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 explore the diagnosis and treatment of phyllodes tumor of the breast. Methods Clinical data from 30 patients with phyllodes tumor confirmed surgically and pathologically were analyzed retrospectively. Results Of the 30 cases of phyllodes tumor, there were 16 cases of benign tumor, 9 cases of borderline tumor and 5 cases of malignant tumor according to the standard histological criteria. Local mass excision, total mastectomy, modified radical mastectomy and tumor mass excision were performed in 8, 8 and 13 patients, and 1 patient, respectively. A follow up of 20 cases for 1-24 years found 1 death, but all the others survived. Four patients out of the 20 patients underwent total mastectomy or modified radical mastectomy due to tumor recurrence. Conclusion The preoperative diagnosis of phyllodes tumor is difficult. Intraoperative frozen section examination of the suspicious lesions should be conducted. Multiple slices of the specimen should be performed. Surgical options are closely associated with the prognosis. Wide local excision or total mastectomy is recommended in surgical options.

This study was aimed to explore the clinical efficiency of modified Xiao-Y ao (XY) powder and acupuncture in the treatment of diarrhea-predominant irritable bowel syndrome (D-IBS). A total of 90 D-IBS patients were randomly divided into the treatment group and control group, with 45 patients in each group. Patients in the treatment group received acupuncture combined with modified XY powder. Patients in the control group received oral administration of montmorillonite powder, compound glutamine enteric-coated capsules, compound azintamide enteric coated tablet. Four weeks were one treatment course. After two treatment courses, the pretreatment and posttreatment symptom score, the score of Hamilton Depression Rating Scale (HAMD)/(HAMA), and the overall efficacy were compared. The results showed that compared with pretreatment, clinical symptoms were improved in varying degrees after treatment in both groups (P < 0.05 or P < 0.01). HAMD and HAMA were significantly decreased (P < 0.05). The treatment group had obvious advantages compared to the control group (P < 0.05). The overall efficacy of the treatment group was 91.11%, which was significantly higher than the control group of 68.89%(P < 0.05). It was concluded that modified XY powder and acupuncture can quickly relieve gastrointestinal symptoms, improve anxiety and depression. It is an effective treatment method for D-IBS.

Objective To probe into possibilities and sensitivity of CCD video camera system in the assessment of balance function.Methods The system is composed of a CCD video camera,a video image capture board and analysis software.Three indexes:Trunks,ayAngle (TSS Trunk Sway Speed(TSS) and fall index (FI).the normal group:FI≥I; mild group:0.7≤FI＜I; moderate group:0.4≤FI＜0.7; severe group:FI ＜0.4.Disorder of balance function group:42 patients with cerebrovascular accident,mean age of (67.4±8.0) years.Control group:42 healthy subjects,mean age of (65.3±6.5) years.All cases were measured by Berg balance scale and determinated three times by CCD video camera system with eye opening (eo) and eye closing(ec),and averaged.Results There were very significant differences in TSAeo,TSAec,TSSeo,TSSec,FIeo,FIec between disorder of balance function group and control group (P＜0.01).as well as Berg balance scale (P＜0.05).In disorder of balance function group,the differences among three groups were significant in TSAeo,TSAec,TSSeo,TSSec (P＜0.05).There were significant differences in TSAeo,TSAec,TSSeo,TSSec between severe group and mild group (P＜0.01) as well as in Berg balance scale (P＜0.05).Conclusions CCD video camera system has a higher sensitivity in assessment of body,balance than Berg balance sca land great value in clinical application.

Objective To investigate the relationship between interleukin (IL)-28B gene polymorphisms (rs12979860 and rs8099917) and treatment response in patients with chronic hepatitis C in China.Methods Taqman probes single nucleotide polymorphism genotyping methods were used to detect the genotypes of rs12979860 (C/T) and rs8099917 (T/G) located at IL-28B gene in 105 included patients.The patients were treated with standard doses of pegylated interferon plus ribavirin and were followed up regularly for therapeutic response and adverse reaction.The relationship between IL-28B gene polymorphism and antiviral treatment response of patients were analyzed.Categorical data were analyzed using Pearson chi-square test or Fisher exact test.Results Totally 105 cases were included in our study and 2 cases lost to follow-up because of moving away.Eight-one cases (78.6%) of the remaining 103 patients were CC/TT genotype (CC/TT group) at rs12979860 and rs8099917, 19 cases (18.4%) were CT/TG (CT/TG group) and 3 cases (2.9%)were TT/TG (TT/TG group).No other genotypes were detected and linkage disequilibrium was discovered at the two polymorphism loci (r2=0.11).After 4 weeks of treatment, 35 cases (43.2%) in CC/TT group, 3 cases (15.8%) in CT/TG group and non in TT/TG group achieved rapid virological response (RVR).There were statistically significant differences among three groups (P=0.033).After 12 weeks of treatment, 45 cases (55.6%) in CC/TT group, 6 cases (31.6%) in CT/TG group and none in TT/TG group achieved early virological response (EVR).There were statistically significant differences among three groups (P=0.025).At the end of the treatment, 68 cases (83.9%) in CC/TT group, 10 cases (52.6%) in CT/TG group and only 1 case (33.3%) in TT/TG group achieved end-of-treatment response (ETR).There were significant statistical differences among the three groups (P=0.003).After 24 weeks of follow-up, 62 cases (76.5%) in CC/TT group, 9 cases (47.4%) in CT/TG group and 1 case (33.3%) in TT/TG group achieved sustained virological response (SVR).There were statistically significant differences among the three groups (P=0.014).One hundred and one cases in CC/TT group developed adverse events, among them 19 cases needed clinical treatment.There were 43 cases in CT/TG group developed adverse events and 9 cases needed treatment.Seven cases in TT/TG group developed adverse events and only 1 case needed treatment.There were no statistically significant difference among three groups (χ2=0.139,P>0.05).Conclusions The genotype of rs12979860 (C/T) and rs8099917 (T/G) at IL-28B gene could affect the treatment response in patients with chronic hepatitis C.RVR and SVR are higher in patients with genotype CC/TT, which might help to guide HCV treatment.

Animal models of pulmonary artery hypertension (PAH),aiming to simulate human characteristics of the disease,have contributed extensively to understanding the pathophysiology of PAH and the investigation of experimental treatments.The classical models include monocrotaline models,chronic hypoxia model and so on,more new models were investigated in recent years.These animal models were not able to perfectly mimic human pathological characteristics of PAH because of the defect in different aspects.In this review,both typical and novel methods of PAH modeling were summarized and evaluated to provide a suitable guidance for the settlement of animal models which can meet human characteristics comprehensively.

Objective To investigate the relationship between genetic polymorphisms of ERCC1 and survival rate in advanced non-small cell lung cancer (NSCLC) patients treated with platinum based chemotherapy.Methods A total of 204 patients with advanced NSCLC were routinely treated by platinbased chemotherapy.The polymorphic genotypes were analyzed by MALDI-TOF-MS nethod using DNA samples isolated from peripheral blood before treatment.Besides,5 ％ samples werc extracted randomly for sequencing to test the accuracy of this method.To explored the association between SNP of ERCC1 (118) and prognosis to platinum-based chemotherapy in advanced NSCLC patients.Results Among 204 patients,61 achieved partial response,116 achieved stable response,and 27 achieved progressive disease.The overall response rate was 29.9 ％ (61/204).The effective rates of patients with the ERCC1 (118) C/C genotype,C/T + T/T genotype were 24.0 ％ (29/121) and 38.6 ％ (32/83),respectively,with significant difference (P ＜ 0.05).The response rate of ERCC1 (118) C/T allele carriers was 1.992-fold than that of C/C allele carriers (95 ％ confidence interval:1.083-3.650,P =0.025).MST,1-year survival and 2-year survival rates of patients with the ERCC1 (118) C/C genotype,C/T + T/T genotype were 9.0 months,34.7 ％ (42/121) and 4.1％ (5/121) vs 12.0 months,60.2 ％ (50/83) and 12.0 ％ (10/83),respectively,with significant difference (P ＜ 0.05).Conclusions Polymorphisms of ERCC1 might be associated with overall survival period in patients with advanced NSCLC after treatment with platin-based chemotherapy,which might be the predictive markers for overall survival.

Objective To investigate the effect of microcolumn gel reagent card,micro-column glass bead reagent card and classical test tube on the antibody titer of O-type pregnant women with ABO blood group.Determination of antibody potency of pregnant women with rabbit by reagent card.Methods Using microcolumn gel reagent card,micro-column glass beads reagent card,and classical test tube parallel detection to detect the IgG blood group antibody titer of O blood type pregnant women.Results There was no significant difference in the positive detection rate between the microcolumn gel reagent card and the microcolumn glass beads reagent card at 1:128 and the test tube method at 1:64 (P＞0.05).Conclusion The clinical reference value of microcolumn gel reagent card and microcolumn glass beads reagent kit for detecting antibody titer of IgG blood group in O-type pregnant women should be set to ≥ 1:128.

Objective To explore prevention and cure effects of the freeze-dried human fibrin glue as the way of the lacrimal duct embolization on xerophthalmia in perimenopausal female rabbit.Methods A total of 72 female rabbits,after anti infection treatment and were cut off third eyelid,were made into perimenopausal xerophthalmia rabbit models.After surgery,all of these rabbits were randomly divided into 6 groups (12 rabbits per group):No treatment group after surgery (group A),PBS prevention group (group B),freeze-dried human fibrin prevention group (group C);no treatment group after modeling (modeling time:Two weeks after surgery,group D),PBS treatment group (group E),freeze-dried human fibrin treatmentgroup (group F).The Schirmer test (SIT),corneal fluorescein (FL) and corneal confocal microscope were performed before and 2 weeks,4 weeks,6 weeks after injection.Results There were statistical differences in FL score and SIT in group A,group B and group C among different time points (F =27.346,10.608;P =0.000,0.001);There were statistical differences between FL scores and SIT among three groups (F =7.579,6.786;P =0.002,0.007);There was significant difference in FL scores and SIT trends among three groups(F =44.897,3.424;P =0.000,0.045).The FL score and SIT of group D,group E and group F were significantly improved after treatment for 2 weeks,4 weeks and 6 weeks,the differences were statistically significant (t =2.906,3.654,4.504;P =0.022,0.017,0.013.t =4.573,5.759,7.231;P =0.032,0.019,0.008);The difference between FL score and SIT in group E and group F was statistically significant after treatment (t =2.776,4.124,5.324;P =0.032,0.026,0.017.t =1.969,3.122,4.324;P =0.038,0.023,0.009).After injection of 6 weeks,the epithelial basal cells (F =17.306,P =0.002) and inflammatory cells (F =34.024,P =0.000) of group A,B and C were significant changed,the differences were statistically significant.After injection of 6 weeks,the epithelial basal cells (F =3.749,P =0.042)and inflarnmatory cells(F=8.806,P =0.005) of group D,E and F were significant changed,the differences were also statistically significant.Conclusion Lacrimal duct embolization with freeze-dried human fibrin glue is effective for the xerophthalmia.

Objective To detect anti-M_2 autoantibody using recombinant BCOADC-E_2.Methods We purified recombinant BCOADC-E_2 by Ni~(2+)affinity chromatography column and then detect anti-M_2 autoan- tibody in the sera of patients with primary biliary cirrhosis(PBC)by Western blot test(WBT)and enzyme linked immunosorbent assays(ELISA).Results Among 60 sera from PBC patients,33 were positive,all of controls were negative.Conclusion The recombinant BCOADC-E_2 can be used to detect anti-M_2 autoanti- body specifically and sensitively.It is helpful for the diagnosis of PBC.