Objective:To discuss the regulation requirements of software based on the analysis of software-related recalls of medical devices. Methods:The data of software-related recalls of medical devices in America were collected and processed, and the type, situation, cause and trend of software-related recalls were analyzed, then the suggestions on the regulation requirements of software were proposed. Results:During the four periods from 1983 to 2011, the percentage of software-related recalls vs medical device recalls in America increased from 6%to 19%, and the year-on-year growth rate of software-related recalls rose by 47%to 164%, significantly higher than medical device recalls in the same period (from 13%to 54%). Especially, the problem of software-related recalls in radiology medical devices was the most serious. Conclusion: The regulatory situation of software is more complicated and severe, so the regulation requirements of software, including software validation, adverse event monitoring and usability design, need to be further strengthened according to the particularity of software.

[Objective]To evaluate a simple,safty and effective therapeutic option to treate subaxial cervical fracture-dislocation with locked-facet.[Method]With the patients being awake and supervized under X-ray fluoroscopy,the authors used the early and continued closed skull traction-reduction to treate 16 cases of traumatic subaxial cervical fracture-dislocation with locked-facet.Before the beginning of the treatment,all the patients were taken for X-ray plain films and MRI/CT examinations as well as American Spinal Injury Association(ASIA) neurological function grade.The dynamic ASIA neurological function scale and X-ray fluoroscopy examnations were asked during the skull traction–reduction procedures.The average interval from the traumatic events to begin to skull traction–reduction was 31 hours(6-52 hours).The authors would continue the skull traction to maintain the anatomy position as soon as they succeeded in reducing the dislocation with locked-facet,forthmore they would take the anterior operation or combinations with anterior and posterior operations during the best condition.[Result]The MRI scans showed that there were 8 disc hernations and 5 disc disruptions at the dislocation levels before traction–reduction procedures.The ASIA scale were 7 grade C,5 grade D and 4 grade E,respectively.All the 16 cases succeeded in reduction as well as no neurological deterioration occurred.The postreduction MRI scans showed that 2 disc herations had converted to nearly normal disc position and another 4 disc hernations remained unchanged.Accordingly,2 disc disruption remained unchanged and another case had converted to disc hernation.The average traction weight was 19 kg(10~32 kg) and average traction time was 53 minutes(30~135 minutes).[Conclusion]Under the intensive dynamic ASIA neurological function grade and X-Ray fluoroscopy examnations,with the patients being awake and co-operation,the early and continued closed skull traction-reduction and then performing elective anterior or anterior-posterior surgery depending on the patient's overall and local status to treate subaxial cervical fracture-dislocation with locked-facet is safe and effective.

Objective To investigate the effects of transfection of chemokine receptor CXCR4 antisense-RNA on the functional expression of VEGF-C mRNA and the invasive ability of colon cell line HT-29 in vitro.Methods PCR primers were designed according to the coding sequence of CXCR4 gene.EcoR Ⅰ and BamH Ⅰ recognition sequences and cutting sites were added to the 5' end of the antisense primer.The purified PCR fragment was retro-inserted into the cloning site of eukaryotic expression vector pcDNA3.1(+).The pcDNA3.1(+)for CXCR4 antisense-RNA was transfected into colon cancer HT-29 cells by liposome transfection.The expression of VEGF-C mRNA was detected by RT-PCR.The expression of CXCR4 protein was determined by Western blot.At the same time,cell growth kinetics was assessed by MTT assay,and in vitro invasive ability was assessed with Boyden chamber.Results CXCR4 antisense-RNA recombinant was successfully constructed.The expression of VEGF-C mRNA in antisense-CXCR4 transfected(HT-29tran)group decreased by 54.2%,while the expression of VEGF-C mRNA in vacant-transfected(HT-29KZ)group only decreased by 9.4% campared with non-transfected(HT-29)group.The difference between the two groups mentioned above was remarkable(P

Objective To study the pattern of cerebral gray matter and white matter volume changes among smokers with differ-ent level of nicotine dependence (addition)using voxel-based morphometry (VBM).Methods The current case-control study recrui-ted 53 healthy male smokers and 53 healthy non-smokers from outpatients of our hospital during January 2013 to May 2014.Personal information (including for example age,sex and addition dependence of subjects)was collected using a questionnaire.3D-T1 images of whole brain structure were collected and were analyzed using DARTEL toolbox of SPM8.Smokers were divided into mild to mod-erate nicotine dependence group (n=23)and severe nicotine dependence group (n=30)based on Fagerstr?m Test for Nicotine De-pendence (FTND)score.Independent sample t-test analyses were performed to compare the volumes of gray matter and white mat-ter between smokers with different levels of nicotine dependence and non-smokers.Results Compared with non-smokers,gray and white matter volumes of smokers were smaller in multiple brain areas,mainly in the middle occipital gyrus,posterior cingulate,cer-ebellum anterior lobe,precuneus,caudate body and insula,which however,had larger number and scope of focal areas with gray and white matter atrophy in the mild to moderate nicotine dependence group than that in the severe nicotine dependence group.Conclusion Smokers with mild to moderate nicotine dependence have more pronounced gray and white matter atrophy than that smokers with severe nicotine dependence have.

OBJECTIVE: To investigate the relationship between pure-tone average (PTA), the fractional anisotropy (FA) of the auditory pathway, cognitive cortex and auditory cortex in presbycusis. METHOD: Twenty-five elderly subjects with presbycusis were participated in the study. PTA, speech discrimination abilities were evaluated in each subject. Diffusion tensor imaging (DTI) was applied to access the FA of the IC, the superior frontal gyrus and the Heschl's gyrus. Compare the difference between two sides of the values of FA in the three areas. Bivariate correlation analysis was performed to evaluate the effects of PTA and FA of the inferior colliculus (IC), the superior frontal gyrus and the Heschl's gyrus on speech discrimination abilities. RESULT: There were no significant differences between the left and right side of the inferior colliculus (P > 0.05). Higher FA values were recorded at the left side of the Heschl's gyrus and the superior frontal gyrus (P < 0.05). Both PTA and the FA of the superior frontal gyrus have a negative association with speech discrimination abilities (P < 0.01, P < 0.05), while the FA of the Heschl's gyrus has a positive association with speech discrimination abilities (P < 0.05). CONCLUSION Our findings indicated that the speech discrimination abilities of the elderly is not only related to the peripheral auditory function, but also to the central auditory and cognitive function.
Aged ; Audiometry, Pure-Tone ; Auditory Cortex ; physiopathology ; Auditory Pathways ; Diffusion Tensor Imaging ; Humans ; Inferior Colliculi ; physiopathology ; Presbycusis ; diagnosis ; Speech Perception

Objective To analyze mutations in the ATP2A2 gene in a Kazakh family with Darier's disease.Methods Clinical data were collected from 49 members from a family with Darier's disease,and peripheral blood samples were obtained from 44 family members and 100 unrelated healthy people.Genomic DNA was extracted from these blood samples.PCR and DNA sequencing were performed to detect mutations in the ATP2A2 gene.Results Darier's disease was inherited in an autosomal dominant manner in this family.A G→A heterozygous mutation (1288-1G→A) was identified at position 1288-1 at the splice site in exon 12 of the ATP2A2 gene in 11 patients in this family,but not in 33 healthy members or 100 healthy controls.Conclusion Darier's disease in this family may be caused by the heterozygous mutation (1288-1G→A)at the splice site in exon 12 of the ATP2A2 gene.

AIM: To investigate the mechanism of proliferation effect induced by (R,R)-XY-10 and (S,S)-XY-10 on retinal pigmented epithelial cells(ARPE-19).METHODS: Human retinal pigmented epithelial cells(ARPE-19) and human umbilical vein endothelial cells (HUVECs) were used to investigate the effect of (R,R)-XY-10 and (S,S)-XY-10 on cell growth,and their mechanisms of proliferative action by using ERK、 AKT、PI3K、Protein kinase C (PKC)and Nitric oxide synthase (NOS) inhibitors.RESULTS: (R,R)-XY-10 and (S,S)-XY-10 dose-dependently increased ARPE-19 cell proliferation,but not on HUVECs. When treated with proliferative inhibitors,H7(5μmol/L)、hypericin(20μmol/L)、PD98059(2μmol/L)、LY294002(50μmol/L)、SH-5 (10μmol/L) and L-NAME (100μmol/L),the proliferative effect was reduced by H7、hypericin、PD98059 and LY294002,but not by SH-5 and L-NAME.CONCLUSION: (R,R)-XY-10 and (S,S)-XY-10 can induce cell proliferation through MAPK and PI3K dependent pathway. KEYWORDS: age-related macular degeneration; (R,R)-XY-10; (S,S)-XY-10; ARPE-19 cells; human umbilical vein endothelial cells; proliferation

Chemotherapy-induced neuropathy is a serious clinical problem for patients receiving cancer treatment. The aim of this study was to investigate the potential efficacy of pregabalin in chemotherapy-induced neuropathy in rats. A total of 35 male Sprague-Dawley rats were randomly divided into 5 groups: group 1, naive control; group 2, treated with pregabalin (30 mg/kg p.o., for 8 days); group 3, docetaxel was given by single intravenous infusion at 10 mg/kg; groups 4 and 5, pregabalin at 10 mg/kg and 30 mg/kg respectively was orally administered for 8 days after the docetaxel treatment. On day 8, behavioral test was performed, and substance P and CGRP release in dorsal root ganglion (DRG) and sciatic nerve were analyzed by electron microscope. Our results showed that docetaxel induced mechanical allodynia, mechanical hyperalgesia, heat hypoalgesia, cold allodynia, and sciatic nerve impairment and substance P and CGRP release in DRG. However, oral administration of pregabalin (10 mg/kg and 30 mg/kg) for 8 consecutive days significantly attenuated docetaxel-induced neuropathy by ameliorating heat hypoalgesia, cold allodynia, impairment of sciatic nerve and reducing the release of substance P and CGRP. The findings in the present study reveal that pregabalin may be a potential treatment agent against chemotherapy-induced neuropathy.

The urate transporter 1 (URAT1) which controls urate reabsorption is a membrane transporter in the apical membrane of human renal proximal tubule epithelial cells. It was found that about 90% of patients suffer from hyperuricemia due to insufficient uric acid excretion. Therefore, the development of URAT1 inhibitors that can reduce the level of serum uric acid in vivo by enhancing renal urate excretion has been a hot spot in seeking anti-gout drugs in recent years. In this article, the representative URAT1 inhibitors with uric acid-lowering or anti-gout effects are reviewed, and related medicinal chemical strategies are analyzed, hoping to provide valuable insights into the discovery of new URAT1 inhibitors.