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.A preliminary study of mechanosensitive channels Piezo 1 and Piezo 2 promoting neurogenic bladder fibrosis in young rats
Lei LYU ; Yanping ZHANG ; Qi LI ; Junkui WANG ; Shuai YANG ; Zhaokai ZHOU ; Shuai LI ; Yibo WEN ; Yakai LIU ; Guowei SI ; Xingchen LIU ; Jianguo WEN
Journal of Modern Urology 2025;30(4):343-349
Objective: To explore the changes of mechanosensitive channels Piezos (Piezo 1 and Piezo 2) in neurogenic bladder (NB) of young rats and their effects,so as to provide reference for clinical search of new therapeutic targets. Methods: A total of 30 female young SD rats were divided into 5 groups based on random number table method:sham operation group (sham),2-week nerve transection group (NB-2W),6-week nerve transection group (NB-6W),2-week nerve transection + Piezos inhibitor group (NB-P-2W) and 6-week nerve transection + Piezos inhibitor group (NB-P-6W),with 6 rats in each group.The NB models were constructed by transecting the L6 and S1 spinal nerves of young rats.The NB-2W and NB-6W groups were not intervened after modeling,while the NB-P-2W and NB-P-6W groups were intraperitoneally injected with Piezos inhibitor GsMTx4 (10 mg/kg) every 2 days after modeling.Bladder cystometry and ultrasound were performed after 2 and 6 weeks of transection.The expressions of Piezos and fibrosis-related indexes (Collagen Ⅰ and α-smooth muscle actin) were detected in bladder tissues. Results: The results of bladder cystometry showed that the basal bladder pressure in NB-2W group was significantly increased,while it was slightly decreased but was still higher in NB-6W group than in the sham group (P<0.05).Basal bladder pressure was lower in NB-P-2W group than in NB-2W group,but was higher than that in the sham group; basal bladder pressure was lower in NB-P-6W group than in NB-6W group,but higher than that in the sham group (P<0.05).Compared with the sham group,the NB-2W and NB-6W groups had firstly increased and then decreased maximum cystometric capacity (MCC) (P<0.05).Compared with NB-2W group,NB-P-2W group had lower bladder leakage point pressure (BLPP),but higher MCC and bladder compliance (BC) (P<0.05).Compared with NB-6W group,NB-P-6W group had significantly lower BLPP but higher MCC and BC (P<0.05).HE and MASSON staining and ultrasound results showed that,with the extension of nerve transection time,bladder fibrosis gradually worsened,the bladder wall became rough and thickened,calculi were visible inside,and hydronephrosis gradually appeared; the degree of fibrosis in NB-P-2W and NB-P-6W groups was less than that in NB-2W and NB-6W groups,and no hydronephrosis was observed in the upper urinary tract.In addition,Western blotting and immunohistochemical results showed that NB-2W and NB-6W groups had significantly higher relative expression levels of Piezos,Collagen Ⅰ and α-SMA than the sham group (P<0.01),while NB-P-2W and NB-P-6W groups had lower relative expression levels of Piezos,Collagen Ⅰ and α-SMA than NB-2W and NB-6W groups (P<0.01). Conclusion: The increased expressions of mechanosensitive channels Piezos in NB young rats may be involved in the progression of bladder fibrosis,but its mechanism needs further study.
3.Influencing factors of overactive bladder in college freshmen and the impacts on anxiety,quality of life,and social interaction
Guowei SI ; Ce GAO ; Sida SHAO ; Feng SI ; Yakai LIU ; Songyang WANG ; Maochuan FAN ; Huiqing ZHANG ; Qifeng DOU ; Jianguo WEN
Journal of Modern Urology 2025;30(6):513-519
Objective: To investigate the influencing factors of overactive bladder (OAB) in college freshmen and the impacts of OAB on their mental health, quality of life and social interaction. Methods: An epidemiological questionnaire survey was conducted in an anonymous manner on the prevalence of OAB among 5300 freshmen aged 17 to 22 years enrolled in the 2023—2024 academic year in Xinxiang Medical University and Sanquan College of Xinxiang Medical University.The questionnaire included questions on basic information, history of urinary tract infection, constipation, smoking, history of alcohol consumption, history of coffee/strong tea drinking, history of carbonated beverage drinking, redundant prepuce, phimosis, holding urine, chronic insomnia, self-rating anxiety scale (SAS), quality of life score (QoL), and social avoidance and distress scale (SADS).The influencing factors of OAB were analyzed with multivariate logistic regression analysis.The subjects were grouped according to whether they had OAB, and the differences in SAS, QoL and SADS between the OAB group and non-OAB group were compared.The impacts of OAB on the anxiety level, quality of life, and social interaction were analyzed with multiple linear regression analysis. Results: The overall prevalence rate of OAB was 4.9% (244/5018).Multivariate logistic regression analysis showed that the history of urinary tract infection (OR=0.177), constipation (OR=0.636), smoking (OR=0.582), alcohol consumption (OR=0.685), coffee/strong tea drinking (OR=0.387), carbonated beverage drinking (OR=0.631), redundant prepuce (OR=0.673), phimosis (OR=0.311), urine holding (OR=0.593), and chronic insomnia (OR=0.256) were influencing factors for the occurrence of OAB (P<0.05).The OAB group had higher SAS score [(41.18±6.54) vs. (38.61±6.36)], QoL score [(3.65±1.20) vs. (2.79±0.95)], social avoidance score [(6.25±1.86) vs. (5.86±1.51)], social distress score [(6.27±1.59) vs. (5.97±1.32)], and total SADS score [(12.51±2.35) vs. (11.84±2.01)] than the non-OAB group (P<0.05).The results of multiple linear regression analysis showed that OAB could independently affect the scores of QoL, SAS, and SADS.The OAB group had higher scores of QoL, SAS, and SADS compared with the non-OAB group (P<0.001). Conclusion: History of urinary tract infection, constipation, smoking, alcohol consumption, coffee/strong tea drinking, carbonated beverage drinking, redundant prepuce, phimosis, urine holding, and chronic insomnia are influencing factors for the occurrence of OAB in male college students.Moreover, OAB has negative impacts on their mental health, quality of life, and social interaction.
4.Comparing the effectiveness of lithium disilicate glass ceramic onlays and full crowns in the restoration of cracked teeth that have undergone root canal therapy
ZHANG Hao ; TIAN Yuan ; LI Zhuangzhuang ; ZHANG Min ; ZHOU Haolin ; LIU Jianguo
Journal of Prevention and Treatment for Stomatological Diseases 2025;33(8):639-649
Objective:
This study compares the effects of lithium disilicate glass ceramic onlays and full crowns in restoring cracked teeth that have undergone root canal therapy, providing a reference for the restoration method of cracked teeth that have undergone root canal therapy.
Methods:
This study was approved by the hospital’s medical ethics committee, and all patients signed the informed consent form. Patients with cracked teeth who underwent root canal treatment in our hospital from January 2022 to January 2023 were enrolled in this study. According to the inclusion and exclusion criteria, 60 patients were screened and enrolled, with a total of 60 affected teeth. The patients were divided into the onlay group and full crown group at a ratio of 2:3 using the random number table method. Lithium disilicate glass ceramic onlays were used to restore the affected teeth in the onlay group (24 cases), and lithium disilicate glass ceramic full crowns were used to restore the affected teeth in the full crown group (36 cases). At 3, 6, and 12 months after the repair, the restoration effect was evaluated and compared with the modified USPH Standard (the aesthetic, functional, and biological aspects of restorations). According to the biological definition of survival, survival analysis was conducted on the affected teeth in both groups.
Results:
At 3, 6, and 12 months after the repair, 85% of cases in the onlay group achieved grade A, while 80% of cases in the full crown group achieved grade A. There was no statistically significant difference in the restoration effects between the onlay group and the full crown group (P > 0.05). The 12-month survival rate of cracked teeth in the onlay group reached 95.65%, and the 12-month survival rate of cracked teeth in the full crown group reached 94.12%. There was no statistically significant difference in the retention of the affected teeth (P > 0.05). There was no significant effect of age, gender, tooth position, dentition, direction of cracks, the number of marginal ridges associated with cracks, or the type of restoration on the survival status of cracked teeth. (P > 0.05).
Conclusion
For cracked teeth that have undergone root canal therapy, the short-term effect of lithium disilicate glass ceramic onlays is comparable to that of full crowns, and both have good short-term effects. Onlays are less invasive and are expected to become an alternative restoration method to full crowns.
6.A Case of Endometrial Metastasis in Lung Adenocarcinoma after EGFR-TKIs Treatment Failure and Literature Review.
Fangqian SHEN ; Zuling HU ; Hua YANG ; Puyu LIU ; Yuju BAI ; Jianguo ZHOU ; Hu MA
Chinese Journal of Lung Cancer 2025;28(7):551-557
The incidence and mortality rates of lung cancer remain high, making it the leading cause of cancer-related deaths. In women, the predominant histological subtype is lung adenocarcinoma, commonly associated with epidermal growth factor receptor (EGFR) mutations, and EGFR-tyrosine kinase inhibitors (EGFR-TKIs) can significantly improve patient prognosis. Metastasis of primary lung cancer to the endometrium is extremely rare and is often misdiagnosed as a primary reproductive system tumor, and its occurrence indicates poor prognosis. This article reports a case of an advanced lung adenocarcinoma patient with EGFR mutation, who developed abnormal vaginal bleeding after EGFR-TKIs treatment failure, and biopsy confirmed endometrial metastasis. A review of similar cases is also presented.
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Humans
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Female
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ErbB Receptors/metabolism*
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Endometrial Neoplasms/genetics*
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Lung Neoplasms/genetics*
;
Protein Kinase Inhibitors/therapeutic use*
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Adenocarcinoma of Lung/drug therapy*
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Treatment Failure
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Middle Aged
;
Adenocarcinoma/genetics*
7.Cost-utility analysis of sacituzumab govitecan versus single-agent chemotherapy in the treatment of HR+/HER2- advanced metastatic breast cancer
Yinmei HE ; Xiao LI ; Xiaoli LIU ; Longzhou LI ; Yan GAO ; Jianguo YU ; Jiajie LUAN ; Yilai WU
China Pharmacy 2024;35(20):2493-2498
OBJECTIVE To estimate the cost-utility of sacituzumab govitecan (SG) versus single-agent chemotherapy in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced metastatic breast cancer. METHODS From the perspective of the Chinese medical system, a three-state partitioned survival model was constructed to examine the cost-utility of SG versus single-agent chemotherapy based on TROPiCS-02 trial. The cycle length was set to 1 month, and the time horizon was 10 years. The annual discount was 5%. The model output included total costs and quality adjusted life month (QALM), and incremental cost-effectiveness ratio (ICER) was calculated for cost-utility analysis, by setting willingness-to-pay (WTP) threshold at 3 times gross domestic product (GDP) per capita of China in 2023 (22 340 yuan/QALM). Univariate sensitivity analyses, probability sensitivity analyses, and scenario analyses were performed to evaluate the robustness of the results and calculate the price threshold when SG had economic advantages. RESULTS SG group gained incremental 4.25 QALM and 561 570 yuan compared with single-agent chemotherapy, which resulted in an ICER of 132 102/QALM that was higher than WTP. The results of the univariate sensitivity analysis showed that the monthly average cost of SG had the greatest impact on the results; the results of probability sensitivity analysis showed that the probability of SG scheme being cost-effective at the WTP threshold was 0. The results of scenario analysis showed that the conclusions of this study were robust under different time horizons (5, 10, 15 years). The price threshold for SG being cost-effective was 1 344 yuan per 180 mg. CONCLUSIONS Based on the perspective of Chinese medical system, SG appears to be not cost-effective compared with single-agent chemotherapy for HR+/ HER2- advanced metastatic breast cancer at the price of 8 400 yuan per 180 mg. A substantial price cut should be taken to be cost- effective.
8.Clinical observation of levosimendan in the treatment of septic shock combined with myocardial depression
Fang XIONG ; Chao LIU ; Kexiang ZHANG ; Qilong ZHOU ; Hua LU ; Jianguo CHEN ; Xi YUE ; Jianxin ZHAO ; Pengfei PAN
China Pharmacy 2024;35(20):2517-2521
OBJECTIVE To explore the effects of levosimendan on cardiac function, hemodynamics and prognosis of patients with septic shock complicated with myocardial depression, and evaluate the safety of levosimendan. METHODS Patients with septic shock complicated with myocardial depression who were admitted to the Department of Critical Care Medicine of Chongqing University Three Gorges Hospital from April 2021 to August 2023, underwent adequate fluid resuscitation, had a mean arterial pressure (MAP) ≥65 mmHg, and received pulse indicator continuous cardiac output (PiCCO) monitoring were enrolled. The patients were randomly divided into dobutamine group and levosimendan group according to a random number table, with 20 patients in each group. Both groups received intravenous infusion of Norepinephrine bitartrate injection at a dose of 0.1-2.0 μg/(kg·min). On this basis, the dobutamine group additionally received intravenous infusion of Dobutamine hydrochloride injection at a dose of 5- 10 μg/(kg·min) for 3 to 7 days, while the levosimendan group additionally received intravenous infusion of Levosimendan injection at a dose of 0.1-0.2 μg/(kg·min) for 24 hours. Heart rate (HR) and hemodynamic parameters [systolic blood pressure, diastolic blood pressure, MAP, central venous pressure (CVP)], PiCCO monitoring parameters [cardiac function index (CFI), cardiac index (CI), stroke volume index (SVI), extravascular lung water index, global end-diastolic volume index, pulmonary vascular permeability index (PVPI), global ejection fraction (GEF), systemic vascular resistance index, left ventricular contractility index], and prognosis indicators [death within 3 days after administration, mechanical ventilation time,intensive care unit (ICU) stay time, 28-day mortality rate] were compared between the two groups before treatment and at 24 and 72 hours after treatment. Adverse reactions were E-mail:recorded for both groups. RESULTS Compared with before treatment in the same group, CFI, CI and GEF at 24 hours after treatment, CI and GEF at 72 hours after treatment in the dobutamine group, as well as SVI at 24 hours after treatment and SVI and GEF at 72 hours after treatment in the levosimendan group were significantly increased; PVPI at 72 hours after treatment in the dobutamine group was significantly decreased (P<0.05). Compared with the dobutamine group during the same period, patients in the levosimendan group had significantly lower HR and significantly higher CVP at 24 hours after treatment (P<0.05). Within 3 days after administration, there were no deaths in either group; there were no statistically significant differences in mechanical ventilation time, ICU stay time, 28-day mortality rate, or the incidence of adverse reactions between the two groups (P>0.05). CONCLUSIONS For patients with septic shock complicated with myocardial depression who have undergone adequate fluid resuscitation and have a MAP of ≥65 mmHg, levosimendan is comparable to dobutamine in improving cardiac function and hemodynamic parameters, without affecting patients’ prognosis or increasing the risk of adverse reactions such as hypotension.
9.Analysis of the influence of Chinese health policy on the promotion process of ophthalmology day sur-gery and its specific practice
Xueyi LIU ; Jianguo ZHAO ; Ruiqiang SUN ; Meiyu DENG ; Qian WANG
Modern Hospital 2024;24(3):336-339
With the reform of the national medical and health system entering a new stage of high-quality development of public hospitals,the large-scale implementation of day surgery in hospitals is imminent in the face of increasing patient demand.In this paper,the medical administration management and medical insurance policies related to day surgery in China and their im-pacts were sorted out,and the example of large-scale implementation of day surgery by a specialized ophthalmic medical institu-tion through pre-hospitalization mode was used to illustrate how to use management tools to break through the bottleneck in the promotion process of day surgery,and the positive effect of large-scale development of day surgery on both doctors and patients was expounded.
10.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.


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