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.Comparison of two methods of tube closure in patients with hepatic failure treated with a dual plasma molecular adsorbent system combined with plasma exchange
Shangyan JIANG ; Jiangying HAN ; Yunyun WANG ; Junfei ZHANG ; Liu TIAN
The Journal of Practical Medicine 2025;41(15):2320-2324
Objective To explore the effects of different sealing methods in the treatment of liver failure patients using a dual plasma molecular adsorption system combined with plasma exchange.Methods A total of 120 patients with liver failure admitted between January 2022 and October 2024 were enrolled in the study and randomly divided into an observation group and a control group,each consisting of 60 patients.Both groups received treatment with a dual plasma molecular adsorption system combined with plasma exchange.The control group was administered heparin sodium for catheter sealing,whereas the observation group received protamine prior to hepa-rin sodium catheter sealing.The study compared the two groups in terms of liver function indicators—including aspartate aminotransferase(AST),alanine aminotransferase(ALT),and bilirubin—coagulation function indicators such as fibrinogen and international normalized ratio(INR),hemoglobin(HGB)levels,catheter blockage rates,and the incidence of adverse reactions.Results No statistically significant differences were observed in liver function,coagulation function,or routine blood parameters between the two patient groups following treatment(P>0.05).However,the incidence of blockage in the observation group(3.33%)was significantly lower than that in the control group(20.00%),with the difference being statistically significant(P<0.05).Additionally,no significant differences were found in the occurrence of adverse reactions between the two groups(P>0.05).Conclusions The treatment of liver failure involves the use of a dual plasma molecular adsorption system combined with plasma exchange.Administering protamine prior to heparin sodium sealing has minimal impact on the patient's liver function,blood parameters,coagulation profile,and incidence of adverse reactions,yet it effectively reduces the risk of circuit clotting.
3.Intervention of Breast Cancer by Regulating Wnt/β-catenin Signaling Pathway with Traditional Chinese Medicine: A Review
Lu LING ; Jingyu XU ; Junfei ZHAO ; Songjiang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):320-330
Breast cancer is one of the most common cancers in the world, and its incidence rate is also rising in China and tends to happen in younger age groups. The classical Wnt/β-catenin signaling pathway is an important target in the treatment of breast cancer, playing a key role in the whole process of breast cancer development by regulating the expression of related signal proteins and genes. Traditional Chinese medicine has a profound history and practical experience in the treatment of malignant tumors, and the development of modern technology further highlights the therapeutic advantages of traditional Chinese medicine, which has multiple targets and components. Research shows that Chinese medicine can effectively slow down the proliferation of breast cancer cells by regulating the Wnt/β-catenin signaling pathway, and has a significant inhibitory effect on the development of breast cancer. Based on this, this paper summarized domestic and foreign relevant studies on the regulation of the Wnt/β-catenin signaling pathway with traditional Chinese medicine in the treatment of breast cancer, analyzed the mechanism of traditional Chinese medicine treating breast cancer by intervening in this signaling pathway, and summarized 44 different types of traditional Chinese medicine monomers, including terpenes (triptolide, andrographolide, etc.), flavonoids (scutellarin, sinensetin, etc.), polysaccharides (Angelica sinensis polysaccharides, etc.), phenols (curcumin, polydatin, etc.), and alkaloids (lycorine, etc.). In addition, there are 3 traditional Chinese medicines (Ganoderma lucidum, Radix actinidia chinensis, and Antrodia camphorata), 1 group of medicine pairs (Trionycis Carapax-Zedoary Turmeric), and 8 traditional Chinese medicine formulas (Compound Tubeimu, Huangqi Jiedu Tang, Xihuang Wan, Liuwei Dihuang Wan, Jiazhu Tang, Aiduqing Fang, Sini San, and compound Kushen injection). By regulating the Wnt/β-catenin signaling pathway and its key molecules, these single herbs, monomers, and compound herbs can reverse the epithelial mesenchymal transformation process, reduce the activity of stem cells, and inhibit the growth and metastasis of cancer cells. Besides, it can also enhance the sensitivity of drugs and radiotherapy and combat breast cancer, providing a new perspective for drug development and treatment strategies for breast cancer.
4.TCM Intervention in Prostate Cancer via Wnt/β-catenin Signaling Pathway: A Review
Lu LING ; Jingyu XU ; Junfei ZHAO ; Songjiang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):304-312
Prostate cancer is a malignant tumor that primarily arises from the epithelial tissue of the prostate in men. With the aggravation of population aging in China, the incidence rate of this disease has been continuously rising. Although the exact cause of prostate cancer remains unclear, it has been proven to be closely related to various factors, including individual genetic susceptibility, genetic mutations, dietary habits, and lifestyle. Research has shown that abnormal activation of the Wnt/β-catenin signaling pathway also plays an important role in the occurrence and development of prostate cancer. Multiple experimental results have revealed that traditional Chinese medicine (TCM), with its multi-target and multi-stage mechanisms of action, exerts significant regulatory effects on key biological processes such as proliferation, migration, invasion, angiogenesis, and epithelial-mesenchymal transition (EMT) of prostate cancer cells. TCM has shown excellent potential in preventing prostate cancer progression and improving patient prognosis and has become a research focus in prostate cancer treatment in recent years. Based on this, this study reviewed the research on the regulation of the Wnt/β-catenin signaling pathway by TCM in the treatment of prostate cancer at home and abroad. It analyzed the mechanisms by which TCM intervention exerts anti-prostate cancer effects via this signaling pathway, identifying 29 different types of active ingredients in TCM, including alkaloids (e.g., capsaicin, berberine), flavonoids (e.g., icariin and hyperoside), polyphenols (e.g., gastrodin and honokiol), terpenes (e.g., oridonin), quinones (e.g., aloe-emodin), coumarins (e.g., agrimonolide), and saponins (e.g., saikosaponin-d). Additionally, one TCM medicinal substance (arsenic), one drug pair (Danggui - Qieyi combination), and two TCM formulae (Yishen Tonglong Tang and Guben Qingyuan Formula) were included. The study aims to deepen the understanding of the pathological mechanism of prostate cancer and to explore possible therapeutic targets, thereby providing new perspectives and approaches for clinical research and new drug development, and ultimately promoting the advancement and innovation of prostate cancer treatment strategies.
5.TCM Intervention in Prostate Cancer via Wnt/β-catenin Signaling Pathway: A Review
Lu LING ; Jingyu XU ; Junfei ZHAO ; Songjiang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):304-312
Prostate cancer is a malignant tumor that primarily arises from the epithelial tissue of the prostate in men. With the aggravation of population aging in China, the incidence rate of this disease has been continuously rising. Although the exact cause of prostate cancer remains unclear, it has been proven to be closely related to various factors, including individual genetic susceptibility, genetic mutations, dietary habits, and lifestyle. Research has shown that abnormal activation of the Wnt/β-catenin signaling pathway also plays an important role in the occurrence and development of prostate cancer. Multiple experimental results have revealed that traditional Chinese medicine (TCM), with its multi-target and multi-stage mechanisms of action, exerts significant regulatory effects on key biological processes such as proliferation, migration, invasion, angiogenesis, and epithelial-mesenchymal transition (EMT) of prostate cancer cells. TCM has shown excellent potential in preventing prostate cancer progression and improving patient prognosis and has become a research focus in prostate cancer treatment in recent years. Based on this, this study reviewed the research on the regulation of the Wnt/β-catenin signaling pathway by TCM in the treatment of prostate cancer at home and abroad. It analyzed the mechanisms by which TCM intervention exerts anti-prostate cancer effects via this signaling pathway, identifying 29 different types of active ingredients in TCM, including alkaloids (e.g., capsaicin, berberine), flavonoids (e.g., icariin and hyperoside), polyphenols (e.g., gastrodin and honokiol), terpenes (e.g., oridonin), quinones (e.g., aloe-emodin), coumarins (e.g., agrimonolide), and saponins (e.g., saikosaponin-d). Additionally, one TCM medicinal substance (arsenic), one drug pair (Danggui - Qieyi combination), and two TCM formulae (Yishen Tonglong Tang and Guben Qingyuan Formula) were included. The study aims to deepen the understanding of the pathological mechanism of prostate cancer and to explore possible therapeutic targets, thereby providing new perspectives and approaches for clinical research and new drug development, and ultimately promoting the advancement and innovation of prostate cancer treatment strategies.
6.Consideration and Suggestions on Dosage Labeling Issues in Chinese Patent Medicines Instructions
Juan XU ; Gaiping WANG ; Yu ZHANG ; Lingjun DONG ; Junfei WANG ; Hongfeng LIU ; Weihong CHEN
Herald of Medicine 2025;44(5):720-726
Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60%)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30% lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.
7.Comparison of two methods of tube closure in patients with hepatic failure treated with a dual plasma molecular adsorbent system combined with plasma exchange
Shangyan JIANG ; Jiangying HAN ; Yunyun WANG ; Junfei ZHANG ; Liu TIAN
The Journal of Practical Medicine 2025;41(15):2320-2324
Objective To explore the effects of different sealing methods in the treatment of liver failure patients using a dual plasma molecular adsorption system combined with plasma exchange.Methods A total of 120 patients with liver failure admitted between January 2022 and October 2024 were enrolled in the study and randomly divided into an observation group and a control group,each consisting of 60 patients.Both groups received treatment with a dual plasma molecular adsorption system combined with plasma exchange.The control group was administered heparin sodium for catheter sealing,whereas the observation group received protamine prior to hepa-rin sodium catheter sealing.The study compared the two groups in terms of liver function indicators—including aspartate aminotransferase(AST),alanine aminotransferase(ALT),and bilirubin—coagulation function indicators such as fibrinogen and international normalized ratio(INR),hemoglobin(HGB)levels,catheter blockage rates,and the incidence of adverse reactions.Results No statistically significant differences were observed in liver function,coagulation function,or routine blood parameters between the two patient groups following treatment(P>0.05).However,the incidence of blockage in the observation group(3.33%)was significantly lower than that in the control group(20.00%),with the difference being statistically significant(P<0.05).Additionally,no significant differences were found in the occurrence of adverse reactions between the two groups(P>0.05).Conclusions The treatment of liver failure involves the use of a dual plasma molecular adsorption system combined with plasma exchange.Administering protamine prior to heparin sodium sealing has minimal impact on the patient's liver function,blood parameters,coagulation profile,and incidence of adverse reactions,yet it effectively reduces the risk of circuit clotting.
8.Consideration and Suggestions on Dosage Labeling Issues in Chinese Patent Medicines Instructions
Juan XU ; Gaiping WANG ; Yu ZHANG ; Lingjun DONG ; Junfei WANG ; Hongfeng LIU ; Weihong CHEN
Herald of Medicine 2025;44(5):720-726
Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60%)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30% lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.
9.Comparison of different laparoscopic treatments for upper urinary tract urothelial carcinoma
Meng ZHU ; Junfei GU ; Yuepeng LIU ; Zihao LI ; Chao MA ; Lixin REN
Journal of Modern Urology 2024;29(7):597-601
Objective To compare the clinical efficacy of peritoneolaparoscopic single position nephreteral total length resection(PSPNTLR)and posterior laparoscopic subabdominal incision technique(PLSIT)in the treatment of upper urothelial carcinoma(UTUC).Methods A total of 82 UTUC patients treated in our hospital during Jan.2018 and Feb.2021 were divided into the observation group(n=41,treated with PSPNTLR)and control group(n=41,treated with PLSIT)according to the random number table method.Perioperative indicators,pain degree,inflammatory factors,bladder recurrence and distant metastasis were compared between the two groups.Results The operation time[(122.15±15.14)min vs.(160.88±17.26)min],hospitalization time[(10.07±2.14)d vs.(12.22±3.13)d]and postoperative exhaust time[(1.46±0.57)d vs.(3.10±0.88)d]were significantly shorter,the intraoperative blood loss[(42.85±4.88)mL vs.(78.22±8.17)mL]and drainage volume[(53.61±9.74)mL vs.(81.56±11.06)mL]were significantly less in the observation group than in the control group(P<0.05).The visual analogue score(VAS)of the observation group at 6,12 and 24 h after operation was significantly lower than that of the control group(P<0.05).The levels of interleukin-6(IL-6)and C-reactive protein(CRP)were increased in both groups one day after surgery,but the indexes were increased more significantly in the control group(P<0.05).During the 2-year follow-up after surgery,there were no statistical difference in bladder recurrence(12.20%vs.14.63%)and distant metastasis(9.76%vs.4.88%)between the two groups(P>0.05).Conclusion Both PSPNTLR and PLSIT have good therapeutic safety,but PSPNTLR is more effective in improving perioperative indicators,reducing postoperative pain,and inhibiting inflammatory factors.
10.Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation: A prospective clinical study
Ying HUANG ; Ziqin ZHOU ; Yong ZHANG ; Xiaohua LI ; Nianjin XIE ; Hongwen FEI ; Hui LIU ; Junfei ZHAO ; Jian ZHUANG ; Jimei CHEN ; Shusheng WEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(06):872-877
Objective To evaluate early outcomes of transthoracic pulmonary valve implantation for the treatment of moderate and severe pulmonary regurgitation by using homemade self-expanding valve (SalusTM). Methods Patients with severe pulmonary regurgitation who underwent transthoracic pulmonary valve implantation in Guangdong Provincial People’s Hospital from September 2, 2021 to November 25, 2022 were prospectively enrolled. The early postoperative complications and improvement of valve and heart function were summarized and analyzed. Results A total of 25 patients were enrolled, including 16 males and 9 females, with an average age of 24.5±1.5 years and an average weight of 57.0±3.0 kg. The mean systolic diameters of the bifurcation near the main pulmonary artery, the stenosis of the middle segment of the aorta and near the valve of the right ventricular outflow tract of the patients were 31.8±7.4 mm, 30.6±5.9 mm and 38.4±8.0 mm, respectively. All patients were successfully implanted with valves, and there were no serious complications such as death, coronary compression, stent fracture, valve displacement and infective endocarditis in the early postoperative period. The indexed left atrial longitudinal diameter, indexed right atrial longitudinal diameter, and indexed right ventricular outflow tract anteroposterior diameter decreased significantly after the operation. The degree of tricuspid and pulmonary valve regurgitation and the indexed regurgitation area decreased significantly. The above differences were statistically significant (P<0.05). Conclusion The early outcomes of transthoracic pulmonary valve implantation with homemade self-expanding pulmonary valve (SalusTM) in the treatment of severe pulmonary regurgitation is relatively good, and the long-term outcomes need to be verified by the long-term follow-up studies with large samples.

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