Objective To explore the risk factors of painful diabetic neuropathy (PDN) in patients with type 2 diabetes mellitus (T2DM). Methods A total of 269 patients with type 2 diabetes mellitus (T2DM) who were treated in the Department of Endocrinology at Zhangjiagang Hospital Affiliated to Soochow University from January 2020 to December 2024 were selected. The patients were divided into two groups: T2DM without PDN (n=190) and T2DM with PDN (n=79). The general characteristics and biochemical indicators of the two groups of patients were compared. Multivariate logistic regression was used to analyze the associated factors with PDN in T2DM. The receiver operating characteristic (ROC) curve was used to evaluate fasting C-peptide (FC-P), body mass index (BMI), and disease duration to predict the risk of PDN. Results Compared with the T2DM group without concurrent PDN, the T2DM group with concurrent PDN had a longer disease course, lower BMI, higher HDL-C, lower FC-P, and a higher proportion of diabetic retinopathy. The differences between the two groups were statistically significant (P<0.05). The results of multivariate logistic regression analysis showed that BMI, duration, and FC-P were associated factors of PDN. Conclusion BMI, duration and FC-P are associated factors of painful neuropathy complicated with type 2 diabetes.

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 explore the mechanism of Quhan Zhufeng Mixture on proliferation and apoptosis of rheumatoid arthritis fibroblast-like synoviocyte(RA-FLS)based on NDRG2/JAK2/STAT3 signaling pathway.Methods RA-FLS cells were cultured in vitro,and were divided into ① blank serum group,methotrexate group,Quhan Zhufeng Mixture low-,medium-and high-dosage groups;② blank serum group,AG490 group,Quhan Zhufeng Mixture low-,medium-and high-dosage groups.Different concentrations of drug-containing serum were used to intervene cells.Cell proliferation was detected by CCK-8 method,apoptosis was detected by flow cytometry,and mRNA expressions of Bax,Bcl-2,Caspace-3,Caspace-9,N-myc downstream regulatory gene 2(NDRG2),Janus kinase 2(JAK2)and signal transduction and transcription activator 3(STAT3)were detected by RT-qPCR,Western blot was used to detect the protein expressions of Bax,Bcl-2,Caspace-3,Caspace-9,NDRG2,JAK2,STAT3,p-JAK2 and p-STAT3 in cells.Results Compared with the blank serum group,cell survival rate in methotrexate group,Quhan Zhufeng Mixture all dosage groups significantly decreased(P<0.01),the apoptosis rate significantly increased(P<0.01),the mRNA and protein expressions of Bax and Caspase-9 significantly increased(P<0.05,P<0.01),while the mRNA and protein expression of Bcl-2 significantly decreased(P<0.01),and Caspase-3 mRNA and protein expression in methotrexate group and Quhan Zhufeng Mixture medium-and high-dosage groups significantly increased(P<0.01).Compared with the blank serum group,the mRNA and protein expression of NDRG2 significantly increased in Quhan Zhufeng Mixture all dosage groups(P<0.05,P<0.01),the mRNA and protein expressions of JAK2 and STAT3 were significantly reduced in AG490 group and Quhan Zhufeng Mixture medium-and high-dosage groups(P<0.05,P<0.01),and the expressions of p-JAK2 and p-STAT3 proteins were significantly reduced(P<0.01).Conclusion Quhan Zhufeng Mixture can regulate the proliferation and apoptosis of RA-FLS by regulating the activity of NDRG2/JAK2/STAT3 signaling pathway,playing a role in treating rheumatoid arthritis.

Objective:To investigate the feasibility and value of nomogram based on base line clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) characteristics for pretreatment predicting the depth of myometrial invasion and tumor grade of endometrioid endometrial carcinoma (EEC).Methods:Preoperative baseline clinical characteristics and DCE-MRI characteristics of 194 EEC patients were prospectively collected at Obstetrics and Gynecology Hospital, Fudan University from October 2020 to January 2022 and used as a training set. Univariate analysis was conducted to compare baseline clinical characteristics and DCE-MRI quantitative parameters [including tumor volume, and mean, median, and standard deviation of volume transfer constant (K trans), rate constant (K ep), extravascular extracellular volume fraction (V e), and initial area under the enhancement curve (iAUC)] between patients with deep myometrial invasion (DMI) and those with superficial myometrial invasion (SMI), as well as between high-grade and low-grade EEC. Multivariate logistics regression analysis was used to identify independent predictors for the construction of nomogram. An independent external testing set comprising 127 EEC patients was retrospectively collected from Zhongshan Hospital, Fudan University and Zhongshan Hospital, Fudan University (Xiamen Branch). The area under the receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were used for evaluating the model′s predictive performance and clinical net benefit, respectively. Results:(1) The depth of myometrial invasion: univariate analysis showed that in the training set, the EEC patients with DMI differed significantly from those with SMI in clinical characteristics including higher proportion of postmenopausal state and overweight [body mass index (BMI)≥25 kg/m2], and abnormal levels of serum cancer antigen (CA) 125, CA 199, and human epididymis protein 4 (HE4), and in DCE-MRI quantitative parameters including tumor volume, and median, mean, and standard deviation of K trans, median of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, CA 199, tumor volume, and mean of iAUC were independent predictors of the depth of myometrial invasion, and constructed the nomogram (recorded as Nomogram_1), achieving an AUC of 0.861 (95% CI: 0.803-0.919) in the training set. In the independent external testing set, the AUC was 0.876 (95% CI: 0.815-0.938), with corresponding sensitivity of 82.0%, specificity of 80.7%, accuracy of 81.1%, positive predictive value (PPV) of 65.3%, and negative predictive value (NPV) of 91.0% for predicting DMI. (2) The EEC grade: univariate analysis showed that in the training set, high-grade EEC patients differed significantly from low-grade EEC in clinical characteristics including patient′s age, the proportion of postmenopausal state and overweight, and abnormal levels of serum CA 125, and in DCE-MRI quantitative parameters including tumor volume, median, mean, and standard deviation of K trans, median and mean of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, tumor volume, and median of V e emerged as independent predictors of EEC grade, and constructed the nomogram (recorded as Nomogram_2), achieving an AUC of 0.845 (95% CI: 0.786-0.893) in the training set. While in the external testing set, the AUC was 0.819 (95% CI: 0.744-0.894), with corresponding sensitivity of 72.4%, specificity of 72.4%, accuracy of 72.4%, PPV of 43.8%, and NPV of 89.9% for predicting high-grade EEC. (3) The DCA curves demonstrated that both Nomogram_1 and Nomogram_2 yielded obvious positive clinical net benefits across a wide range of threshold probabilities. Conclusion:The nomogram based on pretreatment clinical and DCE-MRI characteristics has the potential to noninvasive predict the depth of myometrial invasion and grade of EEC, providing valuable reference information for clinical management decision-making.

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 explore the improvement of the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection and conduct safety tests including abnormal toxicity test,allergic reaction test,hemolysis and coagulation test.Methods:Ginkgo Leaf Extract and Dipyridamole Injection from 3 different manufactures(A,B and C)were tested respectively through abnormal toxicity test and acute toxicity test in mice,active systemic anaphylaxis test in guinea pigs and hemolysis test in vitro.Five mice were used in each batch for abnormal toxicity test according to the abnormal toxicity test method in general notice of the Chinese Pharmacopoeia 2020 Volume Ⅳ(1141),and 50 mice were selected in each batch for acute toxicity test to determine the median lethal dose(LD50)or maximum tol-erable dose(MTD)of Ginkgo Leaf Extract and Dipyridamole Injection,which were used to establish the method of abnormal toxicity experiment.The anaphylaxis of Ginkgo Leaf Extract and Dipyridamole Injection was evaluated by active systemic anaphylaxis test in guinea pigs,which was used to establish the method of allergic test.The hemoly-sis test of Ginkgo Leaf Extract and Dipyridamole Injection was studied by conventional tube method in vitro(macro-scopic observation)and improved hemolysis method in vitro(spectrophotometric method),which were used to establish the method of hemolysis and coagulation test.Results:① In manufacture A,the results of abnormal toxicity test were showed that LD50 was20.8 mL·kg-1and MTD was 16.5 mL·kg-1.No death or abnormal reac-tions were observed in mice tested for abnormal toxicity of 2 manufactures(B and C),and MTD was 50 and 40 mL·kg-1,respectively.②The no-observed-adverse-effect dose of Ginkgo Leaf Extract and Dipyridamole Injec-tion from 3 manufactures to guinea pig intravenous was 0.83 mL·kg-1,and no allergic reaction symptoms were observed when Ginkgo Leaf Extract and Dipyridamole Injection was diluted 4 times to challenge the sensitized guinea pigs(equivalent to human clinical dosage).③Differences were observed in the hemolytic effects of Ginkgo Leaf Extract and Dipyridamole Injection from 3 manufactures,but no obvious hemolytic reaction occurred when it was diluted 1.2 times(equivalent to 5%of the maximum clinical concentration).Conclusion:It is recommended to add abnormal toxicity test,allergic reaction test,hemolysis and coagulation test in the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection as safety test items to control the risk.The proposed method is diluting Ginkgo Leaf Extract and Dipyridamole Injection by 5 times,4 times and 1.2 times to perform abnormal toxicity test,allergic reaction test,hemolysis test and coagulation test respectively.

ObjectiveTo investigate the value of serum D-lactic acid，intestinal fatty acid binding protein （I-FABP），and E-selectin （Es） in early diagnosis of infection after gastrointestinal surgery and their relationship with curative effect and traditional Chinese medicine （TCM） syndromes. MethodsForty-nine patients with abdominal infection after gastrointestinal surgery treated in Xianju County Traditional Chinese Medicine Hospital from June 2020 to August 2023 were selected as the infection group，and another 53 non-infected patients after gastrointestinal surgery were selected as the non-infected group. The serum D-lactic acid，I-FABP，and Es levels at the first，third，fifth， and seventh days after surgery were compared between the two groups，and the Pearson correlation coefficient was used to analyze the correlation of serum indexes. The receiver operating （ROC） curve and the area under the curve （AUC） of the patients were analyzed to analyze the value of each serum index in diagnosing infection after gastrointestinal surgery. At the same time，the serum indexes of patients with different therapeutic effects were monitored dynamically on the first，third，fifth， and seventh days of treatment. Logistic regression was used to analyze the relationship between serum indexes and curative effect. The relationship between TCM syndromes and serum indexes was analyzed. ResultsThe levels of serum D-lactic acid，I-FABP，and Es in the two groups decreased on the first，third，fifth， and seventh days. There were significant differences among groups， time， and interaction （P<0.01）. On the third day，serum D-lactic acid was positively correlated with I-FABP and Es，and I-FABP was positively correlated with Es （P<0.01）. On the third day after surgery，the AUC of D-lactic acid + I-FABP + Es in the diagnosis of infection after gastrointestinal surgery was 0.861，higher than 0.727 of D-lactic acid，0.745 of I-FABP， and 0.797 of Es （P<0.05）. The levels of serum D-lactic acid，I-FABP，and Es in patients with remission infection were decreased continuously on the first，third，fifth，and seventh days. Patients with exacerbation of infection showed a continuous upward trend，and there were significant differences among groups， time， and interaction （P<0.01）. The TCM syndromes of the patients were heat toxicity syndrome，acute deficiency syndrome，blood stasis syndrome， and fu-Qi obstruction syndrome，accounting for 61.22%，20.41%，12.24%， 6.12% respectively. There were no significant differences in different syndromes，time， and interaction. ConclusionSerum D-lactic acid，I-FABP，and Es can be used for early diagnosis of abdominal infection after gastrointestinal surgery，and the change of indicators can reflect the therapeutic effect and prognosis of patients with infection，but there is no significant correlation between the change of indicators and TCM syndromes.

Objective:To explore the improvement of the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection and conduct safety tests including abnormal toxicity test,allergic reaction test,hemolysis and coagulation test.Methods:Ginkgo Leaf Extract and Dipyridamole Injection from 3 different manufactures(A,B and C)were tested respectively through abnormal toxicity test and acute toxicity test in mice,active systemic anaphylaxis test in guinea pigs and hemolysis test in vitro.Five mice were used in each batch for abnormal toxicity test according to the abnormal toxicity test method in general notice of the Chinese Pharmacopoeia 2020 Volume Ⅳ(1141),and 50 mice were selected in each batch for acute toxicity test to determine the median lethal dose(LD50)or maximum tol-erable dose(MTD)of Ginkgo Leaf Extract and Dipyridamole Injection,which were used to establish the method of abnormal toxicity experiment.The anaphylaxis of Ginkgo Leaf Extract and Dipyridamole Injection was evaluated by active systemic anaphylaxis test in guinea pigs,which was used to establish the method of allergic test.The hemoly-sis test of Ginkgo Leaf Extract and Dipyridamole Injection was studied by conventional tube method in vitro(macro-scopic observation)and improved hemolysis method in vitro(spectrophotometric method),which were used to establish the method of hemolysis and coagulation test.Results:① In manufacture A,the results of abnormal toxicity test were showed that LD50 was20.8 mL·kg-1and MTD was 16.5 mL·kg-1.No death or abnormal reac-tions were observed in mice tested for abnormal toxicity of 2 manufactures(B and C),and MTD was 50 and 40 mL·kg-1,respectively.②The no-observed-adverse-effect dose of Ginkgo Leaf Extract and Dipyridamole Injec-tion from 3 manufactures to guinea pig intravenous was 0.83 mL·kg-1,and no allergic reaction symptoms were observed when Ginkgo Leaf Extract and Dipyridamole Injection was diluted 4 times to challenge the sensitized guinea pigs(equivalent to human clinical dosage).③Differences were observed in the hemolytic effects of Ginkgo Leaf Extract and Dipyridamole Injection from 3 manufactures,but no obvious hemolytic reaction occurred when it was diluted 1.2 times(equivalent to 5%of the maximum clinical concentration).Conclusion:It is recommended to add abnormal toxicity test,allergic reaction test,hemolysis and coagulation test in the quality standard of Ginkgo Leaf Extract and Dipyridamole Injection as safety test items to control the risk.The proposed method is diluting Ginkgo Leaf Extract and Dipyridamole Injection by 5 times,4 times and 1.2 times to perform abnormal toxicity test,allergic reaction test,hemolysis test and coagulation test respectively.

The traditional medical quality management model has many problems,such as excessive reliance on experience,poor coordination among departments,and lagging supervision,innovating medical quality management models has become an essential issue for the high-quality development of hospitals.A tertiary Grade A general hospital built a"data element multiplier"ecological chain for medical quality management,and established a complete closed-loop management system for medical quality management under the"Internet plus"model.Finally,the mobile medical quality management platform was built.Jointly driven by"Internet plus"and"data element multiplier",the level of lean management has been significantly improved,providing practical reference for hospitals at the same level.

Objective:To investigate the current state of death cognition among healthcare providers in hematology department and their attitudes toward hospice care for patients with hematologic malignancies.Methods:A cross-sectional investigation study was conducted. A total of 198 medical staff in hematology department of 4 teaching hospitals, including the First School of Clinical Medicine of Guangdong Medical University, Fujian Medical University Union Hospital, the Affiliated Hospital of Putian University and the First Affiliated Hospital of Gannan Medical University from March 2024 to June 2024 were selected as the investigation subjects. The general situation and background of medical staff in hematology department were investigated by using the "General Sociological Questionnaire". "Death Attitude Description Scale (Chinese version)" was used to investigate the status of death cognition among medical staff in hematology department. "Frommelt Attitudes Toward Care of the Dying Scale Form B (Chinese version)" was used to investigate the hospice care attitude of medical staff in hematology department. The survey results of doctors and nurses were compared.Results:There were 105 doctors and 93 nurses in hematology department included in this study. A total of 198 qualified "General Sociology Questionnaires" were collected. After excluding 6 unqualified questionnaires, 192 copies of "Death Attitude Description Scale (Chinese version)" and "Frommelt Attitudes Toward Care of the Dying Scale Form B (Chinese version)" were collected. There were statistically significant differences in gender, educational background, political status and experience of taking care of terminally ill patients between doctors and nurses (all P < 0.05). The scores of approaching acceptance, neutral acceptance, death escape, death fear and flight acceptance were (4.35±0.37), (4.03±0.51), (2.98±0.62), (2.54±0.29) and (2.19±0.42) points, respectively in the doctor group; the corresponding scores were (3.12±0.41), (3.89±0.46), (2.66±0.63), (2.81±0.57) and (2.37±0.65) points, respectively in the nurse group, and the differences between the 2 groups were statistically significant (all P < 0.05). The total score of hospice care attitude of doctors in hematology department was (108±15) points, and that of nurses was (116±13) points, and the difference was statistically significant ( t = -3.61, P < 0.001). The hospice care attitude of doctors and nurses towards patients with hematologic malignancies is generally between positive and neutral. The nurse group showed more recognition of the positive role of the patient's family members in the process of hospice care, and the doctor group showed more recognition of the promoting role of medical staff in hospice care. There were statistically significant differences in hospice care attitude scores of medical staff in hematology department to patients with different occupational background, gender, age, place of residence, family discussion about death, whether the only child, whether they had the experience of taking care of terminally ill patients, and whether they suffered from serious illness and religious belief (all P < 0.05). Conclusions:The death cognition of medical staff in hematology department is neutral, and they show a certain sense of hospice care.