Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective:To evaluate the efficacy of eradication therapy based on potassium-competitive acid blocker (P-CAB) for Helicobacter pylori( HP) infection in re-eradication therapy (the second-line therapy treatment after initial eradication failure of HP infection) and determine whether it can achieve the ideal eradication rate (90%). Methods:From January 2022 to December 2023, the clinical data of patients who received vonoprazan-based HP re-eradication therapy were collected in Department of Gastroenterology, the First Affiliated Hospital of Soochow University. The patients were divided into 4 groups according to their different HP treatment regimens, including VAMB group (vonoprazan 20 mg, quaque die( qd)+ amoxicillin 1 g, bis in die( bid)+ minocycline 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 156 cases), VA group (vonoprazan 20 mg, bid+ amoxicillin 1 g, ter in die( tid); 44 cases), VMFB group (vonoprazan 20 mg qd+ minocycline 100 mg, bid+ furazolidone 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 42 cases), and VAFB group (vonoprazan 20 mg, qd+ amoxicillin 1 g, bid+ furazolidone 100 mg, bid + potassium bismuth citrate 220 mg, bid; 13 cases). All the 4 groups of patients took the medication for 14 days. The 13C or 14C urea breath test would be conducted 4 weeks after the treatment. The overall eradication rate to evaluate the treatment efficacy. The eradication rate and adverse reaction rate were calculated for each group, and the eradication rates and adverse reaction rates between groups were compared using the chi-square test or Fisher′s exact test. Results:The total eradication rate of HP infection based on P-CAB therapy was 91.8% (234/255), and the total adverse reaction rate was 5.1% (13/255). The eradication rate and adverse reaction rate were 92.9% (145/156) and 3.2% (5/156) in the VAMB group, 84.1% (37/44) and 0 in the VA group 95.2% (40/42) and 11.9% (5/42) in the VMFB group, 12/13 and 3/13 in the VAFB group, respectively. Additionally, there was no statistical difference in the eradication rate among the 4 groups (Fisher′s exact test, P=0.227), but there was a statistical difference in the adverse reaction rates (Fisher′s exact test, P=0.002), and the adverse reaction rate of the VAFB group was higher than that of VAMB and VA groups and the differences were statistically significant (both Fisher′s excact test, P=0.016 and 0.010). Conclusions:The total HP re-eradication rate based on P-CAB therapies can reach 91.8%, achieving the ideal eradication rate of HP infection. The VA therapeutic regimen has the lowest incidence of adverse reactions, representing a novel therapeutic option for HP re-eradication.

This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans ; Nasal Cavity/surgery* ; Nasal Surgical Procedures ; China ; Consensus ; Sinusitis/surgery* ; Dermal Fillers

Objective:To explore the effects of smoking on peripheral regulatory T cells (Tregs), transforming growth factor beta1 (TGF-β 1) and interleukin-10 (IL-10) in elderly patients with non-small cell lung cancer (NSCLC). Methods:This was a cross-sectional study. A total of 43 elderly patients (≥60 years old) who were hospitalized in the Department of Geriatrics Medicine, Guangzhou First People′s Hospital from January 2018 to December 2024 and were newly diagnosed with NSCLC were recruited. According to smoking history, patients were divided into non-smoking group (15 cases), low smoking group (13 cases, smoking index<400) and high smoking group (15 cases, smoking index≥400). Venous blood samples were collected from participants, plasma and cells were separated. Flow cytometry was used to measure the proportions of Tregs and the expression of forkhead box P3 (Foxp3) in peripheral blood. Plasma levels of TGF-β 1 and IL-10 were measured by enzyme-linked immunosorbent assay. The effects of smoking on peripheral Tregs, TGF-β 1, and IL-10 in elderly patients with NSCLC were analyzed. Data were analyzed by one-way ANOVA, rank-sum test, and Fisher′s exact test. Results:The proportions of Tregs in non-smoking group, low smoking group and high smoking group were 2.50% (2.32%, 2.81%), 2.83% (2.48%, 3.72%), and 3.01% (2.37%, 3.73%), respectively, and there were no statistically significant differences among the three groups ( H=3.845, P>0.05). The proportions of Foxp3 +Tregs were (3.72±0.84)%, (4.64±1.10)%, and (4.68±1.27%), respectively. The mean fluorescence intensities (MFI) of Foxp3 were 123.0 (108.0, 128.0), 131.0 (123.5, 350.0), and 222.0 (141.0, 311.0), respectively. Both the proportions of Foxp3 +Tregs and the MFI of Foxp3 were higher in low smoking group and high smoking group than those in non-smoking group (all P<0.05). However, there were no significant differences between low smoking group and high smoking group (all P>0.05). The concentrations of IL-10 were 2.27 (1.42, 3.95), 3.42 (2.30, 5.08), and 3.26 (2.35, 6.28) ng/L, respectively. There were no statistically significant differences among the three groups ( H=2.930, P>0.05). The concentrations of TGF-β 1 were (10.72±9.37), (13.46±10.39), and (25.28±16.67) ng/ml, respectively. The concentration of TGF-β 1 in high smoking group was higher than that in non-smoking group and low smoking group (all P<0.05). However, there was no statistically significant difference between low smoking group and non-smoking group ( P>0.05). Conclusions:Smoking intensity may be correlated with the immunosuppressive function of Tregs in elderly patients with NSCLC. Higher smoking levels are associated with increased Foxp3 expression in Tregs and elevated plasma levels of TGF-β 1, potentially enhancing the immunosuppressive function of Tregs.

Objective:To compare the physical properties of three-dimensional porous scaffolds with varying concentrations of acellular cartilage matrix (ACM), and to identify an optimal plan for the constructing tissue-engineered cartilage.Methods:(1) The cartilage particles were obtained by sampling, freezing, and crushing bovine knee cartilage. (2) ACM from was extracted from bovine articular cartilage through trypsin digestion, nuclease digestion, washing, and purification of cartilage particles. (3) Three-dimensional porous scaffolds were constructed using different concentrations of ACM: group A (100%), group B (60%), and group C (30%). (4) The scaffolds underwent gross observation, histological evaluation, DNA quantification, microstructural analysis, and measurement of physical properties.Results:Histological analysis revealed no discernible cell morphology or residual cell fragments in the ACM scaffolds across all groups. Hematoxylin and eosin (HE) staining, along with Sirius red staining, indicating the presence of collagen, suggesting retention to a certain extent. DNA quantification demonstrated a residual DNA concentration of (1.103 ± 0.174) ng/mg, confirming that the scaffolds were completely acellular. Scanning electron microscopy showed that the pore diameter of scaffolds in groups A, B, and C significantly decreased with the increase of ACM concentration, with no significant differences among the groups. Physical parameters indicated that scaffold density, yield strength, and Young’s modulus in groups A, B, and C were positively correlated with ACM concentration, while water absorption and porosity were negatively correlated. The pore diameters of scaffolds in all three groups ranged between 100 and 200 μm, with porosity exceeding 80%. Additionally, the water absorption and expansion rates were all above 450%, meeting the requirements for tissue engineering scaffolds. The Young’s modulus for scaffolds in group A and group B was (4.440±0.340) MPa and (0.963±0.320) MPa, respectively, which approached the mechanical properties of normal human articular cartilage.Conclusion:The three-dimensional porous scaffolds constructed with ACM at 100% and 60% concentrations demonstrate high water absorption and expansion rate, porosity, pore diameter, and mechanical properties comparable to those of normal cartilage tissue, making them suitable alternatives for tissue-engineered cartilage construction.

OBJECTIVE This study investigated the clinical implications of endothelial cell-specific molecule 1(ESM-1)in obstructive sleep apnea(OSA)patients,with particular focus on its dynamic correlation with adhesion molecules,aiming to elucidate the regulatory role of ESM-1 in OSA-associated vascular endothelial impairment.METHODS This cross-sectional study enrolled participants undergoing polysomnography(PSG)at the Sleep Medicine Center of Beijing Anzhen Hospital,Capital Medical University between March 2017 and January 2018.Based on the inclusion criteria,161 participants were ultimately included and divided into OSA group(n=118)and control group(n=43).Demographic data and polysomnography parameters were collected.We used a powerful high-throughput Multiplex Immunobead Assay technology to simultaneously test plasm cytokines levels of ESM-1,inter-cellular adhesion molecule 1(ICAM-1),vascular cell adhesion molecule 1(VCAM-1).Circulating C-reactive protein(CRP)and homocysteine(Hcy)were detected by routine blood chemistry panel.RESULTS Circulating ESM-1 levels were significantly elevated in patients with OSA compared with healthy controls[819.73(612.36-1393.47)pg/ml]vs.[286.17(114.48-513.81)pg/ml,P<0.001].After adjusting for confounding factors,we found that circulating ESM-1 levels were an independent risk factor for OSA(odds ratio=2.162,95%CI=1.522-3.072,P<0.001)and circulating ESM-1 levels were positively associated with ICAM-1 and VCAM-1 levels(β=1.977,95%CI=1.429-2.734,P<0.001).CONCLUSION Circulating ESM-1 levels were significantly increased in patients with OSA,which is closely related with adhesion molecules levels.ESM-1 may be a surrogate endothelial dysfunction marker and an independent risk factor for OSA.

Objective:To evaluate the efficacy of eradication therapy based on potassium-competitive acid blocker (P-CAB) for Helicobacter pylori( HP) infection in re-eradication therapy (the second-line therapy treatment after initial eradication failure of HP infection) and determine whether it can achieve the ideal eradication rate (90%). Methods:From January 2022 to December 2023, the clinical data of patients who received vonoprazan-based HP re-eradication therapy were collected in Department of Gastroenterology, the First Affiliated Hospital of Soochow University. The patients were divided into 4 groups according to their different HP treatment regimens, including VAMB group (vonoprazan 20 mg, quaque die( qd)+ amoxicillin 1 g, bis in die( bid)+ minocycline 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 156 cases), VA group (vonoprazan 20 mg, bid+ amoxicillin 1 g, ter in die( tid); 44 cases), VMFB group (vonoprazan 20 mg qd+ minocycline 100 mg, bid+ furazolidone 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 42 cases), and VAFB group (vonoprazan 20 mg, qd+ amoxicillin 1 g, bid+ furazolidone 100 mg, bid + potassium bismuth citrate 220 mg, bid; 13 cases). All the 4 groups of patients took the medication for 14 days. The 13C or 14C urea breath test would be conducted 4 weeks after the treatment. The overall eradication rate to evaluate the treatment efficacy. The eradication rate and adverse reaction rate were calculated for each group, and the eradication rates and adverse reaction rates between groups were compared using the chi-square test or Fisher′s exact test. Results:The total eradication rate of HP infection based on P-CAB therapy was 91.8% (234/255), and the total adverse reaction rate was 5.1% (13/255). The eradication rate and adverse reaction rate were 92.9% (145/156) and 3.2% (5/156) in the VAMB group, 84.1% (37/44) and 0 in the VA group 95.2% (40/42) and 11.9% (5/42) in the VMFB group, 12/13 and 3/13 in the VAFB group, respectively. Additionally, there was no statistical difference in the eradication rate among the 4 groups (Fisher′s exact test, P=0.227), but there was a statistical difference in the adverse reaction rates (Fisher′s exact test, P=0.002), and the adverse reaction rate of the VAFB group was higher than that of VAMB and VA groups and the differences were statistically significant (both Fisher′s excact test, P=0.016 and 0.010). Conclusions:The total HP re-eradication rate based on P-CAB therapies can reach 91.8%, achieving the ideal eradication rate of HP infection. The VA therapeutic regimen has the lowest incidence of adverse reactions, representing a novel therapeutic option for HP re-eradication.

Objective:To compare the physical properties of three-dimensional porous scaffolds with varying concentrations of acellular cartilage matrix (ACM), and to identify an optimal plan for the constructing tissue-engineered cartilage.Methods:(1) The cartilage particles were obtained by sampling, freezing, and crushing bovine knee cartilage. (2) ACM from was extracted from bovine articular cartilage through trypsin digestion, nuclease digestion, washing, and purification of cartilage particles. (3) Three-dimensional porous scaffolds were constructed using different concentrations of ACM: group A (100%), group B (60%), and group C (30%). (4) The scaffolds underwent gross observation, histological evaluation, DNA quantification, microstructural analysis, and measurement of physical properties.Results:Histological analysis revealed no discernible cell morphology or residual cell fragments in the ACM scaffolds across all groups. Hematoxylin and eosin (HE) staining, along with Sirius red staining, indicating the presence of collagen, suggesting retention to a certain extent. DNA quantification demonstrated a residual DNA concentration of (1.103 ± 0.174) ng/mg, confirming that the scaffolds were completely acellular. Scanning electron microscopy showed that the pore diameter of scaffolds in groups A, B, and C significantly decreased with the increase of ACM concentration, with no significant differences among the groups. Physical parameters indicated that scaffold density, yield strength, and Young’s modulus in groups A, B, and C were positively correlated with ACM concentration, while water absorption and porosity were negatively correlated. The pore diameters of scaffolds in all three groups ranged between 100 and 200 μm, with porosity exceeding 80%. Additionally, the water absorption and expansion rates were all above 450%, meeting the requirements for tissue engineering scaffolds. The Young’s modulus for scaffolds in group A and group B was (4.440±0.340) MPa and (0.963±0.320) MPa, respectively, which approached the mechanical properties of normal human articular cartilage.Conclusion:The three-dimensional porous scaffolds constructed with ACM at 100% and 60% concentrations demonstrate high water absorption and expansion rate, porosity, pore diameter, and mechanical properties comparable to those of normal cartilage tissue, making them suitable alternatives for tissue-engineered cartilage construction.

Objective:To explore the effects of smoking on peripheral regulatory T cells (Tregs), transforming growth factor beta1 (TGF-β 1) and interleukin-10 (IL-10) in elderly patients with non-small cell lung cancer (NSCLC). Methods:This was a cross-sectional study. A total of 43 elderly patients (≥60 years old) who were hospitalized in the Department of Geriatrics Medicine, Guangzhou First People′s Hospital from January 2018 to December 2024 and were newly diagnosed with NSCLC were recruited. According to smoking history, patients were divided into non-smoking group (15 cases), low smoking group (13 cases, smoking index<400) and high smoking group (15 cases, smoking index≥400). Venous blood samples were collected from participants, plasma and cells were separated. Flow cytometry was used to measure the proportions of Tregs and the expression of forkhead box P3 (Foxp3) in peripheral blood. Plasma levels of TGF-β 1 and IL-10 were measured by enzyme-linked immunosorbent assay. The effects of smoking on peripheral Tregs, TGF-β 1, and IL-10 in elderly patients with NSCLC were analyzed. Data were analyzed by one-way ANOVA, rank-sum test, and Fisher′s exact test. Results:The proportions of Tregs in non-smoking group, low smoking group and high smoking group were 2.50% (2.32%, 2.81%), 2.83% (2.48%, 3.72%), and 3.01% (2.37%, 3.73%), respectively, and there were no statistically significant differences among the three groups ( H=3.845, P>0.05). The proportions of Foxp3 +Tregs were (3.72±0.84)%, (4.64±1.10)%, and (4.68±1.27%), respectively. The mean fluorescence intensities (MFI) of Foxp3 were 123.0 (108.0, 128.0), 131.0 (123.5, 350.0), and 222.0 (141.0, 311.0), respectively. Both the proportions of Foxp3 +Tregs and the MFI of Foxp3 were higher in low smoking group and high smoking group than those in non-smoking group (all P<0.05). However, there were no significant differences between low smoking group and high smoking group (all P>0.05). The concentrations of IL-10 were 2.27 (1.42, 3.95), 3.42 (2.30, 5.08), and 3.26 (2.35, 6.28) ng/L, respectively. There were no statistically significant differences among the three groups ( H=2.930, P>0.05). The concentrations of TGF-β 1 were (10.72±9.37), (13.46±10.39), and (25.28±16.67) ng/ml, respectively. The concentration of TGF-β 1 in high smoking group was higher than that in non-smoking group and low smoking group (all P<0.05). However, there was no statistically significant difference between low smoking group and non-smoking group ( P>0.05). Conclusions:Smoking intensity may be correlated with the immunosuppressive function of Tregs in elderly patients with NSCLC. Higher smoking levels are associated with increased Foxp3 expression in Tregs and elevated plasma levels of TGF-β 1, potentially enhancing the immunosuppressive function of Tregs.