1.Integrated evidence chain (Eff-iEC) based effectiveness evaluation of a multifunctional traditional Chinese medicine formula: Taking Xiaoyao San as an example
Caiping HE ; Ye LUO ; Zhiqi LI ; Haocheng YANG ; Lu LIU ; Yingjie XU ; Xiaoyan CHEN ; Siqi HUANG ; Jincai WEN ; Xiaoyan ZHAN ; Zhaofang BAI ; Xu ZHAO ; Xiaohe XIAO
Science of Traditional Chinese Medicine 2026;4(1):96-103
The study focuses on the concept of multifunctional traditional Chinese medicine (TCM) formulas and aims to evaluate the efficacy of the classical formula Xiaoyao San (逍遥散). Study employs the integrated evidence chain (Eff-iEC) method to organize, integrate, and evaluate its therapeutic efficacy in treating different diseases with the same therapy, and to investigate the feasibility of using Eff-iEC to evaluate the multifunctionality of TCM formulas. The evaluation covered Xiaoyao San's therapeutic effects on depression, premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Concurrently, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used for evaluation, and authoritative medical documents were incorporated to corroborate the recognition of Xiaoyao San within the medical community. Depression and menopausal syndrome received higher ratings than other conditions in the Eff-iEC, GRADE, and Medical Community Recognition assessments. The Eff-iEC evidence grade for Xiaoyao San was rated as "High" or above for chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Premenstrual syndrome received a "Moderate +" rating. The GRADE evidence level was "Low-〇〇⨁⨁" for depression, premenstrual syndrome, and chronic hepatitis; "Moderate-〇⨁⨁⨁" for dyspepsia and menopausal syndrome; and "Very Low-〇〇〇⨁" for irritable bowel syndrome. Depression and menopausal syndrome had the highest inclusion frequency, appearing in all 4 categories. Premenstrual syndrome, chronic hepatitis, and dyspepsia are not recommended in Western medical guidelines, but they are included in TCM guidelines, the China National Basic Medical Insurance Drug List, and the China National Essential Drug List. Irritable bowel syndrome appears only in the China National Basic Medical Insurance Drug List and China National Essential Drug List. The evaluation results obtained using the Eff-iEC method align with Medical Community Recognition, providing an objective and comprehensive assessment of Xiaoyao San's efficacy. The findings suggest that Xiaoyao San has strong evidence for treating depression and menopausal syndrome. However, further experimental and clinical trials are needed to assess its efficacy in treating premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, and dyspepsia. These results support the clinical efficacy and rational use of Xiaoyao San, expand the application scope of the Eff-iEC method, and offer valuable insights and methodological references for the comparative evaluation of multifunctional TCM formulas.
2.Clinical Efficacy of Janus Kinase Inhibitors in Combination with Chinese Herbal Medicine for Rheumatoid Arthritis:A Retrospective Study and A Meta-analysis
Chenguang ZHAN ; Shengqin YANG ; Xin LI ; Yu WEN ; Peng ZHANG ; Xingrui YAN ; Haifang DU ; Maojie WANG ; Xiaodong WU ; Liyan MEI ; Xiumin CHEN ; Yanlin LI ; Runyue HUANG
Journal of Traditional Chinese Medicine 2026;67(5):534-543
ObjectiveTo evaluate the efficacy and safety of Janus kinase (JAK) inhibitors combined with Chinese herbal medicine (CHM) in treating rheumatoid arthritis (RA). MethodsClinical data from 169 RA patients were retrospectively collected. Among them, 71 cases received JAK inhibitors as the control group, while 98 cases received JAK inhibitors plus CHM as the observation group, both treated for 24 weeks. The rheumatoid factor (RF), cyclic citic peptide antibody (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and white blood cell count (WBC) were recorded before and after treatment. Databases including CNKI, Wanfang, VIP, PubMed and Web of Science were searched from inception till August 31st, 2025 for randomized controlled trials (RCTs) on the combined use of JAK inhibitors and CHM for RA. The methodological quality of the included studies was evaluated using the risk of bias assessment tool. Meta-analyses were performed for RF, anti-CCP, ESR, CRP, 28-joint disease activity score (DAS28), overall clinical effective rate, and incidence of adverse events. Sensitivity analysis were also performed. ResultsThe retrospective study demonstrated that after treatment, ESR, CRP, and anti-CCP levels decreased in the observation group, while ESR and CRP levels decreased in the control group (P<0.05). Moreover, ESR and RF levels in the observation group were lower than those in the control group (P<0.05). A total of 9 RCTs involving 770 patients were included in the meta-analysis. The results indicated that the JAK inhibitors plus CHM group was superior to the JAK inhibitors group in reducing RF (MD=-8.97, 95%CI -15.01 to -2.94, P=0.004), CRP (MD=-3.34, 95%CI -3.82 to -2.86, P<0.001), ESR (MD=-5.33, 95%CI -7.98 to -2.69, P<0.001), and DAS28 score (MD=-0.54, 95%CI -0.74 to -0.34, P<0.001), as well as in improving the overall clinical effective rate (OR=4.53, 95%CI 2.55 to 8.03, P<0.001). No statistically significant differences were observed between groups in anti-CCP levels (SMD=-2.08, 95%CI -4.41 to 0.24, P=0.080) or incidence of adverse events (OR=0.93, 95%CI 0.55 to 1.57, P=0.790). ConclusionThe combination of JAK inhibitors and CHM demonstrates remarkable efficacy in treating RA, contributing to improved disease activity and reduced inflammatory markers with a favorable safety profile.
3.Intravesical injections of botulinum toxin A for the treatment of refractory urinary frequency and incontinence in 35 children
Zhan WANG ; Yibo WEN ; Zhaokai ZHOU ; Shuai YANG ; Lei LYU ; Yanping ZHANG ; Qi LI ; Qingwei WANG ; Wen ZHU ; Guoxian ZHANG ; Yakai LIU ; Huiqing ZHANG ; Jianguo WEN
Chinese Journal of Applied Clinical Pediatrics 2025;40(7):521-525
Objective:To investigate the efficacy and safety of intravesical injections of botulinum toxin A (BTX-A) for the treatment of pediatric refractory urinary frequency and incontinence (UFI), and to analyze the factors predicting the therapeutic effect of BTX-A injections.Methods:A retrospective case series study was made on 35 children with UFI [(12.3±4.2) years old], including 13 males (37.1%) and 22 females (62.9%), treated in the First Affiliated Hospital of Zhengzhou University from January 2021 to March 2024.Urotherapy and drug treatments were ineffective in all children, who then received intravesical injections of BTX-A.The urodynamic study (UDS) was performed 1 week before treatment and 3 months after treatment, and the Overactive Bladder Symptom Score (OABSS) and Incontinence Quality of Life (I-QOL) were collected.Perioperative and postoperative adverse events were also recorded.A global response assessment (GRA) score of ≥2 at 3 months postoperatively was defined as effective treatment.According to the postoperative GRA score, the patients were divided into effective and ineffective groups to explore the predictive factors affecting the outcome of BTX-A treatment, such as age, gender, preoperative urodynamic parameters, and the types of urinary incontinence. t-test was used to compare quantitative data such as age, UDS parameters, OABSS, and I-QOL scores.The comparison of count data such as gender and urinary incontinence types was conducted using Fisher′s exact test. Results:The bladder compliance, bladder capacity ratio, OABSS and I-QOL scores of patients significantly improved after BTX-A injection (all P<0.05).The 77.1% (27/35) of the patients were satisfied with BTX-A treatment effects.The main adverse event during the follow-up was a temporary increase in postvoid residual urine after injecting BTX-A (7 cases), which was alleviated by the Creade action or clean intermittent catheterization.There was significant difference in age [(13.00±4.32) years vs.(10.00±2.67) years] and preoperative bladder compliance [(11.21±5.74) mL/cmH 2O vs.(5.13±2.42) mL/cmH 2O] between effective (27 cases) and ineffective groups (8 cases) ( t=2.383, 2.899, all P<0.05).The differences in preoperative bladder capacity ratio, maximum filling detrusor pressure, postvoid residual urine, voiding efficiency, gender, and the types of urinary incontinence were not statistically significant between the two groups (all P>0.05). Conclusions:Intravesical injection of BTX-A is a safe and effective treatment for children with refractory UFI.A young age and poor bladder compliance at treatment are associated with poor prognosis of BTX-A treatment.
4.Construction and evaluation of a risk prediction model for acute kidney injury in severe burn patients
He-dong XIANG ; Wen-zhao CHEN ; Hong-zhuang ZHANG ; Li-tao WEI ; Pei ZHAN ; Wei YANG ; Chang-quan LI ; Meng QIAO ; Chao-wei CHEN ; Zhi-qiang TIAN
Journal of Regional Anatomy and Operative Surgery 2025;34(10):886-891
Objective To explore the influencing factors of acute kidney injury in severe burn patients,and to construct a visual risk nomogram model.Methods A total of 390 patients with severe burn admitted to the Institute of Burn Frostbite and Tissue Function Reconstruction of Chinese People's Armed Police Force Specialty Medical Center from January 2018 to January 2022 were collected as an internal training data set,and 50 patients with severe burn admitted from February to December 2022 were collected as an external validation data set.The 390 patients of the internal training data set were divided into the acute kidney injury group and the non-acute kidney injury group according to the occurrence of acute kidney injury,and the baseline data of patients in the two groups were compared.Univariate and multivariate Logistic regression were used to analyze the risk factors of acute kidney injury in severe burn patients of the internal training data set,and a nomogram model was drawn.Subsequently,the model was verified both internally and externally.Kaplan-Meier analysis and Log-rank test were used to compare the 90-day survival rate of patients between the acute kidney injury group and the non-acute kidney injury group.Results The burn area(OR=1.18,95%CI:1.06 to 2.36,P=0.004),sequential organ failure assessment(SOFA)score(OR=1.81,95%CI:1.21 to 5.92,P<0.001),inhalation injury(OR=3.21,95%CI:1.23 to 6.35,P<0.001),neutrophil to lymphocyte ratio(NLR)(OR=1.22,95%CI:1.05 to 3.65,P<0.001)and albumin(ALB)(OR=0.78,95%CI:0.57 to 0.92,P=0.011)were the independent risk factors for the development of acute kidney injury in severe burn patients.The nomogram model was established by the above factors.The area under the receiver operating characteristic curve(AUC)of the internal training data set was 0.833(95%CI:0.752 to 0.935),the sensitivity was 81.2%,and the specificity was 83.2%.The AUC of the external validation data set was 0.842(95%CI:0.762 to 0.912),the sensitivity 87.2%,and the specificity was 78.7%.The 90-day survival rate of patients in the acute kidney injury group after burns was significantly lower than that in the non-acute kidney injury group(P<0.001).Conclusion Larger burn area,higher SOFA score,combined inhalation injury,increased NLR,and decreased ALB level are the risk factors for the occurrence of acute kidney injury in severe burn patients,which are related to the 90-day survival rate of patients after burns.The nomogram model based on the risk factors can provide certain reference for clinical individualized prevention and treatment of acute kidney injury in severe burn patients.
5.Comparative study of idiopathic pulmonary fibrosis in mice induced by bleomycin of different concentrations
Xinxin ZHANG ; Yizi XIE ; Huiting HUANG ; Yong JIANG ; Hang LI ; Gang LIAO ; Wujin WEN ; Shaofeng ZHAN ; Xiufang HUANG
Acta Laboratorium Animalis Scientia Sinica 2025;33(5):673-683
Objective To investigate the establishment and evaluation of an idiopathic pulmonary fibrosis(IPF)mouse model induced by the intratracheal infusion of bleomycin(BLM)of different concentrations.Methods Male C57BL/6J mice were randomly divided into a control group,Model-L group(1.5 mg/kg,BLM),Model-M group(2.5 mg/kg,BLM),and Model-H group(3.5 mg/kg,BLM).An IPF mouse model was constructed by one-time intratracheal infusion of BLM.The general status,body mass,survival rate,and lung coefficient of mice in different groups were compared.Pathological changes in lung tissue,the hydroxyproline content,fibrosis markers and inflammatory factor levels were observed.Results Compared with the control group,the survival rate decreased and body weight showed a downward trend in the low-,medium-,and high-dose model groups,with significant increases in lung coefficients.Inflammatory infiltration(P<0.01)and collagen deposition(P<0.0001)were observed in the lung tissues of all model groups.Hydroxyproline levels in lung tissue and serum were significantly elevated(P<0.05).The mRNA levels of fibrosis markers α-Sma,Fn1,and Col1a1 were upregulated(P<0.001),with significant increases in corresponding protein expression(P<0.05).The mRNA expression of the inflammatory factor Tgfb1 also increased(P<0.0001).Conclusion 1.5,2.5 and 3.5 mg/kg BLM can induce an IPF model in C57BL/6J mice.Based on the results observed for survival rate,body mass,lung coefficient changes,lung tissue gross and pathological changes,and fibrosis-related biomarkers,2.5 mg/kg BLM is the optimal concentration for inducing an IPF mouse model.
6.Efficacy of direct versus double-balloon occlusion techniques in endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction: a retrospective cohort study (with video)
Zhaorong WU ; Wei ZHAN ; Wenting LI ; Tian TIAN ; Qin YIN ; Shanshan SHEN ; Lei WANG ; Wen LI
Chinese Journal of Digestive Endoscopy 2025;42(11):864-870
Objective:To compare the clinical efficacy of direct versus double-balloon occlusion in endoscopic ultrasound-guided gastroenterostomy (EUS-GE) for benign and malignant gastric outlet obstruction (GOO).Methods:Clinical data of patients with GOO who underwent EUS-GE at Nanjing Drum Tower Hospital between April 2017 and July 2024 were analyzed in a retrospectively cohort study. The patients were divided into the direct technique group ( n=36) and the double-balloon occlusion technique group ( n=105). The technical success rate, clinical success rate, procedure time, postoperative stay, stent replacement rate, and incidence of adverse events were compared between the two groups. Results:The technical success rates of the two groups were comparable, 97.2% (35/36) and 94.3% (99/105) ( χ2=0.065, P=0.798), so were the clinical success rates, 94.4% (34/36) and 86.7% (91/105) ( χ2=0.932, P=0.334). However, the direct technique group demonstrated significantly shorter procedure time and postoperative stay compared to the double-balloon occlusion group [33.4 (23.2, 42.3) min VS 43.4 (31.7, 63.1) min, Z=-3.057, P=0.002; 4.0 (3.00, 5.75) days VS 6.0 (5.00, 9.00) days, Z=-4.031, P<0.001]. Adverse event rates [11.1% (4/36) VS 11.4% (12/105), χ2<0.001, P=1.000] and stent replacement rates [5.6% (2/36) VS 9.5% (10/105), χ2=0.152, P=0.696] showed no significant differences. Conclusion:Both EUS-GE techniques achieve comparable efficacy and safety for GOO. However, the direct technique showed significant advantages over the double-balloon occlusion technique in terms of shorter procedure time and reduced postoperative hospital stay.
7.Comparative study of idiopathic pulmonary fibrosis in mice induced by bleomycin of different concentrations
Xinxin ZHANG ; Yizi XIE ; Huiting HUANG ; Yong JIANG ; Hang LI ; Gang LIAO ; Wujin WEN ; Shaofeng ZHAN ; Xiufang HUANG
Acta Laboratorium Animalis Scientia Sinica 2025;33(5):673-683
Objective To investigate the establishment and evaluation of an idiopathic pulmonary fibrosis(IPF)mouse model induced by the intratracheal infusion of bleomycin(BLM)of different concentrations.Methods Male C57BL/6J mice were randomly divided into a control group,Model-L group(1.5 mg/kg,BLM),Model-M group(2.5 mg/kg,BLM),and Model-H group(3.5 mg/kg,BLM).An IPF mouse model was constructed by one-time intratracheal infusion of BLM.The general status,body mass,survival rate,and lung coefficient of mice in different groups were compared.Pathological changes in lung tissue,the hydroxyproline content,fibrosis markers and inflammatory factor levels were observed.Results Compared with the control group,the survival rate decreased and body weight showed a downward trend in the low-,medium-,and high-dose model groups,with significant increases in lung coefficients.Inflammatory infiltration(P<0.01)and collagen deposition(P<0.0001)were observed in the lung tissues of all model groups.Hydroxyproline levels in lung tissue and serum were significantly elevated(P<0.05).The mRNA levels of fibrosis markers α-Sma,Fn1,and Col1a1 were upregulated(P<0.001),with significant increases in corresponding protein expression(P<0.05).The mRNA expression of the inflammatory factor Tgfb1 also increased(P<0.0001).Conclusion 1.5,2.5 and 3.5 mg/kg BLM can induce an IPF model in C57BL/6J mice.Based on the results observed for survival rate,body mass,lung coefficient changes,lung tissue gross and pathological changes,and fibrosis-related biomarkers,2.5 mg/kg BLM is the optimal concentration for inducing an IPF mouse model.
8.Construction and evaluation of a risk prediction model for acute kidney injury in severe burn patients
He-dong XIANG ; Wen-zhao CHEN ; Hong-zhuang ZHANG ; Li-tao WEI ; Pei ZHAN ; Wei YANG ; Chang-quan LI ; Meng QIAO ; Chao-wei CHEN ; Zhi-qiang TIAN
Journal of Regional Anatomy and Operative Surgery 2025;34(10):886-891
Objective To explore the influencing factors of acute kidney injury in severe burn patients,and to construct a visual risk nomogram model.Methods A total of 390 patients with severe burn admitted to the Institute of Burn Frostbite and Tissue Function Reconstruction of Chinese People's Armed Police Force Specialty Medical Center from January 2018 to January 2022 were collected as an internal training data set,and 50 patients with severe burn admitted from February to December 2022 were collected as an external validation data set.The 390 patients of the internal training data set were divided into the acute kidney injury group and the non-acute kidney injury group according to the occurrence of acute kidney injury,and the baseline data of patients in the two groups were compared.Univariate and multivariate Logistic regression were used to analyze the risk factors of acute kidney injury in severe burn patients of the internal training data set,and a nomogram model was drawn.Subsequently,the model was verified both internally and externally.Kaplan-Meier analysis and Log-rank test were used to compare the 90-day survival rate of patients between the acute kidney injury group and the non-acute kidney injury group.Results The burn area(OR=1.18,95%CI:1.06 to 2.36,P=0.004),sequential organ failure assessment(SOFA)score(OR=1.81,95%CI:1.21 to 5.92,P<0.001),inhalation injury(OR=3.21,95%CI:1.23 to 6.35,P<0.001),neutrophil to lymphocyte ratio(NLR)(OR=1.22,95%CI:1.05 to 3.65,P<0.001)and albumin(ALB)(OR=0.78,95%CI:0.57 to 0.92,P=0.011)were the independent risk factors for the development of acute kidney injury in severe burn patients.The nomogram model was established by the above factors.The area under the receiver operating characteristic curve(AUC)of the internal training data set was 0.833(95%CI:0.752 to 0.935),the sensitivity was 81.2%,and the specificity was 83.2%.The AUC of the external validation data set was 0.842(95%CI:0.762 to 0.912),the sensitivity 87.2%,and the specificity was 78.7%.The 90-day survival rate of patients in the acute kidney injury group after burns was significantly lower than that in the non-acute kidney injury group(P<0.001).Conclusion Larger burn area,higher SOFA score,combined inhalation injury,increased NLR,and decreased ALB level are the risk factors for the occurrence of acute kidney injury in severe burn patients,which are related to the 90-day survival rate of patients after burns.The nomogram model based on the risk factors can provide certain reference for clinical individualized prevention and treatment of acute kidney injury in severe burn patients.
9.Interpretation of the Asian Consensus on systemic therapy for pancreatic ductal adenocarcinoma
Chenlei WEN ; Siyi ZOU ; Fanlu LI ; Qian ZHAN ; Baiyong SHEN
Journal of Surgery Concepts & Practice 2025;30(6):461-468
Pancreatic ductal adenocarcinoma (PDAC) is difficult to diagnose in its early stages. Most patients are diagnosed at a locally advanced or metastatic stage. Systemic therapy has become the key to improve survival. To bridge the differences in guidelines across Asian countries and address regional clinical practice needs, 14 leading experts in the Asia-Pacific region developed the “Asian Consensus on systemic therapy for pancreatic ductal adenocarcinoma” on the Delphi method. The consensus centers on 14 core recommendations (R1-R14) and proposes stratified management strategies based on disease stage. For resectable PDAC, adjuvant modified FOLFIRINOX (mFOLFIRINOX) is the preferred option, while for the patients with poor performance status gemcitabine plus capecitabine, S-1 monotherapy, and other regimens can be selected. For borderline resectable PDAC, neoadjuvant therapy is recommended, with GnP or FOLFIRINOX as the preferred regimens. For locally advanced PDAC, combination or monochemotherapy is selected based on their performance status. For metastatic PDAC, first-line options include GnP, NALIRIFOX, or mFOLFIRINOX, with second-line therapy the cross-use of gemcitabine-based and 5-FU-based regimens are emphasized. This consensus provides for the first time a comprehensive and standardized management framework for systemic therapy of PDAC in Asia, aiming to enhance regional homogeneity in clinical practice and improve patient outcomes. This article interpreted the consensus content with the goal of guiding clinical practice.
10.Berg Balance Scale score is a valuable predictor of all-cause mortality among acute decompensated heart failure patients.
Yu-Xuan FAN ; Jing-Jing CHENG ; Zhi-Qing FAN ; Jing-Jin LIU ; Wen-Juan XIU ; Meng-Yi ZHAN ; Lin LUO ; Guang-He LI ; Le-Min WANG ; Yu-Qin SHEN
Journal of Geriatric Cardiology 2025;22(6):555-562
OBJECTIVE:
To investigate possible associations between physical function assessment scales, such as Short Physical Performance Battery (SPPB) and Berg Balance Scale (BBS), with all-cause mortality in acute decompensated heart failure (ADHF) patients.
METHODS:
A total of 108 ADHF patients were analyzed from October 2020 to October 2022, and followed up to May 2023. The association between baseline clinical characteristics and all-cause mortality was analyzed by univariate Cox regression analysis, while for SPPB and BBS, univariate Cox regression analysis was followed by receiver operating characteristic curves, in which the area under the curve represented their predictive accuracy for all-cause mortality. Incremental predictive values for both physical function assessments were measured by calculating net reclassification index and integrated discrimination improvement scores. Optimal cut-off value for BBS was then identified using restricted cubic spline plots, and survival differences below and above that cut-off were compared using Kaplan-Meier survival curves and the log-rank test. The clinical utility of BBS was measured using decision curve analysis.
RESULTS:
For baseline characteristics, age, female, blood urea nitrogen, as well as statins, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitors, were predictive for all-cause mortality for ADHF patients. With respect to SPPB and BBS, higher scores were associated with lower all-cause mortality rates for both assessments; similar area under the curves were measured for both (0.774 for SPPB and 0.776 for BBS). Furthermore, BBS ≤ 36.5 was associated with significantly higher mortality, which was still applicable even adjusting for confounding factors; BBS was also found to have great clinical utility under decision curve analysis.
CONCLUSIONS
BBS or SPPB could be used as tools to assess physical function in ageing ADHF patients, as well as prognosticate on all-cause mortality. Moreover, prioritizing the improvement of balance capabilities of ADHF patients in cardiac rehabilitation regimens could aid in lowering mortality risk.

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