1.Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method
Tengfei LI ; Qingyong ZHENG ; Jianguo XU ; Yiyi LI ; Yongjia ZHOU ; Caihua XU ; Mingyue ZHANG ; Jiexiang TIAN ; Gang WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(1):101-111
Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.
2.Establishment and application of evaluation criteria for rational use of pyrotinib
Yiyi LIAO ; Xin LI ; Yaowen XIA ; Hongmei ZHAO ; Qingqing CHEN
China Pharmacy 2025;36(6):742-747
OBJECTIVE To establish drug utilization evaluation (DUE) criteria for pyrotinib to promote its appropriate application in clinical practice. METHODS Based on the label of Pyrotinib maleate tablets, with relevant guiding principles and diagnostic and treatment guidelines as the evaluation basis, DUE criteria for pyrotinib were determined through the Delphi method. Attribute hierarchical model (AHM) and entropy weight method (EWM) were used to combine and assign weights to each indicator within the DUE criteria. Additionally, the weighted technique for order preference by similarity to an ideal solution (TOPSIS) method was applied to perform rationality evaluation of medication in archived medical records from Hainan Provincial Tumor Hospital and Hainan Western Central Hospital regarding the use of pyrotinib from November 2019 to November 2023. RESULTS The established DUE criteria for pyrotinib included 4 primary indicators (prescription authority, indications for use, medication process, and medication outcomes) and 11 secondary indicators. The secondary indicators with higher weights were the route of administration and dosage (0.257) and indications in the label (0.241). Among the 88 archived cases included, there were 28 cases of inappropriate medication (31.82%), 43 cases of generally appropriate medication (48.86%), and 17 cases of appropriate medication (19.32%). The main issues related to inappropriate medication involved off-label use (42.05%) and inappropriate routes of administration and dosage (43.18%). CONCLUSIONS DUE criteria for pyrotinib established using the AHM-EWM-weighted TOPSIS method is highly operational and results in quantifiable evaluation outcomes. The overall rationality of the use of pyrotinib in the above hospitals remains to be improved, and there are some issues, like the off-label use,and inappropriate routes of administration and dosage being liaoyylyy@163.com unreasonable.
3.Re-examination of Atractylodis Rhizoma and Dosage of Whole Formula in Yuejiuwan
Yanping HAN ; Yiyi ZHANG ; Huimin GAO ; Raorao LI ; Li YAO ; Zhaoxiang SUN ; Zhuo MA ; Huamin ZHANG ; Wei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):223-233
Yuejuwan is a classic formula widely used by doctors to relieve liver and depression, with precise clinical efficacy in traditional Chinese medicine (TCM). The authors used bibliometric methods to collect and collate 495 ancient data related to Yuejuwan, and 105 valid data were screened out, involving 68 ancient Chinese medical books. After systematic verification of the origin of the formula of Yuejuwan, the main treatment symptoms, the principle of the formula, the composition of the drug, the dosage, the preparation method, the decoction method, and other information, the results showed that Yuejuwan originated from the Danxi Xinfa (《丹溪心法》) of the Yuan Dynasty by ZHU Zhenheng, and it is composed of five medicines, namely Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, Massa Medicata Fermentata, and Gardeniae Fructus. In terms of drug base, Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, and Gardeniae Fructus are in line with the records in the 2020 edition of Chinese Pharmacopoeia, and Massa Medicata Fermentata is used. The preparation method is as follows: Massa Medicata Fermentata and Gardeniae Fructus are fried, and Cyperi Rhizoma is roasted in vinegar. Chuanxiong Rhizoma is used in the raw form, and Atractylodis Rhizoma is prepared with rice swill. The formula can regulate Qi and relieve depression and broaden the middle and remove fullness. It is clinically used for the treatment of six types of depression syndromes, chest and diaphragm plumpness, abdominal distension and leg acid, acid swallowing and vomiting, eating and drinking disharmony, toothache, mouth and tongue sores, and other diseases. The most used dosage of the formula in the ancient records through the ages is converted into the modern dosage, namely 3.05 g Atractylodis Rhizoma, 3.05 g Cyperi Rhizoma, 3.05 g Chuanxiong Rhizoma, 3.05 g Massa Medicata Fermentata, and 3.05 g Gardeniae Fructus, and the daily dosage is 15.25 g. The converted dosage is similar to that recorded in the 2020 edition of the Chinese Pharmacopoeia. The formula is in pill form, and medicine should be taken with lukewarm boiled water after the meal. Through the excavation of the ancient literature related to Yuejuwan, the key information of the formula is identified, with a view to providing a more accurate reference for the clinical application of Yuejuwan and subsequent in-depth investigation.
4.Re-examination of Atractylodis Rhizoma and Dosage of Whole Formula in Yuejiuwan
Yanping HAN ; Yiyi ZHANG ; Huimin GAO ; Raorao LI ; Li YAO ; Zhaoxiang SUN ; Zhuo MA ; Huamin ZHANG ; Wei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):223-233
Yuejuwan is a classic formula widely used by doctors to relieve liver and depression, with precise clinical efficacy in traditional Chinese medicine (TCM). The authors used bibliometric methods to collect and collate 495 ancient data related to Yuejuwan, and 105 valid data were screened out, involving 68 ancient Chinese medical books. After systematic verification of the origin of the formula of Yuejuwan, the main treatment symptoms, the principle of the formula, the composition of the drug, the dosage, the preparation method, the decoction method, and other information, the results showed that Yuejuwan originated from the Danxi Xinfa (《丹溪心法》) of the Yuan Dynasty by ZHU Zhenheng, and it is composed of five medicines, namely Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, Massa Medicata Fermentata, and Gardeniae Fructus. In terms of drug base, Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, and Gardeniae Fructus are in line with the records in the 2020 edition of Chinese Pharmacopoeia, and Massa Medicata Fermentata is used. The preparation method is as follows: Massa Medicata Fermentata and Gardeniae Fructus are fried, and Cyperi Rhizoma is roasted in vinegar. Chuanxiong Rhizoma is used in the raw form, and Atractylodis Rhizoma is prepared with rice swill. The formula can regulate Qi and relieve depression and broaden the middle and remove fullness. It is clinically used for the treatment of six types of depression syndromes, chest and diaphragm plumpness, abdominal distension and leg acid, acid swallowing and vomiting, eating and drinking disharmony, toothache, mouth and tongue sores, and other diseases. The most used dosage of the formula in the ancient records through the ages is converted into the modern dosage, namely 3.05 g Atractylodis Rhizoma, 3.05 g Cyperi Rhizoma, 3.05 g Chuanxiong Rhizoma, 3.05 g Massa Medicata Fermentata, and 3.05 g Gardeniae Fructus, and the daily dosage is 15.25 g. The converted dosage is similar to that recorded in the 2020 edition of the Chinese Pharmacopoeia. The formula is in pill form, and medicine should be taken with lukewarm boiled water after the meal. Through the excavation of the ancient literature related to Yuejuwan, the key information of the formula is identified, with a view to providing a more accurate reference for the clinical application of Yuejuwan and subsequent in-depth investigation.
5.Perioperative digital surveillance with a multiparameter vital signs monitoring system in a gastric cancer patient with diabetes.
Reziya AIERKEN ; Z W JIANG ; G W GONG ; P LI ; X Y LIU ; F JI
Chinese Journal of Gastrointestinal Surgery 2025;28(11):1318-1322
Objective: To evaluate the application value of a digital technology-based multiparameter vital signs monitoring system in perioperative comprehensive full-cycle surveillance. Methods: A comprehensive multidimensional vital signs monitoring system was developed through the integration of medical-grade wireless wearable devices, incorporating patch-type ambulatory electrocardiographic monitor, continuous glucose monitoring sensor, pulse oximeter, wireless digital thermometer, smart wristband, and bioelectrical impedance analyzer. This system facilitates continuous real-time acquisition of multiple physiological parameters including electrocardiogram, blood glucose, oxygen saturation, body temperature, physical activity, and body composition indices. The acquired data were systematically integrated and analyzed through a four-level digital architecture consisting of nurse mobile interfaces, bedside patient terminals, centralized ward monitoring displays, and hospital management information systems. One patient with gastric cancer complicated by diabetes mellitus was selected for full-cycle digital monitoring from preoperative evaluation to hospital discharge. The technical performance of the monitoring system was assessed in terms of data acquisition continuity and timeliness of abnormal event alerts. Results: The monitoring system effectively identified early postoperative abnormalities, such as decreased oxygen saturation and blood glucose fluctuations, providing timely guidance for clinical intervention. The built-in algorithm enabled visualization of perioperative stress levels through heart rate variability indices and continuous glucose monitoring data. The patient demonstrated good compliance with early postoperative mobilization, and the satisfaction score for monitoring management was 4 points based on the Likert 5-point scale. Conclusions: The multiparameter vital signs monitoring system enhanced the precision of perioperative management through continuous and dynamic physiological status assessment. Its modular design aligns with the principles of enhanced recovery after surgery, offering a novel technological solution for intelligent perioperative management.
Humans
;
Stomach Neoplasms/physiopathology*
;
Vital Signs
;
Monitoring, Physiologic/instrumentation*
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Diabetes Mellitus
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Wearable Electronic Devices
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Perioperative Period
6.The toxic components, toxicological mechanism and effective antidote for Gelsemium elegans poisoning.
Niping LI ; Yaorong YANG ; Shengyuan ZHANG ; Bin JIANG ; Wei ZHANG ; Haibo WANG ; Lixin CHEN ; Liwei WANG ; Yiyi LI ; Lei SHI ; Wencai YE ; Lei WANG
Acta Pharmaceutica Sinica B 2025;15(9):4872-4885
Gelsemium elegans (G. elegans) is an extremely poisonous plant that is widely distributed in southern China and southeastern Asia. G. elegans poisoning events occur frequently in southern China, and are therefore an urgent public health problem requiring multidisciplinary action. However, the toxic components and toxicological mechanisms remain unclear. Here, we describe a systematic investigation on the toxic components of G. elegans, resulting in the isolation and identification of 120 alkaloids. Based on acute toxicity screening, the structure-toxicity relationship of Gelsemium alkaloids was proposed for the first time. Moreover, gelsedine- and humantenine-type alkaloids were detected in the clinical blood sample, and were confirmed to be causative in the poisoning. The most toxic compound, gelsenicine (1), had selective inhibitory effects toward ventral respiratory group (VRG) neurons in the medulla, which is the main brain region controlling respiration in the central nervous system. Gelsenicine (1) strongly inhibited the firing of action potentials in VRG neurons through its ability to stimulate GABAA receptors, the main receptors involved in inhibitory neurotransmission. Application of GABAA receptor antagonists successively reversed action potential firing in gelsenicine (1)-treated VRG neurons. Importantly, the GABAA receptor antagonists securinine and flumazenil significantly increased the survival of poisoned animals. Our findings provide insight into the components and mechanisms of G. elegans toxicity, and should assist the development of effective emergency treatments for G. elegans poisoning.
7.A meta-analysis of the association between green space and dyslipidemia
Chenxi LUO ; Tianjing HE ; Jicheng ZHU ; Yiyi HUANG ; Lu MA ; Yang LI
Journal of Public Health and Preventive Medicine 2024;35(5):10-14
Objective To explore the association between green space and the risk of dyslipidemia. Methods “Dyslipidemia” and “ Normalized Difference Vegetation Index (NDVI)” were used as search terms to search PubMed, Embase, and Web of Science databases for studies up to September 2023. ARHQ statistical assessment and review tool and NOS scale were employed to evaluate the quality of the studies. R 4.3.1 software was used for meta-analysis. Results A total of 11 studies were included, of which 5 cross-sectional studies and 5 cohort studies were rated as “high quality”. The results of meta-analysis showed that an increase in NDVI in some buffer zones was associated with reduced risks of hypercholesterolemia, hypertriglyceridemia, low HDL-C, and high LDL-C, while an increase in NDVI in 100m buffer zone was significantly associated with reduced risks of all these four diseases, with hypercholesterolemia (OR=0.87, P<0.05), hypertriglyceridemia (OR=0.94, P<0.05), low HDL-C (OR=0.95, P<0.05), and high LDL-C (OR=0.87, P<0.05). Sensitivity analysis suggested that the results of most meta-analyses were robust. Conclusion With the increase in green space near residential areas, the risk of dyslipidemia may decrease.
8.Textual Research on Key Information of Classic Formula Gualou Niubangtang
Yanping HAN ; Yiyi ZHANG ; Mengyuan YANG ; Raorao LI ; Li YAO ; Zhaoxiang SUN ; Zhuo MA ; Huimin GAO ; Wei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):224-232
Gualou Niubangtang is a classic formula for eliminating swelling and dispersing lumps, commonly used in the clinical treatment of breast diseases in traditional Chinese medicine (TCM). This paper employed bibliometric methods to collect and organize 12 pieces of data from ancient texts related to Gualou Niubangtang, ultimately screening 10 valid references from 10 ancient Chinese medical books. Information regarding the prescription origin, main indications, formulation principles, drug composition, dosages, preparation methods, and decoction techniques was systematically verified. The results indicate that Gualou Niubangtang originates from the Orthodox Manual of External Medicine (Wai Ke Zheng Zong) by Chen Shigong in the Ming Dynasty. The formula consists of 12 Chinese medicines, including Citri Reticulatae Pericarpium, Arctii Fructus, Gardeniae Fructus, Lonicerae Japonicae Flos, Glycyrrhizae Radix et Rhizoma, Trichosanthis Semen, Scutellariae Radix, Trichosanthis Radix, Forsythiae Fructus, Gleditsiae Spina, Bupleuri Radix, and Citri Reticulatae Pericarpium Viridm. In terms of drug origins, the dominant radical for Trichosanthis Semen and Trichosanthis Radix is Trichosanthes kirilowii, and the historical dominant radical for Glycyrrhizae Radix et Rhizoma is Glycyrrhiza uralensis. The nine medicines, Citri Reticulatae Pericarpium, Arctii Fructus, Gardeniae Fructus, Lonicerae Japonicae Flos, Scutellariae Radix, Forsythiae Fructus, Gleditsiae Spina, Bupleuri Radix, and Citri Reticulatae Pericarpium Viridm, are consistent with the 2020 edition of the Chinese Pharmacopoeia. The preparation methods involve frying Arctii Fructus, removing the heart from Forsythiae Fructus, while the remaining 10 medicines are used raw. The efficacy includes clearing heat, removing toxins, reducing swelling, and dispersing lumps. Clinically, it is used to treat conditions such as breast carbuncles, breast gangrene, and knot-like swellings and pain. The dosage, converted to modern standards, includes 3.73 g of Trichosanthis Semen, 3.73 g of Trichosanthis Radix, 3.73 g of Arctii Fructus, 3.73 g of Scutellariae Radix, 3.73 g of Gardeniae Fructus, 3.73 g of Forsythiae Fructus, 3.73 g of Gleditsiae Spina, 3.73 g of Lonicerae Japonicae Flos, 3.73 g of Glycyrrhizae Radix et Rhizoma, 3.73 g of Citri Reticulatae Pericarpium, 1.85 g of Citri Reticulatae Pericarpium Viridm, and 1.85 g of Bupleuri Radix. The preparation is in the form of a decoction, with the 12 medicines added to 400 mL of water and decocted until 160 mL. The liquid is then mixed with 200 mL of yellow wine and taken before meals three times a day. Through the excavation and organization of ancient literature regarding Gualou Niubangtang, key information has been identified to provide a scientific basis for its clinical application and further development.
9.A pilot study on clinical application of three-dimensional morphological completion of lesioned mandibles assisted by generative adversarial networks
Ye LIANG ; Qian WANG ; Yiyi ZHANG ; Jingjing HUAN ; Jie CHEN ; Huixin WANG ; Zhuo QIU ; Peixuan LIU ; Wenjie REN ; Yujie MA ; Canhua JIANG ; Jiada LI
Chinese Journal of Stomatology 2024;59(12):1213-1220
Objective:To explore the clinical application pathway of the CT generative adversarial networks (CTGANs) algorithm in mandibular reconstruction surgery, aiming to provide a valuable reference for this procedure.Methods:A clinical exploratory study was conducted, 27 patients who visited the Department of Oral and Maxillofacial Surgery, Xiangya Hospital of Central South University between January 2022 and January 2024 and required mandibular reconstruction were selected. The cohort included 16 males and 11 females, with the age of (46.6±11.5) years; among them, 7 cases involved mandibular defects crossing the midline. The CTGANs generator produced 100 images, and the mean squared error (MSE) was calculated for differences between any two generated images. Preoperative cone-beam CT data from 5 patients were used to construct a labeled test database, divided into groups: normal maxilla, normal mandible, diseased mandible, and noise (each group containing 70 cross-sectional images). The CTGANs discriminator was used to evaluate the loss values for each group, and one-way ANOVA and intergroup comparisons were performed. Using the self-developed KuYe multioutcome-option-network generation system (KMG) software, the three-dimensional (3D) completion area of the mandible under cone-beam CT was defined for the 27 patients. The CTGANs algorithm was applied to obtain a reference model for the mandible. Virtual surgery was then performed, utilizing the fibular segment to reconstruct the mandible and design the surgical expectation model. The second-generation combined bone-cutting and prebent reconstruction plate positioning method was used to design and 3D print surgical guides, which were subsequently applied in mandibular reconstruction surgery for the 27 patients. Postoperative cone-beam CT was used to compare the morphology of the reconstructed mandible with the surgical expectation model and the mandibular reference model to assess the three-dimensional deviation.Results:The MSE for the CTGANs generator was 2 411.9±833.6 (95% CI: 2 388.7-2 435.1). No significant difference in loss values was found between the normal mandible and diseased mandible groups ( P>0.05), while both groups demonstrated significantly lower loss values than the maxilla and noise groups ( P<0.001). All 27 patients successfully obtained mandibular reference models and surgical expectation models. In total, 14 162 negative deviation points and 15 346 positive deviation points were observed when comparing the reconstructed mandible morphology with the surgical expectation model, with mean deviations of -1.32 mm (95% CI:-1.33- -1.31 mm) and 1.90 mm (95% CI: 1.04-1.06 mm), respectively. Conclusions:The CTGANs algorithm is capable of generating diverse mandibular reference models that reflect the natural anatomical characteristics of the mandible and closely match individual patient morphology, thereby facilitating the design of surgical expectation models. This method shows promise for application in patients with mandibular defects crossing the midline.
10.Preparation and application of novel photosensitive nanoparticles in tumor photodynamic therapy
Mengzhou GUO ; Huan LIU ; Tong LI ; Yiyi YU
Chinese Journal of Clinical Medicine 2024;31(4):577-585
Objective To prepare a novel photosensitive nanoparticle and to evaluate its physicochemical properties,and effect on the efficacy of photodynamic therapy.Methods 5,15-dibromo-10,20-diphenylporphine(DBN),tetrafluoroterephthalonitrile(TFN),and the amphiphilic polymer methoxy-polyethylene glycol-distearoylphosphatidylethanolamine(DSPE-MPEG2000,PEG)were dissolved in tetrahydrofuran(THF)by co-precipitation method to prepare novel photosensitive nanoparticles,named DBN/TFN@PEG.The physicochemical properties of DBN/TFN@PEG were characterized.Both novel and conventional nanoparticles were continuously irradiated with a 660 nm laser,and the fluorescence intensity of nanoparticles,representing reactive oxygen species(ROS)production levels,was measured using a fluorescence spectrophotometer at different irradiation times.Tumor cells were co-incubated with the nanoparticles and irradiated with a 660 nm laser.ROS levels within the tumor cells were detected using immunofluorescence,and the ratio of dead to live tumor cells was determined using PI/Calcein-AM staining.Results Prepared DBN/TFN@PEG nanoparticles with hydrated particle size of approximately 107.8 nm were uniformly distributed in the solution.Compared to conventional nanoparticles,the ROS production capacity of DBN/TFN@PEG was significantly higher(P<0.01).Immunofluorescence results showed that the generation of ROS levels in the tumor cells of DBN/TFN@PEG group were significantly higher than in the conventional nanoparticles group under laser irradiation(P<0.01).PI/Calcein-AM staining results indicated a significantly higher ratio of dead tumor cells in the DBN/TFN@PEG group compared to the conventional nanoparticle group(P<0.01).Conclusions DBN/TFN@PEG has stable physicochemical properties and uniform distribution in the solution.As effective photosensitizers,DBN/TFN@PEG can exhibit stronger ability to induce ROS generation in tumor cells,and may enhance the efficacy of photodynamic therapy in cancer.


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