Objective:To discuss the regulation requirements of software based on the analysis of software-related recalls of medical devices. Methods:The data of software-related recalls of medical devices in America were collected and processed, and the type, situation, cause and trend of software-related recalls were analyzed, then the suggestions on the regulation requirements of software were proposed. Results:During the four periods from 1983 to 2011, the percentage of software-related recalls vs medical device recalls in America increased from 6%to 19%, and the year-on-year growth rate of software-related recalls rose by 47%to 164%, significantly higher than medical device recalls in the same period (from 13%to 54%). Especially, the problem of software-related recalls in radiology medical devices was the most serious. Conclusion: The regulatory situation of software is more complicated and severe, so the regulation requirements of software, including software validation, adverse event monitoring and usability design, need to be further strengthened according to the particularity of software.

To develop estradiol transdermal film-forming spray (TFS), various polymers were screened using solvent appearance, spray ability, film-forming rate and appearance as indices. The influence of polymer type, plasticizer and penetration enhancer on the transdermal flux were investigated by selecting porcine skin as model, and transdermal flux of TFS was compared with commercial patch and gel. The drug existing state in the formed film was investigated by differential scanning calorimetry (DSC). The solvent appearances, spray abilities, film-forming rates and appearances of eudragit E PO, RL PO, hydroxypropyl cellulose EF, polyvinylpyrrolidone K30, Plasdone S630 and Agrimer VA64 were suitable for the preparation of TFS. TFS prepared by Eudragit RL PO had the biggest transdermal flux of estradiol among all the polymers investigated. Triethyl citrate, the plasticizer, decreased the transdermal flux. Azone increased the transdermal flux, while oleic acid, isopropyl myristate and menthol had opposite effects. TFS had a higher transdermal rate and a higher accumulative penetrated estradiol of 24 h than commercial patch and gel. The DSC result showed that estradiol was spread as molecule in the formed film of TFS. It was indicated that TFS could be expected to be an effective transdermal drug delivery system.

Lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH) obviously impair the quality of life of middle-aged and elderly men. Current management of BPH includes wait-and-watch, medical therapy, and conventional surgery. As a new approach, minimally invasive surgery has been playing an increasingly important role in the management of BPH, with potential advantages of less operative trauma, quicker recovery, lower risk of postoperative complications and higher quality of life. This review mainly discusses prostatic urethral lift (Urolift® System), transurethral water vapor therapy (Rezūm® System) and robot-guided high-energy water ablation (PROCEPT Aquablation™ System).
Aged ; Humans ; Lower Urinary Tract Symptoms ; Male ; Middle Aged ; Minimally Invasive Surgical Procedures ; Postoperative Complications ; Prostatic Hyperplasia ; surgery ; Quality of Life ; Treatment Outcome ; Urethra ; surgery

Objective To clarify the risk factors of postoperative recurrence of early gastric cancer (EGC)patients who underwent radical gastrectomy.Methods We investigated follow-up records of 336 EGC patients on whom curative operations were performed at the First Affiliated Hospital of Dalian Medical University between January 1994 and January 2008 with special reference to 12 cases of cancer recurrence.Results The 5-year survival rate of D1 was 89.0％,D1 + t was 91.4％,D1 + β was 91.8％,D2 was 92.5％,D3 was 90.0％(P =0.981).The recurrence rate was 3.6％(12/336).The recurrence time was 17-58 months,the survival time was 33-68 months.Six cases suffered from hematogenous recurrences,four cases from lymph node recurrences,two cases from remnant stomach recurrences.The recurrence rate of SM was higher than M(P =0.015),lymph node positive was high than negative(P =0.011),D1 was higher than D2(P =0.025).Conclusions The recurrence rate of EGC correlated with depth of invasion,lymph node metastasis and lymph node dissection.

Objective To evaluate the effect of dexmedetomidine on liver injury in the rats with ob?structive jaundice. Methods Forty?five healthy male Sprague Dawley rats, weighing 250-300 g, aged 8-9 weeks, were divided into 3 groups ( n=15 each) using a random number table: sham operation group ( S group) , obstructive jaundice group ( OJ group) and dexmedetomidine group ( D group) . Obstructive jaun?dice was induced in rats by division and double ligation of the common bile duct in OJ and D groups. Dexmedetomidine 100 μg∕kg was injected intraperitoneally at 72 h after establishment of the model in group D. At 3, 5 and 24 h after administration, blood samples were collected from hearts for determination of the plasma alanine aminotransferase (ALT) and C?reactive protein (CRP) levels. After blood sampling at each time point, the specimens from the external right lobe of the liver were obtained for detection of the expres?sion of Toll?like receptor 4 ( TLR4) mRNA ( by real?time polymerase chain reaction) and TLR4 content ( by enzyme?linked immunosorbent assay) in liver tissues and for pathological examination of liver tissues ( with light microscope) . Results Compared with group S, the plasma ALT and CRP levels were significantly increased at each time point after administration, and the expression of TLR4 mRNA in liver tissues was significantly up?regulated, and TLR4 content in liver tissues was significantly increased in OJ and D groups ( P<0?05) . Compared with group OJ, the plasma ALT and CRP levels were significantly decreased at each time point after administration, and the expression of TLR4 mRNA in liver tissues was significantly down?regulated, and TLR4 content in liver tissues was significantly decreased in group D ( P<0?05) . The degree of damage to liver tissues was significantly attenuated in group D compared with group OJ, and was aggrava?ted in group D compared with group S. Conclusion Dexmedetomidine can reduce liver injury in the rats with obstructive jaundice.

Anthracosis ; diagnosis ; Diagnostic Errors ; Humans ; Lung Diseases ; diagnosis ; Male ; Middle Aged ; Pulmonary Artery

Objective To discuss the effect of pylorus-preserving gastrectomy for early gastric cancer(EGC). Methods Between August 1995 and December 2005, 52 cases of EGC underwent pyloruspreserving gastrectomy(PPG) and 159 cases of EGC underwent distal gastrectomy(DG), Clinicopathlogic data and follow-up results of the two groups were analyzed retrospectively, and gastric emptying and gallbladder function of 15 cases PPG and 17 cases DG were compared at the same time.Results Compared with DG group, patients in PPG group maintain the body weight, gastric emptying and gallbladder function. There was no significant difference between PPG group (92. 3% ) and DG group (93.1% ) in overall 5-year survival rate ( P = 0. 881 ). The 5-year survival rate of the the PPG group with lymph node dissection was D1 100%, D1+α 92. 3%, D1+β 88.9%, D2 87. 5% respectively.Conclusions For early gastric cancer, the pylorus-preserving gastrectomy is effective for maintaining the postoperative function with similar long term survival as that of distal gastrectomy.

Objective To evaluate the effects on trabeculectomy combined with implantation of anterior lens capsule.Design Radomized,controlled experimental study.Participants 36 experimental albino rabbits.Methods 36 albino rabbits were divided into 3 groups randomly.The rabbit and human anterior lens capsules were implanted under the scleral flap in trabeculectomy in group A and group B respectively,while only trabeculectomy in control group.The average follow-up period was 12 months.Main Outcome Mea- sures Intraocular pressures(IOP),filtering bleb,complications.Results The postoperative IOP of the experimental groups decreased sig- nificantly as compared with preoperative IOP at 12 week postoperatively.Retention of reflective filtering bleb in experimental groups was longer than that in contral group(5.12?0.43week,5.05?0.59week,2.74?0.32week,P＜0.05).The passage of humor outflow kept open in ex- perimental groups and became closed in control group at 12 week postoperatively.Anterior lens capsule wasn't attacked by T or B lym- phocyte seen with electron microscope.Conclusions Implantation of anterior lens capsule may help to postpone filtering bleb scarring in the trabeculectomy.This study provides experimental basis for the clinical practice.

After percutaneous coronary intervention (PCI) was performed,since CHD risk factors still exist, coronary restenosis rate remains high.Therefore, self-management after PCI is very important.The present article made a review on current condition and research progress of self-management in patients after PCI, aiming at providing reliable evidence for rehabilitation after PCI.

Objective To study the relationship between the cerebral artery stenosis and the carotid artery elasticity in the ischemia stroke patients by echo-tracking technique.Methods Ninety-two ischemia stroke patients were divided into both the mild cerebral arteries stenosis and moderate-severe cerebral arteries stenosis groups.CT angiography was performed to evaluate the stenosis of cerebral artery.The changes of the carotid diameter during cardiac cycles were obtained by echo-tracking technique and the quantitative parameters of pressure-strain elastic modulus (Ep),stiffness (β) and arterial compliance (AC) were calculated automatically. Results①There were significant differences (P＜0.05) between the ischemia stroke patient group and the normal adults group in β，Ep and AC.② There were significant differences (P＜0.05) between the mild cerebral arteries stenosis groups and the moderate-severe cerebral arteries stenosis groups in β and Ep.AC was lower in patients with the mild cerebral arteries stenosis groups than that in the moderate-severe cerebral arteries stenosis groups.Conclusions The carotid artery elasticity in ischemia stroke patients were significantly different from normal adults.In the ischemia stroke patients,the stiffer the carotid artery was,the higher the likelihood of moderate-severe cerebral stenosis was.