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.

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.

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

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

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.

Objective To establish the standard of quality control for Pericarpium Citri Reticulatae Viride (PCRV) and to identify two kinds of PCRV which are collected in different times. Methods In this article,volatile components and flavonoid in 10 batches of samples which were collected from eight provinces were determined by GC and HPLC-DAD,respectively. Their fingerprints were handled by weighted similarity of range and by principal component analysis (PCA). Results According to the result of similarity and classification,there were obvious differences between the two kinds of PCRV.To know whether the differences have great influences on the pharmacological actions of PCRV, pharmacological studies will be needed. Weighted similarity is suitable for this system which has a high content of similar components. Conclusion These methods are effective and will help us to establish the criterion of quality control for PCRV.

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 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.

OBJECTIVE: To observe the effects of Ginkgolides inhalation on eosinophils infiltration in airway of asthmatic guinea pig model. METHODS: Guinea pigs were divided into seven groups(n=8 in each group): model group, ginkgolides inhalation low, medium and high dosage groups(5, 10, 20mg?kg-1, respectively), ginkgolides ip group (at a dosage of 20 mg?kg-1), Dexamethasone ip group (at a dosage of 10 mg?kg-1), normal control group. The eosinophils (EOS) in bronchoalveolar lavage fluid (BALF) and trachea were counted. RESULTS: As compared with normal control group, the number of EOS in BALF was significantly increased in model group, but that in BALF and trachea of the Ginkgolides inhalation group was significantly reduced(P