1.A multicenter, randomized, controlled, phase Ⅲ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer.
Binghe XU ; Fuguo TIAN ; Jingrui YU ; Yanqiu SONG ; Jianhua SHI ; Baihong ZHANG ; Yanjun ZHANG ; Zhiping YUAN ; Qiong WU ; Qingyuan ZHANG ; Kejun NAN ; Qiang SUN ; Weilian LI ; Jianbing HU ; Jingwang BI ; Chun MENG ; Hong DAI ; Hongchuan JIANG ; Shun YUE ; Bangwei CAO ; Yuping SUN ; Shu WANG ; Zhongsheng TONG ; Peng SHEN ; Gang WU ; Lili TANG ; Yongchuan DENG ; Liqun JIA ; Kunwei SHEN ; Wu ZHUANG ; Xiaodong XIE ; Youhua WU ; Lin CHEN
Chinese Journal of Oncology 2016;38(1):23-27
OBJECTIVETo explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application.
METHODSAccording to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 μg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 μg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle.
RESULTSThe duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 μg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 μg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581).
CONCLUSIONSIn patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 μg/kg/d, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms ; drug therapy ; Carboplatin ; administration & dosage ; adverse effects ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Cyclophosphamide ; administration & dosage ; adverse effects ; Epirubicin ; administration & dosage ; adverse effects ; Female ; Granulocyte Colony-Stimulating Factor ; therapeutic use ; Humans ; Incidence ; Induction Chemotherapy ; Lung Neoplasms ; drug therapy ; Neutropenia ; chemically induced ; epidemiology ; prevention & control ; Polyethylene Glycols ; Recombinant Proteins ; administration & dosage ; Taxoids ; administration & dosage ; adverse effects
2.First-in-man Implantation of the XINSORB Bioresorbable Sirolimus-eluting Scaffold in China.
Jia-Hui CHEN ; Yi-Zhe WU ; Li SHEN ; Feng ZHANG ; Zhi-Feng YAO ; Jia-Sheng YIN ; Meng JI ; Qi-Bing WANG ; Lei GE ; Ju-Ying QIAN ; Xi HU ; Jian XIE ; Jun-Bo GE
Chinese Medical Journal 2015;128(9):1275-1276
Adult
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Coronary Restenosis
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surgery
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Drug-Eluting Stents
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Humans
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Male
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Sirolimus
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therapeutic use
3.Construction of expression vector pLCK-CD69-IRES-EGFP and generation of CD69 transgenic mice.
Jing WANG ; Yan HU ; Bi-qin TAN ; Jia-jia WANG ; Meng-ting ZHAO ; Qin-jie WENG ; Di-feng ZHU ; Hui-ying WANG
Journal of Zhejiang University. Medical sciences 2015;44(5):511-516
OBJECTIVETo construct the expression vector pLCK-CD69-IRES-EGFP that contains mouse cell surface activation protein CD69 and enhanced green fluorescent protein(EGFP),and to generate CD69 transgenic mice based on this vector.
METHODSFirst, RNA was extracted from mouse lung tissue and cDNA was synthesized via reverse transcription. PCR primer was designed through the PubMed searching, then mouse CD69 DNA fragment was amplified with PCR. Second, this DNA fragment was subcloned to the pInsulater-LCK-IRES-EGFP plasmid and constructed the transgenic vector after the verification of nucleotide sequence. Third, the expression vector was then transfected into 293 T cells and its expression in 293 T cells was observed under fluorescence microscope. Last, microinjection was performed to transfer the expression vector pLCK-CD69-IRES-EGFP into fertilized eggs, which were implanted into pseudo-pregnant recipient mice. After birth the tail samples of the pups were obtained for the purpose of genotyping to determine the transgenic founders. Fluorescence microscope and flow cytometer were used to measure the expression of CD69 on cells.
RESULTSThe construction of the expression vector pLCK-CD69-IRES-EGFP was verified by enzyme digestion and DNA sequencing. The transfected 293 T cell showed expression of the protein under fluorescence microscope. Identification of PCR for the tail tissue of the pups confirmed the present of CD69 transgene and resting lymphocytes demonstrated the expression of CD69.
CONCLUSIONThe construction of expression vector pLCK-CD69-IRES-EGFP and generation of CD69 transgenic mice have been successfully processed, which lays a foundation of the solid pattern studies in inflammatory diseases.
Animals ; Antigens, CD ; genetics ; Antigens, Differentiation, T-Lymphocyte ; genetics ; DNA, Complementary ; Genetic Vectors ; Genotype ; Green Fluorescent Proteins ; genetics ; Lectins, C-Type ; genetics ; Mice ; Mice, Transgenic ; Plasmids ; Polymerase Chain Reaction ; Sequence Analysis, DNA ; Transfection
4.Vagus Nerve Stimulation for Pediatric and Adult Patients with Pharmaco-resistant Epilepsy.
Fan-Gang MENG ; Fu-Min JIA ; Xiao-Hui REN ; Yan GE ; Kai-Liang WANG ; Yan-Shan MA ; Ming GE ; Kai ZHANG ; Wen-Han HU ; Xin ZHANG ; Wei HU ; Jian-Guo ZHANG ;
Chinese Medical Journal 2015;128(19):2599-2604
BACKGROUNDOver past two decades, vagus nerve stimulation (VNS) has been widely used and reported to alleviate seizure frequency worldwide, however, so far, only hundreds of patients with pharmaco-resistant epilepsy (PRE) have been treated with VNS in mainland China. The study aimed to evaluate the effectiveness of VNS for Chinese patients with PRE and compare its relationship with age cohort and gender.
METHODSWe retrospectively assessed the clinical outcome of 94 patients with PRE, who were treated with VNS at Beijing Fengtai Hospital and Beijing Tiantan Hospital between November 2008 and April 2014 from our database of 106 consecutive patients. The clinical data analysis was retrospectively examined.
RESULTSSeizure frequency significantly decreased with VNS therapy after intermittent stimulation of the vagus nerve. At last follow-up, we found McHugh classifications of Class I in 33 patients (35.1%), Class II in 27 patients (28.7%), Class III in 20 patients (21.3%), Class IV in 3 patients (3.2%), and Class V in 11 patients (11.7%). Notably, 8 (8.5%) patients were seizure-free while ≥50% seizure frequency reduction occurred in as many as 60 patients (63.8%). Furthermore, with regard to the modified Engel classification, 12 patients (12.8%) were classified as Class I, 11 patients (11.7%) were classified as Class II, 37 patients (39.4%) were classified as Class III, 34 patients (36.2%) were classified as Class IV. We also found that the factors of gender or age are not associated with clinical outcome.
CONCLUSIONSThis comparative study confirmed that VNS is a safe, well-tolerated, and effective treatment for Chinese PRE patients. VNS reduced the seizure frequency regardless of age or gender of studied patients.
Adolescent ; Adult ; Child ; Child, Preschool ; Drug Resistance ; Epilepsy ; therapy ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Treatment Outcome ; Vagus Nerve Stimulation ; methods ; Young Adult
5.Cloning and expression analysis of a acetyl-CoA U-acetyltransferase gene (TwAACT) from Tripterygium wilfordii.
Yu-jun ZHAO ; Meng ZHANG ; Yu-jia LIU ; Ping SU ; Tian-yuan HU ; Xin CHEN ; Wei GAO ; Lu-qi HUANG
China Journal of Chinese Materia Medica 2015;40(5):847-852
In this study, based on the transcriptome data, we cloned the full-length cDNAs of TwAACT gene from Tripterygium wilfordii suspension cells, and then analyzed the bioinformation of the sequence, detected the genetic differential expression after being induced by methyl jasmonate (MeJA) by RT-PCR. The full-length cDNA of the TwAACT was 1 704 bp containing a 1 218 bp open reading frame (ORF) encoding a polypeptide of 405 amino acids (GeneBank accession No. KP297934). The deduced isoelectric point (pI) was 6.10, a calculated molecular weight was about 41.20 kDa, and online prediction showed that TwAACT had two catalytic active sites. After the induction of MeJA, the relative expression level of TwAACT increased rapidly. The expression level of TwAACT was highest at 24 h. TwAACT was cloned firstly, that laid the foundation for identifying thegene and illustrating thebiosynthesis mechanism and its synthetic biology.
Acetyl-CoA C-Acetyltransferase
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chemistry
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genetics
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metabolism
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Amino Acid Sequence
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Cloning, Molecular
;
Gene Expression Regulation, Plant
;
Models, Molecular
;
Molecular Sequence Data
;
Phylogeny
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Plant Proteins
;
chemistry
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genetics
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metabolism
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Sequence Alignment
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Tripterygium
;
chemistry
;
classification
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enzymology
;
genetics
6.Effect of hereditary and environmental factors on the executive function of twin children.
Xiaomei HU ; Xingshun MA ; Wenfen ZHU ; Yixiao FU ; Yingqing ZHOU ; Huaqing MENG ; Xiao HOU ; Lu JIA ; Qing QIN ; Yingcheng WANG ; Wei DENG ; Tao LI
Journal of Southern Medical University 2014;34(9):1291-1294
OBJECTIVETo explore the influence of genetic and environmental factors on the executive function of twin children.
METHODSThe executive function of 122 twin pairs from Chongqing (aged from 6 to 18 years) were investigated with the perseverative errors of the Wisconsin Card Sorting Test. Structural equation modeling was performed to evaluate the effects of the additive genetic factors (A), dominance genetic latent factors (D) and individual specific environmental factors (E) on the executive functions.
RESULTSThe effects of D and E on perseverative errors were 0. 77 (95%CI: 0.65-0.84) and 0.23 (95%CI: 0.16-0.35), respectively. The probability of perseverative errors showed a significant negative correlation with family functioning and with the total GHQ-12 scores of the fathers and mothers (r:-0.335, -0.335, and -0.219, respectively, P<0.01). Perseverative errors were not significantly correlated with the parenting styles and stress life events.
CONCLUSIONPerseverative errors are influenced by a common dominance genetic latent factor and individual specific environmental factors, but the role of environmental factors such as family functioning and parental health can not be ignored.
Adolescent ; Child ; Environment ; Executive Function ; Genotype ; Humans ; Neuropsychological Tests ; Phenotype
7.Development of a liquid chromatography-tandem mass spectrometry method for determination of butoconazole nitrate in human plasma and its application to a pharmacokinetic study.
Meng-meng JIA ; Ying ZHOU ; Xiao-meng HE ; Yi-lai WU ; Hu-qun LI ; Hui CHEN ; Wei-yong LI
Journal of Huazhong University of Science and Technology (Medical Sciences) 2014;34(3):431-436
A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of butoconazole in human plasma. Human plasma samples of 0.2 μL were pretreated by a single step protein precipitation procedure and analyzed using a high performance liquid chromatography (HPLC) electrospray tandem mass spectrometer system. The compounds were eluted isocratically on an Inertsil ODS-SP column (100 mm×2.1 mm, 3 μm), ionized using a positive ion atmospheric pressure electrospray ionization source and analyzed using multiple reaction monitoring (MRM) mode. The ion transitions monitored were m/z 412.8→165.1 for butoconazole and m/z 453.4→230.3 for the internal standard. The chromatographic run time was 3.5 min per injection, with retention time of 2.47 min and 2.15 min for butoconazole and repaglinide, respectively. The method was validated to be linear over the range of 20 to 8000 pg/mL (r>0.999) by using a weighted (1/x(2)) quadratic regression. The mean recovery rate was more than 86.7%, and the intra- and inter-day precision of the quality control samples (QCs) was less than 8.3% and the accuracy ranged from 96.0% to 110.2%, which indicated that the quantitative method was reliable and accurate. The method is simple, rapid, and has been applied successfully to a pharmacokinetics study of butoconazole nitrate suppositories in healthy Chinese females.
Administration, Intravaginal
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Adult
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Antifungal Agents
;
blood
;
chemistry
;
pharmacokinetics
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Calibration
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Chromatography, Liquid
;
methods
;
Female
;
Humans
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Imidazoles
;
administration & dosage
;
blood
;
pharmacokinetics
;
Middle Aged
;
Molecular Structure
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Reproducibility of Results
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Tandem Mass Spectrometry
;
methods
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Time Factors
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Young Adult
8.Application of intraoperative magnetic resonance imaging and multimodal navigation in surgical resection of glioblastoma.
Fang-Ye LI ; Xiao-Lei CHEN ; Xiao-Yong SAI ; Jia-Shu ZHANG ; Shen HU ; Jin-Jiang LI ; Gang ZHENG ; Ting ZHANG ; Ye LI ; Meng-Zhuo HOU ; Bai-Nan XU
Chinese Journal of Surgery 2013;51(6):542-546
OBJECTIVETo evaluate the efficacy of intraoperative magnetic resonance imaging (iMRI) and multimodal navigation in surgical resection of glioblastoma.
METHODSBetween February 2009 and July 2010, 76 glioblastoma patients underwent surgical resection guided by iMRI and multimodal navigation. The cohort consisted of 43 male and 33 female patients, with a mean age of 49 years (range: 14-79 years). Rates of gross total resection (GTR) and extent of resection (EoR) were calculated at first and final iMRI scans.Pearson χ(2) test was used to compare the rates of GTR.
RESULTSiMRI and multimodal navigation were successfully implemented in all cases. Rates of GTR were misestimated by neurosurgeons in 24 cases (31.6%), which were confirmed by first iMRI. Total tumor resection were achieved in 20 cases (26.3%) as a result of iMRI scan, increasing the rates of gross total resection from 52.6% to 78.9% (χ(2) = 11.692, P = 0.001). Extent of resection in 28 patients who underwent further tumor resection were increased from 81.5% to 98.1%, leading to the overall extent of resection improved from 92.3% to 98.4%. At 3-month follow-up, 3 cases (3.9%) developed permanent neurologic deficits. The mean clinical follow-up was 15.6 months (range 3.0-45.0 months). The 2-year overall survival rate was 19.7%. The median progression-free survival of gross total resection group was 12 months (95% CI: 10.1-13.9 months), compared with 9 months (95%CI: 7.9-10.1 months) of the subtotal resection group (χ(2) = 4.756, P = 0.029). The overall survival of gross total resection group was 16 months (95% CI: 13.7-18.3 months), compared with 12 months (95% CI: 9.7-14.3 months) of the subtotal resection group (χ(2) = 7.885, P = 0.005).
CONCLUSIONCombined with multimodal navigation, iMRI helps maximize surgical resection of glioblastoma, preserving neurological function while increasing progression-free survival and overall survival.
Adolescent ; Adult ; Aged ; Brain Neoplasms ; surgery ; Female ; Glioblastoma ; surgery ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Monitoring, Intraoperative ; methods ; Neuronavigation ; Young Adult
9.Influence of preoperative chemoradiotherapy on pulmonary function and postoperative pulmonary complication in esophageal cancer patients.
Rong-gui HU ; Jian-hua FU ; Kong-jia LUO ; Xu ZHANG ; Hong YANG ; Meng-zhong LIU ; Hui LIU ; Qun LI ; Yong-hong HU ; Xiao-dong LI ; Ting LIN
Chinese Journal of Gastrointestinal Surgery 2013;16(9):827-830
OBJECTIVETo study the influence of preoperative chemoradiotherapy (CRT) on pulmonary function and postoperative pulmonary complications in esophageal cancer patients.
METHODSPulmonary function and postoperative pulmonary complications of 63 esophageal cancer patients undergoing preoperative CRT and operation in Cancer Center of Sun Yat-sen University between 2002 and 2013 were collected retrospectively. The influence of preoperative CRT on pulmonary functional indexes and postoperative pulmonary complications were analyzed.
RESULTSAfter preoperative CRT, DLco% decreased significantly (83.7±17.7 vs. 96.4±17.8, P<0.01), while no obvious changes in other indexes were found. Postoperative pulmonary complication rate was 34.9% (22/63), including 19 cases of pneumonia and 3 cases of acute pulmonary injury/acute respiratory distress syndrome. Differences in postoperative pulmonary complication rates were not statistically significant between patients with DLco% <80 and those with DLco% ≥80 patients (29.7% vs. 41.7%, P>0.05), and between patients with DLco% decline ≥15% and those with DLco% decline <15% patients (31.6% vs. 37.8%, P>0.05).
CONCLUSIONPreoperative CRT can damage the diffusion function but not ventilation function of esophageal cancer patients, and does not increase the postoperative pulmonary complication rate.
Chemoradiotherapy ; Esophageal Neoplasms ; drug therapy ; physiopathology ; radiotherapy ; Female ; Humans ; Lung ; physiopathology ; Male ; Middle Aged ; Perioperative Care ; Postoperative Complications ; prevention & control ; Retrospective Studies
10.Effects of rosiglitazone on cholesterol contents and scavenger receptor class B type I expression in RAW264.7 foam cells.
Fang XU ; Ying MENG ; Zhilu WANG ; Wanling LI ; Junzheng JIA ; Wenfen GUO ; Wanxia XIE ; Haiying HU ; Xutang HU
Journal of Southern Medical University 2012;32(12):1792-1795
OBJECTIVETo observe the effect of rosiglitazone on the content of cholesterol and expressions of Acy-coenzyme A: cholesterol acyltransferase 1 (ACAT-1) and scavenger receptor class B type I (SR-BI) in RAW264.7 macrophage-derived foam cells and explore the anti-atherosclerotic mechanism of rosiglitazone.
METHODSRAW264.7 macrophages were incubated with oxidized low-density lipoproteins (ox-LDL) or with both ox-LDL and rosiglitazone (5, 10, or 20 µmol/L). Oil red O staining was used to observe the formation of foam cells, and cholesterol oxidase was used to determine the content of cellular cholesterol contents. Western blotting was used observe the expressions of ACAT-1 and SR-BI in RAW264.7 foam cells.
RESULTSCompared with the control cells, RAW264.7 macrophage-derived foam cells showed significantly increased contents of total cholesterol and free cholesterol (P<0.01) and ACAT-1 expressions (P<0.05) with mildly increased SR-BI expression (P>0.05). Rosiglitazone treatments significantly lowered the contents of total cholesterol and free cholesterol (P<0.05), decreased the expression of ACAT-1 (P<0.05), and increased SR-BI expression (P<0.05) in the foam cells in a dose-dependent manner.
CONCLUSIONRosiglitazone can decrease the contents of total and free cholesterol, down-regulate ACAT-1 expression and up-regulate SR-BI expression in the foam cells produce the anti-atherosclerotic effect.
Acetyl-CoA C-Acetyltransferase ; metabolism ; Cell Line ; Cholesterol ; metabolism ; Foam Cells ; cytology ; drug effects ; metabolism ; Humans ; Scavenger Receptors, Class B ; metabolism ; Thiazolidinediones ; pharmacology

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