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118 result(s) for "Xuebin, Han"
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Intracardiac echocardiography Chinese expert consensus
In recent years, percutaneous catheter interventions have continuously evolved, becoming an essential strategy for interventional diagnosis and treatment of many structural heart diseases and arrhythmias. Along with the increasing complexity of cardiac interventions comes ever more complex demands for intraoperative imaging. Intracardiac echocardiography (ICE) is well-suited for these requirements with real-time imaging, real-time monitoring for intraoperative complications, and a well-tolerated procedure. As a result, ICE is increasingly used many types of cardiac interventions. Given the lack of relevant guidelines at home and abroad and to promote and standardize the clinical applications of ICE, the members of this panel extensively evaluated relevant research findings, and they developed this consensus document after discussions and correlation with front-line clinical work experience, aiming to provide guidance for clinicians and to further improve interventional cardiovascular diagnosis and treatment procedures.
Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2)
Background Heterozygous familial hypercholesterolemia (HeFH) is largely underdiagnosed and undertreated in China where few patients achieved recommended target levels of low density lipoprotein cholesterol (LDL-C). We conducted the first randomized, placebo-controlled clinical trial in Chinese patients with HeFH to assess the efficacy and safety of tafolecimab, a novel fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody. Methods Patients diagnosed with HeFH by Simon Broome criteria and on a stable lipid-lowering therapy for at least 4 weeks were randomized 2:2:1:1 to receive subcutaneous tafolecimab 150 mg every 2 weeks (Q2W), tafolecimab 450 mg every 4 weeks (Q4W), placebo Q2W or placebo Q4W in the 12-week double-blind treatment period. After that, participants received open-label tafolecimab 150 mg Q2W or 450 mg Q4W for 12 weeks. The primary endpoint was the percent change from baseline to week 12 in LDL-C levels. Secondary endpoints included proportion of participants achieving ≥50% LDL-C reductions and proportion of participants with LDL-C <1.8 mmol/L at week 12 and 24, the change from baseline to week 12 in non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B and lipoprotein(a) levels, as well as the change from baseline to week 24 in lipid levels. Results In total, 149 participants were randomized and 148 received at least one dose of the study treatment. At week 12, tafolecimab treatment induced significant reductions in LDL-C levels (treatment difference versus placebo [on-treatment estimand]: −57.4% [97.5% CI, −69.2 to −45.5] for 150 mg Q2W; −61.9% [−73.4 to −50.4] for 450 mg Q4W; both P <0.0001). At both dose regimens, significantly more participants treated with tafolecimab achieved ≥50% LDL-C reductions or LDL-C <1.8 mmol/L at week 12 as compared with corresponding placebo groups (all P <0.0001). Meanwhile, non-HDL-C, apolipoprotein B and lipoprotein(a) levels were significantly reduced in the tafolecimab groups at week 12. The lipid-lowering effects of tafolecimab were maintained till week 24. During the double-blind treatment period, the most commonly-reported adverse events in the tafolecimab groups included upper respiratory tract infection, increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase and hypertension. Conclusions Tafolecimab administered either 150 mg Q2W or 450 mg Q4W yielded significant and persistent reductions in LDL-C levels and showed a favorable safety profile in Chinese patients with HeFH. Trial registration ClinicalTrials.gov, NCT04179669.
Multiply doses of FDC of rosuvastatin and ezetimibe versus rosuvastatin monotherapy in Chinese patients with hypercholesterolemia (ROSE-CH): multicenter, randomized-controlled trial
Objective Rosuvastatin plus ezetimibe improves the lipid-lowering effect through different mechanisms of action. This study intended to compare the efficacy and safety of the fixed-dose combination (FDC) of rosuvastatin/ezetimibe vs. rosuvastatin alone in hypercholesterolemia patients. Methods ROSE-CH (ROSuvastatin and Ezetimibe in Chinese Hypercholesterolemia patients) was a multicenter, randomized, double-blind, positive drug-controlled, superiority-tested phase III clinical trial; 743 patients were randomized into rosuvastatin/ezetimibe 10/10 mg, 5/10 mg, and 2.5/10 mg groups, as well as rosuvastatin 10 mg and 5 mg groups at a 1:1:1:1:1 ratio. A total of 143, 127, 263, and 137 patients had low, intermediate, high, and very-high baseline atherosclerotic cardiovascular disease (ASCVD) risks. The study period spanned from December 24, 2021, to December 6, 2022. Results Efficacy and safety assessments were conducted in 670 and 696 patients. Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to week (W)12 was greater in the rosuvastatin/ezetimibe 10/10 mg group vs. rosuvastatin 10 mg group [least-squares means (LSmean): -51.48% vs. -42.47%], rosuvastatin/ezetimibe 5/10 group vs. rosuvastatin 5 mg group (LSmean: -50.08% vs. -40.17%), and rosuvastatin/ezetimibe 2.5/10 mg group vs. the rosuvastatin 5 mg group (LSmean: -48.47% vs. -40.17%) (all P  < 0.001). The same trend was observed for the percentage change in LDL-C from baseline to W4 and W8 (all P  < 0.001). In patients with baseline very high ASCVD risk, the achievement of LDL-C target at W12 was higher in rosuvastatin/ezetimibe 10/10 mg vs. rosuvastatin 10 mg groups and rosuvastatin/ezetimibe 2.5/10 mg vs. rosuvastatin 5 mg groups (both P  < 0.05). The incidence of adverse events was 36.0%, 38.7%, 25.2%, 31.4%, and 38.6% in each group. Regarding serious adverse events, the incidence was 2.2%, 2.9%, 0.7%, 3.6%, and 0.7% in each group. The incidence of drug-related adverse events was relatively high, which was 26.6%, 31.4%, 18.5%, 23.6%, and 29.0% in each group, respectively, irrespective of the absence of serious drug-related adverse events. Conclusion The FDC of rosuvastatin/ezetimibe has superior LDL-C-lowering effects over rosuvastatin alone, with good safety profiles in hypercholesterolemia patients.
Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
There lacks real‐world study with a large sample size assessing olmesartan medoxomil‐amlodipine besylate (OM‐AML) tablet. Therefore, this study aimed to evaluate the efficacy and safety of OM‐AML tablet in patients with essential hypertension. Totally, 1341 patients from 36 medical centers with essential hypertension who took OM‐AML (20/5 mg) tablet were analyzed in the current prospective, single‐arm, multi‐center, real‐world study (SVK study). Seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) at baseline, week (W)4 and W8 were measured. The mean (±SE) change of SeSBP/SeDBP was ‐10.8 ± 0.4/‐6.6 ± 0.3 mmHg at W4 and ‐12.7 ± 0.5/‐7.6 ± 0.3 mmHg at W8, respectively. At W4, 78.8% and 29.0% patients achieved BP target by China and American Heart Association (AHA) criteria; at W8, 84.7% and 36.5% patients reached blood pressure (BP) target by China and AHA criteria, accordingly. Meanwhile, 80.2% and 86.4% patients achieved BP response at W4 and W8, respectively. Home‐measured SeSBP and SeDBP decreased from W1 to W8 (both p < .001). Besides, patients’ and physicians’ satisfaction were elevated at W8 compared with W0 (both p < .001). The medication possession rate was 94.8% from baseline to W4 and 91.3% from baseline to W8. The most common drug‐related adverse events were nervous system disorders (4.6%), vascular disorders (2.6%), and general disorders and administration site conditions (2.3%) by system organ class, which were generally mild and manageable. In conclusion, OM‐AML tablet is one of the best antihypertensive agents in patients with essential hypertension.
Research progress of biomarkers in early detection of chemotherapy-induced cardiotoxicity
With the advances of drug therapy, the prognosis of cancer patients has seen remarkable improvements, and cancer-related mortality has decreased significantly. However, the followed drug-related cardiotoxicity becomes a serious threat to patients’ living quality and survival rate. Cardiovascular toxicity associated with some chemotherapy drugs is reversible and dose-dependent. If early identification is possible, early cardiovascular protection measures or adjustment of chemotherapy regimens can be taken to improve the prognosis of patients. Therefore, early prevention and monitoring of chemotherapy-related cardiotoxicity are critical for cancer patients and survivors. Among them, biomarkers are an important method for the early identification of myocardial injury.
Multiply doses of FDC of rosuvastatin and ezetimibe versus rosuvastatin monotherapy in Chinese patients with hypercholesterolemia
Rosuvastatin plus ezetimibe improves the lipid-lowering effect through different mechanisms of action. This study intended to compare the efficacy and safety of the fixed-dose combination (FDC) of rosuvastatin/ezetimibe vs. rosuvastatin alone in hypercholesterolemia patients. ROSE-CH (ROSuvastatin and Ezetimibe in Chinese Hypercholesterolemia patients) was a multicenter, randomized, double-blind, positive drug-controlled, superiority-tested phase III clinical trial; 743 patients were randomized into rosuvastatin/ezetimibe 10/10 mg, 5/10 mg, and 2.5/10 mg groups, as well as rosuvastatin 10 mg and 5 mg groups at a 1:1:1:1:1 ratio. A total of 143, 127, 263, and 137 patients had low, intermediate, high, and very-high baseline atherosclerotic cardiovascular disease (ASCVD) risks. The study period spanned from December 24, 2021, to December 6, 2022. Efficacy and safety assessments were conducted in 670 and 696 patients. Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to week (W)12 was greater in the rosuvastatin/ezetimibe 10/10 mg group vs. rosuvastatin 10 mg group [least-squares means (LSmean): -51.48% vs. -42.47%], rosuvastatin/ezetimibe 5/10 group vs. rosuvastatin 5 mg group (LSmean: -50.08% vs. -40.17%), and rosuvastatin/ezetimibe 2.5/10 mg group vs. the rosuvastatin 5 mg group (LSmean: -48.47% vs. -40.17%) (all P < 0.001). The same trend was observed for the percentage change in LDL-C from baseline to W4 and W8 (all P < 0.001). In patients with baseline very high ASCVD risk, the achievement of LDL-C target at W12 was higher in rosuvastatin/ezetimibe 10/10 mg vs. rosuvastatin 10 mg groups and rosuvastatin/ezetimibe 2.5/10 mg vs. rosuvastatin 5 mg groups (both P < 0.05). The incidence of adverse events was 36.0%, 38.7%, 25.2%, 31.4%, and 38.6% in each group. Regarding serious adverse events, the incidence was 2.2%, 2.9%, 0.7%, 3.6%, and 0.7% in each group. The incidence of drug-related adverse events was relatively high, which was 26.6%, 31.4%, 18.5%, 23.6%, and 29.0% in each group, respectively, irrespective of the absence of serious drug-related adverse events. The FDC of rosuvastatin/ezetimibe has superior LDL-C-lowering effects over rosuvastatin alone, with good safety profiles in hypercholesterolemia patients.
Edoxaban for stroke prevention in atrial fibrillation and factors associated with dosing: patient characteristics from the prospective observational ETNA-AF-China registry
Real-world data on effectiveness and safety of a single non-vitamin K antagonist oral anticoagulant in the Chinese population with atrial fibrillation (AF) are limited. This study reports characteristics of patients treated with edoxaban and factors associated with dosing patterns from routine care in China. ETNA-AF-China (NCT04747496) is a multicentre, prospective, observational study enrolling edoxaban-treated patients from four economic regions with a targeted 2-year follow-up. Of the 4930 patients with AF (mean age: 70.2 ± 9.5 years; male, 57.1%), the mean creatinine clearance (CrCl), CHA 2 DS 2 -VASc, and HAS-BLED scores were 71.2 mL/min, 2.9, and 1.6. Overall, 6.4% of patients were perceived as frail by investigators. Available label dose reduction criteria (N = 4232) revealed that 3278 (77.5%) patients received recommended doses and 954 (22.5%) non-recommended doses. Northeast (53.0%) and West (43.1%) regions had the highest prescriptions of 60 mg and 30 mg recommended doses, respectively. Non-recommended 30 mg doses were more frequently prescribed in patients with antiplatelet use and history of heart failure than recommended 60 mg. Multivariate analysis identified advanced age as the strongest associated factor with non-recommended doses. Frailty had the strongest association with 30 mg except for age, and history of TIA was the most relevant factor associated with 60 mg. In conclusion, patients in the ETNA-AF-China study were predominantly aged 65 years and older, had mild-to-moderate renal impairment and good label adherence. Advanced age was associated with non-recommended doses, with frailty most common for non-recommended 30 mg and a history of TIA for the non-recommended 60 mg dose.
Microwave Involved Synthesis of Graphene/Polyaniline Nanocomposite with Superior Electrochemical Performance
A microwave irradiation involved process was applied to fabrication of graphene/polyaniline nanocomposite via in-situ polymerization of aniline monomers on graphene sheets. Structure and morphology of composites were characterized through scanning electron microscopy, Raman spectra, X-ray diffraction, Fourier transform infrared spectroscopy and X-ray photoelectron spectra. Electrochemical performances for energy storage applications were examined by cyclic voltammetry, electrochemical impedance spectroscopy and galvanostatic charge/discharge measurements. Owing to the homogeneous coating of polyanilline on the large surface of graphene, graphene/polyaniline composite-based electrode exhibits remarkably enhanced capacitive behavior with a specific capacitance of 429 F/g at 0.2 A g-1, a good cyclic stability and an excellent conducting behavior, which are much superior to those of individual components of composites. The improved electrochemical behavior of the composite resulting from the irradiation of microwave suggests the promising potentials for supercapacitors.
Efficacy and safety of olmesartan medoxomil‑amlodipine besylate tablets (Sevikar®) in older patients with essential hypertension: Subgroup analysis from the Sevikar study
Essential hypertension is a notable threat for the older (age, ≥65 years) population. However, to the best of our knowledge, a real-world study assessing olmesartan medoxomil-amlodipine besylate (OM-AML) tablets in older Chinese patients with essential hypertension has not been performed. Therefore, the present study aimed to evaluate the efficacy and safety of OM-AML tablets in these patients. A total of 463 older Chinese patients with essential hypertension treated with OM-AML (20/5 mg) tablets (Sevikar®) were analyzed in a prospective, single-arm, multi-center, real-world study. Seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) at baseline, and at week (W)4 and W8 after OM-AML tablet administration were measured. The mean ± standard error change of SeSBP/SeDBP was -10.3±0.8/-4.6±0.5 and -12.5±0.8/-5.6±0.5 mmHg at W4 and W8, respectively. At W4, 74.1 and 26.8% of patients achieved BP target according to the China and American Heart Association (AHA) criteria, while at W8, 78.0 and 38.7% of patients reached these BP targets accordingly. Finally, 76.5 and 80.5% of patients achieved BP response at W4 and W8, respectively. Furthermore, home-measured SeSBP and SeDBP were significantly decreased from W1 to W8 (both P<0.001). Additionally, the satisfaction of both patients and physicians was elevated at W8 compared with at W0 (both P<0.001). The medication possession rate from baseline to W4 and W8 was 95.5 and 92.5%. The most common drug-associated adverse events by system organ classes were nervous system disorder (4.5%), vascular disorder (2.8%), and general disorder and administration site conditions (2.6%), which were generally mild. In conclusion, OM-AML tablets may be considered effective and safe in lowering BP, enabling the achievement of guideline-recommended BP targets in older Chinese patients with essential hypertension.