1.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
2.Effects of subanesthetic dose of esketamine on postoperative anxiety and recovery in patients undergoing laparo-scopic cholecystectomy
Zhangzhen ZHONG ; Xian ZHENG ; Ting XU ; Jie WANG ; Hui CAO ; Xinggen ZHOU ; Hui LI ; Jiacheng ZHAO ; Hui LIU ; Chao ZHANG
China Pharmacy 2026;37(2):204-209
OBJECTIVE To investigate the effects of subanesthetic dose of esketamine on postoperative anxiety and recovery in patients undergoing laparoscopic cholecystectomy. METHODS A total of 200 patients scheduled for laparoscopic cholecystectomy at Suzhou Ninth Hospital Affiliated to Soochow University from January 2023 to December 2024 were randomly assigned to control group (n=100) and observation group (n=100). One minute before the initiation of anesthesia, patients in the control group received intravenous injections of Propofol emulsion injection, Sufentanil citrate injection, and Succinylcholine chloride injection. On this basis, patients in the observation group received an intravenous injection of Esketamine hydrochloride injection. The anxiety status of patients in both groups was compared, along with their general intraoperative conditions (including sufentanil dosage, duration of pneumoperitoneum, operative time, anesthesia time, and extubation time), postoperative recovery, incidence of adverse reactions, and the need for dezocine rescue analgesia. Heart rate and mean arterial pressure, entropy index (state entropy and response entropy), inflammatory marker levels [interleukin-6 (IL-6) and C-reactive protein (CRP)], numerical rating scale (NRS) for pain intensity were compared between the two groups at different time points. RESULTS No significant differences were found between the two groups in pneumoperitoneum duration, operative time, anesthesia time,extubation time, incidence of postoperative dry mouth, entropy index or length of stay in the post-anesthesia care unit (P>0.05). Compared with the control group, the observation group showed significantly lower postoperative STAI-S scores, reduced intraoperative sufentanil consumption, decreased incidence of postoperative nausea, vomiting, and shivering, the need for dezocine rescue analgesia, as well as lower plasma IL-6 and CRP levels at 24 h after surgery, and NRS (P<0.05). The heart rate and mean arterial pressure of patients in the observation group at the start of surgery, end of surgery, and during extubation were all significantly higher than those in the control group (P<0.05). CONCLUSIONS Subanesthetic dose of esketamine can effectively alleviate postoperative anxiety, reduce intraoperative opioid consumption, suppress postoperative inflammatory response, relieve postoperative pain, and promote recovery in patients undergoing laparoscopic cholecystectomy.
3.Treatment of Hyperthyroidism Combined with Atrial Fibrillation:from the Liver
Yao XU ; Yan ZHOU ; Hui LI ; Yifang HAO ; Jintao ZHANG ; Longmei YAN ; Yaxuan XING ; Jingchun ZHANG
Journal of Traditional Chinese Medicine 2026;67(11):1225-1230
Hyperthyroidism (HT) is frequently complicated by atrial fibrillation (AF) in clinical practice. Based on traditional Chinese medicine (TCM) zang-xiang (藏象) theory and clinical experience, both HT and AF are closely associated with dysfunction of the liver. The pathogenesis is initiated by the liver failing to govern the free flow of qi, and liver constraint and qi stagnation, with the key turning points being liver constraint transforming into fire and the internal stirring of liver wind, ultimately leading to liver blood depletion and insufficient nourishment of the heart spirit. Thus, it is proposed to treat the disease from the liver, with stage-specific therapeutic approaches according to the evolution of the disease. In the early stage, the treatment should focus on soothing the liver and relieving constraint to reduce goiter and calm the heart, while in the progressive stage, the method of clearing liver and draining fire is suggested to subdue yang and stabilize palpitations. In the acute stage, the strategy is calming the liver and nourishing yin to subdue yang and extinguish wind. In the later stage, it is suggested to soften the liver and benefit qi, so as to nourish yin and restore pulse. These methods are sequentially applied to synergistically reduce goiter and stabilize palpitations, providing a therapeutic approach for HT complicated by AF.
4.Screening and quantitative analysis of Q-Marker for anti-renal fibrosis of Shenqi shenshuai mixture based on untargeted metabolomics and bioinformatics
Yuhang ZHOU ; Yuqi LI ; Zhuo GAO ; Qingfeng RUAN ; Xiaoxuan ZENG ; Hui WANG ; Chuanqi HUANG ; Hongfeng XU
China Pharmacy 2026;37(13):1716-1721
OBJECTIVE To screen and quantitatively analyze the quality marker (Q-Marker) associated with anti-renal fibrosis in Shenqi shenshuai mixture (SQSS), so as to provide references for the analysis of pharmacodynamic substances and new drug transformation of SQSS. METHODS The chemical components of SQSS were characterized by untargeted metabolomics. Combined with network pharmacology, gene expression omnibus (GEO) and connectivity map (CMAP) databases, the anti-renal fibrosis Q-Markers of SQSS were screened. HPLC-MS/MS was applied to determine the contents of Q-Markers in 10 batches of SQSS. RESULTS A total of 1 319 compounds were identified from SQSS via untargeted metabolomics,and 84 active ingredients with anti-renal fibrosis activity were further screened out, such as formononetin. Nine anti-renal fibrosis Q-Markers were obtained by network pharmacology and GEO database, including berberine, quercetin, honokiol, nicotinamide, daidzein, coumarin, kaempferol, formononetin and amygdalin. The quantitative results showed that the average contents of the above components (excluding amygdalin) in 10 batches of SQSS were 2.523, 1.942, 26.848, 1.415, 0.692, 0.171, 0.374, 7.401 μg/mL, respectively. CONCLUSIONS Nine anti-renal fibrosis Q-Markers of SQSS were screened in this study, and the contents of eight among them were determined. The results can provide a basis for elucidating the pharmacodynamic material basis and promoting the new drug transformation of SQSS.
5.Screening and quantitative analysis of Q-Marker for anti-renal fibrosis of Shenqi shenshuai mixture based on untargeted metabolomics and bioinformatics
Yuhang ZHOU ; Yuqi LI ; Zhuo GAO ; Qingfeng RUAN ; Xiaoxuan ZENG ; Hui WANG ; Chuanqi HUANG ; Hongfeng XU
China Pharmacy 2026;37(13):1716-1721
OBJECTIVE To screen and quantitatively analyze the quality marker (Q-Marker) associated with anti-renal fibrosis in Shenqi shenshuai mixture (SQSS), so as to provide references for the analysis of pharmacodynamic substances and new drug transformation of SQSS. METHODS The chemical components of SQSS were characterized by untargeted metabolomics. Combined with network pharmacology, gene expression omnibus (GEO) and connectivity map (CMAP) databases, the anti-renal fibrosis Q-Markers of SQSS were screened. HPLC-MS/MS was applied to determine the contents of Q-Markers in 10 batches of SQSS. RESULTS A total of 1 319 compounds were identified from SQSS via untargeted metabolomics,and 84 active ingredients with anti-renal fibrosis activity were further screened out, such as formononetin. Nine anti-renal fibrosis Q-Markers were obtained by network pharmacology and GEO database, including berberine, quercetin, honokiol, nicotinamide, daidzein, coumarin, kaempferol, formononetin and amygdalin. The quantitative results showed that the average contents of the above components (excluding amygdalin) in 10 batches of SQSS were 2.523, 1.942, 26.848, 1.415, 0.692, 0.171, 0.374, 7.401 μg/mL, respectively. CONCLUSIONS Nine anti-renal fibrosis Q-Markers of SQSS were screened in this study, and the contents of eight among them were determined. The results can provide a basis for elucidating the pharmacodynamic material basis and promoting the new drug transformation of SQSS.
6.Epidemiological characteristics of nasopharyngeal microbiota profiles in community children under 5 years in Haidong City, Qinghai Province
Hui ZHOU ; Zizhe GUO ; Xueyao LIANG ; Shuangfei XU ; Weibing WANG
Shanghai Journal of Preventive Medicine 2025;37(1):39-47
ObjectiveTo describe the characteristics of the nasopharyngeal microbiota in children under 5 years of age in Haidong City, Qinghai Province and analyze its associated factors, so as to provide basic data for the evolution and development of nasopharyngeal microbiota in children. MethodsA total of 230 community children from Haidong City, Qinghai Province were included in the study. Participants’ basic information was collected by local volunteers from parents/guardians at enrollment. 16S rDNA sequencing was used to identify the bacterial diversity and abundance of nasopharyngeal microbial community. Bioinformatics methods were used to analyze the characteristics of the nasopharyngeal microbiota, compare the differential species, and investigate the correlation with age. ResultsThere was no statistical difference in either Chao1 index or Shannon index of nasopharyngeal microbial communities among children with different ages (P>0.05). Besides, the structure of nasopharyngeal microbiota in children of different ages was different, either (P=0.020). Age, ethnicity and delivery mode, to some extent, could explain the differences in the structure of nasopharyngeal microbiota in children. There were statistically significant differences in the abundance of Dolosigranulum, Staphylococcus and Corynebacterium in the nasopharyngeal microbiota of children with different ages (P<0.05). Differential analysis revealed that Corynebacterium was found to be over-represented in children under 1 year of age, while Dolosigranulum was found to be over-represented in children between 2 and 3 years old. Furthermore, the results of correlation analysis showed that, Moraxella was positively correlated with Corynebacterium, Dolosigranulum and Streptococcus, but negatively correlated with Pseudomonas. In addition, a strong positive correlation was detected between the Dolosigranulum and Corynebacterium. ConclusionThe diversity of nasopharyngeal microbial community among children under 5 years in Haidong City, Qinghai Province is stable. However, there are differences in the species structure, mainly in the abundance difference of Dolosigranulum, Staphylococcus and Corynebacterium. This study provides basic data on the evolution and maturation of nasopharyngeal microbial communities in early childhood, which can provide a scientific basis for the early prevention and diagnosis of respiratory tract infections in children.
7.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
8.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
9.Establishment and Evaluation of Insomnia Animal Models with Heart and Spleen Deficiency
Jieyao DIAO ; Hui XU ; Yunfeng ZHOU ; Zhen WANG ; Xin ZHAO ; Haoguang QU ; Chongyang GUAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):234-243
Heart and spleen deficiency syndrome is the most common syndrome type in patients with insomnia. Based on the theory of disease syndrome-combined animal model, this paper used multiple databases to search for the keywords "heart and spleen deficiency", "insomnia", "sleepless", "disease syndrome-combined animal model", "model evaluation", etc. It selected the literature related to the animal model of insomnia with heart and spleen deficiency in the past 20 years to evaluate from the aspects of model establishment, modeling factors, syndrome model, disease model, macro characterization & macro characterization evaluation scale, micro indicators, etc. It is found that the existing animal model of insomnia with heart and spleen deficiency is not completely constructed by the method of disease syndrome combination of disease modeling factors and syndrome modeling factors. In the model using this method, the single establishment factor of heart and spleen deficiency does not conform to the clinical reality of disease, and the selection of the factors for the insomnia model is not closely related to or even separated from the syndrome performance. There is a problem of insufficient quantification of macro representation when the macro representation of the model replaces the symptoms related to heart and spleen deficiency syndrome and insomnia in an equivalent manner for macro representation evaluation, which can be improved according to the quantitative ideas and examples of the existing macro representation and macro representation evaluation scale. There are few specific indicators of heart and spleen deficiency syndrome in micro indicators. The micro research of heart and spleen deficiency syndrome and the essence of other traditional Chinese medicine (TCM) syndromes can be carried out by metabonomics and other technologies combined with the theory of corresponding prescription and syndrome, along the specific related ideas of "prescription and syndrome, treatment principle and selection of prescription, treatment principle and selection of acupoints, as well as therapeutic mechanism and syndrome essence". The future users and researchers of animal models of insomnia with heart and spleen deficiency can get improved methods and ideas through the shortcomings of animal models of heart and spleen deficiency listed in this paper and construct animal models of insomnia with heart and spleen deficiency that are more suitable for clinical practice, so as to establish a more perfect modeling method and evaluation system of disease syndrome-combined animal model.
10.Establishment and Evaluation of Insomnia Animal Models with Heart and Spleen Deficiency
Jieyao DIAO ; Hui XU ; Yunfeng ZHOU ; Zhen WANG ; Xin ZHAO ; Haoguang QU ; Chongyang GUAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):234-243
Heart and spleen deficiency syndrome is the most common syndrome type in patients with insomnia. Based on the theory of disease syndrome-combined animal model, this paper used multiple databases to search for the keywords "heart and spleen deficiency", "insomnia", "sleepless", "disease syndrome-combined animal model", "model evaluation", etc. It selected the literature related to the animal model of insomnia with heart and spleen deficiency in the past 20 years to evaluate from the aspects of model establishment, modeling factors, syndrome model, disease model, macro characterization & macro characterization evaluation scale, micro indicators, etc. It is found that the existing animal model of insomnia with heart and spleen deficiency is not completely constructed by the method of disease syndrome combination of disease modeling factors and syndrome modeling factors. In the model using this method, the single establishment factor of heart and spleen deficiency does not conform to the clinical reality of disease, and the selection of the factors for the insomnia model is not closely related to or even separated from the syndrome performance. There is a problem of insufficient quantification of macro representation when the macro representation of the model replaces the symptoms related to heart and spleen deficiency syndrome and insomnia in an equivalent manner for macro representation evaluation, which can be improved according to the quantitative ideas and examples of the existing macro representation and macro representation evaluation scale. There are few specific indicators of heart and spleen deficiency syndrome in micro indicators. The micro research of heart and spleen deficiency syndrome and the essence of other traditional Chinese medicine (TCM) syndromes can be carried out by metabonomics and other technologies combined with the theory of corresponding prescription and syndrome, along the specific related ideas of "prescription and syndrome, treatment principle and selection of prescription, treatment principle and selection of acupoints, as well as therapeutic mechanism and syndrome essence". The future users and researchers of animal models of insomnia with heart and spleen deficiency can get improved methods and ideas through the shortcomings of animal models of heart and spleen deficiency listed in this paper and construct animal models of insomnia with heart and spleen deficiency that are more suitable for clinical practice, so as to establish a more perfect modeling method and evaluation system of disease syndrome-combined animal model.

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