Objective To compare the difference of peripheral blood leucocyte percentages in malaria patients among Sysmex‐XE5000 ,CellaVisionDM96 and manual microscope classification ,and to verify the accuracy and reliability of the Sysmex‐XE5000 automatic blood corpuscle detection instrument for detecting the leukocyte classification in blood routine .Methods The leucocyte percentages data in 82 cases of malaria detected by using the Sysmex‐XE5000 in the Shenzhen Municipal Third People′s Hospital from January 2011 to December 2015 were retrospectively collected ;the peripheral blood smear in 82 cases of malaria obtained the percentages after the classification by the CellaVisionDM 96 ;then the peripheral blood smear was performed the leucocyte classifica‐tion by the manual microscopy for calculating the percentage .Results In the pairwise comparison of percentage obtained from the peripheral blood leucocyte classification by Sysmex‐XE5000 ,CellaVisionDM96 and manual microscopy ,only the monocytes percent‐age had statistical difference between CellaVisionDM 96 and manual microscopy (P<0 .05) ,the other differences had no statistical significance (P>0 .05) .Conclusion By comparing the peripheral blood leucocyte percentages data in malaria patients by Sysmex‐XE5000 ,CellaVisionDM96 and manual microscopic classification ,it is indicated that the leukocyte classification data by Sysmex‐XE5000 are accurate and reliable ,malaria parasite does not affect peripheral blood leukocyte classification ,but it is necessary to pay more attention to monocytes classification in CellaVision DM 96 classification .

This article introduces the basic situation of the pilot medical devices registrant of Guangdong province, by analyzing the approval pilot enterprise and product information, results and characteristics of inductive work, points out many problems such as Shenzhen enterprises account for a large proportion, lack of benefits, response inactive, etc. analyzes the related reasons, including the existence of the alternative policies, the protection of intellectual property rights, cost factors, tend to increasee industry development foundation, etc., and puts forward suggestions for the perfect job, including speeding up legislation, building a demonstration project, improving regulation ability, etc.
China ; Equipment and Supplies

BACKGROUND: The biomechanical features of the plate internal fixation for the fractures are commonly analyzed utilizing direct contact and low accuracy sensor. However, it has some limitations such as direct contact and low accuracy. The digital speckle method used in the biomechanics of fractures is more accurate to analyze the characteristics of the screw breakage.OBJECTIVE: To measure the displacement of screws under different tensile force conditions after the internal fixation surgery of compression plate for adult thighbone using digital speckle method. METHODS: A total of six femur samples from adults were used to prepare model of midshaft humerus fractures. Each of two ends of fractured samples was fixed with five screws, and the pull test was conducted under the load of 200 and 300 N by electronic versatile machine to measure the displacement of the screws under 10 conditions. RESULTS AND CONCLUSION: The displacement distance of the screw was significantly longer under 300 N loading force compared with 200 N (P < 0.01). Except screws 1 and 10, 2 and 9, 3 and 8, 4 and 7, and 5 and 6, there were significant differences in the displacement between any two screws (P < 0.05). Results showed that the displacement of the screws increased with increasing pulling force, and the displacement near the fracture line significantly changed with pulling force.

Objective To investigate MRI manifestations of lumbar and proximal femoral bone marrow changes before and after recombinant human granulocyte colony stimulating factor (rhG-CSF) was subcutaneous injected for healthy adults.Methods Twenty healthy blood stem cell donors without hematologic disease were enrolled in this study. All of them underwent lumbar sagittal and proximal femur coronal MRI examination with spin echo T1 WI and fat-suppressed T2WI.The first examination were performed before subcutaneous injection of rhG-CSF for comparison. In 4-7 days and 30-60 days after injection, the other two examinations were performed. The signal changes of lumbar and proximal femoral bone marrow were investigated by reading pictures and calculating the contrasted noise ratio (CNR).ResultsBefore rhG-CSF injection, all patients presented normal signal intensity of hone marrow. In 4-7 days after injection, all the 20 cases presented homogeneous signal decrease in lumbar vertebral bodys on T1 WI, accompanied by reduced fatty signal. In proximal femur, patchy or stripped hypointensity areas were found in intertrochanteric and subtrochanteric areas on T1 WI. On fat-suppressed T2 WI images, the signal of lumbar and proximal femoral bone marrow changed to equal or slightly-high signal intensity. In all cases,abnormal signal areas presented in lumbar and proximal femoral bone marrow occurred simultaneously in the same case.In the 10 cases received the third MRI during 30-60 days after rhG-CSF injection, signal intensity of lumbar bone marrow turned to normal in all sequence, but abnormal signal intensity areas were still existed and extended to distal part in femoral bone marrow, which appeared as symmetric stripped or patchy equal or slightly-low signal intensity on T1 WI and equal or slightly-high signal intensity on T2 WI. The CNR of lumbar bone marrow to subcutaneous fat before rhG-CSF injection, in 4-7 days and 30-60 days after rhG-CSF injection were 114. 11 ± 15. 11,71.04 ± 12. 25 and 91.64 ± 1 I. 68, respectively. Significant difference was found between before rhG-CSF injection and 4-7 days after injection ( P ＜ 0. 05 ) , but no significant difference between the others( P ＞ 0. 05 ). Conclusion After injection of rhG-CSF, the short-term changes of hematopoietic cells and fat content in bone marrow can be displayed on MRI, which provided non-invasive information for bone marrow transplantation.

Objective To analyze the specimen types,ward distribution and risk factors for infections caused by extended-spectrum β-lactamase(ESBLs)-producing-Escherichia coli(ECO) in recent two years,so as to provide bacteriological basis for both hospital infection control and clinical anti-infection treatment.Methods Non-repetitive 443 ECO strains isolated from the hospitalized patients in the Third People′s Hospital of Shenzhen were collcted,and the phoenix100 system was employed for bacterial identification and antimicrobial susceptibility tests.ESBLs-ECO was further confirmed by the double-disk synergy test,and the risk factors caused ESBLs-ECO were statistically analyzed.Results A total of 115 strains of ESBLs-ECO were identified among the 443 strains of ECO,which accounted for 26.0%.The ESBLs-ECO strains were mainly isolated from the sputum,urine,and blood specimens.Among the isolated ESBLs-ECO strains,20.9% were isolated from the department of Tuberculosis,13.9% from the department of pediatric,12.2% from the department of live disease,and 8.7% from the department of infection.The male sex,surgery and use of the third generation cephalosporins were independent risk factors of ESBLs-ECO infection.Conclusion The isolation rate of ESBLs-ECO in this hospital is high.It is necessary for the hospital to strengthen the control of nosocomial infections according to the risk factors.More attention should be payed on male patients,the standardization of surgical operation and disinfection,and the restriction of using the third generation cephalosporins,so as to reduce the incidene of ESBLs-ECO infections.

Objective To investigate potential problems and solutions within the data of national surveillance of Keshan disease(KSD), to improve the quality of surveillance data and the reliability of the results. Methods Four key variables (name, sex, age, and KSD diagnosis) in the national surveillance data of KSD in 2009 were cleaned by SPSS 15.0. Cleaning contents included duplicate records, missing values, outliers and logic errors. Name, sex, age, currently residing in townships and currently residing in villages and other variables were combined into different filters to find duplicate records by the command of Identify Duplicate Cases , then the duplicate records were returned to the data reporting agencies, and finally delete or merge. Data with missing values, outliers, or logical errors were found by commands of Frequencies, Descriptives and Select if, then the duplicate records were returned to the data reporting agencies. Data were revised based on not only the feedback , but also by using the relationship between variables, and by consulting KSD clinical experts. Results Four hundred and sixty-four cases of duplicate records were found and cleaned. The number of missing values was 2 047 (specifically, name 0, sex 3, age 32 and KSD diagnosis 2 012). The number of outliers was 1 988 (specifically, name 6, sex 3, age 10 and KSD diagnosis 1 969). The records of 5 kinds of logic errors of KSD diagnosis were 105 in all. Conclusion There are duplicate records, missing values, outliers and logic errors in the national surveillance data of KSD, cleaning work could improve the quality of surveillance data, ensure the authenticity and rliability of the monitoring data.

Peripheral blood CD_5~+B cell was detected by flow cytometry in patients with Graves′ disease (GD) before and after treatment. As compared with normal controls, peripheral blood CD_5~+B cells in a group of 43 patients with GD showed a significant increase in number [(17.0+5.1)% vs (39.5+12.4)%, P

Objective:To investigate the expression level of small nucleolar RNA SNORD15A in bone marrow of patients with acute leukemia (AL) and its relationship with clinical characteristics and prognosis of patients.Methods:Bone marrow blood samples of 53 newly treated AL patients and 29 healthy subjects without clinical diagnosis of hematologic diseases or other malignant diseases (control group) at the Affiliated Hospital of Guangdong Medical University from March 2018 to December 2021 were collected. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to detect the relative expression of SNORD15A in bone marrow blood mononuclear cells of the two groups. The median relative expression of SNORD15A (0.148) was used as the boundary, and AL patients were divided into low expression group (<0.148) and high expression group (≥0.148). The relationship between the expression level of SNORD15A and the clinical characteristics, clinical indicators and overall survival (OS) of AL patients was analyzed. Kaplan-Meier method was used for survival analysis and log-rank test was performed; Cox proportional hazards model was used for univariate and multivariate analyses of OS of patients.Results:The relative expression of SNORD15A was 0.148 (0.012-1.376) in newly treated AL patients and 0.921 (0.513-2.288) in the control group, and the difference was statistically significant ( Z = -6.85, P < 0.01). The differences in SNORD15A relative expression between patients with different prognostic stratification, efficacy and with or without fever and bleeding were statistically significant (all P < 0.05). The differences in platelet count, plateletcrit and albumin levels between SNORD15A low expression group and high expression group were statistically significant (all P < 0.05), and the differences in molecular biology and cytogenetic characteristics were not statistically significant (all P > 0.05). The patients in SNORD15A high expression group had better OS than the low expression group ( P < 0.05). The results of univariate Cox regression analysis showed that SNORD15A was an influencing factor for patients' OS ( HR = 0.063, 95% CI 0.005-0.766, P < 0.05); the results of multivariate Cox regression analysis showed that fatigue ( HR = 4.754, 95% CI 1.014-22.290), fever ( HR = 0.147, 95% CI 0.029-0.746) and hemoglobin ( HR = 0.970, 95% CI 0.944 -0.998) were independent influencing factors for OS (all P < 0.05). Conclusions:SNORD15A is lowly expressed in AL and may be an indicator for disease monitoring and prognostic assessment in AL patients.

Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.