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.Development,reliability and validity of nurses'knowledge,attitude and practice questionnaire on medication management for patients with dysphagia
Yi LIU ; Liqun ZHU ; Sheng SUI ; Ruo ZHUANG ; Yiyi NI ; Yuanyuan MI ; Lei BAO ; Li LI ; Lanping ZHENG ; Mengmeng CHEN
Chongqing Medicine 2024;53(5):738-744
Objective To develop nurses'knowledge,attitude and practice questionnaire on medication management for patients with dysphagia,and test its reliability and validity.Methods Based on the evidence-based summary of the best evidence of medication management for patients with dysphagia,guided by the the-ory of knowledge,attitude and practice,the basic dimensions and item pool of the questionnaire were deter-mined through group discussion,Delphi expert consultation and pre-investigation.In order to revise the ques-tionnaire,437 nurses from 10 tertiary hospitals in Jiangsu Province were conveniently selected for investigation,and the reliability and validity of the questionnaire were tested according to the survey results.Results The nurses'knowl-edge,attitude and practice questionnaire on medication management for patients with dysphagia included 43 items in three dimensions.The three dimensions were analyzed by exploratory factors,and six common factors with characteristic roots>1 were extracted.Two factors were extracted from the knowledge dimension,and the cumulative variance contribution rate was 74.958%,One factor was extracted from the attitude dimen-sion,and the cumulative variance contribution rate was 77.655%.Three factors were extracted from the prac-tice dimension,and the cumulative variance contribution rate was 72.274%.The factor load of each item was 0.618-0.902,Cronbach's α coefficient of the total questionnaire was 0.949,and the test-retest reliability was 0.909.The overall content validity coefficient of the questionnaire was 0.922,and the content validity coeffi-cient for each item was 0.800-1.000.Conclusion The nurses'knowledge,attitude and practice questionnaire on medication management for patients with dysphagia developed in this study has good reliability and validi-ty,and could be used as an effective tool to evaluate the status quo of nurses'medication management for pa-tients with dysphagia.
6.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.
7.Comparative study of 18F-PSMA-1007, 18F-FDG PET/CT and mpMRI in the diagnosis of prostate cancer
Yiyi JIANG ; Fucen LIU ; Boliang LI ; Yichao WANG ; Minshan JIN ; Jun ZHANG ; Hui DAI
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(3):147-152
Objective:To compare the diagnostic efficacy of 18F-prostate specific membrane antigen (PSMA)-1007 PET/CT, 18F-FDG PET/CT and multi-parameter MRI (mpMRI) in prostate cancer (PCa). Methods:Retrospective analysis was conducted on data from 22 patients ((72.6±6.2) years) with pathologically confirmed PCa in the Affiliated Taizhou People′s Hospital of Nanjing Medical University between April 2021 and September 2022. All patients underwent 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT, and mpMRI examination within 30 d, and the imaging parameters were collected, including PSMA-SUV max, FDG-SUV max, minimum apparent diffusion coefficient (ADC min), mean apparent diffusion coefficient (ADC mean), PSMA-SUV max/ADC min, PSMA-SUV max/ADC mean, FDG-SUV max/ADC min, FDG-SUV max/ADC mean. Patients were divided into groups based on the International Society of Urological Pathology (ISUP) grading (≤3 vs >3) and serum total prostate specific antigen (TPSA; ≤20 μg/L vs >20 μg/L), and differences of imaging parameters between groups were compared (Mann-Whitney U test or independent-sample t test). ROC curves were generated to evaluate the diagnostic ability of each parameter for different levels of PCa. χ2 test and ROC curve analysis were used to compare the detection rate and diagnostic efficiency of three imaging methods for primary focus, lymph node metastasis, and bone metastasis in PCa. Results:Differences were found between ISUP≤3 ( n=6) and >3 ( n=16) groups in PSMA-SUV max/ADC min, PSMA-SUV max/ADC mean, PSMA-SUV max, and ADC min ( z values: from -2.65 to -2.36, t=3.60, P values: 0.002-0.018). But there was no significant difference found between TPSA≤20 μg/L ( n=5) and >20 μg/L ( n=17) groups in all indices ( z values: from -1.76 to -1.45, t values: -1.19 and 1.28, all P>0.05). The optimal cut-off value for PSMA-SUV max/ADC min in differentiating high-grade and low-grade PCa was determined to be 22.628×10 3. In the patient-based analysis, no statistical difference was found in the detection rate of PCa primary tumors among 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT, and mpMRI ( χ2=1.91, P=0.767). However, the detection rates of lymph node and bone metastasis among three imaging methods were significantly different (72.73%(16/22), 59.09%(13/22), 36.36%(8/22) and 81.82%(18/22), 63.64%(14/22), 45.45%(10/22); χ2 values: 6.03, 6.29; P values: 0.049, 0.043). 18F-PSMA-1007 PET/CT resulted in a 36.36%(8/22) increase in N stage and the 40.91%(9/22) increase in M stage compared to mpMRI. Conclusions:PSMA-SUV max/ADC min is a valuable parameter for differentiating high-grade and low-grade PCa. 18F-PSMA-1007 PET/CT demonstrates superior detection rate of PCa lymph node and bone metastasis compared to 18F-FDG PET/CT and mpMRI, and exhibits higher diagnostic efficiency, so it can be recommended for NM staging in patients with PCa.
8.Intracranial infection due to Mycobacterium lentiflavum: a case report and literature review
Chuanxia LI ; Yiyi WANG ; Qian LI ; Liandi LU ; Wei YE ; Jing PAN ; Sihu PAN
Chinese Journal of Neurology 2024;57(2):164-170
Objective:To analyze the clinical characteristics of intracranial infection caused by Mycobacterium lentiflavum. Methods:The clinical data of a patient with intracranial infection caused by Mycobacterium lentiflavum admitted to Tianjin Haihe Hospital in May 2023 were collected. Meanwhile relevant literatures in databases were searched. Only 1 English literature (1 patient) was obtained. The clinical characteristics of this patient and the case reported in the literature were analyzed and summarized. Results:Totally 2 patients, including this case, and the patient with meningoencephalitis caused by Mycobacterium lentiflavum reported in the literature, both are females, 42 and 55 years old respectively, both manifested a chronic course, without fever, and presented progressive headache and cognitive impairment. Clinical manifestations also included abnormal mental behavior, limb weakness, and seizure. At the early stage, only intracranial pressure increased, and cerebrospinal fluid tests were negative. As the disease aggravated, there was an elevation of cerebrospinal fluid cells and protein, with normal levels of glucose and chloride. Using brain tissue obtained by biopsy for polymerase chain reaction or next-generation sequencing examination, the pathogenic microorganism was confirmed, which made accurate diagnosis possible. Antibiotic treatment had good efficacy, with a long treatment course and a good prognosis. Conclusions:Central nervous system infection caused by Mycobacterium lentiflavum is very rare, and a chronic disease course makes diagnosis very difficult. The treatment effect is significant, and the prognosis is excellent.
9.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.
10.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.


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