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.Clinical Efficacy and Mechanism of Anmei Dan in Treating Insomnia with Amnesia Based on Principle of Treating Different Diseases with Same Method: A Review
Qiqi FENG ; Bo XU ; Kang SUN ; Miao ZHU ; Zhi ZHANG ; Jing XIA ; Guangjing XIE ; Yuan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):107-116
In modern society, the comorbidity of insomnia with amnesia has shown a significantly increasing incidence and become increasingly severe, emerging as a public health issue that endangers people's physical and mental health and quality of life. Anmei Dan (AMD), originally recorded in the Shishi Milu by CHEN Shiduo in the Qing Dynasty, possesses profound theoretical foundations and distinct clinical advantages in ameliorating insomnia with amnesia. Basic research has unequivocally confirmed its definite therapeutic effects on insomnia with amnesia and revealed partial mechanisms. AMD is therefore a veritable classic prescription embodying the principle of treating different diseases with the same method for insomnia and amnesia. However, few researchers have reviewed the related research progress. This article systematically summarized the theoretical connotations of traditional Chinese medicine in treating insomnia with amnesia, delineated the multi-component material basis of AMD in ameliorating insomnia with amnesia (including various chemical components such as ginsenosides, jujubosides, and salvianolic acids), and evaluate its multi-dimensional clinical efficacy (e.g., prolonging total sleep time, improving sleep efficiency, and enhancing memory). Moreover, it systematically summarizes the multi-pathway mechanisms of action. The results indicate that AMD has a clear material basis, definite clinical efficacy, and a favorable safety profile in ameliorating insomnia and amnesia. AMD may exert the therapeutic effect by regulating sleep-wake rhythms, enhancing synaptic plasticity, inhibiting neuroimmune inflammation, and modulating autophagy, oxidative stress, and energy metabolism. In conclusion, AMD exerts synergistic effects through multi-component, multi-dimensional, and multi-pathway approaches, serving as an important prescription for enriching and developing the theory of treating different diseases with the same method for insomnia with amnesia.
4.Mechanisms of Diabetic Tendinopathy and Exercise Intervention
Ya-Ke WU ; Rui DENG ; Yu-Miao XIE ; Fang ZOU ; Shuai-Wei QIAN
Progress in Biochemistry and Biophysics 2026;53(8):2041-2052
Diabetic tendinopathy is a common and disabling musculoskeletal complication of diabetes, clinically characterized by tendon thickening, pain, impaired healing capacity and compromised biomechanical performance, collectively undermining joint function and quality of life. Its pathogenesis is multifactorial. On the one hand, chronic hyperglycaemia promotes the abnormal accumulation of advanced glycation end products (AGEs) within tendon collagen, leading to non-enzymatic crosslinking and engagement of the receptor for AGEs (RAGE), which in turn triggers inflammasome activation and sustains inflammatory responses. On the other hand, the diabetic milieu disrupts collagen metabolic homeostasis, impairs microvascular function and induces peripheral neuropathy; together, these alterations drive extracellular matrix degeneration and weaken the mechanical properties of tendon. Exercise, as a non-pharmacological intervention, can ameliorate these pathological changes through multiple integrated mechanisms. First, exercise attenuates tendon inflammation and restores microenvironmental homeostasis. Regular physical activity reduces AGE-RAGE signalling, thereby suppressing downstream expression of tumour necrosis factor (TNF) and interleukin-1β (IL-1β), while upregulating the anti-inflammatory cytokine interleukin-10 (IL-10). This shift from a pro-inflammatory to a pro-resolving milieu not only restrains chronic inflammation but may also limit excessive inflammasome activation in tenocytes and tissue-resident immune cells. Second, exercise enhances local expression of insulin-like growth factor 1 (IGF-1), thereby activating the phosphoinositide 3-kinase (PI3K)-protein kinase B (Akt) signalling pathway. This axis stimulates tenocyte proliferation, augments synthesis of type I collagen —— the principal load-bearing component of tendon —— and thereby promotes tissue repair, preserves tensile strength and supports matrix synthesis and structural integrity. In addition, exercise improves blood supply and nutrient delivery to tendon by increasing the expression of vascular endothelial growth factor (VEGF), connective tissue growth factor (CTGF) and the small leucine-rich proteoglycan decorin (DCN), thereby enhancing capillary growth, coordinating collagen fibrillogenesis and actively suppressing pathological vascular calcification. Exercise also increases the expression of angiopoietin-like 4 (ANGPTL4), fibroblast growth factor 2 (FGF-2) and CD34. Through the concerted actions of these factors, exercise promotes angiogenesis, restores the microvascular network and ensures adequate oxygen and nutrient supply to relatively ischaemic tendon tissue. Finally, exercise elevates levels of brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), supporting neuronal survival, axonal growth and the function of sensory and sympathetic nerve endings within tendon, thereby exerting neurotrophic and neuromodulatory effects and improving tendon innervation and neuromuscular control. Moreover, exercise upregulates collapsin response mediator protein 2 (CRMP-2), a molecule involved in axonal guidance and regeneration, and moderately increases the activity of substance P (SP), thereby helping to regulate neurogenic inflammation, pain perception and trophic support for tenocytes. Drawing together current evidence, this review systematically summarizes the mechanisms underlying diabetic tendinopathy and examines the mechanistic basis of exercise intervention, with the aim of providing a theoretical framework for the development of precise exercise strategies for affected individuals. However, several key issues remain unresolved: the therapeutic efficacy and mechanistic specificity of different exercise modalities in diabetic tendinopathy have yet to be defined, and early diagnostic biomarkers remain insufficiently characterized. Future studies should apply multi-omics approaches to profile AGE subtypes, miRNA signatures and collagen metabolic products, and should also clarify the adverse effects and underlying mechanisms of excessive exercise or mechanical overloading in diabetic tendinopathy. Such efforts will further elucidate the therapeutic effects and mechanisms of exercise in diabetic tendinopathy and provide a stronger basis for precision exercise prescription and fitness guidance in patients with diabetes.
5.Pathogenic Mechanisms and Advances in Diagnosis and Treatment of Cancer-Related Anorexia
Zehao LIU ; Miao XU ; Peng XUE ; Shijie ZHU ; Feiyu XIE
Cancer Research on Prevention and Treatment 2026;53(8):616-624
Cancer-related anorexia (CRA) is a common and severe complication of malignant tumors. It is characterized by persistent appetite loss, early satiety, and reduced food intake. It directly leads to malnutrition, decreased treatment tolerance, reduced quality of life, and worsened prognosis. Its pathogenesis is complex, involving a multilayered network of interactions, including the dysregulation of the hypothalamic feeding center, imbalance of peripheral appetite hormones and systemic inflammatory mediators, and actions of tumor-derived factors. It is also highly influenced by anticancer treatments, such as chemotherapy, radiotherapy, and surgery. Current clinical management is dominated by multimodal comprehensive therapy based on progestogens, glucocorticoids and prokinetic agents, combined with nutritional support, rehabilitation exercise, psychological intervention and traditional Chinese medicine. However, highly effective approaches capable of fundamentally reversing the disease course of CRA are still lacking. This article provides a systematic review of the pathophysiological mechanisms, clinical assessment tools, and comprehensive treatment strategies for CRA. It also presents a discussion on future research directions based on the latest advances to provide a theoretical basis and reference for optimizing clinical practice and developing novel intervention strategies.
6.Interpretation and Enlightenment of Expert Consensus on Clinical Application of Yifei Zhike Capsules
Wenye FENG ; Hongchun ZHANG ; Xuefeng YU ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Jing REN ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(23):178-185
ObjectiveTo interpret the main contents of the Expert Consensus on Clinical Application of Yifei Zhike Capsules (hereinafter referred to as the Consensus), analyze its evidence basis, and explore future research directions, thus providing a reference for rational drug use in clinical practice. MethodsThe core contents of the Consensus are summarized. Focusing on clinical issues, this paper summarizes the recommendations and consensus suggestions in the Consensus and explains them from aspects such as indications, key advantages, usage and dosage, combined medication, contraindications, precautions, and safety. ResultsThe Consensus clearly states that Yifei Zhike capsules can be used for acute or chronic bronchitis, pulmonary tuberculosis and other respiratory system diseases. It for the first time proposes that the applicable TCM syndrome of Yifei Zhike capsules is Qi-Yin deficiency together with combined phlegm and stasis. For different diseases, the Consensus provides specific usage instructions, dosage, and treatment course recommendations, supplementing the contents not covered in the drug instructions. In terms of combined medication, the Consensus emphasizes the principle of using this drug in combination with standardized chemotherapy regimens or conventional Western medicines and the applicability for the treatment of pulmonary tuberculosis and moderate to severe acute or chronic bronchitis. In terms of safety, the Consensus proposes methods for identifying common adverse reactions, drug contraindications, and precautions based on a review of the existing data and preliminarily builds a risk management framework. However, the evidence on which the Consensus is based are mostly early studies, with small sample sizes, which result in the low evidence grades (mainly C and D) of some recommendations. ConclusionThe Consensus provides specific guidance for the clinical use of Yifei Zhike capsules. However, due to the limited quality of the existing research evidence, more high-quality clinical studies are needed in the future to further verify its efficacy, safety, and explore its broader application prospects.
7.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):1787-1799
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 evi-dence.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 likeli-hood 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.
8.A multicenter retrospective study on the clinicopathological features, genetic variant profiles and prognosis of patients with previously untreated Diffuse large B-cell lymphoma.
Yongning JIANG ; Jie ZHANG ; Yaping ZHANG ; Yi XIA ; Yi MIAO ; Haiwen NI ; Jinning SHI ; Xiaohui ZHANG ; Min XU ; Haiying HUA ; Yun ZHUANG ; Wenzhong WU ; Maozhong XU ; Xiaoyan XIE ; Zhuxia JIA ; Yuqing MIAO ; Min ZHAO ; Jianyong LI ; Wenyu SHI
Chinese Journal of Medical Genetics 2025;42(9):1069-1077
OBJECTIVE:
To explore the impact of age on the genetic variant spectrum and prognosis of patients with previously untreated Diffuse large B-cell lymphoma (DLBCL).
METHODS:
A retrospective analysis was conducted on the clinical data and follow-up information of 254 previously untreated DLBCL patients from 14 hospitals in the Jiangsu Cooperative Lymphoma Group (JCLG) enrolled from July 2018 and July 2023. Following extraction of DNA from tumor tissue samples, next-generation sequencing (NGS) technique was employed to analyze the genetic variant spectrum of the DLBCL patients, with an evaluation of the relationship between age and genetic variants as well as prognosis. This study was approved by the Medical Ethics Committee of the Affiliated Hospital of Nantong University (Ethics No.: 2023-K048-01).
RESULTS:
The median age of the 254 DLBCL patients was 62 years old, with 55% of patients aged 60 years or above. Clinical evaluation showed that younger (< 60 years) patients had higher complete response (CR) (70% vs. 59%), and objective response rate (ORR) (88% vs. 79%) than older patients, though the difference between the two groups was not statistically. Survival analysis indicated that both the five-year overall survival (OS) (82.7% vs. 71.7%, P = 0.006) and progression-free survival (PFS) (70.6% vs. 50.2%, P < 0.05) rates were significantly higher in younger patients. NGS showed that 99.6% of the patients harbored genetic variants, with PIM1, KMT2D, TP53, MYD88, and CD79B being the most common genes. Age significantly affected the variant frequency of certain genes, with MYC variants serving an adverse prognostic factor for OS in younger patients (P = 0.002), while TP53 (P = 0.024) and BCL2 (P = 0.002) variants significantly impacted OS in older patients. Prognostic analysis identified age ≥ 60 years (HR = 3.439, 95%CI: 1.318~9.874), presence of B symptoms (HR = 2.871, 95%CI = 1.133~7.307), and elevated lactate dehydrogenase (HR = 3.528, 95%CI = 1.231~10.66) as independent adverse prognostic factors.
CONCLUSION
Age, genetic variants, and clinical factors may significantly affect the prognosis of the DLBCL patients. Younger patients have better survival compared to older patients. Variants of the MYC, BCL2, and TP53 genes are closely associated with poor prognosis.
Humans
;
Lymphoma, Large B-Cell, Diffuse/diagnosis*
;
Middle Aged
;
Female
;
Male
;
Retrospective Studies
;
Aged
;
Prognosis
;
Adult
;
Aged, 80 and over
;
High-Throughput Nucleotide Sequencing
;
Young Adult
;
Adolescent
;
Genetic Variation
9.Study on the clinical value of dynamic AI ultrasonic intelligent assisted diagnosis system for preoperative evaluation of thyroid nodules with diameter≤1.0 cm
Xin MIAO ; Shaoteng XIE ; Zheng WAN ; Wen TIAN ; Bing WANG ; Jing YAO ; Zelong YANG ; Yanbing JIAN ; Junwen DING ; Linlin ZHANG ; Chen LI
Chinese Journal of Endocrine Surgery 2025;19(1):24-29
Objective:To investigate the clinical value of dynamic AI ultrasonic intelligent assisted diagnosis system for preoperative evaluation of thyroid nodules with diameter ≤1.0 cm.Methods:From Apr. 1, 2023, to Dec. 30, 2023, 742 thyroid nodules with diameter ≤1.0 cm were removed from 532 patients with thyroid nodule disease who received surgical treatment in the Department of Thyroid (hernia) of the First Medical Center of the Chinese People’s Liberation Army General Hospital. Among them, 423 were d≤0.5 cm. 319 cases (235 males and 507 females) with 0.5
10.Optimization of extraction process for Bletillae Rhizoma and evaluation of its anti-oxidant,tyrosinase inhibitory activities
Shan-shan WANG ; Yi-yuan LUO ; Ye-fei XIE ; Xin-miao JIANG ; Ping PAN ; Kun-ming QIN ; Hong-jiang CHEN
Chinese Traditional Patent Medicine 2025;47(7):2171-2177
AIM To optimize the extraction process for Bletillae Rhizoma,and to evaluate its anti-oxidant,tyrosinase inhibitory activities.METHODS With ultrasound time,ethanol concentration and solid-liquid ratio as influencing factors,the total extraction content of gastrodin,protocatechualdehyde,p-hydroxybenzaldehyde,1,4-bis[4-(gluconoxy)benzyl]-2-isobutylmalate-2-glucoside,1,4-bis[4-(gluconoxy)benzyl]-2-isobutylmalate,yam Ⅲ,dihydropinosin and 3'-O-methylyam Ⅲ as an evaluation index,the extraction process was optimized by Box-Behnken response surface method.Subsequently,the extract's scavenging effects on DPPH,ABTS+free radicals,and inhibitory ability on tyrosinase were determined.RESULTS The optimal conditions were determined to be 49 min for ultrasound time,55%for ethanol concentration,1∶30 for solid-liquid ratio,and 2 times for extraction frequency,the total extraction content was 13.18 mg/g.The extract demonstrated the IC50 of 10.12,314.07 and 1.70 μg/g on DPPH,ABTS+free radicals and tyrosinase,respectively.CONCLUSION This simple,reliable and stable method can be used for the extraction for Bletillae Rhizoma with strong anti-oxidant,tyrosinase inhibitory activities.

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