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.Longitudinal observation of ocular biometric parameters after intravitreal ranibizumab injection for retinopathy of prematurity
Jing YANG ; Qian WANG ; Conghui LI ; Le ZHANG
International Eye Science 2026;26(9):1501-1505
AIM:To assess the longitudinal changes in ocular biometric parameters after intravitreal ranibizumab(IVR)injection for the treatment of retinopathy of prematurity(ROP)in premature infants during the first year of life.METHODS:A longitudinal observational and comparative study was conducted on premature infants diagnosed with type 1 ROP, with a one-year follow-up. In treatment group, patients were administered with ranibizumab injection. The control group was set up without any intervention. All the patients were examined by A-scan ultrasound biometry at 0(40 gestational wk), 3, 6, and 12 mo of corrected gestational age(GA). Anterior chamber depth(ACD), lens thickness(LT), vitreous chamber depth(VCD), and axial length(AL)were measured. Anterior segment(AST)was calculated by summing up the ACD and LT.RESULTS:A total of 60 premature infants(60 eyes)were enrolled in this study, with a mean postmenstrual age of 36.80±2.86 wk, including 30 cases(30 eyes)in the treatment group and 30 cases(30 eyes)in the control group. The mean birth weight was 1157.50±232.12 and 1327.00±432.92 g, and the mean GA was 28.46±1.70 and 30.25±2.12 wk in treatment and control groups, respectively. No significant differences were found in all parameters at baseline(P>0.05). However, after correcting GA by 3, 6, and 12 mo, ACD was significantly greater than that of the control group at the 3rd, 6th, and 12th mo. LT was significantly thinner in the treatment group at the 3rd and 6thmo, but no statistically significant difference was observed between the two groups by the 12th mo. Throughout the follow-up period, AST, VCD, and AL were no significant differences in two groups(all P>0.05).CONCLUSION:Ranibizumab administered for the treatment of ROP only affected on ACD and LT. No significant effects are observed on AST, VCD, and AL during the first year of life.
3.Wall-broken ganoderma lucidum spore powder protects against DEN/CCl4-induced hepatocellular carcinoma in mice by modulating the Nrf2 pathway
Hai JIN ; Shuo WAN ; Qian LIU ; Siyu ZHAO ; Jing LI ; Jiaxing ZHU ; Jiaxing AN ; Feng JIN
Acta Universitatis Medicinalis Anhui 2026;61(7):1176-1182
ObjectiveTo investigate the therapeutic effect of wall-broken ganoderma lucidum spore powder (GLS) on a mouse model of hepatocellular carcinoma and to explore its underlying mechanism. MethodsFifty 2-week-old C57BL/6J mice were divided into a control group, a model group and low, medium and high-dose GLS groups(0.25, 0.5, 1.0 g/kg ), with 10 mice in each group. A DEN/CCL4 mouse hepatocellular carcinoma model was established, and GLS was administered by gavage starting from the 8th week, once a day for 14 weeks. At the end of the final administration, the number of liver nodules was observed , and the serum alpha-fetoprotein (AFP) was detected using enzyme-linked immunosorbent assay. The content of catalase (CAT) in serum and liver tissue was determined by ammonium molybdate method. The content of reduced glutathione (GSH) in serum and liver tissue was measured by microplate assay. The content of glutathione peroxidase (GSH-PX) in serum and liver tissue was detected by colorimetric method. Immunohistochemistry (IHC-P) was employed to detect the protein expression of proliferating cell nuclear antigen (PCNA). R eal-time fluorescence quantitative polymerase chain reaction was utilized to detect the relative expression of nuclear factor E2-related factor 2 (Nrf2), Kelch-like epichlorohydrin-associated protein 1 (Keap1), NAD(P)H quinone oxidoreductase 1 (Nqo1), heme oxygenase-1 (Ho-1) and glutamate cysteine ligase catalytic subunit (Gclc) mRNA. ResultsCompared with the control group, the content of serum AFP were significantly higher in the model group (P<0.01), while the contents of CAT, GSH and GSH-PX in liver and serum were significantly lower in the model group (P<0.01). The relative expression of Keap1 and Nqo1 mRNA was significantly higher (P<0.01), the relative expression of Nrf2, Ho-1, Gclc mRNA relative expression was significantly lower (P<0.01), and the positive expression rate of PCNA was significantly higher (P<0.01). Compared with the model group, the total number of liver nodules and content of serum AFP in the administered group were significantly lower (P<0.01), and the contents of CAT, GSH, and GSH-PX in the liver and serum of mice significantly increased (P<0.05 or P<0.01). The expression of Keap1 and Nqo1 mRNA significantly decreased (P<0.05). The expression of Nrf2, Ho-1 and Gclc mRNA significantly increased (P<0.05), and positive expression rate of PCNA significantly decreased (P<0.01). ConclusionGLS has a significant protective effect on DEN/CCL4 -induced mouse hepatocellular carcinoma model, and the mechanism of action is related to the regulation of oxidative stress in mouse liver.
4.Investigation of Effect of Different Drying Conditions on Appearance Characteristics and Internal Indicators of Pinelliae Rhizoma Based on Standardization
Suqing LIU ; Xueli ZHANG ; Jing ZHANG ; Cong YANG ; Changfu YANG ; Jun YU ; Bingpeng ZHENG ; Huiwu LI ; Yanhua JIANG ; Chang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):208-215
ObjectiveTo explore the effect of different drying conditions on the appearance and intrinsic quality indicators of Pinelliae Rhizoma for screening suitable drying conditions, so as to provide reference for its standardized production and quality evaluation. MethodsDifferent dried samples of Pinelliae Rhizoma were prepared by lime-assisted sweating method and intermittent drying method. Visual analysis was employed to measure the color brightness values(L*) of the surface, cross-section and powder of the samples, texture analyzer was used to determine the hardness of the samples under different drying conditions. The total starch content was calculated by measuring the contents of amylose and amylopectin in the samples with ultraviolet-visible spectroscopy. High performance liquid chromatography(HPLC) was used to determine the contents of seven nucleoside components(uracil, hypoxanthine, uridine, inosine, guanosine, β-thymidine and adenosine) in the samples. Pearson correlation analysis was conducted to explore the correlation between the external characteristics and intrinsic indicators of the different dried samples. Principal component analysis(PCA) was used to comprehensively rank the data of various indicators, and partial least squares-discriminant analysis(PLS-DA) was used to screen differential components with variable importance in the projection(VIP) value>1. Furthermore, the difference between the optimal drying condition for Pinelliae Rhizoma and the traditional sun-drying method was explored by independent samples t-test. ResultsWith the increase of temperature, the color of the intermittently dried samples gradually deepened, while their hardness gradually decreased. Concurrently, the contents of extract, total starch, uridine and adenosine exhibited an upward trend, whereas the contents of uracil, hypoxanthine and inosine displayed a downward trajectory. Compared with the intermittent drying group, the content of extract in the samples subjected to lime-assisted sweating increased. With the increase of lime dose, the hardness and the total content of nucleoside components in the samples showed a downward trend, while the total starch content showed an upward trend. Correlation analysis showed that the comprehensive score of L* was negatively correlated with the contents of uracil, hypoxanthine and inosine, and positively correlated with the contents of uridine, guanosine and adenosine. Hardness was negatively correlated with adenosine content, and positively correlated with the contents of inosine, uracil and hypoxanthine. Through comprehensive consideration and comprehensive score of principal components, the method of 5% lime-mixed sweating for 6 days emerged as the top-ranking approach. Except for the extract, the results of independent samples t-test showed that there was no significant difference between the 5% lime-mixed sweating for 6 days and the traditional sun-drying in terms of other content indicators. ConclusionThe whiteness and firmness of Pinelliae Rhizoma exhibit significant correlations with its chemical composition, while uridine, uracil, guanosine, adenosine and inosine are the key constituents responsible for the quality difference of Pinelliae Rhizoma under different drying conditions. The lime-assisted sweating method optimized in this study can be proposed as a viable alternative to the traditional sun-drying method. This method not only ensures the quality of the medicinal material but also effectively reduces the drying time and prevents mold contamination, which provides a valuable reference for the standardization of drying conditions and the establishment of quality evaluation criteria for Pinelliae Rhizoma.
5.Quality evaluation of Mongolian medicine Sendeng-4 based on qualitative and quantitative analysis combined with chemical pattern recognition
Fengye ZHOU ; Jun LI ; Qian ZHANG ; Rongjie LI ; Wei ZHANG ; Jing LIU ; Fang WANG ; Shengnan LI
China Pharmacy 2025;36(9):1040-1045
OBJECTIVE To evaluate the quality of Mongolian medicine Sendeng-4 based on qualitative and quantitative analysis combined with chemical pattern recognition, in order to provide the reference for its quality control. METHODS The chemical components in Sendeng-4 were analyzed qualitatively by HPLC-Q-Exactive-MS. The contents of 16 components (methyl gallate, ethyl gallate, epicatechin, dihydromyricetin, genipin-1-O-β-D-gentiobioside, caffeic acid, catechin, corilagin, deacetylasperulosidic acid methyl ester, rutin, geniposide, luteolin, myricetin, quercetin, ferulic acid, and toosendanin) in 15 batches of Sendeng-4 (sample S1-S15) were quantitatively analyzed by HPLC-MS/MS. Cluster analysis (CA), principal component analysis (PCA), and orthogonal partial least squares discriminant analysis were conducted and variable importance projection (VIP) value greater than 1 was used as the index to screen the differential components. RESULTS A total of 73 chemical components were identified in Sendeng-4, including 20 flavonoids, 16 tannins, 14 organic acids, etc. According to the quantitative analysis, the results exhibited that the average contentsthe of above 16 components in 15 batches of Sendeng-4 were 3.683-7.730, 2.391-6.952, 2 275.538-4 377.491, 2 699.188-3 537.924, 858.266-1 377.393, 3.366-11.003, 140.624-315.683,414.629-978.334, 285.501-1 510.457, 27.799-48.325, 3 625.415-6 309.563, 0.506-0.656, 442.337-649.283, 47.093-59.736, 12.942-15.822, 127.738-326.649 μg/g, respectively. According to the results of CA and PCA, 15 batches of samples could be clustered into two categories: S1-S3, S5-S6, S9-S10 and S13 were clustered into one category; S4, S7-S8, S11-S12, S14-S15 were clustered into one category. VIP values of geniposide, epicatechin, deacetylasperulosidic acid methyl ester and genipin-1-O- β-D-gentiobioside were all greater than 1. CONCLUSIONS HPLC-Q-Exactive-MS and HPLC-MS/MS techniques are employed for the qualitative and quantitative analysis of Sendeng-4. Through chemical pattern recognition analysis, four differential components are identified: geniposide, epicatechin, deacetylasperulosidic acid methyl ester, and genipin-1-O-β-D-gentiobioside.
6.Effects of Modified Guomin Decoction (加味过敏煎) on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern:A Randomized,Double-Blind,Placebo-Controlled Trial
Jing NIE ; Rui PANG ; Lingjiao QIAN ; Hua SU ; Yuanwen LI ; Xinyuan WANG ; Jingxiao WANG ; Yi YANG ; Yunong WANG ; Yue LI ; Panpan ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1031-1037
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction (加味过敏煎, MGD) in patients with mild to moderate atopic dermatitis (AD) of the traditional Chinese medicine (TCM) pattern of heart fire and spleen deficiency, and to explore its possible mechanisms. MethodsIn this randomized, double-blind, placebo-controlled study, 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion, while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy, TCM syndrome scores, Visual Analogue Scale (VAS) for pruritus, Dermatology Life Quality Index (DLQI) scores, Scoring Atopic Dermatitis (SCORAD) and serum biomarkers, including interleukin-33 (IL-33), interleukin-1β (IL-1β), immunoglobulin E (IgE), and tumor necrosis factor-α (TNF-α) were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% (28/36) in the treatment group and 38.89% (14/36) in the control group, with cure rates of 19.44% (7/36) and 2.78% (1/36), respectively. The treatment group showed significantly better clinical outcomes compared to the control group (P<0.05). The treatment group exhibited significant reductions in total TCM syndrome scores, including erythema, edema, papules, scaling, lichenification, pruritus, irritability, insomnia, abdominal distension, and fatigue scores, as well as reductions in VAS, DLQI, SCORAD, and serum IgE and IL-33 levels (P<0.05 or P<0.01). Compared to the control group, the treatment group had significantly better improvements in all indicators except for insomnia (P<0.05). No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus, improves TCM syndromes and quality of life, and enhances clinical efficacy, possibly through modulation of immune responses.
7.Concordance and pathogenicity of copy number variants detected by non-invasive prenatal screening in 38,611 pregnant women without fetal structural abnormalities.
Yunyun LIU ; Jing WANG ; Ling WANG ; Lin CHEN ; Dan XIE ; Li WANG ; Sha LIU ; Jianlong LIU ; Ting BAI ; Xiaosha JING ; Cechuan DENG ; Tianyu XIA ; Jing CHENG ; Lingling XING ; Xiang WEI ; Yuan LUO ; Quanfang ZHOU ; Ling LIU ; Qian ZHU ; Hongqian LIU
Chinese Medical Journal 2025;138(4):499-501
8.Aging and perioperative brain health: Mechanisms, management, and future.
Peilin CONG ; Qian CHEN ; Qianqian WU ; Jing WANG ; Xinwei HUANG ; Qian ZHANG ; Zheping CHEN ; Huanghui WU ; Yuxin ZHANG ; Mengfan HE ; Zhouxiang LI ; Li TIAN ; Lize XIONG
Chinese Medical Journal 2025;138(19):2381-2398
Globally, over 300 million surgeries are performed each year, and more than 50% of surgeries involve patients aged 65 and older. Aging poses significant challenges to perioperative brain health, as the deterioration of brain structure and function increases susceptibility to postoperative neurological complications. Protecting perioperative brain health remains a worldwide clinical challenge. With senescence, the brain undergoes a progressive decline in homeostasis across various molecular, cellular, and regional functions. Anesthetics and surgical stimuli may accelerate the disruption of brain homeostasis and exacerbate age-related neurodegeneration. This review provides a framework for understanding how anesthesia and surgery can affect brain health in the aging population and contribute to postoperative neurological complications, with a particular focus on perioperative neurocognitive disorder.
9.Exon Sequencing of HNF1β in Chinese Patients with Early-Onset Diabetes
Siqian GONG ; Hong LIAN ; Yating LI ; Xiaoling CAI ; Wei LIU ; Yingying LUO ; Meng LI ; Si-min ZHANG ; Rui ZHANG ; Lingli ZHOU ; Yu ZHU ; Qian REN ; Xiuying ZHANG ; Jing CHEN ; Jing WU ; Xianghai ZHOU ; Xirui WANG ; Xueyao HAN ; Linong JI
Diabetes & Metabolism Journal 2025;49(2):321-330
Background:
Maturity-onset diabetes of the young (MODY) due to variants of hepatocyte nuclear factor 1-beta (HNF1β) (MODY5) has not been well studied in the Chinese population. This study aimed to estimate its prevalence and evaluate the application of a clinical screening method (Faguer score) in Chinese early-onset diabetes (EOD) patients.
Methods:
Among 679 EOD patients clinically diagnosed with type 2 diabetes mellitus (age at diagnosis ≤40 years), the exons of HNF1β were sequenced. Functional impact of rare variants was evaluated using a dual-luciferase reporter system. Faguer scores ≥8 prompted multiplex ligation-dependent probe amplification (MLPA) for large deletions. Pathogenicity of HNF1β variants was assessed following the American College of Medical Genetics and Genomics (ACMG) guidelines.
Results:
Two rare HNF1β missense mutations (E105K and G454R) were identified by sequencing in five patients, showing functional impact in vitro. Another patient was found to have a whole-gene deletion by MLPA in 22 patients with the Faguer score above 8. Following ACMG guidelines, six patients carrying pathogenic or likely pathogenic variant were diagnosed with MODY5. The estimated prevalence of MODY5 in Chinese EOD patients was approximately 0.9% or higher.
Conclusion
MODY5 is not uncommon in China. The Faguer score is helpful in deciding whether to perform MLPA analysis on patients with negative sequencing results.
10.Usefulness of intraoperative choledochoscopy in laparoscopic subtotal cholecystectomy for severe cholecystitis
Rui-Hui ZHANG ; Xiang-Nan WANG ; Yue-Feng MA ; Xue-Qian TANG ; Mei-Ju LIN ; Li-Jun SHI ; Jing-Yi LI ; Hong-Wei ZHANG
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):192-198
Laparoscopic subtotal cholecystectomy (LSC) has been a safe and viable alternative to conversion to laparotomy in cases of severe cholecystitis. The objective of this study is to determine the utility of intraoperative choledochoscopy in LSC for the exploration of the gallbladder, cyst duct, and subsequent stone clearance of the cystic duct in cases of severe cholecystitis. A total of 72 patients diagnosed with severe cholecystitis received choledochoscopy-assisted laparoscopic subtotal cholecystectomy (CALSC). A choledochoscopy was performed to explore the gallbladder cavity and/or cystic duct, and to extract stones using a range of techniques. The clinical records, including the operative records and outcomes, were subjected to analysis. No LSC was converted to open surgery, and no bile duct or vascular injuries were sustained. All stones within the cystic duct were removed by a combination of techniques, including high-frequency needle knife electrotomy, basket, and electrohydraulic lithotripsy. A follow-up examination revealed the absence of residual bile duct stones, with the exception of one common bile duct stone, which was extracted via endoscopic retrograde cholangiopancreatography. In certain special cases, CALSC may prove to be an efficacious treatment for the management of severe cholecystitis. This technique allows for optimal comprehension of the situation within the gallbladder cavity and cystic duct, facilitating the removal of stones from the cystic duct and reducing the residue of the non-functional gallbladder remnant.

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