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.Visual acuity and corrected visual acuity of children and adolescents in Shanghai City
Chinese Journal of School Health 2025;46(1):24-28
Objective:
To investigate the visual acuity and correction conditions of children and adolescents in Shanghai, so as to provide a scientific basis for developing intervention measures to prevent myopia and protect vision among children and adolescents.
Methods:
From October to December 2022, a stratified cluster random sampling survey was conducted, involving 47 034 students from 16 municipal districts in Shanghai, covering kindergartens (≥5 years), primary schools, middle schools, general high schools and vocational high schools. According to the Guidelines for Screening Refractive Errors in Primary and Secondary School Students, the Standard Logarithmic Visual acuity Chart was used to examine naked vision and corrected vision of students, and general information was collected. The distribution and severity of visual impairment in different age groups were analyzed, and χ 2 tests and multivariate Logistic regression were used to explore factors associated with visual impairment.
Results:
The detection rate of visual impairment among children and adolescents was 76.2%, with a higher rate among females (78.8%) than males ( 73.8 %), higher among Han ethic students ( 76.2 %) than minority students (71.2%), and higher among urban students (76.7%) than suburban students (75.8%), all with statistically significant differences ( χ 2=162.6, 10.4, 5.5, P <0.05). The rate of visual impairment initially decreased and then increased with age, reaching its lowest at age 7 (53.8%) and peaking at age 17 (89.6%) ( χ 2 trend = 3 467.0 , P <0.05). Severe visual impairment accounted for the majority, at 56.6%, and there was a positive correlation between the severity of visual impairment and age among children and adolescents ( r =0.45, P <0.05). Multivariate Logistic regression showed that age, BMI, gender, ethnicity and urban suburban status were associated with visual impairment ( OR =1.18, 1.01, 1.38 , 0.79, 0.88, P <0.05). Among those with moderate to severe visual impairment, the rate of spectacle lens usage was 62.8%, yet only 44.8 % of those who used spectacle lens had fully corrected visual acuity. Females (64.9%) had higher spectacle lens usage rates than males (60.6%), and general high school students had the highest spectacle lens usage (83.9%), and there were statistically significant differences in gender and academic stages ( χ 2=57.7, 4 592.8, P <0.05).
Conclusions
The rate of spectacle lens usage among students with moderate to severe visual impairment is relatively low, and even after using spectacle lens, some students still do not achieve adequate corrected visual acuity. Efforts should focus on enhancing public awareness of eye health and refractive correction and improving the accessibility of related health services.
3.Study on meal preferences of school aged children based on discrete choice experiment
Chinese Journal of School Health 2025;46(1):45-49
Objective:
To explore the relative importance of different food attributes and levels in food decision making of school aged children, and to understand their meal preferences, so as to provide the evidence for formulating precise intervention strategies for dietary behaviours of school aged children.
Methods:
From May to June 2024, a total of 854 children aged 11 to 15 years old were selected from 2 middle schools (each school in urban and rural areas) in both Hubei Province and Anhui Province by stratified cluster random sampling method to conduct a D-optimal discrete choice experiment. The mixed Logit model was used to analyze children s preference for meal attributes and different levels, and to calculate the relative importance (RI) of attributes and willingness to pay (WTP) in meal choices.
Results:
The included five food attributes had statistical significance on meal choice of school aged children ( P <0.05). The relative importance of food attributes affecting the meal choices of school aged children in descending order were dining mode ( RI =31.26%), food varieties ( RI =30.56%), cooking method( RI =23.84%), taste( RI =8.06%) and price ( RI =6.27%). Among them, school aged children preferred home cooked meals ( β =0.74) (WTP=86.3 yuan),varied foods(grain/tubers+vegetables+fish, meat, eggs and beans) ( β =0.61) (WTP=71.9 yuan), fried/roasted cooking ( β =0.51) and spicy taste ( β =0.33).Price was negatively correlated with meal choices( β =-0.01) ( P <0.05). Based on residential area and body mass index (BMI), the stratified analysis showed that dining mode was highest in the relative importance for rural children with overweight and obese children ( RI =31.28%,34.17%), both of whom preferred home cooked meals ( β =0.76, 0.91), and meals containing fish, meat, eggs and beans with grain/tubers or grain/tubers and vegetables in terms of food choice (area: β =0.53, 0.53 ; BMI: β =0.55, 0.56) ( P <0.05).
Conclusions
School aged children have different preferences for different attributes of meals. The quality of school meals should be improved,the cost of buying healthy meals should be reduced,targeted family health education should be carried out,and healthy cooking methods should be advocated.
4.The introduction on standards system of the pharmaceutical packaging materials in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; YU Hui ; WANG Yan ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):067-076
The standard of Pharmaceutical packaging materials is an important part of the Chinese Pharmacopoeia. This article focuses on working background, general idea, working process, main framework, and its role and significance of the pharmaceutical packaging materials standards system in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia 2025 Edition.
5.The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; WANG Lin ; ZHANG Gongchen ; MA Shihong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):077-082
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the standards system of Water for Pharmaceutical Purposes has been perfected. This article focuses on the Work Background, Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
6.Comparison of SEC-RI-MALLS and SEC-RID methods for determining molecular weight and molecular weight distribution of PLGA
WANG Baocheng ; ZHANG Xiaoyan ; ZHOU Xiaohua ; ZHAO Xun ; MA Congyu ; GAO Zhengsong ; SHI Haiwei ; YUAN Yaozuo ; HANG Taijun
Drug Standards of China 2025;26(1):110-116
Objective: To establish a method for determining the molecular weight and molecular weight distribution of Poly(Lactide-co-Glycolide Acid) (PLGA) using Size Exclusion Chromatography-Refractive Index-Multiangle Laser Light Scattering (SEC-RI-MALLS) and Size Exclusion Chromatography-Refractive Index (SEC-RID), and to compare the results obtained from these two methods.
Methods: For SEC-RI-MALLS, tetrahydrofuran was used as the mobile phase, Shodex GPC KF-803L was employed as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, and an injection volume of 100 μL. For SEC-RID, tetrahydrofuran was also used as the mobile phase, Agilent PLgel 5 μm MIXD-D was used as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, differential detector temperature at 35 ℃, and an injection volume of 20 μL. The molecular weight and molecular weight distribution were calculated using Agilent’s GPC software. The newly established methods were validated methodologically, and the molecular weight and molecular weight distribution of 13 batches of samples were determined.
Results: The precision, accuracy, stability, and repeatability tests for SEC-RI-MALLS showed RSD values of 1.35%, 1.58%, 1.53%, and 1.26%, respectively. The SEC-RID method exhibited good linearity (r=0.999 9), with RSD values for precision, accuracy, stability, and repeatability tests (n=6) of 2.05%, 1.62%, 1.30%, and 2.97%, respectively. The results obtained from SEC-RI-MALLS were lower than those from SEC-RID, and the molecular weight distribution coefficient was smaller, but the results from the paired T-test performed with the value measured by SEC-RID method and the value measured by SEC-RI-MALLS method multiplied a conversion coefficient of 1.5 showed no significant difference between the two methods.
Conclusion: Both methods are stable and reliable, and can be used for the determination of PLGA molecular weight and molecular weight distribution based on the specific situations.
7.Research on pulmonary nodule recognition algorithm based on micro-variation amplification
Zirui ZHANG ; Zichen JIAO ; Xiaoming SHI ; Tao WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):339-344
Objective To develop an innovative recognition algorithm that aids physicians in the identification of pulmonary nodules. Methods Patients with pulmonary nodules who underwent thoracoscopic surgery at the Department of Thoracic Surgery, Affiliated Drum Tower Hospital of Nanjing University Medical School in December 2023, were enrolled in the study. Chest surface exploration data were collected at a rate of 60 frames per second and a resolution of 1 920×1 080. Frame images were saved at regular intervals for subsequent block processing. An algorithm database for lung nodule recognition was developed using the collected data. Results A total of 16 patients were enrolled, including 9 males and 7 females, with an average age of (54.9±14.9) years. In the optimized multi-topology convolutional network model, the test results demonstrated an accuracy rate of 94.39% for recognition tasks. Furthermore, the integration of micro-variation amplification technology into the convolutional network model enhanced the accuracy of lung nodule identification to 96.90%. A comprehensive evaluation of the performance of these two models yielded an overall recognition accuracy of 95.59%. Based on these findings, we conclude that the proposed network model is well-suited for the task of lung nodule recognition, with the convolutional network incorporating micro-variation amplification technology exhibiting superior accuracy. Conclusion Compared to traditional methods, our proposed technique significantly enhances the accuracy of lung nodule identification and localization, aiding surgeons in locating lung nodules during thoracoscopic surgery.
8.Mechanism of imperatorin in ameliorating doxorubicin resistance of breast cancer based on transcriptomics
Yiting LI ; Wei DONG ; Xinli LIANG ; Hu WANG ; Yumei QIU ; Xiaoyun DING ; Hao ZHANG ; Huiyun BAO ; Xianxi LI ; Xilan TANG
China Pharmacy 2025;36(5):529-534
OBJECTIVE To investigate the ameliorative effect and potential mechanism of imperatorin (IMP) on doxorubicin (DOX) resistance in breast cancer. METHODS The effects of maximum non-toxic concentration (100 μg/mL) of IMP combined with different concentrations of DOX (12.5, 25, 50, 75, 100 μg/mL) on the proliferation of MCF-7/DOX cells were determined by MTT method. MCF-7/DOX cells were divided into blank control group (1‰ dimethyl sulfoxide), DOX group (50 μg/mL), IMP+DOX group (100 μg/mL IMP+50 μg/mL DOX) and IMP group (100 μg/mL). mRNA and protein expressions of multidrug resistance protein 1 (MDR1) and multidrug resistance-associated protein 1 in each group were measured. The relevant pathways and targets involved in the improvement of DOX resistance in breast cancer cells by IMP were screened and validated by using transcriptome sequencing technology, along with gene ontology (GO) enrichment analyses and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses. RESULTS Compared with DOX alone, the combination of IMP and DOX reduced the half inhibitory concentration of DOX on MCF-7/DOX cells from 81.965 μg/mL to 43.170 μg/mL, the reverse fold was 1.90, and the mRNA expression of MDR1 was significantly down-regulated (P<0.05). The results of GO enrichment analyses and KEGG pathway enrichment analyses indicated that the reversal of DOX resistance in breast cancer by IMP was mainly associated with the regulation of biological processes such as detoxification, multiple biological processes, and cell killing. The main pathway involved was the p53 signaling pathway, and the key targets mainly included constitutively photomorphogenic protein 1 (COP1), cyclin E1 (CCNE1), growth arrest and DNA damage-inducible protein 45A E-mail:tangxilan1983@163.com (GADD45A) and GADD45B. The results of the verification experiments showed that compared with DOX group, there was a trend of up-regulation of COP1 mRNA, and significant down- regulation of CCNE1, GADD45A, and GADD45B mRNA expression in IMP+DOX group (P<0.05). CONCLUSIONS The effect of IMP in ameliorating DOX resistance in breast cancer is related to its regulation of COP1, CCNE1, GADD45A and GADD45B targets in the p53 signaling pathway.
9.Identification of tortoiseshell glue and antler glue in Qixiong zuogui granules and content determination of 12 chemical components
Mengxiao JIA ; Chunhui CHANG ; Yang LIU ; Yaqian WANG ; Yunke ZHANG ; Yongyan JIA
China Pharmacy 2025;36(5):540-545
OBJECTIVE To identify tortoiseshell glue and antler glue in Qichong zuogui granules, and determine the contents of 12 chemical components. METHODS Identification and content determination were performed by using liquid chromatography- tandem mass spectrometry (LC-MS/MS) method. The identification was performed on Hypersil GOLD column with a mobile phase consisted of acetonitrile-0.1% formic acid solution (gradient elution); the electrospray ion source was used to scan in the positive ion multi-reaction detection mode. The mass charge ratio (m/z) 631.3→546.4, 631.3→921.4 was the detection ion pair for tortoiseshell glue, and the m/z 765.4→554.0, 765.4→733.0 was the detection ion pair for antler glue. The determination method for 12 chemical components was as follows: Accucore C18 column, methanol-0.1% formic acid as mobile phase (gradient elution); scanning range of positive and negative ions was m/z 100→1 000 with the electric spray ion source and single ion detection scanning mode. RESULTS Average retention times of the molecular ion peaks for characteristic peptide segments of tortoiseshell glue and antler glue were 6.28 and 6.77 min, respectively; the linear relationship of 12 chemical components was good within their respective concentration ranges, such as astragaloside Ⅳ, calycosin-7-O-β-D-glucoside, calycosin, chlorogenic acid, ferulic acid, betaine, amygdalin, rutin, hydroxysafflor yellow A, hyperoside, loganin, cyasterone (r>0.999); RSDs for precision, stability (24 h) and reproducibility tests were all less than 5%. The average sample recovery rates ranged from 98.04% to 101.08%. The average contents of 12 components were 1.83, 25.73, 13.76,56.71, 23.80, 49.82, 807.49, 15.01, 317.02, 60.21, 202.71 and 17.70 μg/g, respectively. CONCLUSIONS In this study, tortoiseshell glue and antler glue in Qixiong zuogui granules are identified, and the contents of 12 chemical components therein are determined. This provides a reference for the quality control of this granule.
10.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
Yaxiong LI ; Fusang WANG ; Mei ZHANG ; Jiawei LIN ; Wenge CHEN ; Min HUANG ; Junyan WU
China Pharmacy 2025;36(5):606-611
OBJECTIVE To provide technical support for improving recognition rate of adverse drug events (ADEs) related to traditional Chinese medicine (TCM) formula granules and decoction pieces among inpatient patients. METHODS By referencing the global trigger tool (GTT) whitepaper, literature on adverse reactions to TCM, and expert review opinions, ADE trigger items for TCM formula granules and decoction pieces used in the inpatients were established. GTT was applied to analyze ADEs in inpatients who had used TCM formula granules and decoction pieces in our hospital from August 2013 to August 2023, utilizing the Chinese Hospital Pharmacovigilance System. The effectiveness of GTT and the characteristics of these ADEs were analyzed. RESULTS A total of forty-eight triggers were established, including thirty-two laboratory test indexes, thirteen clinical symptoms, and three antidotes. Among the 1 682 patients included, GTT identified 652 potential ADEs, 284 true positive ADEs,with a trigger rate of 38.76% and a positive predictive value of 43.56%. After review by the auditor, 278 cases of ADEs were finally confirmed, with an incidence rate of 16.53%, significantly higher than the number of spontaneously reported ADEs during the same period (0). The 278 cases of ADEs were mostly grade 1 (223 cases), mainly involving hepatobiliary system, gastrointestinal system, blood- lymphatic system, etc;a total of 219 types of TCMs are involved,and the top five suspected TCMs used at a frequency higher than 1% were Poria cocos, Codonopsis pilosula, Atractylodes macrocephala, fried Glycyrrhiza uralensis, and Scutellaria baicalensis. CONCLUSIONS The established GTT can improve the recognition rate of ADEs for hospitalized patients using traditional Chinese medicine formula granules and decoction pieces.


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