1.Risk factors of postoperative fever in primary aldosteronism patients
Yuchao HUANGFU ; Tao XU ; Yiqing DU ; Lizhe AN ; Luping YU
Journal of Modern Urology 2025;30(1):22-28
[Objective] To explore the risk factors of postoperative fever in primary aldosteronism (PA) patients. [Methods] Clinical data of 116 PA patients undergoing adrenalectomy in Peking University People's Hospital during Jan.2018 and Jul.2021 were retrospectively analyzed.Based on postoperative body temperature, the patients were divided into fever group (body temperature ≥38.0 ℃, n=41) and non-fever group (body temperature <38.0 ℃, n=75). Clinical features were analyzed between the two groups.The fever group was subdivided into low fever group (38.0 ℃≤body temperature <38.5 ℃, n=19) and high fever group (body temperature ≥38.5 ℃, n=22). The clinical data of the subgroups were compared. [Results] The incidence of postoperative fever was 35.3%.Logistic regression analysis showed that lower lowest potassium on records (OR=0.419, 95%CI: 0.196-0.894, P=0.025), lower high-density lipoprotein cholesterol (HDL-C) (OR=0.112, 95%CI: 0.018-0.687, P=0.018), and postoperative adrenal insufficiency (OR=4.158, 95%CI: 1.731-9.989, P=0.001) were independent risk factors for postoperative fever.There was no difference between the high and low fever groups.After surgery, infection occurred in 1 patient, adrenal insufficiency in 40 (34.5%) patients, but long-term follow-up indicated that no patients needed lifelong glucocorticoid replacement. [Conclusion] Fever is a common postoperative complication in PA patients, most likely due to transient adrenal insufficiency.Glucocorticoid supplementation should be administered appropriately and timely based on laboratory tests and clinical manifestations.Evaluation of adrenal function is highly recommended for patients undergoing adrenalectomy.
2.Multidimensional analysis of accuracy of CTU, contrast-enhanced MRI and CEUS in qualitative diagnosis of renal space-occupying lesions
Linjie WU ; Ying YU ; Xiaojie BAI ; Zihao QI ; Hang ZHENG ; Zhongqiang GUO
Journal of Modern Urology 2025;30(1):48-52
[Objective] To compare the diagnostic accuracy of three imaging modalities, inlducing CT urography (CTU), contrast-enhanced MRI (CE-MRI), and contrast-enhanced ultrasound (CEUS) in the qualitative diagnosis of renal space-occupying lesions. [Methods] A retrospective analysis was performed on 542 patients with renal lesions confirmed by surgical pathology in our hospital during Jan.2019 and May 2024.The diagnostic results of CTU, CE-MRI and CEUS were compared and analyzed based on the patients' clinical and pathological data. [Results] The diagnostic accuracy rate of CTU, CE-MRI and CEUS were 84.50%, 83.14% and 86.14%, respectively.For the 161 patients who underwent all three examinations, CEUS was significantly more accurate than CTU (84.16% vs. 77.02%, P=0.018), while there was no significant difference between CTU or CEUS and CE-MRI (79.81%) (P>0.05). Further analysis found that for lesions ≤4 cm, the accuracy of the three examinations was as follows: CEUS=CTU 79.55%, CE-MRI 76.14%, with no significant difference (P>0.05). However, for lesions >4 cm, CEUS ranked the first, followed by CE-MRI and CTU (89.73% vs. 84.25% vs. 73.97%), and CEUS and CE-MRI were better than CTU (P<0.05). Additionally, for the diagnosis of clear cell renal carcinoma and benign renal space-occupying lesions, there was no statistically significant difference among the three imaging modalities (P>0.05), while for the qualitative diagnosis of non-clear cell renal carcinoma, CEUS ranked the first, followed by CE-MRI and CTU (83.87% vs. 74.19% vs. 56.45%), and CE-MRI and CEUS were better than CTU (P<0.05). [Conclusion] All of them have important diagnostic value, and the appropriate selection should be based on patients' specifc conditions.CEUS and CE-MRI are more accurate in the qualitative diagnosis of renal space-occupying lesions than CTU, especially for large lesions and non-clear cell carcinoma.
3.Effect of Dingzhi Xiaowan on PI3K/Akt/mTOR/HIF-1α Pathway in Post-stroke Cognitive Impairment Model Mice
Han ZHANG ; Yu WANG ; Xiaoqin ZHONG ; Zhenqiu NING ; Dafeng HU ; Minzhen DENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):1-11
ObjectiveTo investigate the effect of Dingzhi Xiaowan (DZXW) in post-stroke cognitive impairment (PSCI) model mice. MethodsThe cerebral ischemia-reperfusion injury model of mice was established by using the middle cerebral artery occlusion method. Forty C57BL/6 male mice were randomly divided into the sham operation group, model group, low-dose DZXW group (1.43 g·kg-1), and high-dose DZXW group (2.56 g·kg-1), with 10 mice in each group. Both the sham operation group and the model group were treated with equal amounts of normal saline by gavage, and the above four groups of mice were gavaged once a day for 30 consecutive days. Morris water maze test was used to evaluate the learning memory ability of mice. Serum levels of amyloid precursor protein (APP), amyloid 42 (Aβ42), acetylcholinesterase (AChE), and superoxide dismutase (SOD) were measured by enzyme-linked immunosorbent assay (ELISA). Deoxyribonucleotide end transferase-mediated nick end labelling (TUNEL) assay was applied to detect the degree of apoptosis in the mouse's hippocampal neurons. Western blot was used to detect the protein expression of phosphoinositol-3 kinase (PI3K), protein kinase B (Akt), mammalian target of rapamycin (mTOR), hypoxia-inducible factor 1-alpha (HIF-1α), B-cell lymphoma 2 (Bcl-2) homologous structural domain protein (Beclin1), sequestosome 1 (p62), microtubule-associated protein light chain 3 (LC3), Bcl-2, and Bcl-2-associated X protein (Bax) in hippocampal tissue. Prussian blue staining was used to detect iron deposition in hippocampal tissue. Transmission electron microscopy was taken to observe the ultrastructure of the mouse's hippocampal neurons. ResultsCompared with the sham operation group, the latency, APP, Aβ42, AChE, TUNEL positivity, ferric ion deposition, HIF-1α, Beclin1, Bax, and LC3Ⅱ/Ⅰ were significantly increased in the model group (P<0.01), while the number of crossing platforms, SOD, p-PI3K, p-Akt, p-mTOR, p62, and Bcl-2 were significantly decreased (P<0.01). Compared with the model group, the latency, APP, Aβ42, AChE, TUNEL positivity rate, ferric ion deposition, HIF-1α, Beclin1, Bax, and LC3Ⅱ/Ⅰ were significantly reduced in the DZXW groups (P<0.05), while the number of crossing platforms, SOD, p-PI3K, p-Akt, p-mTOR, p62, and Bcl-2 were significantly higher (P<0.05). ConclusionDZXW can alleviate cognitive impairment induced by oxidative stress-aggravated hippocampal neuronal damage in PSCI model mice by modulating the PI3K/Akt/mTOR/HIF-1α autophagy signalling pathway.
4.Mechanism of Buyang Huanwutang in Inhibiting Ferroptosis and Enhancing Neurological Function Recovery After Spinal Cord Injury via GPX4-ACSL4 Axis
Luchun XU ; Guozheng JIANG ; Yukun MA ; Jiawei SONG ; Yushan GAO ; Guanlong WANG ; Jiaojiao FAN ; Yongdong YANG ; Xing YU ; Xiangsheng TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):20-30
ObjectiveTo explore the mechanism by which Buyang Huanwutang regulates the glutathione peroxidase 4 (GPX4)-acyl-CoA synthetase long-chain family member 4 (ACSL4) axis to inhibit ferroptosis and promote neurological functional recovery after spinal cord injury (SCI). MethodsNinety rats were randomly divided into five groups: sham operation group, model group, low-dose Buyang Huanwutang group (12.5 g·kg-1), high-dose Buyang Huanwutang group (25 g·kg-1), and Buyang Huanwutang + inhibitor group (25 g·kg-1 + 5 g·kg-1 RSL3). The SCI model was established by using the allen method. Tissue was collected on the 7th and 28th days after operation. Motor function was assessed by using the Basso-Beattie-Bresnahan (BBB) scale. Hematoxylin-eosin (HE), Nissl, and Luxol fast blue (LFB) staining were performed to observe spinal cord histopathology. Transmission electron microscopy was used to examine mitochondrial ultrastructure. Immunofluorescence staining was used to detect the number of NeuN-positive cells and the fluorescence intensity of myelin basic protein (MBP), GPX4, and ACSL4. Real-time fluorescent quantitative polymerase chain reaction (Real-time PCR) was used to analyze the mRNA expression of GPX4 and ACSL4. Enzyme linked immunosorbent assay (ELISA) was performed to measure the levels of reactive oxygen species (ROS), malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD). Colorimetric assays were used to determine the iron content in spinal cord tissue. ResultsCompared to the sham operation group, the model group exhibited significantly reduced BBB scores (P<0.01), severe pathological damage in spinal cord tissue, and marked mitochondrial ultrastructural disruption. In addition, the model group showed a decrease in the number of NeuN-positive cells (P<0.01), reduced fluorescence intensity of MBP and GPX4 (P<0.01), lower levels of GSH and SOD (P<0.01), and downregulated mRNA expression of GPX4 (P<0.01). Moreover, compared to the sham operation group, the model group had elevated levels of ROS, MDA, and tissue iron content (P<0.01), along with increased fluorescence intensity and mRNA expression of ACSL4 (P<0.01). Compared with the model group and Buyang Huanwutang + inhibitor group, the Buyang Huanwutang group showed significantly improved BBB scores (P<0.05, P<0.01) and exhibited less severe spinal cord tissue damage, reduced edema and inflammatory cell infiltration, increased neuronal survival, and more intact myelin structures. Additionally, mitochondrial ultrastructure was significantly improved in the Buyang Huanwutang group. Compared to the model group and Buyang Huanwutang + inhibitor group, the Buyang Huanwutang group significantly increased the number of NeuN-positive cells and the fluorescence intensity of MBP (P<0.05, P<0.01). Furthermore, Buyang Huanwutang significantly increased the fluorescence intensity and mRNA expression of GPX4 (P<0.01) and decreased the fluorescence intensity and mRNA expression of ACSL4 (P<0.01) compared to the model group and Buyang Huanwutang + inhibitor group. Finally, the Buyang Huanwutang group significantly decreased ROS, MDA, and tissue iron content (P<0.01) and significantly increased GSH and SOD levels (P<0.01) compared to the model group and Buyang Huanwutang + inhibitor group. ConclusionBuyang Huanwutang inhibits ferroptosis through the GPX4/ACSL4 axis, reduces secondary neuronal and myelin injury and oxidative stress, and ultimately promotes the recovery of neurological function.
5.Effect of Berberine-Baicalin Combination on Fecal Microbiota Transplantation-induced Type 2 Diabetes Mellitus Due to Internal Accumulation of Dampness-heat in Mice from Perspectives of Gut Microbiota and Metabolomics
Mengjie CHEN ; Yimin LIU ; Yun ZHOU ; Keming YU ; Min XIA ; Hongning LIU ; Yanhua JI ; Zhijun ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):52-64
ObjectiveTo investigate the mechanisms by which the combination of berberine (BBR) and baicalin (BAI) ameliorates type 2 diabetes mellitus (T2DM) due to internal accumulation of dampness-heat from the perspectives of gut microbiota and metabolomics. MethodsAntibiotics were used to induce pseudo-sterile mice. Thirty pseudo-sterile mice were randomized into a normal fecal microbiota transplantation group (n=10) and a T2DM (syndrome of internal accumulation of dampness-heat) fecal microbiota transplantation group (n=20). The mice were then administrated with suspensions of fecal microbiota from healthy volunteers and a patient with T2DM due to internal accumulation of dampness-heat by gavage, respectively. Each mouse received 200 µL suspension every other day for a total of 15 times to reshape the gut microbiota. The T2DM model mice were then assigned into a model group (n=8) and a BBR-BAI group (n=11). BBR was administrated at a dose of 200 mg·kg-1, and BAI was administrated in a ratio of BBR-BAI 10∶1 based on preliminary research findings. The administration lasted for 8 consecutive weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), insulin (INS), triglycerides (TG), total cholesterol (CHOL), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels were measured to evaluate the effects of the BBR-BAI combination on glucose and lipid metabolism and liver function in T2DM mice. Hematoxylin-eosin staining was employed to observe pathological changes in the colon tissue. The expression of claudin-1, zonula occludens-1 (ZO-1), and occludin in the colon tissue was determined by Western blot. Real-time quantitative polymerase chain reaction(Real-time PCR) was employed to assess the levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the colon tissue. The fecal microbiota composition and differential metabolites were analyzed by 16S rRNA sequencing and ultra-high performance liquid chromatography-quadrupole-time of flight tandem mass spectrometry (UPLC-Q-TOF-MS), respectively. ResultsThe BBR-BAI combination lowered the FBG, HbA1c, and INS levels (P<0.05, P<0.01) and alleviated insulin resistance (P<0.01) in T2DM mice. Additionally, BBR-BAI elevated the levels of ZO-1, occludin, and claudin-1 (P<0.05, P<0.01) and down-regulated the expression levels of TNF-α, IL-1β, and IL-6 in the colon (P<0.05, P<0.01). The results of 16S rRNA sequencing showed that BBR-BAI increased the relative abundance of Ligilactobacillus, Phascolarctobacterium, and Akkermansia (P<0.05), while significantly decreasing the relative abundance of Alistipes, Odoribacter, and Colidextribacter (P<0.05). UPLC-Q-TOF-MS identified 28 differential metabolites, which were primarily involved in arachidonic acid metabolism and α-linolenic acid metabolism. ConclusionBBR-BAI can ameliorate T2DM due to internal accumulation of dampness-heat by modulating the relative abundance of various bacterial genera in the gut microbiota and the expression of fecal metabolites.
6.Quercetin Attenuates Ferroptosis Against LPS-induced Acute Kidney Injury Rats via Modulating Keap1/Nrf2/ARE Pathway
Haoruo YANG ; Dajun YU ; Yu ZHANG ; Bin YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):65-75
ObjectiveTo investigate the effect and therapeutic role of quercetin on ferroptosis in lipopolysaccharide (LPS)-induced acute kidney injury (AKI) rats based on the Kelch-like epichlorohydrin-related protein-1 (Keap1)/nuclear factor erythroid-2-related factor 2 (Nrf2)/antioxidant response element (ARE) pathway. MethodsSixty male SD rats were randomly divided into normal group, model group, quercetin high-dose (100 mg·kg-1) and low-dose (10 mg·kg-1) groups, ferroptosis inhibitor Ferrostatin 1 (FER1) group (5 mg·kg-1), and quercetin high-dose + Nrf2 inhibitor group (ML385, 30 mg·kg-1). Except for the normal group, the AKI rat model was established in each group by intraperitoneal injection of LPS (10 mg·kg-1). Following successful modeling, each treatment group received the corresponding dose of drug intervention, while the normal and model groups were administered an equal volume of normal saline. The intervention lasted for 3 weeks. Serum creatinine (SCr) and blood urea nitrogen (BUN) levels were measured biochemically to assess renal function. Serum tumor necrosis factor-α (TNF-α) and interleukin (IL)-1β and IL-6 levels were detected by enzyme-linked immunosorbent assay (ELISA). The levels of Fe2+, malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione (GSH) in renal tissue were detected. Hematoxylin-eosin (HE), Masson, and periodic acid-Schiff (PAS) staining were employed to observe pathological morphological changes in renal tissue. Mitochondrial morphological changes were observed using transmission electron microscopy. Reactive oxygen species (ROS) levels in renal tissue were detected by immunofluorescence (IF). The protein and mRNA expression levels of Keap1, Nrf2, heme oxygenase-1 (HO-1), glutathione peroxidase 4 (GPX4), transferrin receptor (TFR1), and kidney injury molecule-1 (KIM-1) were assessed by immunohistochemistry (IHC) and real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). ResultsCompared with the normal group, the model group exhibited significantly elevated serum levels of SCr, BUN, TNF-α, IL-1β, IL-6, Fe2+ and MDA in renal tissue, and significantly reduced SOD and GSH levels (P<0.01). Pathological injury in renal tissue was severe, with evident mitochondrial damage characteristic of ferroptosis and a reduced mitochondrial count. ROS levels in renal tissue were significantly increased. The protein and mRNA expression levels of Keap1, TFR1, and KIM-1 in renal tissue were significantly elevated, while those of Nrf2, HO-1, and GPX4 were significantly decreased (P<0.01). Compared with the model group, serum levels of SCr, BUN, TNF-α, IL-1β, IL-6, Fe2+ and MDA in renal tissue in the quercetin dosage groups and FER1 group showed varying degrees of reduction, while SOD and GSH levels were significantly increased (P<0.05). Pathological injury in renal tissue was markedly alleviated, mitochondrial damage improved, and mitochondrial counts increased. ROS levels in renal tissue were significantly reduced. The protein and mRNA levels of Keap1, TFR1, and KIM-1 in renal tissue were significantly decreased, while those of Nrf2, HO-1, and GPX4 were significantly increased, with the most notable improvement in the high-dose quercetin group (P<0.05). In comparison to the high-dose quercetin group, the ML385 group significantly weakened the protective effect of quercetin on AKI rats (P<0.05). ConclusionQuercetin effectively inhibits ferroptosis, improves renal tissue injury, and repairs renal function in AKI rats, and its mechanism may be related to the activation of the Keap1/Nrf2/ARE pathway.
7.Mechanism of Gushining Granules in Attenuating Dexamethasone-induced Apoptosis of Bone Marrow Mesenchymal Stem Cells via Activating PI3K/Akt/Bad Signalling Pathway
Chengyu CHU ; Lei ZHU ; Long LIANG ; Feng WANG ; Xuejian YU ; Wenwu LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):115-122
ObjectiveTo establish steroid-induced osteonecrosis of the femoral head (SANFH) cell model by using dexamethasone (DEX)-induced bone marrow mesenchymal stem cells (BMSCs) and demonstrate that Gushing Granules (GSNs) exert an improving effect by activating the phosphatidylinositol-3-kinase/protein kinase B/B-lymphoma-2 gene related promoter (PI3K/Akt/Bad) signalling pathway. MethodsFirstly, SD rats were orally administered with drugs at a dose of 0.9 g·kg-1 to prepare GSN-containing serum, and CCK-8 screening was used to determine the optimal dosage and duration of action. Then, BMSCs were cultured and treated with 1×10-6 mol·L-1 DEX, 10% GSN-containing serum, and inhibitor LY294002 of PI3K/Akt signalling pathway for 24 hours to model and group SANFH cells. Cell viability and proliferation were detected by using CCK-8 assay kit and EdU staining kit. Flow cytometry was used to detect cell apoptosis. An alkaline phosphatase (ALP) assay kit was employed to detect ALP expression. In order to detect the PI3K/Akt/Bad signalling pathway and protein and mRNA expression of apoptosis-related proteins such as apoptosis regulatory factors B-cell lymphoma-2 gene (Bcl-2), and Bcl-2-associated X protein (Bax), osteocalcin (OCN), and Collagen Ⅰ, we used Western blot and Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). ResultsThe CCK-8 assay kit determined that the optimal dosage for GSN-containing serum is 10%, and the duration of action is 48 hours. After modelling and grouping the cells in each group, the detection results showed that the SANFH model group had significantly lower cell viability, cell proliferation, and ALP expression, as well as protein and mRNA expressions of PI3K, Akt, Bad, Bcl-2, OCN, and Collagen I compared to the blank group. The nucleic acid and protein levels of the Bax index and the cell apoptosis rate detected by flow cytometry significantly increased (P<0.05,P<0.01). After treatment with GSN-containing serum, cell viability, cell proliferation, and ALP expression, as well as expressions of PI3K, Akt, Bad, Bcl-2, OCN, and Collagen Ⅰ nucleic acids and proteins were significantly increased, while the nucleic acid and protein levels of the Bax index and the cell apoptosis rate detected by flow cytometry significantly decreased(P<0.05,P<0.01). Compared with the GSN drug-containing serum group, the simultaneous treatment with the inhibitor LY294002 and GSN drug-containing serum reversed the improvement effect of GSN. Specifically, the cell viability, cell proliferation, ALP expression, and the nucleic acid and protein levels of PI3K, Akt, Bad, Bcl-2, OCN, and Collagen Ⅰ were all significantly decreased, while the nucleic acid and protein levels of the Bax index and the cell apoptosis rate detected by flow cytometry were significantly increased (P<0.05, P<0.01). ConclusionGSNs antagonize DEX-induced apoptosis of BMSCs by activating the PI3K/Akt/Bad signalling pathway, providing a scientific theoretical basis for the clinical treatment of SANFH with GSNs.
8.Antidepressant Mechanisms of Polygalae Radix: A Review
Liming LIU ; Shuaijun PENG ; Pan SU ; Yucheng LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):300-309
Depression is a high-incidence mental disorder with complex causes and multifaceted pathogenic mechanisms. Its pathogenesis has not yet been fully elucidated, which has hindered the development of novel and highly effective antidepressant drugs. This condition severely affects human physical and mental health while imposing a significant socio-economic burden. At present, several hypotheses exist regarding the pathogenesis of depression, including monoamine neurotransmitter imbalances, neurotrophic factor deficiencies, neural plasticity impairments, glutamate dysregulation, neuroinflammatory disorders, gut microbiota imbalances, and mitochondrial autophagy dysfunction. Currently, most clinical antidepressants are monoamine neurotransmitter reuptake inhibitors. Although they exhibit certain therapeutic effects, they are associated with significant drawbacks, such as severe adverse reactions and poor patient compliance. In contrast, traditional Chinese medicine (TCM), characterized by its multi-targeted effects, mild efficacy, and minimal side effects, has demonstrated significant advantages in the treatment of depression. Chinese medicine Polygalae Radix possesses the functions of calming the mind, enhancing cognitive functions, harmonizing the heart and kidneys, and dispelling phlegm to open orifices. It is often included in compound prescriptions for the clinical treatment of depression. Based on current hypotheses regarding the pathogenesis of depression, this paper systematically reviews research progress on the antidepressant mechanisms of Polygalae Radix from multiple perspectives, including its active components, its use in herbal pairings, and its inclusion in TCM compound prescriptions. This review aims to provide a scientific basis for the clinical application of Polygalae Radix in antidepressant therapy and to serve as a reference for the modernization of its antidepressant research.
9.Anti-osteoporosis Effect of Isorhamnetin: A Review
Shilong MENG ; Xu ZHANG ; Yawei XU ; Yang YU ; Wei LI ; Yanguang CAO ; Xiaolin SHI ; Wei ZHANG ; Kang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):347-352
Osteoporosis is a common senile bone metabolism disease, clinically characterized by decreased bone mass, destruction of bone microstructure, increased bone fragility, and easy fracture. It tends to occur in the elderly and postmenopausal women, seriously threatening the quality of life and physical and mental health of the elderly. At present, the treatment of osteoporosis is mainly based on oral western medicines, such as calcium, Vitamin D, and bisphosphonates. Still, there are drawbacks such as a long medication cycle and many adverse reactions. In recent years, due to the advantages of multi-component, multi-pathway, and multi-target, some traditional Chinese medicines and effective ingredients can regulate the osteogenic and osteoclastic differentiation process in both directions and are widely used in the prevention and treatment of osteoporosis. Hippophae rhamnoides is a commonly used herbal medicine, and its fruits are rich in flavonoids, polyphenols, fatty acids, vitamins, and trace elements, which have been proven to have a good anti-osteoporosis effect. Isorhamnetin is the main effective ingredient of Hippophae rhamnoides fruits, which has many pharmacological effects such as anti-inflammation, anti-oxidative stress, anti-aging, and anti-tumor. Studies have shown that isorhamnetin can participate in the regulation of bone metabolism and has a good anti-osteoporosis effect. However, the pharmacological effects and related mechanisms of isorhamnetin against osteoporosis have not been systematically summarized. Therefore, this paper reviewed the pharmacological effects and related mechanisms of isorhamnetin against osteoporosis by referring to relevant literature to provide more basis for the development and application of isorhamnetin.
10.Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China
Yuan QIAO ; Fangyi MA ; Yubei HAN ; Mingyue ZHAO ; Minghuan JIANG ; Yu FANG
China Pharmacy 2025;36(2):146-153
OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China, and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI, Wanfang Data, PubMed and Web of Science were systematically searched, and the retrieval time was from the inception to December 31st, 2023. The summary and analysis were performed from the aspects of theme selection, indicator system construction, evaluation methods, comprehensive decision-making, quality control, etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs, Chinese patent medicines, cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8, all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making, quality control, or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However, there are still issues and challenges such as incomplete evaluation methods and standards, few cases of evaluation results being converted into decision-making, and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored; when the evidence-based basis is insufficient, real-world research should be conducted as much as possible, so as to accelerate the policy transformation of evaluation results.

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