1.Efficacy Connotation and Mechanisms of Shudi Qiangjin Pills Against Steroid-induced Osteonecrosis of Femoral Head Based on "Disease-Syndrome-Formula" Association Network
Zhijian CHEN ; Suya ZHANG ; Longlong DING ; Guixin ZHANG ; Bo LIU ; Baohong MI ; Yanqiong ZHANG ; Na LIN ; Weiheng CHEN ; Chunzhu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):88-99
ObjectiveTo elucidate the efficacy connotation of Shudi Qiangjin pills (SQP) against liver and kidney deficiency in steroid-induced osteonecrosis of femoral head (SONFH) from the perspective of the "disease-syndrome-formula" association and to clarify the underlying mechanisms based on in vivo and in vitro experiment validation. MethodsThe chemical components and the corresponding putative targets of SQP were collected from the Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine (TCMIP) v2.0, the Encyclopedia of Traditional Chinese Medicine (ETCM) v2.0, and HERB databases. The SONFH-related genes were identified based on the differential expression profiles of peripheral blood of patients with SONFH compared to the healthy volunteers, and the disease phenotype-related targets were collected from the TCMIP v2.0 database. Then, the interaction network of "SONFH-related genes and candidate targets of SQP" was constructed based on "gene-gene interaction information", and the major network targets were screened by calculating the topological characteristic values of the network followed by the functional mining according to the Kyoto Encyclopedia of Genes and Genomes (KEGG) database and the SoFDA database. After that, the SONFH rat model was prepared by lipopolysaccharide combined with methylprednisolone injection, and 2.5, 5, 7.5 g·kg-1 SQP (once per day, equivalent to 1, 2, and 3 times the clinical equivalent dose, respectively) or 7.3×10-3 g·kg-1 of alendronate sodium (ALS, once per week, equivalent to the clinical equivalent dose) was given for 8 weeks. The effect characteristics of SQP and ALS in the treatment of SONFH were evaluated by micro-computed tomography scanning, hematoxylin and eosin staining, alkaline phosphatase (ALP) staining, immunohistochemical staining, enzyme-linked immunosorbent assay, and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling(TUNEL)staining, and a comparative efficacy analysis was conducted with ALS. In addition, SONFH cell models were prepared by dexamethasone stimulation of osteoblasts, and the intervention was carried out with the medicated serum of SQP at the aforementioned three doses. Cell counting kit-8, ALP staining, ALP activity assay, alizarin red staining, and flow cytometry were employed to investigate the regulatory effect of SQP on osteoblasts. The expression levels of osteogenesis-related proteins and key factors of the target signaling axis were detected by quantitative real-time polymerase chain reaction and Western blot. ResultsThe network analysis results demonstrated that the candidate targets of SQP primarily exerted their therapeutic effects through key signaling pathways, including phosphoinositide 3-kinase(PI3K)/protein kinase B(Akt), lipid metabolism and atherosclerosis, prolactin, chemokines, and neurotrophic factors pathways. These pathways were significantly involved in critical biological processes such as muscle and bone metabolism and the regulation of the "neuro-endocrine-immune" network, thereby addressing both modern medical symptoms (e.g., delayed skeletal maturation and recurrent fractures) and traditional Chinese medicine (TCM) symptoms (e.g., fatigue, aversion to cold, cold limbs, and pain in the limbs and joints in patients with SONFH characterized by liver and kidney deficiency syndrome. Among these pathways, the PI3K/Akt signaling pathway exhibited the highest degree of enrichment. The in vivo experimental results demonstrated that starting from the 4th week after modeling, the modeling group exhibited a significant reduction in body weight compared to the control group (P<0.05). After six weeks of treatment, all dosage groups of SQP showed significantly higher body weights compared to the model group (P<0.01). Compared with the normal group, the model group exhibited significant decreases in bone mineral density (BMD), bone volume fraction (BV/TV), trabecular number (Tb.N), osteocalcin (OCN), alkaline phosphatase (ALP) levels in femoral head tissue, and serum bone-specific alkaline phosphatase (BALP) (P<0.01), along with significant increases in trabecular separation (Tb.Sp), empty lacunae rate in tissue, and apoptosis rate (P<0.01). In comparison to the model group, the SQP intervention groups showed significant improvements in BMD, BV/TV and Tb.N (P<0.01), significant reductions in Tb.Sp, empty lacunae rate and apoptosis rate (P<0.05), and significant increases in protein levels of OCN and ALP as well as BALP content (P<0.05). The in vitro experimental results revealed that all dosage groups of SQP medicated serum showed no toxic effects on osteoblast. Compared with the normal group, the model group displayed significant suppression of osteoblast proliferation activity, ALP activity, and calcified nodule formation rate (P<0.01), significant decreases in mRNA transcription levels of OCN and Runt-related transcription factor 2 (RUNX2) (P<0.01), significant reductions in protein content of osteopontin (OPN), typeⅠ collagen (ColⅠ)A1, B-cell lymphoma-2 (Bcl-2), PI3K, and phosphorylated (p)-Akt (P<0.01), and a significant increase in apoptosis rate (P<0.01). Compared with the model group, the SQP medicated serum intervention groups exhibited significant increases in proliferation activity, ALP activity, calcified nodule formation rate, mRNA transcription levels of OCN and RUNX2, and protein content of OPN, ColⅠA1, Bcl-2, PI3K, and p-Akt (P<0.05), along with a significant decrease in apoptosis rate (P<0.01). ConclusionSQP can effectively reduce the disease severity of SONFH with liver and kidney deficiency syndrome and improve bone microstructure, with the therapeutic effects exhibiting a dose-dependent manner. The mechanism may be related to its regulation of key processes such as muscle and bone metabolism and the correction of imbalances in the "neuro-endocrine-immune" network, thereby promoting osteoblast differentiation and inhibiting osteoblast apoptosis. The PI3K/Akt signaling axis is likely one of the key pathways through which this formula exerts its effects.
2.Mechanism of Action of Guishenwan in Treatment of Ovarian Insufficiency Diseases: A Review
Yao CHEN ; Sainan TIAN ; Bin'an WANG ; Shengyu WANG ; Wen'e LIU ; Lei LEI ; Li TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):317-324
Guishenwan (GSW), originating from Jingyue Quanshu (Zhang Jingyue's Complete Works), is a classic traditional Chinese medicine (TCM) formula with a history of over 400 years. Designed for kidney essence deficiency syndrome, it is clinically applied to treat diseases associated with essence-blood deficiency, such as ovarian insufficiency diseases in women, oligospermia-induced infertility in men, and lumbar disc herniation. Numerous studies have confirmed its significant efficacy and advantages in managing ovarian insufficiency diseases, including diminished ovarian reserve (DOR), premature ovarian insufficiency (POI), and premature ovarian failure (POF). According to recent literature, the therapeutic mechanisms of GSW in treating ovarian insufficiency diseases involve regulating the hypothalamic-pituitary-ovarian axis (HPOA) function, ameliorating reproductive endocrine disorders, improving ovarian function, modulating relevant signaling pathways, and exerting immunoregulatory and anti-inflammatory effects. A review of GSW in clinical treatment revealed that clinical applications of GSW, particularly in combination with Western medicine, not only alleviate symptoms but also compensate for the limitations of hormone replacement therapy, thereby reducing recurrence, minimizing adverse reactions, and enhancing safety. This review aims to provide a scientific basis for the rational clinical use of GSW in ovarian insufficiency diseases, offer innovative TCM strategies for developing novel ovarian-protective drugs, promote the integration of TCM and Western medicine in reproductive medicine, and ultimately contribute a Chinese approach to global management of ovarian insufficiency diseases.
3.Mechanisms of Sini San in Regulation of Gut Microbiota Against Depression and Liver Injury in CUMS Rats
Junling LI ; Yan ZHANG ; Lei WANG ; Fang QI ; Zhenzhen CHEN ; Tianxing CHEN ; Yuhang LIU ; Xueying WANG ; Xianwen TANG ; Yubo LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):33-40
ObjectiveTo explore the efficacy and mechanisms of Sini San in the treatment of depression and liver injury based on gut microbiota. MethodsThirty-two male Sprague-Dawley (SD) rats were randomly divided into a normal group, model group (M), Sini San group (MS, 2.5 g·kg-1), and fluoxetine group (MF, 2 mg·kg-1). Except for the normal group, rats in the other three groups were subjected to chronic unpredictable mild stress (CUMS). After 8 weeks, the open-field test and sucrose preference test were conducted. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum corticosterone (CORT), adrenocorticotropic hormone (ACTH), corticotropin-releasing factor (CRF), lipopolysaccharide (LPS), Zonulin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), γ-aminobutyric acid (GABA) levels in the hippocampus and prefrontal cortex, and brain-derived neurotrophic factor (BDNF) levels in the hippocampus. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect hippocampal BDNF mRNA expression. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were measured using the ultraviolet lactate dehydrogenase method. The ultrastructure of the intestinal epithelium was observed by electron microscopy, and gut microbiota in rat feces were analyzed using 16S rDNA high-throughput sequencing. ResultsCompared with the normal group, the sucrose preference of rats in the model group was significantly reduced (P0.01), whereas it was significantly increased in the Sini San group compared with the model group (P0.05). Compared with the normal group, hippocampal GABA protein levels and BDNF mRNA expression in the model group were significantly decreased (P0.05), and compared with the model group, both were significantly increased in the Sini San group (P0.05, P0.01). Compared with the normal group, serum LPS and Zonulin levels in the model group were significantly increased (P0.05, P0.01), and compared with the model group, Zonulin levels in the Sini San group were significantly decreased (P0.05). No obvious changes were observed in the ultrastructure of the jejunal mucosa among groups. Compared with the normal group, widened and blurred tight junctions, sparse and shortened microvilli, and mitochondrial swelling with cristae disruption in epithelial cells were observed in the ileal and colonic mucosa of the model group, which were markedly improved in the Sini San and fluoxetine groups. The results of 16S rDNA high-throughput sequencing showed that Sini San improved CUMS-induced dysbiosis of Bacteroidetes and Proteobacteria. Correlation analysis indicated that Bacteroidetes and Proteobacteria were significantly correlated with depression-related indicators, liver function, and intestinal mucosal permeability. ConclusionSini San exerts antidepressant and hepatoprotective effects by improving Bacteroidetes and Proteobacteria and inhibiting the increase in intestinal mucosal permeability in CUMS rats.
4.Yimei Baijiang Formula Treats Colitis-associated Colorectal Cancer in Mice via NF-κB Signaling Pathway
Qian WU ; Xin ZOU ; Chaoli JIANG ; Long ZHAO ; Hui CHEN ; Li LI ; Zhi LI ; Jianqin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):119-130
ObjectiveTo explore the effects of Yimei Baijiang formula (YMBJF) on colitis-associated colorectal cancer (CAC) and the nuclear factor kappaB (NF-κB) signaling pathway in mice. MethodsSixty male Balb/c mice of 4-6 weeks old were randomized into 6 groups: Normal, model, capecitabine (0.83 g
5.Mechanisms of Sini San in Regulation of Gut Microbiota Against Depression and Liver Injury in CUMS Rats
Junling LI ; Yan ZHANG ; Lei WANG ; Fang QI ; Zhenzhen CHEN ; Tianxing CHEN ; Yuhang LIU ; Xueying WANG ; Xianwen TANG ; Yubo LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):33-40
ObjectiveTo explore the efficacy and mechanisms of Sini San in the treatment of depression and liver injury based on gut microbiota. MethodsThirty-two male Sprague-Dawley (SD) rats were randomly divided into a normal group, model group (M), Sini San group (MS, 2.5 g·kg-1), and fluoxetine group (MF, 2 mg·kg-1). Except for the normal group, rats in the other three groups were subjected to chronic unpredictable mild stress (CUMS). After 8 weeks, the open-field test and sucrose preference test were conducted. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum corticosterone (CORT), adrenocorticotropic hormone (ACTH), corticotropin-releasing factor (CRF), lipopolysaccharide (LPS), Zonulin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), γ-aminobutyric acid (GABA) levels in the hippocampus and prefrontal cortex, and brain-derived neurotrophic factor (BDNF) levels in the hippocampus. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect hippocampal BDNF mRNA expression. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were measured using the ultraviolet lactate dehydrogenase method. The ultrastructure of the intestinal epithelium was observed by electron microscopy, and gut microbiota in rat feces were analyzed using 16S rDNA high-throughput sequencing. ResultsCompared with the normal group, the sucrose preference of rats in the model group was significantly reduced (P<0.01), whereas it was significantly increased in the Sini San group compared with the model group (P<0.05). Compared with the normal group, hippocampal GABA protein levels and BDNF mRNA expression in the model group were significantly decreased (P<0.05), and compared with the model group, both were significantly increased in the Sini San group (P<0.05, P<0.01). Compared with the normal group, serum LPS and Zonulin levels in the model group were significantly increased (P<0.05, P<0.01), and compared with the model group, Zonulin levels in the Sini San group were significantly decreased (P<0.05). No obvious changes were observed in the ultrastructure of the jejunal mucosa among groups. Compared with the normal group, widened and blurred tight junctions, sparse and shortened microvilli, and mitochondrial swelling with cristae disruption in epithelial cells were observed in the ileal and colonic mucosa of the model group, which were markedly improved in the Sini San and fluoxetine groups. The results of 16S rDNA high-throughput sequencing showed that Sini San improved CUMS-induced dysbiosis of Bacteroidetes and Proteobacteria. Correlation analysis indicated that Bacteroidetes and Proteobacteria were significantly correlated with depression-related indicators, liver function, and intestinal mucosal permeability. ConclusionSini San exerts antidepressant and hepatoprotective effects by improving Bacteroidetes and Proteobacteria and inhibiting the increase in intestinal mucosal permeability in CUMS rats.
6.Yimei Baijiang Formula Treats Colitis-associated Colorectal Cancer in Mice via NF-κB Signaling Pathway
Qian WU ; Xin ZOU ; Chaoli JIANG ; Long ZHAO ; Hui CHEN ; Li LI ; Zhi LI ; Jianqin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):119-130
ObjectiveTo explore the effects of Yimei Baijiang formula (YMBJF) on colitis-associated colorectal cancer (CAC) and the nuclear factor kappaB (NF-κB) signaling pathway in mice. MethodsSixty male Balb/c mice of 4-6 weeks old were randomized into 6 groups: Normal, model, capecitabine (0.83 g
7.Effect of Ningying Formula (宁瘿方) Combined with Low-Dose Antithyroid Drugs on Reducing Relapse Risk for Patients with Graves' Hyperthyroidism in Remission Stage:A Retrospective Cohort Study
Yuqin HUANG ; Mingshuai ZHANG ; Shijian LIU ; Feng TAO ; Yi CHEN
Journal of Traditional Chinese Medicine 2026;67(1):45-52
ObjectiveTo evaluate the effect of Ningying Formula (宁瘿方) combined with low-dose antithyroid drugs (ATDs) on the relapse risk for patients with Graves' hyperthyroidism (GH) during the remission phase, and to analyze the related factors between GH relapse and thyrotropin receptor antibody (TRAb) negativity, so as to provide evidence for the standardized management of GH in remission stage. MethodsA single-center retrospective cohort study was conducted, including 269 GH patients in the remission stage. After propensity score matching (PSM), 102 matched pairs (204 patients) were established. The control group received low-dose ATDs as maintenance therapy, while the exposure group received the core Ningying Formula in addition to low-dose ATDs. The primary outcome was the GH recurrence rate; the secondary outcome was the thyrotropin receptor antibody (TRAb) negativity rate (TRAb<1.75 IU/L). Safety outcomes included treatment-related adverse events. Differences between groups were assessed using Cox regression models and Kaplan-Meier curves, with sensitivity analysis performed using inverse probability of treatment weighting (IPTW). ResultsThe median follow-up in the matched cohort was 28.07 months. Regarding the GH recurrence outcome, the recurrence rate in the exposure group (18/102, 17.6%) was significantly lower than that in the control group (31/102, 30.4%; χ²=4.539, P=0.033); regarding the TRAb negativity outcome, the TRAb negativity rate in the exposure group (50/102, 49.0%) was significantly higher than that in the control group (23/102, 22.5%; χ²=15.551, P<0.001). Multivariate Cox regression analysis for recurrence showed that Ningying Formula treatment reduced the risk of recurrence [HR=0.324, 95%CI(0.170, 0.617), P<0.001]. Male [HR=2.209, 95%CI(1.079, 4.520), P=0.030], higher initial TRAb level [per 1 IU/L increase: HR=1.033, 95%CI(1.003, 1.064), P=0.032], and larger thyroid volume [per 1 ml increase: HR=1.045, 95%CI(1.003, 1.088), P=0.035] were identified as independent risk factors for recurrence; multivariate Cox regression analysis for TRAb negativity indicated that Ningying Formula treatment promoted TRAb negativity [HR=1.826, 95%CI(1.091, 3.056), P=0.022], while a higher initial TRAb level was associated with a lower probability of negativity [HR=0.974, 95%CI(0.950, 0.998), P=0.032]. Survival analysis showed significant differences in relapse rate between groups (Log-Rank P=0.003) and in TRAb outcomes (Log-Rank P=0.034). The incidence of treatment-related adverse events was similar between groups (P=0.757). The IPTW sensitivity analysis was consistent with the primary analysis, indicating robust results. ConclusionThe Ningying Formula combined with low-dose ATDs can significantly reduce the risk of recurrence and can improve the TRAb negativity rate in GH patients during the remission stage, without increasing common adverse events, making it an optional strategy for reducing relapse risk during remission. Male gender, higher baseline TRAb level, and larger thyroid volume indicate a higher risk of recurrence, warranting focused follow-up and stratified management.
8.Study on the new workflow of PIVAS based on intelligent auxiliary devices
Haiwen DING ; Sheng LIU ; Zhaolin CHEN ; Liqin TANG ; Tong TONG
China Pharmacy 2026;37(1):99-104
OBJECTIVE To build a new workflow of pharmacy intravenous admixture services (PIVAS), effectively connect intelligent equipment, and promote the intelligent development of PIVAS. METHODS Based on intelligent auxiliary equipment, PIVAS workflow was optimized, and a process-oriented model was established. This model integrated intelligent prescription review (automatic prescription review+manual intervention mode), intelligent labeling, intelligent allocation, intelligent sorting, and finished infusion quality inspection system. Furthermore, an assessment was conducted to examine unreasonable medical order rate of intelligent prescription review, the working efficiency and error rate of intelligent labeling machine and intelligent sorting machine, and the dispensing efficiency and accuracy of intelligent dispensing robot. RESULTS Under the intelligent prescription review mode, the rate of unreasonable medical orders decreased from 0.157% to 0.050% (P<0.05); automatic labeling efficiency reached 21.7 sheets/min, surpassing the manual labeling efficiency of 13.8 sheets/min (P<0.05), and the daily labeling error rate decreased from 6.1‰ to 2.5‰ (P<0.05). Simultaneously operating two dispensing robots significantly improved the efficiency of batch dispensing and reduced the residual amount of liquid medicine (P<0.05); additionally, a quality testing system for finished infusion was established, involving appearance, Tyndall effect, insoluble particles, turbidity, absorbance, pH and osmotic pressure, to ensure the quality of finished infusion and reduce the risk of infusion. CONCLUSIONS The new process of PIVAS connected with intelligent devices in our hospital can improve work efficiency, reduce dispensing errors, ensure the quality of finished infusion, and improve the level of pharmaceutical care.
9.Research progress on antibody-drug conjugates in the treatment of triple-negative breast cancer
Danna LIU ; Shuangshuang SONG ; Lu CHEN ; Yongqiang SUN ; Bo SUN ; Hanli ZHOU ; Xiaoli ZHAO ; Tiandong KONG
China Pharmacy 2026;37(1):124-129
Antibody-drug conjugates (ADCs) are a novel class of anti-tumor agents composed of a targeted monoclonal antibody, a cytotoxic drug, and a linker connecting the two. They combine the high specificity of antibodies with the potent cytotoxicity of chemotherapeutic agents. Triple-negative breast cancer (TNBC) is characterized by high aggressiveness, elevated risks of recurrence and metastasis, and poor prognosis, largely due to the lack of effective therapeutic targets. This review summarizes the research progress of ADCs in the treatment of TNBC. It has been found that ADCs targeting human epidermal growth factor receptor 2 (such as trastuzumab deruxtecan), trophoblast cell surface antigen 2 (such as sacituzumab govitecan and datopotamab deruxtecan), zinc transporter LIV-1 (such as ladiratuzumab vedotin), HER-3 (such as patritumab deruxtecan), epidermal growth factor receptor (such as AVID100), and glycoprotein non-metastatic melanoma protein B (such as glembatumumab vedotin) have all demonstrated promising therapeutic effects against TNBC. Despite challenges including acquired resistance and treatment-related toxicities, ADCs are undoubtedly reshaping the therapeutic landscape for TNBC and are expected to occupy a more central position in TNBC treatment in the future.
10.Reevaluation of systematic evluation of Xianling gubao capsules for knee osteoarthritis
Dongdong CAO ; Jixin CHEN ; Weijie YU ; Tianci GUO ; Yu ZHANG ; Puyu NIU ; Aifeng LIU
China Pharmacy 2025;36(2):232-238
OBJECTIVE To conduct a reevaluation of the systematic review (SR)/meta-analysis on the use of Xianling gubao capsules (XLGBC) for knee osteoarthritis (KOA), and provide evidence-based support for the clinical use of the drugs. METHODS Computerized searches including CNKI, Wanfang Data, VIP, China Biomedical Literature Database, the Cochrane Library, PubMed, Embase and Web of Science were conducted to collect systematic reviews (SR) or meta-analyses of XLGBC for the treatment of KOA from the inception to May 31st, 2024. The report quality, methodological quality, risk of bias and evidence quality were assessed using the PRISMA 2020 statement, AMSTAR 2 scale, ROBIS tool and GRADE tool, respectively. A comprehensive quality analysis of the quantitative results from the SR/meta-analysis was also performed. RESULTS A total of five SR/meta-analyses were included. The evaluation results based on the PRISMA 2020 statement showed that one study report was relatively complete (21 points), while four studies had deficiencies (18-20 points). The assessment using the AMSTAR 2 scale indicated that the methodological quality of all five studies was rated as very low. According to the ROBIS tool evaluation, the risk of comprehensive bias in all five studies was classified as high. GRADE tool evaluation revealed that among 49 outcome indicators, 5 (10.2%) were rated as moderate-quality evidence (10.2%), 12 as low-quality evidence (24.5%), and 32 as very low-quality evidence (65.3%). The results of comprehensive quality analysis showed that the clinical efficacy, visual analogue scale score, pain relief time, comprehensive indexes of knee joint function, the levels of inflammatory factors and the incidence of adverse events in patients with XLGBC combined with conventional treatment were significantly better than conventional treatment alone (P<0.05). CONCLUSIONS Compared with conventional treatment, XLGBC in combination with conventional treatment for KOA may have some efficacy and safety advantages. However, due to the low quality of evidence for the outcome indicators included in the studies, the conclusions should be interpreted with caution.

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