1.Clinical Efficacy of Gandou Fumu Decoction in Treating Hepatolenticular Degeneration with Liver Fibrosis of Liver-kidney Deficiency and Phlegm-blood Stasis Syndrome
Pingping YANG ; Meixia WANG ; Changchang CAO ; Zhuang TAO ; Jiang DU ; Yun XU ; Wenming YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):182-191
ObjectiveThis paper aims to evaluate the intervention effect of Gandou Fumu Decoction (GDFMD) in treating hepatolenticular degeneration with liver fibrosis of liver-kidney deficiency and phlegm-blood stasis syndrome, thereby providing evidence-based medical evidence for the treatment of Wilson's disease (WD)-related liver fibrosis with traditional Chinese medicine through clinical efficacy analysis. MethodsA total of 70 patients with WD-related liver fibrosis of liver-kidney deficiency and phlegm-blood stasis syndrome meeting the inclusion criteria were enrolled from Anhui Provincial Hospital of TCM from October 1, 2023, to October 1, 2024. Participants were divided into a control group and an observation group, with 35 cases in each group. The control group received conventional copper chelation therapy with sodium dimercaptopropanesulfonate (DMPS). On this basis, the observation group was additionally administered GDFMD orally. Each treatment course lasted eight days, for a total of four treatment courses. Efficacy evaluations were performed before treatment and after the second and fourth treatment courses, respectively. The clinical efficacy and safety of GDFMD in the treatment of WD-related liver fibrosis were assessed by comparing the changes in liver stiffness measurement (LSM), liver serological markers [alanine aminotransferase (ALT), aspartate aminotransferase (AST), type Ⅳ collagen (C-Ⅳ), laminin (LN), N-terminal propeptide of type Ⅲ procollagen (PⅢNP), and hyaluronic acid (HA)], fibrosis index based on 4 factors (FIB-4), AST to platelet ratio index (APRI), unified Wilson's disease rating scale part Ⅱ (UWDRS-Ⅱ), traditional Chinese medicine (TCM) syndrome score, 24-hour urinary copper, and safety indicators between the two groups before and after treatment. ResultsCompared with those before treatment, LSM levels decreased in both groups after two and four treatment courses (P<0.05). Compared with those after treatment, there was no statistically significant difference in the improvement of LSM levels in the observation group after two treatment courses, and the improvement of LSM levels in the observation group was more obvious after four treatment courses (P<0.05). Compared with those before treatment, the levels of HA, LN, PⅢNP, and C-Ⅳ decreased in both groups after two and four treatment courses (P<0.05). Compared with those after treatment, there was no statistically significant difference in the improvement of the C-Ⅳ levels in the observation group after two treatment courses, and the levels of HA, LN, and PⅢNP were more obvious (P<0.05). After four treatment courses in the observation group, the levels of HA, LN, PⅢNP, and C-Ⅳ were improved more significantly (P<0.05). Compared with those before treatment, ALT and AST levels decreased in both groups after two and four treatment courses (P<0.05). Compared with the control group after treatment, there was no statistically significant difference in the improvement of ALT and AST levels in the observation group after two treatment courses, and the improvement of ALT and AST levels in the observation group was more obvious after four treatment courses (P<0.05). Compared with those before treatment, APRI score and FIB-4 index level decreased in both groups after two and four treatment courses (P<0.05). Compared with those in control group after treatment, there was no statistically significant difference in the improvement of APRI score and FIB-4 index level in the observation group after two treatment courses, and the APRI score in the observation group was more obvious after four treatment courses (P<0.05), with no statistically significant improvement in the FIB-4 index difference. Compared with those before treatment, the levels of TCM syndrome scores decreased in both groups after two and four treatment courses (P<0.05). Compared with that of the control group after treatment, there was no statistically significant difference in the improvement of the level of TCM syndrome scores in the observation group after two treatment courses, and the improvement of the level of TCM syndrome scores in the observation group was more obvious after four treatment courses (P<0.05). Compared with those before treatment, the UWDRS-Ⅱ scores in both groups after two treatment courses were not improved obviously, and the UWDRS-Ⅱ scores in both groups decreased after four treatment courses (P<0.05). Compared with those of the control group after treatment, there was no statistically significant difference in the improvement of the UWDRS-Ⅱ scores in the observation group after two treatment courses, and the improvement of the UWDRS-Ⅱ scores in the observation group after four treatment courses was more obvious (P<0.05). Compared with those before treatment, the 24-h urine copper levels were significantly higher in both groups after two and four treatment courses (P<0.05). Compared with those in the control group after treatment, the 24-h urine copper levels in the observation group were significantly higher after two and four treatment courses (P<0.01). After two treatment courses, the 24-h urine copper level in the observation group showed a gradual decreasing trend, although it was higher than that before treatment. After four treatment courses, the control group had an improvement rate of 91.43%, an effective rate of 34.29%, and an apparent rate of 2.86%. The observation group had an improvement rate of 94.29%, an effective rate of 71.43%, and an apparent rate of 8.57%. The efficacy of the observation group was better than that of the control group (P<0.05). Conclusion① The efficacy of GDFMD combined with DMPS therapy in patients with WD-related liver fibrosis of liver-kidney deficiency and phlegm-blood stasis syndrome is significantly better than that of single DMPS therapy, and the advantages of the combined therapy are more obvious with the prolongation of the treatment cycle. ② GDFMD combined with the DMPS therapy program in the long-term application exhibits no obvious adverse reactions with good safety, which is worthy of clinical popularization and application.
2.Clinical Efficacy of Gandou Fumu Decoction in Treating Hepatolenticular Degeneration with Liver Fibrosis of Liver-kidney Deficiency and Phlegm-blood Stasis Syndrome
Pingping YANG ; Meixia WANG ; Changchang CAO ; Zhuang TAO ; Jiang DU ; Yun XU ; Wenming YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):182-191
ObjectiveThis paper aims to evaluate the intervention effect of Gandou Fumu Decoction (GDFMD) in treating hepatolenticular degeneration with liver fibrosis of liver-kidney deficiency and phlegm-blood stasis syndrome, thereby providing evidence-based medical evidence for the treatment of Wilson's disease (WD)-related liver fibrosis with traditional Chinese medicine through clinical efficacy analysis. MethodsA total of 70 patients with WD-related liver fibrosis of liver-kidney deficiency and phlegm-blood stasis syndrome meeting the inclusion criteria were enrolled from Anhui Provincial Hospital of TCM from October 1, 2023, to October 1, 2024. Participants were divided into a control group and an observation group, with 35 cases in each group. The control group received conventional copper chelation therapy with sodium dimercaptopropanesulfonate (DMPS). On this basis, the observation group was additionally administered GDFMD orally. Each treatment course lasted eight days, for a total of four treatment courses. Efficacy evaluations were performed before treatment and after the second and fourth treatment courses, respectively. The clinical efficacy and safety of GDFMD in the treatment of WD-related liver fibrosis were assessed by comparing the changes in liver stiffness measurement (LSM), liver serological markers [alanine aminotransferase (ALT), aspartate aminotransferase (AST), type Ⅳ collagen (C-Ⅳ), laminin (LN), N-terminal propeptide of type Ⅲ procollagen (PⅢNP), and hyaluronic acid (HA)], fibrosis index based on 4 factors (FIB-4), AST to platelet ratio index (APRI), unified Wilson's disease rating scale part Ⅱ (UWDRS-Ⅱ), traditional Chinese medicine (TCM) syndrome score, 24-hour urinary copper, and safety indicators between the two groups before and after treatment. ResultsCompared with those before treatment, LSM levels decreased in both groups after two and four treatment courses (P<0.05). Compared with those after treatment, there was no statistically significant difference in the improvement of LSM levels in the observation group after two treatment courses, and the improvement of LSM levels in the observation group was more obvious after four treatment courses (P<0.05). Compared with those before treatment, the levels of HA, LN, PⅢNP, and C-Ⅳ decreased in both groups after two and four treatment courses (P<0.05). Compared with those after treatment, there was no statistically significant difference in the improvement of the C-Ⅳ levels in the observation group after two treatment courses, and the levels of HA, LN, and PⅢNP were more obvious (P<0.05). After four treatment courses in the observation group, the levels of HA, LN, PⅢNP, and C-Ⅳ were improved more significantly (P<0.05). Compared with those before treatment, ALT and AST levels decreased in both groups after two and four treatment courses (P<0.05). Compared with the control group after treatment, there was no statistically significant difference in the improvement of ALT and AST levels in the observation group after two treatment courses, and the improvement of ALT and AST levels in the observation group was more obvious after four treatment courses (P<0.05). Compared with those before treatment, APRI score and FIB-4 index level decreased in both groups after two and four treatment courses (P<0.05). Compared with those in control group after treatment, there was no statistically significant difference in the improvement of APRI score and FIB-4 index level in the observation group after two treatment courses, and the APRI score in the observation group was more obvious after four treatment courses (P<0.05), with no statistically significant improvement in the FIB-4 index difference. Compared with those before treatment, the levels of TCM syndrome scores decreased in both groups after two and four treatment courses (P<0.05). Compared with that of the control group after treatment, there was no statistically significant difference in the improvement of the level of TCM syndrome scores in the observation group after two treatment courses, and the improvement of the level of TCM syndrome scores in the observation group was more obvious after four treatment courses (P<0.05). Compared with those before treatment, the UWDRS-Ⅱ scores in both groups after two treatment courses were not improved obviously, and the UWDRS-Ⅱ scores in both groups decreased after four treatment courses (P<0.05). Compared with those of the control group after treatment, there was no statistically significant difference in the improvement of the UWDRS-Ⅱ scores in the observation group after two treatment courses, and the improvement of the UWDRS-Ⅱ scores in the observation group after four treatment courses was more obvious (P<0.05). Compared with those before treatment, the 24-h urine copper levels were significantly higher in both groups after two and four treatment courses (P<0.05). Compared with those in the control group after treatment, the 24-h urine copper levels in the observation group were significantly higher after two and four treatment courses (P<0.01). After two treatment courses, the 24-h urine copper level in the observation group showed a gradual decreasing trend, although it was higher than that before treatment. After four treatment courses, the control group had an improvement rate of 91.43%, an effective rate of 34.29%, and an apparent rate of 2.86%. The observation group had an improvement rate of 94.29%, an effective rate of 71.43%, and an apparent rate of 8.57%. The efficacy of the observation group was better than that of the control group (P<0.05). Conclusion① The efficacy of GDFMD combined with DMPS therapy in patients with WD-related liver fibrosis of liver-kidney deficiency and phlegm-blood stasis syndrome is significantly better than that of single DMPS therapy, and the advantages of the combined therapy are more obvious with the prolongation of the treatment cycle. ② GDFMD combined with the DMPS therapy program in the long-term application exhibits no obvious adverse reactions with good safety, which is worthy of clinical popularization and application.
3.Analysis of the characteristics and risk factors of dyslipidemia in 315 children with Wilson disease
Yunyun XU ; Daiping HUA ; Shufan GE ; Qiaoyu XUAN ; Lanting SUN ; Wenming YANG ; Han WANG
Acta Universitatis Medicinalis Anhui 2026;61(9):1672-1678
ObjectiveTo analyze the lipid characteristics and related risk factors of children with Wilson disease (WD). MethodsThe clinical data of 315 children with WD and 248 healthy children who underwent physical examination were retrospectively collected. The differences in lipid levels between the two groups were compared. The WD group was divided into the normal lipid group (85 cases) and the dyslipidemia group (230 cases) according to lipid levels. General data and biochemical indicators were compared between the two groups, and multivariate Logistic regression analysis was used to analyze the independent risk factors for dyslipidemia in children with WD. ResultsThe incidence of dyslipidemia in children with WD was 73.0% (230/315), comprising 77 cases (33.5%) of hypertriglyceridemia, 11 cases (4.8%) of hypercholesterolemia, 104 cases (45.2%) of combined hyperlipidemia, 9 cases (3.9%) of hyperlipoprotein(a)emia, and 29 cases (12.6%) of hypoalphalipoproteinemia. There were statistically significant differences in age distribution among different types of dyslipidemia (P<0.05), whereas no significant differences were observed in gender distribution (P>0.05). Compared with the normal lipid group, the dyslipidemia group showed significantly higher levels of homocysteine, superoxide dismutase (SOD), platelet count (PLT), fibrinogen, alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transferase, uric acid, cystatin C (Cys-C), type IV collagen (C-IV), and laminin (all P<0.05). Multivariate Logistic regression analysis showed that C-IV (OR=5.037, 95% CI: 2.562-9.900), PLT (OR=2.297, 95% CI: 1.580-3.339), Cys-C (OR=2.008, 95% CI: 1.395-2.890), and SOD (OR=1.996, 95% CI: 1.342-2.970) were all independent risk factors for dyslipidemia in children with WD. ConclusionChildren with WD have a high incidence of dyslipidemia, which is dominated by combined hyperlipidemia and hypertriglyceridemia. C-IV, PLT, Cys-C, and SOD are independent risk factors for dyslipidemia in children with WD.
4.Gandouling Regulates PI3K/Akt/mTOR Autophagy Signaling Pathway via LncRNA H19 for Treatment of Wilson Disease Liver Fibrosis
Xin YIN ; Han WANG ; Daiping HUA ; Lanting SUN ; Yunyun XU ; Wenming YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):131-138
ObjectiveTo investigate the potential mechanisms and pathways through which Gandouling (GDL) exerts its effects in the treatment of liver fibrosis in Wilson disease. MethodsSixty male SD rats were randomly divided into six groups: the normal group, the model group, the GDL low-, medium-, and high-dose groups (0.24, 0.48, 0.96 g·kg-1), and the penicillamine group (90 mg·kg-1), with 10 rats in each group. A copper-loaded Wilson disease rat model was established by gavage administration of 300 mg·kg-1 copper sulfate pentahydrate to all groups except the normal group. Hematoxylin-eosin (HE) staining and Masson staining were used to observe the pathomorphological changes in the liver. Enzyme-linked immunosorbent assay (ELISA) was employed to measure the levels of hyaluronic acid (HA), laminin (LN), procollagen type-Ⅲ peptide (PC-Ⅲ), and collagen type-Ⅳ (C-Ⅳ). Transmission electron microscopy was used to examine the ultrastructure of liver tissues. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the expression levels of liver tissues and serum exosomal long noncoding RNA H19 (LncRNA H19), phosphatidylinositol 3-kinase (PI3K), protein kinase B (Akt), and mammalian target of rapamycin (mTOR). Western blot analysis was performed to assess the expression levels of PI3K, Akt, mTOR, and their phosphorylated forms, as well as autophagy-related proteins Beclin1 and microtubule-associated protein 1 light chain 3B (LC3-Ⅱ/LC3-Ⅰ) in liver tissues. Beclin1 and LC3-Ⅱ fluorescence signal intensity was observed by immunofluorescence. ResultsCompared with the normal group, the model group exhibited inflammatory cell infiltration in hepatocytes, unclear nuclear boundaries with cell cleavage and necrosis, and collagen fiber deposition around confluent areas. The levels of HA, LN, PC-Ⅲ, and C-Ⅳ were significantly elevated (P<0.01). Transmission electron microscopy revealed an increased number of autophagic vesicles, with autophagic lysosomes exhibiting a single-layer membrane structure following degradation of most envelopes. Expression levels of Beclin1 and LC3-Ⅱ/LC3-Ⅰ were significantly increased (P<0.01), and fluorescence signals of Beclin1 and LC3-Ⅱ were markedly enhanced. The protein expression levels of PI3K, Akt, mTOR, p-PI3K, p-Akt, and p-mTOR were reduced (P<0.01), while LncRNA H19 expression was increased (P<0.01), and mRNA expression levels of PI3K, Akt, and mTOR were decreased (P<0.01). After treatment with GDL, the degree of liver fibrosis was significantly improved, with decreased levels of HA, LN, PC-Ⅲ, and C-Ⅳ. The number of autophagic vesicles was significantly reduced, and expression levels of Beclin1 and LC3-Ⅱ/LC3-Ⅰ proteins were lower (P<0.01). The fluorescence signals of Beclin1 and LC3-Ⅱ weakened dose-dependently. The protein levels of PI3K, Akt, mTOR, p-PI3K, p-Akt, and p-mTOR were elevated (P<0.01), while the expression level of LncRNA H19 was reduced (P<0.01). Furthermore, the mRNA expression levels of PI3K, Akt, and mTOR increased (P<0.05, P<0.01). ConclusionGDL may alleviate liver fibrosis and reduce liver injury by regulating the PI3K/Akt/mTOR autophagy signaling pathway via LncRNA H19.
5.Value of serum TK1,HIF-1α and SCC levels in the diagnosis and prognosis of esophageal cancer
Haijun XU ; Honghong YANG ; Wenming LI ; Jun YU
International Journal of Laboratory Medicine 2025;46(11):1341-1346
Objective To investigate the value of serum thymidine kinase 1(TK1),hypoxia-inducible fac-tor-1α(HIF-1α)and squamous cell carcinoma antigen(SCC)in the diagnosis and prognosis of esophageal cancer.Methods A total of 105 patients with esophageal cancer treated in the Qinhuai Medical Zone of East-ern Theater General Hospital from February 2019 to October 2021 were selected as the study group,and 80 healthy subjects were selected as the control group during the same period.The serum levels of TK1,HIF-1αand SCC were compared between study group,control group and patients with different pathological charac-teristics.Patients with esophageal cancer were followed up for 3 years,and the overall survival(OS)and pro-gression-free survival(PFS)were recorded.Receiver operating characteristic curve was used to analyze the di-agnostic efficiency of serum TK1,HIF-1α and SCC combined detection for esophageal cancer,Pearson correla-tion analysis was used to analyze the correlation between the serum indicators,and Kaplan-Meier survival a-nalysis was used to analyze the OS and PFS of patients with different serum levels of TK1,HIF-1α and SCC.Multivariate COX regression was performed to analyze prognostic factors.Results Compared with the control group,the serum TK1,HIF-1α and SCC levels in the study group increased(P<0.05).The area under the curve(AUC)of serum TK1,HIF-1α,SCC alone and combined for diagnosis of esophageal cancer were 0.893,0.744,0.841,0.922,respectively,and their combined diagnoses of esophageal cancer had the largest AUC.Se-rum TK1,HIF-1α and SCC in patients with different TNM stages and differentiation stages were significantly different(P<0.05).Serum TK1,HIF-1α and SCC in patients with lymph node metastasis were higher than those without lymph node metastasis(P<0.05).Serum TK1 was positively correlated with HIF-1α and SCC levels in patients with esophageal cancer(P<0.05).The survival functions of OS and PFS in TK1,HIF-1αand SCC low expression group were better than those in high expression group(P<0.05).Multivariate COX regression analysis showed that low differentiation and lymph node metastasis were independent risk factors for poor prognosis in esophageal cancer patients(P<0.05).Conclusion Serum levels of TK1,HIF-1α and SCC are increased in patients with esophageal cancer,the combined diagnosis of the three is effective.The high expression of TK1 and HIF-1αand SCC will shorten OS and PFS.
6.Relationship between serum miR-9-5p,miR-21-5p and miR-206 and hemorrhagic transformation occurs and prognosis in patients with large artery atherosclerotic cerebral infarction after thrombolysis
Wenming XU ; Xing WEI ; Dacai GONG ; Bin GE ; Chunling GAO
International Journal of Laboratory Medicine 2025;46(16):1933-1940
Objective To investigate the relationship between serum microRNA(miRNA,miR)-9-5p,miR-21-5p and miR-206 and hemorrhagic transformation(HT)occurs and prognosis in patients with large ar-tery atherosclerotic cerebral infarction(ACI-LAA)after thrombolysis.Methods A total of 265 patients with ACI-LAA admitted to the hospital from April 2021 to November 2023 were selected as the research objects.According to whether HT occurred after intravenous thrombolysis,they were divided into non-HT group and HT group,and the expression levels of serum miR-9-5p,miR-21-5p and miR-206 were compared between the two groups.The general data of patients with ACI-LAA were collected.Univariate and multivariate Logistic regression analysis were used to analyze the influencing factors of HT occurs in patients with ACI-LAA after thrombolysis.The receiver operating characteristic(ROC)curve was used to analyze the efficacy of serum miR-9-5p,miR-21-5p and miR-206 expression levels in predicting HT occurs after thrombolysis in patients with ACI-LAA.The patients with ACI-LAA were followed up for 90 d.According to the modified Rankin scale(mRS)score,the patients were divided into a good prognosis group and a poor prognosis group,and the expression levels of serum miR-9-5p,miR-21-5p and miR-206 were compared between the two groups.Univa-riate and multivariate Logistic regression analysis were used to analyze the influencing factors of poor progno-sis in patients with ACI-LAA.ROC curve was used to analyze the efficacy of serum miR-9-5p,miR-21-5p and miR-206 expression levels in predicting poor prognosis of patients with ACI-LAA.Results HT occurred in 74(27.92%)of 265 patients with ACI-LAA after thrombolysis.Compared with the non-HT group,the National Institutes of Health Stroke Scale(NIHSS)score atadmission,the proportion of hypertension,the proportion of infarct size ≥10 cm2,and the expression levels of serum miR-21-5p and miR-206 were significantly in-creased in the HT group(P<0.05).However,the expression level of serum miR-9-5p was decreased(P<0.05).Hypertension,high NIHSS score at admission,the proportion of infarct size ≥10 cm2,high expression of miR-21-5p and miR-206 were risk factors for HT occurs in patients with ACI-LAA after intravenous thrombolysis,and high expression of miR-9-5p was a protective factor(P<0.05).The ROC curve showed that the area under the curve(AUC)and 95%CI of single and combined detection of serum miR-9-5p,miR-21-5p and miR-206 for predicting HT occurs were 0.796(0.726-0.866),0.779(0.711-0.846),0.784(0.714-0.854),0.891(0.839-0.943),respectively.Among 265 patients with ACI-LAA,83 patients(31.32%)had poor prognosis at 90 d of follow-up.Compared with the good prognosis group,the age,NIHSS score at admis-sion,the proportion of HT,the proportion of infarct size ≥10 cm2,and the expression levels of serum miR-21-5p and miR-206 were increased(P<0.05),and the expression level of serum miR-9-5p was decreased(P<0.05)in the poor prognosis group.Advanced age,high NIHSS score at admission,HT,infarct size ≥10 cm2,high expression of miR-21-5p,and high expression of miR-206 were risk factors for poor prognosis of ACI-LAA patients,and high expression of miR-9-5p was a protective factor(P<0.05).The ROC curve showed that The AUC(95%CI)of single and combined detection of serum miR-9-5p,miR-21-5p and miR-206 for predicting poor prognosis were 0.754(0.691-0.818),0.779(0.719-0.838),0.792(0.815-0.919),0.931(0.902-0.960),respectively.Conclusion Low expression of serum miR-9-5p,high expression of miR-21-5p and high expression of miR-206 are associated with the HT occurs and poor prognosis in patients with ACI-LAA after thrombolysis,and the combined detection of the three indicators has a high predictive value for the HT occurs and poor prognosis.
7.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
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.
8.Analysis of Muscle Synergies and Compensation Mechanisms in Thigh Amputees under Different Gait Patterns
Run ZHOU ; Yang LÜ ; Xiaoxu ZHANG ; Wenming CHEN ; Jian XU
Journal of Medical Biomechanics 2025;40(2):307-315
Objective To explore the differences in muscle synergies of healthy individuals,intact limbs and residual limbs of above-knee amputees under different gaits,provide references for electromyographic control of the prosthetics.Methods Surface electromyography(sEMG)signals of 7 muscles(4 thigh muscles,3 calf muscles)were collected from 7 healthy individuals and 3 lower-limb amputees during level walking,ascending/descending slopes,and ascending/descending stairs.Muscle synergy weights(W)and temporal activation coefficients(H)were extracted using concatenated non-negative matrix factorization(CNMF).The W matrices were compared using the coefficient of determination R2,and the activation coefficients were analyzed using statistical parametric mapping(SPM).Furthermore,peak activation and activation integral were used for hierarchical clustering analysis.Results The comparison of W matrices indicated a similar set of muscle synergies between the healthy group and the intact limb of amputees,whereas the residual limb showed greater variability in synergies.The analysis of H showed statistically significant differences in muscle activation throughout the gait cycle for all amputees.Clustering of time-domain features revealed that amputees exhibited higher activation integral and peak values in their intact limb during ascending slopes.Conclusions This study provides an in-depth investigation of the neuromuscular compensation strategies in lower-limb amputees under different gaits,offering theoretical insights for gait rehabilitation and assisting in the development of EMG-controlled prosthetics.
9.Analysis of Muscle Synergies and Compensation Mechanisms in Thigh Amputees under Different Gait Patterns
Run ZHOU ; Yang LÜ ; Xiaoxu ZHANG ; Wenming CHEN ; Jian XU
Journal of Medical Biomechanics 2025;40(2):307-315
Objective To explore the differences in muscle synergies of healthy individuals,intact limbs and residual limbs of above-knee amputees under different gaits,provide references for electromyographic control of the prosthetics.Methods Surface electromyography(sEMG)signals of 7 muscles(4 thigh muscles,3 calf muscles)were collected from 7 healthy individuals and 3 lower-limb amputees during level walking,ascending/descending slopes,and ascending/descending stairs.Muscle synergy weights(W)and temporal activation coefficients(H)were extracted using concatenated non-negative matrix factorization(CNMF).The W matrices were compared using the coefficient of determination R2,and the activation coefficients were analyzed using statistical parametric mapping(SPM).Furthermore,peak activation and activation integral were used for hierarchical clustering analysis.Results The comparison of W matrices indicated a similar set of muscle synergies between the healthy group and the intact limb of amputees,whereas the residual limb showed greater variability in synergies.The analysis of H showed statistically significant differences in muscle activation throughout the gait cycle for all amputees.Clustering of time-domain features revealed that amputees exhibited higher activation integral and peak values in their intact limb during ascending slopes.Conclusions This study provides an in-depth investigation of the neuromuscular compensation strategies in lower-limb amputees under different gaits,offering theoretical insights for gait rehabilitation and assisting in the development of EMG-controlled prosthetics.
10.Association Between Epicardial Atrioventricular Groove Fat Thickness and Prognosis of Patients With Dilated Cardiomyopathy
Iokfai CHEANG ; Xu ZHU ; Qiang QU ; Shengen LIAO ; Huaxin YUAN ; Gengmin LIANG ; Jinjing SHI ; Ziqi CHEN ; Yanli ZHOU ; Wenming YAO ; Yi XU ; Xinli LI
Chinese Circulation Journal 2025;40(5):463-468
Objectives:To investigate the predictive value of epicardial fat volume(EFV)and atrioventricular groove fat thickness(AVGT)—morphological biomarkers of epicardial adipose tissue—for major adverse cardiovascular events(MACE)in patients with dilated cardiomyopathy(DCM).Methods:This study enrolled 216 DCM patients.EFV and AVGT were obtained from cardiac magnetic resonance imaging(CMR).Patients were divided into event-free group(n=142)and event group(n=74)based on MACE occurrence during follow-up.Receiver operating characteristic(ROC)curve analysis was used to determine optimal cutoff values.Survival differences were assessed using Kaplan-Meier analysis,Cox proportional hazards regression analysis was used to identify independent risk factors,and restricted cubic spline(RCS)models were used to evaluate dose-response relationships.Results:AVGT and EFV were significantly higher in the event group than in event-free group(both P<0.05).ROC analysis identified optimal MACE-predicting cutoffs as follows:AVGT≥7.74 mm(area under the curve[AUC]=0.57)and EFV≥78.6 ml(AUC=0.62).Kaplan-Meier analysis revealed significantly lower MACE-free survival rates in patients with AVGT≥7.74 mm and EFV≥78.6 ml(both P<0.05).Cox regression analysis confirmed that AVGT(HR=2.18,95%CI:1.34-3.54)and EFV(HR=1.81,95%CI:1.11-2.96)were independent MACE risk factors(both P<0.05)in this patient cohort.RCS models demonstrated the significant linear associations between EFV/AVGT and MACE risk(bothoverall P<0.05).Conclusions:EFV and AVGT,the non-invasive imaging biomarkers quantifying and characterizing fat distribution,are independently correlated with elevated MACE risk in DCM patients.These metrics serve as potential prognostic indicators,enriching risk stratification indicators for early identification of high-risk patients and guiding personalized medication strategies.

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