By analysis on the risk management regulations and the situation of medical device after the product on the market, information list of problems and risk analysis process of the production and after-production were described, simultaneously, the suggestions were put forward to risk management after the product on the market, with the aim of providing reference for manufacturers and administrators.
Equipment Safety ; Product Surveillance, Postmarketing ; Risk Management

Traditional Chinese medicine psychotherapy and morita therapy are both influenced by oriental culture. But, the traditional Chinese medicine psychotherapy is based on TCM theory, belonging to the accumulated experience. It treats the patient with mental disorder and has not standard treatment model, and the patients’ informed-consent were not fullfilled. Morita therapy is based on the modern medicine, and it has systematic and complete psychology theory foundation and standard operation, and the patient has well informed-consent.

25 cases of saddle nose anaplasty with hydroxylaptite ceramics have been reported in this paper.Anaesthesia and the operating methods have been modified to make the operating ef- fects more satisfactory.All of the merits of the modification have been discussed in the paper.

A new radical operational procedure designed by ourselves has been used on 40 cases of congenital megacolon in our department during 1977-1991, The result of the follow-up sur- vey of 35 cases was gained. The operative curative rate was 97.1% and mortality was 2.9%. The characteristic is that the method of extraction by around-anastomosis stitches was used. Several important factors which affected operative effects were discussed. Four radical operational methods were compared. Our results demonstrate that the new method is effec- tive, safe, practical and feasible particularly in Yunnan. This study provides an ideal operational method in the clinical treatment of congenital megacolon.

Objective To compare the efficacy of isophane protamine biosynthetic human insulin premixed 30R( Novolin 30R) and biosynthetic human insulin ( Novolin R) combined with protamine biosynthetic human insulin (Novolin N) in the treatment of gestational diabetes mellitus and the patients compliance .Methods According to the digital table ,40 patients with gestational diabetes mellitus were randomly divided into A group ( 20 cases ) and B group(20 cases).A group was treated with Novolin 30R,while B group was given Novolin R combined with Novolin N.The blood glucose levels,the incidence of hypoglycemia during hospitalization ,clinical efficacy,security,conven-ience of insulin injection and compliance were compared and evaluated in the two groups .Results In A group after treatment,the compliance rate was 70.00%(14/20),that in B group was 75.00%(15/20),there was no significant difference(χ2 =0.125,P>0.05).In A group,the incidence rate of hypoglycemia was 10.00%(2/20),that in B group was 5.00%(1/20),there was no significant difference (χ2 =0.360,P>0.05).After treatment,the fasting blood glucose,postprandial 2 hours blood glucose levels in the two group were decreased significantly ( t =5.883, 5.248,6.856,7.549,all P<0.05),but the differences were not statistically significant between the two groups after treatment [(4.9 ±1.0)mmol/L vs.(4.8 ±1.2)mmol/L,(6.6 ±1.6)mmol/L vs.(6.3 ±1.8)mmol/L,t=0.085, 0.553,all P>0.05].In A group,the incidence rate of irregularly injected insulin was 1.23%(4/324),which was significantly lower than 3.58%(23/642) in B group(χ2 =4.37,P<0.05).Conclusion Novolin 30R program and Novolin R combined with Novolin N program can effectively control the glucose of gestational diabetes ,the clinical re-sults are satisfactory and relatively safe ,but the former is more acceptive by the patients .

Objective To observe the changes of cardiac function in liver cirrhosis decompensation stage.Methods This article reports the cardiac function changes of 32 cases liver cirrhosis patients in decompeusation stage as compared with 35 health persons.Some heart parameters are measured.Results In liver cirrhosis decompensation stage the EV of mitral valve and EV/AV in diastole function decreased significantly,the TEV of tricuspid valve decreased(P

Objective:To observe the effect of periodontal initial therapy on the serum level of lipid in the patients with both periodontitis and hyperlipidemia.Methods:Twenty patients with both hyperlipidemia and moderate to severe chronic periodontitis were enrolled in this study.Periodontal parameters [plaque index(PLI),bleeding on probing(BOP),bleeding index(BI),probing depth(PD) and attachment level(AL)] were evaluated prior to and 3 months after periodontal initial therapy.Simultaneously,the patients' serum levels of total cholesterol,triglyceride,high-lipoprotein cholesterol,low-lipoprotein cholesterol were also measured.Results:(1) Three months after periodontal therapy,the periodontal infection and inflammation in patients reduced comparing with baseline.The PD,PLI,BI,and BOP decreased significantly(the PD,PLI,BI,and BOP reduced from 3.98?0.12 to 2.39?0.13,1.23?0.10 to 0.84?0.08,2.63?0.14 to 1.48?0.08 and 94.26?1.84 to 33.57?2.06,respectively;P

Objective:To evaluate the clinical value of radionuclide imaging with ~(131)I-MIBG in the diagnosis of adrenal medullary lesions.Methods:The ~(131)I-MIBG adrenal medullary imaging results of 48 patients(12 with primary hypertension as control group,21 with pheochromocytoma,and 15 with adrenal medullary hyperplasia)were analyzed and compared with those of CT and B ultrasonography.The uptake ratio of adrenal gland to background and to myocardium were calculated and compared by ROI sequence.Results:In ~(131)I-MIBG imaging,for the patients with pheochromocytoma,11 of them were found abnormal radioac- tive increase of one adrenal gland;2 ectopic pheochromocytoma were demonstrated;3 were found with multiple abnormal ra- dioactive increase in the whole body besides adrenal gland were demonstrated with malignant pheochromoeytoma;one adrenal gland was shown clearly of 3 patients and 2 patients appeared negative,with the positive rate of 90.5%.Of the patients with adrenal medullary hyperplasia,8 were found with one adrenal gland imaging and 3 with two adrenal gland imaging;4 patients appeared with negative,with the positive rate of 73.3%.The uptake ratio(obtained by ROI sequence)in pheochromocytoma and hyperplasia group were remarkably higher than that in control group,of which pheochromocytoma group was remarkably higher than hyperplasia group.Conclusion:~(131)I-MIBG imaging is an effective tool in the localizing and qualitative diagnosis of adrenal medullary lesions.ROI sequence can increase the positive rate and benefit the differential diagnosis.

Objective:To compare the rat models of ulcerative colitis induced by 2,4,6-trinitro-benzene-sulfonic acid(TNBS) and immune-comb method.Methods:SD rats were randomly distributed into groupⅠ(immune-comb method),groupⅡ(TNBS/ethanol),groupⅢ(50% ethanol) and groupⅣ(control).The rats in groupⅠwere sensitized 2 times by antigen made of rabbit colon mucosa in 2-week intervals.After abrosia for 24 hours,each rat in four groups received enema of 0.65 ml different fluids,which were:TNBS 100mg/kg +50%ethanol for groupⅠand Ⅱ,50%ethanol for group Ⅲ,and normal sodium for control group.Rats were sacrificed on day 1,21 and week 8,12 after enema to observe the macroscopical focus of infection in bowels and the microscopical changes.Results:The typical erosion and ulcer changes appeared in groupⅠandⅡ,and there was accompanying pathological changes in the end piece of ileum in groupⅠ.The pathological changes for groupⅠcould keep for 8 weeks,while those for group Ⅱtrended to heal 3 weeks later.The pathological changes in groupⅢonly were hyperemia,oedema and a few anabrosis or superficial ulcer,keeped for 21days.There was no tissue damage in group Ⅳ.Conclusion:Immune-comb method is comparatively the ideal method to establish the model,,because it has a good reproducibility,a long persistence time,and the pathological changes resemble more to those of man..

Objective:To clone human PRKCB1 gene open reading frame(ORF) in order to further research on it's function.Methods:RT-nested PCR method was adopted to the amplify the total length of human PRKCB1 ORF from human umbilical vein endothelial cell(HUVEC).T vector was inserted into the harvested fragment after a tail was added.With blue white screening,the gene ORF encoding human PKC?Ⅱ was obtained by special primers amplifying recombinant plasmids,and linked into T vector.Then the plasmid was identified by sequencing.Results:The human PRKCB1 ORF was amplified successfully with RT-nested PCR and T/A cloning,and the gene sequence was completely consistent with that reported in GenBank.Conclusion:Human PRKCB1 gene ORF was successfully cloned.The strategy of cloning may provide technical references for some genes hard to be cloned.