1.Efficacy and safety of a digital navigation template combined with cervical pedicle screw implantation: study protocol for a prospective, single-center, self-controlled, clinical trial
Wei WEI ; yan Long XING ; xun Jia JIAO ; Lei ZHAO ; qing Ai LU
Chinese Journal of Tissue Engineering Research 2017;21(35):5644-5648
BACKGROUND: Cervical pedicle screw fixation is a reliable method for the treatment of traumatic and non-traumatic cervical instability and cervical disc removal and fixation; however, the operation risks and the failure rate of screw insertion are still high. At present, the digital navigation template with digital computer technology, used in the department of orthopedics, has the advantages of accurate screw insertion and a small error in the screw insertion depth. OBJECTIVE: To observe the clinical efficacy and safety of the digital navigation template combined with cervical pedicle screw implantation. METHODS: This is a prospective, single-center, self-controlled, clinical trial. Thirty-two patients with cervical spondylosis will be recruited from the Harrison International Peace Hospital, Hebei Province, China. Before surgery, a three-dimensional (3D) navigation model of the cervical vertebrae will be designed by 3D reconstruction. The navigation template will be generated by 3D printing. The cervical pedicle screws will be implanted according to preoperatively designed models and the screw positions will be observed by computerized tomography (CT) after surgery. The patients will be followed up for 40 months. The primary outcome measure is the excellent and good rate of screw position 40 months after implantation. The secondary outcome measures include the Visual Analog Scale score, American Spinal Injury Association classification, cervical X-ray and CT images before implantation and 40 months after implantation, and the incidence of adverse reactions 40 months after implantation. The protocols have been approved by the Ethics Committee of the Harrison International Peace Hospital in China (approval number: 20120630). The study protocol has been conducted in accordance with the Declaration of Helsinki,formulated by the World Medical Association.Written informed consent will be obtained from all participants. The recruitment of subjects will begin in December 2017. Samples and data will be collected from December 2017 to April 2019. Outcome measures will be analyzed in October 2020. This trial will be completed in November 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17013481). DISCUSSION: We will verify a high success rate of cervical pedicle screw implantation using the digital navigation template. The operation is simple and quick, with good efficacy and safety.
2.Mutation analysis of the HBV reverse transcriptase in nucleos(t)ide-treated patients with chronic HBV infection.
Xiu-Juan JIAO ; Xun PENG ; Xiu-Min JIAO ; Jin-Sheng WANG ; Xie-Wen SUN ; Pei-Li ZHAO ; Shou-Yun WANG ; Jia-Qun LIU ; Tong LI ; Jing-Xian YANG
Chinese Journal of Experimental and Clinical Virology 2012;26(6):453-455
OBJECTIVETo characterize genotypic resistance within HBV RT region in chronic hepatitis B (CHB) patients with nucleos(t)ide analogue (NA) treatment.
METHODSSerum samples of 229 CHB patients with NA treatment were obtained. Full-length HBV RT sequences were amplified, sequenced and analyzed, on the following NA resistant (NAr) mutations belonging to different NAr pathways.
RESULTSAmong 229 HBV isolates, 14.41% (33/229) and 85.59% (196/229) were genotype B and C, respectively; and the patients with HBV genotype C may be more susceptible to develope resistant mutations than patients with HBV genotype B(chi2 = 2.95, P < 0.05). NAr mutations were detected in 63 CHB patients. Mutations were not found at rtI169, rtT184, rtA194 or rtS202. RtM204 mutations were detected at the highest frequency among 63 mutants (40/63, 63.49%) and found to display 11 combination mutation patterns, in which rtM204I were associated with rtL80I/V and rtL180M, and rtM204V were associated with rtL1l80M, respectively. Conclusions There are complicated mutation patterns in the HBV RT region for chronic hepatitis B (CHB) patients with nucleos(t)ide analogue (NA) treatment. RtM204V/I mutation was the highest.
Adolescent ; Adult ; Aged ; Antiviral Agents ; therapeutic use ; Female ; Hepatitis B virus ; drug effects ; enzymology ; genetics ; Hepatitis B, Chronic ; drug therapy ; virology ; Humans ; Male ; Middle Aged ; Mutation ; drug effects ; Nucleosides ; therapeutic use ; Nucleotides ; therapeutic use ; RNA-Directed DNA Polymerase ; genetics ; metabolism ; Viral Proteins ; genetics ; metabolism ; Young Adult
3.Anti-inflammatory effects of a synthetic peptide derived from pigment epithelium-derived factor on H₂O₂-induced corneal injury in vitro.
Yi LU ; Jia FENG ; Lili YANG ; Hongfeng TANG ; Ji JIN ; Xun XU
Chinese Medical Journal 2014;127(8):1438-1444
BACKGROUNDThe common pathological characteristics of corneal injury include inflammatory factors activation, vascular endothelial cells or inflammatory cells infiltration into lesions, corneal edema, corneal neovascularization (CNV), and scar formation. PEDF-34 is the functional fragment of pigment epithelium-derived factor (PEDF) that has anti-angiogenic and anti-inflammatory properties and contains an N-terminal 34-amino acid peptide. This study was to investigate the anti-inflammatory effects of PEDF-34 on H2O2-induced corneal injury in vitro.
METHODSAfter cultured in H2O2 (0.1 mmol/L) for 2 hours, human corneal fibroblasts (HCFs) and human umbilical vein endothelial cells (HUVECs) were treated with PEDF-34-nanoparticles (NPs) at different concentrations (0.1, 0.5, 1.0, 2.0 µg/ml) or 2.0 µg/ml control-NPs for 24 hours. The viable cells were quantified using the MTT assay. Western blotting or ELISA analysis was performed for measuring the human vascular endothelial growth factor (VEGF) and intercellular adhesion molecule-1 (ICAM-1) expression of both HCFs and HUVECs. VEGF and nuclear factor κB (NF-κB) mRNA levels of HCFs were semi-quantified by RT-PCR.
RESULTSThe survival rates of HCFs or HUVECs stimulated by H2O2 did not decrease significantly (P > 0.05) compared to those in the normal conditions. As compared to control-NP group, PEDF-34-NPs had dose-dependent inhibitive effect on HUVECs with the MTT assay, but not HCFs. Western blotting analysis showed that the VEGF and ICAM-1 levels in the HCFs and HUVECs stimulated by H2O2 were significantly higher than those in the normal conditions, which were decreased dramatically in those treated with PEDF-34-NPs. RT-PCR analysis revealed that the VEGF mRNA and NF-κB mRNA levels increased in H2O2-stimulated HCFs, while both of them decreased in PEDF-34-NP groups dose dependently.
CONCLUSIONSPEDF-34-NPs may play an important role in regulating the NF-κB pathway, inhibiting inflammatory activity. PEDF-34-NPs may be a potential new drug for treating corneal injury in the future.
Anti-Inflammatory Agents ; chemistry ; pharmacology ; Cells, Cultured ; Corneal Injuries ; chemically induced ; metabolism ; Eye Proteins ; chemistry ; Human Umbilical Vein Endothelial Cells ; drug effects ; metabolism ; Humans ; Hydrogen Peroxide ; pharmacology ; Nerve Growth Factors ; chemistry ; Peptides ; chemistry ; pharmacology ; Serpins ; chemistry