1.Interpretation of Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines (RIGHT for CPM)
Liaoyao WANG ; Hejing PAN ; Le ZHANG ; Wenya WANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):211-218
The clinical practice guidelines for Chinese patent medicines (CPM) provide reference for the selection of national drug catalogs, the formulation of prescription collections in medical institutions, and the clinical use of CPM, constituting an important part of traditional Chinese medicine (TCM) guidelines. As a crucial part of Chinese drug supply guarantee system, CPM plays an important role in the treatment, prevention, and healthcare of many disease categories, whereas the application of CPM has problems of misuse and even abuse. To standardize the application of CPM, a research team at Zhejiang Chinese Medical University developed the Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines (RIGHT for CPM) based on the RIGHT checklist framework. The RIGHT for CPM checklist gathers key information from published CPM guidelines, existing TCM reporting checklists, and the RIGHT checklist and its extensions to form an initial pool of reporting items. Seventeen experts from different disciplines were invited to conduct two rounds of Delphi surveys, and the final checklist was reviewed and approved for publication by 18 leading experts in TCM research and guideline reporting from China and abroad. The RIGHT for CPM checklist adds 16 sub-items and revises 2 sub-items on the basis of the RIGHT checklist, highlighting the characteristics of CPM guideline reporting. It considers CPM selection and inclusion criteria, policy access, indications and symptoms, drug combination instructions, drug use in special populations, precautions, and recommendations of Western medical physicians, among others. This can further improve the quality and transparency of CPM guideline reporting, promote standardized reporting of CPM guidelines, and facilitate the rational clinical use of CPM. This article interprets the development process of the RIGHT for CPM checklist and the items that highlight the characteristics of CPM guidelines, with a view to promoting the application of the RIGHT for CPM checklist.
2.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
3.Research progress on impact of micro/nanoplastics exposure on reproductive health
Yan HUANG ; Yuanyuan HUANG ; Yanxi ZHUO ; Yiqin LIN ; Qipeng LI ; Xiaofeng ZHENG ; Wenxiang WANG ; Yuchen LI ; Wenya SHAO ; Henggui CHEN
Journal of Environmental and Occupational Medicine 2025;42(4):490-496
Micro/nanoplastics (MNPs), recognized as emerging environmental pollutants, are widely distributed in natural environments. Due to their small particle size and significant migratory capacity, MNPs can infiltrate diverse environmental matrices, then invade and accumulate in the organism via the skin, respiration, and digestion. Recently, concerns have grown over the detrimental effects and potential toxicity of MNPs on reproductive health. This review summarized published epidemiological and toxicological studies related to MNPs exposure and their effects on reproductive health. Firstly, this review critically examined the current landscape of epidemiological evidence and found that MNPs (e.g., polystyrene, polypropylene, polyvinyl chloride, polyethylene, etc.) are present in various biological specimens from both males and females, and their presence may be associated with an increased risk of reproductive disorders. Secondly, extensive toxicological studies revealed that MNPs exposure induces reproductive health damage through mechanisms such as disrupting the microstructure of reproductive organs and altering molecular-level expressions. Oxidative stress, inflammatory responses, and apoptosis are identified as potential links between MNPs exposure and reproductive damage. Finally, this review addressed the prevalent shortcomings in existing studies and proposed future directions to tackle the challenges posed by MNPs-induced reproductive harm. These insights aim to inform strategies for safeguarding public reproductive health and ecological security, providing a scientific foundation for mitigating risks associated with MNPs pollution.
4.Sequencing and analysis of the complete mitochondrial genome of Bulinus globosus
Peijun QIAN ; Mutsaka-Makuvaza MASCELINE JENIPHER ; Chao LÜ ; Yingjun QIAN ; Wenya WANG ; Shenglin CHEN ; Andong XU ; Jingbo XUE ; Jing XU ; Xiaonong ZHOU ; Midzi NICHOLAS ; Shizhu LI
Chinese Journal of Schistosomiasis Control 2025;37(2):116-126
Objective To analyze the structural and phylogenetic characteristics of the mitochondrial genome from Bulinus globosus, so as to provide a theoretical basis for classification and identification of species within the Bulinus genus, and to provide insights into understanding of Bulinus-schistosomes interactions and the mechanisms of parasite transmission. Methods B. globosus samples were collected from the Ruya River basin in Zimbabwe. Mitochondrial DNA was extracted from B. globosus samples and the corresponding libraries were constructed for high-throughput sequencing on the Illumina NovaSeq 6000 platform. After raw sequencing data were subjected to quality control using the fastp software, genome assembly was performed using the A5-miseq and SPAdes tools, and genome annotation was conducted using the MITOS online server. Circular maps and sequence plots of the mitochondrial genome were generated using the CGView and OGDRAW software, and the protein conservation motifs and structures were analyzed using the TBtools software. Base composition and codon usage bias were analyzed and visualized using the software MEGA X and the ggplot2 package in the R software. In addition, a phylogenetic tree was created in the software MEGA X after sequence alignment with the software MAFFT 7, and visualized using the software iTOL. Results The mitochondrial genome of B. globosus was a 13 730 bp double-stranded circular molecule, containing 2 ribosomal RNA (rRNA) genes, 22 transfer RNA (tRNA) genes, and 13 protein-coding genes, with a marked AT preference. The mitochondrial genome composition of B. globosus was similar to that of other species within the Bulinus genus. Phylogenetic analysis revealed that the complete mitochondrial genome sequence of B. globosus was clustered with B. truncatus, B. nasutus, and B. ugandae into the same evolutionary clade, and gene superfamily analysis showed that the metabolism-related proteins of B. globosus were highly conserved, notably the cytochrome c oxidase family, which showed a significant consistency. Conclusions This is the first whole mitochondrial genome sequencing to decode the compositional features of the mitochondrial genome of B. globosus from Zimbabwe and its evolutionary relationship within the Bulinus genus, which provides important insights for further understanding of the phylogeny and mitochondrial genome characteristics of the Bulinus genus.
5.Application and Production of Systematic Review and Meta-Analyses of Preclinical Studies in the Field of Traditional Chinese Medicine
Wenya WANG ; Chengyang JING ; Lanjun SHI ; Bin MA ; Xing LIAO
Journal of Traditional Chinese Medicine 2025;66(13):1333-1339
Preclinical studies include pharmacology, toxicology, pharmacokinetics research of animal experiments and in vitro experiments, which are crucial steps in the pre-marketing drugs and medical products, and are essential for exploring the mechanisms of traditional Chinese Medicine (TCM) therapeutic mechanism and promoting clinical translation. Systematic reviews and meta-analyses of preclinical studies in the field of TCM can comprehensively integrate preclinical evidence, consolidate research findings, assess the quality and risk of bias of included studies, enhance the utilization of research results, reduce resource waste, and promote the iterative optimization of TCM research models and evaluation indicators. This article introduced the process and methodology of conducting systematic review and meta-analyses of preclinical studies in TCM from nine steps, defining the research question, forming a research team, writing and registering a study protocol, conducting a comprehensive search, screening literature, evaluating included studies, extracting data, synthesizing data (meta-analysis), and reporting systematic reviews. It aims to provide methodological references for conducting systematic reviews and meta-analyses of preclinical studies in TCM and to promote the establishment and improvement of the evidence system in the field of TCM.
6.Protective Effect of Gegen Qianliantang on Intestinal Mucosal Barrier in Ulcerative Colitis Mice via STAT3/NF-κB Axis Regulating Th1/Treg Differentiation
Beilei DENG ; Anan WANG ; Wenya FENG ; Lixin WANG ; Tiansong ZHANG ; Chengyong MA ; Xiutian GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):12-21
ObjectiveTo explore the protective effect and mechanism of Gegen Qianliantang (GQT) on intestinal mucosal barrier function in dextran sulfate sodium (DSS)-induced ulcerative colitis (UC) model mice. MethodsA UC model was established in C57BL/6 mice using a 2.5% DSS solution. Mice were randomly divided into five groups (n=8 per group): blank group, model group, mesalazine sustained-release granule group (0.52 g·kg-1), high-dose GQT group (2.23 g·kg-1), and low-dose GQT group (1.12 g·kg-1). Fecal characteristics and body weight changes were observed before and after treatment. The body weight loss and disease activity index (DAI) of UC mice were calculated to evaluate symptom severity. Hematoxylin-eosin (HE) staining and Alizarin blue-periodic acid-Schiff (AB-PAS) staining were used to detect histological changes in colon tissue. Immunohistochemistry was used to detect the expression of zonula occludens-1 (ZO-1) and mucin 2 (MUC2). Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of pro-inflammatory cytokines interferon-γ (IFN-γ), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), IL-17A, and anti-inflammatory cytokine IL-10. Flow cytometry was used to detect the activation of helper T lymphocyte subsets (Th1, Th17), regulatory T cells (Treg), and regulatory B cells (Breg) in spleen and colon tissues. Western blot was used to detect the expression levels of T-bet, forkhead box protein P3(FoxP3), nuclear transcription factor(NF)-κB p65, phosphorylated NF-κB p65 (p-NF-κB p65), signal transducer and activator of transcription 3(STAT3), and phosphorylated STAT3 (p-STAT3). ResultsCompared with the model group, both high- and low-dose GQT groups significantly improved the body weight loss and DAI scores (P<0.05), alleviated colonic inflammation, and showed optimal efficacy in the high-dose group. AB-PAS staining showed that compared with the model group, both the high- and low-dose GQT groups significantly increased goblet cell proliferation and mucin secretion, indicating improved mucosal barrier function. GQT upregulated the expression of ZO-1 and MUC2 in colon tissue (P<0.05), suppressed IFN-γ, IL-6, and TNF-α secretion (P<0.05), elevated IL-10 secretion (P<0.05), but had no significant effect on IL-17A. At the same time, high- and low-dose GQT intervention increased the activation of CD4+ FoxP3+ Treg cells (P<0.05) and suppressed activation of CD4+ IFN-γ+ Th1 cells (P<0.05). Western blot showed that GQT downregulated T-bet, NF-κB p65, and STAT3 protein expression (P<0.05), upregulated FoxP3 (P<0.05), and also reduced phosphorylation levels of p-NF-κB p65 and p-STAT3 (P<0.05). ConclusionGQT can upregulate the activation of CD4+ FoxP3+ Treg cells, reduce the activation of CD4+ IFN-γ+ Th1 cells, inhibit the secretion of IFN-γ, IL-6, and TNF-α, and increase the secretion of IL-10. It enhances the expression of MUC2 and ZO-1 in colon tissue, thereby alleviating inflammatory damage to the intestinal mucosa and restoring mucosal barrier integrity. These effects may be related to its regulation of NF-κB p65 and STAT3 signaling pathways, ultimately regulating the activation of transcription factors T-bet and FoxP3.
7.Mechanism of action of Polygonum multiflorum in inducing liver injury: A study based on signaling pathways
Zihan LIANG ; Jiahui LI ; Shuang CHENG ; Zhuoya YUAN ; Wenya RONG ; Yajie LIU ; Yujie HAO ; Ruilin WANG
Journal of Clinical Hepatology 2024;40(3):626-632
Polygonum multiflorum (PM), a commonly used Chinese herbal medicine in clinical practice, has been associated with frequent reports of liver injury in recent years, and the medication safety of PM has attracted more and more attention in China and globally. This article reviews the recent research advances in the signaling pathways and mechanisms of PM in causing drug-induced liver injury (DILI) and aims to provide new ideas for the proper and rational use of PM in clinical practice. The results show that PM is involved in the regulation of various signaling pathways, and it leads to the death of hepatocytes by destroying mitochondrial function, exacerbating bile acid accumulation, and inducing immune response, oxidative stress, and endoplasmic reticulum stress, thereby inducing the development and progression of DILI through multiple targets, pathways, and levels.
8.Mechanism of Aurantii Fructus and Its Active Components in Regulating Gastrointestinal Motility: A Review
Junbao YU ; Jiayuan ZHU ; Wenya MEI ; Jiawei HE ; Yuqing LONG ; Zhihui WANG ; Xiaorong LIU ; Xiangdan LIU ; Ribao ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(10):290-298
Gastrointestinal motility disorder is an important cause of digestive system diseases. Patients often suffer from nausea, vomiting, gastric retention, gastroparesis, constipation, and many other symptoms, and their quality of life is seriously reduced. Prokinetic agents are routinely used in clinical practice, but their long-term use is prone to problems such as reduced efficacy and increased adverse reactions. Since the incidence of gastrointestinal diseases has continued to rise globally in recent years, there is an urgent need for clinical development of safe and effective treatment strategies. Aurantii Fructus, a traditional Chinese medicine, has the effect of smoothing Qi and eliminating distention, and it has been used to treat gastrointestinal diseases for thousands of years. In modern clinical practice, it is mainly used for the treatment and auxiliary treatment of various gastrointestinal diseases such as functional dyspepsia, functional constipation, and irritable bowel syndrome. The efficacy is remarkable, and no adverse reactions have been reported at conventional doses. Therefore, it can greatly improve the symptoms of patients with gastrointestinal diseases and improve their quality of life. Modern research has revealed that there are many active components in Aurantii Fructus, among which flavonoids have the highest content and the most types. Flavonoids are the main active components in Aurantii Fructus to regulate gastrointestinal motility. Aurantii Fructus and its active components can affect gastrointestinal hormones, neural pathways, Cajal mesenchymal cells, and other multiple mechanisms. They can adjust gastrointestinal motility and correct gastrointestinal motility disorders, showing potential application value in the treatment of gastrointestinal motility disorders. However, a comprehensive analysis of Aurantii Fructus in this aspect is still lacking. This study summarized the pharmacological activities of active components of Aurantii Fructus extract and its flavonoids, volatile oils, alkaloids, and coumarin on the regulation of gastrointestinal motility and explored the latest research progress on its mechanism. Finally, the adverse reactions of Aurantii Fructus were summarized. It aims to provide a scientific basis for the research and clinical application of Aurantii Fructus and its active components in the regulation of gastrointestinal motility.
9.Analysis of Specific Chromatogram of Classical Formula Qianghuo Shengshi Tang Reference Samples
Wenya GAO ; He XU ; Mingli LI ; Haiyu ZHAO ; Yanyan ZHOU ; Hongjie WANG ; Jian YANG ; Xiaolu WEI ; Zhikun FAN ; Nan SI ; Baolin BIAN
Chinese Journal of Modern Applied Pharmacy 2024;41(10):1350-1356
OBJECTIVE
To establish the specific chromatogram of Qianghuo Shengshi Tang(QHSS) reference sample, clarify the key quality attributes of QHSS, providing reference for the quality evaluation of QHSS reference sample.
METHODS
The SilGreen C18 column(4.6 mm×250 mm, 5 μm) was used. The mobile phase consisted acetonitrile and 0.2% formic acid aqueous solution. The detection wavelength was 328 nm. Established an HPLC characteristic spectrum analysis method for the reference sample of QHSS. A variety of chromatographic columns and different instruments were applied to investigate the adaptability of the system. HPLC-LTQ-Orbitrap MS was used to identify the specific peaks of the QHSS reference samples in positive ion mode.
RESULTS
There were 14 peaks in the specific chromatogram, which belonged to Notopterygii Rhizoma Et Radix, Angelicae Pubescentis Radix, Ligustici Rhizoma Et Radix, Chuanxiong Rhizome, Viticis Fructus, respectively. Ferulic acid(peak 3) was reference peak. A total of 22 compounds were identified by mass spectrometry, including coumarin and flavonoids.
CONCLUSION
The established specific chromatogram method of QHSS is simple, stable and reproducible. The material basis of QHSS reference sample is basically determined, providing a reference for the development and quality control of QHSS.
10.Prediction of potential geographic distribution of Oncomelania hupensis in Yunnan Province using random forest and maximum entropy models
Zongya ZHANG ; Chunhong DU ; Yun ZHANG ; Hongqiong WANG ; Jing SONG ; Jihua ZHOU ; Lifang WANG ; Jiayu SUN ; Meifen SHEN ; Chunqiong CHEN ; Hua JIANG ; Jiaqi YAN ; Xiguang FENG ; Wenya WANG ; Peijun QIAN ; Jingbo XUE ; Shizhu LI ; Yi DONG
Chinese Journal of Schistosomiasis Control 2024;36(6):562-571
Objective To predict the potential geographic distribution of Oncomelania hupensis in Yunnan Province using random forest (RF) and maximum entropy (MaxEnt) models, so as to provide insights into O. hupensis surveillance and control in Yunnan Province. Methods The O. hupensis snail survey data in Yunnan Province from 2015 to 2016 were collected and converted into O. hupensis snail distribution site data. Data of 22 environmental variables in Yunnan Province were collected, including twelve climate variables (annual potential evapotranspiration, annual mean ground surface temperature, annual precipitation, annual mean air pressure, annual mean relative humidity, annual sunshine duration, annual mean air temperature, annual mean wind speed, ≥ 0 ℃ annual accumulated temperature, ≥ 10 ℃ annual accumulated temperature, aridity and index of moisture), eight geographical variables (normalized difference vegetation index, landform type, land use type, altitude, soil type, soil textureclay content, soil texture-sand content and soil texture-silt content) and two population and economic variables (gross domestic product and population). Variables were screened with Pearson correlation test and variance inflation factor (VIF) test. The RF and MaxEnt models and the ensemble model were created using the biomod2 package of the software R 4.2.1, and the potential distribution of O. hupensis snails after 2016 was predicted in Yunnan Province. The predictive effects of models were evaluated through cross-validation and independent tests, and the area under the receiver operating characteristic curve (AUC), true skill statistics (TSS) and Kappa statistics were used for model evaluation. In addition, the importance of environmental variables was analyzed, the contribution of environmental variables output by the models with AUC values of > 0.950 and TSS values of > 0.850 were selected for normalization processing, and the importance percentage of environmental variables was obtained to analyze the importance of environmental variables. Results Data of 148 O. hupensis snail distribution sites and 15 environmental variables were included in training sets of RF and MaxEnt models, and both RF and MaxEnt models had high predictive performance, with both mean AUC values of > 0.900 and all mean TSS values and Kappa values of > 0.800, and significant differences in the AUC (t = 19.862, P < 0.05), TSS (t = 10.140, P < 0.05) and Kappa values (t = 10.237, P < 0.05) between two models. The AUC, TSS and Kappa values of the ensemble model were 0.996, 0.954 and 0.920, respectively. Independent data verification showed that the AUC, TSS and Kappa values of the RF model and the ensemble model were all 1, which still showed high performance in unknown data modeling, and the MaxEnt model showed poor performance, with TSS and Kappa values of 0 for 24%(24/100) of the modeling results. The modeling results of 79 RF models, 38 MaxEnt models and their ensemble models with AUC values of > 0.950 and TSS values of > 0.850 were included in the evaluation of importance of environmental variables. The importance of annual sunshine duration (SSD) was 32.989%, 37.847% and 46.315% in the RF model, the MaxEnt model and their ensemble model, while the importance of annual mean relative humidity (RHU) was 30.947%, 15.921% and 28.121%, respectively. Important environment variables were concentrated in modeling results of the RF model, dispersed in modeling results of the MaxEnt model, and most concentrated in modeling results of the ensemble model. The potential distribution of O. hupensis snails after 2016 was predicted to be relatively concentrated in Yunnan Province by the RF model and relatively large by the MaxEnt model, and the distribution of O. hupensis snails predicted by the ensemble model was mostly the joint distribution of O. hupensis snails predicted by RF and MaxEnt models. Conclusions Both RF and MaxEnt models are effective to predict the potential distribution of O. hupensis snails in Yunnan Province, which facilitates targeted O. hupensis snail control.


Result Analysis
Print
Save
E-mail