A5101946529- Cancer Immunotherapy and Biomarkers
- Bladder and Urothelial Cancer Treatments
- Urinary and Genital Oncology Studies
- Acute Myocardial Infarction Research
- Multiple and Secondary Primary Cancers
- Atrial Fibrillation Management and Outcomes
- Cardiac Arrhythmias and Treatments
- Cancer Genomics and Diagnostics
- Advanced Breast Cancer Therapies
- Economic and Financial Impacts of Cancer
- Heart Failure Treatment and Management
- Prostate Cancer Treatment and Research
- PARP inhibition in cancer therapy
- Bone Tumor Diagnosis and Treatments
- Venous Thromboembolism Diagnosis and Management
- Cardiovascular Function and Risk Factors
- Acute Myeloid Leukemia Research
- Obstructive Sleep Apnea Research
- Ginseng Biological Effects and Applications
- Traditional Chinese Medicine Analysis
- Cancer Treatment and Pharmacology
- Pulmonary Hypertension Research and Treatments
- Renal cell carcinoma treatment
- Statistical Methods in Clinical Trials
- Cardiovascular and Diving-Related Complications
Hebei Medical University
2025
Second Hospital of Hebei Medical University
2025
Chinese Academy of Medical Sciences & Peking Union Medical College
2011-2024
United States Food and Drug Administration
2017-2024
Beijing Hospital
2024
Center for Drug Evaluation and Research
2017-2024
Office of Science
2021-2023
Second Military Medical University
2009-2021
Fu Wai Hospital
2007-2021
First Affiliated Hospital of Soochow University
2021
On August 3, 2017, the FDA granted regular approval to Vyxeos (also known as CPX-351; Jazz Pharmaceuticals), a liposomal formulation of daunorubicin and cytarabine in fixed combination, for treatment adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or (AML) myelodysplasia-related changes (AML-MRC). Approval was based on data from Study CLTR0310-301, randomized, multicenter, open-label, active-controlled trial comparing standard combination ("7+3") 309 patients 60-75...
We performed a pooled analysis of multiple trials poly(ADP-ribose) polymerase inhibitors (PARPi) in metastatic castration-resistant prostate cancer (mCRPC) to investigate the efficacy PARPi each individual homologous recombination repair (HRR) mutated (m) gene.
Abstract Tagraxofusp-erzs (Elzonris, Stemline) is a cytotoxin that targets CD123-expressing cells. On December 21, 2018, FDA approved tagraxofusp-erzs for the treatment of blastic plasmacytoid dendritic cell neoplasms (BPDCN) in adult and pediatric patients 2 years older. Approval was based on response rate single-arm trial, Study STML-401-0114; pivotal cohort included 13 with treatment-naïve BPDCN who received monotherapy. The complete or clinical (CR/CRc) 54% (95% CI: 25%–81%), median...
The US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), 1 (
The US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
On May 3, 2019, the FDA granted regular approval to ado-trastuzumab emtansine (KADCYLA), for adjuvant treatment of patients with HER2-positive early-breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane-based chemotherapy and trastuzumab-based treatment. Approval was based on data from KATHERINE trial, which randomized receive or trastuzumab. At 3 years, event-free rate disease-free survival in arm 88.3% [95% confidence interval (CI), 85.8-90.7] compared 77.0% (95%...
The U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib in May 2020 for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostate cancer (mCRPC) who have been treated androgen receptor-directed therapy a taxane. This was based on data from ongoing multicenter, open-label single-arm trial TRITON2. primary endpoint, confirmed objective response rate, 62 met above criteria, 44% (95%...
On April 3, 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (EV) plus pembrolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible cisplatin-containing chemotherapy. Substantial evidence effectiveness was obtained from EV-103/KEYNOTE-869 (NCT03288545), a multicohort study. Across cohorts, total 121 received EV 1.25 mg/kg (maximum 125 mg) intravenously on days 1 and 8 21-day cycle 200 mg day each until disease...
The gut microbiota (GM) is recognized as a critical factor in sustaining overall health and regulating the immune system. However, precise function of GM pathogenesis bacterial pneumonia (BP), well potential involvement cells these mechanisms, remains inadequately understood. Given that BP represents substantial public issue, elucidating protective role against this condition considerable significance. We employed bidirectional two-sample univariate Mendelian randomization (UVMR) approach to...
PURPOSE The US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, locally advanced, or metastatic breast cancer (MBC) who have received at least one previous endocrine therapy whose tumors harbor more phosphatidylinositol 3-kinase ( PIK3CA )/AKT Serine/Threonine Kinase 1 AKT1 )/phosphatase tensin homolog PTEN ) alterations, as detected by an...
Abstract On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Substantial evidence of effectiveness was obtained from EV-302/KEYNOTE-A39 (NCT04223856), an open-label, randomized trial evaluating EV Pembro versus cisplatin carboplatin gemcitabine (Plat Gem) in previously untreated la/mUC. A total 886 were (1:1) receive 1.25 mg/kg intravenously on...
PURPOSE To explore trial-level and patient-level associations between response (complete remission [CR] CR + with incomplete hematologic [CRi] or platelet [CRp] recovery), event-free survival (EFS), overall (OS) in newly diagnosed acute myeloid leukemia (AML) trials of intensive chemotherapy. METHODS We identified data from eight randomized, active-controlled chemotherapy submitted to the US Food Drug Administration for treatment AML (N = 4,482). Associations odds ratios (ORs) CRi CRp,...
On December 14, 2023, the United States Food and Drug Administration (FDA) approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 or death-ligand 1 (PD-1/PD-L1) inhibitor vascular endothelial growth factor tyrosine kinase (VEGF-TKI). FDA granted traditional approval based on LITESPARK-005 (NCT04195750), an open-label, randomized, head-to-head trial of 746 RCC that progressed both PD-1/PD-L1 VEGF-TKI....
Abstract A rapid, sensitive, and accurate ultra‐performance liquid chromatography‐UV detection method was developed validated for simultaneous determination of seven active alkaloids, berberine, palmatine, coptisine, jatrorrhizine, epiberberine, evodiamine, rutaecarpine, in the Coptis‐Evodia herb couple Zuojin pill preparation. The original had a total time about 11 min, which reduced to 4.7 min by further optimization gradient elution conditions with eluent comprising water/methanol/formic...
Abstract An optimized microwave‐assisted extraction method using water (MAE‐W) as the extractant and an efficient HPLC analysis were first developed for fast simultaneous determination of D (+)‐(3,4‐dihydroxyphenyl) lactic acid (Dla), salvianolic B (SaB), lithospermic (La) in Radix Salviae Miltiorrhizae . The key parameters MAE‐W optimized. It was found that degradation SaB inhibited when stable content Dla, La, danshen obtained. Furthermore, compared to conventional methods, proposed is a...
We compared admission systolic blood pressure (SBP), diastolic (DBP), pulse (PP), and mean arterial (MAP) in predicting 30-day all-cause mortality patients with ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock.A retrospective study was performed 7,033 consecutive STEMI patients. Multivariate-adjusted hazard ratios (HRs) a 10mm Hg increment quartiles of each were determined by Cox proportional analyses; Wald χ (2) tests used to compare the strength...
The purpose of this study was to investigate whether cinnabar causes renal inflammation and fibrosis in rats. Rats were dosed orally with (1 g/kg/day) for 8 weeks or 12 weeks. control rats treated solvent (5% carboxymethylcellulose solution) over the same time periods, respectively. Renal mercury (RHg), urinary (UHg), serum creatinine (SCr), urine kidney injury molecule 1 (KIM-1), pathology, mediators examined. At both weeks, RHg, UHg, KIM-1 significantly higher group than group, although...
Context: Coptidis Rhizoma–Euodiae Fructus couple (CEC) is a classic traditional Chinese medicine preparation consisting of Rhizoma and Euodiae at the ratio 6:1, used to treat gastro-intestinal disorders. Alkaloids are main bioactive component. This research provides comprehensive analysis information for quality control CEC.