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53. Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Capsid Assembly Modulator GST-HG141 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial

Author

Li, Cuiyun, primary, Wu, Min, additional, Zhang, Hong, additional, Mai, Jiajia, additional, Yang, Lizhi, additional, Ding, Yanhua, additional, Niu, Junqi, additional, Mao, John, additional, Wu, Wenqiang, additional, Zhang, Dong, additional, Tang, Yanan, additional, and Yan, Wenhao, additional

Published
2021
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60. Safety, tolerability, and pharmacokinetics of the novel pan-phosphodiesterase inhibitor ZSP1601 in healthy subjects: a double-blinded, placebo-controlled first-in-human single-dose and multiple-dose escalation and food effect study

Author

Zhu, Xiaoxue, primary, Wu, Min, additional, Wang, Hong, additional, Li, Haijun, additional, Lin, Junjie, additional, Peng, Yun, additional, Hu, Yue, additional, Li, Cuiyun, additional, and Ding, Yanhua, additional

Published
2021
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62. A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects

Author

Zhang, Hong, primary, Chen, Hong, additional, Li, Xiaojiao, additional, Wu, Min, additional, Zhu, Xiaoxue, additional, Li, Cuiyun, additional, Liu, Jingrui, additional, Wei, Haijing, additional, Hu, Yue, additional, Wang, Jingjing, additional, Yang, Yongmin, additional, Zhu, Xiangyang, additional, and Ding, Yanhua, additional

Published
2021
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64. Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study

Author

Zhang, Hong, primary, Wu, Min, additional, Sun, Jixuan, additional, Zhu, Xiaoxue, additional, Li, Cuiyun, additional, Ding, Yanhua, additional, Zhang, Xiaodi, additional, Chai, Katherine, additional, and Li, Xiaojiao, additional

Published
2021
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66. Multivariate Analysis Of The Diagnostic Yield Of Conventional Bronchoscopy In Peripheral Lung Adenocarcinoma

Author

Gao, Wei, Li, Cuiyun, Wang, Hui, Han, Ping, and Nie, Yunqiang

Subjects
bronchoscopy, bronchial lumen biopsy, Cancer Management and Research, bronchus cut off sign, lepidic type-predominant, micropapillary type-predominant, Original Research
Abstract

Wei Gao,1 Cuiyun Li,2 Hui Wang,2 Ping Han,2 Yunqiang Nie2 1Department of Blood Screening Test, Linyi People’s Hospital, Linyi 276000, People’s Republic of China; 2Department of Respiratory Medicine, Linyi People’s Hospital, Linyi 276000, People’s Republic of ChinaCorrespondence: Yunqiang NieDepartment of Respiratory Medicine, Linyi People’s Hospital, Linyi 276000, People’s Republic of ChinaTel +86 189 5397 1615Email 1612698346@qq.comBackground: The new subtypes of lung adenocarcinoma reflect local invasive growth, pulmonary alveoli, and intraluminal spreading, while the effective improvement of the diagnostic yield of bronchoscopy still remains unclear. This study aims to explore whether the subtypes of lung adenocarcinoma and other factors affect the diagnostic yield of bronchoscopy.Methods: All patients were performed 64-row CT examination and bronchoscopy.Results: The bronchus cutoff sign in 48 cases and the endoscopic diagnostic yield was 60.4%. The lumen of the lobes and segments was invaded in 59 cases, and the endoscopic diagnostic yield was 54.2%.The lymph node metastasis was detected in 46 cases, and the endoscopic diagnostic yield was 60.9%. In addition, 42 cases showed acinar type-predominant, and the endoscopic diagnostic yield was 28.6%. Eighteen cases showed solid type-predominant, and the endoscopic diagnostic yield was 33.3%. The micropapillary type-predominant was noted in 17 cases, with the endoscopic diagnostic yield as 94.1%. The papillary type-predominant was in 14 cases, and the endoscopic diagnostic yield was 42.9%. The lepidic type-predominant was seen in 13 cases, and the endoscopic diagnostic yield was 7.7%. The mean diameter of tumors with a positive endoscopic diagnostic yield was 4.34±2.65cm, and the mean diameter of tumors with a negative diagnostic yield was 2.83±1.47cm. Multivariate analysis showed that micropapillary lung adenocarcinoma affected the endoscopic diagnostic yield (OR=37.594, 95% CI: 4.074–346.94) .Tumor diameter affects endoscopic diagnostic yield (OR=1.39, 95% CI: 1.073–1.802), bronchus cutoff sign is easy to obtain endoscopic diagnostic yield (OR=4.86, 95% CI: 1.606–14.704), and lymph node metastasis affects the endoscopic diagnostic yield (OR=3.696, 95% CI: 1.255–10.883).Conclusion: The micropapillary subtype lung adenocarcinoma has a certain influence on the diagnostic yield of bronchoscopy. When the lung adenocarcinoma has a large tumor diameter, bronchus cutoff sign and lymph node metastasis, it is easy to obtain a diagnostic yield of bronchoscopy.Keywords: bronchoscopy, micropapillary type-predominant, lepidic type-predominant, bronchial lumen biopsy, bronchus cut off sign

Published
2019

67. A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men

Author

Zhang, Hong, primary, Wang, Hong, additional, Wei, Haijing, additional, Chen, Hong, additional, Liu, Jingrui, additional, Li, Cuiyun, additional, Zhu, Xiaoxue, additional, Li, Xiaojiao, additional, Yu, Jinchen, additional, Zhou, Yinbo, additional, Yang, Xiaolei, additional, Wang, Zhaohe, additional, Wu, Min, additional, and Ding, Yanhua, additional

Published
2021
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80. Pharmacokinetics, pharmacodynamics and tolerability of single and multiple doses of janagliflozin, a sodium‐glucose co‐transporter‐2 inhibitor, in Chinese people with type 2 diabetes mellitus

Author

Li, Xiaojiao, primary, Zhu, Xiaoxue, additional, Liu, Jingrui, additional, Li, Qianqian, additional, Zhang, Hong, additional, Li, Cuiyun, additional, Wu, Min, additional, Gao, Lei, additional, Wen, He, additional, Li, Xixi, additional, Tang, Xinran, additional, Liu, Li, additional, and Ding, Yanhua, additional

Published
2020
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83. Biosynthesis of zinc nanoparticles using Allium saralicum R.M. Fritsch leaf extract; Chemical characterization and analysis of their cytotoxicity, antioxidant, antibacterial, antifungal, and cutaneous wound healing properties

Author

Zhang, Chunnan, primary, Liu, Jiayu, additional, Ahmeda, Ahmad, additional, Liu, Yandong, additional, Feng, Jianyu, additional, Guan, Hui, additional, Li, Cuiyun, additional, Nowrozi, Masoumeh, additional, Zangeneh, Mohammad Mahdi, additional, Zangeneh, Akram, additional, and Almasi, Maryam, additional

Published
2020
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90. Elucidating the immunomodulatory effect of daidzein in Benzo(a)pyrene -Induced lung cancer mice model through modulation of proliferating cell nuclear antigen, NF-κB, CYP1A1, and NRF.

Author

Feng, Jianyu, Meng, Wei, Liu, Yandong, Li, Cuiyun, Zhang, Chunnan, Wang, Peng, Almoallim, Hesham, Manikandan, Velu, and Guan, Hui

Subjects
PROLIFERATING cell nuclear antigen, LUNGS, LUNG cancer, CYTOCHROME P-450 CYP1A1, ANIMAL disease models, PYRENE
Abstract

Background: Lung cancer is the second most predominant reason for cancer deaths globally. It is estimated to be approximately 30% among the cancer deaths. Daidzein (DAZ) is a polyphenolic compound present commonly in soy-based plants and is proven to have various therapeutic properties. Objectives: In this study, we aimed to understand the immunomodulatory activity of DAZ in the mice model with benzo(a)pyrene (B(a)P)-induced lung carcinoma. Materials and Methods: The mice were divided into five groups: Group I served was the control group; Group II animals were challenged with B(a)P; Group III animals were treated with DAZ before challenge with B(a)P; Group IV animals were treated with DAZ after challenging the animals with B(a)P; and Group V animals were treated with DAZ alone till the end of the experimental period. Tumor incidence was calculated, and the following parameters were analyzed: Body weight, lung weight, total number of tumors, percentage of inhibition, immunoglobulin (Ig) levels (immunoglobulin G, immunoglobulin A, and immunoglobulin M), key marker enzymes, and proinflammatory cytokines in both treated and normal mice. The lung tissues were analyzed through the histopathological analysis. Results: According to our results, all the markers that favor the growth of cancer were increased in the lung cancer group. After the administration of DAZ, all the markers returned to their original levels. Conclusion: In conclusion, DAZ protected the cells against the B(a)P-induced inflammatory responses in lung cancer. [ABSTRACT FROM AUTHOR]

Published
2022
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91. A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects.

Author

Zhang, Hong, Li, Xiaojiao, Liu, Jingrui, Li, Cuiyun, Wu, Min, Zhu, Xiaoxue, Sun, Jixuan, Fang, Min, and Ding, Yanhua

Subjects
TOCILIZUMAB, PHARMACOKINETICS, LEUKOCYTE count, IMMUNE response, CONFIDENCE intervals
Abstract

QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects. A randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence of QX003S (8 mg/kg) with that of Actemra® as a reference drug. QX003S (N = 40) and Actemra® (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% to 18.78%. The 90% confidence intervals of the ratios for Cmax, AUC0–t andAUC0–∞ in both groups were within the range of 80–125%. After administration, the number of subjects who tested positive for anti-drug antibodies (ADA) in the QX003S group and Actemra® groups was 6 (14.3%) and 14 (34.1%), respectively. Adverse reactions occurred in 100% and 97.6% subjects in the QX003S and Actemra® groups, respectively. The most common adverse reactions were decrease in fibrinogen level and neutrophil and leukocyte counts. The PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects. The trial is registered at Chinese Clinical Trial website () This was the first clinical report of a new proposed tocilizumab biosimilar, QX003S. This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@). The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles. [ABSTRACT FROM AUTHOR]

Published
2021
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92. Correlation between high-resolution computed tomography lung nodule characteristics and EGFR mutation in lung adenocarcinomas

Author

Nie,Yunqiang, Liu,Hongjun, Tan,Xiao, Wang,Hui, Li,Fuzhou, Li,Cuiyun, Han,Ping, Lyv,Xin, Xu,Xinyi, Guo,Miao, Nie,Yunqiang, Liu,Hongjun, Tan,Xiao, Wang,Hui, Li,Fuzhou, Li,Cuiyun, Han,Ping, Lyv,Xin, Xu,Xinyi, and Guo,Miao

Abstract

Yunqiang Nie,1 Hongjun Liu,2 Xiao Tan,3 Hui Wang,1 Fuzhou Li,4 Cuiyun Li,1 Ping Han,1 Xin Lyv,1 Xinyi Xu,1 Miao Guo5 1Department of Respiratory Medicine, Linyi People’s Hospital, Linyi 276000, China; 2Department of Internal Medicine, 120 Emergency Command Center of Linyi City, Linyi 276002, China; 3Department of Pathology, Linyi People’s Hospital, Linyi 276000, China; 4Department of Radiology, Linyi People’s Hospital, Linyi 276000, China; 5Department of Geriatrics, Linyi People’s Hospital, Linyi 276000, China Background: The aim of this study was to investigate the correlation of EGFR mutation on the high-resolution computed tomography (HRCT) features in lung adenocarcinoma. Patients and methods: A total of 121 patients were diagnosed with lung adenocarcinoma from January 2014 to December 2016. The correlation of indexes (gender, age, tumor diameter, and EGFR mutation) was analyzed based on the HRCT characteristics of lung adenocarcinoma. Results: There were 73 cases of EGFR mutation and 48 cases of wild-type EGFR. One hundred and three cases had pleural indentation that was significant in patients with EGFR mutation than those with wild-type EGFR (P=0.038). Forty-two out of 121 cases exhibited the bronchus cutoff sign. Patients with EGFR mutation were likely to develop the bronchus cutoff sign (P=0.017). Sixty-one out of 121 cases exhibited the lobulation sign, which was significant in patients with EGFR mutation than those with wild-type EGFR (P<0.001). A significant correlation was found between lobulation sign and tumor diameter (P=0.024). Forty-eight out of 121 and 23 out of 121 cases showed the vessel and vacuole signs, respectively. However, patients with EGFR mutation did not exert a significant correlation on either of these signs (P=0.555 and P=0.372, respectively). A statistical significance was not observed in indexes such as age, gender, and tumor diameter on pleural indentation, bronchus cutoff sign, vesse

Published
2019

93. Safety and pharmacokinetics of a new biosimilar trastuzumab (HL02): a Phase I bioequivalence study in healthy Chinese men

Author

Zhang, Hong, Liu, Ting, Wu, Min, Wei, Haijing, Li, Cuiyun, Li, Xiaojiao, Liu, jingrui, Chen, Hong, Ding, Yanhua, and Liu, Li

Abstract

ABSTRACTObjectivesThe study aimed to explore the bioequivalence of a proposed biosimilar HL02 vs. its reference products (US-trastuzumab) among healthy Chinese men.MethodsIn this study, nine healthy male subjects received single ascending doses of trastuzumab biosimilar (HL02, 2–8 mg/kg), and then a randomized, double-blind, two-arm, parallel study was conducted to investigate the PK similarity of HL02 (6 mg/kg) with that of US-trastuzumab as a reference drug.ResultsPK properties exhibited by HL02 (N= 55) were similar to those of US-trastuzumab (N= 52). The comparison of biosimilarity with US-trastuzumab showed that the 90% confidence intervals (CIs) of the ratios for Cmax, AUC0-t, and AUC0-∞were within 80–125%. Nineteen subjects were positive for ADA and negative for NAb in both HL02 and US-trastuzumab groups. In total, 81.67% of subjects in HL02 and 78.95% in US-trastuzumab groups showed treatment-related mild or moderate adverse events, mild elevation of transaminase level being the most common adverse events (AE) recorded.ConclusionsThe PK characteristics and immunogenicity exhibited by HL02 were similar to that of the reference product, US-trastuzumab. The safety profiles were similar in both the treatment groups with mild-moderate adverse effects.

Published
2022
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94. Antiviral Activity and Pharmacokinetics of the Hepatitis B Virus (HBV) Capsid Assembly Modulator GLS4 in Patients With Chronic HBV Infection.

Author

Zhang, Hong, Wang, Fengjiao, Zhu, Xiaoxue, Chen, Yunfu, Chen, Hong, Li, Xiaojiao, Wu, Min, Li, Cuiyun, Liu, Jingrui, Zhang, Yingjun, Ding, Yanhua, and Niu, Junqi

Subjects
CLINICAL drug trials, COMBINATION drug therapy, DNA, HEPATITIS viruses, ANTIVIRAL agents, RANDOMIZED controlled trials, BLIND experiment, DESCRIPTIVE statistics, CHRONIC hepatitis B, LONGITUDINAL method
Abstract

Background GLS4 is a first-in-class hepatitis B virus (HBV) capsid assembly modulator (class I) that can inhibit HBV replication by interfering with the assembly and disassembly of HBV nucleocapsid. Here, we evaluated its antiviral activity, pharmacokinetics, and tolerability in a double-blind, randomized, parallel, entecavir-controlled study. Methods Twenty-four patients with chronic HBV were randomized to receive a 28-day course of GLS4 (120 or 240 mg) and ritonavir (100 mg) combination (cohorts A and B, respectively) or entecavir treatment (cohort C) at a 1:1:1 ratio. Patients were followed up for 40 days in a phase 1b study. Results The GLS4/ritonavir combination was a tolerated combination for the treatment of chronic HBV infection. A total of 2, 3, and 3 subjects presented with alanine aminotransferase flare in cohorts A, B, and C, respectively. This contributed to the withdrawal of 1, 2, and 1 patient from cohorts A, B, and C, respectively. The mean Ctrough of GLS4 was 205–218 ng/mL, which was approximately 3.7–3.9 times the 90% effective concentration (55.8 ng/mL), with a lower accumulation (accumulation rate, 1.1–2.0). In cohorts A, B, and C, the mean declines in HBV DNA after 28 days of treatment were −1.42, −2.13, and −3.5 log10 IU/mL; in hepatitis B surface antigen were −0.06, −0.14, and −0.33 log10 IU/mL; in pregenomic RNA were −0.75, −1.78, and −0.96 log10 copies/mL; and in hepatitis B core antigen were −0.23, −0.5, and −0.44 log10 U/mL, respectively. Conclusions Treatment with 120 mg GLS4 was tolerated and had antiviral activity in patients with chronic HBV infection. Clinical Trials Registration Chinese Clinical Trial Registry; CTR20160068. http://www.chinadrugtrials.org.cn. [ABSTRACT FROM AUTHOR]

Published
2021
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95. Pharmacokinetics and Safety of Chiglitazar, a Peroxisome Proliferator‐Activated Receptor Pan‐Agonist, in Patients < 65 and ≥ 65 Years With Type 2 Diabetes.

Author

Li, Xiaojiao, Yu, Jia, Wu, Min, Li, Qianqian, Liu, Jingrui, Zhang, Hong, Zhu, Xiaoxue, Li, Cuiyun, Zhang, Jinwen, Ning, Zhiqiang, and Ding, Yanhua

Subjects
GLUCAGON-like peptide-1 agonists, PEROXISOME proliferator-activated receptors, TYPE 2 diabetes, PHARMACOKINETICS
Abstract

The effect of age on the pharmacokinetics and safety of chiglitazar was evaluated in patients < 65 and ≥ 65 years with type 2 diabetes mellitus (T2DM). A total of 20 T2DM patients (<65 vs ≥65 years 1:1) completed the study. Patients received multiple doses of 48 mg chiglitazar once daily for 7 days consecutively. After the first dosing, chiglitazar maximum plasma concentration (Cmax) and area under the plasma concentration‐time curve (AUC) in patients ≥ 65 years were similar to those observed in patients < 65 years, with the geometric mean ratio (GMR) for Cmax and AUC being 97.22% and 96.83%, respectively. No significant difference was observed in Cmax (GMR, 97.23%) in the steady state. Compared with the patients < 65 years, a slight increase (8%‐13%) of AUC was observed in the patients ≥ 65 years after multiple doses. Chiglitazar was generally well tolerated following multiple doses in both age groups. In conclusion, there were no significant clinical influences on the pharmacokinetic properties and safety profiles of chiglitazar between patients with T2DM < 65 and ≥ 65 years, indicating that in the future it is not required to adjust the dosing regimen by age for T2DM patients ≥ 65 years. [ABSTRACT FROM AUTHOR]

Published
2021
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97. Clinical Evaluation of the Tolerability and Pharmacokinetics of Azilsartan, a Potent Angiotensin Receptor Blocker, in Healthy Chinese Subjects

Author

Li, Xiaojiao, primary, Liu, Jingrui, additional, Sheng, Changcheng, additional, Chen, Hong, additional, Cui, Dongyang, additional, Chen, Guiling, additional, Zhang, Hong, additional, Zhu, Xiaoxue, additional, Wu, Min, additional, Li, Cuiyun, additional, Shen, Zhenwei, additional, Guo, Yingjie, additional, Ding, Yanhua, additional, and Jiao, Zheng, additional

Published
2019
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100. A phase I, randomized, double-blinded, single-dose study evaluating the pharmacokinetic equivalence of the biosimilar IBI305 and bevacizumab in healthy male subjects

Author

Zhang, Hong, primary, Zhu, Xiaoxue, additional, Wei, Haijing, additional, Li, Cuiyun, additional, Chen, Hong, additional, Li, Xiaojiao, additional, Wu, Min, additional, Liu, Jingrui, additional, Chen, Guiling, additional, Zhou, Hui, additional, Zheng, Shirui, additional, and Ding, Yanhua, additional

Published
2019
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