Objective To analyze the correlation of vertebral osteophyte and lumbar disc degeneration in the elderly people and explore the possible mechanism of osteophyte formation. Methods X-ray and MRI data of 120 elderly people with backache or leg pain were retrospectively analyzed. Osteophyte was classified into four grades by X-ray according to the method proposed by Nathan. Discs with osteophyte were defined as occurring when osteophyte of grade II or greater were present. Lumbar disc degeneration was classified into five grades by MRI according to the method proposed by Pfirrmann. The obtained parameters were statistically treated and analyzed. Results Osteophyte and age were positively correlated at every lumbar disc level (P < 0.05). The proportion of osteophyte in L3/4 (76.7%) and L4/5 (70.08%) were more severe than that in L1/2 (31.7%) and L2/3 (46.7%). Osteophyte and lumbar disc degeneration were positively correlated at every lumbar disc level (P < 0.01). Conclusion Osteophyte becomes more severe with the increasing of lumbar disc degeneration. The vertebral stress after lumbar disc degeneration may be the main cause of osteophyte.

At present, there is a growing call for overseas registration applicants to transfer the products that have been approved for import registration to China's domestic production. It deserves our regulatory authorities to study how to face and properly deal with this issue. First of all, this paper systematically combs the regulatory requirements of FDA, EU and Japan on the change of manufacturing site address. Secondly, the paper briefly analyzes the current regulatory differences between domestic and imported devices. Finally, according to the experience and practice of foreign countries, combined with the actual situation of our country, this paper puts forward suggestions on how to meet the needs of overseas registrants to transfer products to domestic production.
Equipment and Supplies ; Marketing

Objective To explore the changes of plasma corticotrophin releasing factor (CRF) levels in the young rats with hypoxic-ischemic brain damage.Methods Two hundred and forty young rats were randomly divided into three groups:hypoxic-ischemic brain damage group ( model group,n =80),sham-operated group ( n =80),and normal control group ( n =80).The plasma CRF levels of rats in three groups were detected at 1 h,3 h,6 h,12 h,l d,3 d,5 d and 18 d after hypoxia-ischemia,per ten rats for each time point.Plasma CRF levels were measured by radioimmunoassay.Results Plasma CRF levels of model group,shamoperated group and normal control group showed no significant difference in the young rats after 1 h,3 h,6 h,12 h of hypoxia-ischemia ( P ＞ 0.05 ).But plasma CRF levels in the model group were respectively significantly lower than those of sham-operated group and normal control group after 1 d and 3 d of hypoxia-ischemia ( P ＜0.001 ),and then recovered to the control group levels after 5 d and 18 d of hypoxia-ischemia ( P ＞0.05 ).Conclusion Hypoxia-ischemia affects plasma CRF levels in the young rats,which is related with the duration after hypoxia-ischemia.

OBJECTIVE:To investigate the effectiveness and economics of 10 mg/d rosuvastatin and 20 mg/d atorvastatin in the treatment of hyperlipidemia (HLP). METHODS:The information of 180 HLP patients selected from Tianmen Municipal First People's Hospital during Mar. 2015-Feb. 2016 were divided into group A and B according to medication regimen,with 90 cases in each group. Group A was given Atorvastatin calcium tablet 20 mg,qd;group B was given Rosuvastatin calcium tablet 10 mg,qd. Treatment course of 2 groups lasted for 8 weeks. Blood lipid indexes before and after treatment,lipid-lowering efficacy,the rate of qualified blood lipid and the occurrence of ADR after treatment were compared between 2 groups. Cost-effectiveness analysis was adopted for economic evaluation. RESULTS:Before treatment,there was no statistical significance in the levels of blood lipid in-dexes between 2 groups (P>0.05). After treatment,TC and LDL-C levels of 2 groups were significantly lower than before treat-ment,and those of group B were significantly lower than those of group A,with statistical significance(P<0.05). Total response rate of lipid-lowering in group B(97.78％)was significantly higher than group A(86.67％),and the rate of qualified blood lipid (66.67％)was also significantly higher than group A(51.11％),with statistical significance(P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). The costs of group A and B were 488.32,436.24 yuan,and cost-effectiveness ratios were 5.63,4.46;incremental cost-effectiveness ratio was -4.69. The plan of group B had cost-effective-ness advantage. The results of cost-effectiveness analysis were supported by sensitivity analysis. CONCLUSIONS:In the view of short-term efficacy,10 mg/d rosuvastatin plan is better than 20 mg/d atorvastatin plan in lowering lipid and has cost-effectiveness advantage,and both have similar safety.

Objective:To discuss the level changes and significance of IL-2,IFN-γ,TNF-α in patients with bladder cancer.Methods:66 patients with bladder cancer who were treated in our hospital from February 2015 to December 2016 were enrolled in this study,which was denoted by bladder cancer group,65 patients with cystitis glandularis who were treated in our hospital during the same period were selected as cystitis group,another 65 healthy persons who were examined in our hospital during the same period were selected as control group,and compared the levels of IL-2,IFN-γ and TNF-α in each group,and the levels of IL-2,IFN-γand TNF-α in patients with bladder cancer of different types and clinical stages.The correlation of IL-2,IFN-γ and TNF-α levels with pathological types and clinical stages were analyzed.Results:The levels ofIL-2 and INF-γ in bladder cancer group were significantly lower than those in cystitis group and control group,the level of TNF-α was significantly higher than that of cystitis group and control group,the difference was statistically significant (P＜0.05).There was no significant difference in IL-2,IFN-γ and TNF-α levels in different types of bladder cancer patients (both P＞0.05).IL-2,IFN-γ levels in T2 to T4 bladder cancer patients were significantly lower than Tis to T1,TNF-α level was significantly higher than Tis to T1,the difference was statistically significant (both P＜0.05).According to Spearman method evaluation correlation founded that IL-2,IFN-γlevels in patients with bladder cancer were negatively correlated with clinical stage,TNF-α level was positively correlated with clinical stage.However,there was no correlation between IL-2,IFN-γ and TNF-α levels in patients with pathological type.Conclusion:IL-2,IFN-γ expression in bladder cancer patients are decreased significantly,while TNF-α expression is increased significantly,and the above three indexes of patients are related to clinical stage,but not related to pathological type.

Objective To explore the diagnosis and treatment of poorly differentiated endocardial sarcoma. Method The clinical data of a child with poorly differentiated endocardial sarcoma was retrospectively analyzed. Results One-year-old girl was admitted for diarrhea, polypnea, cyanosis, and cough. Abnormal heart sound was found by auscultation. Leads Ⅱ, Ⅲ, and aVF of ECG showed high peaked P wave. The diagnosis of poorly differentiated endocardial sarcoma was confirmed by echocardiography and pathology after cardiac operation. Three months after discharge from the hospital, the patient suddenly came into coma and died. Conclusion The diagnosis of poorly differentiated endocardial sarcoma is mainly based on clinical manifestations, echocardiography and pathology. Surgical resection is the first choice and chemotherapy and radiotherapy play a supporting role. However, there is no cure for it currently.

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.
China ; Device Approval ; Technology

Objective To This article mainly takes the Shenzhen Baoan people's Hospital pre-hospital department as the observation object,analyses the spacial site data distribution of pre-hospital,to realize optimum allocation for pre-hospital resource.Methods By means of the intelligentized ambulance,the site data of the pre-hospital is obtainecd,so is the pre-hospital hot map.With the hot map,the special pre-hospital characteristics is researched.Results The three spatial data characteristics of pre-hospital medical are proposed,i.e.,non-uniform,relative stability,individual difference.Conclusions These three characteristics provide us with a new method and a new basis for decision making.In this paper,based on the pre-hospital characteristic,a modeling method of non-uniform relative stability model is proposed,and the optimized distribution of hospital site is discussed by applying planning mathematics.

In order to investigate the protective effects of the overexpression of bcl-xl gene on local cerebral infarction in the transgenic mice subject to permanent occlusion of middle cerebral artery, the models of bcl-xl transgenic mice were established and subjected to cerebral infarction by intralu- minal occlusion of the middle cerebral artery. The infarct volume and the neurological scores were observed and comparison between the wild type mice and the transgenic mice was made. It was found that the infarct volume and the neurological scores in the transgenic mice were significantly decreased as compared with those in the wild type mice. It was suggested that the overexpression of bcl-xl gene in transgenic mice could reduce the infarct volume and improve the neurological function of the mice.

The healing training was an important method to improve living ability and quality of life of patients with schizophrenia.This article introduced a living skill training scheme applied in out-patients whose course of disease shorter than 5 years.