1.Development of a dual-track predictive model for active ankylosing spondylitis by combining the sacroiliac joint resistance index and systemic immune-inflammation index
Yuhong OUYANG ; Jianxiong ZHENG ; Xing ZHANG ; Wenjiao KANG ; Qianqiong CHEN ; Haili SHEN
Chinese Journal of Rheumatology 2026;30(2):1-8
Objective:To construct a "local-systemic" dual-track prediction model integrating the resistance index (RI) score of bilateral sacroiliac joints and the systemic immune-inflammation index (SII), and to evaluate its predictive efficacy for the active stage of ankylosing spondylitis (AS).Methods:A total of 205 patients with ankylosing spondylitis (AS) from the Second Hospital of Lanzhou University between April 2022 and April 2025 were retrospectively enrolled and categorized into an active group ( n=113) and a remission group ( n=92). Hematological parameters and ultrasound data were collected. The resistance index (RI) of the synovial area in bilateral sacroiliac joints was measured by Doppler ultrasound and scored as follows: RI < 0.5: 3 points; RI 0.5~0.55: 2 points; RI > 0.55: 1 point; undetectable blood flow: 0 points. A total bilateral RI score (range 0 to 6) was calculated. The systemic immune-inflammation index (SII) was derived as (neutrophils× platelets)/lymphocytes. Normality was tested for all continuous variables; normally distributed data were compared using the t-test, while non-normally distributed data were analyzed with the Mann-Whitney U test. Categorical variables were compared using the χ2 test or analysis of variance.Variable selection was performed using Lasso regression, and a multivariate logistic regression model was developed to assess predictive performance. Results:The proportion of patients with a bilateral RI total score≥5 was significantly higher in the active group compared to the remission group (50 of 113, 44.3% vs 2 of 92, 2.2%, χ2=55.63, P<0.001). Multivariate logistic regression analysis, after adjustment for confounding variables, identified the SII [ OR(95% CI)=1.01(1.00, 1.01), P<0.001], bilateral RI total score [ OR(95% CI)=1.67(1.29, 2.26), P<0.001], erythrocyte sedimentation rate [ OR(95% CI)=1.19(1.11, 1.30), P<0.001], and mean corpuscular hemoglobin concentration [ OR(95% CI)=1.09(1.03, 1.17), P<0.001] as independent risk factors for active AS. Conversely, lymphocyte count [ OR(95% CI)=0.42(0.18, 0.92), P=0.030] and globulin [ OR(95% CI)=0.89(0.80, 0.99), P=0.040] were significantly associated with protective effects. The bilateral RI total score demonstrated the strongest predictive effect, with each 1-point increase associated with a 67% elevation in the risk of active disease. ROC curve analysis indicated that the area under the curve (AUC) for predicting whether AS is in the active disease phase was 0.94 for the combined model (SII+bilateral RI total score), compared with 0.93 for the SII-alone model and 0.92 for the bilateral RI total score-alone model, demonstrating superior predictive performance of the combined model (SII+bilateral RI total score). An online prediction tool has been developed based on the combined model. Conclusion:The dual-track prediction model, which integrates local joint hemodynamic characteristics and systemic immune-inflammatory status, facilitates a multidimensional assessment of the risk of active AS and provides an objective basis for early identification.
2.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
Chunyan GUO ; Yi ZHANG ; Yuxin YANG ; Yuguang LIANG ; Qian DING ; Qian WANG ; Chengyue ZHANG ; Yu SUN ; Peng GUO
China Pharmacy 2026;37(9):1206-1210
OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis (RCA) in a problem-oriented manner combined with knowledge-attitude-practice (KAP) theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group, and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials, while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge, attitude and practice on the basis of routine pharmaceutical services, according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products, as well as the incidences of minor and major protocol violations, were all significantly lower in the observation group than in the control group ( P <0.001). The main types of protocol violations in both groups included missed/under-/over-dosing of medications, non-adherence to administration time, failure to adjust dosage as required, and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations, the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group ( P <0.001, P <0.001, P =0.025). However, there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups ( P >0.05). CONCLUSIONS Pharmaceutical services led by pharmacists, based on problem-oriented RCA and combined with KAP theory, can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials, thereby safeguarding the safety and rights of study participants.
3.Change in the number of peripheral blood regulatory T cells in patients with chronic kidney disease and its correlation with vascular calcification
Di ZHANG ; Hui WU ; Jing CHEN ; Liyu LIN ; Shaomin GONG ; Xiaoyan ZHANG ; Xiaoqiang DING ; Han ZHANG
Chinese Journal of Clinical Medicine 2026;33(2):285-292
Objective To explore the number of peripheral blood regulatory T cells (Treg) in patients with chronic kidney disease (CKD) and its correlation with vascular calcification. Methods This was a single-center, cross-sectional, and observational study. Non-dialysis patients with CKD treated at Zhongshan Hospital, Fudan University from March 2021 to March 2022 were enrolled. Abdominal aortic calcification (AAC) was assessed using lateral abdominal X-ray. Number of Treg and cytokine levels were measured by flow cytometry. Logistic regression analysis was performed to evaluate the related factors for AAC in CKD patients. Results A total of 83 patients were included, aged 17–86 years, with 57 males (68.7%). The distribution of CKD stages was as follows: stage G1 in 7 patients (8.4%), stage G2 in 17 patients (20.5%), stage G3 in 21 patients (25.3%), stage G4 in 19 patients (22.9%), and stage G5 in 19 patients (22.9%). No AAC was observed in patients with stages G1 and G2, while the prevalence of AAC in patients with stages G3, G4, and G5 was 23.8%, 21.1%, and 26.3%, respectively. Compared with stage G1 patients, those with stages G3–5 showed decreased number of peripheral blood Treg and elevated levels of interleukin (IL)-6 and IL-17F (P<0.05). The area under the receiver operating characteristic curve for number of peripheral blood Treg in predicting AAC in CKD patients was 0.766 (95%CI 0.652–0.879, P=0.002). Logistic regression analysis showed that decreased number of Treg was related factor for AAC in CKD patients (OR=0.957, 95%CI 0.922–0.992, P=0.018). Conclusion As CKD progresses, number of peripheral blood Treg significantly decreases, which is correlated with AAC in CKD patients.
4.Analysis of drug resistance and infection-related risk factors of carbapenem-resistant Klebsiella pneumoniae and extended-spectrum β-lactamase-producing Escherichia coli in patients with severe pneumonia in ICU
Baocheng ZHANG ; Sheng’an DIAO ; Jie SHEN ; Yiru SHAO
Chinese Journal of Clinical Medicine 2026;33(2):293-298
Objective To analyze the rates of drug resistance of carbapenem-resistant Klebsiella pneumoniae (CRKP) and extended-spectrum β-lactamase-producing Escherichia coli (ESBL-E.coli) in bronchoalveolar lavage fluid (BALF) of critically ill patients with severe pneumonia and artificial airway and risk factors of CRKP. Methods Patients with severe pneumonia and artificial airway treated in the Center of Emergency and Intensive Care Unit, Jinshan Hospital, Fudan University from May 2022 to May 2025 were selected. Klebsiella pneumoniae (K. pneumoniae) and Escherichia coli (E.coli) isolated and cultured from BALF of these patients were analyzed. The drug resistance rates of the two bacteria were compared. The multivariate logistic regression was used to analyze related risk factors for CRKP infection. Results A total of 384 patients were included, and 384 strains were cultured, including 330 strains (85.9%) of K. pneumoniae and 54 strains (14.1%) of E.coli. The infection rate of K. pneumoniae was higher. Compared with E.coli, the drug-resistant gene expression rate of K. pneumoniae was lower (37.3% vs 57.4%, P<0.01). The resistance rates of CRKP to cefotaxime, cefepime, aztreonam, and imipenem were higher than those of ESBL-E.coli (P<0.003). Both CRKP and ESBL-E.coli had high sensitivity to polymyxin and tigecycline. Multivariate logistic regression showed duration of mechanical ventilation ≥ 7 days, and combination of ≥ 2 antibiotics for over 7 days were independent risk factors for CRKP infection (P<0.01). Conclusions For patients with severe pneumonia and artificial airway in ICU, K. pneumoniae is the main bacterial infection. CRKP and ESBL-E.coli in BALF exhibit different degrees of drug resistance to various antibacterial agents, both have the characteristic of multidrug resistance, and are sensitive to polymyxin and tigecycline. Prevention and control of risk factors related to CRKP should be formulated particularly.
5.Efficacy and safety of CT-guided radiofrequency ablation as a surgical alternative for multiple pulmonary nodules
Changhui MA ; Bin ZHANG ; Linxiang YU ; Zhong GUAN ; Junyi YANG ; Haiwen ZHEN
Chinese Journal of Clinical Medicine 2026;33(2):299-305
Objective To evaluate the efficacy and safety of CT-guided percutaneous radiofrequency ablation (RFA) as an alternative for video-assisted thoracoscopic surgery (VATS) in treating multiple pulmonary nodules. Methods A retrospective analysis was conducted on the clinical data of 113 patients with multiple pulmonary nodules admitted to Jiangsu Provincial Hospital of Traditional Chinese Medicine from October 2020 to October 2022. The patients were divided into the RFA group (n=50) and the VATS group (n=63) based on the treatment method. Perioperative indicators (operation time, intraoperative blood loss, postoperative length of hospital stay), oncological outcomes (recurrence-free survival [RFS], overall survival [OS]), and postoperative complication rates were compared between the two groups. Univariate and multivariate Cox regression analysis was performed to identify independent prognostic factors. Results The operation time in the RFA group was significantly shorter than that in the VATS group ([75.2±20.1] min vs [102.3±28.7]) min, P<0.001). No statistically significant differences were observed in intraoperative blood loss and postoperative length of hospital stay. After follow-up of 24 (12, 30) months, no statistically significant differences were found in RFS (HR=1.25, P=0.445) or OS (HR=1.42, P=0.402) between the two groups. Mixed ground-glass nodules with high solid component and solid nodule were identified as independent risk factors for RFS (HR=2.44, P=0.023; HR=2.97, P=0.007) and OS (HR=2.87, P=0.022; HR=3.43, P=0.005) in patients with multiple pulmonary nodules. The total complication rate in the RFA group was lower than that in the VATS group (12.0% vs 34.9%, P=0.009). Conclusions The efficacy of CT-guided RFA in treating multiple pulmonary nodules is comparable to that of VATS, with good safety, and it shows promise as an alternative to surgical treatment for multiple pulmonary nodules.
6.Research progress on the prevention and treatment of drug-induced myocardial injury related to anti-tumor therapy with Chinese traditional medicine
Yanan GU ; Guoping LI ; Wei ZHANG ; Dingfang CAI ; Xiaolin WANG
Chinese Journal of Clinical Medicine 2026;33(2):330-338
With the widespread application of chemotherapy, immunotherapy, and targeted therapy, cardiotoxicity associated with anti-tumor treatment has gained increasing attention. Drug-induced cardiac injury can significantly impact patients’ quality of life and may even limit the overall efficacy of anti-tumor therapy. The underlying mechanisms include oxidative stress, inflammatory responses, mitochondrial dysfunction, apoptosis, and immune dysregulation. Owing to multitarget effects, low toxicity, and holistic regulatory properties, Chinese traditional medicines have demonstrated considerable potential in cardioprotection. This review summarizes the principal mechanisms of drug-induced myocardial injury related to anti-tumor therapy and highlights recent advances in the prevention and treatment of cardiotoxicity using Chinese medical formulae, such as compound danshen dripping pills, nuanxinkang, qili qiangxin capsules, and shengmai powder, as well as their bioactive constituents. The cardioprotective effects of these agents are discussed in terms of their antioxidative, anti-inflammatory, immunomodulatory, and mitochondrial-protective actions. Furthermore, it highlights certain traditional medicines that exhibit unique advantages in synergistic cardioprotective and anti-tumor therapy. Future efforts should focus on well-designed, systematic clinical studies to facilitate the translational application of integrated Chinese and Western medicine in cardio-oncology.
7.Construction and analysis of machine learning models for preoperative prediction of glioma grading and isocitrate dehydrogenase mutation status
Yuting WANG ; Junle ZHU ; Shuang QIN ; Saifei SUN ; Xin ZHANG ; Qi LÜ
Chinese Journal of Clinical Medicine 2026;33(1):3-15
Objective To construct machine learning models based on preoperative inflammatory and radiological features for the prediction of glioma grading and isocitrate dehydrogenase (IDH) mutation status, and to analyze application values of these models and identify the optimal predictive models. Methods A retrospective analysis was conducted on the data of pathologically confirmed glioma patients admitted to Tongji Hospital Affiliated to Tongji University from March 2019 to March 2023. LASSO regression was used to screen feature variables, and predictive models were constructed based on logistic regression (LR), random forest (RF), support vector machine (SVM), gradient boosting decision tree (XGBoost) and K-nearest neighbor (KNN) algorithms. The model performance was comprehensively evaluated using metrics including discrimination ability, area under the precision-recall curve (AUC), accuracy, F1 score and Brier score. The DeLong test was adopted to compare the AUC values among different models; Friedman rank-sum test was used to determine the overall performance differences of the models, with the Nemenyi test applied for multiple comparison correction. Results In the task of glioma grading prediction, the LR model achieved the highest comprehensive score (0.726), and no significant difference was observed between the LR model and the other four models; age was positively correlated with glioma grading (P=0.003). In the task of IDH mutation status prediction, the XGBoost model obtained the highest comprehensive score (0.832), which was superior to the LR (0.762, P=0.035) and KNN models (0.754, P=0.025), while no statistical differences were found between the XGBoost model and the RF or SVM models. Conclusions The LR model for glioma grading prediction and XGBoost model for IDH mutation prediction constructed based on a task-oriented strategy achieve a favorable interpretability while ensuring optimized performance, thereby providing reliable decision support for the individualized diagnosis and treatment of glioma.
8.Effectiveness of generative large language model MedGo in nursing decision-making for elderly patients with multimorbidity
Qiaoyun YAN ; Min LI ; Yawen YAN ; Yaqing NI ; Yun GU ; Jiawen QIN ; Haiping YU ; Haitao ZHANG ; Liming ZHAO
Chinese Journal of Clinical Medicine 2026;33(1):16-23
Objective To explore the effectiveness of the generative large language model MedGo in nursing decision-making for elderly patients with multimorbidity. Methods A quasi-randomized controlled trial study was conducted involving 6 junior nurses, 6 senior nurses and the MedGo model from January 1, 2025 to March 31, 2025 at the Emergency Internal Medicine Ward of Shanghai East Hospital Affiliated to Tongji University. Clinical data of 120 elderly patients with multimorbidity were analyzed to compare the performance of the three groups in four tasks (nursing diagnosis assessment, nursing intervention formulation, complication identification, and complication prevention) from three evaluation dimensions: decision-making time consumption, decision accuracy, and decision-making quality. Results In terms of decision-making time, the senior nurse group completed all four tasks faster than the junior nurse group (P<0.01), and the MedGo group completed all four tasks faster than the junior nurse group (P<0.001) and the senior nurse group (P<0.001). In terms of decision-making accuracy, senior nurse group scored higher than junior nurse group in all four tasks (P<0.001), while the MedGo group outperformed the senior nurse group only in complication identification (P<0.001). In terms of decision-making quality, the MedGo group scored higher than junior nurse group (P<0.001) and senior nurse group (P<0.001) in all four tasks. Conclusions The MedGo model demonstrates advantages of high efficiency, accuracy, and quality in nursing decision-making for elderly patients with multimorbidity; senior nurses outperform junior nurses in decision-making, providing diverse references for clinical nursing decision-making.
9.Effects of dapagliflozin on inflammatory level and prognosis in patients with type 2 diabetes mellitus and acute myocardial infarction
Mengmei LI ; Weifeng ZHANG ; Xiaowen ZHEN ; Weisheng LIU
Chinese Journal of Clinical Medicine 2026;33(1):38-44
Objective To investigate the effects of dapagliflozin on inflammatory factors and prognosis in patients with type 2 diabetes mellitus (T2DM) and acute myocardial infarction (AMI). Methods In a randomized, double-blind trial, 146 patients with T2DM and AMI (within 7 days of onset) were divided into dapagliflozin (dapagliflozin 10 mg/d combining AMI standard therapy) and control (AMI standard therapy) groups, and were followed up for 12 months. Serum levels of interleukin-1β (IL-1β), IL-6, high-sensitivity C reactive protein (hs-CRP) at baseline, 1, 3, 6, and 12 months, and left ventricular ejection fraction (LVEF), brain natriuretic peptide (BNP), and major adverse cardiovascular events (MACE) rate at 12 months were compared between the two groups. Kaplan-Meier curves were used to analyze the cumulative incidences of MACE in the two groups. Results Three patients were withdrawn or dropped out. At 12 months, IL-1β, IL-6, and hs-CRP levels were significantly lower in dapagliflozin group (n=71) than those in control group (n=72, P<0.01), approaching normal levels. Compared with the control group, LVEF was higher (P<0.01), BNP was lower (P<0.01), MACE incidence was lower (P=0.047) in dapagliflozin group at 12 months. Generalized linear mixed models showed significant group-time interactions in IL-1β, IL-6, and hs-CRP (P<0.001), and these factors declined faster in the dapagliflozin group. Kaplan-Meier curve showed the cumulative incidences of MACE and heart failure were lower in dapagliflozin group than those in non-dapagliflozin group (P<0.05). Conclusions For patients with T2DM patients and AMI, dapagliflozin has good anti-inflammatory and cardioprotective effects.
10.Clinical efficacy of Huangkui capsules in the treatment of targeted drug-related proteinuria in patients with hepatocellular carcinoma
Miao LI ; Jia YUAN ; Chu LIU ; Maopei CHEN ; Xin XU ; Ningling GE ; Yi CHEN ; Lan ZHANG ; Rongxin CHEN ; Yan WANG
Chinese Journal of Clinical Medicine 2026;33(1):88-94
Objective To investigate the therapeutic effect of Huangkui capsules on targeted drug-related proteinuria in patients with hepatocellular carcinoma (HCC). Methods A retrospective analysis was conducted on clinical data of HCC patients with targeted drug-related proteinuria from June 2023 to December 2024 at Zhongshan Hospital, Fudan University. According to the treatment plan, patients were divided into the conventional treatment group and the Huangkui combination treatment group (Huangkui capsules combined with conventional treatment), and the clinical efficacy between the two groups was compared. The logistic regression analysis was used to identify the main factors affecting treatment efficacy. Results The Huangkui combination treatment group (n=29) showed a significantly higher overall effective rate (79.3% vs 42.3%, P=0.005), and an earlier proteinuria improvement (median time: 3 months vs 6 months, P=0.008) than the conventional treatment group (n=26) . The multivariate logistic regression analysis showed angiotensin-converting enzyme inhibitor (ACEI) or angiotensin Ⅱ receptor blocker (ARB) using (OR=0.190, 95%CI 0.045-0.808, P=0.025), targeted drug adjustment (OR=0.132, 95%CI 0.030-0.581, P=0.007), and Huangkui capsules using (OR=0.168, 95%CI 0.039-0.730, P=0.017) were protective factors for treatment efficacy of targeted drug-related proteinuria. Conclusions On the basis of conventional treatment, additive treatment with Huangkui capsules can alleviate targeted drug-related proteinuria faster and more effectively in HCC patients.

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