OBJECTIVE:To excavate and evaluate the security alert signals of linezolid after marketing,and to provide refer-ence for rational drug use in clinic. METHODS:The reporting odds ratio(ROR)method was used to excavate the security alert signals from the adverse drug events(ADE)data in the OpenFDA platform of FDA during second quarter of 2004-2016. The low-er limit of 95%CI >1 was regarded as suggestive of ADE alert signal. RESULTS:A total of 6828534 reports were extracted, among which there were 7224 reports mainly induced by linezolid. Top 10 ADE reports were thrombocytopenia,drug interac-tion,thrombocytopenia,nausea,anaemia,serotonin syndrome,diarrhoea,pyrexia,drug ineffective,vomiting. After the detec-tion of top 200 ADE reports by ROR method,120 signals related to 18 system organ class(SOC)were identified. Top 5 ADE sig-nals in turn by SOC were medical examination,nervous system disorders,blood and lymphatic system disorders,metabolism and nutrition disorders,cardiac disorders. The high risk signals with clinical reference value included 42 cases of optic neuropathy (ROR=56.33),350 cases of serotonin syndrome(ROR=52.86),162 cases of lactic acidosis(ROR=18.30),31 cases of endo-carditis (ROR=15.38),566 cases of thrombocytopenia (ROR=14.29),122 cases of bone marrow failure (ROR=14.20),261 cases of panhematopenia (ROR=11.92),86 cases of disseminated intravascular coagulation (ROR=10.91),58 cases of toxic epidermal necrolysis(ROR=9.06),etc. As for ADE reports,male was slightly higher than female,and the patients in age group of ≥45 reported evidently more compared to younger age group. CONCLUSIONS:By detecting and evaluating alert signals of li-nezolid through OpenFDA platform,we could effectively lay the foundation for further research of pharmacovigilance.

Objective To investigate cause analysis and treatment strategy of cage migration after lumbar interbody fusion.Methods Retrospective study was performed on 9 cases with cage migration after lumbar interbody fusion from January 2009 to February 2015 in our hospital.There were 4 males and 5 females,and mean age was 61.6 years (rang,38-75 years).The types of cage included Titanium metal cage used in 3 cases,cylindrical thread cage in 1 case and PEEK cage in the other cases.Bilateral instrumented posterior lumbar interbody fusion was found in 7 cases,and unilateral fixation in 2 cases.Analyze the risk factors of cage migration and the strategies of revision surgery,and evaluate the radiological outcomes and clinical efficacy of revision surgery.Results Risk factors of cage backward migration are as follows:nucleus pulposus left too much in 6 cases,poor cartilage endplate resection in 4 cases,small size of cage selection in 5 cases,unsatisfied cage placement in 2 cases,and improper operation in 1 case.Follow-up survey was fulfilled in all patients,the follow-up time was 6 to 32 months,and bony union was detected in all patients.No cage re-migration,non-fusion,or loosen pedicle screw was found during follow-up period.Clinical symptoms were all improved after revision.Conclusion The causes of cage migration after bilateral or unilateral instrumented transforaminal lumbar interbody fusion were complicated.Risk factors of cage migration may be poor intervertebral space preparation,small cage size,and improper cage placement,which may be not associated with unilateral fixation.Excellent or good radiological outcomes and clinical efficacy depend on a reasonable revision surgery.

Breeding and quality control of SPF nude mice involves many links and works .The quality and quantity of animals are directly affected by breeding management and quality control .A standardized breeding system of SPF BALB/c nude mice were gradually established at the center after 2007.This paper introduces specific practices and experience in facilities, stock, breeding management , and quality control of SPF BALB/c nude mice, in order to provide the reference for related breeding and study in SPF BALB/c nude mice.

OBJECTIVE:To investigate the general regularity and characteristics of propylthiouracil (PTU)-associated small vasculitis (ASV),and to provide reference for rational drug use in the clinic. METHODS:ADR/ADE case reports of PTU-ASV published during 1990-2016 were retrieved. The data of 118 ADR cases were analyzed statistically. RESULTS:The incidence of PTU-ASV was higher in female and was highest in 18-59 age group. Drug dose of 87 patients were within 600 mg/d,and the inci-dence of PTU-ASV was the highest within 1-5 years after medication. Main clinical manifestations were renal and lung function in-jury. After drug withdrawal,59 patients received hormone therapy,and 30 patients received hormone combined immunosuppressive agent. Finally,115 patients were recovered and 3 patients died. CONCLUSIONS:In older to reduce or avoid the occurrence of ADR,it is necessary to regularly check antineutrophil cytoplasmic antibody related indexes and evaluate the symptoms of ADR.

Objective To explore the normal values for two-dimension solid state high resolution anorectal manometry (HRAM) in healthy adult volunteers.Methods The healthy adult volunteers were recruited by advertisement and underwent solid state HRAM in the left lateral position.Anorectal pressures and rectal sensation were recorded and analyzed.Results (1) A total of 126 Chinese healthy adult volunteers (male:50 cases (39.7％);age:(37.5 ± 14.2) years old) were recruited in this study.(2)Mean anal resting pressure (MERP) was (71.8 ± 17.3) mmHg (1 mmHg =0.133 kPa).Maximum anal resting pressure (MARP) was (79.3 ± 17.8) mmHg,Maximum anal squeeze pressure (MSP) was (178.7 ± 52.8) mmHg.Anal high pressure zone (HPZ) length was (3.4 ± 0.6) cm.During simulated evacuation,residual anal pressure (RAP) was (63.8 ±20.5) mmHg,and anal relaxation rate (ARR) was (37.0 ± 11.5) ％.Rectal threshold volume for first sensation (FST),desire to defecate (DDT),urgency to defecate (UDT) and maximum discomfort (MDT) was (47.4 ±10.0) ml,(84.5 ±18.2) ml,(125.8 ± 28.5) ml,and (175.5 ±36.1) ml,respectively.(3) Compared with female subjects,male subjects had higher MSP [(211.0 ± 50.7) mmHg vs (157.5 ± 42.5) mmHg],RAP [(71.6 ± 18.1) mmHg vs (58.8 ± 20.5) mmHg]and rectal MDT[(187.0 ±36.4) mmHg vs (168.0 ±34.1)mmHg],but lower ARR [(32.1 ±8.0)％ vs (40.2 ±12.3)％],all P＜0.01.(4) MERP,MARP,MSP and rectal MDT were higher in young group (≤ 40 years old),all P ＜ 0.05.Conclusions These observations provide normal values for two-dimension solid state HRAM,which have significant difference between genders and different age groups.

Objective:To analyze the expression of 25-hydroxyvitamin D [25(OH)D] in serum and vitamin D receptor (VDR) in descending duodenum of adult patients with celiac disease and the correlation between 25 (OH) D, VDR and the clinical characteristics and indexes of celiac disease.Methods:From September 1, 2020 to May 1, 2022, 37 patients who were diagnosed with celiac disease (celiac disease group) in the Department of Gastroenterology of People′s Hospital of Xinjiang Uygur Autonomous Region were enrolled. During the same period, according to gender, age and nationality matched at a ratio of 1 to 1, 37 patients who visited the hospital with suspected symptoms of celiac disease and finally were excluded from the diagnosis of celiac disease after screening (non-celiac disease group) were selected. General data and clinical characteristics of all the patients were collected, including diarrhea, bone mineral density (BMD), Marsh stage. Serum 25(OH)D levels were detected, and the expression of VDR(high or low expression) in the descending duodenum was evaluated by immunohistochemical staining. Independent sample t test, chi-square test and Spearman correlation analysis were used for statistical analysis. Results:The serum 25(OH)D level and the proportion of patients with high VDR expression in the celiac disease group were both lower than those of the non-celiac disease group ((12.40±8.93) μg/L vs. (16.78±7.09) μg/L; 45.9%, 17/37 vs. 75.7%, 28/37), and the proportion of patients with diarrhea was higher than that of the non-celiac disease group (45.9%, 17/37 vs. 21.6%, 8/37), and the differences were statistically significant ( t=-2.52, χ2=6.86 and 4.89, all P<0.05). The serum 25(OH)D level was positively correlated with the VDR expression level in the descending duodenum both in the celiac disease group and the non-celiac disease group ( r=0.75 and 0.64, both P<0.001), and was not correlated with the diarrhea symptoms in the 2 groups (both P>0.05). There was a positive correlation between serum 25(OH)D and BMD in the celiac disease group ( r=0.48, P=0.017), and serum 25(OH)D was also correlated with BMD in the non-celiac disease group ( r=0.93, P<0.001). The VDR expression level in the descending duodenum was negatively correlated with the Marsh stage in the celiac disease group ( r=-0.36, P=0.031), while the VDR expression level was not related to the Marsh stage in the non-celiac disease group ( P>0.05). Conclusions:Vitamin D metabolism imbalance exists in the serum and duodenal mucosa of adult patients with celiac disease, which is related to the severity of osteoporosis and histopathology. It is suggested that patients with celiac disease should receive vitamin D metabolism regulation treatment.

Objective:To explore the clinical efficacy of open-door laminoplasty in treatment of cervical spinal hyperextension injury accompanied with or without spinal cord-canal mismatch.Methods:A retrospective case-control study was performed to analyze the clinical data of 42 patients with cervical spine hyperextension in Shanghai Ninth People’s Hospital，Shanghai Jiaotong University School of Medicine from January 2016 to June 2019. There were 31 males and 11 females at age range of 40-78 years［（59.7 ± 9.9）years］. All patients underwent open-door laminoplasty.Preoperative Japanese Orthopaedic Association score（JOA）was（10.2 ± 3.8）points，and American Spinal Injury Association（ASIA）spinal cord injury score was（260.4 ± 47.5）points. Those with spinal cord occupation rate（SCOR）equal to or more than 70% were classified as spinal cord-canal mismatched group（n=21），and those with SCOR less than 70% were classified as spinal cord-canal matched group（n=21）. ASIA total score，ASIA upper and lower limb motor scores，ASIA sensory score，JOA score，surgical improvement rates and complications were compared between the two groups before operation，at postoperative one week and at the latest follow-up.Results:All patients were followed up for 12-26 months［（19.1 ± 2.3）months］. Both groups had significantly improved ASIA total score at postoperative one week and at the latest follow-up，compared with that before operation（ P < 0.05）. The two groups showed no significant difference in ASIA total score at postoperative one week（ P > 0.05）. ASIA total score in unmatched group was（307.6 ± 9.9）points at the latest follow-up，significantly lower than that in matched group［（315.4 ± 8.7）points］（ P < 0.01）. ASIA upper limb motor score in mismatched group was（29.1 ± 7.0）points and（36.6 ± 6.5）points at postoperative one week and at the latest follow-up，significantly lower than that in matched group［（42.0 ± 5.7）points，（47.4 ± 2.5）points］（ P < 0.01），while there was no significant difference in ASIA lower limb motor score and sensory score between the two groups（ P > 0.05）. Both groups showed significantly improved JOA score at postoperative one week and at the latest follow-up，compared with that before operation（ P < 0.05）. JOA score in mismatched group was（11.5 ± 3.0）points and（12.5 ± 3.0）points at postoperative one week and at the latest follow-up，significantly lower than that in matched group［（13.5 ± 2.4）points，（15.0 ± 2.0）points］（ P < 0.01）. Postoperative improvement rate in matched group was 95%（20/21），and was 85%（18/21）in mismatched group（ P < 0.05）. Cervical axial pain occurred in 3 patients in each group and C 5 nerve root palsy in 2 patients in matched group，all of which were relieved after conservative treatment. No implant loosening or breakage occurred during follow-up. Conclusions:Open-door laminoplasty can improve part of the nerve function of patients with cervical hyperextension injury. However，the overall improvement degree of nerve function especially recovery of upper limb motor function in patients with spinal cord-canal mismatch is inferior to those in spinal cord-canal matched patients.

Objective: To compare the safety of continued warfarin therapy and bridging anticoagulation therapy during hospital stay in patients undergoing percutaneous coronary intervention (PCI). Methods: We retrospectively analyzed patients on warfarin therapy referred for PCI in Beijing Anzhen Hospital from January 2008 to December 2016. The patients were divided into continued warfarin therapy (n=195) or bridging anticoagulation therapy (n=311) groups. After Propensity Score Matching, data from matched patients (n=123 in each group) were analyzed. Bleeding complications and major adverse cardiac events including death, myocardial infarction, target vessel revascularization, and stent thrombosis were assessed. Results: There were no significant difference in the rate of death (2.4%(3/123) vs. 1.6%(2/123),P=0.54), acute myocardial infarction (4.1%(5/123) vs. 4.9%(6/123), P=0.78),re-revascularization (0.8%(1/123) vs. 1.6%(2/123),P=0.16), stent thrombosis (1.6%(2/123) vs. 1.6%(2/123),P=1.00) and stroke between the two groups. Prevalence of minor bleeding complications was significantly higher in the bridging therapy group (15.4%(19/123) vs. 9.8%(12/123),P=0.01). Rate of access-site complications (hematoma:4.1%(5/123) vs. 2.4%(3/123),P=0.20; pseudoaneurysm:2.4%(3/123) vs. 2.4%(3/123),P=1.00; arteriovenous fistula:0.8%(1/123) vs. 1.6%(2/123),P=0.09; and retroperitoneal hematoma:0(0/123) vs. 0.8%(1/123),P=0.23) were similar between the two groups. Conclusion For patients receiving chronic warfarin therapy, the uninterrupted oral anticoagulant treatment is as safe as bridging therapy in PCI patients.

Objective To investigate the susceptibility and resistance of clinical isolates from hospitals in several regions of China .Methods Fifteen general hospitals and two children′s hospitals were involved in this program . Antimicrobial susceptibility testing was carried out according to a unified protocol using Kirby‐Bauer method or automated systems .Results were analyzed according to CLSI 2014 breakpoints .Results A total of 78 955 clinical isolates were collected from January to December 2014 ,of which gram negative organisms and gram positive cocci accounted for 72 .6% and 27 .4% ,respectively . Methicillin‐resistant strains in S .aureus(MRSA)and coagulase negative Staphylococcus(MRCNS)accounted for an average of 44 .6% and 83 .0 % ,respectively .The resistance rates of methicillin‐resistant strains to β‐lactams and other antimicrobial agents were much higher than those of methicillin‐susceptible strains .However ,92 .0% of MRSA strains were still susceptible to trimethoprim‐sulfamethoxazole ,while 85 .6% of MRCNS strains were susceptible to rifampin .No staphylococcal strains were found resistant to vancomycin ,teicoplanin or linezolid .In Enterococcus spp .,the resistance rates of E .f aecalis strains to most tested drugs (except chloramphenicol) were much lower than those of E . f aecium .Some strains of both species were resistant to vancomycin .Vancomycin resistant strains of E . f aecalis and E . f aecium were mainly V anA ,V anB or V anM type based on their phenotype or genotype .Regarding non‐meningitis S .pneumoniae strains ,the prevalence of penicillin‐susceptible S .pneumoniae strains isolated from both adults and children were higher than those isolated in 2013 ,but the prevalence of penicillin‐intermediate S . pneumoniae or penicillin‐resistant S . pneumoniae strains decreased . The prevalence of ESBLs producingstrainswas55.8% in E.coliand29.9% in Klebsiellaspp.(K.pneumoniaeand K.oxytoca)and24.0% in Proteus mirabilis isolates on average . ESBLs‐producing Enterobacteriaceae strains were more resistant than non‐ESBLs‐producing strains in terms of antibiotic resistance rates . The strains of Enterobacteriaceae were still highly susceptible to carbapenems .Overall less than 10 % of these strains were resistant to carbapenems . About 62 .4% and 66 .7% of Acinetobacter spp .(A .baumannii accounts for 93 .0 % ) strains were resistant to imipenem and meropenem ,respectively . Compared with the data of year 2013 ,extensively‐drug resistant strains in K . pneumoniae and A .baumannii increased . Conclusions The antibiotic resistance of clinical bacterial isolates is growing .The disseminated multi‐drug or pan‐drug resistant strains in a special region poses a serious threat to clinical practice and implies the importance of strengthening infection control .

OBJECTIVE：To eva luate the risk of abno rmal female reproductive system haemorrhage induced by novel oral anticoagulants （NOACs）. METHODS ：The abnormal female reproductive system haemorrhage reports induced by 4 kinds of NOACs as “dabigatran etexilate ”，“rivaroxaban”，“apixaban”and“edoxaban”were used as the first suspected dugs to collected from FDA adverse event reporting system （FAERS）database during Jan. 1st，2004-May 31st，2019. The report odd ratio （ROR） method was used to detect the signal of abnormal female reproductive system haemorrhage induced by NOACs. RESULTS ：A total of 2 658 adverse events related to abnormal female reproductive system haemorrhage were collected from FAERS database ， involving 330 reports of dabigatran etexilate ，2 049 reports of rivaroxaban ，267 reports of apixaban ，and 12 reports of edoxaban. The abnormal female reproductive system haemorrhage caused by dabigatran etexilate ，apixaban and edoxaban mainly occurred in patients aged 75 and older ，accounting for 37.27％，36.70％ and 58.33％ respectively；that of rivaroxaban mainly occurred in patients with 45-64 years old ，accounting for 33.04％. The incidence of severe adverse events （SAE）induced by dabigatran etexilate，rivaroxaban，apixaban and edoxaban were 96.36％，84.53％，47.19％ and 58.33％，respectively. All of patients in the included reports were mainly hospitalized and hospitalization stay wa s prolonged ，accounting for 64.78％，90.01％，86.51％ and 71.43％ ，respectively. A total of 12 suspected signals were detected，involving cervix uteri ，fallopian tube ，ovary，pelvis cavity，uterus，vagina，urinary tract ，etc. Among them ，there were 11 positive signals of rivaroxaban ，and the bleeding events were concentrated in vaginal hematoma [ROR ＝12.07， 药。95％CI（8.51，17.12）]，postmenopausal hemorrhage [ROR ＝ 9.89，95％CI（8.31，11.77）]，pelvic hematoma [ROR ＝7.68，95％CI（5.66，10.43）]. There were 4，4 and 2 suspicious signals for dabigatran etexilate ，apixaban and edoxaban. The main bleeding events of both apixaban [ ROR＝5.18，95％CI（1.81，5.85）] and edoxaban [ROR ＝48.19，95％CI（6.76，343.77）] were vaginal hematoma ；dabigatran etexilate-induced pelvic hematoma [ROR ＝ 12.56，95％CI（8.92，17.70）] had the strongest signal ，followed by urinary tract bleeding [ROR ＝5.41，95％CI（3.34，8.76）] and pelvic hemorrhage [ ROR＝2.53，95％CI（1.88，3.40）]. CONCLUSIONS ：Totally 4 kinds of NOACs can cause abnormal female reproductive system haemorrhage ，and the incidence of SAE is high ，of requiring hospitalization or prolonging hospitalization time. The risk of haemorrhage in rivaroxaban is the highest ，usually manifesting as vaginal hematoma ，postmenopausal hemorrhage and pelvic hematoma. Dabigatran etexilate mainly induce pelvic hematoma ，while apixaban and edoxaban are mainly cause vaginal hematoma.