The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.
China ; Durable Medical Equipment ; Licensure ; legislation & jurisprudence

Objective To investigate the clinical effect of different local anesthetic epidural anesthesia for cesarean section. Methods 60 maternal intended to be carried out cesarean section by epidural anesthesia were randomly divided into two groups. A group(n =30 cases) was administrated with 0.5% ropivacaine to anesthesia,and B group(n = 30 cases) was administrated with 0. 5% bupivacaine to anesthesia. The changes of hemodynamic were monitored,and the analgesic effect and adverse reactions were observed in the two groups. Results The differences of blood pressure, heart rate had no statistical significance between the two groups (all P＞0.05);Compared to B group, the anesthesia onset time, anesthesia time between the start of fetus, analgesic effect, adverse reactions of A group were significantly different (t = 4. 347,4. 528, x2 = 3. 834, 6. 429, all P ＜ 0. 05 ) ; Neonatal Apgar score showed no significant differences between the two groups ( P ＞ 0. 05 ). Conclusion Anesthesia with 0.5% ropivacaine for cesarean section had satisfactory anesthesia effect,and less adverse reactions.

The article reviewed the function of general practitioners in Beijing Jiaotong University Health Service Center, which was transitioned from sole curative service to both curative and preventive services. The article also discussed the role as gatekeeper for health system played by practitioners in university health service centers.

Objective To evaluate the efficacy and safety of domestic cefepime ,ceftazidime and cefathiami-dine on bacterial infection in gynecology .Methods 460 patients were randomly divided into Group A (155 patients) for 2.0g.bid of cefepime,Group B (155 patients) for 2.0g.bid of ceftazidime and Group C (150 patient) for 2.0g. bid of cefathiamidine ( intramuscular injection:once every 12 hours ) , and the periods of treatment were all 7 to 10 days.Control observation and study was carried out following Guiding Principle of Clinical Application of Antibacterial Agents.Results The clinical efficacies in Groups A ,B and C were 94.84%,82.58% and 67.33%respectively(χ2 =11.63,37.96,all P<0.05);the bacterial clearance rates were 92.52%,81.38% and 64.71%respectively(χ2 =8.00,9.97,all P<0.05).The clinical efficacy of Group A >that of Group B>that of Group C;the adverse effectives were 9.68%,10.32% and 9.33% respectively (χ2 =0.09,P>0.05).Conclusion Cefepime may still be used as the first line drugs ,and drug resistance of various degrees has occurred to ceftazidime and cefathi -amidine,and especially cefathiamidine ,which should be used with caution .

OBJECTIVE:To observe the safety and efficacy of second-generation recombinant factor Ⅷ (Kogenate FS) for treatment of patients with hemophilia A in China. METHODS: 16 patients with hemophilia A were treated with Kogenate FS. The factor Ⅷ antibodies and factorⅧ activities (FⅧ∶ C) were determined before and after the treatment. RESULTS: In the treatment of Kogenate FS for 16 patients with hemophilia A,15 (93.75%) recovered and 1 (6.25%) improved,and irreversible adverse drug reaction was seen in only 1 case. CONCLUSION: The second-generation recombinant factor Ⅷ product (Kogenate FS) was safe,efficacious and well-tolerated for patients with hemophilia A in China.

Objective To investigate the clinical effect of standard large bone flap decompression for severe craniocerebral injury.Methods This study was performed in 58 patients with severe traumatic brain injury,according to different surgical methods,the patients were divided into control group and study group,29 cases in each group.The control group was treated with conventional bone flap craniotomy,and the study group was treated with large bone flap decompression surgery.The clinical effect and complications were compared between the two groups.Results After operation,the patients were followed up for 5 months.The mortality of the study group (10.34%)was significantly lower than that of the control group (27.59%),and the difference was statistically significant (χ2 =3.98,P <0.05).In addition,the good rate of the study group (55.17%)was significantly higher than that of the control group (27.59%),and the difference was significant (χ2 =4.55,P <0.05).The preoperative intracranial pressure had no significant difference between the two groups.While at postoperative 1d,3d and 5d,the intracranial pressure of the study group was significantly lower than that of the control group,and the difference was statistically significant (t =3.55,4.02,6.12,all P <0.05).The scores of GOS and BAI in the study group were significantly higher than those in the control group (t =5.02,4.21,P <0.05 ).The incidence rates of complications such as cerebrospinal fluid leakage,trauma of cerebral infarction,trauma of epilepsy,hydrocephalus,wound infection of the study group were sig-nificantly lower than those of the control group,and the differences were statistically significant (χ2 =4.00,5.02, 456,4.22,3.99,all P <0.05).Conclusion Compared with conventional craniotomy,open standard big bone flap decompression can significantly reduce the mortality rate,decrease intracranial pressure,and improve the quality of life of patients,it has better curative effect and prognosis for patients with severe craniocerebral injury,and is worthy of clinical application.

AIM:To observe the effect of motilium on bronchial asthma associated with gastroesophageal reflux(GER BA). METHODS:50 cases of GER BA, were treated with routine anti asthma and motilium 20 mg tid,ranitidine 0.3 g,amoxicillin 0.5 g and metronidazolum 0.2 g tid for chronic gastritis cases, and losec 20 mg for the gastric acid rdflux at night. The treatment lasted for 1-4 wk, and then stopped to observe the response of the treatmeat. The recurrent cases would be treated as the above again. RESULTS:45 cases were cured in the 4 wk,no case recrudesced in 6 mon. 5 cases needed another the treatment for 1-4 wk since the recurrence, and 4 of the 5 cases were cured. CONCLUSION: Motilium has a good curative effect in preventing and curing bronchial asthma associated with gastroesophageal reflux.entfor1 -4wksin

ObjectiveTo investigate the effects of fluoxetine on viability and lipopolysaccharide (LPS)-induced TNF-α release of primary cultured rat astrocytes.MethodsThe cells were plated on 96-well tissue culture plates and treated with (5,10,20,40) μM fluoxetine for 24 hours,MTT method was used to measure the cell viability.The cells were plated on 48-well tissue culture plates,treated sequentially with (5,10,20,40) μM fluoxetine and 1 μg/ml LPS,and enzymatic linked immunosorbent assay(ELISA) was used to detect the TNF-α level of the cell supematant.ResultsCompared to viability of the control group( OD value:0.20 ± 0.017 ),fluoxetine at the dose of 20 μM,40 μM increased the viability of astrocytes ( OD value:0.23 ± 0.013,0.24 ± 0.012 ) (P ＜0.05,P＜0.01 ).Treatment with LPS for 24 hours,the level of TNF-α was significantly increased ( 53.84 ±24.84) pg/ml compared to the control group( 8.00 ± 10.87)pg/ml (P ＜ 0.01 ),fluoxetine at a dose of 10 μM can suppressed LPS-induced TNF-α release from astrocytes ( 28.85 ± 3.36 ) pg/ml (P ＜ 0.05 ).ConclusionFluoxetine can increase astrocytes viability and suppress LPS-induced TNF-α release from astrocytes.

Objective To investigate the correlation between the incidence of thyroid carcinoma and TSH, and to provide evidence for clinical application.MethodsSelect 450 cases of patients with thyroid from August 2014 to August 2016 in our hospital as the object of study in this group, the analysis of gender and age of patients, lymph nodes, tumor, laboratory examination results, to explore the relationship between TSH levels and thyroid cancer.ResultsThyroid patients with TSH was significantly higher than that in benign tumor group (P<0.05);the level of TSH and patients with lesion diameter, tumor stage, lymph node metastasis and capsule invasion was significantly correlated (P<0.05), but the level of TSH and age, gender, tumor number, vascular invasion and no significant correlation;TSH the level of thyroid cancer patients were significantly increased (P<0.05).ConclusionThe level of TSH in serum is closely related to the occurrence and development of thyroid cancer, and is closely related to lymph node metastasis and tumor stage, and the higher TSH level can increase the risk of thyroid cancer.

Objective To investigate the effects of glucocorticoid(GC) on the expression of CD80 and CD4+CD25+T cells in peripheral blood lymphocyte of patients with multiple sclerosis (MS). Methods With flow cytometer,the positive rates of CD80 and CD4+CD25+T cells in peripheral blood lymphocyte were detected in 21 acute MS patients pre and post treatment separately,and compared with the nomal control group.The secols of Expanded Disablility Status Scale(EDSS) were compared pre and post treatment in MS patients.Results The positive rate of CD80[(5.031?1.782)%]in the MS patients pre treatment was obviously less than that in control group's [(6.436?2.035)%](P