Objective:This study evaluates the performance of chemiluminescence assay, which is designed to detect Hepatitis D Virus (HDV) Immunoglobulin G (IgG) antibodies.Methods:A comparative analysis was conducted among chemiluminescence anti-HDV IgG reagent, the magnetic particle-based domestic reagent A and domestic reagent B, and the Robo Gene HDV RNA kit, using 1909 HBsAg-positive plasma samples. This comparison aimed to delineate clinical specificity and detection accuracy. The anti-HDV IgG reagent precision was assessed at three different concentration levels following the Clinical Laboratory Standards Institute EP5-A2 guidelines. The specificity of the assay was validated using 200 HAV IgM positive, 545 HBsAg-positive but anti-HDV IgG-negative, 350 anti HCV positive plasma samples and 200 healthy human blood samples. Additionally, a concordance study was conducted with 545 HBsAg-positive and 37 anti-HDV IgG-positive plasma samples, comparing the anti-HDV IgG reagent against reagent A.Results:1 909 HBsAg-positive plasma samples were tested using 3 anti HDV IgG reagent and 1 HDV RNA reagent, 19 samples were identified as anti-HDV IgG-positive. The anti-HDV IgG demonstrated superior accuracy and specificity. The assay exhibited excellent precision, with intra-assay coefficient of variation (CV) values ranging from 1.57% to 4.30%, and inter-assay CV values between 1.71% and 4.67% for detecting samples at high, medium, and low concentration levels. Concordance with Reagent A showed consistent results in both positive and negative detections.Conclusion:In this study, the anti-HDV IgG reagent (chemiluminescence method) displayed outstanding specificity in detecting clinical samples and exhibited a high conformity rate with commercialized reagents, making it potentially suitable for screening anti-HDV IgG in HBsAg-positive samples.

Objective:This study aims to evaluate the quality and explore the preliminary clinical applications of a domestically developed hepatitis D virus nucleic acid quantification reagent (abbreviated as"domestic HDV RNA reagent").Methods:The sensitivity and accuracy of the reagent were evaluated in accordance with the WHO HDV RNA international standard, employing the Bio-Rad CFX Opus 96 real-time fluorescence quantitative PCR analysis system. Serial dilutions of pseudo-viruses or cell culture-derived virus were used to determine the linear range of the domestic HDV RNA reagent. Specificity was assessed using positive samples of HAV, HBV, HCV infection, and HEV national reference materials. Precision was evaluated with samples at both high and low concentrations. In a comparative analysis, 30 HDV IgG positive samples were tested using both the domestic HDV RNA reagent and the RoboGene HDV RNA kit based on the ABI 7500 FAST DX system. The Pearson correlation coefficient (r) was used to examine the correlation between the two reagents.Results:The domestic HDV RNA reagent demonstrated a high sensitivity of up to 6 IU/ml, consistent with that of the comparator reagent. The calibration curve for WHO HDV RNA standards had a slope of -3.286, with an amplification efficiency of 101.6%. The linear detection range spanned from 10 to 10 8 IU/ml for eight HDV genotypes. The domestic HDV RNA reagent exhibited exceptional specificity, without cross-reactivity observed with HAV, HBV, HCV, or HEV. Accuracy assessments at five concentration levels met the required standards, with intra-assay precision coefficient of variation ( CV) ranging from 1.20% to 4.20%, and inter-assay precision CV from 1.20% to 7.90%. The detection results for HDV IgG positive samples were highly correlated with the comparator reagent ( r=0.984, P<0.001), achieving a diagnostic accuracy of 100% compared to sequencing results. Conclusion:In this study, the domestic HDV RNA reagent possesses excellent specificity, accuracy, precision, and a broad linear range, attaining a sensitivity level on par with international reagents of the same type.

Ankylosing spondylitis (AS) combined with spinal fractures with thoracic and lumbar fracture as the most common type shows characteristics of unstable fracture, high incidence of nerve injury, high mortality and high disability rate. The diagnosis may be missed because it is mostly caused by low-energy injury, when spinal rigidity and osteoporosis have a great impact on the accuracy of imaging examination. At the same time, the treatment choices are controversial, with no relevant specifications. Non-operative treatments can easily lead to bone nonunion, pseudoarthrosis and delayed nerve injury, while surgeries may be failed due to internal fixation failure. At present, there are no evidence-based guidelines for the diagnosis and treatment of AS combined with thoracic and lumbar fracture. In this context, the Spinal Trauma Academic Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate the Clinical guideline for the diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture ( version 2023) by following the principles of evidence-based medicine and systematically review related literatures. Ten recommendations on the diagnosis, imaging evaluation, classification and treatment of AS combined with thoracic and lumbar fracture were put forward, aiming to standardize the clinical diagnosis and treatment of such disorder.

Objective:To investigate the related factors of vertebral body height reloss after pedicle screw fixation of thoracolumbar fracture and to determe the optimum prediction point.Methods:A retrospective case control study was made on 215 patients with thoracolumbar fracture admitted to Second Affiliated Hospital of Soochow University from January 2010 to December 2017. There were 155 males and 60 females，aged 21-80 years［（48.6±10.4）years］. According to Denis fracture classification，there were 73 patients with compression fractures（type A in 15 patients，type B in 51，type C in 7），135 burst fractures（type A in 28 patients，type B in 87，type C in 20）and flexion distraction fractures（type A in 4，type B in 2，type C in 1）. All patients were treated by pedicle screw fixation. Follow-up lasted for 12- 48 months［（23.8±8.2）months］. Vertebral body height loss occurred in 86 patients（loss group），but did not in 129 patients（non-loss group）. The two groups were compared concerning sex，age，osteoporosis self-assessment tool for Asians（OSTA），body mass index（BMI），fracture types，number of fractured vertebrae，preoperative sagittal Cobb angle，preoperative degree of vertebral compression，number of screws placed in injured vertebrae，extent of vertebral reset and other related factors. Univariate analysis was used to identify the correlation of those factors with vertebral body height reloss. Multivariate Logistic regression analysis was performed to identify the independent factors for the height reloss with the receiver operating characteristic curve（ROC）and area under the curve（AUC）calculated to evaluate the optimum point in prediction of vertebral height reloss.Results:The two groups showed no significant differences in sex，age，BMI，fracture types，number of injured vertebrae，preoperative sagittal Cobb angle and number of screws placed in injured vertebrae（ P>0.05），but the differences were statistically significant in OSTA，preoperative degree of vertebral compression and extent of vertebral reset（ P<0.05）. According to the univariate analysis，OSTA，preoperative degree of vertebral compression and extent of vertebral reset were significantly correlated with the occurrence of vertebral body height reloss（ P<0.05）. According to the multivariate Logistic regression，OSTA（ OR=1.109，95% CI 0.527-0.685， P<0.05）and preoperative degree of vertebral compression（ OR =0.038，95% CI 0.539-0.689， P<0.05）were significantly related to vertebral body height reloss. The AUC relating OSTA and preoperative degree of vertebral compression to vertebral body height reloss was 0.604 and 0.614，respectively. The optimum prediction point of OSTA and preoperative degree of vertebral compression for vertebral body height reloss was 1.9 and 31.3%，respectively. Conclusions:OSTA and the preoperative degree of vertebral compression are independent risk factors for vertebral body height reloss. OSTA≤1.9 or preoperative degree of vertebral compression ≥31.3% indicates a significantly higher risk of postoperative vertebral body height reloss.

Objective:To study the real-world outcome of China FDA-approved Sofosbuvir (SOF)/Velpatasvir (VEL) in Northwest China.Methods:In this multicenter, prospective, real-world cohort study, we recruited patients from 10 sites from Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated cirrhosis. The primary endpoint was sustained virological response at 12-weeks post-treatment (SVR12) and safety. The secondary endpoint was the change of liver function after the achievement of SVR12.Results:Totally, 143 patients were enrolled in the study, four patients were lost to follow-up and one died during the follow-up, 138 patients were included in per-protocol analysis. Of the 138 patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver cirrhosis, 10.1% HBsAg +, 6.5% renal dysfunction, 5.1% treatment-experienced, and 16.7% patients received ribavirin treatment. The genotype distribution was as follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 96.5% (138/143, 95% CI: 93.5%-99.6%) for intention-to-treat analysis, and in per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), as well as increased ALB and platelet count (all P < 0.001) at post-treatment 12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) occurred in 2 patients, one of whom needed a short-term interruption of treatment due to fatigue. Conclusion:In this real-world cohort study, 12-week SOF/VEL regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) with excellent safety profile among patients with HCV GT1/2/3 infection including patients with GT3 and cirrhosis, and led to improvement of liver function.

Multi-species solid-state fermentation in a mud pit is one of the typical features of strong-flavor baijiu, in which archaea plays important roles, however, the archaeal community distribution and diversity during fermentation are still lack of research. The biomass, composition and succession of archaea communities in fermented grains and pit mud were analyzed by high throughput sequencing. The potential interaction between archaea and bacteria was analyzed by co-occurrence network. Results demonstrate that the average biomass of archaea in pit mud was about 200 times higher than that of fermented grains. There was no significant difference in archaeal community structure between fermented grains and pit mud (r=0.017, P=0.074), but succession patterns between them showed significant correlation (r=0.30, P=0.03). Methanobacterium was the most abundant archaea in fermented grains and pit mud, and other dominant groups included Methanosarcina, Methanocorpusculum, Methanoculleus, and Methanobrevibacter. The co-occurrence network analysis showed that Methanobacterium was positively correlated with most bacteria in fermented grains and pit mud, especially with Hydrogenispora and Caproiciproducens, the dominant bacteria in pit mud. Our results revealed the temporal and spatial distribution characteristics and potential functions of the archaeal community in the mud pit of strong-flavor baijiu.
Alcoholic Beverages/analysis* ; Archaea/genetics* ; Bacteria ; Fermentation ; Taste

Objective:To evaluate the effect of zoledronic acid administration for osteoporotic vertebral compression fracture (OVCF) after treatment with percutaneous kyphoplasty (PKP).Methods:A retrospective case-control study was performed on 430 elderly patients with OVCF admitted to the Second Affiliated Hospital of Soochow University from January 2012 to December 2016. There were 31 males and 399 females, with age of 52-92 years[(72.8±8.3)years]. Fracture segments were at T 5-T 10 (82 vertebrae), T 11-L 2 (389 vertebrae) and L 3-L 5 (173 vertebrae). In zoledronic acid group ( n=178), patients were given zoledronic acid 3 days after PKP surgery. In basic treatment group ( n=252), patients were only given basic treatment after PKP surgery. Bone mineral density was measured before operation and one year after operation. Visual analogue scale (VAS) and Oswestry disability index (ODI) were assessed before operation, 3 days and one year after operation. Incidence rate of refracture, mortality and complication rate were recorded after operation. Results:All patients were followed up for 12-60 months (mean, 27 months). Before operation and at postoperative 1 year, the vertebral bone mineral density in zoledronic acid group was (-2.3±1.5)SD and (-1.2±2.3)SD ( P<0.05), and that in basic treatment group was (-2.2±1.2)SD and (-2.1±1.1)SD ( P>0.05). At postoperative 1 year, the bone mineral density in zoledronic acid group was significantly better than that in basic treatment group ( P<0.05). At preoperative 3 days, postoperative 3 days and postoperative 1 year, the VAS was (8.6±0.8)points, (2.8±0.8)points, (2.1±0.8)points in zoledronic acid group, and was (8.5±1.1)points, (2.9±0.9)points, (3.0±2.3)points in basal treatment group; ODI was 48.7±5.3, 24.0±2.9, 22.3±3.3 in zoledronic acid group, and was 48.3±6.1, 24.5±3.8, 27.6±4.0 respectively in basal treatment group. The VAS and ODI were significantly reduced in two groups at postoperative 3 days and 1 year compared to those before operation ( P<0.05). Moreover, the VAS and ODI in zoledronic acid group were significantly lower than those in basal treatment group at postoperative 1 year ( P<0.05). At postoperative 2 years, the incidence rate of refracture in zoledronic acid group was 10.1%(18/178), significantly lower than 16.7%(43/252) in basic treatment group ( P<0.05). Mortality rate in zoledronic acid group was 5.1%(9/178), and that in basic treatment group was 6.3%(16/252) ( P>0.05). No serious complications were observed in both groups such as nerve injury or pulmonary embolism. Conclusion:For OVCF patients, zoledronic acid given after PKP can improve the bone mineral density, reduce pain, fasten function recovery, and effectively decrease the refracture rate.

Objective To investigate the clinical efficacy of treating injury to the upper cervical spine with posterior internal fixation without bone graft fusion.Methods Included in this retrospective study were 35 patients with upper cervical injury who had been treated at Department of Orthopedics,The Second Affiliated Hospital to Soochow University from June 2010 to August 2017.They were 21 males and 14 females with an average age of 44.1 years (from 26 to 56 years).They were all treated firstly by posterior occipitocervical internal fixation or internal fixation with atlantoaxial pedicle screws without bone graft fusion.The internal fixation was then removed after a solid bone union was confirmed by X-ray.The scores of Japanese Orthopedic Association (JOA),visual analogue scale (VAS),Neck disability index (NDI) and neck stiffness were used to evaluate the functional recovery of the upper cervical spine.We also observed the rotational range of the upper cervical spine using functional CT scan of C 1-C2.Results All the pedicle screws were successfully implanted after satisfactory intraoperative reduction,leading to no injury to the vertebral artery or spinal cord.All patients were followed up for an average of 18.1 months (from 7 to 28 months).At preoperation,post-implantation and final follow-up,the JOA scores were 6.5 ± 1.4,7.7 ± 1.5 and 16.1 ± 0.8 points,the VAS scores 6.1 ± 1.6,2.8 ± 0.8 and 1.1 ± 0.9 points,and the NDI scores 37.9 ± 2.6,20.3 ± 3.8 and 3.7 ± 1.7 points,showing significant improvements after internal fixation and after removal of internal fixation (P ＜ 0.05).Serious neck stiffness was observed in none of the 35 patients,mild neck stiffness in 12 patients and freedom from neck stiffness in 23 patients.The postoperative radiological analysis revealed fine fracture reduction and bony union in all.After 6 to 12 months the rotation of upper cervical spine was obviously improved and the left-to-right range of rotation of C 1-C2 was 35.4° ± 2.6° as revealed by functional CT scan.Conclusion For the middle aged and young patients with new injury to the upper cervical spine,the posterior occipitocervical internal fixation or internal fixation with atlantoaxial pedicle screws can be performed without bone graft fusion at the first stage and removal of internal fixation can be done at the second stage so that the atlantoaxial rotation can be preserved to ensure satisfactory clinical efficacy while bone union can be also ensured and pain reduced.

Objectives To detect the level of soluble programmed death 1 (sPD-1) and soluble programmed death ligand 1 (sPD-L1) in serum and urine of children with primary nephrotic syndrome (PNS),and explore its clinical significance.Methods From July 2017 to November 2017,children with PNS admitted to the Children's Hospital Affiliated to Soochow University were divided into onset group (36 cases) and remission group (33 cases).Thirty healthy children who underwent medical examination for enrollment,undersize or overweight in the outpatient department of pediatric health care and inpatient department of Endocrinology were selected as healthy control group.Serum and urine samples were collected,in which the levels of sPD-1 and sPD-L1 were detected by enzyme-linked immunosorbent assay (ELISA).The correlation between serum and urine sPD-1,sPD-L1 levels and lymphocyte subsets,urinary protein were analyzed by Pearson and Spearman correlation analysis.Results The level of sPD-1 in serum was lower in remission group than those in healthy controlgroup [1.60(0.48,8.15) ng/ml vs 7.38(2.15,19.02) ng/ml,P ＜ 0.01].The level of urinary sPD-1 in onset group was higher than that in remission group [1.21(0.61,2.56) pg/μg vs 0.51(0.31,0.97) pg/μg,P ＜0.001] and healthy control group [1.21(0.61,2.56) pg/μg vs 0.82(0.34,1.15) pg/μg,P ＜ 0.01].The levels of sPD-L1 in serum and urine were higher in onset and remission group than those in healthy control group (P ＜ 0.001).The level of sPD-1 in the serum was positive correlated with the numbers of CD3+,CD3+CD4+,CD3+ CD8+ T lymphocytes and CD3-CD19+,CD19+CD23+ B lymphocytes (r=0.537,0.478,0.454,0.429 and 0.374;P=0.002,0.008,0.012,0.018 and 0.042).The level of sPD-1 in the urine had positive relation with the ratio of 24 hours urinary albumin and weight (24 h UmAlb/Wt),N-acetylglucosaminidase and urinary creatinine (UNAG/Cr) and β2 microglobulin and urinary creatinine (Uβ2MG/Cr) (r=0.409,0.588 and 0.276;P=0.016,0.000 and 0.032).Conclusions The dynamic changes of sPD-1 and sPD-L1 in serum and urine suggested that PD-1/PD-L1 signaling pathway is involved in the development process of childhood primary nephrotic syndrome.

Objectives To investigate the etiology, renal pathology, treatment, and prognosis of children's urinary system injury after hematopoietic stem cell transplantation (HSCT). Methods Clinical data of 81 children with urinary dysfunction after HSCT admitted to the Hematology Department in Children's Hospital of Soochow University were analyzed, and relevant literatures were reviewed. Results In 81 cases (50 males and 31 females), the age ranges from 8 months to 17 years old. Thirty cases (37%) with prerenal injury were recovered after active rehydration and other symptom specific treatment. There were 9 (11.1%) children with renal injury, four cases were given up therapy or transferred to other hospitals, thus lead to an unknown prognosis. Kidney biopsy was performed in the remaining five cases for pathological investigation. After active symptom-speific and etiology-based treatment, serum creatinine and glomerular filtration rate of four cases return to normal. But in the long-term follow-up,one case died of recurrence of primary disease, reinfusion of hematopoietic stem cell combined with renal failure. The remaining 3 patients were with chronic kidney disease (CKD). One case with renal thrombotic microangiopathy was in the chronic dialysis. Postrenal renal injuries were mainly hemorrhagic cystitis (28.4%) and urinary tract infection (16%). After a large dose of rehydration, urine alkalization and anti-infection therapy, they were recovered in the short term with a good prognosis. Conclusions Urinary injury after HSCT is mainly divided into three categories: prerenal, renal and postrenal, in which renal injury is prone to frequent recurrence.