1.Analysis of Toxicity Characteristics and Rational Drug Use of Polygoni Multiflori Radix
Qiongyi FU ; Yupu QI ; Yu HUAN ; Yagang SONG ; Xiangxiang WU ; Mingsan MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):222-231
ObjectivePolygoni Multiflori Radix is a commonly used tonic traditional Chinese medicine (TCM) in clinical practice, but liver injury has often been reported in recent years. Some related preparations containing Polygoni Multiflori Radix have been reported by the National Medical Products Administration many times for the risk of liver injury. This has caused extensive discussion on the potential toxicity of TCM in China and abroad, which has limited the clinical use of Polygoni Multiflori Radix to some extent. To understand the adverse reactions of Polygoni Multiflori Radix, the safe and rational use of Polygoni Multiflori Radix in clinical practice was discussed. MethodsThe pharmacovigilance thought of modern Chinese medicine and the TCM pharmacovigilance system framework of ''identification of poison, use of poison, anti-poison, and detoxification'' were employed to mine the relevant toxicity records, usage and dosage, processing compatibility, and contraindication of taking Polygoni Multiflori Radix in ancient books. The drug safety information of Polygoni Multiflori Radix was summarized by comparing with modern reports. ResultsA total of 74 ancient books related to Polygoni Multiflori Radix were included, suggesting that the toxicity of Polygoni Multiflori Radix was recognized in ancient times. The main chemical components of Polygoni Multiflori Radix had both efficacy and toxicity, and the adverse reactions may be related to long-term use, excessive use, and individual differences. The results showed that the toxic components of Polygoni Multiflori Radix could be reduced by peeling, steaming with black beans, and processing without iron tools. The toxic effects of Polygoni Multiflori Radix could be reduced by the compatibility of Polygoni Multiflori Radix with Poria, Psoraleae Fructus, and Cistanches Herba. ConclusionReasonable dosage, standard processing, correct compatibility, and syndrome differentiation are the key points to standardize the use of Polygoni Multiflori Radix and reduce the incidence of adverse reactions. Clinically, the toxicity classification of TCM should be strengthened, and the susceptible population should be prioritized. The detection indicators and early warning mechanisms should be improved, and precise drug dosage and course of treatment should be guaranteed. These measures can ensure the safe use of Polygoni Multiflori Radix.
2.Analysis of Toxicity Characteristics and Rational Drug Use of Polygoni Multiflori Radix
Qiongyi FU ; Yupu QI ; Yu HUAN ; Yagang SONG ; Xiangxiang WU ; Mingsan MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):222-231
ObjectivePolygoni Multiflori Radix is a commonly used tonic traditional Chinese medicine (TCM) in clinical practice, but liver injury has often been reported in recent years. Some related preparations containing Polygoni Multiflori Radix have been reported by the National Medical Products Administration many times for the risk of liver injury. This has caused extensive discussion on the potential toxicity of TCM in China and abroad, which has limited the clinical use of Polygoni Multiflori Radix to some extent. To understand the adverse reactions of Polygoni Multiflori Radix, the safe and rational use of Polygoni Multiflori Radix in clinical practice was discussed. MethodsThe pharmacovigilance thought of modern Chinese medicine and the TCM pharmacovigilance system framework of ''identification of poison, use of poison, anti-poison, and detoxification'' were employed to mine the relevant toxicity records, usage and dosage, processing compatibility, and contraindication of taking Polygoni Multiflori Radix in ancient books. The drug safety information of Polygoni Multiflori Radix was summarized by comparing with modern reports. ResultsA total of 74 ancient books related to Polygoni Multiflori Radix were included, suggesting that the toxicity of Polygoni Multiflori Radix was recognized in ancient times. The main chemical components of Polygoni Multiflori Radix had both efficacy and toxicity, and the adverse reactions may be related to long-term use, excessive use, and individual differences. The results showed that the toxic components of Polygoni Multiflori Radix could be reduced by peeling, steaming with black beans, and processing without iron tools. The toxic effects of Polygoni Multiflori Radix could be reduced by the compatibility of Polygoni Multiflori Radix with Poria, Psoraleae Fructus, and Cistanches Herba. ConclusionReasonable dosage, standard processing, correct compatibility, and syndrome differentiation are the key points to standardize the use of Polygoni Multiflori Radix and reduce the incidence of adverse reactions. Clinically, the toxicity classification of TCM should be strengthened, and the susceptible population should be prioritized. The detection indicators and early warning mechanisms should be improved, and precise drug dosage and course of treatment should be guaranteed. These measures can ensure the safe use of Polygoni Multiflori Radix.
3.Fabrication and evaluation of an inositol hexaphosphate-zinc hydrogel with dual capabilities of self-mineralization and osteoinduction
LIU Mingyi ; MIAO Xiaoyu ; CAI Yunfan ; WANG Yan ; SUN Xiaotang ; KANG Jingrui ; ZHAO Yao ; NIU Lina
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(1):29-40
Objective:
To fabricate a hydrogel loaded with inositol hexaphosphate-zinc and preliminarily evaluate its performance in self-mineralization and osteoinduction, thereby providing a theoretical basis for the development of bone regeneration materials.
Methods:
The hydrogel framework (designated DF0) was formed by copolymerizing methacryloyloxyethyltrimethylammonium chloride and four-armed poly(ethylene glycol) acrylate, followed by sequentially loading inositol hexaphosphate anions via electrostatic interaction and zinc ions via chelation. The hydrogel loaded only with inositol hexaphosphate anions was named DF1, while the co-loaded hydrogel was named DF2. The self-mineralization efficacy of the DF0 , DF1 and DF2 hydrogels was characterized using scanning electron microscopy, transmission electron microscopy (TEM), energy dispersive spectroscopy (EDS), and selected area electron diffraction (SAED). The biocompatibility was assessed via live/dead cell staining and a CCK-8 assay. The osteoinductive capacity of the DF0 , DF1 and DF2 hydrogels on MC3T3-E1 cells was assessed via alkaline phosphatase (ALP) and Alizarin Red S (ARS) staining. In the aforementioned cell experiments, cells cultured in standard medium served as the control group
Results:
The DF0, DF1, and DF2 hydrogels were successfully synthesized. Notably, DF1 and DF2 exhibited distinct self-mineralization within 6 days. Results from TEM, EDS, and SAED confirmed that the mineralization products were amorphous calcium phosphate in group DF1, and amorphous calciumzinc phosphate in group DF2. Biocompatibility tests revealed that none of the hydrogels (DF0, DF1, and DF2) adversely affected cell viability or proliferation. In osteogenic induction experiments, both ALP and ARS staining were intensified in the DF1 and DF2 groups, with the most profound staining observed in the DF2 group.
Conclusion
The developed inositol hexaphosphate-zinc hydrogel (DF2) demonstrates the dual capacity to generate calcium-phosphate compounds through self-mineralization while exhibiting excellent osteoinductive properties. This biocompatible, dual-promoting osteogenic hydrogel presents a novel strategy for bone regeneration.
4.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.
5.From Single Components to Complex Systems: Application Characteristics, Advantages, and Prospects of Traditional Chinese Medicine Nano-self-assembly
Shuo NAN ; Yilong HU ; Jinying ZHANG ; Mingsan MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):314-322
The active components in traditional Chinese medicine (TCM) generally have problems such as poor solubility and low bioavailability, which seriously restrict their clinical efficacy. In recent years, TCM nano-self-assembly based on the non-covalent interactions between molecules has become the research frontier in this field because it can spontaneously form an orderly structure and improve the insoluble components in the body. Moreover, TCM nano-self-assembly has shown unique advantages in the treatment of fibrosis, inflammatory and immune diseases, infectious diseases, and cancer. This article summarizes the research context, structural system, and potential as a pharmacological substance basis of TCM nano-self-assembly by reviewing recent published studies, with focuses on the application of TCM nano-self-assembly in the treatment of diseases from single components to complex systems. In addition, this article summarizes its advantages, mechanism characteristics, and main challenges faced. At present, this field still faces issues such as insufficient mechanism research, a lack of in-depth understanding of the competitive assembly rules of multiple components, difficulty in quality control, unclear in vivo processes and safety, and obstacles to clinical translation. To address these issues, this article proposes a series of solutions, including introducing molecular dynamics simulation and artificial intelligence to predict assembly behavior, using experimental techniques to analyze non-covalent interactions, establishing a comprehensive evaluation system with multiple indicators, using isotope labeling and in vivo imaging techniques to dynamically track in vivo processes, conducting standardized safety evaluation, promoting the filing of hospital preparations and new drug applications, and strengthening early communication between research and regulation. Finally, this article points out the future development directions, aiming to provide reference for subsequent research and clinical translation.
6.From Single Components to Complex Systems: Application Characteristics, Advantages, and Prospects of Traditional Chinese Medicine Nano-self-assembly
Shuo NAN ; Yilong HU ; Jinying ZHANG ; Mingsan MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):314-322
The active components in traditional Chinese medicine (TCM) generally have problems such as poor solubility and low bioavailability, which seriously restrict their clinical efficacy. In recent years, TCM nano-self-assembly based on the non-covalent interactions between molecules has become the research frontier in this field because it can spontaneously form an orderly structure and improve the insoluble components in the body. Moreover, TCM nano-self-assembly has shown unique advantages in the treatment of fibrosis, inflammatory and immune diseases, infectious diseases, and cancer. This article summarizes the research context, structural system, and potential as a pharmacological substance basis of TCM nano-self-assembly by reviewing recent published studies, with focuses on the application of TCM nano-self-assembly in the treatment of diseases from single components to complex systems. In addition, this article summarizes its advantages, mechanism characteristics, and main challenges faced. At present, this field still faces issues such as insufficient mechanism research, a lack of in-depth understanding of the competitive assembly rules of multiple components, difficulty in quality control, unclear in vivo processes and safety, and obstacles to clinical translation. To address these issues, this article proposes a series of solutions, including introducing molecular dynamics simulation and artificial intelligence to predict assembly behavior, using experimental techniques to analyze non-covalent interactions, establishing a comprehensive evaluation system with multiple indicators, using isotope labeling and in vivo imaging techniques to dynamically track in vivo processes, conducting standardized safety evaluation, promoting the filing of hospital preparations and new drug applications, and strengthening early communication between research and regulation. Finally, this article points out the future development directions, aiming to provide reference for subsequent research and clinical translation.
7.Analysis of Animal Model of Anxiety Disorder Based on Clinical Characteristics of Syndromes in Traditional Chinese and Western Medicine
Baoling HUANG ; Yilong HU ; Jingying YANG ; Mingsan MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):235-242
ObjectiveThis study aims to analyze animal models of anxiety disorder based on the clinical characteristics of anxiety disorder in traditional Chinese and Western medicine, systematically assess the clinical compatibility, and provide suggestions for the construction of animal models with a high degree of clinical compatibility between traditional Chinese and Western medicine. MethodsRelevant literature on animal models of anxiety disorder was retrieved from global databases. Scoring scales were developed according to the etiology, pathogenesis, and diagnostic criteria of anxiety disorder in both traditional Chinese and Western medicine. The animal models of anxiety disorder in the literature were analyzed, and their clinical compatibility was systematically assessed to identify reference-worthy models. ResultsThe average clinical compatibility of existing animal models of anxiety disorder was 42.13% for traditional Chinese medicine and 50.94% for Western medicine. Among these, the chronic unpredictable mild stress (CUMS) model had the highest compatibility with both traditional Chinese and Western medicine. However, current models rarely reflect the clinical syndromes of traditional Chinese medicine in depth, and show limitations in syndrome differentiation. ConclusionThe existing animal models of anxiety disorder are mostly established using single-factor approaches, which fail to comprehensively simulate the onset process and physiopathological characteristics of anxiety disorder. These models also neglect the syndrome-based indicators emphasized in traditional Chinese medicine. In the future, the model development should incorporate the clinical characteristics of syndromes in both traditional Chinese and Western medicine, establish standardized evaluation criteria for anxiety disorder models, and utilize multifactorial approaches to enhance the representativeness of animal models in traditional Chinese medicine.
8.A prediction model for hypertension risk among residents aged 18 to 79 years
GONG Haiying ; XUE Fengyu ; LIU Xiaofen ; XING Ruiting ; MIAO Yuyang ; ZHAO Yao
Journal of Preventive Medicine 2025;37(10):1075-1080
Objective:
To construct a hypertension risk prediction model for residents aged 18-79 years, so as to provide an assessment tool for early screening and prevention of hypertension in high-risk groups.
Methods:
The permanent residents aged 18-79 years from 6 townships (streets) in Fangshan District of Beijing Municipality were selected as the study subjects using a multi-stage stratified random sampling method from March to June 2023. Demographic information, lifestyle, body mass index (BMI), blood pressure, fasting blood glucose, and blood lipid were collected through questionnaire survey, physical examination, and laboratory tests. Subjects were randomly divided into training and validation sets at a 7∶3 ratio. The logistic regression model was used to screen the risk factors of hypertension, and a hypertension risk prediction nomogram was constructed. Receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis were used to verify the discrimination, fit, and clinical application value of the model.
Results:
A total of 4 438 subjects were included, including 2 365 males (53.29%) and 2 073 females (46.71%), with a mean age of (44.99±14.90) years. The prevalence of hypertension was 35.29% (1 566 cases), and the standardized prevalence was 24.74%. The logistic regression model screened out 9 influencing factors of hypertension. The nomogram was established as ln[p/ (1-p)]= -2.873 + 0.935×40-<50 years + 1.463×50-<60 years + 1.908×60-<70 years + 2.346×70-79 years + 0.298×male-0.675×college degree or above + 0.384×smoking + 0.227×drinking + 0.572×overweight + 1.449×obesity + 0.557×heart rate ≥80 beats/min + 0.428×diabetes + 0.484×dyslipidemia. The area under the ROC curve of the validation set was 0.821 (95%CI: 0.798-0.843), and the calibration curve results showed that the calibration curve fitted the actual curve well. Decision curve analysis showed that the threshold probability was in the range of 0.10 to 0.70, and the model had good predictive value and clinical application value.
Conclusion
The nomogram based on age, gender, educational level, smoking, drinking, body mass index, heart rate, diabetes, and dyslipidemia can be used to predict the risk of hypertension among residents aged 18-79 years.
9.Optimized ROX index can predict transitioning to mechanical ventilation in acute hypoxic respiratory failure pediatric patients on HFNC:a real-world study
Yao LIU ; Shaodong ZHAO ; Mingxing FAN ; Le JING ; Hongjun MIAO
Chinese Journal of Emergency Medicine 2025;34(6):782-788
Objective:To evaluate the predictive value of the ROX index and its modified versions for assessing the therapeutic efficacy of high-flow nasal cannula oxygen therapy (HFNC) in pediatric patients with acute hypoxemic respiratory failure (AHRF).Methods:This retrospective study analyzed clinical data from 130 AHRF children admitted to the Pediatric Intensive Care Unit (PICU) of Nanjing Medical University Affiliated Children’s Hospital between January 2020 and December 2024. Patients were categorized into two groups: HFNC success ( n=99) and HFNC failure ( n=31). Clinical parameters were compared between groups, and the predictive performance of the ROX index and its modified variants (ROP, ROXH, ROPH) at various time points was assessed. Univariate and multivariate logistic regression analyses were conducted to identify independent risk factors for HFNC failure. Results:The HFNC failure group exhibited significantly higher baseline PaCO 2 levels (37.2 mmHg vs. 34.1 mmHg, P<0.05) and prolonged PICU stays (21 days vs. 12 days, P<0.01) compared to the success group. During treatment, the success group demonstrated marked improvements in oxygenation parameters (S/F ratio, P/F ratio) and ROX-derived indices (ROX, ROP, ROXH, ROPH) ( P<0.01). Multivariate analysis identified FiO 2 within 12 hours post-treatment and the ROPH index as independent predictors of HFNC failure ( P<0.05). ROC curve analysis revealed that the relative change in ROPH before and after treatment had the highest predictive accuracy (AUC=0.836, optimal cutoff=0.053, sensitivity=95.3%, specificity=70%) among all evaluated indices. Conclusions:Modified ROX indices, particularly the ROPH index, serve as reliable predictors of HFNC outcomes in children with AHRF. Dynamic monitoring of these indices may enable early identification of patients at risk for treatment failure, facilitating timely clinical intervention.
10.Salvia miltiorrhiza components and gut microbiota interactions in Helicobacter pylori infection.
Shao-Jian LI ; Jin-Xin MIAO ; Fei WANG ; Hao-Yu WANG ; Yao-Wu MA ; Ying JIANG ; Xia XUE
Journal of Integrative Medicine 2025;23(5):462-470
Salvia miltiorrhiza (Danshen) is a traditional Chinese herb that is commonly known for its cardiovascular and hepatoprotective benefits. Recent studies have confirmed that Danshen and its bioactive components can influence gut microbial homeostasis, thereby affecting Helicobacter pylori (HP) colonization in the human stomach. HP is a bacterial pathogen associated with various gastrointestinal diseases. Current HP treatments mainly involve antibiotics and proton pump inhibitors. However, their efficacy is strongly compromised by the rapid emergence of antibiotic resistance in HP and genetic heterogeneity among patients. The interaction between Danshen and gut microbial status provides a novel perspective for HP treatment. Understanding the medical properties of Danshen in altering gut microbiota and eliminating HP, as well as the underlying mechanisms, is important for improving human gastrointestinal healthcare. This review investigates the interaction between Danshen and gut microbiota and its impact on HP infection using databases including Web of Science, PubMed, and Google Scholar. We explored the unconventional intersection between Danshen, gut microbiota, and HP infection, shedding light on their intricate interplay and potential therapeutic implications. A comprehensive understanding of this interaction provides valuable insights into developing novel therapeutic strategies that target the gut microbiota to mitigate HP-associated gastrointestinal disorders. Please cite this article as: Li SJ, Miao JX, Wang F, Wang HY, Ma YW, Jiang Y, Xue X. Salvia miltiorrhiza components and gut microbiota interactions in Helicobacter pylori infection. J Integr Med. 2025; 23(5):462-470.
Salvia miltiorrhiza/chemistry*
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Gastrointestinal Microbiome/drug effects*
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Humans
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Helicobacter Infections/microbiology*
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Helicobacter pylori/drug effects*
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Drugs, Chinese Herbal/therapeutic use*


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