BACKGROUND:The Specification of Quality Management for Medical Device Production (for Trial Implementation) issued by the China Food and Drug Administration (CFDA) on December 16, 2009 was demanded to be initially implemented in medical device manufacturers with a higher risk in sterility and implant before January 1, 2011. The revised version was published on December 29, 2014 and came into effect on March 1, 2015. OBJECTIVE:To put forward specific suggestions through analyzing the status of 31 sterile implantable medical device manufacturers in Sichuan Province and the corresponding implementation situation of the specification for trial implementation. METHODS:The relevant data of these 31 manufacturers were collected through the quality management system assessment, supervision and inspection, flight inspection and questionnaire survey. And the data were analyzed statistically. RESULTS AND CONCLUSION:The overall size of medical device manufacturers in Sichuan Province is small. There are still some other problems, such as no advanced equipment, low quality of employees, lack of funds and inappropriate management, in these manufacturers. Considering these, we have given some guiding recommendations from the aspects of production and supervision.

Objective To investigate the effect of combined Metformin and esomeprazole therapy on plasma levels of gastrin,blood glucose,glycosylated hemoglobin(HbA1c) and insulin in elderly patients with type 2 diabetes.Methods A randomized,double-blind,placebo-controlled study of 41 elderly patients with type 2 diabetes was conducted.Patients were randomly assigned into treatment group(combination therapy with Metformin 0.5 g,bid or tid and Esomeprazole 20 mg,qd,for 12 weeks)and placebo group(Metformin monotherapy 0.5 g,bid or tid,for 12 weeks).Fasting blood samples were taken from vein before and after treatment.Fasting serum levels of gastrin,glucose,HbA1c,insulin,lipids,liver and renal functions were compared between the two groups.The homeostasis model of assessment for insulin resistance index(HOMA-IR) and insulin secretion index (HOMA-β)were calculated,and complications were recorded.Results There were no significant differences in body mass index and waist circumference between the two groups.Serum gastrin level was slightly increased in the treatment group 12 weeks after treatment,but without statistically significance [(127.20±9.21)ng/L vs.(131.53±7.84)ng/L,P＞0.05],and serum gastrin level had no significant differences in the placebo group before and after treatment [(128.42±4.58)ng/L vs.(127.51±3.47)ng/L,P＞0.05].However,there were no significant differences in the changes of blood glucose,HbA1c,insulin,HOMA-β and HOMA-IR before versus after therapy,and between the two group(all P＞0.05).Conclusions Combined Metformin and insulin therapy cannot increase serum gastrin and insulin levels and has no significant effect on reducing blood glucose and HbA1c levels in elderly patients with type 2 diabetes.

Objective To investigate the similarities and differences of endoscopic and pathological char- acteristics between long and short segment Barrett's esophagus.Methods One hundred and twenty-eight cases of Barrett's esophagus identified both by endoscopy and pathology were enrolled in this retrospective study. Among them,40 cases were long segment Barrett's esophagus (LSBE) and 88 were short segment Barrett's esophagus (SSBE).The age distribution,sex distinction,endoscopic manifestations and pathological changes were assessed.Data were statistically analyzed by t-test or u-test.Results There were no differences in age distribution and sex distinction between LSBE and SSBE groups (P＞0.05).The ring pattern was the most prominent type accounting for 62.5% in LSBE group.The island pattern was the most prominent type accounting for 85.2% in SSBE group.There were significant differences in the rates of specialized intestinal metaplasia between LSBE and SSBE groups(47.5% vs 14.8%,P＜0.01).Moreover,among the special- ized intestinal metaplasia,low grade (15.0% vs 4.5%),medium grade (12.5% vs 3.4%) and high grade dysplasia (5.0% vs 0.0%) between LSBE and SSBE groups also had statistical differences (all P＜0.05).Conclusions LSBE may have more tendency in dysplasia than that of SSBE.We should pay attention to the importance of endoscopic manifestations and pathological diagnosis.

Background Posterior capsular opacification(PCO) is common complication after extrecapsular extract of cataract.Matrix metalloproteinases-3 (MMP-3) can degrade all the extracellular matrix except polyose.The gene therapy of PCO upon MMP-3 is the researching hot topic.Fibronectin ( FN ) is a degrade gelatin,so its expression can reflect the effect of MMP-3 on LECs indirectly. Objective The aim of this study was to construct MMP-3 eukaryotic recombination plasmid and transfect to lens epithelium cells(LECs) for the observation of MMP3 expression,and to explore the feasibility of gene therapy for after cataract. Methods Six fresh lenses were obtained from pigs.LECs were cultured using explant method.The eukaryotic expression vector pEGFP-N1-MMP-3 was reconstructed with MMP-3 and pEGFP-N1 plasmids.The accuracy of MMP-3 gene fragment was confirmed by double enzyme digestion and DNA sequencing analysis.After transfecting pEGFP-N1-MMP-3 into LECs of pig,the expression of MMP-3 protein in the cells was indirectly observed by green fluorescent protein.The expression of FN in LECs was detected using Western blot. Results The result of double enzyme digestion was consistent with the base number of pEGFP-N1 plasmids and target fragment.By enlacing the result of DNA sequencing analysis with software,the resemblance of the DNA sequence of MMP-3 from recombination plasmid pEGFP-N1-MMP-3 and that of homo MMP-3 was 99.6％,indicating that the target fragment was inserted to pEGFP-N1 plasmids successfully.Green fluorescence for GFP was seen in the LECs in pEGFP-N1-MMP-3 transfected group,but absent response for GFP was in empty vector group.Western blot revealed that the relative expression level of FN in LECs was 0.666±0.008 in pEGFP-N1-MMP-3 trasfected group and 0.326 ±0.071 in empty vector group,with a significant difference between these two groups(P=0.000). Conclusions Eukaryotic recombination plasmid pEGFP-N1-MMP-3 is successfully constructed,and MMP-3 can be expressed in LECs after transfected.These results lay a foundation for the further research of MMP-3 gene therapy for PCO.

Rhizome atractylodes macrocephalae is the dry roots of Atractylodes macrocephala Koidz. It is one of commonly used Chinese medicine. In the ″Shennong's Herbal″, it was listed as the top grade. It mainly contains volatile oil, atractylenolides, atractylodes polysaccharides, glycosides and amino acids.And it has the medical functions of good for spleen and intestine, diuretic and dehumidifi?cation, hidroschesis, miscarriage prevention and soon.In order to provide references for further devel?opment and utilization, this paper systematic arranged the Chinese medicine atractylodes chemical composition, pharmacological effects, processing technology and effect of processing technology on chemical composition and pharmacological action.

OBJECTIVETo investigate the early clinical efficacy of induced membrane technique for reconstruction of large bone defects after debridement in adults with chronic osteomyelitis of limbs.

METHODSFrom March 2010 to March 2012,a total of 23 adult patients with chronic osteomyelitis of limbs were treated in our department. There were 15 males and 8 females, with a mean age 35.2 years old (ranged from 26 to 49 years old). Sixteen patients had open fracture history. According to the lesion site, there were 12 cases of tibia, 7 cases of femur, 3 cases of humerus, and 1 case of both radius and ulna. Among them, 19 patients had diseases in diaphysis and 4 patients in the metaphysis. The mean interval from infection to operation was 6.9 months (ranged from 4 to 13 months). All the patients were treated by using induced membrane technique. The follow-up evaluation included clinical complications, time of bone healing and limbs function. The Chinese version of SF-36 scores was used in the assessment of quality of life pre- and post-operation.

RESULTSThe average duration of follow-up was (27.6 ± 5.3) months (ranged from 18 to 43 months). Two patients had postoperative flap edge necrosis, 1 patient had superficial iliac incision infection, no obvious complications were recorded. Twenty patients obtained radiological union at a mean time of 4.6 months (ranged from 3 to 7 months). Among them, 16 patients treated with lower limbs surgery achieved full weight-bearing at about 5.2 months (ranged from 4 to 8 months) postoperatively. Four patients suffered from reinfection during follow-up, but 3 of them achieved complete bone healing after the second surgeries with induced membrane technique. At the final follow-up, there was a substantial improvement in each dimension scores and total scores of SF-36 as compared with those before surgery.

CONCLUSIONWhen treating with adult chronic osteomyelitis of limbs, the induced membrane technique can effectively reconstruct large bone defects after debridement, significantly shorten treatment cycle, provide satisfactory results with minimal complications, promote good recovery of limbs function and require relatively simple operation technique.

Adult ; Chronic Disease ; Extremities ; surgery ; Female ; Humans ; Male ; Middle Aged ; Osteomyelitis ; surgery ; Reconstructive Surgical Procedures ; methods

Objective To analyze the safety and efficacy of ultrasound-guided microwave ablation (MWA) for patients with primary hepatocellular carcinoma (HCC) at dangerous locations.Methods Data of 375 patients with HCC underwent MWA were retrospectively analyzed.According to the location of tumors,the patients were classified into dangerous group (distance from vital tissues to lesions ≤5 mm) and non-dangerous group (distance from vital tissues to lesions ＞5 mm).The efficacy of MWA and the incidence of serious complications of the two groups were compared.Results There were 196 patients with 258 lesions in dangerous group and 179 patients with 233 lesions in non-dangerous group.No statistical differences of the completed ablation rate was found between dangerous group (97.67％ [252/258]) and non-dangerous group (97.85％ [228/233],P=0.61).The 1-,3-,5-year local tumor progression (LTP) rates were 9.57％,19.72％,24.18％ in dangerous group and 7.34％,13.44％,14.61％ in non-dangerous group.The 1-,3-,5-year progression free survival (PFS) rates were 68.88％,36.22％,25.37％ in dangerous group and 73.74％,43.17％,19.12％ in non-dangerous group.The 1-,3-,5-year overall survival (OS) rates in dangerous group and non-dangerous group were 90.87％,69.50％,60.05％ and 94.97％,74.24％,64.91％,respectively.No statistically significant differences of the 1-,3-,5-year LTP,OS and PFS rates were found between the two groups (P=0.11,0.19,0.17).The serious complications rates were 3.06 ％ (9/196) and 1.11 ％ (2/179) in dangerous group and non-dangerous group,respectively,which had no statistically significant difference between the two groups (P =0.35).Conclusion Ultrasound-guided percutaneous MWA is safe and effective for patients with HCC at dangerous locations.The adjuvant methods can help MWA to gain the similar local and long-term outcomes for patients with HCC at dangerous locations to those at non-dangerous locations.

Objective To investigate clinical efficacy and safety of endoscopic multiband mucosec-tomy(EMBM)for esophageal submucosal tumors(SMTs).Methods Data of 51 patients with SMTs diag-nosed between Jan 2012 and Aug 2014 were retrospectively studied.Of the 51 patients,33 patients(34 le-sions)received EMBMand 18 patients received endoscopic submucosal resection(ESMR).The operation success rates,complete resection rates,procedure time,complications and the follow-up of group EMBMand group ESMR were compared.Results All of 51 cases had successful endoscopic treatment with no perfora-tion,infection or obvious bleeding.Follow-up showed no recurrence after operation.Compared with group ESMR,group EMBM had higher complete resection rate [97.1% (33 /34)VS 61.1% (11 /18 ),P =0.010],shorter operation time[(6.3 ±1.8)min VS (21.4 ±3.8)min,P =0.001]and lower complication rate[6.1%(2 /33)VS 27.8%(5 /18),P =0.024].Conclusion EMBM is simple,safe and effective for treating SMTs originating from muscularis mucosa or submucosa which are less than 2.0 cm in diameter.

Objective To investigate the risk factors of biliary tract complications in patients with liver cancer after thermal ablation and the prevention methods.Methods One thousand seven hundred and ninety-seven patients with liver cancer underwent percutaneous thermal ablation were enrolled in this retrospective study.According to the relative position of the tumor and biliary tract,patients were classified into 4 groups:with the tumor close to the first branch (group Ⅰ),the second branch (group Ⅱ),the third branch of bile duct (group Ⅲ) and far away from the biliary tract (group Ⅳ).The tumor response and complications,especially biliary tract complications after ablation therapy of subgroups were analyzed.Results A total of 2 356 sessions were performed in 1 797 patients with 3 200 lesions.The local progression rates of the tumors close to and far away from biliary were 10.0 ％ and 8.2 ％ (P =0.080) and the rate of complete ablation were 96.5 ％ and 97.2 ％ (P =0.298),respectively.Fourteen patients suffered from major biliary complications after thermal ablation.Biliary complication incidences of the patients with the tumor close to the first,the second biliary tract were 6.5 ％ and 2.9 ％ respectively,which were all higher than those of the patients with the tumor close to the third(0.3％) and far away from biliary duct(0.2％).Conclusions Percutaneous thermal ablation is an efficient and safe method in the treatment of tumors close to biliary tract and with a low incidence of major biliary complications.Patients with a tumor close to the large branch of biliary duct were at high risk of complications.Those tumors,therefore,should be ablated with assisting methods and extra care.

OBJECTIVE To explore the effect and mechanisms of LW-AFC,a new formula derived from Liu Wei Di Huang Tang,on irradiation-induced reduction of mice adult hippocampal neurogenesis. METHODS C57BL/6J mice were randomly divided into seven groups (n=10): control group, LW-AFC group (1.6 g·kg-1), Liu Wei Di Huang Tang (LW) group (10 g·kg-1), brain derived neurotrophic factor (BDNF) group, irradiation group, irradiation+LW group, and irradiation+LW-AFC group. Reduction of mice adult hippocampal neurogenesis was induced by cranial irradiation.LW-AFC was administered by oral gavage for 30 d after cranial irradiation treatment. Immunofluorescence and Nissl′s staining were performed for histological morphology assessment. Bromodeoxyuridine (BrdU) staining was used in the detection of proliferation cells. The peripheral blood and hippocampal homogenate were collected to measure the content of tumor necrosis factor-α (TNF-α), interferon-gamma (INF-γ), interleukin-1β (IL-1β),IL-4 and IL-10.The hippocampal homogenate was used for Western blot to detect the BDNF-TrkB signal pathway, including extracellular regulated protein kinases1/2 (ERK1/2) and BDNF target protein. Morris water maze and new object recognition test were performed to examine the cognitive function of mice.The mice forced swimming and tail suspension test were used to assess alteration in depressive behavior. Long term potentiation was used to examine the synaptic plasticity change of mice. RESULTS Adult hippocampal neurogenesis was significantly reduced after irradiation of 20 Gray dose (10 Gray per day, total 2 d). LW-AFC treatment increased the BrdU number of irradiated mice (P<0.05). In Morris water maze test, LW-AFC group showed decreased escape latency in the learning period (P<0.05), while increased the number of crossing the platform in the memory period. LW-AFC can also reduce the immobility time of mice in the tail suspension test (P<0.01). CONCLU-SION LW-AFC modulates adult neurogenesis to ameliorate cognitive impairment and reduce depres-sive behavior in radiation injury mice.