1.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
2.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
3.Tirzepatide in chronic weight management: From mechanism to clinical application
Yingying LUO ; Ziwei LIN ; Linong JI
Chinese Journal of Endocrinology and Metabolism 2025;41(7):596-600
Obesity is a common chronic disease associated with an increased risk of multiple comorbidities and premature mortality. Tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide 1 (GLP-1) receptor agonist, has demonstrated significant efficacy in multiple studies in reducing body weight and fat mass, improving body composition and metabolic parameters, lowering the risk of obesity-related complications and improving health and quality of life. This review summarizes the underlying mechanisms of tirzepatide and recent advances in its clinical research, providing a reference for clinical practice.
4.Design and considerations of cardiovascular outcomes trials in type 2 diabetes
Yingying LUO ; Rui WANG ; Linong JI
Chinese Journal of Endocrinology and Metabolism 2025;41(9):793-798
Recent large cardiovascular outcomes trials(CVOT) in patients with type 2 diabetes mellitus have demonstrated that several glucose-lowering agents provide cardiovascular benefits, advancing treatment concepts while also posing new ethical and clinical challenges for the design and conduct of future trials if traditional placebo-controlled designs are continued. In this context, conducting active-controlled CVOTs with optimized design strategies should be considered as a future research trend. This article reviews the design and clinical implications of CVOTs for glucose-lowering agents and explores potential directions for improvement, aiming to provide insights into optimized design strategies for future trials.
5.Construction of a Modern TCM Epidemic Diagnosis and Treatment System
Yingying YANG ; Jinli LUO ; Qingwei LI ; Chuanxi TIAN ; Qiang WANG ; Han WANG ; Linhua ZHAO ; Xiaolin TONG
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(11):1407-1413
Traditional Chinese medicine(TCM)has rich experience in the diagnosis and treatment of epidemics,but the basic con-cepts and diagnosis and treatment strategies of TCM for epidemics have not yet formed a common understanding.This paper preliminar-ily constructs a diagnosis and treatment system of TCM epidemics from the perspective of"type differentiation-stage differentiation-syndrome differentiation"by combing the basic concepts of the etiology,pathogenesis,and identification of epidemics,taking state-target differentiation and treatment as the general principle.First,the epidemics are divided into five types:cold epidemics,warm epi-demics,cold-damp epidemics,damp epidemics,and miscellaneous epidemics;then,according to the overall course of the epidemics,they are divided into four stages:"initial stage-peak stage-extreme stage-relapse stage",the initial stage is the stage of exterior syn-dromes,the peak stage is the stage of heat peak,the extreme stage is the stage of internal closure and external loss,and the relapse stage is the stage of recovery of the healthy qi and retreat of the evil qi;finally,on the basis of staging,combined with the syndrome char-acteristics of various epidemics(five types of background diseases)at different stages,the syndromes are divided demonstratively.Through the construction of a modern diagnosis and treatment system of TCM epidemics,the basic theoretical concepts and basic diag-nosis and treatment strategies of epidemics can be clarified,various new and emerging infectious diseases can be actively responded to,and a diagnosis and treatment plan for a new and emerging infectious disease can be quickly constructed.
6.18 F-PSMA-1007 PET/MRI for diagnosing seminal vesicle invasion of prostatic cancer
Yingying LUO ; Yihong YANG ; Zhiwen YOU ; Xing CHEN ; Zirong ZHOU ; Zengbei YUAN ; Haifeng WANG ; Jun ZHAO ; Haiyan WANG
Chinese Journal of Medical Imaging Technology 2025;41(2):310-315
Objective To observe the value of 18F-prostate specific membrane antigen(PSMA)-1007 PET/MRI for diagnosing seminal vesicle invasion(SVI)of prostatic cancer(PCa).Methods Totally 92 male patients with PCa who underwent radical prostatectomy were retrospectively enrolled and divided into positive group(n=26)and negative group(n=66)based on postoperative pathology showed SVI or not.PET/MRI parameters,including maximum standard uptake value(SUVmax),minimum apparent diffusion coefficient(ADCmin),mean apparent diffusion coefficient(ADCmean),SUVmax/ADCmin,SUVmax/ADCmean,PSMA tumor volume(PSMA-TV)and total lesion PSMA(TL-PSMA)were compared between groups.The receiver operating characteristic curve was drawn,and the efficacy of each parameter for diagnosing SVI was analyzed.Results Among 92 cases of PCa,18F-PSMA-1007 PET/MRI showed 30 cases with SVI and 62 cases without SVI,with accuracy of 73.91%,sensitivity of 61.54%,specificity of 78.79%,positive predictive value of 53.33%and negative predictive value of 83.87%.Significant differences of ADCmin,PSMA-TV and TL-PSMA were found between groups(all P<0.05).The area under the curve(AUC)of SUVmax,ADCmin,ADCmean,SUVmax/ADCmin,SUVmax/ADCmean,PSMA-TV and TL-PSMA for diagnosing SVI of PCa was 0.554,0.341,0.396,0.603,0.581,0.755 and 0.705,respectively.The AUC of PSMA-TV was higher than other parameters except for TL-PSMA,with sensitivity of 84.60%and specificity of 56.10%.Conclusion 18 F-PSMA-1007 PET/MRI was helpful for diagnosing SVI of PCa.
7.Rustic Opinion on"Reverse Spread to the Pericardium"
Jinli LUO ; Yayun WANG ; Yingying YANG ; Qingwei LI ; Ling ZHOU ; Ye MIN ; Linhua ZHAO ; Xiaolin TONG
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):421-424
"When warm evil is received,it first attacks the lungs and then spread to the pericardium reversely"is the general rule of warm diseases.Doctors of different dynasties have different views on the phrase"reverse spread to the pericardium",especially the word"reverse".Professor Tong Xiaolin proposed that the heart governs the mind,the pericardium and the heart are connected in qi,and when the heart is affected by evil,the pericardium instead suffers from the evil.The"reverse spread to the pericardium"proposed by Ye Tianshi is actually the spread of warm evil to the brain.Taking meningococcal meningitis as the basic disease,it can be matched one by one with the typical stages of the transmission of Wei-Qi-Ying-Xue.Combined with the theory of Dingjiao,it is believed that the function of"the heart governing the mind"focuses more on the brain in the modern anatomical sense.Combining traditional Chinese medicine's ideas on diagnosis and treatment of warm diseases with modern medicine,revealing the essence of the disease,grasping the core of the pathogenesis,analyzing the word"reverse"from a new perspective,and exploring its true meaning,is of great significance for clarifying its connotation,exploring the development laws of warm diseases,and guiding the diagnosis and treatment of warm disea-ses.
8.Clinicopathological features and prognosis of rectal neuroendocrine tumor with grade 2
Zhenkai LUO ; Qi ZHANG ; Xiaoting MA ; Renshen XIANG ; Shuaibing LU ; Deyang KONG ; Yu SUN ; Yingying FENG ; Wei PEI ; Lin FENG ; Yuelu ZHU ; Lin YANG ; Haizeng ZHANG
Chinese Journal of Oncology 2025;47(1):108-117
Objective:To explore the clinicopathological features of rectal neuroendocrine tumor (R-NET) G2, identify prognostic factors, and summarize treatment experience.Methods:The clinical data of patients diagnosed with R-NET G2 by pathological diagnosis admitted to Cancer Hospital of the Chinese Academy of Medical Sciences from January 2003 to September 2023 were retrospectively analyzed. The Fisher's exact test and Kaplan-Meier curves were performed to analyze the association between pathological features and prognosis.Results:A total of 22 patients were enrolled in this study and 21 patients were followed up for a period of 6-98 months with a median follow-up time of 42 months. 5 patients died due to tumor progression during the follow-up period. The 1-, 3-, and 5-year cancer-specific survival (CSS) of the whole group were 100.0%, 92.9%, and 69.6%, respectively. Of the 22 patients, 20 underwent surgical treatment, of which 15 underwent postoperative adjuvant therapy; 2 underwent medical treatment for liver and bone multiple metastases. The 5-year survival rates of patients with tumours ≥2 cm in length, T2-3 stage, lymph node metastasis, and distant metastasis (57.1%, 68.8%, 66.7%, and 63.6%, respectively) were shorter than those of patients with tumours <2 cm in length, T1 stage, no lymph node metastasis, and no distant metastasis (all 100.0%, P<0.001). In addition, patients with liver metastases had larger primary tumor diameters and higher T-stages compared with those without distant metastasis ( P<0.05). Conclusions:R-NET G2 has a high degree of malignancy compared with G1 and a high propensity for metastasis. Clinicians should formulate appropriate diagnostic and treatment strategies based on factors such as tumor size, depth of invasion, lymph node status, presence of distant metastasis, and the location and extent of distant metastasis.
9.Treatment of trigeminal neuralgia with botulinum toxin type A and cobrotoxin: a case report
Yingying XU ; Shuyang MA ; Ying LI ; Jili BAO ; Zhou XU ; Chengwei GUO ; Jing LIU ; Weifeng LUO
Chinese Journal of Neurology 2025;58(4):426-429
Trigeminal neuralgia is characterized by intense pain in the sensory distribution area of the trigeminal nerve. It can be triggered by non-noxious stimuli such as brushing teeth and washing face. At present, the treatment of trigeminal neuralgia mainly includes oral drugs and surgical treatments. A 92-year-old patient with trigeminal neuralgia was reported. The pain could not be alleviated because the patient was unable to tolerate the side effects of drugs and surgical treatment. Taking into account the onset time and the duration of the curative effect, botulinum toxin type A was combined with cobrotoxin for the treatment of the patient. As a result, the pain symptoms were rapidly alleviated and remained in a relieved state for 8 months. The clinical characteristics of this patient were summarized in this article, and the possible synergistic mechanisms of action of the 2 drugs were discussed. The ultimate objective is to furnish a broader spectrum of alternatives and references for clinical practice.
10.Construction of a machine learning prognostic prediction model based on psoas muscle index for patients with decompensated liver cirrhosis
Mingyang LUO ; Dong YAN ; Xin WANG ; Yingying WANG ; Huiling LI ; Yafei LI ; Fei GAO ; Can ZHANG ; Yanli ZENG
Chinese Journal of Hepatology 2025;33(7):667-673
Objective:To explore the effect of psoas muscle index (PMI) and construct a machine learning model to validate the 180-day prognosis in patients with decompensated liver cirrhosis.Methods:Retrospective data were collected from patients with decompensated liver cirrhosis at Henan Provincial People's Hospital from January 2022 to November 2022. The area of the psoas muscle index (PMI) at the level of the third lumbar vertebra was measured and calculated based on the abdominal X-ray computed tomography images stored in the Eastern China Hospital Information System (HIS). Patients were divided into low PMI and normal PMI groups according to the receiver operating characteristic curve. Patients clinical data and complication status were collected.The general conditions of both groups were compared using a t-test, chi-square test, and Mann-Whitney U test. The Kaplan-Meier method was applied for survival analysis. The outcome variable was 180-day mortality, and variables were selected using Cox and LASSO regression. The dataset was divided into training and testing sets in a 7∶3 ratio. Machine learning algorithms were used to build models in the training set, and model performance was validated by the test set. The model for MELD-Na score was compared with the model for End-Stage Liver Disease score. Results:A total of 298 patients with decompensated liver cirrhosis were included.The MELD scores, Child-Pugh classification, and NRS2002 scores, along with the incidence rate of complications such as ascites, hepatic encephalopathy, infections, and gastrointestinal bleeding, were significantly higher in the low PMI than the normal PMI group, with statistically significant differences ( P<0.05). The area under a receiver operating characteristic curve for the extreme gradient boosting model was higher than traditional clinical scores (MELD score 0.658, MELD_Na score 0.719) in the machine learning model. Furthermore, the application of SHAP results model indicated that PMI, hemoglobin, NRS2002 score, direct bilirubin, and blood ammonia were important factors in predicting the prognosis of patients with decompensated liver cirrhosis. Conclusion:A low PMI is closely related to poorer survival rates and the development of complication rates in patients with decompensated liver cirrhosis. The machine learning prediction model based on this construction, especially extreme gradient boosting, has favorable predictive performance, which is superior to the traditional clinical scoring system and can provide patients with the most accurate risk assessment and individualized treatment plan.

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