【Objective】 To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. 【Methods】 A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. 【Results】 The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the first infusion, the level of factor Ⅷ activity in the subjects increased significantly, and the FⅧ activity increased by 100% or more in more than 79% of the subjects. The average infusion efficiency of FⅧ activity in all subjects was more than 100%. In 70% of the subjects, the pain was relieved rapidly and /or the bleeding symptoms were significantly improved 8 hours after each bleeding infusion, and the improvement rate of bleeding symptoms and signs reached 100% 72 hours after infusion. 【Conclusion】 After infusion of human coagulation factor Ⅷ, the activity level of factor Ⅷ in patients with hemophilia A significantly increased. The infusion efficiency can reach a optimal level, and the bleeding symptoms can be significantly improved.

【Objective】 To establish and evaluate a nephelometric assay for the determination of immunoglobulin A (IgA) residues in human intravenous immunoglobulin(IVIG). 【Methods】 BN ProSpec^© automatic protein analyzer and its supporting immunoglobulin A determination kit (nephelometry) produced by German Siemens and the national standard of human IgA were used to establish the nephelometric assay to determine IgA residue in test products and verify the methodology. The test products include IVIG (pH4) prepared by low-temperature ethanol protein separation process and a novel IVIG prepared by chromatography. 【Results】 The average deviation of three calibration curves for IgA residues determination by the nephelometric assay were 1.08%, 0.95% and 1.54%,, and the three deviations of the quality control were 4.00%, -2.30% and -0.20%, respectively, which indicated good calibration and quality control. In the specificity test, the average recovery rates of IgA for reference substance 1 containing 100g/L maltose and reference substance 2 containing 20g/L glycine were 102.7% and 105.8%, respectively. The relative standard deviation (RSD) values of the repeatability tests of the two test products were 3.9% and 1.9%, and the RSD values of the intermediate precision test were 3.6% and 2.3%, respectively.The difference values at each time point in the durability test of test products′ storage time were all less than 10%, and the RSD values of the two test products in the durability test of kits of different batches were 2.8% and 2.2%, respectively. In the accuracy test, the average recovery rates of IVIG (pH4) added to the standard were 94.2%, 101.7% and 96.2%, respectively, and the average recovery rates of the novel IVIG added to the standard were 102.8%, 106.3% and 99.7%, respectively. The average recovery rate of the limit quantification test was 101.0%, and the RSD was 4.0%. 【Conclusion】 Nephelometric assay has the advantages of strong specificity, high precision and accuracy, good repeatability, simple and rapid operation, and automation, and can be used for the determination of IgA residue in IVIG (pH4) and novel IVIG products.

Objective To analyze the safety of laparoscopic splenectomy for traumatic splenic rupture.Methods The clinical data of 62 patients with traumatic splenic rupture treated by laparoscopic splenectomy in our hospital from Jan 2013 to Jan 2018 were retrospectively analyzed.Results All 62 patients successfully underwent laparoscopic surgery except for 1 case who was converted to open surgery.One case suffered from postoperative bleeding.There was no infection,serious pancreatic leakage and other major complications.The total amount of intraoperative bleeding was 1 600 ml on average,the average operation time was 135 min,the average splenectomy time was 55 min,and the average hospital stay was 12.5 d.Conclusion Laparoscopic splenectomy is a safe and reliable minimally invasive operation for traumatic splenic rupture.

Objective To understand the development of healthcare-associated infection(HAI)management organ-izations in China in the past 30 years.Methods Development of HAI management organizations in 12 provinces (municipalities,autonomous regions)in China was surveyed.Results A total of 166 hospitals were surveyed,96 (57.83%)were tertiary hospitals.Among 164 hospitals which had a history of development of HAI management department,46(28.05%)before 1995,63(38.14%)in 1995-2005,and 55(33.54%)in 2005-2015 set up HAI management departments.HAI management professionals per 1 000 beds in 165 hospitals decreased from 4.80 in 1995 to 4.09 in 2015,occupational categories in HAI management departments in 1995 -2015 were significantly different (χ2 =26.22,P <0.01).The constituent ratios of education background and profession of HAI manage-ment professionals in each province in 1995-2015 were significantly different(χ2 =242.91,47.10,respectively,all P <0.01).In 1995 and 2005,70.81%,53.30% of professionals were with college degree or below;in 2015,the percentage of professionals with bachelor’s degree,doctoral degree,and master’s degree were 53.79%,2.45%, and 22.86% respectively.Most professionals were nursing staff,but the percentage decreased from 58.38% in 1995 to 45.96% in 2015.Conclusion Although HAI management organizations have developed for 30 years and made some achievements,there still remain some problems,the proportion of professionals needs to be enhanced,and personnel structure should be optimized.

Objective To understand the development situation of healthcare-associated infection (HAI)manage-ment departments in the rational antimicrobial application and management in hospitals in China.Methods A total of 166 hospitals from 12 provinces,municipalities,autonomous regions,and military hospitals were selected for survey,the participation of HAI management departments in the rational clinical antimicrobial application and man-agement in different years was compared.Results Of 166 hospitals,68(40.96%)in 2005,119(71.69%)in 2010, and 160(96.39%)in 2015 participated in the establishment of management organizations for rational antimicrobial application (χ2 =121.143,P <0.001).The percentage of HAI management departments participating in antimicro-bial management increased from 10.24%(n=17)in 2005 to 22.29%(n=37)in 2010,and 31.33%(n=52)in 2015 (χ2 =22.172,P < 0.001 ).The percentages of HAI management departments participating in formulating cata-logues for antimicrobial varieties and classification,stipulating permission for antimicrobial use,joining antimicrobi-al management teams,monitoring bacterial resistance,managing antimicrobial prophylaxis in clean incision,super-vising clinical antimicrobial use,conducting clinical consultation,and evaluating prescription were 10.87% -30.72% in 2005,25.90%-65.06% in 2010,and 36.14%-95.18% in 2015 (all P <0.01).Intensity of antimicro-bial use (defined daily dose/100 bed-days,DDD/ 100 bed-days)decreased from 69.16 in 2005 to 41.40 in 2015, antimicrobial usage rate decreased from 46.98% in 2005 to 36.90% in 2015,among patients receiving therapeutic antimicrobial use,specimens sending for pathogenic detection increased from 20.58% in 2005 to 49.39% in 2015. Conclusion Departments of HAI management in China play important role in management of rational antimicrobial application.

Objective To evaluate the effect of evidence-based bundle intervention strategy on reducing the inci-dence of central line-associated bloodstream infection (CLABSI).Methods Prospective and multicenter study was adopted,patients admitted to 54 intensive care units (ICUs)of 41 hospitals and with central venous catheters (CVCs)between October 1 ,2013 and September 30,2014 were monitored .Baseline data between October 2013 and March 2014 were collected as pre-intervention data;from April to September 2014,the participated hospitals performed intervention strategy,post-intervention data were compared with pre-intervention data.Results The usage rate of CVCs before and after intervention was significantly different (44.18% vs 44.63%,χ2 =5.526,P =0.019).Incidence of CLABSI before and after intervention was not significantly different(RR ,0.82[95%CI ,0.59-1 .13],P =0.10).Constituent ratio of catheter insertion sites between pre-and post-intervention was significantly different (χ2 =76.264,P <0.001),femoral vein catheterization rate as well as proportion of two and above catheter insertion sites after intervention decreased(17.25% VS 13.72%;2.27% VS 1 .44%,respectively);hand hygiene implementation rate and accuracy rate after intervention were both higher than before intervention (79.73% vs 76.14%,P <0.001 ;91 .47% vs 74.26%,P <0.001 ,respectively);constituent ratio of skin disinfectant applica-tion before and after intervention was significantly different(χ2 =3.861 ,P <0.001 ),proportion of chlorhexidine ethanol increased (29.62% VS 50.56%);except daily assessment and record,compliance to other prevention and control measures before and after intervention were all significantly different(all P <0.001);utilization rate of max-imal sterile barrier,qualified rate of dressing of operators,and port disinfection were all significantly enhanced. Conclusion Bundle intervention in intubation and maintenance are implemented effectively,but intervention effect on CLABSI needs further study.

Objective To investigate the status and risk factors of surgical site infection (SSI)in hospitals in Chi-na,so as to provide theoretical basis for the prevention and treatment of SSI.Methods Four types of surgeries (colorectal surgery,abdominal hysterectomy,femoral neck repair surgery,and vascular surgery)in 29 hospitals were monitored prospectively,risk factors for SSI were analyzed.Results A total of 6 309 surgical procedures were investigated,incidence of SSI was 1 .60%.Incidences of SSI in patients receiving colorectal surgery,abdominal hys-terectomy,femoral neck repair surgery,and vascular surgery were 4.47%(74/1 655 ),1 .03%(22/2 139),0.21 %(5/2 372),and 0.00% (0/143 )respectively.The incidences of SSI were different among different regions (χ2 =114.213,P <0.05).The most common SSI was superficial incisional infection,the next was deep incisional infec-tion.The major pathogens causing SSI were Escherichia coli ,Enterococcus spp .,coagulase negative staphylococ-cus ,Staphylococcus aureus ,and Klebsiella pneumoniae .The independent risk factors for SSI were male patients, long duration of surgery,and high NNIS score.Conclusion The risk of SSI is varied with different types of surger-ies.Male,long duration of surgery,and high NNIS score can increase the risk of postoperative SSI.

Objective To explore the incidence of surgical site infection (SSI)and compliance to bundled interven-tion measures,and evaluate the effect of bundled interventions on controlling SSI.Methods From October 2013 to September 2014,three types of surgeries (colorectal surgery,abdominal hysterectomy,and femoral neck repair sur-gery)in 29 hospitals in China were monitored,October 2013 to March 2014 was baseline investigated stage,April 2014 to September 2014 was intervention stage.Results A total of 6 166 episodes of surgeries were monitored,the incidence of SSI was 1 .64%,incidence of SSI following colorectal surgery,abdominal hysterectomy,and femoral neck repair surgery were 4.47%,1 .03%,and 0.21 % respectively.The P 75 time of three types of surgeries were 3,2,and 2 hours respectively.Compared with the baseline stage,the compliance to most intervention measures im-proved after intervention,the largest increase in the compliance to interventions was disinfection with chlorhexidine-containing disinfectant at surgical sites of colorectal surgery (increased by 29.09%),followed by preoperative shower of femoral neck repair surgery (increased by 26.24%),preoperative shower of colorectal surgery(increased by 22.95%),and skin preparation on the day of operation (increased by 20.75%).Incidences of SSI in three types of surgeries were not significantly different before and after intervention(all P >0.05).Conclusion The incidences of SSI are different among different types of surgeries,the compliance to most bundled intervention measures has im-proved to some extent after intervention,but effectiveness of intervention measures needs to be further observed.

Objective To explore the relationship of the radiological characteristics and clinical symptoms of ossification of the posteriorlongitudinal ligament (OPLL) of cervical spine. Methods 200 OPLL patients were recruited into this study. The data of JOA scores of theOPLL patients were collected. The stenotic rate of the cervical spine canal was calculated by the sagittal plane CT. The sorts and ossificatedcervicle were also identified by the images. Results The stenotic rate of the cervical spine canal was 19.8% to 60.3% with average 42.9%,the JOA scores was 4 to 15, averaged 10. Linear regression showed the stenotic rate of the cervical spine canal was negatively correlatedwith the JOA scores (P<0.01). There were 94 cases for segmental-type, 46 for mixed-type, 23 for continuous-type and 37 for focal-type. Thethird and fourth cervical vertebrae were susceptible to ossify. Conclusion The higher the OPLL occupation ratio, the worse the clinicalOPLL symptoms. The OPLL patients following clinical symptoms with spinal cord oppression are more likely the segmental-type.

ObjectiveTo explore the relationship of single nucleotide polymorphism (SNPs) of the bone morphogenetic protein-4 (BMP-4) gene with the morbidity and severity of the ossification of posterior longitudinal ligament (OPLL) of the spine in Chinese patients. MethodsThe venous blood samples of 200 OPLL patients and 200 non-OPLL controls were measured with the DNA sequences in four locus of BMP-4 gene with polymerase chain reaction(PCR). ResultsThere was a significant association between the rs17563，rs2855532 polymorphism and the occurrence of OPLL （P＜0.05）. The ''T'' allele in these 2 SNPs promotes the extent of OPLL (P<0.05). However, no significant association in morbidity and severity was found between the other 2 SNPs (rs1957860, rs2071047). ConclusionSNPs in rs17563，rs2855532 associates with the morbidity and severity of the ossification of posterior longitudinal ligament of the spine in Chinese patients.