1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Study on the Relationship between Serum sCD25,IGF-Ⅰ and Immunophenotype and Therapeutic Efficacy in Newly Diagnosed Multiple Myeloma Patients
Rong OUYANG ; Da-lin ZHANG ; Yan ZHOU ; Fa-mao LI ; Yi-wu ZHENG
Progress in Modern Biomedicine 2025;25(10):1725-1733
Objective:To investigate the relationship between serum soluble interleukin-2 receptor(sCD25)and insulin-like growth factor-Ⅰ(IGF-Ⅰ)and the immunophenotype and therapeutic efficacy of newly diagnosed multiple myeloma(MM)patients.Methods:125 newly diagnosed MM patients(MM group)who received treatment at Tianmen First People's Hospital from January 2023 to June 2024 were selected,and another 70 healthy individuals who underwent physical examinations at our hospital during the same period were selected(control group).The serum sCD25 and IGF-Ⅰ levels in newly diagnosed MM patients of different stages were compared,and newly diagnosed MM patients were divide into remission group(76 cases)and non remission group(49 cases)based on treatment efficacy,the serum sCD25 and IGF-Ⅰ levels between the remission group and non remission group were compared.The patients were divided into high sCD25 group and low sCD25 group,high IGF-Ⅰ group and low IGF-Ⅰgroup according to the median levels of serum sCD25 and IGF-Ⅰ,the immunophenotypic differences between high sCD25 group and low sCD25 group,as well as high IGF-Ⅰ group and low IGF-Ⅰ group were analyzed.Serum sCD25 and IGF-Ⅰ for evaluating the efficacy of newly diagnosed MM patients were analyzed by receiver operating characteristic(ROC)curve.Factors affecting the therapeutic effect of newly diagnosed MM patients were analyzed by multivariate logistic regression analysis.Results:Serum sCD25 and IGF-Ⅰ levels in the control group were significantly lower than those in the MM group(P<0.05).There was a statistically significant difference in serum sCD25 and IGF-Ⅰ levels among newly diagnosed MM patients at different stages(P<0.05).Serum sCD25 and IGF-Ⅰ levels in stage Ⅲ newly diagnosed MM patients were significantly higher than those in stage Ⅰ and Ⅱ(P<0.05),And stage Ⅱ was higher than that in stage Ⅰ(P<0.05).The positive expression rate of CD56 in the high sCD25 group was higher than that in the low sCD25 group,there was no significant difference in the positive expression rates of CD117 and CD200 between the two groups(P>0.05).The positive expression rates of CD56 and CD117 in the high IGF-Ⅰ group were higher than those in the low IGF-Ⅰ group(P<0.05),and there was no significant difference in the positive expression rate of CD200 between the two groups(P>0.05).Serum sCD25 and IGF-Ⅰ levels in the remission group were significantly lower than those in the non remission group(P<0.05).ROC curve analysis showed that,the area under the curve(AUC)for evaluating the efficacy of newly diagnosed MM patients using serum sCD25 and IGF-Ⅰ detection alone and in combination were 0.748,0.775 and 0.832,respectively,and the AUC for combined detection was greater than that for each indicator detected separately.The results of multivariate Logistic regression model showed that elevated serum sCD25 level,elevated serum IGF-Ⅰ level and MM stage Ⅲ were independent risk factors affecting the efficacy of newly diagnosed MM patients(P<0.05).Conclusion:Serum sCD25 and IGF-Ⅰ levels are closely related to the disease stage and therapeutic efficacy of newly diagnosed MM patients.Combined detection has a high evaluation value for efficacy and can be used as an important evaluation index affecting efficacy.
3.Reform and practice of the teaching mode in the course of "maternal, child, and adolescent health"
Ling ZHANG ; Honghui RONG ; Chuanfen ZHENG ; Fengju LI ; Dali YI ; Ji'an CHEN
Chinese Journal of Medical Education Research 2025;24(3):337-341
In response to the current problems in the traditional methods used for teaching the course of "maternal, child, and adolescent health", including the monotony of teaching modes, poor learning outcomes, limited use of information technology-based teaching, and the need for improved faculty professionalism, this study explored the reform and practice of teaching modes for this course. Teaching reform centered on a task-driven pre-class learning guide, supported by the development of a resource platform. This platform was used to assign pre-class and post-class tasks. An information technology-based platform facilitated teaching implementation during class. Systematical analysis and evaluation were performed on the teaching process and implementation effects. By continuously optimizing course design, adjusting teaching strategies, and improving the autonomy and learning efficiency of students, the system can be used to improve teaching effectiveness and quality. This system provides a reference for information technology-based teaching reform in similar courses.
4.Research progress on the role and mechanism of high mobility group box protein 1 after spinal cord injury
Xin XUE ; Chang-zheng YIN ; Jin-hui CHEN ; Lu-rong HUANG ; Xin ZHENG ; Yi-min LI ; Guo-bao XIAO ; Ping ZHANG ; Jian-hua ZHAO
Journal of Regional Anatomy and Operative Surgery 2025;34(10):918-923
High mobility group box protein 1(HMGB1)is one of the most widely expressed protein member in the HMGs family,which is well known for its involvement in the body inflammatory response.Previous researches have found that it plays a significant role in cell migration,immune identification and neuroprotection.Spinal cord injury is a disease that causes severe damage to the nervous system,and neural circuits are disrupted after a spinal cord injury,which leads to many conditions including ischemia and hypoxia,inflammatory responses,demyelinating lesions,and glial scar formation that are detrimental to nerve regeneration and repair,making it one of the most difficult diseases to treat in the modern spinal surgery field.HMGB1 is upregulated after spinal cord injury,thereby regulating neuroinflam-matory responses,and participating in the neuronal apoptosis,promoting neuronal regeneration,and inducing neural stem cell differentiation and migration,which plays an important role in the process of neural function recovery.This paper summarizes the structure and function of HMGB1,as well as its role in spinal cord injury,in order to provide direction for founding therapeutic target for neurological function recovery after spinal cord injury.
5.Impact of fresh and frozen-thawed embryo transfer on pregnancy outcomes in elderly women with DOR
Jingjing XING ; Zheng WANG ; Rong LI ; Li LI
Chinese Journal of Reproduction and Contraception 2025;45(6):591-599
Objective:To investigate the impact of fresh and frozen-thawed embryo transfer on pregnancy outcomes in patients with diminished ovarian reserve (DOR) at an advanced age.Methods:Using a retrospective cohort study design, we enrolled elderly women with DOR who underwent their first in vitro fertilization and embryo transfer (IVF-ET) treatment at Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital between January 2018 and December 2022. Patients were grouped according to the cycle type of their first embryo transfer: a fresh cycle transfer group (group A, n=563) and a frozen-thawed cycle transfer group (group B, n=234). Propensity score matching (PSM, 1∶1) was used to match the baseline characteristics and embryo transfer information of the two groups, resulting in 184 patients in each group. The impact of fresh versus frozen-thawed embryo transfer on reproductive outcomes in elderly DOR patients was analyzed. Results:1) There were no statistically significant differences in general data, ovarian stimulation, and laboratory parameters of embryos between the two groups after PSM (all P>0.05). 2) The clinical pregnancy rate [23.91% (44/184)], the implantation rate [16.55% (48/290)], the ongoing pregnancy rate [16.85% (31/184)], and the live birth rate [16.30% (30/184)] in group A were significantly higher than those in group B [14.67% (27/184), P=0.025; 10.27% (30/292), P=0.026; 9.78% (18/184), P=0.046; 9.24% (17/184), P=0.042], with statistically significant differences. There were no statistically significant differences in miscarriage rate, multiple pregnancy rate, preterm birth rate, gestational age at delivery, and neonatal birth weight between the two groups (all P>0.05). 3) After controlling for confounding factors, frozen-thawed embryo transfer, female age, and the number of transferred quality embryos were independent factors influencing clinical pregnancy ( OR=0.486, 95% CI: 0.275-0.858, P=0.013; OR=0.761, 95% CI: 0.686-0.844, P<0.001; transferring one high-quality embryo OR=5.213, 95% CI: 1.501-18.105, P=0.009; transferring two high-quality embryos OR=8.144, 95% CI: 2.072-32.009, P=0.003) and live birth ( OR=0.468, 95% CI: 0.240-0.916, P=0.027; OR=0.733, 95% CI: 0.645-0.834, P<0.001; transferring one high-quality embryo OR=5.457, 95% CI: 1.218-24.448, P=0.027; transferring two high-quality embryos OR=5.900, 95% CI: 1.132-30.754, P=0.035). 4) After controlling for confounding factors, in transfer cycles of patients older than 40 years, the clinical pregnancy rate in group A [14.46% (12/83)] was significantly higher than that in group B [4.88% (4/82)], with a statistically significant difference ( OR=0.285, 95% CI: 0.086-0.946, P=0.040). In single cleavage-stage embryo transfer cycles, the clinical pregnancy rate [21.79% (17/78)] and the live birth rate [16.67% (13/78)] in group A were significantly higher than those in group B [9.21% (7/76), OR=0.311, 95% CI: 0.113-0.857, P=0.024; 6.58% (5/76), OR=0.468, 95% CI: 0.24-0.916, P=0.027], with both statistically significant differences. In cycles with transfer of only one high-quality embryo, the clinical pregnancy rate [27.66% (26/94)] and the live birth rate [20.21% (19/94)] in group A were significantly higher than those in group B [13.54% (13/96), OR=0.347, 95% CI: 0.157-0.765, P=0.009; 10.42% (10/96), OR=0.407, 95% CI: 0.171-0.968, P=0.042], with both statistically significant differences. Conclusion:Fresh cycle embryo transfer can achieve better reproductive outcomes in elderly women with DOR, especially in patients older than 40 years, in single cleavage-stage embryo transfer cycles, or when only one high-quality embryo is available. Fresh cycle embryo transfer should be prioritized in these situations.
6.Research progress on the role and mechanism of high mobility group box protein 1 after spinal cord injury
Xin XUE ; Chang-zheng YIN ; Jin-hui CHEN ; Lu-rong HUANG ; Xin ZHENG ; Yi-min LI ; Guo-bao XIAO ; Ping ZHANG ; Jian-hua ZHAO
Journal of Regional Anatomy and Operative Surgery 2025;34(10):918-923
High mobility group box protein 1(HMGB1)is one of the most widely expressed protein member in the HMGs family,which is well known for its involvement in the body inflammatory response.Previous researches have found that it plays a significant role in cell migration,immune identification and neuroprotection.Spinal cord injury is a disease that causes severe damage to the nervous system,and neural circuits are disrupted after a spinal cord injury,which leads to many conditions including ischemia and hypoxia,inflammatory responses,demyelinating lesions,and glial scar formation that are detrimental to nerve regeneration and repair,making it one of the most difficult diseases to treat in the modern spinal surgery field.HMGB1 is upregulated after spinal cord injury,thereby regulating neuroinflam-matory responses,and participating in the neuronal apoptosis,promoting neuronal regeneration,and inducing neural stem cell differentiation and migration,which plays an important role in the process of neural function recovery.This paper summarizes the structure and function of HMGB1,as well as its role in spinal cord injury,in order to provide direction for founding therapeutic target for neurological function recovery after spinal cord injury.
7.Research progress in effect of traditional Chinese medicine on aerobic glycolysis in colorectal cancer.
Xu MA ; Sheng-Long LI ; Guang-Rong ZHENG ; Da-Cheng TIAN ; Gang-Gang LU ; Jie GAO ; Yu-Qi AN ; Li-Yuan CAO ; Liang LI ; Xiao-Yong TANG
China Journal of Chinese Materia Medica 2025;50(6):1496-1506
Colorectal cancer(CRC) is a common malignant tumor worldwide. Due to the treatment intolerance and side effects, CRC rank the top among various cancers regarding the incidence and mortality rates. Therefore, exploring new therapies is of great significance for the treatment of CRC. Aerobic glycolysis(AEG) plays an important role in the microenvironment formation, proliferation, metastasis, and recurrence of CRC and other tumor cells. It has been confirmed that intervening in the AEG pathway can effectively curb CRC. The active ingredients and compound prescriptions of traditional Chinese medicine(TCM) can effectively inhibit the proliferation, metastasis, and drug resistance and regulate the apoptosis of tumor cells by modulating AEG-associated transport proteins [eg, glucose transporters(GLUT)], key enzymes [hexokinase(HK) and phosphofructokinase(PFK)], key genes [hypoxia-inducible factor 1(HIF-1) and oncogene(c-Myc)], and signaling pathways(MET/PI3K/Akt/mTOR). Accordingly, they can treat CRC, reduce the recurrence, and improve the prognosis of CRC. Although AEG plays a key role in the development and progression of CRC, the specific mechanisms are not yet fully understood. Therefore, this article delves into the intrinsic connection of the targets and mechanisms of the AEG pathway with CRC from the perspective of tumor cell glycolysis and explores how active ingredients(oxymatrine, kaempferol, and dioscin) and compound prescriptions(Quxie Capsules, Jiedu Sangen Decoction, and Xianlian Jiedu Prescription) of TCM treat CRC by intervening in the AEG pathway. Additionally, this article explores the shortcomings in the current research, aiming to provide reliable targets and a theoretical basis for treating CRC with TCM.
Humans
;
Colorectal Neoplasms/genetics*
;
Drugs, Chinese Herbal/therapeutic use*
;
Glycolysis/drug effects*
;
Animals
;
Medicine, Chinese Traditional
;
Signal Transduction/drug effects*
8.Tanreqing Capsules protect lung and gut of mice infected with influenza virus via "lung-gut axis".
Nai-Fan DUAN ; Yuan-Yuan YU ; Yu-Rong HE ; Feng CHEN ; Lin-Qiong ZHOU ; Ya-Lan LI ; Shi-Qi SUN ; Yan XUE ; Xing ZHANG ; Gui-Hua XU ; Yue-Juan ZHENG ; Wei ZHANG
China Journal of Chinese Materia Medica 2025;50(8):2270-2281
This study aims to explore the mechanism of lung and gut protection by Tanreqing Capsules on the mice infected with influenza virus based on "the lung-gut axis". A total of 110 C57BL/6J mice were randomized into control group, model group, oseltamivir group, and low-and high-dose Tanreqing Capsules groups. Ten mice in each group underwent body weight protection experiments, and the remaining 12 mice underwent experiments for mechanism exploration. Mice were infected with influenza virus A/Puerto Rico/08/1934(PR8) via nasal inhalation for the modeling. The lung tissue was collected on day 3 after gavage, and the lung tissue, colon tissue, and feces were collected on day 7 after gavage for subsequent testing. The results showed that Tanreqing Capsules alleviated the body weight reduction and increased the survival rate caused by PR8 infection. Compared with model group, Tanreqing Capsules can alleviate the lung injury by reducing the lung index, alleviating inflammation and edema in the lung tissue, down-regulating viral gene expression at the late stage of infection, reducing the percentage of neutrophils, and increasing the percentage of T cells. Tanreqing Capsules relieved the gut injury by restoring the colon length, increasing intestinal lumen mucin secretion, alleviating intestinal inflammation, and reducing goblet cell destruction. The gut microbiota analysis showed that Tanreqing Capsules increased species diversity compared with model group. At the phylum level, Tanreqing Capsules significantly increased the abundance of Firmicutes and Actinobacteria, while reducing the abundance of Bacteroidota and Proteobacteria to maintain gut microbiota balance. At the genus level, Tanreqing Capsules significantly increased the abundance of unclassified_f_Lachnospiraceae while reducing the abundance of Bacteroides, Eubacterium, and Phocaeicola to maintain gut microbiota balance. In conclusion, Tanreqing Capsules can alleviate mouse lung and gut injury caused by influenza virus infection and restore the balance of gut microbiota. Treating influenza from the lung and gut can provide new ideas for clinical practice.
Animals
;
Drugs, Chinese Herbal/administration & dosage*
;
Mice
;
Lung/metabolism*
;
Mice, Inbred C57BL
;
Capsules
;
Orthomyxoviridae Infections/virology*
;
Gastrointestinal Microbiome/drug effects*
;
Male
;
Humans
;
Female
;
Influenza A virus/physiology*
;
Influenza, Human/virology*
9.Research progress on role of competitive endogenous RNA networks in heart failure and intervention by traditional Chinese medicine.
Pei-Li YANG ; Li-Rong ZHENG ; Ying-Qiang ZHAO
China Journal of Chinese Materia Medica 2025;50(12):3232-3243
Heart failure(HF) is the terminal stage of various cardiovascular diseases, characterized by high morbidity and mortality, and it represents one of the major disease burdens for families and society. In recent years, as research on the molecular mechanisms of HF has deepened, a competing endogenous RNA(ceRNA) network mediated by long non-coding RNAs(lncRNAs) and circular RNAs(circRNAs) has been gradually constructed. Extensive research results have confirmed that the ceRNA network is widely involved in pathological processes such as inflammation, oxidative stress, myocardial hypertrophy, apoptosis, remodeling of extracellular matrix components and structure, and ferroptosis in HF. It reveals the complex pathological mechanisms of HF at the epigenetic level. Traditional Chinese medicine(TCM) plays a unique role in improving symptoms and prognosis of HF and intervenes in the ceRNA network in HF through multi-level and multi-target mechanisms. It improves key pathological processes such as myocardial fibrosis and inflammation, making progress in treating HF at the molecular level. This article summarized recent Chinese and international research on the regulatory mechanisms of ceRNA networks in HF, elaborated on the mechanisms of action of ceRNA networks in different pathological stages of HF, and summarized how effective components and compounds of TCM intervene in the ceRNA network to improve HF, so as to refine the molecular mechanisms of HF and provide directions for more precise molecular targeted therapeutic strategies.
Humans
;
Heart Failure/metabolism*
;
Medicine, Chinese Traditional
;
Animals
;
Drugs, Chinese Herbal/therapeutic use*
;
RNA, Circular/genetics*
;
RNA, Long Noncoding/metabolism*
;
Gene Regulatory Networks/drug effects*
;
RNA/metabolism*
;
RNA, Competitive Endogenous
10.Analysis of abnormal ALT in blood donors in five Zang autonomous prefectures of Qinghai Province, China: characteristics and screening strategies
Yingnan DANG ; ; Rong TANG ; Liqin HUANG ; Hailin WU ; Tingting CHEN ; Shengju LI ; Yanli SUN ; Xin ZHENG ; Yanxia LI ; Xianlin YE ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(4):502-507
[Objective] To investigate the factors associated with alanine aminotransferase (ALT) abnormalities in multi-ethnic blood donors across five Zang autonomous prefectures in the plateau regions of Qinghai Province, and to provide evidence for ensuring blood safety and formulating screening strategies. [Methods] A retrospective analysis was performed on the ALT abnormal test results of blood donors in the Zang autonomous prefectures of Qinghai from 2022 to 2024. The correlations between ALT levels and factors including gender, age, altitude, and infectious markers were investigated. [Results] The overall ALT unqualified rate among blood donors in this region was 9.01%. Significant differences in ALT levels were observed across genders and age groups (P<0.05). Variations in ALT abnormality rates were also noted among different plateau regions (P<0.05). Overall, ALT values exhibited an increasing trend with rising altitude. The average ALT unqualified rates were 11.19% in Zang donors, 7.96% in Han donors, and 4.79% in donors from other ethnic groups (P<0.05). No statistically significant association was observed between ALT abnormality and the presence of HBV/HCV infectious markers (P>0.05). [Conclusion] In the plateau areas of Qinghai, multi-ethnic blood donors have a relatively high ALT levels and ALT unqualified rates, showing distinct regional characteristics. ALT elevation in voluntary blood donors is related to non-pathological factors such as gender, age, and dietary habits, but not to infectious indicators.

Result Analysis
Print
Save
E-mail