This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.
Materials Management, Hospital ; Quality Assurance, Health Care

Objective To analyze the features of EMU survived casualties and the rescue during a head -on- rear collision between two EMU trains on 23 July 2011 ( July 23 train collision accident) at Wenzhou station.Methods The casualties treated in many major hospitals in Wenzhou were surveyed within 24 hours after the accident occurred.The data of age,gender,type of injury and injury severity of the wounded were analyzed.Results A total of 136 casualties were treated within the first 24 hours after the accident occurred,and the male patients and female patients accounted for 55.89％ and 44.11％ respectively,blunt trauma was the main cause of injuries.The percent of multiple injuries in the wounded survivals accounted for 79.41％.The most common injury site of the survived casualties was chest,followed by four limbs and spine.All the wounded were rescued on the spot and were referred to the hospitals with better medical facilities.Conclusions There was no significant difference in gender of the wounded.Blunt trauma was the leading cause of injuries,and the chest,four limbs and spine were the liable parts of body to be traumatized.Saving life,triaging and transferring the wounded as soon as possible were the major algorithm during the initial stage of medical rescue after the accident occurred.

Innate lymphoid cell is a type of newly discovered innate immune cell , which can function as adaptive T cells . Based on the transcription factors and the expression of effector cytokines , innate lymphoid cells can be categorized into three sub-groups:ILC1, ILC2 and ILC3.The inflammatory factors these produced by ILC play an important role in the development of inflamma -tory bowel disease (IBD), but ILC3 can secrete IL-22, which promotes the restoration of intestinal epithelial cells .Exploring the func-tion of ILC has a great significance in the treatments of IBD .This article reviews their phenotype , function and also relationship with IBD.

Objective To evaluate the impact of sepsis bundle treatment on morbidity of sepsis or septic shock in burned patients. Methods A retrospective clinical study was conducted on burned patients with severe sepsis or sepsis shock in burn intensive care unit. 95 patients were divided into control group(43 patients) and study group (52 patients)according to their treatment. The relationship between sepsis bundle index and sepsis, septic shock and 28-day mortality respectively were analyzed with logistic regression analysis. The compliance of sepsis bundles,and 28-day mortality were noted. Results The 28-day mortility rate,the mobidity of sepsis and septic shock in study group was lower than that of control group (P ＜ 0. 05). It could be found that 6-hour EGDT and 24-hour EGDT was the independent protective factor of sepsis and septic shock through logistic regression analysis ,and blood gas analysis, EGDT and vasoactive drug were correlated with 28-day mortality(P ＜0. 05). Compliance with sepsis bundles of 6-hour EGDT and 24-hour EGDT in study group was only 51.9%, and 63.2% respectively. Conclusion Sepsis bundle was able to improve survival rate in severe burn patients. Compliance with sepsis bundles in burn medical staff needed a buring improve.

Objective To evaluate the causes,prevention and treatment ot laparoscopic comphca- tions in urologic surgery.Methods From May 2000 to May 2004,135 urologic laparoscopies were per- formed,including 17 transperitoneal laparoscopies and 118 retroperitoneal laparoscopies.Of the135 cases,26 had adrenal adenoma extirpation;31 had roof-removal and decompression of renal cyst;25 had radical ne- phrectomy;6 had pyeloplasty;2 had partial resection of renal capsula and encapsulation of the great omen- tum;2 had partial nephrectomy;4 had pelviureteral resection;13 had ligation of renal pedicle lymphatic ves- sel;2 had ureterolysis;7 had ureterolithotomy;12 had ligation of spermophlebectasis;5 had exploration,re- duction and fixation of undescended testis.The intra-and post-operative complications were retrospectively reviewed and clinically analyzed.Results Overall,14 cases(10.4%)had complications.Intraoperative complications occurred in 10 cases,including 6 cases of peritoneal injuries,which were clamped during oper- ation;4 of vascular injuries,which resulted in conversion to open surgery.Postoperative complications oc- curred in 4 cases,including 2 of subcutaneous emphysema,which was spontaneously absorbed at 5 and 7 d after operation;1 of incision seepage,which was drained for 40 d and then disappeared;and 1 of urine reten- tion,for which urethral catheterization was kept for 3 d and then the patient had voluntary voiding.No death occurred in this series.Conclusions Understanding the characteristics of laparoscopic complications in u- rologic surgery and systematic training of the surgeons can reduce the occurrence of complications.

OBJECTIVETo study the effect of Yishen Daluo Decoction (YDD) on the expression of protein lipoprotein (PLP), oligodendrocyte transcription factor 1 (Olig 1), and oligodendrocyte transcription factor 2 (Olig2) in mice with experimental autoimmune encephalomyelitis (EAE).

METHODSTotally 40 mice were randomly divided into 4 groups, i.e., the normal group, the model group, the Chinese medicine (CM) group, and the Western medicine (WM) group, 10 mice in each group. Each mouse in the model, CM, and WM groups was subcutaneously injected with 200 microL antigen emulsion (containing 150 micro g PLP139 -151 and 400 micro g H37RA) in two parts at the upper abdomen on the first day. 100 microLBordetella pertussis juice (containing 0. 6 x 10(6) Bordetella pertussis) was injected by caudal vein on the first and the third day. On the 7th day after modeling, each mouse in the normal group and the model group was intragastrically given normal saline (0. 1 mL/10 g). YDD (0. 2 g crude drug/10 g) was intragastrically given to mice in the CM group, and prednisone (0. 039 mg/10 g) was intragastrically given to mice in the WM group. All mice were intervened for 54 days. Changes of PLP, Olig1, and Olig2 in the brain tissue of EAE mice were detected by Western blot. Results The levels of PLP and Olig2 in the brain tissue of the model group were less than those of the normal group (P <0.05). Compared with the model group, the levels of PLP, Olig1, and Olig2 in the brain tissue increased in the CM group (P <0.05); the levels of PLP and Olig2 in the brain tissue increased in the WM group (P <0.05). Compared with the WM group, the level of Olig1 in the brain tissue increased in the CM group (P <0.05).

CONCLUSIONYDD could enhance remyelination by elevating the levels of Olig1 and Olig2 in the brain tissue of EAE mice.

Animals ; Basic Helix-Loop-Helix Transcription Factors ; metabolism ; Brain ; Drugs, Chinese Herbal ; pharmacology ; Encephalomyelitis, Autoimmune, Experimental ; metabolism ; Gene Expression ; Mice ; Nerve Tissue Proteins ; metabolism ; Oligodendrocyte Transcription Factor 2 ; Transcription Factors

Objective To investigate whether the left ventricular delayed contraction site determined by tissue Doppler imaging might be an optimal left ventricular lead position for improved outcomes of cardiac resynchronization therapy (CRT) in patients with non-ischemic cardiomyopathy. Methods Thirty-three patients subjected to CRT were selected, and all were performed conventional ultrasound cardiography and tissue Doppler examinations before operation. The left ventricular delayed contraction site was determined according to the interval between the onset of QRS and the peak systolic velocity. Retrograde coronary venography was performed during operation, and the left ventricular lead site was selected according to the left ventricular delayed contraction site determined by tissue Doppler examination before operation. The coronary sinus lead site was determined under the guidance of X ray of dorsaventral, lateral, right anterior oblique and left anterior oblique positions. Patients were divided into group A(n=20, the left ventricular lead site was in line with the delayed contraction site) and group B (n=13, the left ventricular lead site was not in line with the delayed contraction site). Results There was no significant difference in age, NYHA grading, left ventricular end-systolic volume(LVESV), left ventricular ejection fraction(LVEF), pulmonary arterial systolic pressure, QRS width and Ts-SD between the two groups before operation(P> 0.05). Six months after CRT, there was no significant difference in NYHA grading, LVESV and mitral regurgitation(MR) grading between the two groups(P>0.05), while the increase in LVEF and decrease in LVESV of group A were more significant than those of group B (P<0.01). Conclusion In patients with non-ischemic cardiomyopathy, CRT significantly improves left ventricular performance, and the more favourable outcomes are achieved in those pace at the delayed contraction site. Tissue Doppler imaging may help to guide the implant of left ventricular lead.

Humans ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/diagnosis* ; Death, Sudden/etiology*

ObjectiveTo evaluate the effectiveness of transcatheter Amplatzer device closure on patent ductus arteriosus(PDA),and to give some evidences for the clinical application.MethodsAll studies in the world regard to the controlled trials(CT) about transcatheter Amplatzer device closure and cardiac surgery on PDA were searched and made synthetic evaluation by means of Meta-analysis.RevMan 4.2.2 software was used for statistical analysis.Cases relative risk(RR)and its 95% confidence interval(CI)of procedure failure,the incidence of complication and residual shunt were calculated.ResultsTotally 5 studies including 349 cases were analyzed.Operation failure of Amplatzer device occlusion was higher than cardiac surgery [5 CT,349 cases,3.0% vs 0,RR=4.29,95%CI(0.77,23.95)](P=0.10).Incidence of complication of Amplatzer device occlusion was lower than cardiac surgery[5 CT,343 cases,3.1% vs 38.0%,RR=0.11,95%CI(0.05,0.23)](P

Objective To investigate the MRI features of intracranial solitary fibrous tumors/hemangiopericytomas (SFT/HPC),and to compare these findings with those of intracranial meningiomas.Methods The clinical features and MRI findings in 28 patients of intracranial SFT/HPC (SFT/HPC group)and 68 patients of meningiomas (meningiomas group) confirmed by operation and pathology were retrospectively analyzed.The indicators of two groups were compared.Results Shape of tumor,signal homogeneous,signal voids of vessel in tumor,hypointense signal nodules on T2WI and enhanded,cystic or necrosis in tumor,meningeal tail sign,changes of the nearby bone,sex,Ki-67％ level,blood lose in surgery had significant differences between SFT/HPC group and meningiomas group (all P＜0.05).Conclusion There are some differences between intracranial SFT/HPC and meningiomas.It is helpful in diagnosis and differential diagnosis through the comparative analysis of the imaging signs.