Sampling inspection by attributes is one of the most popular means for quality control of medical devices, and has widespread application in the process of production and supervision. GB/T 2828 series standards list different types of sampling procedures for inspection by attributes. This study introduced GB/T 2828 series standards and how to design and index the sampling schemes under different scenarios. At the same time, it also provided suggestions on how to balance accuracy and economy, which can provide guidance the application of medical devices manufactures and regulatory departments.
Commerce ; Quality Control ; Reference Standards

Objective:To assess the value of 18F-FDG PET/CT imaging and relevant factors in the interim therapeutic and prognostic evaluation of primary gastrointestinal lymphoma (PGIL) patients. Methods:From January 2008 to January 2018, 41 patients with B-cell PGIL (24 males, 17 females; age: 26-84 years) confirmed by pathology in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine were retrospectively included. 18F-FDG PET/CT was performed before chemotherapy and radiotherapy and after 3-4 courses of chemotherapy. There were 17 cases of mucosa-associated lymphoid tissue (MALT) lymphoma and 24 cases of diffuse large B-cell lymphoma (DLBCL). Mann-Whitney U test was used to compare the differences of metabolic parameters (SUV max, metabolic tumor volume (MTV), total lesion glycolysis (TLG)) before treatment between MALT lymphoma and DLBCL patients. ROC curve analysis was used to analyze the predictive abilities of different parameters for progression-free survival (PFS), and Cox regression analysis was used to analyze the influencing factors for PFS. Results:The median follow-up time of 41 patients was 25 (6-84) months, with the 3-year PFS rate of 55.9% and the overall survival (OS) rate of 80.2%. The baseline SUV max (23.2±11.9), MTV (260.7(66.2, 740.7) cm 3) and TLG (1 902.9(592.2, 8 418.1) g) in DLBCL were significantly higher than those in MALT lymphoma (7.9(6.2, 9.8), 45.9(28.4, 104.2) cm 3, 121.1(72.8, 295.6) g; z values: -4.02, -3.10, -3.92, all P<0.05). ΔSUV max in DLBCL patients (AUC=0.80, P=0.012), ΔSUV max% (AUC=0.89, P=0.007; AUC=0.80, P=0.012), ΔMTV%(AUC=0.91, P=0.005; AUC=0.77, P=0.026) and ΔTLG% (AUC=0.87, P=0.011; AUC=0.77, P=0.026) in MALT lymphoma and DLBCL patients before and after treatment were predictive factors of PFS. Multivariate analysis showed that ΔSUV max% was an independent factor for PFS of MALT lymphoma (hazard ratio ( HR)=17.192, 95% CI: 2.035-145.245, P=0.009), while ΔMTV% and ΔTLG% were factors for PFS of DLBCL (both HR=7.556, 95% CI: 1.968-29.016, P=0.003). Conclusions:There are significant differences in metabolic parameters between MALT lymphoma and DLBCL before treatment. Interim PET/CT is effective for the prediction of prognosis of MALT lymphoma and DLBCL.

Objective:To explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.Methods:A total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.Results:Within the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients ( r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L. Conclusion:The performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.

Objective: To understand current situation and associated factors of brucellosis infection among students in Mongolian middle school in Abaga Banner, and to provide basis for further development of prevention and treatment strategies. Methods: Serological examinations were performed on pupils and middle school students in a Mongolian middle school in Abaga Banner. Questionnaire surveys were used to investigate students knowledge of eating behaviors related to brucellosis infection. Results: A total of 500 primary and middle school students were investigated, and 6 cases of brucellosis were confirmed, and the infection rate was 1.20%. There were 4 cases of male infection and 2 cases of female infection. The infection rate in boys (1.61%) was higher than that of girls (0.79%). Higher proportion was found in 14-year-old group (n=3), accounting for 17.40%. The residence period of 10-15 years includes 6 cases of all infected persons. The number of infections in Narenbaolige Town was 4, accounting for 23.40%. Univariate logistic regression analysis shows that frequent consumption of unsterilized dairy products, milking, processing lambs or slugs and infected cloth The disease was positively correlated (OR=11.80, 139.14, 8.02, P<0.05). Multivariate Logistic regression analysis showed that milking was positively correlated with brucellosis infection(OR=20.19, 95%CI=2.01-202.74, P=0.01). Conclusion The brucellosis infection of Mongolian primary and middle school students in Abaga Banner is related to a variety of related dietary factors, and its prevention and treatment should be strengthened.

Objective:To evaluate the therapeutic effect and safety of microwave ablation plus curettage.Methods:Clinical data of a single group of 12 patients admitted to our hospital from June 2015 to June 2019 who underwent microwave ablation for bone metastasis were retrospectively analyzed. There were 7 males and 5 females, with an average age of 59.5±10.1 (range from 43 to 79) years old. Curettage plus bone cement after microwave ablation was performedand when the lesion involved the sacroiliac joint surface and impaired the bearing arch, the internal fixation was performed with plate and screws. 8 among the 12 patients underwent curettage, bone cement and metal internal fixation after microwave ablation. After microwave ablation, and 4 patients underwent curettage and reconstruction with bone cement alone. The patients were followed up aftersurgery. The observational indicators included: patient survival rate, local recurrence rate, perioperative complications, Operation time, intraoperative blood loss, VAS score, SF-36 score, and MSTS function score. VAS scores and SF-36 scores were recorded before surgery, 1 week after surgery and 3 months after surgery.Results:12 patients were followed up for 4-27 months, with an average follow-up time of 14.2 months and a median follow-up time of 9 months. During the follow-up, 7 patients died and 5 survived, with a 6-month survival rate of 81.8%, a 1-year survival rate of 40.9% and a 2-year survival rate of 27.3%. The mean survival time of the dying patients was 8.8 months (5-18 months), and the median survival time was 7 months. Operation time was 101±21 min and intraoperative blood loss was 295±108 ml. During the follow-up period, local recurrence rate was 8.3% (1/12), and the average postoperative time to recurrence was 4 months. There were no complications such as wound nonunion, wound infection, deep infection, vascular nerve heat injury and internal fixation failure. VAS score before surgery was 7.5 (7, 8) points, VAS score 1 week after surgery was 5 (4, 5) points, and VAS score 3 months after surgery was 5 (4, 5.75) points ( P<0.05). Preoperative SF-36 score was 23 (21, 24.75) points, 1 week after surgery SF-36 score was 47 (46, 54) points, and 3 months after surgery SF-36 score was 50.5 (47, 55.25) points ( P<0.05). 3 months after the operation, the MSTS score was 20.5 (16.25, 21.75) points, of which excellent 16.7% (2/12), good 50% (6/12), medium 16.7% (2/12), poor 16.7% (2/12), and the overall excellent and good rate was 66.7% (8/12). Conclusion:Microwave ablation plus curettage for pelvic metastasis of malignant tumor can significantly relieve local pain, rebuild limb function and improve patients' quality of life, and it`s an alternative treatment for pelvic metastases.

Objective To assess the value of 18F-fluorodeoxyglucose (FDG) PET/CT in the staging,interim therapeutic and prognostic evaluation of mucosa-associated lymphoid tissue (MALT) lymphoma.Methods Thirty-six MALT lymphoma patients (20 males,16 females;average age:61.7 years) confirmed by pathology from January 2008 to January 2018 were retrospectively analyzed.18F-FDG PET/CT were performed before chemotherapy and radiotherapy for staging.The detective sensitivity was evaluated.The staging results of gastric MALT lymphoma and extragastric MALT lymphoma by PET/CT were compared with Fisher exact probability method.PET/CT was performed in 17 of 36 patients after 4 courses of chemotherapy,and 17 patients were divided into positive group (≥≥4) and negative group (＜4) according to scores of Deauville 5-point scale.The progression-free survival (PFS) was evaluated using Kaplan-Meier survival analysis.Results FDG-positive lesions were found in 31 of 36 patients with the sensitivity of 86.1％ (31/36).The results of PET/CT were negative in stage Ⅰ patients.In stage]Ⅱ-Ⅳ patients,the results of 18F-FDG PET/CT combined with bone marrow biopsy were in accordance with the results of clinical staging.The accuracy of PET/CT in staging of gastric MALT lymphoma patients was 9/17,which was significantly lower than that of extragastric MALT lymphoma patients (17/19;P=0.025).The PFS of negative group evaluated by interim PET/CT was longer than that of positive group (x2 =4.16,P＜0.05).The 2-year PFS rates of the 2 groups were (85.7± 13.2)％ and (27.8 ±21.3)％,respectively.The PFS of patients with low expression of Ki-67 was significantly longer than that of patients with high Ki-67 expression (x2=4.22,P＜0.05).Conclusions In stage]Ⅱ-Ⅳ MALT patients,18F-FDG PET/CT combined with bone marrow biopsy can improve the staging accuracy.The staging accuracy of PET/CT in extragastric MALT lymphoma is significantly higher than that of gastric MALT lymphoma.PET/CT and Ki-67 can provide effective information on the prognostic evaluation for patients with MALT lymphoma.

Objective To investigate the clinical effect and prevention of different artificial tears in dry eye after cataract phacoemulsification combined with intraocular lens implantation. Methods Totally 57 patients (57 eyes) with dry eye after phacoemulsification combined with intraocular lens implantation who were diagnosed with cataract in the Department of Ophthalmology in our hospital from October 2016 to October 2017 were randomly divided into 3 groups including sodium hyaluronate group, polyethylene glycol group and control group. All patients underwent phacoemulsi-fication combined with intraocular lens implantation. The control group was given conventional treatment after surgery. The other two groups were given sodium hyaluronate eye drops and polyethylene glycol eye drops on the basis of conventional treatment respectively. The dry eye symptom score, tear film rupture time, Schirmer I test, corneal fluorescein staining score before surgery, at 1 week, 1 month and 3 months after surgery were observed. The therapeutic effect was evaluated. Results In the three groups, the dry eye symptom score and corneal fluorescein staining score after surgery was lower than that before surgery, and the tear film rupture time and Schirmer I test after surgery increased compared with that before surgery. There was significant difference in the recovery of dry eye between the two groups and the control group, of which the sodium hyaluronate group recovered most significantly. Conclusion Cataract pha-coemulsification has an effect on the stability of tear film, which leads to postoperative dry eye. Artificial tear can be used for prevention and treatment. Sodium hyaluronate eye drops are more effective and worthy of clinical application.

Objective To study the plasma metabolomics features of SD rats with wei-qi deficiency respectively in spring, summer, autumn and winter; To seek the potential markers related to wei-qi deficiency; To discuss the essence of wei-qi deficiency.MethodsTwenty male SD rats were adaptively fed 7 days before Chinese Vernal Equinox Day, Summer Solstice, Autumn Equinox and Winter Solstice, synchronous controled with temporal condition. The rats were randomly divided into experimental and control groups according to random number method. Rats in the experimental groupwere made into wei-qi deficiency models through fatigue stimulation alternately with cold and heat stimulation. Blood was collected at 12:00 each solar term. High performance liquid chromatography- mass spectrometry instrument was used to detect plasma metabolites. Partial least squates-discriminant analysis was used to process statistical analysis of the data to compared the original data of plasma metabolomics between the two groups of each season, and explore the difference metabolic markers between each two groups, then speculate the potential biomakers of wei-qi differency.ResultsWith the changes of spring, summer, autumn and winter, significant differences were showed in metabolic profile between the experimental and control groups. Homocysteine showed a significant difference in spring, summer and autumn; Ceramide showed a significant difference in summer and winter; Testosterone showed a significant difference in spring and summer; Cyclic guanosine monophosphate showed a significant difference in autumn and winter; Sarcosine showed a significant difference in spring, summer and winter. The physiological functions of these substances related to lipid metabolism, amino acid metabolism, neurotransmitter and hormone regulation.ConclusionPotential biomakers of wei-qi deficiency changed along with the seasonal variation, which mainly reflected in lipid metabolism, amino acid metabolism, neurotransmitter and hormone regulation.

Objective The clinical effect of phacoemulsification and intraocular lens implantation in the treatment of senile cataract.Methods120 cases of senile cataract patients in September 2014 ~2016 year in December in our hospital, were randomly divided into two groups: the observation group after phacoemulsification combined with intraocular lens implantation, the control group was treated with small incision non phacoemulsification extracapsular cataract extraction.In the comparison of two groups.ResultsAfter treatment, the observation group was 0.5~0.9 the proportion of 51.7%, visual acuity>1 the proportion of 6.7% were significantly higher than control group (P<0.05);the complication rate of observation group was 43.3% lower than the control group 61.7%, the difference was statistically significant (P<0.05).ConclusionPhacoemulsification combined with intraocular lens implantation in senile cataract patients can effectively improve patients' visual acuity, control the occurrence of complications, and the prognosis is good.