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Article ; Online: The application of 5E rehabilitation management mode in the nursing of patients with aortic dissection complicated by obstructive sleep apnea.

Huang, Li-Ling / Yang, Yi / Guo, Jin-Hua / Huang, Yi-Lin / Lin, Li-Xia

2023

Abstract: Objective: This study was designed to explore the effect of 5E rehabilitation mode (encouragement, education, exercise, employment, and evaluation) in patients with aortic dissection (AD) complicated by obstructive sleep apnea (OSA).: Methods: ... ...

Abstract	Objective: This study was designed to explore the effect of 5E rehabilitation mode (encouragement, education, exercise, employment, and evaluation) in patients with aortic dissection (AD) complicated by obstructive sleep apnea (OSA). Methods: Patients with Stanford type B AD (TBAD) complicated by OSA were admitted to Guangdong Provincial People's Hospital from January 2019 to December 2020. They were randomly divided into an experimental group and a control group. After discharge, patients in the control group were given routine nursing and follow-up education, whereas patients in the experimental group were given 5E rehabilitation management mode-based nursing and follow-up education. Upon the nursing intervention, the differences in polysomnography (PSG) parameters, medication adherence, quality of life, blood pressure, and heart rate of patients between the two groups were compared. Logistic regression analysis was performed to evaluate the risk factors for the occurrence of adverse aortic events. Results: A total of 89 patients were enrolled, 49 in the experimental group and 40 in the control group. After the intervention, the control of heart rate, systolic blood pressure, medication adherence, PSG parameters, and quality of life scores in the experimental group were significantly better than those in the control group (P<0.05). The incidence of adverse aortic events including aortic rupture and progressive aortic dilation in the experimental group was significantly lower than that in the control group (P < 0.05). Logistic regression analysis revealed that acute TBAD [odds ratio (OR) = 15.069; 95%confidence interval (CI), 1.738-130.652; P=0.014], history of chronic kidney disease (OR=10.342; 95%CI, 1.056-101.287; P=0.045), and apnea hypopnea index (AHI) ≥ 30 (OR=2.880; 95%CI, 1.081-9.51; P=0.036) were adverse factors affecting adverse aortic events; while 5E rehabilitation management mode (OR=0.063; 95%CI, 0.008-0.513; P=0.010) was a favorable factor for occurrence of adverse aortic events. Conclusion: The findings suggest that continuous nursing based on information carrier 5E rehabilitation management significantly enhanced medication adherence, improved patients' overall quality of life, and decreased the incidence of adverse aortic events in patients TBAD patients and OSA.
Language	English
Publishing date	2023-12-29
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1500381-4
ISSN	1522-1709 ; 1520-9512
ISSN (online)	1522-1709
ISSN	1520-9512
DOI	10.1007/s11325-023-02977-z
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Zs.A 5658: Show issues

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Article ; Online: Effects of balance training on dynamic postural stability in patients with chronic ankle instability: systematic review and meta-analysis of randomized controlled trials.

Jiang, Cai / Huang, Dun-Bing / Li, Xiao-Mei / Guo, Jin-Hua / Guo, Miao-Miao / Yu, Sheng-Xian / Huang, Sai'e / Lin, Zhong-Hua

The Journal of sports medicine and physical fitness

2022 Volume 62, Issue 12, Page(s) 1707–1715

Abstract: Introduction: Chronic ankle instability (CAI), which is characterized by deficient postural control, is associated with functional limitations and diminished self-reported quality of life. Recent studies have suggested that balance training can improve ... ...

Abstract	Introduction: Chronic ankle instability (CAI), which is characterized by deficient postural control, is associated with functional limitations and diminished self-reported quality of life. Recent studies have suggested that balance training can improve postural control, but high-quality evidence-based research to confirm the effect of balance training on dynamic postural stability in CAI patients is lacking. The purpose of this study was to synthesize current evidence regarding the effect of balance training on dynamic postural stability in CAI patients. Evidence acquisition: PubMed, Embase, Web of Science and Cochrane Library databases were searched for clinical trials that evaluated the effect of balance training on posture and balance in CAI patients from their inception to 15 July 2021. All statistical analyses were performed in RevMan 5.4. The risk of bias was assessed by the Cochrane Collaboration's risk of bias tool, and studies that reported statistically comparable outcomes were analyzed in meta-analyses using random effects models. Heterogeneity was assessed using the I2 statistic index. Evidence synthesis: A total of 12 RCTs included in this meta-analysis and revealed that balance training was effective for improving the dynamic posture stability of CAI patients (SMD=0:90; 95% CI: 0.54 to 1.26; P<0:00001, I Conclusions: Balance training yielded a statistically significant and clinically meaningful improvement in dynamic postural stability in CAI patients. Limited evidence indicates that balance training was more effective than other training methods.
MeSH term(s)	Humans ; Ankle Joint ; Ankle ; Quality of Life ; Randomized Controlled Trials as Topic ; Joint Instability ; Postural Balance ; Chronic Disease
Language	English
Publishing date	2022-03-25
Publishing country	Italy
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ZDB-ID	410823-1
ISSN	1827-1928 ; 0022-4707
ISSN (online)	1827-1928
ISSN	0022-4707
DOI	10.23736/S0022-4707.22.13566-8
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Article ; Online: Geometry and water accessibility of the inhibitor binding site of Na

Aloi, Erika / Guo, Jin-Hua / Guzzi, Rita / Jiang, Ren-Wang / Ladefoged, Lucy Kate / Marsh, Derek / Esmann, Mikael / Bartucci, Rosa / Fedosova, Natalya U

Biophysical journal

2021 Volume 120, Issue 13, Page(s) 2679–2690

Abstract: Spin labels based on cinobufagin, a specific inhibitor of the Na,K-ATPase, have proved valuable tools to characterize the binding site of cardiotonic steroids (CTSs), which also constitutes the extracellular cation pathway. Because existing literature ... ...

Abstract	Spin labels based on cinobufagin, a specific inhibitor of the Na,K-ATPase, have proved valuable tools to characterize the binding site of cardiotonic steroids (CTSs), which also constitutes the extracellular cation pathway. Because existing literature suggests variations in the physiological responses caused by binding of different CTSs, we extended the original set of spin-labeled inhibitors to the more potent bufalin derivatives. Positioning of the spin labels within the Na,K-ATPase site was defined and visualized by molecular docking. Although the original cinobufagin labels exhibited lower affinity, continuous-wave electron paramagnetic resonance spectra of spin-labeled bufalins and cinobufagins revealed a high degree of pairwise similarity, implying that these two types of CTS bind in the same way. Further analysis of the spectral lineshapes of bound spin labels was performed with emphasis on their structure (PROXYL vs. TEMPO), as well as length and rigidity of the linkers. For comparable structures, the dynamic flexibility increased in parallel with linker length, with the longest linker placing the spin label at the entrance to the binding site. Temperature-related changes in spectral lineshapes indicate that six-membered nitroxide rings undergo boat-chair transitions, showing that the binding-site cross section can accommodate the accompanying changes in methyl-group orientation. D
MeSH term(s)	Binding Sites ; Electron Spin Resonance Spectroscopy ; Molecular Docking Simulation ; Sodium-Potassium-Exchanging ATPase/metabolism ; Spin Labels ; Water
Chemical Substances	Spin Labels ; Water (059QF0KO0R) ; Sodium-Potassium-Exchanging ATPase (EC 7.2.2.13)
Language	English
Publishing date	2021-06-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	218078-9
ISSN	1542-0086 ; 0006-3495
ISSN (online)	1542-0086
ISSN	0006-3495
DOI	10.1016/j.bpj.2021.05.018
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Zs.A 235: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Spin‐labeled derivatives of cardiotonic steroids as tools for characterization of the extracellular entrance to the binding site on Na+,K+‐ATPase

Guo, Jin‐Hua / Jacob Lauwring Andersen / Mikael Esmann / Natalya U. Fedosova / Ren‐Wang Jiang

FEBS journal. 2018 June, v. 285, no. 12

2018

Abstract: The information obtained from crystallized complexes of the Na+,K+‐ATPase with cardiotonic steroids (CTS) is not sufficient to explain differences in the inhibitory properties of CTS such as stereoselectivity of CTS binding or effect of glycosylation on ... ...

Abstract	The information obtained from crystallized complexes of the Na+,K+‐ATPase with cardiotonic steroids (CTS) is not sufficient to explain differences in the inhibitory properties of CTS such as stereoselectivity of CTS binding or effect of glycosylation on the preference to enzyme isoforms. The uncertainty is related to the spatial organization of the hydrophilic cavity at the entrance of the CTS‐binding site. Therefore, there is a need to supplement the crystallographic description with data obtained in aqueous solution, where molecules have significant degree of flexibility. This work addresses the applicability of the electron paramagnetic resonance (EPR) method for the purpose. We have designed and synthesized spin‐labeled compounds based on the cinobufagin steroid core. The length of the spacer arms between the steroid core and the nitroxide group determines the position of the reporting group (N‐O) confined to the binding site. High affinity to Na+,K+‐ATPase is inferred from their ability to inhibit enzymatic activity. The differences between the EPR spectra in the absence and presence of high ouabain concentrations identify the signature peaks originating from the fraction of the spin labels bound within the ouabain site. The degree of perturbations of the EPR spectra depends on the length of the spacer arm. Docking of the compounds into the CTS site suggests which elements of the protein structure might be responsible for interference with the spin label (e.g., steric clashes or immobilization). Thus, the method is suitable for gathering information on the cavity leading to the CTS‐binding site in Na+,K+‐ATPase in all conformations with high affinity to CTS.
Keywords	aqueous solutions ; binding sites ; crystallization ; electron paramagnetic resonance spectroscopy ; enzyme activity ; glycosylation ; hydrophilicity ; ouabain ; protein structure ; sodium-potassium-exchanging ATPase ; stereoselectivity ; steroids ; uncertainty
Language	English
Dates of publication	2018-06
Size	p. 2292-2305.
Publishing place	John Wiley & Sons, Ltd
Document type	Article
Note	JOURNAL ARTICLE
ZDB-ID	2173655-8
ISSN	1742-4658 ; 1742-464X
ISSN (online)	1742-4658
ISSN	1742-464X
DOI	10.1111/febs.14480
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Article: Effects of 12 weeks of Tai Chi Chuan intervention on the postural stability and self-reported instability in subjects with functional ankle instability: Study protocol for a randomized controlled trial.

Ke, Xiao-Hua / Huang, Dun-Bing / Li, Yin-Yan / Li, Xiao-Mei / Guo, Jin-Hua / Guo, Miao-Miao / Yu, Sheng-Xian / Ma, Sheng-Chao / Jiang, Cai / Lin, Zhong-Hua

Frontiers in neurology

2022 Volume 13, Page(s) 923669

Abstract: Background: Tai Chi Chuan (TCC) is a physical activity modality that originated in China and is now widely popular around the world. Although there are a series of articles reporting that TCC can improve balance and other functional symptoms in a ... ...

Abstract	Background: Tai Chi Chuan (TCC) is a physical activity modality that originated in China and is now widely popular around the world. Although there are a series of articles reporting that TCC can improve balance and other functional symptoms in a variety of populations, including the elderly, patients with stroke, and patients with Parkinson's disease, its efficiency has not been scientifically and methodically evaluated in subjects with functional ankle instability (FAI). Moreover, there is no literature directly comparing TCC and conventional balance training (CBT) interventions for FAI. The objective of this study is to investigate the comparative effects of TCC intervention and CBT protocols in improving postural balance and subjective instability feelings in patients with FAI. Methods: This study will be a single-center, parallel group, randomized controlled trial. Sixty-eight patients with FAI will be included and randomly assigned in a 1:1 ratio to either an intervention group ( Discussion: This trial will demonstrate whether a 12-week TCC intervention positively affects postural stability and self-reported outcomes in patients with FAI. At the same time, the superiority of its clinical efficacy will also be compared with that of CBT. This study may also help to redefine the value of traditional Chinese exercises in the treatment of chronic ankle instability. Clinical trial registration: Chinese Clinical Trial Registry: ChiCTR2100041790. Registration date: 22 March 2021. http://www.chictr.org.cn/edit.aspx?pid=119501&htm=4.
Language	English
Publishing date	2022-09-21
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2564214-5
ISSN	1664-2295
ISSN	1664-2295
DOI	10.3389/fneur.2022.923669
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Article ; Online: Spin-labeled derivatives of cardiotonic steroids as tools for characterization of the extracellular entrance to the binding site on Na

Guo, Jin-Hua / Jiang, Ren-Wang / Andersen, Jacob Lauwring / Esmann, Mikael / Fedosova, Natalya U

The FEBS journal

2018 Volume 285, Issue 12, Page(s) 2292–2305

Abstract: The information obtained from crystallized complexes of the ... ...

Abstract	The information obtained from crystallized complexes of the Na
MeSH term(s)	Amphibian Venoms/chemistry ; Amphibian Venoms/metabolism ; Animals ; Binding Sites ; Bufanolides/chemistry ; Bufanolides/metabolism ; Cardiac Glycosides/chemical synthesis ; Cardiac Glycosides/metabolism ; Cardiotonic Agents/chemical synthesis ; Cardiotonic Agents/metabolism ; Cations, Monovalent ; Electron Spin Resonance Spectroscopy ; Kidney ; Kinetics ; Ligands ; Molecular Docking Simulation ; Ouabain/chemistry ; Ouabain/metabolism ; Potassium/chemistry ; Potassium/metabolism ; Protein Binding ; Protein Interaction Domains and Motifs ; Protein Structure, Secondary ; Sodium/chemistry ; Sodium/metabolism ; Sodium-Potassium-Exchanging ATPase/chemistry ; Sodium-Potassium-Exchanging ATPase/isolation & purification ; Sodium-Potassium-Exchanging ATPase/metabolism ; Spin Labels/chemical synthesis ; Structure-Activity Relationship ; Swine ; Thermodynamics
Chemical Substances	Amphibian Venoms ; Bufanolides ; Cardiac Glycosides ; Cardiotonic Agents ; Cations, Monovalent ; Ligands ; Spin Labels ; Ouabain (5ACL011P69) ; Sodium (9NEZ333N27) ; Sodium-Potassium-Exchanging ATPase (EC 3.6.3.9) ; Potassium (RWP5GA015D) ; cinobufagin (T9PSN4R8IR)
Language	English
Publishing date	2018-05-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2173655-8
ISSN	1742-4658 ; 1742-464X
ISSN (online)	1742-4658
ISSN	1742-464X
DOI	10.1111/febs.14480
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Zs.A 260: Show issues

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Article: Efficacy and toxicity of nimotuzumab combined with radiotherapy in elderly patients with esophageal squamous cell carcinoma.

Guo, Jin-Hua / Chen, Ming-Qiu / Chen, Cheng / Lu, Hai-Jie / Xu, Ben-Hua

Molecular and clinical oncology

2015 Volume 3, Issue 5, Page(s) 1135–1138

Abstract: This study was conducted to assess the efficacy and toxicity of nimotuzumab combined with radiotherapy (RT) in elderly patients with esophageal squamous cell carcinoma. The clinical data of 16 esophageal squamous cell carcinoma patients, aged >70 years, ... ...

Abstract	This study was conducted to assess the efficacy and toxicity of nimotuzumab combined with radiotherapy (RT) in elderly patients with esophageal squamous cell carcinoma. The clinical data of 16 esophageal squamous cell carcinoma patients, aged >70 years, who were initially treated with nimotuzumab combined with RT, were collected and retrospectively reviewed. The overall response and treatment toxicity were analyzed using SPSS software. All the patients completed the treatment schedule. The response to treatment was assessed at treatment completion and reassessed after 1-2 months: 1 patient achieved complete response (CR), 10 patients achieved partial response (PR), 4 patients exhibited stable disease and 1 patient developed disease progression and succumbed to radiation pneumonitis (RP) 1 month later. The overall response rate (CR+PR) was 68.8%. All 16 patients experienced grade 1-2 radiation esophagitis; no grade 3-4 toxicities were reported. There was one case of treatment-related mortality due to RP during the study. One patient developed a rash on the forearm. No hematological, gastrointestinal, hepatic or renal toxicities were observed. In conclusion, the toxicity of combined nimotuzumab with RT in elderly patients with esophageal cancer was tolerable. However, due to limitations associated with the retrospective nature of this study, the limited number of enrolled cases and the epidermal growth factor receptor expression determination prior to treatment, the efficacy of this treatment modality requires further investigation.
Language	English
Publishing date	2015-07-21
Publishing country	England
Document type	Journal Article
ZDB-ID	2796865-0
ISSN	2049-9469 ; 2049-9450
ISSN (online)	2049-9469
ISSN	2049-9450
DOI	10.3892/mco.2015.606
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Article ; Online: Beneficial reciprocal effects of bone marrow stromal cells and Schwann cells from adult rats in a dynamic co‑culture system in vitro without intercellular contact.

Zhou, Li-Na / Cui, Xiao-Jun / Su, Kai-Xin / Wang, Xiao-Hong / Guo, Jin-Hua

Molecular medicine reports

2015 Volume 12, Issue 4, Page(s) 4931–4938

Abstract: In order to examine how implanted bone marrow stromal cells (BMSCs) encourage peripheral nerve regeneration, the present study investigated the interaction of BMSCs and Schwann cells (SCs) using an indirect in vitro co‑culture model. SCs and BMSCs were ... ...

Abstract	In order to examine how implanted bone marrow stromal cells (BMSCs) encourage peripheral nerve regeneration, the present study investigated the interaction of BMSCs and Schwann cells (SCs) using an indirect in vitro co‑culture model. SCs and BMSCs were obtained from adult Sprague‑Dawley rats. The passaged BMSCs were CD29‑ and CD44‑positive but CD45‑negative and were co‑cultured with the primary SCs using a Millicell system, which allows BMSCs and SCs to grow in the same culture medium but without direct contact. Expression of the typical SC markers S‑100 and glial fibrillary acidic protein (GFAP) of the treated BMSCs as well as the proliferation capacity of the co‑cultured SCs was evaluated by immunocytochemical staining on the 3rd and 5th day of co‑culture. Immunocytochemical staining showed that >75% of the BMSCs in the indirect co‑culture model were GFAP‑ and S‑100‑positive on the 3rd and 5th day after co‑culture, as opposed to <5% of the BMSCs in the control group. On the 3rd day after co‑culture, only a few co‑cultured BMSCs showed the typical SC‑like morphology, while most BMSCs still kept their native appearance. By contrast, on the 5th day after co‑culture, almost all of the co‑cultured BMSCs appeared with the typical SC‑like morphology. Furthermore, 70.71% of the SCs in the indirect co‑culture model were S‑100‑positive on the 5th day of co‑culture, as opposed to >30.43% of the SCs in the control group. These results indicated that BMSCs may interact synergistically with SCs with regard to promoting peripheral nerve regeneration.
MeSH term(s)	Animals ; Cell Differentiation ; Cell Proliferation ; Cells, Cultured ; Coculture Techniques/methods ; Gene Expression Regulation ; Genetic Markers ; Glial Fibrillary Acidic Protein/genetics ; Glial Fibrillary Acidic Protein/metabolism ; Mesenchymal Stromal Cells/cytology ; Nerve Regeneration ; Peripheral Nerves/cytology ; Rats ; Rats, Sprague-Dawley ; S100 Proteins/genetics ; S100 Proteins/metabolism ; Schwann Cells/cytology
Chemical Substances	Genetic Markers ; Glial Fibrillary Acidic Protein ; S100 Proteins
Language	English
Publishing date	2015-10
Publishing country	Greece
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1791-3004
ISSN (online)	1791-3004
DOI	10.3892/mmr.2015.4016
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Article ; Online: Neoadjuvant chemotherapy may not benefit esophageal squamous cell carcinoma patients treated with definitive chemoradiotherapy.

Chen, Ming-Qiu / Lin, Qing-Liang / Chen, Yuan-Gui / Guo, Jin-Hua / Xu, Ben-Hua / Tian, Ye

Journal of the Chinese Medical Association : JCMA

2017 Volume 80, Issue 10, Page(s) 636–643

Abstract: Background: To assess the efficacy of neoadjuvant chemotherapy (NAC) in esophageal squamous cell carcinoma (ESCC) patients treated with definitive chemoradiotherapy (CRT).: Methods: The clinical data of patients with ESCC treated with ... ...

Abstract	Background: To assess the efficacy of neoadjuvant chemotherapy (NAC) in esophageal squamous cell carcinoma (ESCC) patients treated with definitive chemoradiotherapy (CRT). Methods: The clinical data of patients with ESCC treated with chemoradiotherapy with or without NAC were collected and retrospectively reviewed. The overall survival, locoregional failure-free survival, and distant failure-free survival were analyzed statistically. Results: A total of 60 patients fulfilled the inclusion criteria, of which 41 were treated with NAC-CRT and 19 were treated with CRT-alone. Patient characteristics were well balanced between the NAC-CRT and CRT-alone groups, except for the ECOG scores. The tumor response to NAC included 11 patients (26.8%) with partial response (PR), 25 patients (61.0%) with stable disease (SD), 5 patients (12.2%) with progression disease (PD), and no patients with complete response (CR). After CRT, 21 patients achieved CR (14 after NAC-CRT and 7 after CRT-alone), 30 had PR (19 and 11, respectively), 6 maintained SD (5 and 1, respectively), and 3 patients (all in the NAC-CRT group) developed PD. Twenty-nine patients (18 in NAC-CRT and 11 in CRT-alone) succumbed to the disease from locoregional or distant failure, one patient in the NAC-CRT group died of radiation pneumonitis, one patient in the CRT-alone group died from unknown reasons, and 29 patients remained alive. The overall survival, locoregional failure-free survival, and distant failure-free survival at 1 and 2 years in all the patients were 64.9% and 40.5%, 58.6% and 52.0%, and 85.7% and 79.3%, respectively. The overall survival, locoregional failure-free survival, and distant failure-free survival between the NAC-CRT group and the CRT-alone group were not significantly different. Conclusion: In patients with ESCC treated with definitive CRT, NAC treatment using the current regimen does not prolong overall survival, locoregional failure-free survival or distant failure-free survival. Further development of NAC treatment is urgently needed.
MeSH term(s)	Adult ; Aged ; Carcinoma, Squamous Cell/mortality ; Carcinoma, Squamous Cell/therapy ; Chemoradiotherapy ; Esophageal Neoplasms/mortality ; Esophageal Neoplasms/therapy ; Esophageal Squamous Cell Carcinoma ; Female ; Humans ; Male ; Middle Aged ; Neoadjuvant Therapy ; Retrospective Studies
Language	English
Publishing date	2017-07-14
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2107283-8
ISSN	1728-7731 ; 1726-4901
ISSN (online)	1728-7731
ISSN	1726-4901
DOI	10.1016/j.jcma.2017.06.014
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Article ; Online: The Effect Of Food On The Pharmacokinetic Properties And Bioequivalence Of Two Formulations Of Levocetirizine Dihydrochloride In Healthy Chinese Volunteers.

Cheng, Yu / Lin, Bi-Juan / Guo, Jin-Hua / Huang, Bing-Lin / Fang, Lin-Ping / Que, Wan-Cai / Liu, Mao-Bai / Chen, Xin-Feng / Qiu, Hong-Qiang

Drug design, development and therapy

2019 Volume 13, Page(s) 3625–3634

Abstract: Purpose: The aim of this study is to assess the bioequivalence of a new generic formulation and the branded formulation of levocetirizine dihydrochloride in healthy Chinese volunteers under fasting and fed conditions, and food-intake effect on the ... ...

Abstract	Purpose: The aim of this study is to assess the bioequivalence of a new generic formulation and the branded formulation of levocetirizine dihydrochloride in healthy Chinese volunteers under fasting and fed conditions, and food-intake effect on the pharmacokinetic properties is also evaluated. Patients and methods: Volunteers were randomly allocated into two groups to receive a single oral dose of generic formulation and branded formulation under fasting or fed conditions, respectively. Blood samples were collected at designated time points. Plasma concentrations of levocetirizine were determined by UFLC-MS/MS. Safety evaluations were carried out through the study. The main pharmacokinetic parameters of the two formulations of levocetirizine were calculated using non-compartmental analysis incorporated in WinNonlin Results: Forty-nine volunteers were enrolled; 46 completed the studies. Under fasting and fed conditions, the 90% confidence intervals for the geometric mean of generic/branded ratios were in the range of 94.75-107.24% and 99.98-114.69% for the maximum observed concentration, and 97.13-102.50% and 98.36-103.98% for the area under the concentration-time curve. As a result of food intake before administration, the reduced rate and extent of absorption of levocetirizine were observed. Both formulations were generally well tolerated, with no serious adverse reactions reported. Conclusion: The two formulations demonstrated essentially identical pharmacokinetic profiles and were all well within the FDA/CFDA bioequivalence standards. Meanwhile, food intake can delay the absorption rate and reduced the bioavailability of levocetirizine in healthy Chinese volunteers.
MeSH term(s)	Administration, Oral ; Adolescent ; Adult ; Area Under Curve ; Biological Availability ; Cetirizine/administration & dosage ; Cetirizine/adverse effects ; Cetirizine/pharmacokinetics ; Chromatography, High Pressure Liquid ; Cross-Over Studies ; Drugs, Generic/administration & dosage ; Drugs, Generic/adverse effects ; Drugs, Generic/pharmacokinetics ; Female ; Food-Drug Interactions ; Histamine H1 Antagonists, Non-Sedating/administration & dosage ; Histamine H1 Antagonists, Non-Sedating/adverse effects ; Histamine H1 Antagonists, Non-Sedating/pharmacokinetics ; Humans ; Male ; Pilot Projects ; Tandem Mass Spectrometry ; Therapeutic Equivalency ; Young Adult
Chemical Substances	Drugs, Generic ; Histamine H1 Antagonists, Non-Sedating ; levocetirizine (6U5EA9RT2O) ; Cetirizine (YO7261ME24)
Language	English
Publishing date	2019-10-18
Publishing country	New Zealand
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2451346-5
ISSN	1177-8881 ; 1177-8881
ISSN (online)	1177-8881
ISSN	1177-8881
DOI	10.2147/DDDT.S215316
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