to microTBS testing at a crosshead speed of 1 mm/minute and statistical analyses were computed with three-way ANOVA and Tukey's post hoc test at p < 0.05. Three-way ANOVA showed statistically significant effects on bonding effectiveness by lesion type, adhesive system, thermocycling or combinations of the adhesive system and thermocycling (p < 0.05). With sclerotic dentin, although S3 and SE provided comparable microTBS after 24 hours of water storage, S3 showed significantly lower microTBS than SE after thermocycling (p < 0.05). Regardless of lesion type, the microTBS for S3 decreased significantly after 5,000 or 10,000 thermocycles, while the microTBS for SE showed a significant decrease only after 10,000 thermocycles. Regardless of the extent of thermocycling, the microTBS values for either SE or S3 bonded to sclerotic dentin were significantly lower than to normal dentin (p < 0.05). The results suggested that thermocycling had a significant negative effect on the bond strength of the two SEAs tested. In contrast to 2-SEA, 1-SEA might not be a good choice for sclerotic dentin when seeking durability of the resin-dentin bond.
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10.
Hypermethylation of the GATA genes in lung cancer.
Guo, M, Akiyama, Y, House, MG, Hooker, CM, Heath, E, Gabrielson, E, Yang, SC, Han, Y, Baylin, SB, Herman, JG, et al
Clinical cancer research : an official journal of the American Association for Cancer Research. 2004;(23):7917-24
Abstract
PURPOSE In lung cancer, DNA hypermethylation is known to be a common event. EXPERIMENTAL DESIGN Gene expression and methylation status of GATA-4, GATA-5, and GATA-6 were analyzed with cell lines and primary human lung cancers. Methylation profiles of primary lung cancers were analyzed and correlated with clinical as well as histopathological data. RESULTS Complete methylation was detected by methylation-specific PCR for both GATA-4 and GATA-5 in four cell lines (H358, DMS-53, A549, and H1299), all of which had no expression by reverse transcription-PCR analysis. Demethylation with 5-aza-2'deoxycytidine restored expression in each case. GATA-6 was ubiquitously expressed in all of the six cell lines. GATA-4 bisulfite sequencing revealed complete methylation of the GATA-4 promoter in H358 cells, correlating well with its lack of expression at the mRNA level. Only a few CpG sites showed methylation by bisulfite sequencing within the GATA-4 promoter in a cell line that expressed the gene. In 63 cases of primary lung cancers, GATA-4 and GATA-5 promoter methylation was detected in (42 of 63) 67% and (26 of 63) 41%, respectively. GATA-6 remained unmethylated both in cell lines and primary tumors. Six autopsy specimens of normal lung tissue showed no aberrant promoter hypermethylation for the GATA genes. Correlation of concomitant GATA-4 and GATA-5 methylation with clinicopathological parameters only found a statistically significant increase in methylation frequency with increasing patient age (P < 0.001). CONCLUSIONS These epigenetic changes in the GATA genes in lung cancer are tumor-specific, relate to the loss of GATA gene expression, and occur increasingly in the elderly.