1.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
2.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
3.Analysis of Quality Changes of Small Packaged Alismatis Rhizoma Decoction Pieces Under Different Packaging and Storage Conditions
Gaoting YANG ; Rui XIAN ; Zimin WANG ; Zongyi ZHAO ; Zhiqiong LAN ; Xiaoli PAN ; Min LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):179-188
ObjectiveTo screen suitable packaging and storage conditions for small packaged Alismatis Rhizoma decoction pieces, laying the foundation for developing standardized storage, maintenance techniques and determining shelf life. MethodsUsing the accelerated stability test method, the small packaged decoction pieces of Alismatis Rhizoma were placed in polyethylene plastic bags, aluminum foil polyethylene composite bags, and cowhide coated paper bags under temperature of (40±2) ℃ and relative humidity of (75±5)% conditions, the quality testing was conducted at the end of the 0th, 1st, 2nd, 3rd, and 6th month, respectively. Using long-term stability test method, an orthogonal experiment was designed to investigate storage conditions, packaging materials, and packaging methods. At the end of the 0th, 1st, 3rd, 6th, 9th, 12th, 18th, and 24th month, the quality of small packaged Alismatis Rhizoma decoction pieces was tested under different packaging and storage conditions(including 2 packaging methods:vacuum packaging and sealed packaging, 3 storage conditions:room temperature, cool, and modified atmosphere, 3 packaging materials:cowhide coated paper bag, aluminum foil polyethylene composite bag, and polyethylene plastic bag). Then, the G1-entropy weight method combined with orthogonal experiment was used to analyze the quality changes of the decoction pieces under different packaging and storage conditions to identify optimal packaging and storage conditions. The quality testing indicators for Alismatis Rhizoma decoction pieces were expanded beyond those specified in the 2020 edition of the Pharmacopoeia of the People's Republic of China. In addition to the existing indicators(characteristics, moisture content, extractives, and the total content of 23-acetyl alisol B and 23-acetyl alisol C), new indicators including color value, water activity, total triterpenoid content, and alisol B content have been added. ResultsThe accelerated stability test results indicated that the quality of small packaged Alismatis Rhizoma decoction pieces was more stable when packaged in aluminum foil-polyethylene composite materials compared to cowhide-coated paper bags and polyethylene plastic bags. Analysis of the long-term stability test results using the G1-entropy weight method combined with orthogonal experiment revealed that storage conditions had the greatest impact on both raw and salt-processed products, followed by packaging materials, while the packaging method had the least influence. For both types of small packaged Alismatis Rhizoma decoction pieces, modified atmosphere storage demonstrated superior efficacy compared to cool storage or room temperature storage. Storage in aluminum foil-polyethylene composite bags was superior to polyethylene plastic bags or cowhide-coated paper bags. However, the stability of sealed raw products was better than vacuum-packed ones, whereas vacuum-packed salt-processed products exhibited greater stability than their sealed counterparts. ConclusionBased on the results of the quality changes of small packaged Alismatis Rhizoma decoction pieces under different storage conditions, it is recommended that the suitable storage packaging conditions for small packaged raw products are sealed packaging with aluminum foil polyethylene composite bags and controlled atmosphere storage, and the suitable storage and packaging conditions for small packaged salt-processed products are vacuum packaging with aluminum foil polyethylene composite bags and controlled atmosphere storage.
4.Postmenopausal osteoporosis:predictive values of muscle mass,grip strength,and appendicular skeletal muscle index
Zhijie YANG ; Rui ZHAO ; Haolin YANG ; Xiaoyun LI ; Yangbo LI ; Jiachun HUANG ; Yanping LIN ; Lei WAN ; Hongxing HUANG
Chinese Journal of Tissue Engineering Research 2026;30(5):1073-1080
BACKGROUND:The prevalence of osteoporosis is high in postmenopausal women,but muscle mass,grip strength,and how these factors affect osteoporosis are understudied,and the exact link between them has not been clarified.OBJECTIVE:To investigate the correlation between muscle mass,grip strength,appendicular skeletal muscle index and bone mineral density in postmenopausal women with osteoporosis and to assess the potential values of these indices in predicting and diagnosing postmenopausal osteoporosis.METHODS:Eighty-three postmenopausal women were collected from the outpatient clinic of the Third Affiliated Hospital of Guangzhou University of Chinese Medicine from February 2023 to January 2024.General data were collected.Bone mineral density was detected.T-value,muscle mass of each part,grip strength were recorded.The body mass index and appendicular skeletal muscle index were calculated.The patients were categorized into non-osteoporosis group(n=17)and postmenopausal osteoporosis group(n=66)according to T value and fracture history,and were statistically analyzed accordingly.RESULTS AND CONCLUSION:(1)The body mass,body mass index,bone mineral density of the overall lumbar spine,muscle mass and appendicular skeletal muscle index were higher in the non-osteoporosis group than the osteoporosis group(P<0.05).(2)Muscle mass was positively correlated with bone mineral density of the overall lumbar spine and individual vertebrae(P<0.05).(3)Multiple stepwise linear regression analysis showed that body mass and grip strength were linearly and positively correlated with muscle mass;body height and muscle mass were linearly and positively correlated with grip strength,and body mass was linearly and negatively correlated with grip strength.Body mass index was linearly and positively correlated with bone mineral density,and age was linearly and negatively correlated with bone mineral density.(4)Analysis by receiver operating characteristic curve showed that:muscle mass(the area under the curve,sensitivity,specificity and critical value of muscle mass were 0.744,76.50%,74.20%and 36.50 kg,respectively,with P=0.002)and appendicular skeletal muscle index(the area under the curve,sensitivity,specificity and critical value of appendicular skeletal muscle index were 0.739,82.40%,62.10%and 5.81 kg/m2,respectively,and P=0.002)had good predictive value for postmenopausal osteoporosis.To conclude,a reduction in muscle mass and appendicular skeletal muscle index can help to predict the risk of postmenopausal osteoporosis,and the possibility of osteoporosis should be taken into account in postmenopausal women when muscle mass is<36.50 kg or appendicular skeletal muscle index is<5.81 kg/m2,in order to prevent the occurrence of postmenopausal osteoporosis.
5.Postmenopausal osteoporosis:predictive values of muscle mass,grip strength,and appendicular skeletal muscle index
Zhijie YANG ; Rui ZHAO ; Haolin YANG ; Xiaoyun LI ; Yangbo LI ; Jiachun HUANG ; Yanping LIN ; Lei WAN ; Hongxing HUANG
Chinese Journal of Tissue Engineering Research 2026;30(5):1073-1080
BACKGROUND:The prevalence of osteoporosis is high in postmenopausal women,but muscle mass,grip strength,and how these factors affect osteoporosis are understudied,and the exact link between them has not been clarified.OBJECTIVE:To investigate the correlation between muscle mass,grip strength,appendicular skeletal muscle index and bone mineral density in postmenopausal women with osteoporosis and to assess the potential values of these indices in predicting and diagnosing postmenopausal osteoporosis.METHODS:Eighty-three postmenopausal women were collected from the outpatient clinic of the Third Affiliated Hospital of Guangzhou University of Chinese Medicine from February 2023 to January 2024.General data were collected.Bone mineral density was detected.T-value,muscle mass of each part,grip strength were recorded.The body mass index and appendicular skeletal muscle index were calculated.The patients were categorized into non-osteoporosis group(n=17)and postmenopausal osteoporosis group(n=66)according to T value and fracture history,and were statistically analyzed accordingly.RESULTS AND CONCLUSION:(1)The body mass,body mass index,bone mineral density of the overall lumbar spine,muscle mass and appendicular skeletal muscle index were higher in the non-osteoporosis group than the osteoporosis group(P<0.05).(2)Muscle mass was positively correlated with bone mineral density of the overall lumbar spine and individual vertebrae(P<0.05).(3)Multiple stepwise linear regression analysis showed that body mass and grip strength were linearly and positively correlated with muscle mass;body height and muscle mass were linearly and positively correlated with grip strength,and body mass was linearly and negatively correlated with grip strength.Body mass index was linearly and positively correlated with bone mineral density,and age was linearly and negatively correlated with bone mineral density.(4)Analysis by receiver operating characteristic curve showed that:muscle mass(the area under the curve,sensitivity,specificity and critical value of muscle mass were 0.744,76.50%,74.20%and 36.50 kg,respectively,with P=0.002)and appendicular skeletal muscle index(the area under the curve,sensitivity,specificity and critical value of appendicular skeletal muscle index were 0.739,82.40%,62.10%and 5.81 kg/m2,respectively,and P=0.002)had good predictive value for postmenopausal osteoporosis.To conclude,a reduction in muscle mass and appendicular skeletal muscle index can help to predict the risk of postmenopausal osteoporosis,and the possibility of osteoporosis should be taken into account in postmenopausal women when muscle mass is<36.50 kg or appendicular skeletal muscle index is<5.81 kg/m2,in order to prevent the occurrence of postmenopausal osteoporosis.
6.Repair of postoperative defects following orbital tumors resection using 3D-printed preformed titanium meshes: a multicenter long-term retrospective study
Tian YUAN ; Tianfeng ZHAO ; Xiaodong CHEN ; Min XU ; Zaixing WANG ; Rui ZHENG ; Shuo WU ; Qintai YANG ; Zhaohui SHI
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(9):1090-1096
Objective:To investigate the long-term outcomes of using 3D-printed preformed titanium meshes in repair and reconstruction of orbital region.Methods:A retrospective analysis was conducted on patients with tumors invading the naso-orbito-maxillary region who underwent surgical resection and repair/reconstruction with 3D-printed preformed titanium meshes. The patients were collected at three medical centers (the Third Affiliated Hospital of Sun Yat-sen University, Xijing Hospital of Air Force Military Medical University, and Shenzhen Longgang District Ear, Nose and Throat Hospital) from 2016 to 2023. Tumor extent was evaluated radiologically, and the surgical approaches, reconstruction outcomes, surgical complications, and long-term follow-up results were analyzed.Results:A total of 46 patients from the three centers were included in this study, comprising 27 males and 19 females, with an average age of 51 years (range: from 13 to 86 years). Among them, 4 patients had benign tumors, while the remaining 42 had malignant tumors. The median follow-up duration was 60.7 months (range: from 19.0 to 75.0 months). Postoperatively, symmetrical globe position was achieved in 38 cases without significant diplopia; 4 cases exhibited enophthalmos without diplopia, and 4 cases had enophthalmos with diplopia. Twelve patients received preoperative radiotherapy, and 30 patients received postoperative radiotherapy. Six patients developed enophthalmos, and 6 experienced titanium mesh exposure after radiotherapy. Following treatment completion, 3 patients underwent repair using frontal flaps, 1 using a superficial temporal artery island flap, and 2 using free flaps. All remaining patients showed no postoperative infections, and their wounds healed normally.Conclusion:The application of 3D-printed preformed titanium mesh enables precise repair of postoperative defects in patients with naso-orbital tumors, facilitating reliable reconstruction of the orbital and facial contours with straightforward operation and dependable outcomes.
7.Progress of individualized precision therapy for peritoneal metastasis in gastric cancer
Junhua ZHAO ; Yuqing YANG ; Rui MA ; Chengzhi ZHANG ; Zhengchao HONG ; Zhenning WANG
Chinese Journal of Surgery 2025;63(7):552-557
Peritoneal metastasis represents the most aggressive form of gastric cancer metastasis and serves as a primary contributor to poor prognosis. Conventional therapeutic approaches offer limited survival benefits, making the development of novel treatment strategies an urgent medical priority. With advancements in molecular medicine and sociomedical sciences, contemporary cancer management is evolving towards individualized precision medicine. This transition has given rise to a plethora of innovative therapeutic strategies, including molecular typing-driven targeted therapy, immunotherapy, and locally targeted technology. These strategies emphasize the construction of a precise and individualized therapeutic framework through the integration of genomics, imaging genomics, and artificial intelligence-assisted decision-making, which promotes the continuous improvement of treatment strategies for peritoneal metastasis of gastric cancer. This article provides a comprehensive analysis of the prevailing individualized treatment modalities from the standpoint of precision medicine, offering novel perspectives on the management of peritoneal metastasis in gastric cancer.
8.Screening and Identification of Nanobodies Against β-Conglycinin
Jia-Shu CHANG ; Hua-Bo SUN ; Yu-Ting WANG ; Xiao-Hui WANG ; Bo YANG ; Hong-Rui LIU ; Yue-Xin LI ; Yuan-Zhao SUN ; Shao-Peng GU ; Jin-Xin HE
Chinese Journal of Biochemistry and Molecular Biology 2025;41(5):764-770
Soy is a vital source of plant carbohydrates.However,it poses significant allergenic risks,particularly to young children and animals.Among the various proteins in soy,β-conglycinin,which con-stitutes approximately 30%of total soy carbohydrates,is a primary allergen.Undigested β-conglycinin can lead to intestinal damage by inhibiting cell growth,disrupting the cytoskeleton,and inducing apopto-sis.It can also enter the lymphatic and circulatory systems,triggering allergic reactions.Conventional ELISA methods for detecting β-conglycinin rely on polyclonal or monoclonal antibodies,which are limited by their large molecular weight,difficulty in accessing the protein core,and sensitivity to acidic and bas-ic conditions.To address these limitations,this study aimed to develop nanobodies(Nbs)against β-con-glycinin.Nbs,derived from the variable regions of heavy-chain antibodies found in camelids,have a mo-lecular weight approximately one-tenth that of conventional antibodies.They offer advantages such as small size,stable structure,high specificity,and strong affinity.A female alpacas was immunized five times using β-conglycinin,which showed a heavy chain antibody potency of 1∶16 000 by ELISA.Pe-ripheral blood lymphocytes were subsequently isolated and total RNA was extracted.The variable region of the heavy-chain antibody was amplified via PCR,and recombinant plasmids were constructed and transformed into the E.coli competency strain ER2738.The resulting library contained about 3.5×108 CFU/mL,which increased to 1.15×1012 PFU/mL after phage rescue,with a 100%Nbs gene insertion rate,indicating high diversity.Its Nbs phage output was significantly enriched by four rounds of solid-phase elution with an enrichment rate of 155.9.Four rounds of solid-phase panning yielded 35 positive clones,all of which shared the same amino acid sequence upon sequencing.The selected Nb was ex-pressed in a prokaryotic system,and its binding ability to β-conglycinin was confirmed using Western blotting and ELISA.The results demonstrated excellent specificity and affinity.This research lays the groundwork for developing a rapid and efficient detection method for β-conglycinin using Nbs,potentially enhancing food safety and allergen management.
9.Mechanism of disidin domain receptor 1 regulating the proliferation and apoptosis of glioma cells
Kai-tao ZHAO ; Jun-li LIANG ; Rong-jun YANG ; Dong HUANG ; Rui MIAO
Journal of Regional Anatomy and Operative Surgery 2025;34(6):484-488
Objective To explore the regulatory effect and mechanism of disidin domain receptor 1(DDR1)on the proliferation and apoptosis of glioma cells.Methods The expression levels of DDR1 in human glioma cells and normal glial cells were detected by qRT-PCR and Western blot.Glioma cells U251 with stable overexpression and knockdown of DDR1 were constructed by lentivirus infection,the proliferation ability of the stable cell line was detected by CCK-8 assay,and the apoptosis ability was detected by flow cytometry.Western blot was used to detect the activation of related pathways in stable cell lines and explore the regulatory mechanism of DDR1.Results The results of qRT-PCR and Western blot showed that the expression level of DDR1 in human glioma cell U251 was higher than those in human glioma cell U87 and normal glial cell HEB.Therefore,the U251 cell line was selected for subsequent experiments.CCK-8 assay showed that overexpression of DDR1 promote the proliferation of glioma cells,while knockdown of DDR1 inhibit the proliferation of glioma cells.The results of flow cytometry showed that overexpression of DDR1 inhibit the apoptosis of glioma cells,while knockdown of DDR1 induce the apoptosis of glioma cells.Western blot results showed that overexpression of DDR1 activate the PI3K/AKT pathway,while knockdown of DDR1 inhibit the activation of the PI3K/AKT pathway.Conclusion DDR1 can enhance the proliferation ability of glioma cells and inhibit their apoptosis by activating the PI3K/AKT pathway,promoting the development of glioma cells.Therefore,DDR1 may become a potential target for the treatment of glioma.
10.Dynamic changes of serum exosome miR-552 and miR-653 levels be-fore and after chemotherapy in gastric cancer and their relationship with clinical benefit
Xiao-rui ZHAO ; Run-chun HAO ; Meng-jing HE ; Shan-shan SU ; Bing-xin YANG ; Wen-zhong ZHANG
Chinese Journal of Current Advances in General Surgery 2025;28(3):208-212
Objective:To analyze the dynamic changes of serum exosome miR-552 and miR-653 levels in pa-tients with gastric cancer before and after chemotherapy and their relationship with clinical benefit.Methods:IA total of 128 patients with gastric cancer received chemotherapy from January 2022 to January 2024.According to the chemo-therapy effect,the two groups were divided into disease progression group and disease remission group.The levels of serum exosome miR-552 and miR-653 before and after chemotherapy were detected in the two groups,the risk fac-tors affecting the chemotherapy effect of gastric cancer patients were screened,the risk nomogram model was con-structed,and the efficacy was evaluated.Results:The proportion of TNM stage(Ⅲ+Ⅳ),lymph node metastasis,dis-tant metastasis,tumor size(>5 cm),invasion depth(T3/T4)and tumor growth pattern(invasive type)in disease progres-sion group was higher than that in disease remission group(P<0.05).The levels of serum exosomes miR-552 and miR-653 in disease progression group were higher than those in remission group before and after chemotherapy(P<0.05).Compared with before chemotherapy,miR-552 and miR-653 levels in both groups decreased(P<0.05).Logistic regres-sion analysis showed that TNM stage,lymph node metastasis,distant metastasis,tumor size,invasion depth,miR-552 and miR-653 were all risk factors affecting the chemotherapy efficacy of gastric cancer(P<0.05).ROC curve results showed that the AUC,95%CI,sensitivity and specificity of risk nomogram model to predict chemotherapy efficacy of gastric cancer were 0.867,0.672~0.991,92.80%and 80.40%,respectively(P<0.001).Calibration curve results showed that both predicted and actual predicted values were near the ideal curve,and the Hosmer-Lemeshow goodness of fit curve test χ2=1.869,P=0.782.Conclusion:The levels of serum exosomes miR-552 and miR-653 are closely related to the chemotherapy efficacy of gastric cancer,and dynamic monitoring of the above indexes is helpful for the evaluation of the disease and prognosis of gastric cancer.In this study,the risk nomogram model constructed based on the above indexes and other risk factors has high predictive value and clinical practicability for chemotherapy efficacy in patients with gastric cancer.

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