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 explore whether intravenous injection of hydrogen‐rich saline having the protective effect on sodium taurocholate induced severe acute pancreatitis(SAP) associated lung injury(APALI) in rats and its possible mechanisms .Methods Fifty‐four healthy male SD rats were randomly divided into sham‐operation group (Sham group) ,model group (SAP+ NS group) and hydrogen water treatment group (SAP + HRS group) ,and each group was subdivided into 6 ,12 ,24 h subgroups .Six rats were killed at each time point for collecting serum ,lung tissue and pancreas tissue .Serum TNF‐αand IL‐1βlevels ,lung wet /dry weight ratio ,expression of TNF‐αmRNA and IL‐1βmRNA in the lung tissue were detected .The pathological evaluation of pancreas and lung tissue injury was performed .Results (1)The levels of TNF‐α and IL‐1β in serum ,pancreas and lung tissue pathological scores ,TNF‐αmRNA and IL‐1βmRNA expression levels in the lung tissue and lung wet dry weight ratio at the time points of 6 , 12 ,24 h in the SAP+NS group and the SAP+ HRS group were higher than those in the sham group (P<0 .05) .(2) Compared with the SAP+NS group ,the levels of serum TNF‐α,TNF‐αmRNA expression level in the lung tissue and lung wet dry weight ra‐tio at all time points in the SAP+ HRS group were lower(P<0 .05);the levels of serum IL‐1β,pancreas and lung tissue pathologi‐cal score and IL‐1β‐mRNA expression at 6 h in the lung tissue had no statistical difference between the SAP+NS group and SAP+HRS group ,but which at time points of 12 ,24 h in the SAP+ HRS group were lower than those in the SAP+NS group(P<0 .05) . Conclusion HRS realize the protection on APALI possibly via its elective anti‐oxidation action for inhibiting oxidative stress injury related cytokines expression .

Objective To investigate the clinical manifestations, etiology and risk factors of chronic pancreatitis guided by the M-ANNHEIM classification of chronic pancreatitis and to evaluate the validity and clinical significance of this classification. Methods A review of clinical data of inpatients in our hospital from December 2007 to December 2009 was conducted. The classification was carried out according to the pancreatitis were enrolled. There were 256 adult patients and 51 children and adolescent patients (age of onset<18 yr). Among these cases, 129(42%) reported a drinking history. 110 cases (35.8%) had a smoking history, 31 cases (10.1%) presented with hyperlipoidemia. 12 cases had some factors related to pancreatic duct such as pancreas divisum, pancreas trauma. There were 231 (75.2%) cases with calcification of pancreas, 45 (14.7%) with exocrine insufficiency (steatorrhea), 58 (18.9%) with endocrine dysfunction (diabetes mellitus), 32 (10.4%) underwent pancreatic surgeries, and 39 (12.7%) with pancreatic pseudocysts, biliary obstruction, pancreatic cancer and other severe complications. The M-ANNHEIM clinical staging of chronic pancreatitis was: no case in stage 0, 220(71.7%) cases in stage Ⅰ , 69(22.5%) cases in stage Ⅱ ,12(3.9%) cases in stage Ⅲ and 6 cases in stage Ⅳ. The mean value of the M-ANNHEIM score and severity index was 7.78,69 (22.5%) cases were in the minor level, 174 (56.7%) were in the increased level,62(20.2%) cases were in the advanced level. Conclusions The M-ANNHEIM classification of chronic pancreatitis is a simple, objective, accurate and noninvasive tool in clinical practice. This new classification system will be helpful for investigating the impact and interaction of various risk factors on the course of the disease.

Objective To investigate the stent occlusion rate and its risk factor in chronic pancreatitis (CP). Methods From November 2006 to January 2010 a total of 77 pancreatic endoprostheses from 64 patients with CP were tested by simulating the pathophysiologically increased main pancreatic duct (MPD)pressure. The water flow during 15 seconds was recorded 4 times at a pressure of 10 cm water. Kaplan Meier method was used to evaluate the univariate relationship between risk factor and stent occlusion, and Cox regression survival analysis was used to evaluate the multivariate relationship between risk factor and stent occlusion. Results 64 patients with CP were included, with 43 males and 21 females, the mean age was 38 years (range, 4 ～ 80 years). The stents had been placed for a mean of 263 days ( range 26 ～ 759 days).Average stent diameter was 8F (range, 5 ～ 10 F). The overall occlusion rate was 67.5% (52/77), the nonocclusion rates at 90, 180, 360, 540 d were 96. 1% (74/77) , 72.7% (56/77) ,58.4% (45/77) and 35.1% (27/77). In the Cox regression analysis, endoprosthesis diameter ≥8.5F was shown to be the only risk factors for stent occlusion. Conclusions A significant proportion of stents placed after 180 d were not occluded, and were significantly lower than those reported from similar studies overseas. Pancreatic endoprosthesis diameter ≥8. 5F was prone to occlusion.

Objective To investigate if the anticancer prescription Fuzhengyiaitang in combination with progestogen matching chems can have better clinical effects than progestogen alone.Methods Collecting 60 patients and grouped into two randomly.One group named the experimental group and the other is named the control.The experimental group is given Fuzhengyiaitang and progestogen and the control ine is given the progestogen alone.The clinical effects are investigated.Results The experimental group had better clinical effects than the other one and the results had statistical significance.The experimental group are stronger,had better immunal functions and less side effects.Conclusion Fuzhengyiaitang and progestogen match cbems Can have better clinical effects in treating the stage I's operation.

Objective To synthesize the hydrophobic supraparamagnetic ironic oxide(SPIO) loaded and hydrophilic SPIO loaded polymeric nano-vesicles and to investigate the feasibility of using hydrophobic SPIO loaded and hydrophilic SPIO loaded polymeric nano-vesicles to display the tumor in MRI in vivo through animal experiments. Methods The polymeric nano-vesicles were prepared from poly (D, L-lactic acid) (PDLLA) and poly (ethylene glycol) (PEG) by a multiple emulsion/solvent evaporation method.The hydrophobic SPIO and hydrophilic SPIO were loaded in the polymeric nano-vesicles respectively.Eighteen nude mice models with human colorectal carcinoma xenograft were established. They were divided equally into three groups (n = 6). The three groups of nude mice models were injected with water-soluble SPIO, hydrophobic SPIO loaded and hydrophilic SPIO loaded vesicle via the mice caudal vein respectively.Dynamic MRI scan were performed in all the mice models. T2WI signal intensity and T2 relaxation time were measured in the tumor, liver and muscle by using T2 mapping software. ANOVA of repeated measurement was used to analyze if there were significant differences of signal intensity changes among the three groups, while Bonferroni method was used for pair-wise comparison. Results On T2 WI, tumors showed decrease in signal intensity after hydrophobic or hydrophilic SPIO loaded polymeric nano-vesicle injection, while no signal intensity decrease was found in the tumor after water-soluble SPIO administration. The maximum percentage of signal intensity decrease in tumor caused by hydrophobic SPIO loaded and hydrophilic SPIO loaded vesicle were 11.00%, 11.40%, respectively. There was statistical significant difference of signal intensity changes among these three groups (F = 10. 96, P ＜ 0. 01). The decrease in signal intensity in the groups with hydrophilic or hydrophobic SPIO loaded polymeric nano-vesicles injection were more pronounced as compared with that of water-soluble SPIO (P ＜ 0. 05), but there was no significant difference in signal intensity decrease between the groups of hydrophilic and hydrophobic SPIO-loaded polymeric vesicles injection (P ＞0. 05). The three agents could lead to signal intensity decrease in the liver. The maximum percentage of signal intensity decrease in liver caused by water-soluble SPIO, hydrophobic SPIO loaded and hydrophilic SPIO loaded vesicle were 32. 85%, 52. 77%, 56. 89%, respectively. There was statistical significant difference between these groups (F = 161.18, P ＜ 0. 01) . The groups of injecting hydrophilic and hydrophobic SPIO loaded polymeric nano-vesicles had the more obvious signal decrease than the one with water-soluble SPIO (P ＜ 0. 01). Hydrophilic SPIO loaded polymeric nano-vesicles exhibited more signal intensity decrease than hydrophobic SPIO loaded polymeric nano-vesicles (P ＜ 0. 01). All three agents could not lead to T2WI signal decrease in the muscle, and there was no significant difference in signal change on T2 WI among three groups (F = 0. 59, P ＞ 0. 05). Conclusion SPIO loaded polymeric nano-vesicles can cause significant T2WI signal loss in human colonic carcinoma on MR imaging in vivo. It can be used as tumor imaging contrast agents.

Objective:To explore the correlation between carotid lesion severity detected by ultrasound and pregnancy associated plasma protein A (PAPP‐A) expression in patients with acute coronary syndrome (ACS) .Methods :A to‐tal of 78 ACS patients hospitalized in our hospital from Feb 2012 to May 2015 were regarded as ACS group ,mean‐while ,another 78 healthy subjects were enrolled as healthy control group .Correlation between carotid lesion severi‐ty detected by ultrasound and PAPP‐A expression was analyzed . Results:Compared with healthy control group , there were significant rise in serum PAPP‐A concentration [ (0.97 ± 0.32) mg/L vs .(1.56 ± 0.19) mg/L] ,carotid intima‐media thickness [IMT ,(0.84 ± 0.13) mm vs .(1.28 ± 0.16) mm] and Crouse plaque score [ (2.98 ± 1.92) scores vs .(8.24 ± 1.13) scores] in ACS group ,P<0.01 all .Linear correlation analysis indicated that serum PAPP‐A concentration was significant positively correlated with Crouse plaque score and IMT ( r= 0.342、0.243 , P<0.05 all) .Multi‐factor gradual linear regression analysis indicated that carotid Crouse plaque score and IMT were in‐dependent risk factors for PAPP‐A (partial regression coefficient=1.932 ,17.722 ,P<0.01 both) .Conclusion:Ca‐rotid ultrasound Crouse plaque score ,IMT are significantly positively correlated with PAPP‐A expression ,which can indirectly reflect coronary artery disease severity in ACS patients ,it is worth extending .

Objective To conclude and compare the technical characteristics and clinical efficacy of retroperitoneal and transperitoneal approach for robotic partial nephrectomy.Methods 418 patients received robotic partial nephrectomy conducted by one surgeon in the urology department of PLA General Hospital from 2013, December to 2015, October, including 157 cases in retroperitoneal approach and 261 cases in transperitoneal approach.There were no significant difference between the transperitoeal and retroperitoneal approach in patient age(51 years, 51 years, P=0.593), BMI(25.5 kg/m2,25.6 kg/m2, P=0.331), gender(male/female:111/46,186/75,P=0.184), location(left/right,80/77,123/138,P=0.575), tumor size(3.1cm,3.5cm,P =0.356), comorbidities, proportion of solitary kidney(11.5%, 9.6%,P=0.253) or bilateral tumors(1.3%,3.4%,P=0.179), RENAL score(6(5-8),6(5-8),P=0.083), ASA score(2 vs.2)(P=0.310) and preoperative serum creatinine(74.7 μmol/L,76.7 μmol/L, P=0.736).Patients in the retroperitoeal approach group were more likely to have abdomen surgery history (21.7%,14.2%,P=0.049).there was significant difference between two approaches in tumor location in the kidney ( anterior/posterior/others: 9/140/8, 212/36/13, P <0.001 ) Results The operation time (105min, 115min, P =0.041 ) and warm ischemia time ( 15min, 20min, P <0.001 ) were shorter and estimated blood loss(50ml,75ml,P<0.001) was less in the retroperitoneal group.No significant difference was observed in postoperative 24h blood loss(45ml,50ml,P =0.093), intraoperative transfusion rate (2.5%,6.5%,P=0.072) and collective system injury(24.8%,27.6%,P =0.539) between the two groups.Peritoneum break occurred in 25 cases in retroperitoneal group, which were repaired by Hem-o-lock.One intestinal injury occurred in transperitoneal group and was repaired intraoperatively.Three and nine cases in the retroperitoneal and transperitoneal group were converted to radical nephrectomy.One case in the transperitoneal group was found positive margin and received laparoscopic radical nephrectomy.Two liver injury and five spleen injury occurred in the transperitoneal group.For postoperative food intake(1 day, 2 days, P <0.001 ) , the length of indwelling drainage ( 3 days, 4 days, P <0.001 ) and the length of postoperative stay ( 5 days, 6 days, P =0.001 ) , the retroperitoneal group had one day shorter than the transperitoneal group.With the median following-up time of both group, 11 months (IQR:6-16) in RPRPN group and 12 months ( IQR: 7-19 ) , no subject with a tumor recovery or metastasis.Conclusions Retroperitoneal robotic partial nephrectomy is feasible and effective, which is similar to transperitoneal approach.The retroperitoneal approach is superior to transperitoneal approach for posterior, lateral and superior renal tumors.

Objective To evaluate the risk factors of failure in pain resolution in chronic pancreatitis(CP)after endoscopic treatment.Methods We undertook a retrospective cohoa study of subjects with pain caused by CP,who underwent endoscopic treatment from January 1997 to December 2006.Cox proportional-hazards model was used for multivariate analysis of the variables that were possibly related to failure of treatment.Results Follow-up data were obtained from 172 patients(114 males and 58 females,mean age 39.4 yr.Pain resolution after endoscopic treatment was achieved in 148(86.0%).Cox proportional-hazards model showed risk factors of failure in pain resolution after endoscopic treatment were onset age(＞36 years,hazard rate(HR)=3.5),mild and moderate abdominal pain before endoscopy(HR=2.4),no decrease in amount alcohol consume(＜50%,HR=1.9)and inappropriate diet(HR=2.8).Conclusion Patients with CP should abstain from alcohol and have low-fat diet,especially for those with pain onset at older ages (＞36 years)and with mild and moderate abdominal pain before endoscopic treatment.

Objective To formed ranoscale ultrasound contrast agents loading PFOB by selfassembly of amphiphilic block copolymer for ultrasonic imaging in vivo and in vitro.Methods The biodegradable copolymer-poly(ethylene glycol)-b-poly (D, L-lactic acid) (PEG-PDLLA) self-assembled to form PFOB-loaded nanomicelle and nanovesicle with different PFOB concentration by solvent volatilization.The configuration and particle-sizing of resulting nanoparticles was determined,and their ultrasonic imaging in vitro and contrast-enhanced ultrasonography on subcutaneous tissue by focal injection in vivo were observed.Results In transmission electron microscope images, these micelles and vesicles appeared uniformly spherical with smooth surface.All the size distributions were narrow and mean diameters were from 404.3 to 475.8 nm using laser particle-sizing analyzer.In vitro and in vivo experiment showed that,the higher PFOB concentration, the more remarkable effect of ultrasound imaging.Especially, nanovesilces'ultrasonography effect was much better than nanomicelles' under same conditions.Conclusions PFOB-loaded nano-micelles and nano-vesicles prepared by solvent volatilization and self-assembly of PEG-PDLLA can obviously enhance ultrasound contrast and nanovesicle behaves better than nano-micelle.