This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference.
Materials Management, Hospital ; organization & administration

BACKGROUND:Recent studies have shown that adipose-derivedmesenchymal stem cells (ADMSCs) not only have multilineage differentiation potential, but also exert an important role in blood sugar balance and hormone production.OBJECTIVE:To observe the differentiation potential of human ADMSCs (hADMSCs) into functional islet-like cells and the therapeutic effect of hADMSCs transplantation in diabetic rats.METHODS:PDX-1 gene was transfected into hADMSCs by adenovirus. Cell differentiation and insulin secretion were identified and detected by dithizone staining and ELISA, respectively. Twenty male Sprague-Dawley rats were randomly divided into control group (n=4), diabetes group (n=8) and transplantation group (n=8). Rats in the latter two groups were subjected to making diabetic models by 65 mg/kg streptozotocin injection. Afterwards, rats in the transplantation group were given PDX-1 transfected ADMSCs via the tail vein.RESULTS AND CONCLUSION:At 15 days after transfection, the number of insulin positive cells and insulin secretion were both increased significantly (P < 0.05). Fasting glucose levels in the transplantation group decreased significantly (P < 0.05), while the body weight increased significantly (P < 0.05). In the diabetic group, the fasting glucose level still maintained at a high level, and the body weight of rats was significantly decreased. These results implicated that PDX-1 gene could induce hADMSCs differentiating into functional islet-like cells. PDX-1 transfected ADMSCs transplantation is effective in treating diabetic rats, but the mechanism needs further study.

?AIM: To study the association of the single nucleotide polymorphism ( SNP) rs1157699 in the calcitonin receptor-like receptor ( CRLR ) gene with primary angle closure ( PAC) in a Han Chinese population.?METHODS: All samples, involved 232 PAC cases and 306 controls, were obtained from an epidemiologic survey conducted in Funing, Jiangsu Province, China. Genotyping were carried out by TaqMan-MGB probe using the real time quantitative polymerase chain reaction system to study the relationship between SNP of rs1157699 in CRLR gene and PAC.?RESULTS: The prevalence of CRLRrs1157699 genotype was 67.4%, 30.0%, 2.6% for CC, CT, TT in cases, and 71.3%, 27.0%, 1.7% in controls respectively.There was no difference between the two groups in the distribution of genotype and allele frequencies of rs1157699 (P>0.05).?CONCLUSION:Our results do not support a significant role for rs1157699 in CRLR with PAC.

Objective To investigate the value of prenatal diagnosis in identifying the etiology and predicting the prognosis of fetal pleural effusion (FPE).Methods Forty-two cases of FPE were recruited in this study from January 2012 to September 2016.Ultrasound scan and genetic tests were performed on all fetuses.Seven fetuses with severe FPE were given pleurocentesis.Pregnancy outcomes of all the fetuses were followed up.Results FPE was commonly accompanied with other abnormalities,such as ascites,hydrops,hydramnion,hygroma colli,abnormal posturing,joint contractures,arrhythmia and micromandible.Chromosomal abnormality was detected in 11 fetuses (26.2％),of which ten were further confirmed by karyotype analysis,including six with 45,X,three trisomy 21 and one trisomy 18,and one was detected with a 9.83 Mb uniparental disomy (UPD) located at 12q24.21q24.31 by gene chip.One fetus was diagnosed with--SEA/--SEA thalassemia.All of the 12 families decided to terminate the pregnancies after genetic counseling.Among the other 30 fetuses,seven with severe FPE and normal karyotype underwent pleurocentesis.Five of the seven cases were with favorable outcomes,one with progressive hydrops was aborted and one neonate with severe hydrops died after birth.Spontaneous regression of FPE with good outcome was found in two cases.Parents of the other 21 fetuses chose to terminate the pregnancies.Conclusions Prenatal diagnosis is important to identify the etiology and predict the outcome of FPE.Chromosomal abnormality is a relatively common cause of FPE,and 45,X and trisomy 21 are the most common abnormalities.Intrauterine intervention is beneficial for FPE without chromosomal or other definite genetic abnormalities.Genetic test may be of great value for pregnant counseling.

OBJECTIVE To evaluate the clinical features of tumors primarily in the pterygopalatine fossa, and the efficiency of surgical management for these lesions. METHODS The clinical data of 7 cases with tumors primarily in the pterygopalatine fossa were retrospectively studied. Three of them were primary diseases, i.e. fibrous histiocytoma, neurofibroma and cholesteatoma. The other 4 cases were secondary tumors mainly located in pterygopalatine fossa. There were 1 case with epithelial-myoepithelial carcinoma, 1 case with adenoid cystic carcinoma , 1 case with recurrent inverted nasal papilloma, 1 case with recurrent malignant fibrous histiocytoma. Approaches to tumors in pterygopalatine fossa lesions included lateral rhinotomy, and transnasal or transantrum approaches under the nasal endoscope. RESULTS The patient suffered from adenoid cystic carcinoma developed local recurrence 4 months after operation, and extended resection of the recurrent tumor with laser was performed again. No further recurrence was found after following-up for 3 years. Neither local recurrence nor regional metastasis was found in the remaining 6 cases with a follow-up period of 2 to 4 years. The main complication was oronasal fistula. CONCLUSION CT scan or MRI is the main method to the early diagnosis of pterygopalatine fossa tumors. Lateral rhinotomy, endoscopic trasnnasal or transantrum approaches are feasible procedures to resect the tumors.

Objectives:The widespread usage of traditional Chinese medicine (TCM) and the government's emphasis on TCM in China have created a positive macro-environment and great opportunities to develop and strengthen health technology assessment (HTA) in TCM.Over the past ten years,a series of policies have been issued by the government to promote the application of HTA and the development of TCM in China.This study reviews the concepts and characteristics of TCM,summarizes the current status of HTA in TCM,and analyzes the opportunities and challenges faced by HTA development in TCM with respect to deepening of healthcare reforms.Methods:Literature review and website searches were used to acquire information regarding the basic theories of TCM and the current status,opportunities,and challenges for HTA in TCM.Results:The number of articles on HTA in TCM rose substantially,especially those published in China National Knowledge Infrastructure (CNKI).With the optimistic policy environment and huge market demand for TCM,the development of HTA in TCM is expected to flourish in China.However,HTA in TCM also faces numerous challenges such as the absence of a clinical efficacy evaluation system for TCM and insufficient basic research evidence and qualified personnel.Conclusions:TCM has unique characteristic that distinguishes it from Western medicine.Currently,it is important to take all measures to address the existing main challenges and thereby take advantage of the present opportunities to develop and improve HTA in TCM.

INTRODUCTIONMinimally invasive surgical ablation is an emerging alternative method to catheter ablation and the full surgical maze procedure for nonpharmacologic treatment of atrial fibrillation (AF). We present a totally thoracoscopic "box lesion" radiofrequency ablation procedure in patients with paroxysmal or persistent AF.

MATERIALS AND METHODSFrom June 2011 to October 2012, 14 patients with lone paroxysmal (n = 7) or persistent AF (n = 7) were enrolled in this study. Procedures were performed through 3 5-12 mm holes on each side of the chest wall. A bipolar ablation device was used to create a box lesion in the posterior wall of the left atrium that encircled the 4 pulmonary veins (achieving bilateral pulmonary vein/posterior left atrial wall isolation). Perioperative complications were recorded for all patients. Freedom from AF was assessed by 24-hour Holter monitoring every 3 months or during symptoms of arrhythmia.

RESULTSThe ablation was successfully performed in all patients, with median operation time of 128 minutes (range, 45 to 180 minutes). No operative mortality or morbidity were noted during the study period. Freedom from AF was achieved in 12 patients (85.7%) during follow-up (median follow-up 9 months). One patient with persistent AF was shifted to paroxysmal AF. No atrial flutter or atrial tachycardia was noted during the follow-up.

CONCLUSIONThese early results show that totally thoracoscopic surgical ablation using a unique "box lesion" procedure for persistent or paroxysmal AF is a feasible and effective method with good short-term results. Further study is necessary to validate this result.

Adult ; Aged ; Atrial Fibrillation ; surgery ; Catheter Ablation ; methods ; Female ; Humans ; Male ; Middle Aged ; Thoracoscopy

OBJECTIVETo develop an effective and feasible method to construct three-dimensional finite element model of the whole edentulous maxilla and cranial skeleton.

METHODSBased on three-dimensional computer aided design model which was constructed by multi-slices helical CT scanning data of a male's head in specialized software, three-dimensional finite element model of edentulous maxillary and cranial skeleton was established; the stresses distribution in maxilla was investigated under occlusal load with computer simulated a complete overdenture.

RESULTSThe three-dimensional finite element model of edentulous maxilla and cranial skeleton had favorite similarity in geometry, the distributions of stresses in maxilla and the wall of maxillary sinus could be clearly observed.

CONCLUSIONSThe study verifies that this three-dimensional finite element modeling method is feasible and effective.

Aged ; Dental Stress Analysis ; Finite Element Analysis ; Humans ; Imaging, Three-Dimensional ; Jaw, Edentulous ; Male ; Maxilla ; anatomy & histology ; Models, Anatomic ; Skull ; anatomy & histology

OBJECTIVETo investigate the biochemical characteristic of the neurons associated Zusanli (ST 36) in the rat by using Alexa Fluor 594 conjugated cholera toxin subunit B (AF594-CTB) neural tracing and calcitonin gene-related peptide (CGRP) fluorescent immunohistochemical techniques.

METHODSFour male Sprague Dawley rats were injected with AF594-CTB into the corresponding area of the Zusanli in the human body. After 3 surviving days, the rat's spinal cord and dorsal root ganglia (DRGs) at lumbar segments were dissected following perfusion with 4% paraformaldehyde, cut into sections, and then stained with CGRPfluorescent immunohistochemical method.

RESULTSAF594-CTB labeled sensory neurons were detected in the L3-L6 DRGs with high concentration in L4 DRG, and the labeled motor neurons located in the dorsolateral and intermediate regions of lamina IX from L3-L5 segments with high concentration at L4. Meanwhile, CGRPpositive neural labeling distributed symmetrically on both sides of DRGs, anterior and dorsal horns of spinal cord. In the AF594-CTB labeled neurons, 37% sensory neurons and 100% motor neurons expressed CGRPpositive.

CONCLUSIONThese findings present the morphological evidence to demonstrate that the sensory and motor neurons associated Zusanli in the rat distributed with segmental and regional patterns, and contained CGRP-expression.

Acupuncture Points ; Animals ; Calcitonin Gene-Related Peptide ; metabolism ; Male ; Neurons ; metabolism ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo investigate the significance of mutation and single nucleotide polymorphism (SNP) of class III receptor tyrosine kinases such as PDGFRbeta and SHIP in acute myeloid leukemia (AML) patients.

METHODSScreening of the mutation and SNP of PDGFRbeta and SHIP by genomic PCR, RT-PCR, directly sequencing and Mass-ARRAY system was carried out in 273 AML patients.

RESULTSThe mutations of PDGFRbeta R685C and SHIP Q1153L were detected for the first time in AML patients. The positivity ratio was 0.73% and 0.36% respectively.

CONCLUSIONThe mutations of PDGFRbeta R685C and SHIP Q1153L may contribute to leukemogenesis of AML.

Humans ; Inositol Phosphates ; genetics ; Leukemia, Myeloid, Acute ; genetics ; Mass Spectrometry ; Mutation ; Polymerase Chain Reaction ; Polymorphism, Single Nucleotide ; Receptor, Platelet-Derived Growth Factor beta ; genetics ; Reverse Transcriptase Polymerase Chain Reaction