The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.

【Objective】 To analyze the basic characteristics of whole blood donors from blood stations before and after the outbreak of COVID-19. 【Methods】 After excluding invalid data, data related to the basic characteristics of whole blood donors collected from 26 blood stations in China during 2018 to 2021 were statistically analyzed, including the trend of total whole blood donors, the number of repeated blood donors, the frequency of blood donation, the average age of donors and the recruitment of first-time blood donors. 【Results】 Affected by the epidemic, 8 out of 14 indicators were with large variations, accounting for 57%. The overall growth rate of total whole blood donors during the epidemic was higher than before the epidemic (P<0.05).The number of repeated blood donors has shown an increased trend, with a higher number during the epidemic than before (P<0.05). The frequency of blood donation was lower during the epidemic than before(P<0.05).Average ages of blood donors and female blood donors fluctuated widely during the epidemic, both higher than those before the epidemic(P<0.05).The donation rate of first-time blood donors <25 years old and ≥25 years old varied widely and irregularly during the epidemic (both P<0.05). The percentage of first-time blood donors fluctuated irregularly during the epidemic, with overall percentage lower than that before the epidemic(P<0.05). 【Conclusion】 Whole blood donors from 26 blood stations increased after the outbreak of COVID-19, and some indicators in certain areas showed significant fluctuations during the epidemic.

【Objective】 To learn the production efficient of platelet components among prefecture-level blood stations in China, to provide supporting data for those blood stations to optimize the production mode of platelet components and continuously improve production efficiency and supply capacity. 【Methods】 The data from 2017 to 2020 was obtained from 24 prefecture-level blood stations who were the members of the practice comparison network for blood institutes in China. The collection units of apheresis platelets, the number of dual-collections of apheresis platelets and plasma, the average apheresis units of one platelet apheresis procedure, the discarded rate of apheresis platelets, the amount of expired apheresis platelets and the amount of apheresis platelets issued were collected. For concentrated platelets, the prepared amount of platelet concentrates and the amount of expired platelet concentrates were collected; both the quantity of qualified and issued concentrated platelets were submitted for statistical analysis.The total output and efficiency of platelet components were calculated based on the collected data. 【Results】 The average annual growth rate of apheresis platelets collection in 24 prefecture-level blood stations was 12.23%, accounting for 99.80% of the total platelet output; the average collection unit of one platelets apheresis procedure was 1.75; from 2019 to 2020, only 5 blood stations performed dual-collection of platelet and plasma during one apheresis procedure; the discarded rate of apheresis platelets was 0.28%, of which 0.007% was due to expiration. A total of 1 621.2 therapeutic units of concentrated platelets were prepared, and 13.03% of them was discarded due to the expiration. The production efficiency of platelet components was 97.56%, of which the production efficiency of apheresis platelets was 97.61% and the production efficiency of concentrated platelets was 74.43%. 【Conclusion】 There are large regional differences in the supply capacity of platelet components in prefecture-level blood stations. Apheresis platelets are the main resource of platelet components product, and the collection capacity is increasing over the years with the characteristics of high production efficiency and low expiration scrapping rate. However, the preparation of concentrated platelets are still limited with relatively low production and high expiration discarded rate.

The Poly(3,4-ethylenedioxythiophene) graphene ( PEDOT-rGO) composite film was prepared by one step pulse potentiostatic method, based on the π-π* interaction and the polymerization reaction of hydrogen bond between the graphene ( rGO) and the aromatic ring of 3,4-ethylenedioxythiophene ( EDOT) monomer. Then the nickel nanoparticles ( NiNPs ) were electrodeposited on composite film to obtain a composite film-modified glassy carbon electrode ( NiNPs/PEDOT-rGO/GCE ) . The catalytic performance of NiNPs/PEDOT-rGO/GCE towards the oxidation of glucose was studied by electrochemical method. The experimental results showed that the NiNPs/PEDOT-rGO/GCE could be used as a nonenzyematic sensor for detection of glucose. This method had high stability, good selectivity, wide linear range ( 2 μmol/L-58 mmol/L) and low detection limit (0. 7 μmol/L), realizing the rapid and sensitive detection of glucose.

Objective To explore the direct economic loss caused by healthcare-associated infection(HAI)in general hospitals in China.Methods 68 hospitals were selected,a retrospective 1:1 matched survey was conducted to compare the direct medical cost in patients with and without HAI between January 1,2015 and December 31,2015. Results A total of 2 123 pairs of patients with and without HAI were included in the survey.The average cost of hospitalization in HAI and non-HAI groups were ￥25 845.30 and ￥12 006.14 respectively,￥13 839.16 on average was increased due to HAI.The average economic loss in provincial and ministerial levels of hospitals were￥21 409.83.The average economic loss in different regional hospitals were ￥9 725.42-￥18 909.59,and north China ranked the first.Economic loss caused by bloodstream infection and lower respiratory tract infection were more than other sites,which were ￥23 190.09 and ￥18 194.50 respectively.Conclusion HAI resulted in considerable direct economic loss.Prevention and control of HAI,especially bloodstream infection and lower respiratory tract infection should be paid more attention.

Objective To improve hand hygiene (HH)compliance of health care workers (HCWs)in neonatal in-tensive care units(NICUs)in China through a series of intervention measures.Methods A multicenter study was conducted,17 tertiary first class hospitals in 9 provinces and cities were selected,HH compliance of HCWs in these hospitals were investigated every month according to HH investigation method of World Health Organization.From October 1 ,2013 to March 31 ,2014 was pre-intervention stage;from April 1 ,2014 to September 30,2014 was post-intervention stage,timely feedback and intensified training were conducted at post-intervention stage.Results HH compliance rates of HCWs before and after intervention were 80.29% and 80.85% respectively,there was no sig-nificant difference (P >0.05).HH compliance rates of HCWs in different sizes of ICUs were significantly different before and after intervention (all P <0.05),in NICUs with<20 beds and 20-30 beds after the intervention were both significantly higher than before intervention (both P <0.05 ),while >30 beds were significantly lower than before intervention(P <0.001 );HH compliance rate of cleaners increased from 58.82% before intervention to 68.09% after intervention (P <0.05 );Of different hand hygiene indications,except before clean/aseptic task, compliance to the other HH indications were significantly different between before and after intervention(all P <0.05).Conclusion HH compliance is high among HCWs in NICUs in China,intervention measures,such as inten-sified training and timely feedback have certain influence in compliance to HH among HCWs at different sizes of ICUs,of different occupations,and at different HH indications.

Objective To investigate the epidemiological characteristics of device-associated infection (DAI)in neonatal intensive care units(NICUs)of tertiary first-class hospitals in China,and provide scientific evidence for the prevention and control of neonatal DAI.Methods Neonates in NICUs at 17 hospitals of 9 provinces from October 2013 to September 2014 were selected for multicenter study,DAI was surveyed prospectively according to the uni-form diagnostic criteria and methods.Results A total of 12 998 neonates were monitored,the total patient-days were 126 125 d,13 cases of central line-associated bloodstream infection (CLABSI)and 70 cases of ventilator-asso-ciated pneumonia (VAP)occurred,central line utilization rate was 15.56%,incidence of CLABSI was 0.66/1 000 device-days;ventilator utilization rate was 7.67%,incidence of VAP was 7.23/1 000 device-days.Utilization rates of central line and respirator in neonates with body weight ≤ 1 000 g was the highest,which were 61 .06% and 29.91 % respectively;In NICUs with 20-30 beds,utilization rate of central line was the highest(16.67%),and res-pirator was the lowest(4.11 %);of hospitals in different regions,central line and respirator utilization rate in south-west China was the highest.Of different sizes of ICUs,VAP per 1 000 device-days was the lowest in NICUs with 20-30 beds(2.36 ‰).Difference in incidence of CLABSI and VAP per 1 000 device-days in neonates at NICUs of different regions were significantly different;incidence of CLABSI and VAP per 1 000 device-days was highest in southern China(2.68 ‰ and 31 .06‰ respectively),followed by southwest region.Of different quarters,incidence of CLABSI,and VAP per 1 000 device-days were not significantly different(all P >0.05).Conclusion Device utili-zation rate and incidence of DAI in China are both high,and are different in neonates of different birth weight,at different sizes of NICUs,as well as different regions,monitoring should be intensified,prevention and control measures should be implemented according to infection characteristics.

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.