OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's firststrong protectionstandard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.

T4 cells were isolated twice separately from peripheral blood of the same donor.After activation by lectin,the isolated cells were culturedwith the medium containing self-made IL-2 for a long period.The culturedcells were identified for OKT antigens by immuno-fluorescent technique onday 10 and 22 of the cultivation,and the appearance of both T4 and T8antigens on the same cell (double marker cell)could be detected in about60-80%of cultured cells.The double marker T cells decreased in numberand the percentage of single marker T cells,either T4 or T8 cells,increasedgradually along with the cultivation.The function of double marker T cellswere investigated and the suppressor activity of these cells on PWM indu-ced antibody production response by cooperation between B cells and fresh T4cells was found.These results suggest that human peripheral blood T4 andT8 cells are not terminaly differentiated cells,because T4 and T8 antigencan be coexpressed on the same cell during the earlier cultivation.Afterlong period of activation,T4 and T8 double marker cells may change intoeitherT4 or T8 cells.

ObjectiveTo explore the therapeutic effect of continuous veno-venous hemofiltration (CVVH) on the treatment of severe acute pancreatitis (SAP).MethodsAll data about forty-five patients with SAP admitted to the intensive care unit (ICU) from June 2005 through June 2010 were reviewed.These 45 patients were randomly (random number ) divided into routine treatment group (n =22 )and comprehensive treatment group ( n =23 ).In control group,patients were rapidly given with a suffficient liquid support,vasoactive drug to increase organ perfusion,trypsin secretion inhibitor,broad-spectrum antibiotics,enteral nutrition with intestine membrane protective agent in early stage.In the comprehensive treatment group,patients received CVVH integrated with routine treatment.On admission and 72 h posttreatment,the scores of acute physiology and chronic health evaluation Ⅱ ( APACHE Ⅱ ) and multiple organ dysfunction syndrome (MODS),and the results of standard bettery of biochemistry tests indcluding blood urea nitrogen (BUN),serum cratinine (Scr),total bilirubin (TBIL),alanine aminotransferase (ALT),amylase (AMS),C-reactive protein (CRP),TNF-α,IL-6,IL-8 were observed.Time of mechanical ventilation support,length of ICU stay,and survival rate were compared between two groups.ResultsOn admission between the two groups,no statistical significance was seen in the APACHE Ⅱ and MODS score,BUN,Scr,TBIL,ALT,AMS,CRP,TNF-α,IL-6,IL-8 (P ＞ 0.05).But APACHE Ⅱ and MODS score were decreased significantly in comprehensive treatment group than in the routine treatment group,as well as the the level of BUN,Scr,TBIL,ALT,AMS,TNF-α,IL-6,IL-8 and CRP after 72h post-treatment (P＜0.05 ).In routine treatment group and comprehensive treatment group,the time of respirator intervention and length of stay in ICU were (7.6±3.4) d vs.(11.5±4.7) d,(12.3±7.8) dvs.(17.6±9.2) d respectively,the statistical significance was shown ( P ＜ 0.05 ).Compared to the comprehensive treatment group ( 86.96％ ),the survival rate ( 59.09％ ) were lower in routine treatment group ( P ＜ 0.05 ).ConclusionsCVVH combined with routine treatment,which can remove inflammatory agents and toxins,maintain homoeostasis,and improve oxygenation,is effective in treatment of SAP and can improve patient survival rate.

To observe the effect of indomethacin suppository 100 mg before endoscopic retrograde cholangiopancreatography (ERCP) on the level of platelet microparticles (PMPs) in patients with post-ERCP pancreatitis (PEP). A total of 191 patients receiving ERCP were collected from June 2019 to October 2020 in the First Affiliated Hospital of Anhui Medical University and were randomly divided into the indometacin group ( n=96) and the control group ( n=95) by random number table method. The indometacin group received 100 mg indometacin suppositories before ERCP and the control group received placebo of equal quality. Levels of PMPs before operation, 3 hours and 24 hours after operation were measured by flow cytometry. The levels of IL-1, IL-6 and TNF-α in the plasma before ERCP, 3 hours and 24 hours after ERCP were also detected. The incidence of PEP in the indometacin group was 5.21% (5/96), which was significantly lower than that in the control group [13.68% (13/95), P=0.044]. The preoperative PMPs level in the indometacin group (1 910.01/μL) was slightly lower than that in the control group (2 351.87/μL) with no significant difference ( P>0.05). The PMPs levels in the indometacin group 3 hours and 24 hours after ERCP (1 671.47 /μL, 862.74/μL) were significantly lower than those of the control group (2 443.75/μL, 2 536.76/μL, both P<0.05). Inflammatory cytokines including IL-1, IL-6 and TNF-α showed the same tendency. Indometacin can reduce the incidence of PEP, for the reason that indometacin may decrease the levels of PMPs.

Objective To statistically analyze the allergen-specific IgE test results for allergic patients and observe the distribution of allergens and their prevalence trends.Methods Allergen-specific IgE test results were collected from 12 486 patients with suspected allergic diseases who attended the outpatient clinic of the Department of Dermatology of the Second Affiliated Hospital of Air Force Medical University from January 2018 to December 2023,and the distribution of the positivity rate of various allergens and their differences among different age,gender and seasonal subgroups were statistically analyzed.Results Allergen-specific IgE positive results were found in 5 109 cases out of 12 486 patients with suspected allergic diseases,with a positive rate of 40.92%.Between different gender groups,the allergen positivity rate were 45.41%(2 371/5 221)in males and 37.69%(2 738/7 265)in females,respectively,and the difference in positivity rate between males and females was statistically significant(x2=74.99,P<0.001).The allergen positivity rate among different age groups was highest in the 3～<6 years group(60.00%),followed by the 6～<18 years group(54.92%),and lowest in the≥60 years group(29.18%),with statistically significant differences in allergen positivity rates among different age groups(x2=344.97,P<0.001).The top three overall allergen positivity rates were milk(11.73%),dwarf ragweed/artemisia/rudolfia/quinoa(11.43%)and house dust mite(10.82%),and the positivity rates of milk and house dust mite had a tendency to increase year by year.The highest allergen positivity rate among groups in different seasons was in summer(42.28%),followed by fall(41.32%)and lowest in winter(38.31%),and the difference in allergen positivity rates among the four seasons was statistically significant(x2=9.09,P=0.028).Dwarf ragweed/artemisia/rutabaga/quinoa had the highest positivity rate in the fall(15.75%),while milk(14.59%)and egg white(2.58%)had the highest positivity rates in the summer,and the differences in the positivity rates of dwarf ragweed/artemisia/rutabaga/quinoa,milk and egg white between the four seasons were statistically significant(x2=92.50,70.45,8.10,all P<0.05).Multiple positives were present for allergen-specific IgE,with 22.18%single positives and 18.92%double and more than double positives.Positive test results for ingestion were mainly distributed in the lower levels,while positive test results for inhalation were more distributed in the higher levels,especially for dwarf ragweed/artemisia/rutabaga/quinoa,which were most distributed in level 6.Conclusion Different types of allergens have different distribution characteristics among different genders,ages and seasons,the distribution levels of positive results are different,and there are multiple positive results.Based on the distribution characteristics of allergens in the region,rational arrangement of the dietary and living shoule be mode to avoid the risks and to reduce the probability of the occurrence of allergic diseases.

Objective To investigate the endoscopic ultrasound (EUS) features of distal biliary stricture (DBS), and to provide a clinical basis for the evaluation of DBS by EUS. Methods Related clinical data were collected from 175 patients with DBS who underwent EUS examination in The First Affiliated Hospital of Anhui Medical University from April 2016 to March 2020 to analyze their clinical manifestation, laboratory examination results, imaging findings, and EUS findings, and the patients were followed up to summarize the EUS features of DBS. The chi-square test was used for comparison of categorical data between groups, and the t -test was used for comparison of continuous data between groups. Results Among the 175 patients with DBS, 85(48.57%) had benign DBS and 90(51.43%) had malignant DBS. Compared with the patients with benign DBS, the patients with malignant DBS had a significantly longer length of stricture on EUS (14.1±3.0 mm vs 7.9±3.0 mm, t =13.358, P < 0.001) and significantly higher incidence rates of the characteristic changes on EUS such as hypoechoic space-occupying lesions in lumen (57.8% vs 34.1%, χ 2 =9.843, P =0.002), peripheral lymph node enlargement (26.7% vs 12.9%, χ 2 =5.147, P =0.023), and pancreatic duct dilatation (51.1% vs 28.2%, χ 2 =9.532, P =0.002). EUS combined with magnetic resonance cholangiopancreatography had a sensitivity of 70.6% in the diagnosis of benign DBS and a sensitivity of 92.2% in the diagnosis of malignant DBS. Conclusion The characteristic EUS features of DBS, such as long length of stricture, hypoechoic lesion, peripheral lymph node enlargement, and pancreatic duct dilatation, may help with the differential diagnosis of DBS in clinical practice.