1.Over 20-year Follow-up Result of Total Knee Arthroplasty for Knee Arthropathy: A Single Center Cohort Study
Yiming XU ; Mingwei HU ; Wei ZHU ; Muyang YU ; Jin LIN ; Jin JIN ; Wenwei QIAN ; Bin FENG ; Xisheng WENG
Medical Journal of Peking Union Medical College Hospital 2025;16(1):35-41
To evaluate long-term survival and clinical outcomes of patients with knee osteo-arthritis undergoing total knee arthroplasty (TKA) through long-term follow-up. This study was based on a previous cohort study that had completed follow-up. We retrospectively collected clinical data of patients with knee arthropathy (including knee osteoarthritis and knee rheumatoid arthritis) who received the first TKA operation in Peking Union Medical College Hospital from 1993 to 2002 and were followed up for more than 20 years, and conducted a unified follow-up on them in November 10, 2024 (the last follow-up). Kaplan-Meier curve was used to evaluate the survival rate. Hospitals for special surgery (HSS) scores and joint range of motion (ROM) were compared before surgery, 10 years after surgery and at the last follow-up to evaluate the clinical efficacy of TKA. Likert scale was used to evaluate patient satisfaction at the last follow-up. A total of 226 patients (246 knees) received their first TKA in Peking Union Medical College Hospital from 1993 to 2002 and were followed up for more than 10 years. Among them, 104 patients (131 knees) were included in the study at the last follow-up, including 21 patients (24 knees) with prosthesis in place, 18 patients (18 knees) who underwent reoperation for various reasons, and 65 patients (89 knees) who died from non-TKA surgical causes. Up to the last follow-up, there were 29 patients (35 knees) with an average follow-up of more than 20 years, and 12 patients (16 knees) completed HSS score, ROM measurement and patient satisfaction evaluation. Kaplan-Meier curve showed that the 10-year, 15-year, 20-year, and 25-year survival rates were 93.6%, 92.4%, 89.8%, and 71.8%, respectively. The HSS score at the last follow-up was lower than that at 10- year postoperative follow-up[(84.69±11.03) scores TKA treatment for knee arthropathy has high long-term prosthesis survival rate, significant improvement of knee joint function and high patient satisfaction.
2.Varieties and Prescription Characteristics of Chinese Patent Medicines for Stroke in China
Jingdan ZHANG ; Wanping SUN ; Xiaoxia LIN ; Shuo ZHANG ; Xue ZHANG ; Jiahui YAO ; Yiming LIU ; Ming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):270-274
ObjectiveTo explore the listed varieties and prescription characteristics of Chinese patent medicines for stroke in China, explore the medication rules of Chinese medicine for stroke, and provide guidance for further clinical research and development of Chinese patent medicines. MethodsExcel 2021 and the Ancient and Modern Medical Record Cloud Platform (V2.3.5) were used to systematically mine and analyze the varieties and prescriptions of Chinese patent medicines for stroke in China. ResultsA total of 244 Chinese patent medicines (two for different dosage forms of the same prescription), 1 736 approval documents for Chinese patent medicines, 792 manufacturers, and 83 varieties of protected Chinese patent medicines were finally included in the database. The top three dosage forms were capsules (75), pills (53), and tablets (42). There were 28 Chinese patent medicines for stroke in the National Essential Drug Catalogue (2018), 129 in the National Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2023), and 4 in the National Non-prescription Drug Catalogue. Among the 138 prescriptions screened out, Chinese patent medicines mainly treated stroke patients with the syndrome of Qi deficiency and blood stasis. The top three most frequent medicinal herbs were Chuanxiong Rhizoma (63), Pheretima (47), and Salviae Miltiorrhizae Radix et Rhizoma (47). The medicinal herbs used were mainly warm, pungent, with the meridian tropism to the liver meridian. The correlation analysis showed that the herb pair with the highest support was Astragali Radix-Chuanxiong Rhizoma, and that with the highest confidence was Carthami Flos-Chuanxiong Rhizoma. Five herb combinations were identified based on the cluster analysis. ConclusionThe Chinese patent medicines for stroke mainly treat patients with the syndrome of Qi deficiency and blood stasis. The medicinal herbs used in the prescriptions mainly have the functions of activating blood and resolving stasis, extinguishing wind and stopping convulsions. Drug compatibility usually focuses on activating blood and resolving stasis, as well as expelling phlegm and opening orifices. This review of the varieties and prescription characteristics of Chinese patent medicines for stroke helps optimize clinical decision-making, guide drug research and development, promote medical research and scientific progress, and provide more effective support and guarantee for the treatment of stroke patients.
3.Clinical application of an artificial intelligence system in predicting benign or malignant pulmonary nodules and pathological subtypes
Zhuowen YANG ; Zhizhong ZHENG ; Bin LI ; Yiming HUI ; Mingzhi LIN ; Jiying DANG ; Suiyang LI ; Chunjiao ZHANG ; Long YANG ; Liang SI ; Tieniu SONG ; Yuqi MENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(08):1086-1095
Objective To evaluate the predictive ability and clinical application value of artificial intelligence (AI) systems in the benign and malignant differentiation and pathological type of pulmonary nodules, and to summarize clinical application experience. Methods A retrospective analysis was conducted on the clinical data of patients with pulmonary nodules admitted to the Department of Thoracic Surgery, Second Hospital of Lanzhou University, from February 2016 to February 2025. Firstly, pulmonary nodules were divided into benign and non-benign groups, and the discriminative abilities of AI systems and clinicians were compared. Subsequently, lung nodules reported as precursor glandular lesions (PGL), microinvasive adenocarcinoma (MIA), and invasive adenocarcinoma (IAC) in postoperative pathological results were analyzed, comparing the efficacy of AI systems and clinicians in predicting the pathological type of pulmonary nodules. Results In the analysis of benign/non-benign pulmonary nodules, clinical data from a total of 638 patients with pulmonary nodules were included, of which there were 257 males (10 patients and 1 patient of double and triple primary lesions, respectively) and 381 females (18 patients and 1 patient of double and triple primary lesions, respectively), with a median age of 55.0 (47.0, 61.0) years. Different lesions in the same patient were analyzed as independent samples. Univariate analysis of the two groups of variables showed that, except for nodule location, the differences in the remaining variables were statistically significant (P<0.05). Multivariate logistic regression analysis showed that age, nodule type (subsolid pulmonary nodule), average density, spicule sign, and vascular convergence sign were independent influencing factors for non-benign pulmonary nodules, among which age, nodule type (subsolid pulmonary nodule), spicule sign, and vascular convergence sign were positively correlated with non-benign pulmonary nodules, while average density was negatively correlated with the occurrence of non-benign pulmonary nodules. The area under the receiver operating characteristic curve (AUC) of the malignancy risk value given by the AI system in predicting non-benign pulmonary nodules was 0.811, slightly lower than the 0.898 predicted by clinicians. In the PGL/MIA/IAC analysis, clinical data from a total of 411 patients with pulmonary nodules were included, of which there were 149 males (8 patients of double primary lesions) and 262 females (17 patients of double primary lesions), with a median age of 56.0 (50.0, 61.0) years. Different lesions in the same patient were analyzed as independent samples. Univariate analysis results showed that, except for gender, nodule location, and vascular convergence sign, the differences in the remaining variables among the three groups of PGL, MIA, and IAC patients were statistically significant (P<0.05). Multinomial multivariate logistic regression analysis showed that the differences between the parameters in the PGL group and the MIA group were not statistically significant (P>0.05), and the maximum diameter and average density of the nodules were statistically different between the PGL and IAC groups (P<0.05), and were positively correlated with the occurrence of IAC as independent risk factors. The average AUC value, accuracy, recall rate, and F1 score of the AI system in predicting lung nodule pathological type were 0.807, 74.3%, 73.2%, and 68.5%, respectively, all better than the clinical physicians’ prediction of lung nodule pathological type indicators (0.782, 70.9%, 66.2%, and 63.7% respectively). The AUC value of the AI system in predicting IAC was 0.853, and the sensitivity, specificity, and optimal cutoff value were 0.643, 0.943, and 50.0%, respectively. Conclusion This AI system has demonstrated high clinical value in predicting the benign and malignant nature and pathological type of lung nodules, especially in predicting lung nodule pathological type, its ability has surpassed that of clinical physicians. With the optimization of algorithms and the adequate integration of multimodal data, it can better assist clinical physicians in formulating individualized diagnostic and treatment plans for patients with lung nodules.
4.Application Value of an AI-based Imaging Feature Parameter Model for Predicting the Malignancy of Part-solid Pulmonary Nodule.
Mingzhi LIN ; Yiming HUI ; Bin LI ; Peilin ZHAO ; Zhizhong ZHENG ; Zhuowen YANG ; Zhipeng SU ; Yuqi MENG ; Tieniu SONG
Chinese Journal of Lung Cancer 2025;28(4):281-290
BACKGROUND:
Lung cancer is one of the most common malignant tumors worldwide and a major cause of cancer-related deaths. Early-stage lung cancer is often manifested as pulmonary nodules, and accurate assessment of the malignancy risk is crucial for prolonging survival and avoiding overtreatment. This study aims to construct a model based on image feature parameters automatically extracted by artificial intelligence (AI) to evaluate its effectiveness in predicting the malignancy of part-solid nodule (PSN).
METHODS:
This retrospective study analyzed 229 PSN from 222 patients who underwent pulmonary nodule resection at Lanzhou University Second Hospital between October 2020 and February 2025. According to pathological results, 45 cases of benign lesions and precursor glandular lesion were categorized into the non-malignant group, and 184 cases of pulmonary malignancies were categorized into the malignant group. All patients underwent preoperative chest computed tomography (CT), and AI software was used to extract imaging feature parameters. Univariate analysis was used to screen significant variables; variance inflation factor (VIF) was calculated to exclude highly collinear variables, and LASSO regression was further applied to identify key features. Multivariate Logistic regression was used to determine independent risk factors. Based on the selected variables, five models were constructed: Logistic regression, random forest, XGBoost, LightGBM, and support vector machine (SVM). Receiver operating characteristic (ROC) curves were used to assess the performance of the models.
RESULTS:
The independent risk factors for the malignancy of PSN include roughness (ngtdm), dependence variance (gldm), and short run low gray-level emphasis (glrlm). Logistic regression achieved area under the curves ( AUCs) of 0.86 and 0.89 in the training and testing sets, respectively, showing good performance. XGBoost had AUCs of 0.78 and 0.77, respectively, demonstrating relatively balanced performance, but with lower accuracy. SVM showed an AUC of 0.93 in the training set, which decreased to 0.80 in the testing set, indicating overfitting. LightGBM performed excellently in the training set with an AUC of 0.94, but its performance declined in the testing set, with an AUC of 0.88. In contrast, random forest demonstrated stable performance in both the training and testing sets, with AUCs of 0.89 and 0.91, respectively, exhibiting high stability and excellent generalizability.
CONCLUSIONS
The random forest model constructed based on independent risk factors demonstrated the best performance in predicting the malignancy of PSN and could provide effective auxiliary predictions for clinicians, supporting individualized treatment decisions.
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Humans
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Male
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Female
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Lung Neoplasms/pathology*
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Middle Aged
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Retrospective Studies
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Artificial Intelligence
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Aged
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Tomography, X-Ray Computed
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Adult
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Solitary Pulmonary Nodule/diagnostic imaging*
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ROC Curve
5.Clinicopathological characteristics of advanced-stage mycosis fungoides
Fen LI ; Lin HE ; Yiming WANG ; Yan ZENG
Journal of Leukemia & Lymphoma 2025;34(2):92-97
Objective:To investigate the clinicopathological features of advanced-stage mycosis fungoides (MF).Methods:A retrospective case-series study was conducted. The clinical data of 5 cases diagnosed with advanced-stage MF in Chengdu Second People's Hospital between January 2015 and July 2023 were analyzed. The clinicopathological features of patients were summarized.Results:There were 2 males and 3 females in 5 MF patients, with the median age of 55 years (45-86 years) and the medical history of 2-16 years. The main symptoms were pruritus and erythema. The lesions were presented by erythema, scales, plaques, blisters, erosion, ulcers, pigmentation, nodules, and erythroderma. Histopathological examination showed different skin lesion patterns such as psoriasis-like, interfacial dermatitis, non-infectious granuloma, deep and shallow perivascular dermatitis, tumors. Among 5 patients, 1 case was mycosis fungoides bullosa, 2 cases were erythrodermic MF, 1 case was granulomatous MF, and 1 case was classical MF. Lymphocyte epidermis was found in 4 cases, cytoplasmic halos cells lined up along the basal layer of the epidermis and Pautrier microabscess were found in 3 cases, large-cell transformation was found in 1 case. Tumor cells were positive for CD3, CD4 and negative for CD8, CD56, ALK and CD20; EBER 1/2 hybridization in situ was negative. CD30 was positive in transformed large cells and T cell receptor gene rearrangement was positive. The tumor cells were detected in bone marrow and peripheral blood of 2 cases and in cerebrospinal fluid of 1 case. Head magnetic resonance imaging of 1 case indicated abnormal signal nodules in the right temporal region and the normal architecture of the lymph nodes in 2 cases was completed destroyed by malignant cells. TNMB stage: 2 cases were in stage Ⅱ B, 2 cases were in stage Ⅳ A2, and 1 case was in stage Ⅳ B. Interferon α-based systemic therapy was performed in 1 case, 2 cases received chemotherapy or combined with intrathecal injection and radiotherapy, and other 2 cases were not treated. All of them just achieved partial remission. Finally, 1 case died of sudden cardiac death, 2 cases died of lung infection, and 2 cases survived with tumors. Conclusions:Advanced-stage MF is presented with different skin lesion manifestations and histopathologic changes. Multidisciplinary combined management helps the diagnosis and treatment of MF.
6.Impact of ferroptosis-related gene expression on cardiovascular outcomes in chronic renal failure
Xuelan LIN ; Kexin LIU ; Xiao GE ; Yiming YU ; Lifang CAO
International Journal of Laboratory Medicine 2025;46(19):2378-2384,2390
Objective To investigate the relationship between ferroptosis-related genes[heme oxygenase-1(HO-1),solute carrier family 7 member 11(SLC7A11),and long-chain acyl-coenzyme A synthetase 4(ACSL4)]expression and cardiovascular events in patients with chronic renal failure(CRF),aiming to pro-vide clinical insights for risk assessment of cardiovascular complications.Methods A total of 124 CRF pa-tients(CRF group)admitted to the hospital from January 2020 to January 2023 and 124 healthy people(con-trol group)who underwent physical examination in the hospital during the same period were selected as the research objects.The levels of ferroptosis-related gene HO-1,SLC7A11 and ACSL4 were detected and com-pared between the two groups.CRF patients were followed up for 12 months after discharge,and they were di-vided into concurrent group(n=56)and non-concurrent group(n=66)according to the occurrence of cardio-vascular events.Spearman correlation analysis was used to investigate the correlation between iron death relat-ed genes HO-1,SLC7A11,ACSL4 and cardiovascular events in CRF patients.Univariate and multivariate Lo-gistic regression analysis were used to investigate the influencing factors of cardiovascular events in CRF pa-tients.Receiver operating characteristic(ROC)curve was used to analyze the predictive value of iron death re-lated genes HO-1,SLC7A11,and ACSL4 for cardiovascular events in CRF patients.Results Serum HO-1 and SLC7A11 levels in CRF group were lower than those in control group(P<0.05),and the ACSL4 level was higher than that in control group(P<0.05).The serum HO-1 and SLC7A11 levels in concurrent group were lower than those in non-concurrent group(all P<0.05),and the serum ACSL4 level was higher than that in non-concurrent group(P<0.05).Ferroptosis-related genes HO-1 and SLC7A11 were negatively correlated with cardiovascular events(r=-0.708,—0.721,P<0.05),while ACSL4 was positively correlated with car-diovascular events(r=0.699,P<0.05).High serum ACSL4 expression and high cTnT level were risk fac-tors for cardiovascular events in CRF patients(P<0.05),and high hemoglobin level and high serum HO-1 and SLC7A11 expression were protective factors for cardiovascular events in CRF patients(P<0.05).ROC curve analysis results showed that the area under the curve(AUC)of serum HO-1,SLC7A11,ACSL4,hemo-globin and cTnT alone for predicting cardiovascular events in CRF patients were 0.787,0.735,0.773,0.651 and 0.782,respectively.The AUC of the combined prediction of ferroptosis-related genes was 0.837,and the AUC of the combined application of five factors was 0.880.According to Delong's test,the AUC of both com-bined application models was significantly higher than those of individual application(P<0.05).The nomo-gram model showed that all ferroptosis-related genes were positively expressed(HO-1<1.5,SLC7A11<1.15,ACSL4≥2.75),and the risk of developing concurrent cardiovascular events in CRF patients could reach over 75%.Conclusion The expression of serum HO-1 and SLC7A11 in CRF patients is decreased,and the ACSL4 expression is increased,which is closely related to cardiovascular events,and the combined detection of three indexes has high value in predicting cardiovascular events in CRF patients.
7.Analysis of the disease burden of esophageal cancer and gastric cancer in China from 1990 to 2021
Chongrui LI ; Shoucai HU ; Bin LI ; Mingzhi LIN ; Yiming HU ; Haitian LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(10):1438-1446
Objective To assess the evolving disease burden of esophageal and gastric cancers in China from 1990 to 2021, with a focus on gender disparities, and construct a predictive model to forecast disease trends from 2022 to 2031, aiming to optimize targeted prevention strategies. Methods Epidemiological data for esophageal and gastric cancers in China (1990-2021) were extracted from the Global Burden of Disease (GBD) 2021 database. Temporal trends were analyzed using Joinpoint regression (version 4.9.1.0), and future trends were predicted via the GM (1, 1) model under grey system theory. Results From 1990 to 2021, tobacco- and alcohol-attributable burdens of esophageal cancer increased, while tobacco- and diet-related burdens of gastric cancer showed no significant change. Deaths and disability-adjusted life years (DALY) for esophageal cancer rose by 40.61% and 17.89%, respectively; gastric cancer deaths increased by 18.95%, though DALY decreased by 1.22%. Both cancers exhibited significant declines in age-standardized mortality rates (−45.78% for esophageal cancer, −53.29% for gastric cancer) and age-standardized DALY rates (−51.45% for esophageal cancer, −57.58% for gastric cancer). China’s age-standardized mortality and DALY rates for both cancers remained consistently higher than global averages. Males exhibited disproportionately higher burdens than females. Predictive modeling projected continued but decelerating declines in disease burdens for both cancers by 2031. Conclusion Over three decades, China achieves measurable reductions in esophageal and gastric cancer burdens, though gastric cancer burdens remain higher than esophageal cancer. Persistent disparities relative to global levels, elevated male burdens, and aging demographics highlight the urgency for prioritized interventions targeting high-risk populations.
8.Chinese interpretation of PROBAST+AI: An updated quality, risk of bias, and applicability assessment tool for prediction models using regression or artificial intelligence methods
Xingmeng WANG ; Guohua DAI ; Wulin GAO ; Hui GUAN ; Lili REN ; Chen CHEN ; Xiaoyang TAN ; Yiming LIN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(12):1686-1695
The development and validation of clinical prediction models based on artificial intelligence (AI) and machine learning methods have become increasingly widespread. However, the prediction model bias risk and applicability evaluation tool developed in 2019 (i.e., PROBAST-2019) has shown significant limitations. Therefore, an expanded and updated version of the PROBAST-2019 tool was released in 2025, known as the PROBAST+AI tool. The tool is divided into two parts including model development and model evaluation. It aims to comprehensively and systematically evaluate potential methodological quality issues in model development, bias risks in model evaluation, and the applicability of models, regardless of the modeling method used. This paper provides a systematic interpretation of the PROBAST+AI tool's items and case analyses, with the aim of guiding and assisting researchers engaged in related studies and promoting the high-quality development of clinical predictive model research.
9.Effect of Raw and Processed Aurantii Fructus Immaturus Switched to Zhishi Shaoyaosan on Function of Brain-Gut-Microbiota Axis in Rats with Constipation-predominant Irritable Bowel Syndrome
Yuanpan YU ; Guimei LIN ; Yiming LI ; Yi YAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(9):1-9
ObjectiveTo research the mechanism underlying the effect of raw and processed Aurantii Fructus Immaturus switched to Zhishi Shaoyaosan (ZSS) on constipation-predominant irritable bowel syndrome (C-IBS) rats via the brain-gut-microbiota axis. MethodEighty rats were randomly divided into the blank, model, positive drug (pinaverium bromide, 15.625 mg·kg-1), raw ZSS, stir-fried ZSS, bran-fried ZSS, charcoal-fried ZSS and finished ZSS groups (3.75 g·kg-1), with 10 rats in each group. Except for the blank group, which received intragastric administration of 0.9% sodium chloride solution at room temperature, all other groups were administered the ice solution at 0 to 4 ℃ (2 mL·d-1, for a total of 14 d) to establish the C-IBS rat model. The fecal water content and the propulsion rate of small intestine were detected after 14 d of continuous drug administration. The levels of 5-hydroxytryptamine (5-HT), vasoactive intestinal peptide (VIP), neuro-peptide Y (NPY), calcitonin gene-related peptide (CGRP), substance P (SP), diamine oxidase (DAO) and D-lactic acid (D-LA) were detected by enzyme linked immunosorbent assay (ELISA). Hematoxylin-eosin (HE) staining was used to observe the changes in colonic pathological injury in each group. The expression levels of cyclic adenosine monophosphate (cAMP), protein kinase A (PKA) and aquaporin-3 (AQP3) mRNA in colon tissues were detected by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and the protein expressions of VIP and AQP3 in colon tissues were detected by Western blot. The content of short chain fatty acids (SCFAs) was determined by gas chromatography-mass spectrometry. ResultCompared with the blank group, the fecal water content and intestinal propulsion rate of rat in the model group were significantly decreased (P<0.01), and the levels of 5-HT, VIP, CGRP and SP in serum were significantly increased. Simultaneously, the NPY levels significantly decreased (P<0.01), the levels of DAO and D-LA in plasma were significantly increased (P<0.01), and the mucosal epithelium of colon tissue was slightly damaged, with reduced goblet cells and significantly reduced luminal granules. The mRNA expression levels of AQP3, cAMP and PKA and the protein expression levels of AQP3 and VIP in colon tissue were significantly decreased (P<0.05, P<0.01). The total amount of SCFAs in feces showed an obvious decreasing trend, with the contents of acetic acid, isobutyric acid, isovaleric acid, valeric acid and caproic acid decreased significantly, while the contents of propionic acid and butyric acid increased significantly (P<0.05, P<0.01). Compared with the model group, the treatment groups increased the intestinal propulsion rate, improved the intestinal mucosal barrier function, and adjusted the level of serum brain-gut peptide in C-IBS rats (P<0.05, P<0.01). The expression levels of AQP3, cAMP, PKA mRNA and VIP, AQP3 protein in colon tissue of rats in all treatment groups were increased. All the treatment groups had a significant downregulation of the content of SCFAs except for isobutyric acid in rat feces, and the effect of ZSS prepared by the bran-fried Aurantii Fructus Immaturus was superior than that of other ZSS. ConclusionThe raw and processed Aurantii Fructus Immaturus switched to ZSS could influence the brain-gut-microbiota axis to treat C-IBS rats and it is more reasonable to use bran-fried Aurantii Fructus Immaturus in ZSS.
10.Long-term outcome of patients with rectal cancer who achieve complete or near complete clinical responses after neoadjuvant therapy: a multicenter registry study of data from the Chinese Watch and Wait Database
Yiming ZHAO ; Weihu WANG ; Wei ZHANG ; Lin WANG ; Shuai LI ; Jingwen WANG ; Leen LIAO ; Guanyu YU ; Zhen SUN ; Yanli QU ; Yang GONG ; Yun LU ; Tao WU ; Yunfeng LI ; Quan WANG ; Guohua ZHAO ; Yi XIAO ; Peirong DING ; Zhen ZHANG ; Aiwen WU
Chinese Journal of Gastrointestinal Surgery 2024;27(4):372-382
Objective:To report the long-term outcomes of Chinese rectal cancer patients after adopting a Watch and Wait (W&W) strategy following neoadjuvant therapy (NAT).Methods:This multicenter, cross-sectional study was based on real-world data. The study cohort comprised rectal cancer patients who had achieved complete or near complete clinical responses (cCRs, near-cCRs) after NAT and were thereafter managed by a W&W approach, as well as a few patients who had achieved good responses after NAT and had then undergone local excision for confirmation of pathological complete response. All participants had been followed up for ≥2 years. Patients with distant metastases at baseline or who opted for observation while living with the tumor were excluded. Data of eligible patients were retrospectively collected from the Chinese Wait-and-Watch Data Collaboration Group database. These included baseline characteristics, type of NAT, pre-treatment imaging results, evaluation of post-NAT efficacy, salvage measures, and treatment outcomes. We herein report the long-term outcomes of Chinese rectal cancer patients after NAT and W&W and the differences between the cCR and near-cCR groups.Results:Clinical data of 318 rectal cancer patients who had undergone W&W for over 2 years and been followed up were collected from eight medical centers (Peking University Cancer Hospital, Fudan University Shanghai Cancer Center, Sun Yat-sen University Cancer Center, Shanghai Changhai Hospital, Peking Union Medical College Hospital, Liaoning Cancer Hospital, the First Hospital of Jilin University, and Yunnan Cancer Hospital.) The participants comprised 221 men (69.4%) and 107 women (30.6%) of median age 60 (26-86) years. The median distance between tumor and anal verge was 3.4 (0-10.4) cm. Of these patients, 291 and 27 had achieved cCR or near-cCR, respectively, after NAT. The median duration of follow-up was 48.4 (10.2-110.3) months. The 5-year cumulative overall survival rate was 92.4% (95%CI: 86.8%-95.7%), 5-year cumulative disease-specific survival (CSS) rate 96.6% (95%CI: 92.2%-98.5%), 5-year cumulative organ-preserving disease-free survival rate 86.6% (95%CI: 81.0%-90.7%), and 5-year organ preservation rate 85.3% (95%CI: 80.3%-89.1%). The overall 5-year local recurrence and distant metastasis rates were 18.5% (95%CI: 14.9%-20.8%) and 8.2% (95%CI: 5.4%-12.5%), respectively. Most local recurrences (82.1%, 46/56) occurred within 2 years, and 91.0% (51/56) occurred within 3 years, the median time to recurrence being 11.7 (2.5-66.6) months. Most (91.1%, 51/56) local recurrences occurred within the intestinal lumen. Distant metastases developed in 23 patients; 60.9% (14/23) occurred within 2 years and 73.9% (17/23) within 3 years, the median time to distant metastasis being 21.9 (2.6-90.3) months. Common sites included lung (15/23, 65.2%), liver (6/23, 26.1%), and bone (7/23, 30.4%) The metastases involved single organs in 17 patients and multiple organs in six. There were no significant differences in overall, cumulative disease-specific, or organ-preserving disease-free survival or rate of metastases between the two groups (all P>0.05). The 5-year local recurrence rate was higher in the near-cCR than in the cCR group (41.6% vs. 16.4%, P<0.01), with a lower organ preservation rate (69.2% vs. 88.0%, P<0.001). The success rates of salvage after local recurrence and distant metastasis were 82.1% (46/56) and 13.0% (3/23), respectively. Conclusion:Rectal cancer patients who achieve cCR or near-cCR after NAT and undergo W&W have favorable oncological outcomes and a high rate of organ preservation. Local recurrence and distant metastasis during W&W follow certain patterns, with a relatively high salvage rate for local recurrence. Our findings highlight the importance of close follow-up and timely intervention during the W&W process.

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