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Volume 32 ， Issue 2 ， 2026
Feature Article
- Abstract：Objective:To evaluate the effect and safety of Chinese herbal compound Huashi Tongbi Formula(HTF) for the treatment of erectile dysfunction (ED) with damp heat affecting Pi (Spleen) pattern, and explore the possible mechanisms based on the analysis of gut microbiota.Methods:In this multicentre, randomized, parallel, positive control, noninferiority trial, a total of 162 ED patients with damp heat affecting Pi pattern were randomly divided into a treatment group (108 patients) and a control group (54 patients) in a 2:1 ratio using a random number table method. The treatment group was administered HTF granules (1 bag each time, twice a day). The control group was given sildenafil citrate tablets (50 mg, orally as needed). Both groups were treated for 8 weeks with a 8-week followed-up period. The main indicator was effective rate after 8-week treatment analysed using intention-to-treat (ITT) and per-protocol (PP) methods, and the secondary indicators included International Index of Erectile Function-5 (IIEF-5) score, Erectile Quality Score (EQS), and Chinese medicine syndrome (CMS) score, which were analysed using ITT every 2 weeks during 8-week treatment period, and every 4 weeks during 8-week follow-up period. The 16S rDNA sequencing was used to analyse the impact of HTF on the gut microbiota. The adverse events (AEs) and changes in safety indicators of the two groups were recorded.Results:A total of 162 patients were included in the ITT analysis, with 23 patients dropping out during the trial period (12 in the treatment group and 11 in the control group), and 139 patients were included in the PP analysis. ITT and PP analyses revealed that after 8-week treatment the difference and 95% confidence intervals (CIs) in the effective rates between the treatment and the control groups were –3.7% (–17.9%, 10.5%) and –4.5% (–18.2%, 9.2%), respectively. At 2 weeks of treatment, the treatment group showed lower IIEF-5 and EQS scores but higher CMS score vs. control (P<0.05); at 4 weeks, IIEF-5 remained lower (P<0.05), while EQS and CMS scores were comparable (P>0.05); by 6 weeks, all scores (IIEF-5, EQS, CMS) were similar between groups (P>0.05); at 8 weeks, IIEF-5 and EQS were comparable, but CMS scores were lower (P<0.05). During 4- and 8-week follow-up, the treatment group had higher IIEF-5 and EQS scores and lower CMS scores (P<0.05). Both groups showed significant improvements in all scores from baseline (P<0.05). There was no significant difference in the safety indicators between groups (P>0.05). After HTF treatment, the relative abundances of Lachnospiraceae and Blautia increased, contributing the most to the differences in the microbial communities between groups. The abundances of Levilactobacillus and Lactiplantibacillus increased, whereas the abundances of Bilophila, Saccharimonadia, Patescibacteria, and others decreased in the treatment group (linear discriminant analysis score>2). Nine predictive functions of the gut microbiota including amino acid related enzymes, exosome, mitochondrial biogenesis, etc. were reduced, whereas protein kinase function increased in the treatment group(P<0.05).Conclusion:HTF showed noninferior efficacy to sildenafil for ED with damp heat affecting Pi pattern, with the advantages of relieving overall symptoms and stable and lasting therapeutic effect after discontinuation, potentially mediated by gut microbiota modulation. (Registration No. ChiCTR2300067825)Keywords：Huashi Tongbi Formula;Chinese medicine;erectile dysfunction;gut microbiota;noninferiority;randomized controlled trials0|0|0Updated：2026-02-14
- Abstract：Objectives:To explore the effect of Pollen Pini (PP) on SMMC-7721 hepatoma cells.Methods:The anti-proliferative effects of PP on SMMC-7721 cells were evaluated using cell counting kit-8 assay following 48 h treatment with concentrations ranging from 1.25 to 37.50 μg/μL. Flow cytometry analysis at the half maximal inhibitory concentration (IC50) revealed significant apoptosis induction and cell cycle alterations. For in vivo evaluation, SMMC-7721 xenograft-bearing nude mice were administered either vehicle (0.9% NaCl) or PP(500 mg/kg) via intraperitoneal injection every other day for 3 weeks. Subsequent tumor analysis included mass spectrometry-based proteomics and examination of phosphoinositide-3 kinase (PI3K)/protein kinase B (Akt)/Myc pathway proteins by immunohistochemistry and Western blot. Combination therapy with 25 μmol/L PI3K inhibitor and PP (IC50) showed optimal efficacy, with Western blot revealing maximal protein modulation at 24 h.Results:PP had an anti-tumor effect on SMMC-7721 cells in vitro, with the IC50 concentration of 18.94 mg/mL. PP could promote the death of SMMC-7721 cells (P<0.01) and regulate the cell cycle more in G0/G1 phase cells (P<0.01). After the treatment effect of PP, the protein content of SMMC-7721 cells changed and the contents of cancer-promoting proteins PI3K, Akt and Myc decreased (P<0.01). PI3K inhibitor could reduce the proliferation of SMMC-7721 cells, and PI3K inhibitor combined with PP significantly reduced the expression of PI3K in SMMC-7721 cells(P<0.01).Conclusion:PP has an anti-tumor effect on SMMC-7721 cells through the PI3K-Akt signaling pathway.Keywords：Pollen Pini;Chinese medicine;SMMC-7721;anti-tumor effect;phosphoinositide-3 kinase;protein kinase B0|0|0Updated：2026-02-14
- Abstract：Objective:To investigate the anticancer activity of curzerene in colorectal cancer (CRC) in vitro and in vivo models.Methods:HT29 and HCT8 cells were treated with different concentrations of curzerene(0, 20, 40, and 60 μg/mL) for 24 h. Cell viability was assessed using cell counting kit 8 assay, and cell proliferation was detected by colony-formation, then apoptosis rate was assessed by flow cytometry analysis. Mitochondrial membrane potential was measured using JC-1 assay kit. Intracellular calcium levels were examined using Fluo-3AM and Mag-fluo-3AM staining. Different inhibitors of cell death, including 3-methyladenine (3-MA), cloroquine (CQ), Nec-1, and carbobenzoxy-valyl-alanylaspartyl-[O-methyl]-fluoromethylketone (Z-VAD-FMK), were also utilised to validate the death mechanisms. The binding ability of curzerene to mitogen-activated extracellular signal-regulated kinase (MEK) proteins was investigated by molecular docking. In addition, the expression of key proteins such as phosphated MEK (p-MEK), phosphated extracellular regulated protein kinase (p-ERK), B-cell lymphoma-2 (Bcl-2), Bcl associated X (Bax), poly ADP-ribose polymerase (PARP) and cleaved PARP were analysed by Western blot. Finally the viable HT29 cells were injected subcutaneously into the right dorsolateral abdomen of male BALB/c nude mice for in vivo potency assessment.Results:Curzerene inhibited proliferation and induced apoptosis in HT29 and HCT8 cells in a time- and dose-dependent manner (all P<0.05). Subsequently, we demonstrated that the apoptosis inhibitor Z-VAD-FMK (P<0.05), but not 3-MA, CQ or necrostatin-1, rescued cells from curzerene-induced death. Compared with the control group, 60 μg/mL curzerene increased the expression of cleaved PARP by affecting intracellular calcium distribution, reactive oxygen species (all P<0.01), decreasing mitochondrial membrane potential and the expressions of p-MEK, p-ERK, Bcl-2, and PARP (all P<0.05), and additionally increased the expression of cleaved PARP with a molecular binding energy of –7.1 kcal/mol. The results showed that curzerene treatment inhibited the activation of MEK/ERK signaling pathway, and pretreatment with the MEK activator C16-PAF significantly alleviated curzerene-induced cell death (all P<0.05). The results of in vivo experiments showed that curzerene significantly inhibited the growth of subcutaneous transplantation tumours in hormonal nude mice.Conclusion:Curzerene induces apoptosis in CRC cells through inhibition of the MEK/ERK signaling pathway, which will hopefully be a potential chemotherapeutic agent for treating CRC patients.Keywords：curzerene;colorectal cancer;mitogen-activated extracellular signal-regulated kinase;extracellular regulated protein kinase;apoptosis;Chinese medicine0|0|0Updated：2026-02-14
- Abstract：Objective:To elucidate the effect of hydroxychavicol (HC) in combination with 5-fluorouracil(5-FU) on purine metabolism and apoptosis in colorectal cancer cell lines HT-29 and DLD-1.Methods:The viability of HT-29 and DLD-1 cells when treated with HC, (0–1,000 μmol/L) 5-FU (0–100 μmol/L) alone, and HC+5-FU for 24 and 48 h was determined. Hypoxanthine (HPX) and xanthine oxidoreductase (XOR) were evaluated, as well as reactive oxygen species (ROS) levels and mitochondrial membrane potential (MMP). The expression levels of genes including nucleoside transporters equilibrative nucleotide transport 1 and 2 (ENT1 and ENT2), the pro-apoptotic gene Caspase-3 (CASP3), and the anti-apoptotic gene BCL2 were analysed by quantitative polymerase chain reaction.Results:Both HPX and XOR levels in cells treated with HC+5-FU were significantly decreased(P<0.05) after 24 and 48 h compared to control cells. ROS levels in HT-29 and DLD-1 treated with HC+5-FU for 24 and 48 h were 26.2% and 21.4%, and 9.1% and 20.5%, respectively, significantly lower than control cells. MMP assays indicated mitochondrial depolarisation. In HT-29 cells, ENT1 and BCL2 were downregulated at 24 h, and CASP3 was upregulated at 48 h. In DLD-1 cells, ENT1 and ENT2 were downregulated, while CASP3 showed a transient decrease at 24 h.Conclusions:The combination of HC + 5-FU demonstrated synergistic effects in HT-29 and DLD-1 cells, disrupting oxidative balance and purine metabolism, as reflected in reduced hypoxanthine levels, XOR activity, and ROS production. This treatment also induced mitochondrial membrane depolarisation and altered apoptosis-related gene expression, supporting its role in apoptosis induction.Keywords：apoptosis;colorectal cancer;hydroxychavicol;purine metabolism;5-fluorouracil0|0|0Updated：2026-02-14
- Abstract：Objective:To investigate the effect and mechanism of panaxadiol saponin component (PDS-C) in radiation-induced cardiac injury (RIHD).Methods:BALB/c mice were radiated by X-ray to establish RIHD mouse models, and randomly divided into 3 groups by using a random number table method (n=10 in each group): the mice in the normal control and RIHD model groups received normal saline, and the PDS-C group was treated with PDS-C(80 mg/kg) for 12 weeks. Cardiac function was observed by ultrasound imaging; serum myocardial enzymes were tested; and pathological examination of cardiac tissue was performed. Differentially transcribed genes of cardiac tissue were analyzed between normal and RIHD mice. The expression levels of inflammatory factors and fibrotic proteins were detected by immunohistochemistry, immunohistofluorescence and Western blot, respectively. Irradiation H9c2 cells were incubated by PDS-C (20, 40, 80 mg/L) for detecting inflammatory factors and fibrotic proteins. Irradiation H9c2 cells were incubated by both phorbol 12-myristate 13-acetate (PMA) as nuclear factor κB (NF-κB) activator and BAY11-7082 as inhibitor to verify the effects of PDS-C on NF-κB transcription factor.Results:Differentially expressed genes between normal and RIHD mice were involved mainly in the NF-κB transcription factor, which is related to cardiac inflammation. PDS-C effectively increased the cardiac ejection fraction and fractional shortening (P<0.05), but decreased the levels of the myocardial enzymes aspartate aminotransferase, creatine kinase, creatine kinase isoenzyme and lactate dehydrogenase in RIHD mice (P<0.05). Pathological examination of cardiac tissue revealed obvious edema, severe necrosis, and nuclear pyknosis in RIHD mice; however, PDS-C clearly alleviated the extent of cardiac damage. Furthermore, PDS-C downregulated interleukin (IL)-1, IL-6, Smad2, connective tissue growth factor, collagen Ⅱ and NF-κB (P<0.05). Cytological experiments revealed that PDS-C decreased reactive oxygen species levels in irradiated H9C2 cells (P<0.05), and the expressions of the above inflammatory factors and fibrosis-related proteins were consistent with the results in mouse models.Conclusion:PDS-C showed cardioprotective effect in alleviating inflammation and fibrosis through inhibition of the NF-κB signaling pathway.Keywords：panaxadiol saponin;Chinese medicine;radiation-induced heart injury;fibrosis;nudear factor-κB signaling pathway0|0|0Updated：2026-02-14
Original Article
- Abstract：Background:Lung cancer remains one of the most malignant cancers worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all cases. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are recommended as first-line treatments for advanced EGFR-mutated NSCLC. Classical Chinese herb formulas have shown potential clinical benefits in NSCLC management. However, few studies have systematically compared the efficacy and safety of EGFR-TKIs monotherapy versus EGFR-TKIs combined with classical Chinese herb formulas.Objective:To evaluate the efficacy and safety of EGFR-TKIs monotherapy versus EGFR-TKIs combined with classical Chinese herb formulas in the treatment of NSCLC.Methods:A systematic search was conducted to identify randomized controlled trials (RCTs) in which patients with NSCLC were randomly assigned to receive either EGFR-TKIs monotherapy or EGFR-TKIs combined with classical Chinese herbal formulas. The combined regimens include EGFR-TKIs plus Chinese herbal compounds (CHCT), EGFR-TKIs plus Chinese traditional medicine injections (CTMIT), and EGFR-TKIs plus Chinese patent medicines (CPMT). Electronic databases search included PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang Data, VIP Database, the International Clinical Trial Registry Platform, and the Chinese Clinical Trial Registry, from inception updated to February 26, 2025. Given that all outcomes were binary, odds ratios (ORs) along with 95% confidence intervals (CIs) were computed. Pairwise comparisons and Bayesian network meta-analyses were used for the same outcome assessment, including progressive disease (PD), disease control rate (DCR), objective response rate (ORR), rash, diarrhea, and drug-induced liver injury (DILI) with the former reporting ORs and 95% CIs while the latter ORs and 95% credible intervals (CrIs).Resuts:A total of 155 RCTs involving 12,441 patients with NSCLC were included. For efficacy outcomes, EGFR-TKIs monotherapy was associated with a higher risk of PD compared with CHCT (OR: 2.43, 95% CrI: 2.11–2.76), CTMIT (OR: 2.98, 95% CrI: 2.47–3.58), and CPMT(OR: 1.94, 95% CrI: 1.44–2.64) combination therapies, while CPMT was associated with a lower risk of PD than CTMIT (OR: 0.65, 95% CrI: 0.46–0.94). In terms of ORR, CHCT (OR: 0.53, 95% CrI: 0.47–0.59), CTMIT (OR: 0.43, 95% CrI: 0.36–0.50), and CPMT(OR: 0.52, 95% CrI: 0.40–0.68) combination therapies all demonstrated significantly higher ORR than EGFR-TKIs monotherapy, with CTMIT also showing a higher ORR compared with CHCT (OR: 0.81, 95% CrI:0.67–0.99). For DCR, combination therapy with CHCT(OR: 0.39, 95% CrI: 0.34–0.46), CTMIT (OR: 0.33,95% CrI: 0.26–0.42), and CPMT (OR: 0.57, 95% CrI: 0.41–0.77) combination therapies were superior to EGFR-TKIs monotherapy, and both CHCT (OR: 1.44, 95% CrI:1.01–2.05) and CTMIT (OR: 1.70, 95% CrI: 1.16–2.50) showed better DCR than CPMT. For safety outcomes, EGFR-TKIs monotherapy was associated with a higher incidence of rash compared with CHCT (OR: 1.82, 95% CrI:1.46–2.30) and CTMIT (OR: 1.55, 95% CrI: 1.01–2.41) combination therapies, a higher incidence of diarrhea compared with CHCT (OR: 2.52, 95% CrI: 1.99–3.21) and CPMT (OR: 2.56, 95% CrI: 1.43–4.58), and a higher incidence of DILI compared with CHCT (OR: 2.02, 95% CrI: 1.33–3.13).Conclusions:This study provides evidence to support the potential value of combining Chinese herbal formulas with EGFR-TKIs in the treatment of NSCLC, aligning with current clinical guidelines. The findings indicate that EGFR-TKIs combined with Chinese herbal formulas (CHCT, CTMIT, CPMT) are associated with higher ORR and DCR, and a lower risk of PD, compared with EGFR-TKIs monotherapy. Additionally, CHCT may reduce the incidence of rash in EGFR-TKIs treated patients. Further well-designed RCTs are warranted to compare the efficacy and safety of different combined therapeutic strategies in NSCLC patients. (Registration No. CRD42024521654)Keywords：Chinese herbal drug;epidermal growth factor receptor tyrosine kinase inhibitor;integrative medicine;network meta-analysis;non-small cell lung cancer1|0|0Updated：2026-02-14
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