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 specific method, efficacy and safety of intrathecal baclofen (ITB) in the treatment of moderate and severe spasticity.Methods:The clinical features, response to ITB trial, clinical outcomes and treatment-related complications after baclofen pump implantation surgery were retrospectively analyzed in patients with moderate to severe spasticity who received ITB treatment in Hong Kong University Shenzhen Hospital from August 2022 to August 2023.Results:The study included 22 patients with moderate to severe spasticity, of whom 18 patients (81.8%) were effective in ITB trial. For these patients with effective trial, the lowest mean Modified Ashworth Scale (MAS) score of lower extremity muscle groups after ITB bolus injection was decreased significantly compared with the baseline mean value before injection (1.29±0.81 vs 3.31±1.18 , t=11.364, P<0.001), and the M/H amplitude ratio of soleus H-reflex at 4 hours after ITB bolus injection was significantly higher than the baseline value (9.61±4.66 vs 3.83±2.69, t=7.780, P<0.001). Among the 18 patients with effective ITB trial, 10 patients received baclofen pump implantation surgery with the informed consent of the patients or their guardians. Compared with the 8 patients without surgery, the baseline mean MAS score of lower extremity muscle groups of the 10 patients who received surgery was higher (3.71±1.06 vs 2.83±1.16, F=5.645, P<0.05), the maximum reduction of mean MAS score of lower extremity muscle groups of the 10 patients who received surgery was greater (2.61±0.99 vs 1.30±0.64, F=20.696, P<0.001). In 10 patients who received baclofen pump implantation surgery, the mean MAS score of lower limb muscle groups was significantly decreased in the first and sixth months after surgery compared with the baseline mean value before surgery (1.64±0.91, 1.16±0.89 and 3.71±1.06, F=39.946, P<0.001). Among them, 2 patients were followed up to 12 months after surgery, 2 patients were followed up to 18 months after surgery, and the mean MAS score of their lower limb muscle groups showed continuous improvement, and 1 patient with cerebral palsy combined with lower urinary tract hyperactive syndrome also showed significant improvement of urgent urinary incontinence after surgery. Up to the last follow-up, the daily dose of baclofen in 10 patients receiving baclofen pump implantation was (143.60±96.24) μg, and no treatment-related complications occurred. Conclusions:ITB can effectively relieve spasticity symptoms and other related neurological dysfunction in patients with moderate and severe spasticity, and the efficacy can be maintained for a long time, and treatment-related complications are rare. Preoperative ITB trial is helpful to screen out patients more suitable for baclofen pump implantation. Patients with higher grade of spasticity at baseline and better efficacy of ITB trial are more suitable for baclofen pump implantation. The soleus H reflex can effectively reflect the change of stretch reflex of lower limb muscle groups in patients with spasticity treated by ITB, and can be used to evaluate the treatment effect of ITB.

Objective To establish a method to characterize the size and density of the female breast based on three-dimensional images of breast cone-beam computed tomography (CBCT), and describe the breast characteristics of women in a region of China, and to explore its value in dosimetric assessment for breast CBCT examinees. Methods We retrospectively surveyed the breast CBCT images of 203 women in a grade A tertiary hospital in a southwestern city of China from January 2021 to March 2023. The effective diameter of the breast at the chest-wall (D_eff), chest wall-to-nipple length (CNL), the effective diameter of the breast at half of CNL (D_h/2), breast volume (BV), glandular volume (GV), and volumetric breast density (VBD) were measured using the specific tools of the Koning Imaging Viewer system. The differences between groups were assessed using the Kruskal-Wallis H test. The correlation between variables was assessed using the Spearman’s correlation coefficient. Results The median values of D_eff, D_h/2, CNL, BV, GV, and VBD of the surveyed population were 11.9 cm, 8.3 cm, 6.5 cm, 327.7 cm³, 47.0 cm³, and 15.4%, respectively. GV and VBD had significant negative correlations with age. D_eff, D_h/2, CNL, and BV were significantly negatively correlated with VBD. Conclusion We established a quantitative method to analyze female breast characteristics based on three-dimensional breast CBCT images, and preliminarily characterized the female breast in a region of China, which can provide methodological support for the investigation of female breast characteristics in various regions of China in the future.

Coronaviruses (CoVs), a family of enveloped positive-sense RNA viruses, are characterized by club-like spikes that project from their surface, unusually large RNA genome, and unique replication capability. CoVs are known to cause various potentially lethal human respiratory infectious diseases, such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and the very recent coronavirus disease 2019 (COVID-19) outbreak. Unfortunately, neither drug nor vaccine has yet been approved to date to prevent and treat these diseases caused by CoVs. Therefore, effective prevention and treatment medications against human coronavirus are in urgent need. In the past decades, many natural compounds have been reported to possess multiple biological activities, including antiviral properties. In this article, we provided a comprehensive review on the natural compounds that interfere with the life cycles of SARS and MERS, and discussed their potential use for the treatment of COVID-19.

Tumor neovascularization plays an important role in the occurrence, development and metastasis of cancer. Non-invasive quantification and detection of tumor neovascularization is crucial for early diagnosis and prognosis assessment of cancer. Targeted molecular imaging has arisen in vascular targeting imaging and precise treatment based on the molecular characteristics of neovascularization. Aminopeptidase N (APN, or CD13) is a multifunctional membrane-bound exopeptidase that is overexpressed in neovascular endothelial cells and some tumor cells but rarely expressed in normal blood vessels, which makes it a potential target for tumor neovascularization imaging and anti-angiogenic therapy. This review summarizes the application progress and the future development trend of target molecular imaging and precise treatment based on CD13.

Objective: To compare the efficacy of intra-articular injection of autologous platelet-rich plasma (PRP) with that of sodium hyaluronate for patients with knee osteoarthritis (KOA). Methods: Fifty KOA patients were randomly divided into a PRP group (n=25) and a sodium hyaluronate group (n=25). Those in the PRP group were injected intra-articularly with 5 ml of autologous PRP every 2 weeks for 6 consecutive weeks, while the sodium hyaluronate group was given intra-articular injections of 2 ml of sodium hyaluronate once a week for 6 weeks. Both groups performed isokinetic strength training three times a week for 6 weeks. Before as well as 6 weeks, 3 months, 6 months and 12 months after the treatment, both groups were followed and evaluated using the Western Ontario and McMaster University osteoarthritis index (WOMAC). A Biodex System 4 isometric muscle strength testing system was used to evaluate the knees′ peak torque (PT) in flexion and extension, total power (TW), and average power (AP). Results: Before the treatment there were no significant differences in pain, stiffness or average WOMAC score between the two groups. Afterward significant improvement was observed in the pain, stiffness and WOMAC scores of both groups. Compared with the sodium hyaluronate group, significantly greater decreases in the average WOMAC pain score were observed in the PRP group after the different intervals. That was also true of the average stiffness scores and the overall average WOMAC scores after 6 and 12 months. The flexor and extensor PT, TW and AP at the angular velocities of 60°/s and 90°/s also improved significantly in both groups after 6 weeks and 12 months, with the improvement of the PRP group significantly greater than that in the control group at the same time points. Conclusion Intra-articular injection of either autologous PRP or sodium hyaluronate can effectively alleviate the clinical symptoms of KOA when combined with isokinetic strength training. However, PRP is the more effective. Its use is worthy of clinical application and promotion.

Objective To analyze the characteristic of Yunnan unexpected sudden death (YUSD) cases by pathological diagnosis of arrhythmogenic right ventricular cardiomyopathy (ARVC),in order to offer clue for ARVC etiologic research of YUSD.Methods The pathological diagnosis results of 9 cases of sudden death of ARVC in Yunnan,as well as epidemiological investigation data,were used to comprehensively analyze the pathological features of the pathological diagnosis of ARVC in Yunnan.Results The 9 cases including 8 females and 1 male,aged 16-47 years.The sudden death time was from June to August,mainly distributed in 8 families from the disease seriously ridden 7 villages.Three of them had a genetic history of family YUSD,2 cases had a history of mental stimulation,1 case had eaten Trogia venenata;and acute symptoms and signs were palpitation,chest tightness,shortness of breath,and loss of consciousness.Pathological observations were the typical ARVC change,mainly right ventricular lesions,with different degrees of cardiac enlargement and extensive adipose tissue infiltration in the ventricular wall.Among them,6 cases of fat infiltration almost reached the full thickness of the heart wall.In addition to the pathological changes of ARVC,8 cases were accompanied by one or several pathological changes in myocarditis,cardiac dysplasia,nephropathy,pulmonary edema,pneumonia and pancreatitis.Of the 9 cases,5 cases were diagnosed with ARVC,2 cases with ARVC and pulmonary edema,1 case with ARVC and acute hemorrhagic necrotizing pancreatitis,and 1 case with ARVC and Trogia venenata poisoning.The clinical examination abnormalities of the family members of the cases mainly showed arrhythmogenic electrocardiography changes and abnormal myocardial enzymes.Conclusions The nine cases have showed typical epidemiology characteristics of YUSD,and cardiachistological changes are consistent with the ARVC pathological diagnostic criteria.A part of YUSD cases may be caused by ARVC,and the inference will be proved by cadaveric pathologic examination and related pathogenic gene detection.

Objective To understand the situation of iodine deficiency disorders and iodine nutrition of children in Yunnan Province after the implementation of new standard of salt iodine,and provide the basic data for prevention and control of iodine deficiency disorders.Methods Using multistage sampling method,Yunnan provincial evaluations for iodine deficiency disorders elimination were carried out.According to the comparative analysis of 2010 (pre-adjustment) and 2015 (post-adjustment) evaluation results,the changes of the median of salt iodine,the coverage rate of iodized salt,the qualified rate of iodized salt,the rate of qualified iodized salt consumption,goiter rate of school children aged 8-10 and the median of urinary iodine were evaluated.Salt iodine was tested using the "Salt Industry General Test Method for Determination of Iodine" (GB/T 13025.7-1999);thyroid volume examination of children using B-scan ultrasonography,thyroid volume calculation and enlargement judgment using "Diagnostic Criteria for Endemic Goiter" (WS 276-2007);and urinary iodine detection using "Urinary Iodine Arsenic Cerium Catalytic Spectrophotometry" (WS/T 107-2006).Results The medians of salt iodine in 2010 and 2015 were 30.6 and 22.4 mg/kg,respectively,the difference was statistically significant (U =317 503.50,P ＜ 0.01).The coverage rates of iodized salt in 2010 and 2015 were 99.6％ (1 681/1 688) and 98.9％ (2 592/2 622),the qualified rates of iodized salt were 98.6％ (1 657/1 681) and 89.7％ (2 325/2 592),and the rates of qualified iodized salt consumption were 98.2％ (1 657/1 688) and 88.7％ (2 325/2 622),and the differences were statistically significant (x2 =6.42,125.11,130.18,P ＜ 0.01);the rates of children goiter in 2010 and 2015 were 0.8％ (25/3 272) and 1.4％(44/3 245),respectively;the medians of urinary iodine of children were 289.0 and 157.3 μg/L,respectively,the difference was statistically significant (U =1 121 669.50,P ＜ 0.01).Conclusion After decreasing of salt iodine level starting from 2012 in Yunnan Province,the children iodine nutrition condition is in a more proper level.

Objective In this study,we explored the role of combination of autophagy inhibition and anti-VEGF in proliferation,migration and tube formation of mouse retinal vascular endothelial cells(RVECs). Methods Well cultured mouse RVECs were randomly divided into four groups:autophagy inhibition group(add-ing autophagy inhibitor 3-MA),anti-VEGF group(adding anti-VEGF-A neutralized antibody),autophagy inhibi-tion+anti-VEGF group(adding the two reagents)and the control group.All cells were then cultured in the hypoxic condition. The cell proliferation,migration and tube formation were detected by EdU,transwell and matrigel as-say,respectively. Results The cell proliferation rate,number of migrated cells and number of tube formation of the other three groups decreased when compared with the control group.These data above in autophagy inhibition+anti-VEGF group were all significantly less than 3-MA group and anti-VEGF group. Conclusion Combination of autophagy inhibition and anti-VEGF may be more effective than simple anti-VEGF in inhibition of retinal neovascu-larization.

Purpose To explore the correlation between multi-slice spiral CT (MSCT) findings of pancreatic neuroendocrine tumor (pNET) and different histological grades,so as to improve the diagnostic accuracy.Materials and Methods MSCT data of 35 pathologically confirmed pNET were retrospectively analyzed.All patients underwent CT plain scan and three-phased contrast-enhanced CT scan.The imaging features and the enhanced parameters in each stage were analyzed.Results Among the 35 pNET,there were 15 G 1,15 G2 and 5 G3.There was no statistically significant difference in age,gender and endocrine function among different grades (P＞0.05).The number of lesions with intact capsule in G1,G2 and G3 was 11,5 and 0,respectively;the number of lesions with cystic change or necrosis was 3,9,and 4,respectively;and the number of lesions with sign of malignancy (locally invasion or metastasis) was 1,1 and 4,respectively.The differences in completeness of capsule,cystic change or necrosis and sign of malignancy among different grades were all statistically significant (P＜0.05).Multivariate analysis suggested that only peripancreatic tissue invasion or metastasis was significantly associated with pathological classification (OR=0.09,95％ CI 0.01-0.86,P＜0.05).The three-stage absolute enhanced degree and the enhanced percentage of pNET in different grades,as well as the relative enhanced degree between lesions in arterial phase and portal venous phase were all statistically significantly different (P＜0.05).Conclusion The MSCT findings of pNET with different pathological grades have certain characteristic.Peripancreatic tissue invasion or metastasis is associated with high-grade tumors,and CT features of different grades can contribute to the preoperative grading of pancreatic neuroendocrine tumors.