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.

Objective:To investigate the analgesic effect of ultrasound-guided posterior quadratus lumborum block (QLB) combined with cocktail therapy after arthroscopic anterior cruciate ligament reconstruction (ACLR) surgery.Methods:A randomized controlled study was conducted on 87 patients who underwent arthroscopic ACLR surgery at the Yan'an Branch of Peking University Third Hospital (Yan'an Hospital of Traditional Chinese Medicine) from February 2021 to April 2023. The patients were randomly divided into three groups using the random number table method: Group A ( n = 29), Group B ( n = 29), and Group C ( n = 29). Group A received ultrasound-guided posterior QLB, Group B received cocktail therapy, and Group C received a combination of ultrasound-guided posterior QLB and cocktail therapy. Visual Analogue Scale (VAS) scores, knee function, intraoperative and postoperative general conditions, stress responses, inflammatory pain mediators, and adverse reactions were compared among the three groups. Results:At 2, 12, and 24 hours after surgery, VAS scores in Group C were (3.25 ± 0.41) points, (2.03 ± 0.28) points, and (0.65 ± 0.09) points, respectively, which were significantly lower than those in Group A [(4.68 ± 0.65) points, (3.28 ± 0.39) points, (1.68 ± 0.22) points, t = 10.02, 14.02, 23.34, all P < 0.001] and Group B [(4.79 ± 0.72) points, (3.20 ± 0.36) points, (1.72 ± 0.24) points, t = 9.49, 13.82, 22.48, all P < 0.001]. At 1 month after surgery, the Knee Society Score and Hospital for Special Surgery knee score in Group C were (92.02 ± 3.33) points and (90.05 ± 3.46) points, respectively, both of which were significantly higher than those in Group A [(81.85 ± 2.27) points, (82.57 ± 2.34) points, t = 13.59, 9.64, both P < 0.001] and Group B [(81.46 ± 2.38) points, (83.22 ± 2.40) points, t = 13.89, 8.73, both P < 0.001]. There were no statistically significant differences in maximum active range of motion and quadriceps strength among the three groups at 72 hours after surgery (both P > 0.05). The time to first ambulation, time to first straight leg raise, rate of rescue analgesia, and the number of effective activations of the analgesic pump in Group C were (22.08 ± 4.36) hours, (2.26 ± 0.30) hours, 3.45%, and (0.75 ± 0.16) times, respectively, all of which were significantly lower than those in Group A ( t = 3.24, 8.20, χ2 = 7.73, t = 19.29, all P < 0.001) and Group B ( t = 3.01, 7.51, χ2 = 6.44, t = 17.34, all P < 0.001). At 24 hours after surgery, serum levels of angiotensin II, adrenocorticotropin, β-endorphin, and prostaglandin E 2 in Group C were significantly lower than those in Groups A and B (all P < 0.05). There was no statistically significant difference in the incidence of adverse reactions among the three groups ( P > 0.05). Conclusion:The combination of cocktail therapy and ultrasound-guided posterior QLB can improve knee function in patients after arthroscopic ACLR surgery and provides effective and safe analgesia.

Objective To investigate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with CT-guided thermal ablation (radiofrequency ablation or microwave ablation) in treating intrahepatic cholangiocarcinoma.Methods The clinical data of 14 patients with pathologicallyproved intrahepatic cholangiocarcinoma,who were admitted to authors' hospital during the period from September 2009 to July 2013 to receive TACE with subsequent radiofrequency ablation (RFA) or microwave ablation (MWA),were retrospectively analyzed.A total of 18 lesions were detected in the 14 patients.The maximal diameter of the lesion (or the sum of maximal diameters if there were multiple lesions) ranged from 2.2 cm to 7.2 cm (mean 4.2±1.4 cm).After TACE,the lesion's complete ablation rate,surgical complications,tumor-free survival time and overall survival time were evaluated.Results Complete ablation was obtained in 15 lesions (83.3％,15/18).The incidence of moderate complications was 6.2％,and no severe complications or death occurred.After the treatment,the patients were followed up for 6-14 months,with a mean of (16.0±10.3) months.At the end of follow-up,6 patients (42.9％,6/14) died.The median tumor-free survival time in patients whose lesions obtained complete ablation was 17 months.The median survival time of all patients was 20 months.The 1-,2-and 3-year overall survival rates were 82.5％,41.3％ and 20.6％ respectively.Conclusion TACE combined with thermal ablation can be regarded as one of the treatment options for intrahepatic cholangiocarcinoma.

Objective To evaluate the efficacy and safety of transcatheter hepatic arterial chemoembolization (TACE) combined with CT guided radiofrequency ablation (RFA) for primary liver cancer in the caudate lobe.Methods Sixteen patients with primary liver cancer in the caudate lobe were treated with combination therapy of TACE and RFA.Complet ablation rate,overall and recurrence-free survival,and complications were evaluated.Results A total of 15 cases achieved complet ablation,complet ablation rate was 93.75％ (15/16).Recurrence-free survival time was 19.35 months,overall survival time was 44.62 months.Overall survival rates were 88.23％,66.65％ and 33.18％ at 1,3,5 years after therapy,respectively.Conclusion TACE combined with RFA is a safe and useful therapeutic option for treatment of primary liver cancer in the caudate lobe.

Objective:To explore the prognostic value of CysC and NT‐proBNP in patients with non‐ST elevation a‐cute coronary syndrome (NSTE‐ACS) .Methods :A total of 166 NSTE‐ACS patients hospitalized in our hospital from Jan 2012 to Dec 2012 were selected .They were followed up for 12 months ,then general data ,levels of CysC , NT‐proBNP ,hsCRP and cTnI etc .and incidence rate of MACE were recorded and measured .According to MACE occurrence during follow‐up or not ,156 cases were divided into non‐MACE group (n=137) and MACE group (n=19) ,risk factors for MACE in NSTE‐ACS patients were analyzed ,receiver operator characteristic curve (ROC) was performed ,and the optimal cutoffs of related indexes predicting MACE occurrence in these patients were analyzed . Results :Compared with non‐MACE group ,there were significant rise in age [ (60.26 ± 10.45) years vs .(64.16 ± 11.21) years] ,levels of CysC [ (1.02 ± 0.11) mg/L vs .(1.15 ± 0.12) mg/L] ,NT‐proBNP [ (251.97 ± 89.65) pg/ml vs .(347.93 ± 107.29) pg/ml] ,hsCRP [ (14.69 ± 3.53) mg/L vs .(17.13 ± 3.68) mg/L] and cTnI [ (0.36 ± 0.46) ng/ml vs .(0.90 ± 0.88) ng/ml] in MACE group ,P<0.05 or <0.01. Multi‐factor regression analysis indica‐ted that CysC ,NT‐proBNP and cTnI levels were independent predictors for MACE in NSTE‐ACS patients ( P<0.05 or <0.01) .ROC curves of CysC ,NT‐proBNP ,cTnI and hsCRP judging prognosis were drawn , only AUC of CysC and NT‐proBNP curves were >0.7 [CysC:0.784 ,95% CI:0.687~0.881 ;NT‐proBNP:0.753 ,95% CI :0.639~0.867] , and it′s analysis indicated that CysC=1.07 mg/L and NT‐proBNP=279.60 pg/ml were their optimal cutoff predicting MACE .Kaplan‐Meier survival curves with above two cutoffs as risk stratification cutoff indicated that survival time of high risk group was significantly shorter than that of low risk group (P<0.05) .Conclusion:Serum CysC and NT‐proBNP levels are independent predictors assessing prognosis in NSTE‐ACS patients .

Objective Comprehensive standards of active implantable medical devices with high risks are required by China's current industrial development, and standard problems and ideas are discussed in this paper.Methods Analysis of the status of China's active implantable medical device standards and international standards. For the booming field for active implantable medical devices with high risks, international standard’s problems, ideas and trends are analyzed. Results Bottleneck of the development of China's active implantable medical device standards is the lack of Chinese medical devices industry actual independent research and development capability. China's independent standard research on the basis of independent core technology of active implantable medical devices is the opportunity to promote the internationalization of China standard.Conclusion Improving the standards of active implantable medical devices based on independent core technology, combined with problems of existing international standards, to further improve and develop international standards and lead high level international technical standards.

Objective To explore the role and expression of cell apoptosis regulatory genes in patients with temporal lobe epilepsy characterized by hippocampus sclerosis.Methods The experimental specimens were obtained from 15 patients with temporal lobe epilepsy (epilepsy group) and 6 control samples (control group) were obtained from temporal lobe excision of brain trauma decompression,investigated neuron apoptosis by HE stain,TdT-mediated dUTP-biotin nick end labeling (TUNEL) method,and determined the expression of bcl-2,bax and caspase-3 by immunohistochemistry.Results The evidence of neuron apoptosis was not found by HE stain in both control group and epilepsy group.Positive cells was not found in control group,but was obviously observed in epilepsy group by TUNEL staining [(4.39 ± 2.04) numbers/100].Unlike that in normal adult brain,bcl-2 immunoreactivity was obviously observed in some neurons in epilepsy group[(6.72 ± 3.36) numbers/100] (P ＜ 0.01).Compared with control group,bax protein in epilepsy group was mild expression (P ＞ 0.05).Two cases in control group were detected the expression of caspase-3 protein,and caspase-3 significantly increased in epilepsy group [(1.07 ± 0.43),(9.54 ± 3.68) numbers/100] (P ＜ 0.01).Conclusions Neuron apoptosis is an important cause of hippocampal sclerosis of human epilepsy.bcl-2 and caspase-3 may play an important role in this process.

Objective To investigate the therapeutic effects of Tongxinluo and its influence on the expression of CD40 and CD40L in artherosclerosis rabbits. Methods 60 male rabbits were divided into three groups randomly,20 of each group: normal control group, model group and Tongxinluo group. The rabbits in model group and Tongxinluogroup were used to prepare the atherosclerosis model induced by high-cholesterol diet. The levels of ET-1, NOwere measurde. Before and 12 weeks after durg treatment,serum total cholesterol ,plaque areas and ratios of intima/media thickness were detected. The expression of CD40 and CD40L mRNA were determinated by quantitive RT-PCR. Results Serum total cholesterol level of Tongxinluo group was decreased compared with model group ( P < 0. 05 ), and they were both much higher than those of normal control group ( P < 0. 01 ); as compared with the model group, aortic plaque areas and ratios of intima/media thickness in Tongxinluo group reduced significantly [ (0.56 ± 0. 07) vs ( 1.16±0.08),P<0.01;(36.88±2.38)% vs (76.58 ±2.86) %,P <0. 0l] ;The expression of CD40 and CD40L mRNA also decreased in Tongxinluo group with statistic significance[ (0.798 ± 0.115 )、 (0. 592 ± 0. 132) vs (0.686±0. 132) 、(0.498 ±0. 108) ,P <0. 01 ) ]. Conclusion Tongxinluo had the ability to anti-artherosclerosis and its possible mechanism was down-regulate the expression of CD40 and CD40L.

Objective To determine the expression of human telomerase reverse transcriptase (hTERT) and P53 in thyroid carcinoma and its relationship with development and prognosis of the carcinoma. Methods Totally 90 cases of thyroid specimens (60 thyroid carcinomas, 10 thyroid adenomas, 10 goitres and 10 normal thyroid tissues) were studied by SP immunohistochemical method. Results Positive immunoreactivity of hTERT and P53 was higher in thyroid carcinoma (P<0.05). The positive rates of hTERT and P53 were higher in undifferentiated carcinomas, carcinomas with lymph nodes metastasis or at stage Ⅲ+Ⅳ than in well-differentiated carcinomas, carcinomas without lymph nodes metastasis or at stage Ⅰ+Ⅱ (P<0.05). The expression of hTERT was significantly related with that of P53 (P<0.05). Conclusion Over-expressed hTERT and P53 may be related to the carcinogenesis and progression of thyroid carcinoma and hTERT expression is related to P53 protein. Examination of expression of hTERT and P53 proteins may be helpful to judge the thyroid cancer's behavior and prognosis.