1.Performance validation of a novel multiplex detection reagent for screening transfusion-associated infectious diseases
Miao LIU ; Qian ZHAO ; Na YAO ; Jing LI ; Jiahui ZHANG ; Ning YE ; Yuena XIE
Chinese Journal of Blood Transfusion 2026;39(5):650-655
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.
2.Application research of linear calibration using two reference substances in the establishment of qualitative standards for multi-component analysis of Saposhnikovia divaricata
YAN Jingyi ; ZHOU Hongxu ; TAO Muke ; XIE LinJuan ; JU Miao ; ZHANG Yi
Drug Standards of China 2026;27(1):0092-0099
Objective: Establishment of a HPLC method for six chemical components in Saposhnikovia divaricata (prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisamminoside, sec-O-glucosylhamaudol, psoralen, and imperatorin), comparison of the advantages and disadvantages of the dual-standard linear calibration method and the relative retention time method, and investigation of the feasibility of the linear calibration using two reference substances for qualitative analysis of multiple components in Saposhnikovia divaricata.
Methods: A HPLC method was employed, using 21 different brands and models of C18 columns. The mobile phase consisted of acetonitrile (A) and 0.02% phosphoric acid aqueous solution (B), with gradient elution (0-20 min, 18%A; 20-45 min, 18%A-50%A; 45-60 min, 50%A). The column temperature was set at 30 ℃, the flow rate was 1 mL·min-1, and the detection wavelength was 254 nm.
Results: The results predicted by the linear calibration using two reference substances were accurate and superior to those of the relative retention time method, and the six components exhibited good linear relationships within their respective ranges.
Conclusion: The established linear calibration using two reference substances accurately predicts the retention times of the target components. This method is stable and reliable, providing a reference for the establishment of digital standards in traditional Chinese medicine.
3.Prioritization of potential drug targets for diabetic kidney disease using integrative omics data mining and causal inference.
Junyu ZHANG ; Jie PENG ; Chaolun YU ; Yu NING ; Wenhui LIN ; Mingxing NI ; Qiang XIE ; Chuan YANG ; Huiying LIANG ; Miao LIN
Journal of Pharmaceutical Analysis 2025;15(8):101265-101265
Diabetic kidney disease (DKD) with increasing global prevalence lacks effective therapeutic targets to halt or reverse its progression. Therapeutic targets supported by causal genetic evidence are more likely to succeed in randomized clinical trials. In this study, we integrated large-scale plasma proteomics, genetic-driven causal inference, and experimental validation to identify prioritized targets for DKD using the UK Biobank (UKB) and FinnGen cohorts. Among 2844 diabetic patients (528 with DKD), we identified 37 targets significantly associated with incident DKD, supported by both observational and causal evidence. Of these, 22% (8/37) of the potential targets are currently under investigation for DKD or other diseases. Our prospective study confirmed that higher levels of three prioritized targets-insulin-like growth factor binding protein 4 (IGFBP4), family with sequence similarity 3 member C (FAM3C), and prostaglandin D2 synthase (PTGDS)-were associated with a 4.35, 3.51, and 3.57-fold increased likelihood of developing DKD, respectively. In addition, population-level protein-altering variants (PAVs) analysis and in vitro experiments cross-validated FAM3C and IGFBP4 as potential new target candidates for DKD, through the classic NLR family pyrin domain containing 3 (NLRP3)-caspase-1-gasdermin D (GSDMD) apoptotic axis. Our results demonstrate that integrating omics data mining with causal inference may be a promising strategy for prioritizing therapeutic targets.
4.Quantitative Determination of Taurine in Functional Drinks by Pre-Column Derivatization Capillary Electrochromatography Coupled with Electrochemiluminescence Detection
Xin TIAN ; Min ZHOU ; Lin XIE ; De-Xia BAI ; Miao-Miao ZHU ; Yong-Jun MA
Chinese Journal of Analytical Chemistry 2025;53(6):1010-1018
Using a novel(OH)n-C60@SiO2@Tm2O3@Ca5(PO4)3(OH)quaternary nano-particles/cross-linked chitosan coated open-tubular capillary column(QNPsC-OTCC)as the analytical column,a new method for highly selective determination of taurine(TAU)in functional drinks using pre-column derivatization capillary electrochromatography coupled with electrochemiluminescence(CEC-ECL)detection was established.In the experiments,it was found that adding hexamethylenetetramine as a co-catalyst in N-methylation derivative reaction could quantitatively convert TAU into a single derivative product that cuold be detected by ECL.With the help of Ru(bpy)32+reagent,the ECL peak intensity of TAU derivative was increased by more than 1000 times compared to the original TAU.In addition,a Ru-containing d-f cyano-bridged heterometallic coordination polymer modified platinum electrode was used instead of a bare platinum electrode as working electrode for ECL detection,which resulted in a further increase of the peak response of TAU derivatives about 5.7 times.Under optimized analytical conditions,by using betastatin hydrochloride(BSH)as the internal standard and simultaneously derivatized with TAU,the relative ratio of peak intensity of TAU and BSH derivatives showed a linear relationship with the initial TAU concentration in a two-segment ranges of 0.2-6.0 mmol/L and 6.0-10 mmol/L.The limit of detection of TAU was 0.09 mmol/L(S/N=3).The developed method was applied to determination of TAU contents in four commercial functional drink samples,and the relative standard deviations(RSDs)for relative intensity ratio were less than 0.9%,and the recoveries were in the range of 95.0%~102.0%,indicating good practicability of the method.
5.Association of metabolic syndrome status change and risk of carotid plaque
Shuang LIU ; Xinlei MIAO ; Ziping SONG ; Xiaoling XIE ; Manling HU ; Yuting SUN ; Fei XU ; Song LENG
Chinese Journal of Endocrinology and Metabolism 2025;41(3):204-211
Objective:To investigate the effect of changes in metabolic syndrome status and persistence on carotid plaque risk.Methods:This retrospective cohort study analyzed individuals who underwent routine health check-ups at the health management center of the Second Affiliated Hospital of Dalian Medical University from 2014 to 2023. Participants with at least three carotid ultrasound records meeting the inclusion criteria were classified into 4 groups based on changes in metabolic status: persistently metabolic health, transitioning from metabolic health to unhealth, transitioning from metabolic unhealth to health, and persistently metabolic unhealth. The cumulative incidence of carotid plaque in these groups was compared. A Cox proportional risk model was used to evaluate the relationship between changes in metabolic syndrome status, the number of metabolic syndrome components, and the risk of carotid plaque development. Restricted cubic spline analysis was applied to explore the association between changes in individual metabolic syndrome components and carotid plaque risk.Results:Compared to the persistently metabolic health group, the persistent unhealth group had the highest risk of developing carotid plaque( HR=1.35, 95% CI 1.05-1.74, P=0.021), followed by those who transitioned from metabolic health to unhealth and those who improved from metabolic unhealth to health. Furthermore, the risk of carotid plaque increased progressively with the number of metabolic syndrome components. Restricted cubic spline analysis revealed a nonlinear relationship between fasting blood glucose change and carotid plaque risk, while systolic blood pressure, diastolic blood pressure, waist circumference, triglycerides, and high-density lipoprotein-cholesterol showed a linear dose-response relationship with carotid plaque. Conclusions:The change of metabolic syndrome is associated with the risk of developing carotid plaque, and maintaining metabolic health, recovering from metabolic syndrome, or minimizing the number of metabolic syndrome components may be effective strategies to prevent carotid plaque formation.
6.Association between thyroid hormone sensitivity indices and metabolic dysfunction-associated steatotic liver disease in euthyroid population
Manling HU ; Xinlei MIAO ; Qianqian WANG ; Shuang LIU ; Xiaoling XIE ; Ziping SONG ; Yuting SUN ; Yangxuan HE ; Song LENG
Chinese Journal of Endocrinology and Metabolism 2025;41(9):747-754
Objective:To explore the relationship between thyroid hormone sensitivity and metabolic dysfunction-associated steatotic liver disease(MASLD) in a population with normal thyroid function, with a particular focus on sex-specific differences.Methods:This retrospective study included 41 355 euthyroid cases who underwent routine health examinations at the Health Management Centre of the Second Affiliated Hospital of Dalian Medical University from January 2014 to December 2023 were included. The free triiodothyronine(FT 3) to free thyroxine(FT 4) ratio(FT 3/FT 4) was calculated in order to reflect the peripheral sensitivity of the thyroid gland. Similarly, thyroid feedback quantile-based index(TFQI), thyrotrophic thyroxine resistance index(TT 4RI), and the FT 3-based TFQI-derived index(TFQI-FT 3) were calculated in order to reflect the central sensitivity of the thyroid gland. A Logistic regression was employed to analyse the effect of sex-specific thyroid hormone sensitivity indices on the prevalence of MASLD. The restricted cubic spline was used to analyse the non-linear relationship between the thyroid sensitivity hormone indices and MASLD. Furthermore, the correlation between the thyroid hormone sensitivity indices and MASLD in different subgroups was also analysed. Results:The prevalence of MASLD in the study population was 28.8%. After adjusting the model for confounders, the risk of MASLD increased by 7%, 3%, 10%, and 5% for each standard deviation increase in FT 3/FT 4, TFQI, TFQI-FT 3, and TT 4RI in the total population, respectively. The risk of MASLD increased by 6% and 5% for each standard deviation increase in FT 3/FT 4 and TFQI-FT 3 in men, respectively. For each standard deviation increase in FT 3/FT 4, TFQI, TFQI-FT 3, and TT 4RI in women, the risk of MASLD increased by 6%, 5%, 11%, and 5%, respectively. Higher FT 3/FT 4 and TFQI-FT 3 were positively associated with the risk of developing MASLD in men, and higher FT 3/FT 4, TFQI, TFQI-FT 3, and TT 4RI were positively associated with the risk of developing MASLD in women. There was a non-linear, inverted U-shaped relationship between TFQI and risk of MASLD in women. Subgroup analyses showed positive associations between FT 3/FT 4, TFQI, TFQI-FT 3, and MASLD. Conclusions:The thyroid hormone sensitivity indices may provide a basis for clinical prevention and management of MASLD in individuals with normal thyroid function. Additionally, FT 3/FT 4 and TFQI-FT 3 may indicate the risk of MASLD in the general population, while TFQI and TT 4RI are more suitable for assessing the risk of MASLD in women.
7.Monte Carlo simulation study of the effect of filter on radiotherapy dosimetry in superficial X-ray therapy apparatus
Li TAO ; Hui ZHANG ; Yikai WU ; Junyi LIU ; Miao QI ; Ning GAO ; Yankui CHANG ; Xi PEI ; Zhi CHEN ; Xie XU
Chinese Journal of Radiological Medicine and Protection 2025;45(3):194-201
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.
8.Treatment plan optimization for intensity-modulated brachytherapy based on the conjugate gradient algorithm
Miao QI ; Junyi LIU ; Shijun LI ; Yankui CHANG ; Jieping ZHOU ; Bing YAN ; Yong CHENG ; Aidong WU ; Xi PEI ; Xie XU
Chinese Journal of Radiological Medicine and Protection 2025;45(1):56-62
Objective:To investigate the application of the conjugate gradient (CG) algorithm to treatment plan optimization for intensity-modulated brachytherapy (IMBT).Methods:The general Monte Carlo software TOPAS was utilized to simulate the 192Ir source of IMBT, and the unit dose contribution matrix was calculated. An objective function was established using the weighted least squares method and was solved using the CG algorithm to achieve optimized IMBT treatment plans. The optimization was validated using five clinical cervical cancer cases under modulation width 60°. The dose distributions of IMBT treatment plans under 45°, 60°, 90°, 120°, and 180° modulation widths were compared using the Wilcoxon test to determine the optimal IMBT treatment plan for cervical cancer treatment. Results:The CG algorithm successfully optimized IMBT treatment plans under modulation width 60° for five cases within 22.2 s on average. On the premise of sufficient target dose coverage, the average D2 cm 3 values of the bladder and rectum in IMBT treatment plans were 3.66 and 1.97 Gy, respectively, representing reductions of 0.54 and 0.69 Gy compared to traditional brachytherapy plans. For the five modulation widths, the D90% values of all IMBT treatment plans reached 6 Gy, without statistically significant differences ( P > 0.05). The average D2 cm 3 values of the bladder in IMBT treatment plans were significantly lower than those in the traditional brachytherapy plans( P<0.05), with modulation width 60° associated with the greatest reduction of 0.61 Gy. In contrast, the average D2 cm 3 values of the rectum under 45°, 60°, and 90° modulation widths decreased by 0.63, 0.54, and 0.45 Gy, respectively, compared to traditional plans, with statistically significant differences( P<0.05). Conclusions:The CG method enables rapid achievement of optimized IMBT treatment plans that meet clinical requirements, and modulation width 60° contributes to valid dosimetric optimization. This study can serve as a guide for the clinical implementation of IMBT.
9.Clinical characteristics and outcomes of elderly patients with stage Ⅰ diffuse large B-cell lymphoma: a study by the Jiangsu Cooperative Lymphoma Group (JCLG)
Yi XIA ; Jing HE ; Weiying GU ; Tao JIA ; Tingxun LU ; Yongle LI ; Jiahao ZHOU ; Bingzong LI ; Haiying HUA ; Ping LIU ; Yuqing MIAO ; Yuexin CHENG ; Xiaoyan XIE ; Yunping ZHANG ; Wenzhong WU ; Zhuxia JIA ; Xuzhang LU ; Chunling WANG ; Liang YU ; Min XU ; Jinning SHI ; Weifeng CHEN ; Wanchuan ZHUANG ; Zhen QIAN ; Jun QIAN ; Haiwen NI ; Yifei CHEN ; Qiudan SHEN ; Jianyong LI ; Wenyu SHI
Chinese Journal of Internal Medicine 2025;64(6):504-513
Objective:To summarize the clinical characteristics of elderly patients with stage Ⅰ diffuse large B-cell lymphoma (DLBCL) and analyze the factors associated with prognosis.Methods:A case series study was conducted by retrospectively collecting clinical data from patients aged over 60 years with newly diagnosed stage Ⅰ DLBCL across 20 medical centers in Jiangsu Province, China, between June 2010 and April 2023. The involved site, classification and treatment plan were summarized. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method, and Cox regression model.Results:The study included 255 patients with a median age of 69 years, of whom 130 (51.0%) were male, 66 (25.9%) were aged ≥75 years and 26 (10.1%) had a high Charlson Comorbidity Index (CCI) score of ≥2. Extranodal involvement was observed in 163 (63.9%) patients, with the stomach (37.4%, 61/163), intestine (19.0%, 31/163), testes (11.0%, 18/163), and breast (7.4%, 12/163) being the most frequently affected sites. The non-germinal center B-cell (non-GCB) subtype was prevalent in 63.7% of patients (142/223), with no significant difference between the nodal and extranodal groups ( P=0.681). Furthermore, 73.9% (184/249) and 11.7% (29/249) of patients received the R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and R-miniCHOP regimen, respectively. The overall 3-year PFS rate was 81.5%, and the 3-year OS rate was 85.6%. Patients aged ≥75 years ( HR=2.910, 95% CI 1.565-5.408, P=0.001) and/or with a CCI score ≥2 ( HR=2.324, 95% CI 1.141-4.732, P=0.020) had a significantly poorer PFS. Incorporating age ≥75 years and CCI score ≥2 into the stage-modified international prognostic index (sm-IPI) can better stratify the prognosis of elderly patients with stage Ⅰ DLBCL. The 3-year PFS rate was 48.7% in the high-risk group versus 85.7% in the low-risk group ( P<0.001). Conclusions:Our findings show that the elderly patients with stage Ⅰ DLBCL were predominantly characterized by extranodal involvement (particularly in the stomach and intestinal tract) and non-GCB subtype. Age ≥75 years and CCI ≥2 were identified as independent prognostic factors. The newly established sm-IPI-75-CCI incorporating these factors demonstrated superior prognostic discrimination compared to conventional risk assessment systems.
10.Interpretation of the group standard of " Humanistic Caring Management Standards for Patients in the Operating Room"
Ruiying YU ; Xinyue MIAO ; Qingmin ZHANG ; Yilan LIU ; Shujie GUO ; Huiling LI ; Guo CHEN ; Chunlan ZHOU ; Ting LIU ; Shuhua DENG ; Hongzhen XIE ; Yu CHENG ; Yinglan LI ; Yanlan MA ; Xia XIN ; Yanjin LIU ; Yongyi CHEN ; Gendi LU ; Xiaoqin GAN ; Feng XU ; Zuwei XIA ; Li HE ; Qinqin CHEN ; Fukang ZHANG ; Songmei WU ; Yi LI ; Wenjuan ZHOU
Chinese Journal of Hospital Administration 2025;41(7):512-517
Humanistic caring for patients in the operating room refers to providing the whole process of caring medical services for patients in the operating room. In order to standardize humanistic caring services for patients in the operating room of medical institutions, improve the comprehensive service level of the operating room, and enhance the surgical experience of patients, the Chinese Association for Life Care released the group standard " Humanistic Caring Management Standards for Patients in the Operating Room" in December 2023. This article interpreted the basic requirements for humanistic caring of patients in the operating room, the environment and facilities for humanistic caring, the procedures and measures for humanistic caring, and the quality management framework, aiming to assist administrators and clinical practitioners across various levels of medical institutions in accurately understanding and effectively implementing the standard, and to provide essential textual reference and practical guidance for promoting the application of the standard.

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