To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine (ICWM) for ulcerative colitis (UC), we aim to develop a customized core outcome set (COS) that incorporates input from various stakeholders. The study design of this COS has been informed by the Core Outcome Measures in Effectiveness Trials Initiative Handbook, with adherence to the guidelines from the Core Outcome Set-STAndards for Reporting statement and Core Outcome Set-STAndardised Protocol Items recommendations. Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC, including healthcare professionals, patients, COS developers, COS users, and methodologists. The process will involve five stages: (1) conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains; (2) conducting semi-structured interviews to obtain important outcomes; (3) choosing the most important outcomes by conducting three-round Delphi surveys; (4) achieving a consensus in a face-to-face meeting to discuss the final COS; and (5) publication, dissemination and implementation of COS. Consequently, this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine (TCM) and ICWM interventions. Please cite this article as: Zhang X, Zhang L, Wang J, Lau CT, Wang N, Zhang X, Wang P, Li J, Han F, Bian Z. A protocol for developing, disseminating and implementing a core outcome set for clinical trials of integrative Chinese and Western medicine for ulcerative colitis. J Integr Med. 2025; 23(6):654-659.
Colitis, Ulcerative/therapy* ; Humans ; Medicine, Chinese Traditional ; Clinical Trials as Topic ; Integrative Medicine ; Research Design ; Outcome Assessment, Health Care ; Delphi Technique

ObjectiveTo explore the mechanism of Bushen Huoxue enema in treating the rat model of kidney deficiency and blood stasis-thin endometrium （KDBS-TE） by transcriptome sequencing. MethodThe rat model of KDBS-TE was established by administration of tripterygium polyglycosides tablets combined with subcutaneous injection of adrenaline. The pathological changes of rat endometrium in each group were then observed. Three uterine tissue specimens from each of the blank group， model group， and Bushen Huoxue enema group were randomly selected for transcriptome sequencing. The differentially expressed circRNAs， lncRNAs， and miRNAs were screened， and the disease-related specific competitive endogenous RNA （ceRNA） regulatory network was constructed. Furthermore， the gene ontology （GO） functional annotation and the Kyoto Encyclopedia of Genes and Genomes （KEGG） pathway enrichment were performed for the mRNAs in the network. ResultCompared with the blank group， the model group showed endometrial dysplasia， decreased endometrial thickness and endometrial/total uterine wall thickness ratio （P<0.01）， and differential expression of 18 circRNAs， 410 lncRNAs， and 7 miRNAs. Compared with the model group， the enema and estradiol valerate groups showed improved endometrial morphology and increased endometrial thickness and ratio of endometrial to total uterine wall thickness （P<0.05）. In addition， 21 circRNAs， 518 lncRNAs， and 17 miRNAs were differentially expressed in the enema group. The disease-related specific circRNA-miRNA-mRNA regulatory network composed of 629 nodes and 664 edges contained 2 circRNAs， 34 miRNAs， and 593 mRNAs. The lncRNA-miRNA-mRNA regulatory network composed of 180 nodes and 212 edges contained 5 lncRNAs， 10 miRNAs， and 164 mRNAs. The mNRAs were mainly enriched in Hippo signaling pathway， autophagy-animal， axon guidance， etc. ConclusionBushen Huoxue enema can treat KDBS-TE in rats by regulating specific circRNAs， lncRNAs， and miRNAs in the uterus and the ceRNA network.

High-voltage pulsed electric field(HV-PEF)ablation technology has demonstrated promising applications in the clinical treatment of chronic obstructive pulmonary disease(COPD).However,its use has been limited to exploratory applications in a small number of cases,and the underlying mechanisms remain largely undefined.To facilitate broader clinical implementation,comprehensive molecular mechanism studies via extensive animal experimentation are essential.Rats,due to their ease of modeling COPD and the availability of comprehensive molecular reagents,serve as an optimal model for such studies.Consequently,the development of electrodes specifically designed for HV-PEF respiratory ablation in SD rats is of significant importance.In this study,we meticulously examined the anatomical structure of rat airways and investigated various equipment parameters,including material composition,rigidity,diameter,electrode ring dimensions,spacing between positive and negative poles,insulation coating for the catheters,welding techniques between the guidewire and electrode ring,and the design of vent holes in the catheter.Based on these considerations,we fabricated PVC ablation electrode catheters with integrated ventilation functionality.Subsequently,we employed finite element simulation to estimate the field strengths that could be applied by these electrodes.The simulation results were then validated in normal rats to assess the electrical safety and efficacy of the electrodes.These findings laid the groundwork for further investigation into the mechanisms of HV-PEF treatment for COPD.

Objective:To investigate the effect of aucubin on behaviors and excessive activation of astrocytic in attention deficit/hyperactivity disorder (ADHD) model mice.Methods:Twelve wild-type C57BL/6 pregnant mice (female, clean grade) were intraperitoneally administered with esketamine (15 mg/kg) to establish an ADHD model in offspring mice. The offspring mice were divided into control+ saline group, control+ aucubin group, Ketamine+ saline group and Ketamine+ aucubin group according to the nest matching principle with 15 in each group.At 14 days after birth, mice in the control+ aucubin group and Ketamine+ aucubin group were administered with aucubin (5 mg/kg, once a day) by gavage for 5 days. Mice in control+ saline group and Ketamine+ saline group were administered with equal volume of 0.9% sodium chloride solution. The offspring mice were housed with their mothers in the same cage until 21 days after birth. Twenty-one days after birth, the offspring mice were evaluated by open field test and elevated plus maze tests. Immunofluorescence assay was used to detect the expression of glutamate decarboxylase 2 (GAD2), γ- aminobutyric acid (GABA) and glial fibrillary acidic protein (GFAP) in the amygdala. The morphological changes of astrocytes were quantitatively analyzed by Sholl analysis. GraphPad Prim 9.0.1 software was used for statistical analysis. The comparison of multiple groups was conducted by one-way ANOVA or Kruskal-Wallis test.Results:(1)The results of behavioral experiments showed that the total distance traveled in the open field test and the residence time in open arm of the elevated plus maze were statistically significant ( F=236.90, H=39.92, both P<0.001). The total distance ((7 044±249)mm, (22 891±2 175)mm, P<0.05) and the residence time in open arm(12.69(9.86, 17.24)s, 2.72(0.57, 3.87)s, P<0.05) of mice in Ketamine+ saline group were both higher than those in control+ saline group.The total distance((22 891±2 175)mm, (8 252±839)mm, P<0.05) and the the residence time in open arm(5.45(1.13, 10.99)s, 12.69(9.86, 17.24)s, P<0.05) of Ketamine+ aucubin group were both lower than those of Ketamine+ saline group.(2)The immunofluorescence results showed that the levels of GAD2, GABA and GFAP intensity in amygdala of mice in the four groups were statistically significant ( F=145.50, 50.08, 53.83, all P<0.05). Compared with control+ saline group, the fluorescence intensities of GAD2 ((100.00±9.60)%, (24.86±4.14)%, P<0.05) and GABA ((100.00±16.84))%, (25.48±5.70)%, P<0.05) of Ketamine+ saline group were down-regulated, and the GFAP((100.00±18.02)%, (223.80±25.85)%, P<0.05) was up-regulated. Compared with Ketamine+ saline group, the fluorescence intensities of GAD2 ((24.86±4.14)%, (56.08±6.55)%, P<0.05) and GABA((25.48±5.70)%, (52.59±15.74)%, P<0.05) in Ketamine+ aucubin group were up-regulated, but the fluorescence intensity of GFAP ((223.80±25.85)%, (157.10±22.10)%, P<0.05) was down-regulated.(3)Sholl analysis indicated that the number of the intersections between the astrocyte processes or the branches of astrocyte processes was statistically significant in the 4 groups ( F=12.47, P<0.05). Compared with control+ saline group, the number of the intersections in Ketamine+ saline group((2.07±0.48), (1.67±0.72), P<0.05) increased. While the number of the intersections in Ketamine+ aucubin group was lower than that of Ketamine+ saline group ((1.20±0.78), (2.07±0.48), P<0.05). Conclusion:Aucubin administration can alleviate ADHD-like behaviors in offspring mice, and the mechanism may be associated with the inhibition of excessive astrocytic activation.

Objective:To explore the economic applicability and safetyof the novel uterovaginal pubic comb suspension(UPCS)surgery with Mersilene tape in the treatment of pelvic organ prolapse(POP).Methods:A ret-rospective analysis was conducted on the clinical data of patients who underwent UPCS surgery due to POP from January 1st,2021 to February 28,2023.They were divided to the UPCS surgery with Mersilene tape group(group A)and suspension surgery with Y-shaped mesh group(group B)respectively.The POP-Q indication points,sus-pension surgery duration,intraoperative bleeding volume,material expense,postoperative catheter retention time,anal exhaust time and hospitalization duration were recorded for both groupbefore and after surgery.Evaluate the severity of POP related symptoms in patients before and after surgery using the pelvic Floor Distress Invento-ry-short Form 20(PFDI-20)and Pelvic Organ Prolapsed/Urinary Incontinence Sexual Questionnaire-12(PISQ-12),and follow up and observe the patients and analyze the complications.Results:A total of 17 POP patients were included in the study.There were 12 patients in group A while 5 patients in group B.The suspension material expense of group A was considerably lower than that of group B(P＜0.05).There was no significant difference between the two groups in preoperative PFDI-20 score,preoperative PISQ-12 score,UPCS surgery duration,intr-aoperative bleeding volume,postoperative urinary catheter retention time,postoperative anal exhaust time and hospitalization duration.All patients showed stable vital signs during the surgery and no severe complications were reported.Compared with the preoperative status,the positions of the Aa,Ba,and C indicatorpoint in group A and group B were all increased significantly(P＜0.05).The PFDl-20 and PISQ-12 scores of the two groups at the last follow-up after surgery showed significant improvement compared to those before surgery(P＜0.05).No signifi-cant difference was found in the PFDI-20 and PISQ-12 scores between the two groups after surgery(P＞0.05).There were no significant differences in the postoperative complications between the two groups(P＞0.05).Con-clusions:Compared with suspension surgery with Y-shaped mesh,UPCS surgery with Mersilene tape is safe and effective in the treatment of POP.The UPCS surgery with Mersilene tape showed better cost-effectiveness in the treatment of POP,and the surgical steps are relatively simple.Therefore,UPCS surgery with Mersilene tape was worthy of promotion in clinical practice.

Objective:To investigate the changes of reactive oxygen species (ROS) in pancreatic cancer cells under the effect of pulsed electric fields (PEF).Methods:Murine-derived pancreatic cancer cells Panc02 were treated with PEF at electric field strengths of 0, 250, 500, 750, and 1 000 V/cm, respectively. The intracellular ROS generation patterns under the different field strengths and at different times after the PEF were investigated in vitro by flow cytometry and immunofluorescence, meanwhile exploring the apoptosis of murine and human pancreatic cancer cells under different field strengths. Twenty 6- to 8-week-old male C57BL/6 SPF mice were prepared as orthotopic pancreatic cancer models and divided into five groups of four mice each: 250 V/cm PEF group, 500 V/cm PEF group, 750 V/cm PEF group, 1 000 V/cm PEF group, and sham operation group. ROS expression in the residual tumor tissues of mice in each group was detected by immunofluorescence.Results:Under the 500 V/cm, 750 V/cm and 1 000 V/cm electric field strength, the proportion of cells with intracellular ROS expression was decreased after 6 h, 12 h, 24 h and 48 h of the PEF compared with 2 h after the PEF, and the differences were statistically significant (all P<0.05). Compared with 0 V/cm PEF group, ROS expression increased in Panc02 cells treated with 500 V/cm and 750 V/cm PEF groups, and the differences were statistically significant (all P<0.05). Compared with 250 V/cm PEF group under the same time, ROS in Panc02 cells treated with 500 V/cm and 750 V/cm electric field strengths increased, and the differences were statistically significant (all P<0.05). The proportions of apoptosis of both Panc02 cells and MIA-PaCa-2 cells increased with rising field strength and peaked at the field strength of 750 V/cm. Compared with the sham-operated group, the expression of ROS was increased in pancreatic cancer tissues of mice in the 500 V/cm PEF-treated group (16.65±6.01 vs. 2.38±1.21, t=-6.53) and 750 V/cm PEF-treated group (16.54±4.41 vs. 2.38±1.21, t=-6.48), and the differences were statistically significant in both cases (both P<0.001). Conclusion:PEF treatment was able to increase the level of ROS in both pancreatic cancer cells and tissues, and more ROS were produced when the electric field strength was 500 and 750 V/cm.

ObjectiveTo investigate the clinical efficacy of negative pressure sealing drainage combined with compound Huangbai liquid on diabetic foot and effects on serum inflammatory factors. MethodA total of 168 patients with diabetic foot treated in Rizhao Hospital of Traditional Chinese Medicine from January 2019 to December 2021 were enrolled and randomly divided into a control group （84 cases） and an experimental group （84 cases）. All patients received basic treatment such as blood glucose control and anti-infection. The patients in the control group were treated with negative pressure drainage combined with normal saline，while those in the experimental group were treated with negative pressure drainage combined with compound Huangbai liquid. The ulcer areas，Visual Analogue Scale （VAS） scores，ankle-brachial index （ABI），CT angiography of the lower extremities （diameter of the dorsalis pedis artery，average blood velocity，and blood flow），and serum inflammatory factors［C-reactive protein （CRP），interleukin-6 （IL-6）， and tumor necrosis factor-α （TNF-α）］ of the two group were compared before and after treatment，and the quality of life，satisfaction，and clinical efficacy of patients in the two groups were assessed after treatment. ResultCompared with the conditions before treatment，the two groups showed reduced ulcer areas，VAS scores，mean blood flow rate of dorsal foot artery，CRP，IL-6，and TNF-α levels （P<0.05），increased ABI，dorsum arterial blood flow，and lumen diameter（P<0.05），and improved quality of life （P<0.05）. Compared with the control group after treatment，the experimental group showed superior improvement in the ulcer area，VAS score，ABI，mean blood flow rate of dorsal foot artery，blood flow，and serum inflammatory factors（P<0.05），better quality of life，and higher satisfaction of treatment effect （P<0.05）. Under different treatment protocols，the total clinical effective rate of the experimental group was 92.86%（78/84），higher than 71.43%（60/84） in the control group （χ²=13.070，P<0.05）. ConclusionNegative pressure sealing drainage combined with compound Huangbai liquid for the treatment of diabetic foot can effectively relieve the clinical symptoms in patients，reduce ulcer area and VAS score，improve the blood circulation in dorsalis pedis artery，and decrease the levels of CRP，IL-6，and TNF-α，thereby inhibiting the occurrence of inflammatory reaction.

Objective:To explore the effect of continuous obstetric-pediatric cooperative nursing on anxiety, depression and the parenting sense of competence in NICU premature mothers.Methods:Totally 140 mothers of NICU preterm infants in hospital from January 2018 to December 2018 were selected and randomly divided into the control group and intervention group according to the method of random number table, and each group 70 cases. The control group received the routine nursing mode in obstetrics and paediatrics and the intervention group received the continuous obstetric-pediatric cooperative nursing based on routine nursing. To compare the anxiety level, depression level, the score of parenting sense of competence, hospitalization days of preterm infants, the outpatient rate and the readmission rate of preterm infants within 1 months of discharge between two groups.Results:The levels of anxiety and depression of the mothers of premature infants in the intervention group during hospitalization ,1 week after discharge and 1 month after discharge were (43.17±6.89), (8.96±2.67), (34.65±6.87), (7.65±1.92), (34.97±6.06), (6.29±1.54) points, lower than control group (47.03±8.06), (10.97±3.34), (45.44±7.72), (9.43±2.61), (41.46±7.26), (8.28±2.23) points, the differences between the two groups showed statistical significance ( t value was 2.331-6.097, P<0.05). The two dimensions of parenting efficacy and parenting satisfaction were (31.47±4.97), (43.38±4.21) points, which were higher than (25.91±5.42), (39.43±5.91) points of the control group, there were significant statistical differences among the two groups ( t value was -6.314 and -4.528, P<0.01). The hospitalization days of premature infants, outpatient and readmission rate within 1 month of discharge were (13.25±3.27) days, 8.57% (6/70), 2.86% (2/70), which were shorter or lower than (15.59±2.79) days, 24.29% (17/70), 12.86% (9/70) in the control group, the differences were statistically significant ( t value was 2.909, χ2 values were 6.295, 4.834, P<0.05). There were significant statistical differences among interaction effect, time effect and intergroup effect ( F values were 4.921-99.310, P<0.05). Conclusion:Obstetrical-pediatric cooperative nursing can effectively to lower the anxiety and depression level of preterm mothers, improve the parental competence, promote the mental health of preterm mothers, and ultimately shorten hospital days and decrease the rate of outpatient and readmission of premature infants, which is conducive to preterm infants′ rehabilitation.

Objective: To evaluate the effect of functional training on the improvement of Cobb Angle, ATR and quality of life in adolescent idiopathic scoliosis. Methods: Database of CNKI, WanFang, WeiPu, Web of Science, PubMed were reconnoitered for the purpose of research articles of Interest. Literature was screened according to the inclusion criteria, randomized controlled trials (RCTS) were collected and Cochrane risk bias assessment methodology quality was used, and Revman 5.3 software was used to conduct combined effector subgroup analysis on outcome indicators (Cobb Angle, ATR, SRS-22 patient questionnaire). Results: A total of 10 RCT (398 AIS patients) were included in the study. There were two high , five moderate and three low quality studies, respectively. Compared with other non operative treatments, functional training could reduce Cobb horn in patients, MD = -6.56 (95% CI =-7.30--5.83, P <0.01, I 2=0). Further subgroup analysis showed that there were no statistically significant differences in effect size between the subgroups of Cobb Angle, age, intervention period and control method at the time of inclusion ( P >0.05). Compared with the non intervention blank group, the functional training group could reduce the Cobb Angle of patients ( MD = -5.25 , 95% CI =-8.27- -2.98 , P < 0.01 ), with high heterogeneity ( I 2=61%). Effect on angle of trunk rotation(ATR):functional training group could reduce patients ATR, MD =-1.91 (95% CI =-2.25--1.57, P <0.01, I 2=0). The impact on the quality of life:functional training of patients with SRS-22 questionnaire function, pain had no statistical significance ( P >0.05), and self image ( MD =0.64, 95% CI =0.53- 0.75 , P <0.01), mental health ( MD =0.44, 95% CI =0.15-0.74, P <0.01), satisfaction ( MD = 0.58 , 95% CI =0.11- 1.06 , P = 0.02 ) were statistically significant. Conclusion Functional training can not only reduce the Cobb Angle and ATR of AIS patients, but also improve the quality of life in terms of self image, mental health and satisfaction of the patients. However, due to heterogeneity and bias, more high quality studies are needed to verify.

Nonalcoholic fatty liver disease (NAFLD) has become one of the most prominent causes of chronic liver diseases and malignancies. However, few therapy has been approved. Radix Bupleuri (RB) is the most frequently used herbal medicine for the treatment of liver diseases. In the current study, we aim to systemically evaluate the therapeutic effects of saikosaponin A (SSa) and saikosaponin D (SSd), the major bioactive monomers in RB, against NAFLD and to investigate the underlying mechanisms. Our results demonstrated that both SSa and SSd improved diet-induced NAFLD. Integrative lipidomic and transcriptomic analysis revealed that SSa and SSd modulated glycerolipid metabolism by regulating related genes, like