Objective: To validate the performance of the Procleix UltrioPlex E assay (Grifols, Spain) on the Procleix Panther automated nucleic acid detection platform, which employs the TMA method to simultaneously detect HIV-1/HIV-2/HCV/HBV/HEV viruses, and to evaluate its value for screening transfusion-associated infectious diseases. Methods: In accordance with the requirements of ISO15189"Application of the Guidelines for the Accreditation of Quality and Capabilities of Medical Laboratories in the Field of Molecular Diagnostics (CNAS-CL02-A009: 2018)", "Guidelines for Performance Validation of Molecular Diagnostic Testing Procedures (CNAS-GL039: 2019)", and the "Technical Operating Procedures for Blood Banks (2019 Edition)", this study validated the reagent's performance in terms of analytical sensitivity validation, performance consistency validation, interference resistance, and cross-contamination resistance. Results: Probit analysis revealed that the 95% detection limits (95% confidence interval) for HBV, HCV, HIV, and HEV were 2.0 IU/mL, 1.5 IU/mL, 18.0 IU/mL and 3.7 IU/mL, respectively, which were consistent with the minimum detection limits stated in the kit's package insert and were comparable to the Procleix Ultrio Elite kit. Both kits were used to test the performance validation serum plate simultaneously, yielding results consistent with the serum plate (Kappa=1), indicating stable performance. Detection of medium-and low-concentration lipemia and weakly positive hemolysis samples demonstrated good interference resistance. Cross-contamination performance validation showed that the kit exhibited excellent cross-contamination resistance. Conclusion: The Procleix UltrioPlex E nucleic acid detection kit enables combined detection of HIV-1, HIV-2, HCV, HBV, and HEV, allowing single-test screening for multiple viruses in donor blood. The kit's analytical performance is stable and meets basic laboratory requirements, making it suitable for screening transfusion-associated infectious diseases in blood banks.

AIM To compare the chemical constituents in traditional decoction and formula granule decoction of classical famous prescription Wendan Decoction.METHODS The HPLC fingerprints were established,after which the contents of adenosine,synephrine,liquiritin,naringin,hesperidin,6-gingerol and adenosine cyclophosphate were determined,cluster analysis,principal component analysis and multidimensional scaling analysis were adopted in the investigation of component differences,and the equivalent of formula granules was adjusted.RESULTS The similarities of HPLC fingerprints for 10 batches of traditional decoctions were higher than those of HPLC fingerprints for 9 batches of formula granule decoctions(P＜0.01).Adenosine,synephrine,liquiritin,hesperidin and cyclic adenosine monophosphate demonstrated higher contents in traditional decoctions than those in formula granule decoctions(P＜0.05),6-gingerol displayed lower content than that in the latter produced by manufacturers A,C(P＜0.05),which was higher than that in the latter produced by manufacturer B(P＜0.01).Various batches of traditional decoctions and formula granule decoctions could be obviously distinguished,adenosine,synephrine and hesperidin exhibited great influences on the classification of principal component analysis,and the quality of formula granule decoctions produced by manufacturer C was closer to that of traditional decoctions.After equivalent correction,the contents of various constituents in formula granule decoctions produced by manufacturers A,C showed no significant differences as compared with those in traditional decoction(P＞0.05).CONCLUSION The formula granules of Wendan Decoction from different manufacturers exist quality differences,so the preparation process and extraction process of this preparation should be optimized to improve quality,and equivalent ratio should be adjusted according to actual requirements to ensure its scientific and rational clinical application.

Objective To investigate the nebulization characteristics of human interferon α1b for injection.To characterize and compare the delivery rate,total drug substance and the aerodynamic characteristics between the two types of nebulizer.Methods Connect two types of nebulizers with a breathing simulator,respectively,and simulate the breathing patterns of an infant and child.Measure the delivery rate,total delivered dose,and delivery uniformity.The aerodynamic properties of human interferon α1b for injection were evaluated by the next generation impactor(NGI).The content of human interferon α1b was quantified by double antibody sandwich ELISA.Results In the three batches of samples in infant mode,the delivery rate and total delivered dose determind by A nebulizer were 0.45,0.49,0.44 μg·min-1,3.06,3.21,3.81 μg,respectcively;and 0.12,0.14,0.16 μg·min-1,0.73,0.73,0.75 μg,respectcively by B nebulizer.In child mode,the delivery rate and total delivered doses determined by A nebulizer were 1.36,1.49,1.20 μg·min-1,7.44,7.17,and 6.54 μg,respectcively;and 0.37,0.36,0.43 μg·min-1,1.66,1.59,and 1.41 μg,respectcively by B nebulizer.In child and infant mode,the ten results of the total drug substance delivered determined by nebulizer A were both between 65%to 135%of the average.The FPD,FPF,MMAD,and GSD determined by A neublizer of three batch samples were 2.48,2.92,2.35 μg,59.0%,57.4%,59.1%,4.18,4.34,4.15 μm,1.94,1.98,2.01,respectively.The FPD,FPF,MMAD and GSD determined by B neublizer of three batches samples were 2.70,3.38,3.06 μg,67.6%,66.4%,66.3%,3.55,3.65,3.68 μm,2.03,2.04,2.06,respectively.Conclusions The data obtained in this research characterized the in vitro nebulization characteristics of human interferon α1b for injection and provided a theoretical basis and reference for in vitro study and clinical practice.The influence of different types of nebulizers on nebulization characteristics was evaluated as well.It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.

Objective To explore the effects and mechanisms of bone marrow mesenchymal stem cells(BMSCs)in regulating microglial polarization on neuropathic pain in rats with sciatic nerve branch-selective injury(SNI).Methods Fifty SD rats were randomly divided into five groups with ten rats in each group;sham group(rats only exposed sciatic nerve without ligation),SNI group(SNI model was estab-lished),BMSCs group[rats were injected with BMSCs(1×106)through the sheath for 3 days after SNI modeling],BMSCs+sh-NC group[rats were intrathecally injected with BMSCs(1×106)and intrathecally injected with knock-down control(adenovirus 2.5×107 IU)for 3 days after SNI modeling],and BMSCs+sh-YY1 group[rats were intrathecally injected with BMSCs(1×106)and intrathecally injected with YY1 knockdown adenovirus(2.5×107 IU)for 3 days after SNI modeling].Neuropathic pain was assessed using paw withdrawal threshold(PWT)and paw withdrawal thermal latency(PWTL)following mechanical stimulation.Immunofluorescence was used to detect the expression of CD86,CD206,iNOS,and Arg1 in the rat spinal cord tissues.Western blotting was used to measure the expression of YY1 and KLF4 in spinal cord tissue.Results Compared with sham group,the values of PWTL and PWT in the SNI group significantly reduced(both P<0.05).In spinal cord tissue,the positive rates of iNOS and CD86 protein increased,whereas the positive rates of CD206 and Arg1 protein and the expression of YY1 and KLF4 decreased(all P<0.05).Compared with the SNI group,the values of PWTL and PWT in the BMSCs and BMSCs+sh-NC groups increased(all P<0.05),the positive rate of CD86 protein in the spinal cord decreased,whereas the positive rate of CD206 protein and the expression of YY1 and KLF4 increased(all P<0.05).Also,the positive rate of iNOS protein in the spinal cord tissue decreased and the positive rate of Arg1 increased in the BMSCs group(all P<0.05).Compared with the BMSCs and BMSCs+sh-NC groups,the PWTL and PWT values in the BMSCs+sh-YY1 group decreased(all P<0.05).The positivity rate of CD86 protein increased,the positivity rate of CD206 protein decreased,and the expression of YY1 and KLF4 decreased in the spinal cord tissue(all P<0.05).Conclusion Intrathecal injection of BMSCs promotes M2 polarization of microglia in the spinal cord and relieves neuropathic pain in rats with SNI,and its mechanism may be related to the upregulation of KLF4 expression mediated by YY1.

Objective To investigate the nebulization characteristics of human interferon α1b for injection.To characterize and compare the delivery rate,total drug substance and the aerodynamic characteristics between the two types of nebulizer.Methods Connect two types of nebulizers with a breathing simulator,respectively,and simulate the breathing patterns of an infant and child.Measure the delivery rate,total delivered dose,and delivery uniformity.The aerodynamic properties of human interferon α1b for injection were evaluated by the next generation impactor(NGI).The content of human interferon α1b was quantified by double antibody sandwich ELISA.Results In the three batches of samples in infant mode,the delivery rate and total delivered dose determind by A nebulizer were 0.45,0.49,0.44 μg·min-1,3.06,3.21,3.81 μg,respectcively;and 0.12,0.14,0.16 μg·min-1,0.73,0.73,0.75 μg,respectcively by B nebulizer.In child mode,the delivery rate and total delivered doses determined by A nebulizer were 1.36,1.49,1.20 μg·min-1,7.44,7.17,and 6.54 μg,respectcively;and 0.37,0.36,0.43 μg·min-1,1.66,1.59,and 1.41 μg,respectcively by B nebulizer.In child and infant mode,the ten results of the total drug substance delivered determined by nebulizer A were both between 65%to 135%of the average.The FPD,FPF,MMAD,and GSD determined by A neublizer of three batch samples were 2.48,2.92,2.35 μg,59.0%,57.4%,59.1%,4.18,4.34,4.15 μm,1.94,1.98,2.01,respectively.The FPD,FPF,MMAD and GSD determined by B neublizer of three batches samples were 2.70,3.38,3.06 μg,67.6%,66.4%,66.3%,3.55,3.65,3.68 μm,2.03,2.04,2.06,respectively.Conclusions The data obtained in this research characterized the in vitro nebulization characteristics of human interferon α1b for injection and provided a theoretical basis and reference for in vitro study and clinical practice.The influence of different types of nebulizers on nebulization characteristics was evaluated as well.It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.

Objective:To explore the dosimetry optimization strategy based on filter thickness and shape selection for the bulb superficial X-ray radiotherapy unit.Methods:Monte Carlo code TOPAS was used to model tubular equipment, and the dose distribution from six X-ray energies (50-150 kV) and five conventional aluminum filters (0.5-3.0 mm) with different thickness were simulated in the water model. The percentage depth dose (PDD) curve along the central axis, the center-axis profile dose at different depths, and the lateral dose distribution were analyzed. The dose distribution of three different designs of aluminum filters (conventional cylindrical, conical and oblique cylindrical filters) was compared to evaluate the effect of dosimetric optimization of different filter shapes.Results:Under the same energy, increasing the thickness of the filter can optimize the superficial skin dose, and the optimization effect of depth dose uniformity can be increased by 26% at a depth of 5.5 mm at 70 kV energy. The raised, flat and inclined dose distribution modes can be achieved by using conventional cylindrical, conical and inclined aluminum filters.Conclusions:By selecting the appropriate X-ray energy and filter thickness, an ideal dose distribution matching the tumor depth can be achieved. The application of personalized filters is also of great significance for diverse target areas.

Objective:To investigate the immuno-inflammatory regulatory effects of the Qing Gan San Jie Xiao Ying Formula(QGSJXYF)on Hashimoto's thyroiditis(HT)by modulating thyroid cell-derived exosomes to provide experi-mental evidence for its immunomodulatory mechanisms.Methods:Nthy-ori-3-1 thyroid cells were treated with QGSJXYF-medicated serum,with untreated cells serving as controls.Exosomes from both groups were extracted and analyzed using nanoparticle tracking analysis(NTA),transmission electron microscopy(TEM),and Western blot to assess concentration,size distribution,morphology,and the expression of characteristic exosomal markers.An inflammatory model of human T lymphocytes(H9)was established and co-incubated with normal exosomes(EXO-C group)or QGSJXYF-treated exosomes(EXO-T group).The levels of inflammatory cytokines in H9 cells were measured using Western blot(WB)and ELISA.Results:Exosome characterization showed that the particle concentration of Nthy-ori-3-1 cell-derived exosomes in both the control and QGSJXYF groups ranged from 1×109 to 1×1011/mL,with particle diameters between 80～300 nm.The exosomes exhibited a typical spherical or cup-shaped morphology with positive expression of TSG101,CD63,and HSP70.Compared with the inflammation model group and the EXO-C group,the EXO-T group significantly reduced the intracellular expression of IL-17A protein in H9 cells(P<0.05)and suppressed IL-17 and IL-6 levels in the cell supernatant(P<0.01).Conclusion:QGSJXYF may exert its anti-inflammatory and thyroid-protective effects by modulating the functional state of thyroid cell-derived exosomes,regulating the inflamma-tory microenvironment,and inhibiting the expression of inflammatory cytokines associated with Hashimoto's thyroiditis.

Objective:To compare minimally invasive surgery with traditional open surgery, analyze the current application status of health economic evaluations in the treatment of digestive tract cancers, such as esophageal cancer, gastric cancer, and colorectal cancer by minimally invasive surgery and provide evidence for the rational selection of clinical treatment, alleviation of disease-related economic burdens, and rational allocation of healthcare resources.Methods:By using five databases, i.e. China National Knowledge Infrastructure, Wanfang data, Chinese Biomedical Literature Database, PubMed, and Embase, a database was established to retrieve all the papers about health economic studies of minimally invasive surgery for esophageal cancer, gastric cancer, and colorectal cancer published until December 31, 2023. Literature was analyzed by using software NoteExpress 3.8, and data were processed using Excel 2021. The quality of included papers was evaluated using the CHEERS 2022 checklist, and Meta-analysis was conducted by using software Stata 17.0.Results:A total of 10 919 relevant papers were retrieved, and 59 studies were included. Only 14 studies (23.7%) used standard health economic evaluation methods. Meta-analysis results revealed no significant differences in direct medical expenditure and total expenditure between minimally invasive surgery and open surgery. However, the expenditure for minimally invasive surgery exhibited a significant increase [mean difference ( MD)=5 973.12 yuan, P<0.001], while hospital stay and indirect expenditure significantly decreased ( MD: -4.85 days and -733.79 yuan, P<0.001). In China, for gastric cancer, the direct medical expenditure of endoscopic surgery was lower than that of open surgery ( MD=-33 000.00 yuan) with no significant difference ( P<0.001). In colorectal cancer cases, the direct medical and surgical expenditures for laparoscopic surgery were higher than those for open surgery ( MD: 4 277.94 yuan and 4 267.80 yuan, P<0.001), while the indirect and total medical expenditures decreased ( MD: -768.34 yuan and -159.10 yuan). Hospital stays in patients who had minimally invasive surgery for all three types of cancer were shorter than those who had open surgery ( P<0.001). Conclusions:In the treatment of gastrointestinal cancer, compared with open surgery, minimally invasive surgery shows higher expenditure, but has advantages, such as shorter hospital stay and lower indirect expenditure, and there were no significant differences in direct medical and total expenditures between the two approaches. When conducting health economic evaluation, factors such as postoperative complications, hospital stay, and patient's economic status should be considered for their impact on total medical expenditure. It is necessary to pay attention to the application of health economic evaluations in healthcare decision-making.

Objective:To investigate the clinical efficacy of minimally invasive double anchoring combined with percutaneous kyphoplasty (PKP) for Kümmell disease.Methods:The clinical data of 24 patients with Kümmell disease who were treated with minimally invasive double anchoring combined with PKP in Cangzhou People's Hospital from October 2022 to March 2024 were retrospectively analyzed. Among them, there were 2 T 10 vertebrae, 5 T 11 vertebrae, 7 T 12 vertebrae, 6 L 1 vertebrae, and 4 L 2 vertebrae. There were 6 males and 18 females. The average age was 72.05±4.52 years (range, 66-80 years). The bone mineral density T value was -3.41±0.77 (range, -2.5-4.5). The stages of Li's Kümmell disease included 13 cases of stage II and 11 cases of stage III. The operation time, intraoperative blood loss, and volume of bone cement injected were recorded. The vertebral index, vertebral angle and Cobb angle of diseased segment were measured before and after operation. The visual analogue scale (VAS) was used to assess the degree of pain, the Oswestry disability index (ODI) and the Japanese Orthopaedic Association (JOA) low back pain scale were used to assess spinal function. The Medical Outcome Study short form 36 item health survey (SF-36) was used to assess the general health status of the patients. The postoperative symptom recovery was evaluated by Odom criteria. Results:The mean operative time of the 24 patients was 35.32±6.86 min, the injected volume of bone cement was 4.39±1.72 ml, and the intraoperative blood loss was 16.56±5.21 ml. All patients were followed up for 10 to 14 months, with an average of 11.7 months. Postoperative CT examination showed that the screw positions were satisfactory, and no loosening or displacement of bone cement mass occurred. On the first day after surgery, the vertebral body index, vertebral body angle and Cobb angle of diseased segment were 77.71%±2.75%, 12.40°±1.53° and 25.77°±4.49°, respectively, which represented significant improvements from the preoperative values of 43.09%±5.66%, 22.12°±2.92° and 46.98°±5.68° before surgery ( P<0.05). At the last follow-up, the values were 76.18%±2.32%, 12.41°±2.53°, 26.14°±4.87°, respectively, which were significantly improved compared with those before surgery ( P<0.05), but there was no statistical significance compared with the first day after surgery ( P>0.05). The VAS, ODI and JOA scores on the first day after surgery were 2.11±0.87 points, 22.46±5.49 points and 27.68±2.45 points, respectively, which were significantly improved compared with those before surgery 7.50±0.98 points, 76.25±8.56 points and 14.96±4.91 points ( P<0.05). At the last follow-up, the values were 2.26±0.88, 23.87±3.25 and 26.58±2.77, respectively, which were significantly improved compared with those before surgery ( P<0.05), and there was no statistical significance compared with the first day after surgery ( P>0.05). All 24 patients completed SF-36 scale assessment, and the results showed that there were statistically significant differences in physiological function, physiological role, physical pain, general health status, social function scores and mental health between the patients before surgery and the last follow-up ( P<0.05), while there were no statistically significant differences in vitality and emotional function ( P>0.05). At the last follow-up, the Odom criteria showed excellent results in 18 cases, good in 4 cases, and fair in 2 cases. Conclusions:The application of minimally invasive double anchoring (single nail fixation) combined with PKP in the treatment of Kümmell disease can effectively prevent the loosening and displacement of bone cement masses, and the fixation effect is satisfactory, which can restore the height of the injured vertebrum, reduce kyphosis and improve spinal function. The clinical symptoms of the patients were significantly improved, and the quality of life was enhanced.

AIM To compare the chemical constituents in traditional decoction and formula granule decoction of classical famous prescription Wendan Decoction.METHODS The HPLC fingerprints were established,after which the contents of adenosine,synephrine,liquiritin,naringin,hesperidin,6-gingerol and adenosine cyclophosphate were determined,cluster analysis,principal component analysis and multidimensional scaling analysis were adopted in the investigation of component differences,and the equivalent of formula granules was adjusted.RESULTS The similarities of HPLC fingerprints for 10 batches of traditional decoctions were higher than those of HPLC fingerprints for 9 batches of formula granule decoctions(P＜0.01).Adenosine,synephrine,liquiritin,hesperidin and cyclic adenosine monophosphate demonstrated higher contents in traditional decoctions than those in formula granule decoctions(P＜0.05),6-gingerol displayed lower content than that in the latter produced by manufacturers A,C(P＜0.05),which was higher than that in the latter produced by manufacturer B(P＜0.01).Various batches of traditional decoctions and formula granule decoctions could be obviously distinguished,adenosine,synephrine and hesperidin exhibited great influences on the classification of principal component analysis,and the quality of formula granule decoctions produced by manufacturer C was closer to that of traditional decoctions.After equivalent correction,the contents of various constituents in formula granule decoctions produced by manufacturers A,C showed no significant differences as compared with those in traditional decoction(P＞0.05).CONCLUSION The formula granules of Wendan Decoction from different manufacturers exist quality differences,so the preparation process and extraction process of this preparation should be optimized to improve quality,and equivalent ratio should be adjusted according to actual requirements to ensure its scientific and rational clinical application.