A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored.
Device Approval ; Equipment Design ; Equipment Safety ; Equipment and Supplies ; standards ; Government Regulation ; Humans ; Models, Theoretical ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Safety Management

Sustained-release tablet has become one of the hottest research spots in the area of sustained release preparations with its unique advantages. At present, a series of shortcomings were exited in the ordinary ginkgo preparations, which were used for the treatment of cardiovascular and cerebrovascular diseases. In order to avoid these shortcomings, ginkgo flavonoids matrix tablets were prepared in this paper. Furthermore, the amount and varieties of matrix material, adhesives and fillers were investigated. Meanwhile, the formulation was optimized by using the method of orthogonal design, and Zero-order, First-order, Higuchi, Ritger-peppas equation were used for the model fitting and mechanism discussing of drug release.
Chemistry, Pharmaceutical ; methods ; Flavonoids ; chemistry ; pharmacology ; Ginkgo biloba ; chemistry ; Kinetics ; Tablets ; chemistry

Objective To investigate the clinical application of modified electroconvulsive therapy (MECT),and provide the references for more standardized and rational use of MECT.Methods A retrospective study was performed by stratified random sampling method.The clinical data of 1 330 psychiatric inpatients from January 2006 to December 2015 in Henan Psychiatric Hospital were analyzed retrospectively,and the clinical application of MECT was investigated,including the proportion of psychiatric inpatients receiving MECT,the situation of combined use of MECT and antipsychotic drugs,and the routine examination results before and after MECT.Results The proportion of receiving MECT in schizophrenic patients was the highest,it is 11.36％ (81/713),the second was depressive episode (5.61％,12/214),followed by dissociative conversion disorder (5.56％,2/36),bipolar disorder (5.34％,7/131),organic mental disorder (3.23 ％,1/31) and other mental disorders (2.93％,6/205).There were significant differences in the distribution of various mental disorders between the non electroshock group and the electroshock group (x2 =21.728,P ＜ 0.05).The proportion of the patients without electric shock and the patients with single drug,two drugs,triple therapy or quadruple therapy was 0.92％,17.43 ％,56.88％,21.10％ and 3.67％,respectively.The proportion of the patients with two or more antipsychotic drugs was 81.65％ in the electroshock group.The antipsychotics were olanzapine (28.44％),clozapine (27.52％),quetiapine (26.61％) and risperidone (24.77 ％) according to the drugs used frequently in the electroshock group.The results of routine blood test were compared among the time points of before treatment,the 1st,2nd,3 rd week of MECT and 1 week after MECT in the shock group,which showed that there was significant difference in white blood cell count (F =2.570,P ＜ 0.05);but there was no significant difference in the levels of platelet,hemoglobin and red blood cell (P ＞ 0.05);the level of white blood cell returned to normal within two weeks in 93.33％ patients with increased white blood count.The myocardial enzymes and liver function tests were not perfect during the treatment of MECT and after treatment.There was no long-term systematic evaluation of cognitive function and quality of life in patients with electroconvulsive shock.Conclusions The probability of using MECT in the patients with schizophrenia is more than that in the patients with depression.MECT is used in combination with two or more antipsychotic drugs.MECT may cause a short increase in white blood cells,but the white blood cell level in most patients can recover to normal levels after symptomatic treatment.The clinical data for treatment and prognosis in patients with MECT are inadequate,so it is necessary to improve the medical record.

Objective To evaluate the pathophysiological change of diabetes and its significance in the treatment of newly-diagnosed type 2 diabetic patients.Methods A total of 322 newly-diagnosed type 2 diabetic patients were included in this study and were divided into 2 groups with normal or impaired islet first-phase insulin secretion according to arginine stimulation test.The former group was assigned to repaglinide (Novo Norm), rosiglitazone (Avandia) and mefformin subgroups and the latter one to repaglinide,rosiglitazone and glipizide subgroups randomly.Results (1)Compared with baseline,fasting plasma glucose,2 h postprandial plasma glucose and HbA_(1C) were significantly decreased in all subgroups after 3 and 6 months of treatment (all P

Objective To develop a wear prediction model for hard-on-hard hip joint replacement under the condition of complex dynamic loading and time-dependent motion, and to apply it to the study on wear prediction of the typical metal-on-metal hip joint replacement in the complicated three-dimensional (3D) physiological motion condition. Methods The finite element model for contact mechanics was established and the fixed-tracked method was adopted to make the dynamic wear reappear on the bearing surface of artificial hip joint with 3D Euler transformation, and the data communication about the corresponding contact and wear for simulation was also made. Results The wear prediction test showed that the spherical bearing geometry of the artificial hip joint gradually became the non-spherical form due to the wear with time; meanwhile, the corresponding contact area was increased, the distribution of the contact pressure tended to be flattened, and the maximum contact pressure was decreased. Conclusions The wear prediction model developed here for metal-on-metal hip joint replacements with bilateral bearing surfaces under the condition of complex dynamic loading and motion could be used to carry out simulation test for the wear prediction of metal-on-metal artificial joint, which provides a new method to understand the wear mechanism of hip joint replacement.

Objective Due to the limitation of manufacturing techniques, possible design optimization selecting and influence of its wearing in clinical application, the bearing surface of hip joint replacements is presented as non-spherical geometry, and the finite element method can be used to study the contact mechanics behavior in such kind of non-spherical hip joint replacement. MethodsThe reconstructing of non-spherical articular surface based on spherical-grid-data model (SGDM) was developed to investigate the effect of contact mechanics of an ellipsoidal head against a spherical cup in a typical metal-on-metal hip joint replacement. Results The maximum contact pressure of the non-spherical bearing was decreased effectively, and meanwhile the contact area was increased when curvature radius of the ellipsoidal head around the centre of the contact zone was increased, while the effects of the cup inclination angle on the maximum contact pressure and contact area of the non spherical bearing under the same load showed relatively small, but the contact pressure distributions were different. Conclusions A well-controlled non-sphericity can improve the magnitude and distribution of contact pressures on metal-on-metal hip joint replacements. In addition, the developed model and evaluation method in this paper can be used for simulation of dynamic contact and wear prediction of non-spherical hip joint replacements.

Objective To study the contact mechanics of metal-on-metal hip joint replacements under different walking conditions, particularly for the edge contact behavior between the cup and the head of the bearing due to large range movement. Methods The finite element model of a typical hip joint replacement with conformal spherical bearing was established to simulate the edge contact of hip joint replacement under the given cup inclination angles and vertical loads. Results The maximum contact pressure decreased slightly and the contact area increased when the cup inclination angles increased within the range of 0°~60°. When the cup inclination angles were more than 80°, the corresponding contact area moved to the cup edge, the maximum contact pressure and distribution range increased, but the position of the maximum contact pressure moved from the initial contact point to the new point with 6°~9° in the direction of the increasing cup inclination angle to balance the corresponding contact pressure distribution and the loaded human weight. Conclusions Different edge contact behavior of hip joint replacements tends to occur due to the bigger cup inclination angle. Therefore, much attention should be paid to the problem of edge contact for both the clinical surgery and the manufacturing of hip joint replacements.

Glioblastoma(GBM)is a lethal cancer with limited therapeutic options.Dendritic cell(DC)-based cancer vaccines provide a promising approach for GBM treatment.Clinical studies suggest that other immu-notherapeutic agents may be combined with DC vaccines to further enhance antitumor activity.Here,we report a GBM case with combination immunotherapy consisting of DC vaccines,anti-programmed death-1(anti-PD-1)and poly I:C as well as the chemotherapeutic agent cyclophosphamide that was integrated with standard chemoradiation therapy,and the patient remained disease-free for 69 months.The patient received DC vaccines loaded with multiple forms of tumor antigens,including mRNA-tumor associated antigens(TAA),mRNA-neoantigens,and hypochlorous acid(HOCl)-oxidized tumor lysates.Furthermore,mRNA-TAAAs were modified with a novel TriVac technology that fuses TAAs with a destabilization domain and inserts TAAs into full-length lysosomal associated membrane protein-1 to enhance major histo-compatibility complex(MHC)class Ⅰ and Ⅱ antigen presentation.The treatment consisted of 42 DC cancer vaccine infusions,26 anti-PD-1 antibody nivolumab administrations and 126 poly I:C injections for DC infusions.The patient also received 28 doses of cyclophosphamide for depletion of regulatory T cells.No immunotherapy-related adverse events were observed during the treatment.Robust antitumor CD4+and CD8+T-cell responses were detected.The patient remains free of disease progression.This is the first case report on the combination of the above three agents to treat glioblastoma patients.Our results suggest that integrated combination immunotherapy is safe and feasible for long-term treatment in this patient.A large-scale trial to validate these findings is warranted.