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.

The clearance of proteins differing in charge and/or size (IgG4, total IgG and albumin) was evaluated in 95 diabetic patients. Urinary IgG4 values increased in group mi-croalbuminuria. The increased urinary IgG4 excretion correlated significantly with the degree of albuminuria and diabetic retinopathy. Urinary total IgG levels increased obviously only in group with massive macroalbuminuria. The IgG4/total IgG ratio was highest in group mi-croalbuminuria, and its change had a special pattern. Urinary IgG4 and IgG4/total IgG ratio may be sensitive parameters in assessing early protein charge-selectivity impairment and in detecting incipient diabetic nephropathy.

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 .

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.

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.

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.

Phase-contrast magnetic resonance imaging (PC-MRI) is a valuable and noninvasive method for evaluating hemodynamics and assessing the severity of disease processes involving the cardiovascular system. The basical principles, influential factors and the applications of PC-MRI in the assessment of cardiovascular diseases were reviewed in this paper.

Objective To observe the effects of Yishen-Pinggan dcoction on the urine microalbumin and the expression of ACE2, AngⅡin the spontaneously hypertensive rat kidney(SHR);to observe the kidney level hepatic side of the protective effect of early renal in SHR hypertension. Methods The same old male SHR and normal rats(Wistar-Kyoto rats, WKY) for the study, at 10 weeks of age, SHR rats were randomly divided into a model group, a Chinese medicine group, and a lotensin group;while WKY rats were served as a normal control group(n=8). They were continuously treated for 12 weeks. Urine mAlb and β2-MG of rats were quantified at pre-experiment and after experiment, immuno-histochemical detection of renal ACE2 and AngⅡwere performed, the obtained results were statistically analyzed by computer image analysis. Result At the 12th week, compared with urinary mAlb(509.3±160.3)ng/ml,β2-MG(0.150±0.037)μg/ml, Ang kidneyⅡ(7 174.24±1 068.99)μm2,kidney ACE2(2 158.90±376.60)μm2 in the WKY group, the urinary mAlb(908.3 ±13.2)ng/ml, β2-MG(0.378±0.099)μg/ml, kidney AngⅡ(11 085.37±1 398.03)μm2 in the hypertension model group were significantly higher(P<0.01), and kidney ACE2(1 375.77±466.21)μm2 was decreased significantly(P<0.01); compared with hypertensive model group, rat urinary mAlb(574.9±197.8)ng/ml,β2-MG(0.198±0.040)μg/ml, kidney AngⅡ(8 462.91±781.23)μm2 in Chinese medicine group, rat urinary mAlb(644.4±147.5)ng/ml, β2-MG(0.206±0.044)μg/ml, kidney AngⅡ(8 696.88±679.70)μm2 in lotensin group were significantly decreased(P<0.01); while kidney ACE2(1 904.02 ± 454.08)μm2 in Chinese medicine group, kidney ACE2(1896.11±445.43)μm2 in lotensin group was significantly increased(P<0.01). Conclusion Yishen-Pinggan decoction can reduce the SHR urinary microalbumin excretion so as to reduce high blood pressure early kidney damage; its role may be associated with its increasing local renal ACE2 expression and reducing the kidney Ang Ⅱ expression.

Objective To detect the serum proteomic patterns using SELDI-TOF-MS ProteinChip array technology in gastric cancer,screen biomarker candidates,build diagnostic models and evaluate its clinical significance in early gastric cancer.Methods SELDI-TOF-MS ProteinChip was used to detect the serum proteomic patterns of 40 patients with gastric cancer and 30 healthy people.The diagnostic models were developed and validated by discriminant analysis.Results The model composed by 3 protein peaks 8592m/z、13725m/z and 8678m/z could do the best in the diagnosis of gastric cancer.The specificity and sensitivity of it were 86.5%(26/30)and 90%(36/40)respectively.Conclusions This method show great potential for the early detection,staging before operation and screening novel and better biomarkers to early gastric cancer.