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

Objective:To investigate the effect of nourishing yin and tonifying yang method on inflammatory response and bone metabolism in patients with T2DM complicated with osteoporosis (OP).Methods:A randomized controlled trial. From January 2022 to December 2023,80 patients with T2DM and OP in our hospital were selected as the observation objects, and they were divided into two groups by random number table method, with 40 cases in each group.On the basis of conventional treatment, the control group chewed vitamin D calcium chewable tablets, and the observation group added nourishing yin and tonifying yang Chinese medicine.Both groups were treated for 6 months. TCM syndrome scores were performed before and after treatment ;the levels of fasting blood glucose (FPG), 2 hPG and HbA1c were detected by intelligent blood glucose monitor;the levels of serum neutrophils and lymphocytes were detected by automatic blood analyzer, and the neutrophil/lymphocyte ratio (NLR) was calculated;the levels of serum IL-1β and TNF-α were detected by automatic chemiluminescence analyzer, the levels of type I procollagen amino terminal propeptide (PINP), type I collagen carboxy terminal peptide β special sequence (β-CTX) and 25-hydroxy vitamin D3 [25-(OH)D3] were detected by ELISA;Bone mineral density (BMD) was detected by bone mineral density detector. The adverse reactions during treatment were observed and recorded, and the clinical efficacy was evaluated.Results:The total effective rate was 92.5 %(37/40) in the observation group and 75.0 % (30/40) in the control group,the difference between the two groups was statistically significant ( χ2=4.50, P=0.034).After treatment, the scores of soreness and weakness of waist and knees, soreness and pain of waist and back, clear and long urine, pale tongue and white coating in the observation group were lower than those in the control group ( t=3.11, 3.75, 3.51, 3.74, P<0.01);the levels of serum FPG, 2 hPG and HbA1c in the observation group were lower than those in the control group ( t=3.11,3.20,3.39, P<0.01).The levels of serum NLR (2.63 ± 0.68 vs. 3.24 ± 0.79, t=3.70), IL-1β [(81.65 ± 8.30) ng/L vs. (89.03 ± 8.98) ng/L, t=3.82] and TNF-α [(35.14 ± 5.11) μg/L vs. (39.96 ± 5.38) μg/L, t=4.11] in the observation group were lower than those in the control group ( P<0.01). After treatment, the levels of PINP [(29.83 ± 3.92) ng/L vs. (34.02 ± 4.03) ng/L, t=4.71] and β-CTX [(21.30 ± 3.95 ) ng/L vs. (25.32 ± 4.18) ng/L, t=4.42] in the observation group were lower than those in the control group ( P<0.01), the levels of 25-(OH)D3 [(42.86 ± 5.12) μg/L vs. (38.08 ± 4.55) μg/L, t=4.41] and BMD [(0.90 ± 0.18) g/cm 3vs. (0.78 ± 0.16) g/cm 3, t=3.15] were higher than those in the control group ( P<0.01).During the treatment, the incidence of adverse reactions was 12.5% (5/40) in the observation group and 10.0 % (4/40) in the control group,there was no significant difference between the two groups ( χ2=0.13, P=0.723). Conclusion:The method of nourishing yin and tonifying yang can effectively improve the TCM syndromes of T2DM patients with OP, reduce the levels of blood glucose and inflammatory factors, improve bone metabolism, improve clinical efficacy and have good treatment safety.

Objective : To investigate the diagnostic value of combined detection of folate receptor-positive circulat- ing tumor cells ( FR + -CTCs) and hemostatic function indicators in improving the diagnosis of gastrointestinal tumors ( GITs) metastasis． Methods: A retrospective analysis was conducted on the clinical data of 115 patients aged 18 to 80 years who were diagnosed with gastrointestinal tumors via pathology and received treatment，including data on FR + -CTCs，hemostatic function indicators，and pathological staging．The collected data encompassed FR + -CTCs levels，coagulation parameters，and pathological staging．Statistical analysis included t-tests，chi-square tests，fish- er ’s exact test，Logistic regression analysis，and receiver operating characteristic ( ROC) curves to assess the diag- nostic value of combined FR + -CTCs and coagulation parameters in detecting tumor metastasis． Results: FR + -CTCs levels and positive rates demonstrated significant associations with clinicopathological characteristics ( gender，histo- logical type，N staging) in GITs patients ( P＜0. 05) ．In patients with metastasis，elevated fibrinogen levels were observed．Adithonallly，platelet counts showed significant increases in N1 －N3 stages ( P＜0. 05) ．Logistic regres- sion analysis showed that PLT and antithrombin Ⅲ ( AT-Ⅲ) were independent risk factors for GITs metastasis ( P＜0. 05) ． The areas under the ROC curves for predicting GITs metastasis were 0. 678 ( 95% CI: 0. 540 - 0. 816) and 0. 664 ( 95% CI: 0. 512 －0. 815) ，respectively．When combining multiple factors，including FR + - CTCs，PLT，AT-Ⅲ , pathological type，FIB，TT，and gender，for the diagnosis of GITs metastasis，the AUC in- creased to 0. 757 ( 95% CI: 0. 621 －0. 893) ，indicating higher sensitivity and specificity compared to using each indicator alone． Conclusion The combined detection of FR + -CTCs and anticoagulation function indicators has a higher diagnostic value for the diagnosis of GITs，providing a valuable basis for the early diagnosis of GITs，espe- cially in metastasis surveillance．

Objective:To evaluate the effects of different exercise therapies on postoperative joint function in patients after total knee arthroplasty (TKA), so as to provide evidence-based evidence for clinical medical staff to choose the best exercise therapy.Methods:China National Knowledge Infrastructure, Wanfang, VIP, Chinese Biomedical Literature Service System, PubMed, Web of Science, Embase, and Cochrane Library were searched for randomized controlled trials of different exercise therapies in patients after TKA from inception to April 1, 2024. Stata 17.0 software was used for network Meta-analysis.Results:A total of 38 articles were included, with 2 921 patients after TKA, exercise therapies involved passive exercise, suspension exercise, Otago exercise, cycling exercise, resistance training, proprioceptive training, virtual reality training, muscle strength training, balance training and motor imagery training. The results of network Meta-analysis showed that in terms of improvement in Hospital for Special Surgery Knee Score (HSS), the top 3 ranking results of surface under the cumulative ranking curve (SUCRA) were cycling (96.0%)>resistance training (84.2%)>proprioceptive training (64.2%). In terms of improvement in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the top 3 SUCRA ranking results were resistance training (99.5%)>motor visualization training (72.3%)>balance training (61.6%). In terms of improvement in pain score, the top 3 SUCRA ranking results were resistance training (70.9%)>motor imagination training (68.1%)>virtual reality training (64.3%). In terms of improvement in Berg Balance Scale, the top 3 SUCRA ranking results were balance training (89.8%)>virtual reality training (83.5%)>proprioceptive training (55.9%). In terms of improvement of knee flexion range of motion, the top 3 SUCRA ranking results were suspension exercise (82.2%)>proprioceptive training (68.4%)>Otago exercise (63.9%).Conclusions:Cycling exercise is the best exercise therapy to improve HSS, resistance training is the best exercise therapy to reduce WOMAC and relieve pain, balance training is the best exercise therapy to improve balance function, suspension exercise is the best exercise therapy to increase knee flexion range of motion, the above 4 exercise therapy have advantages in improving knee function of patients after TKA.

Objective:To evaluate the effects of different exercise therapies on postoperative joint function in patients after total knee arthroplasty (TKA), so as to provide evidence-based evidence for clinical medical staff to choose the best exercise therapy.Methods:China National Knowledge Infrastructure, Wanfang, VIP, Chinese Biomedical Literature Service System, PubMed, Web of Science, Embase, and Cochrane Library were searched for randomized controlled trials of different exercise therapies in patients after TKA from inception to April 1, 2024. Stata 17.0 software was used for network Meta-analysis.Results:A total of 38 articles were included, with 2 921 patients after TKA, exercise therapies involved passive exercise, suspension exercise, Otago exercise, cycling exercise, resistance training, proprioceptive training, virtual reality training, muscle strength training, balance training and motor imagery training. The results of network Meta-analysis showed that in terms of improvement in Hospital for Special Surgery Knee Score (HSS), the top 3 ranking results of surface under the cumulative ranking curve (SUCRA) were cycling (96.0%)>resistance training (84.2%)>proprioceptive training (64.2%). In terms of improvement in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the top 3 SUCRA ranking results were resistance training (99.5%)>motor visualization training (72.3%)>balance training (61.6%). In terms of improvement in pain score, the top 3 SUCRA ranking results were resistance training (70.9%)>motor imagination training (68.1%)>virtual reality training (64.3%). In terms of improvement in Berg Balance Scale, the top 3 SUCRA ranking results were balance training (89.8%)>virtual reality training (83.5%)>proprioceptive training (55.9%). In terms of improvement of knee flexion range of motion, the top 3 SUCRA ranking results were suspension exercise (82.2%)>proprioceptive training (68.4%)>Otago exercise (63.9%).Conclusions:Cycling exercise is the best exercise therapy to improve HSS, resistance training is the best exercise therapy to reduce WOMAC and relieve pain, balance training is the best exercise therapy to improve balance function, suspension exercise is the best exercise therapy to increase knee flexion range of motion, the above 4 exercise therapy have advantages in improving knee function of patients after TKA.

Objective:To examine the risk factors and predictive value of depression following mild acute ischemic stroke in elderly individuals.The aim is to enhance early identification and intervention, ultimately leading to improved prognosis.Methods:A case-control study was conducted on 988 elderly patients with mild acute ischemic stroke.The study collected general population and social data, as well as clinical laboratory data such as blood glucose, blood lipids, and AD7C-NTP in urine.Additionally, the patients underwent assessments using the Montreal Cognitive Assessment Scale(MoCA), National Institutes of Health Stroke Scale(NHISS), Barthel index(BI), Hamilton Anxiety Scale(HAMA), and Hamilton Depression Scale(HAMD).Based on the HAMD depression scale score, the patients were divided into a nopost-stooke depression(NPSD)group and a post-stooke depression(PSD)group.The study then analyzed the related risk factors and predictive value of PSD.Results:A total of 988 patients were eligible for inclusion, with 132 being excluded and 856 being included.The NPSD and PSD groups showed significant differences in age, hypertension, smoking history, education level, and stroke history(all P<0.05).Regarding clinical data, there were statistically significant differences between the two groups in total cholesterol(TC), triacylglycerol(TG), HDL, urinary AD7C-NTP, MoCA, and HAMA scores(all P<0.05).The results of the multi-factor logistic regression analysis revealed that gender( OR=1.975, 95% CI: 1.223-3.190, P=0.005), stroke history( OR=1.352, 95% CI: 0.877-2.086, P=0.042), and HAMA score( OR=1.216, 95% CI: 0.932-1.526, P=0.043)were identified as independent risk factors for post-stroke depression in the elderly.Conversely, MoCA score( OR=0.873, 95% CI: 0.814-0.937, P<0.001)was found to be an independent protective factor.Furthermore, the ROC curve analysis demonstrated that the HAMA score(AUC=0.892, sensitivity: 0.721, specificity: 0.854, cut-off value: 9.5)exhibited significant predictive value, while the other indexes had limited predictive value. Conclusions:Gender, stroke history, and HAMA score have been identified as potential independent risk factors for post-stroke depression(PSD)in the elderly, while MoCA score may serve as an independent protective factor.Notably, HAMA score demonstrates a strong predictive ability for PSD.Early identification of these factors and timely intervention could significantly contribute to improving prognosis.

Objective: To understand the current situation and related factors of tobacco use among high school students in Shannan City, so as to provide reference for tobacco control strategies for high school students. Methods: A self administered questionnaire survey was conducted among 10 052 high school students from 6 high schools in Shannan City, Tibetan Autonomous Region by census methods from April to July in 2023. The comparison of rates was conducted by using Chi square test, and the influencing factors of tobacco use among high school students were analyzed using binomial classification Logistic regression. Results: The rate of high school students in Shannan City trying cigarettes was 17.63%, and the current smoking rate was 10.07%, both of which were higher in boys than girls, and higher in urban areas than in rural areas ( χ 2 gender = 1 262.35 , 869.79; χ 2 area =35.90, 29.16, P <0.01). The smoking rate of students with parents and good friends smoking was higher than that of students with parents and good friends not smoking( χ 2= 190.50 ,1 741.44), and the current smoking rate showed an upward trend with age and age ( χ 2 trend =74.87, 122.86)( P <0.01). The tobacco dependence rate was 41.80%; 75.30% wanted to quit smoking, 83.99% had received smoking cessation assistance, but had received less professional smoking cessation assistance ( 13.41 %). Logistic regression analysis showed that vocational high school students, senior students (second and third grade), parents smoking (both smoking, mother smoking), and good friends smoking (some smoking, most smoking, all smoking) were positively correlated with smoking cigarettes among high school students ( OR=1.51, 1.54, 2.17, 2.22, 1.69, 5.30, 13.28, 8.59, P <0.05). Conclusions The smoking rate of high school students in Shannan City is high and second hand smoke exposure is common. Vocational high schools are the key to prevention and control. Effective cooperation between families, schools, and society should be strengthened to create a smoke free environment and protect students from tobacco hazards.

Objective To develop a portable,modular and multifunctional surgical instrument kit with intelligent recognition for disaster relief.Methods The surgical instrument kit had three variations for thorax and abdomen,limbs and cranium and brain,which was composed of a lip,partitions and drawers.A traceability code was pasted on each surgical instrument kit,and each instrument in the kit was equipped with a RF chip.Results The surgical instrument kit made the average time for operating table preparation and instrument arrangement and that for instrument counting both shortened effectively,and thus the efficiency of medical staffs were enhanced greatly.Conclusion The surgical instrument kit gains advantages in rational configuration and easy operation,and can be used for surgical operation in disaster conditions.[Chinese Medical Equipment Journal,2024,45(2):113-117]

Objectives:To investigate the effect of cardiac rehabilitation exercise guided by cardiopulmonary exercise test on cardiopulmonary function, cardiopulmonary endurance and activities of daily living in patients who had coronary heart disease after percutaneous coronary intervention (PCI).Methods:Seventy patients who had coronary heart disease after PCI treated in the Wenzhou Central Hospital from July 2022 to May 2023 were enrolled perspectively (3 cases eventually dropped out of the study), and they were divided into the control group (33 cases) and the rehabilitation group (34 cases) by random number table method. The control group was given conventional medication after PCI, while the rehabilitation group was additionally provided with exercise rehabilitation for 12 weeks on the basis of the control group. The patient′s cardiopulmonary function indicators, cardiopulmonary endurance indicators and ability of daily living(ADL) score of the two groups were compared before and after treatment.Results:After treatment for 12 weeks, the cardiopulmonary function indicators left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left atrial inner diameter (LAD), left ventricular end-diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), forced expiratory volume in the first second (FEV 1), ratio of FEV 1 to forced expiratory volume (FVC) (FEV 1/FVC), maximum ventilation quantity (MVV) in the rehabilitation group were obviously improved compared with the control group: (102.8 ± 14.4) ml vs. (114.8 ± 20.4) ml, (39.9 ± 13.7) ml vs. (48.4 ± 16.9) ml, (37.1 ± 3.4) mm vs. (38.9 ± 3.6) mm, (50.3 ± 3.6) mm vs. (52.5 ± 4.7) mm, (64.0 ± 6.8)% vs. (59.6 ± 6.5)%, (2.39 ± 0.38) L vs. (2.10 ± 0.26) L, (77.7 ± 4.0)% vs. (73.8 ± 4.3)%, (101.6 ± 18.7) L/min vs. (89.6 ± 11.1) L/min, there were statistical differences ( P<0.05). After treatment for 12 weeks, the cardiopulmonary endurance indicators peak oxygen uptake (VO 2peak), peak oxygen uptake per kilogram of body weight (VO 2peak/kg), anaerobic threshold (AT), peak metabolic equivalent (METspeak), maximum working load (MWL) in the rehabilitation group were obviously improved compared with the control group: (1 441.8 ± 251.9) ml/min vs. (1 272.5 ± 207.0) ml/min, (20.7 ± 3.6) ml/(min·kg) vs. (18.2 ± 2.5) ml/(min·kg), (1 346.8 ± 201.3) ml/min vs. (1 075.4 ± 176.7) ml/min, (5.9 ± 1.1) Met vs. (5.2 ± 0.7) Met, (107.3 ± 29.1) Watt vs. (88.4 ± 17.8)Watt, there were statistical differences ( P<0.05). After treatment for 12 weeks, the ADL scores in the rehabilitation group was higher than that in the control group: (90.9 ± 8.1) scores vs. (85.6 ± 11.6) scores, there was statistical difference ( P<0.05). Conclusions:Carrying out cardiac rehabilitation exercise guided by cardiopulmonary exercise test can significantly enhance the cardiopulmonary function, cardiopulmonary endurance and self-care ability in patients who had accepted PCI for coronary heart disease.