This paper analyzes by many kinds of methods,such as collecting literature,case analysis,positive analysis to discuss the necessity and feasibility of utilizing ISO9000 management idea in the higher vocational medical education field.Then analyzes the utilizing case of Tianjin Medical College.At last,this paper gives some solutions about how to improve it in future.

There are many existing problems which are to be solved in Chinese medical undergraduate education evaluation.It can be improved by founding the scientific scheme for medical undergraduate education evaluation through carrying out the diversification of evaluation subject,formulating a reasonable evaluation system,optimizing the evaluation process,establishing the rule of law and access system and playing the leading role of evaluation.

Holter monitoring remains an useful diagnostic tool in the evaluation of syncope in children if synco-pe remains unexplained after the initial examination.But it should not be used as a screening tool.Holter monitoring is recommended in children who were suspected as cardiac syncope or who had an abnormal electrocardiogram.For chil-dren with frequent syncope,Holter monitoring is highly recommended.More information can be provided with extended Holter monitoring to 48 hours if possible.Heart rate variability is probably useful in predicting head -up tilt test diagno-sis of neurally mediated syncope.

The mechanism of coronary artery thrombosis(CAT)caused by Kawasaki disease is not clear yet.Endothelial injury,hypercoagulability and hemodynamic change of coronary arteries are now considered as the main causes in recent studies.As The clinical symptom of acute thrombus caused by Kawasaki disease is un-conspicuous,cardiac ultrasound should be use actively and thrombolytic therapy should be performed within 12 hours after thrombus formation or the onset of acute myocardial infarction.Intervention or intravenous thrombol-ysis are both proved to be effective.Treatment with oral antitplatelet drugs,such as aspirin,combine with warfa-rin is suggested to relieve acute myocardial infarction in the chronic phase.The adverse reactions of antithrom-botic and anticoagulant drugs should be monitored though they are minor.

The diagnosis of nonparasitic hepatic cysts has been significantly improved with the development of imaging techniques,however,the successful differential diagnosis depends on more careful consideration.The differential diagnosis of multiple hepatic cysts and polycystic liver disease depends on the family heredity,number of cysts,combination of polycystic kidney,division and the results of B ultrasound.The differential diagnosis of hepatic cyst and hepatic cystic adenocarcinoma depends on the imaging features and results of histopathological examination.Recently,laparoscopic surgery has been widespread-ly used in the management of hepatic cystic disease,while it still cannot replace open surgery.The individualized and various treatment should be selected according to the condition of the patients.

The essential factors of bone tissue engineering include seed cell,growth factor and scaffold material.The biological structure,biological function and preparation method of scaffold material,which is the key component in bone tissue engineering,have attracted our attention.An ideal scaffold material needs to have adequate mechanical strength,appropriate degradation speed,good biocompatibility,satisfactory availability,low price,et al.Common scaffold materials in bone tissue engineering mainly consist of inorganic matter,organic matter and natural derivatives.Silk fibroin which is extracted from silkworm protein fiber contains 18 kinds of amino acids.The glycine,alanine,serine are the main types in silk fibroin and its structure consisted of hydrogen bonding,hydrophobic bonding and crystalline region.Those special structures make it has good flexibility and tensile strength.Silk fibroin has other advantages incluing air permeability,moisture permeability and biodegradation.Besides silk fibroin with curing crystallization of diversification that easy to maintain biological affinity and form a special porous structure.Silk fibroin has good film and gel forming ability.Silk fibroin can bond with some other materials to further improve its physical and chemical properties.Silk fibroin can be formed into porous shape,membranous,gel and composite materials scaffold.The materials scaffold which based on silk fibroin has excellent mechanical performance,adjustable degradation speed,high biocompatibility and good osteogenesis performance,besides capability of loading cells,bioactive factors and drugs.In addition,silk fibroin which can be made into gel scaffold,porous scaffold,electrospinning fiber,and compound scaffold et al has three-dimensional porous and biological function for bone tissue engineering as a new choice and application prospect.

Objective: The FDA regulation requirements for medical device software are relatively mature and systematic, and the research on the FDA regulation thinking of medical device software helps to promote the regulation work of the medical device software in our country. Methods:Based on the comparison of the 1998 edition and 2005 edition FDA software submission guidance, the trend of the FDA regulation requirements for medical device software was analyzed, and then its regulation thinking was discussed according to other current effective software-related guidance. Results:FDA integrally improves the submission requirements for all medical device software, especially for the minor Level of Concern software, and simplifies the requirements for design specification, verification and validation, but strengthens the requirements for traceability analysis and revision history. Conclusion: The regulation work of the medical device software in our country needs to fully consider the particularity of the medical device software, strengthen the audit of software quality management system, implement the software traceability analysis, and determine the regulation requirements for software change.

Objective To prepare and identify anti‐CD47 monoclonal antibodies .Methods The gene fragment of CD47 was am‐plified by polymerase chain reaction and cloned into prokaryotic expressing vector pET‐32a(+ ) .Purified reconstructed protein was used to immunize BALB/c mice .The immunized spleen cells were isolated and fused with Sp2/0 cells .After screened ,hybridomas secreting anti‐CD47 monoclonal antibody were acquired .Biological activities of antibodies were investigated by Western blot and flow cytometry .Results The recombinant CD47 extracellular domain protein was successfully expressed in BL21 ,and certificated by sodium dodecyl sulfate polyacrylamide gel electropheresis and Western blot .Data of flow cytometry detection demonstrated that the antiserum had high affinity to CD47 protein .Conclusion Recombinant CD47 and its monoclonal antibody ,with high affinity , were successfully prepared ,which could provide reliable tools for the future study of CD47 .

BACKGROUND:Human amniotic mesenchymal stem cel s have the potential to differentiate into insulin-secreting cel s and have immunomodulatory effects. Additional y, it has been clinical y proved that Gegen Qin Lian Tang can lower blood sugar. OBJECTIVE:To investigate the effects of Gegen Qin Lian Tang combined with human amniotic mesenchymal stem cel transplantation on rat early diabetic retinopathy, by detecting pathological changes, levels of blood indicators and expressions of vascular endothelial growth factor in retinal tissues. METHODS:By intraperitoneal injection of streptozotocin, 42 Wistar rat models with diabetes mel itus were prepared and then randomly divided into model group, human amniotic mesenchymal stem cel transplantation group (cel transplantation group) and combination of human amniotic mesenchymal stem cel s and Gegen Qin Lian Tang group (combination group). At 4 weeks after transplantation, levels of blood sugar and serum insulin in diabetic rats were detected;pathological changes of the retina in diabetic rats were observed by hematoxylin-eosin staining. Besides, expressions of CD45 and vascular endothelial growth factor mRNA were detected using immunohistochemistry staining and RT-PCR technology, respectively. RESULTS AND CONCLUSION:Compared with the model group, the levels of blood glucose and serum insulin in both cel transplantation and combination groups were significantly decreased and increased, respectively, and these changes were even more significant in the combination group (P<0.05). In the model group, the retinal edema could be found, accompanied by structural disorder and irregular cel arrangement, while these retinal lesions were relatively milder in the cel transplantation group and significantly improved in the combination group. In addition, the CD45 expression and in the retina was highest in the model group subsequently fol owed by the cel transplantation group (P<0.05) and lowest in the combination group (P<0.05). Furthermore, compared with the model group, the expression of vascular endothelial growth factor mRNA was also significantly lower in the other two groups, especial y in the combination group (P<0.05). These data show that Gegen Qin Lian Tang combined with human amniotic mesenchymal stem cel transplantation improves the severity of diabetic retinopathy by inhibiting expressions of CD45 and vascular endothelial growth factor in the retinal tissues.

A case of mandible plasma cell myeloma is reported.Plasma cell myeloma is a monoclonal neoplastic proliferation of plasma cells of bone-marrow derivation,usually multi-centric but jaw bones are rarely involved.The treatment requires precise pathological diagno-sis.The prognosis of solitary jaw bone lesions can be good after treatment.