1.Study design and rationale of the TXL-CAP trial: a randomized, double-blind, placebo-controlled, multicenter clinical trial assessing the effect of Tongxinluo capsules on the stability of coronary atherosclerotic plaques.
Mei NI ; Yun TI ; Yan QI ; Meng ZHANG ; Dayue Darrel DUAN ; Chen YAO ; Zhen-Hua JIA ; Yun ZHANG ; Pei-Li BU
Journal of Geriatric Cardiology 2025;22(7):615-624
Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo (TXL) capsule to treat atherosclerosis. However, clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable. In response, we developed this study to investigate the hypothesis that on the basis of statin therapy, treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome (ACS). The TXL-CAP study was an investigator-initiated, randomized, double-blind clinical trial conducted across 18 medical centers in China. Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness (FCT) < 100 μm and lipid arc > 90° as defined by optical coherence tomography (OCT) were recruited. A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL (n = 110) or placebo (n = 110) for a duration of 12 months. The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up. Secondary endpoints included: (1) changes of the maximum lipid arc and length of the target plaque, and the percentage of lipid, fibrous, and calcified plaques at the end of the 12-month period; (2) the incidence of composite cardiovascular events and coronary revascularization within the 12 months; (3) changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society (CCS) grading system and Seattle angina questionnaire (SAQ) score, respectively; and (4) changes in hs-CRP serum levels. The results of the TXL-CAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.
2.Correlation analysis between cognitive function and nutritional status of centenarians
Haimin XU ; Yiling QIU ; Yingjie LI ; Meng TI ; Kewen CHENG ; Jianhua SU ; Siyi FAN ; Ping WU
Chinese Journal of Geriatrics 2025;44(6):822-826
Objective:To investigate the incidence of mild cognitive impairment(MCI)and malnutrition among centenarians, as well as to explore the relationship between cognitive impairment and nutritional status.Methods:A cross-sectional study was conducted between November and December 2023, involving 121 elderly individuals aged ≥ 100 years in the Baoshan District of Shanghai.The survey collected general information and included the Ascertain Dementia 8-item Questionnaire(AD8), the Mini Nutritional Assessment Short-Form(MNA-SF), and anthropometric nutritional measurements such as waist circumference(WC), hip circumference(HC), arm circumference(AC), calf circumference(CC), and grip strength.The prevalence of MCI and malnutrition among centenarians was calculated, and the correlation between MCI and MNA-SF scores, along with anthropometric nutritional measurement indicators, was analyzed.Results:The age range of centenarians was between 100 and 105 years, with an average age of 101.0±3.5 years.The majority of centenarians were female(76.9%), illiterate(58.7%), and lived with family members(73.6%).All participants had medical insurance(100%).Most had no history of long-term smoking 118(97.5%), long-term alcohol consumption 108(89.3%), long-term use of health supplements 109(90.1%), long-term tea or coffee habits 114(94.2%), chronic medical conditions 84(69.4%), or family history of dementia 102(84.3%).Additionally, 62(51.2%)reported their health status over the past year as general.According to the AD8 screening results, the negative and positive detection rates of MCI in centenarians were 79(65.3%)and 47(34.7%), respectively.Based on the MNA-SF scoring results, the detection rates of normal nutrition, malnutrition risk, and malnutrition among centenarians were 36(29.8%), 61(50.4%), and 24(19.8%), respectively.There was a statistically significant difference in AC between the non-MCI group and the MCI group among centenarians( t=0.01, P=0.03).The AD8 scores of centenarians were significantly negatively correlated with AC, CC, and MNA-SF scores( r=-0.20, r=-0.26, r=-0.29; all P<0.05). Conclusions:The cognitive function of centenarians is associated with their nutritional status, indicating that higher cognitive abilities correlate with better nutritional status.
3.Correlation analysis between cognitive function and nutritional status of centenarians
Haimin XU ; Yiling QIU ; Yingjie LI ; Meng TI ; Kewen CHENG ; Jianhua SU ; Siyi FAN ; Ping WU
Chinese Journal of Geriatrics 2025;44(6):822-826
Objective:To investigate the incidence of mild cognitive impairment(MCI)and malnutrition among centenarians, as well as to explore the relationship between cognitive impairment and nutritional status.Methods:A cross-sectional study was conducted between November and December 2023, involving 121 elderly individuals aged ≥ 100 years in the Baoshan District of Shanghai.The survey collected general information and included the Ascertain Dementia 8-item Questionnaire(AD8), the Mini Nutritional Assessment Short-Form(MNA-SF), and anthropometric nutritional measurements such as waist circumference(WC), hip circumference(HC), arm circumference(AC), calf circumference(CC), and grip strength.The prevalence of MCI and malnutrition among centenarians was calculated, and the correlation between MCI and MNA-SF scores, along with anthropometric nutritional measurement indicators, was analyzed.Results:The age range of centenarians was between 100 and 105 years, with an average age of 101.0±3.5 years.The majority of centenarians were female(76.9%), illiterate(58.7%), and lived with family members(73.6%).All participants had medical insurance(100%).Most had no history of long-term smoking 118(97.5%), long-term alcohol consumption 108(89.3%), long-term use of health supplements 109(90.1%), long-term tea or coffee habits 114(94.2%), chronic medical conditions 84(69.4%), or family history of dementia 102(84.3%).Additionally, 62(51.2%)reported their health status over the past year as general.According to the AD8 screening results, the negative and positive detection rates of MCI in centenarians were 79(65.3%)and 47(34.7%), respectively.Based on the MNA-SF scoring results, the detection rates of normal nutrition, malnutrition risk, and malnutrition among centenarians were 36(29.8%), 61(50.4%), and 24(19.8%), respectively.There was a statistically significant difference in AC between the non-MCI group and the MCI group among centenarians( t=0.01, P=0.03).The AD8 scores of centenarians were significantly negatively correlated with AC, CC, and MNA-SF scores( r=-0.20, r=-0.26, r=-0.29; all P<0.05). Conclusions:The cognitive function of centenarians is associated with their nutritional status, indicating that higher cognitive abilities correlate with better nutritional status.
4.Maintenance of common failures of United Imaging uDR588i DR machine:3 case reports
Chinese Medical Equipment Journal 2024;45(4):119-120
The importance of digital radiography machines for imaging diagnosis was described.Three typical circuit failures and their causes of United Imaging uDR588i DR machine were introduced,and suggestions were put forward for failure treat-ment and maintenance.References were provided for medical engineers to treat similar failures.[Chinese Medical Equip-ment Journal,2024,45(4):119-120]
5.EIT-based study of lung ventilation and perfusion regional distribution and ventilation/perfusion matching in different body positions
Ti-Xin HAN ; Yi-Fan LIU ; Meng DAI ; Pu WANG ; Jian-An YE ; Zhi-Bo ZHAO ; Zhan-Qi ZHAO ; Feng FU
Chinese Medical Equipment Journal 2024;45(5):1-7
Objective To compare regional pulmonary ventilation and perfusion and ventilation/perfusion(V/Q)matching in different body positions using electrical impedance tomography(EIT).Methods Ten healthy experimental pigs were selected to collect their EIT lung ventilation and perfusion data in supine,prone,left lateral and right lateral positions.The EIT data underwent analysis and image reconstruction using MATLAB R2022b and EIDORS v3.9.The effective regions with ventilation and perfusion were determined and the V/Q matching regions were computed with the maximum pixel value 20%as the threshold.Comparisons were carried out over the V/Q matching indexes including V/Q match%,dead space%and shunt%and ventilation and perfusion distribution in regions of interest(ROIs)including ROI1,ROI2,ROI3 and ROI4 in different body positions.Results The differences in V/Q match%,dead space%and shunt%of the experimental animals in varied positions were not statistically significant(P>0.05).The regional distribution of pulmonary ventilation and perfusion changed in different positions,and the regional distributions differed in ROIl,ROI2 and ROI3 for ventilation(P<0.05)and in ROI1 and ROI2 for perfusion(P<0.05).The ventilation and perfusion regions were distributed consistently with the gravity-dependent areas in supine and prone positions whereas conversely in the right and left lateral positions.Conclusion The V/Q matching indexes of one subject have high test consistency in different body positions;gravity-dependent areas varied with the changes of the body positions,which affected the distribution of pulmonary ventilation and perfusion regions;EIT can be used for measuring the changed pulmonary ventilation and perfusion due to different positions and determining the influences of position changes on pulmonary ventilation and perfusion and V/Q matching.[Chinese Medical Equipment Journal,2024,45(5):1-7]
6.Study on insulin resistance induced by supernatant of bone marrow mesenchymal stem cells derived from diabetic mice
Bao-Juan LI ; Ke-Chun ZHOU ; ABUDOULA·Mi-re-he-mai-ti ; ZULIHUMA·Re-he-man ; Yu-Meng YE ; Yan-Zhi ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(14):2033-2037
Objective To investigate the role of bone marrow mesenchymal stem cells derived from diabetic mice and their paracrine roles in inducing insulin resistance(IR).Methods The mouse model of diabetes mellitus was established,bone marrow mesenchymal stem cells(BMSC)were extracted and cultured,and the culture supernatant(M-BMSC-CS)was collected.(1)Cell experiment:HepG2 hepatocytes were divided into normal low-glycemic culture group[cultured with low-glycemic DMEM(5.55 mmol·L-1)],M-BMSC-CS experimental group(M-BMSC-CS 75 μL),and high-glycemic and high-lipid control group(given 25 mmol·L-1 high-glycemic DMEM+0.25 mmol·L-1 palmitic acid);(2)Animal experiments:Mice were divided into normal mice group(0.9%NaCl by intraperitoneal injection)and M-BMSC-CS-m group(M-BMSC-CS by intraperitoneal injection of normal mice(injection dose 0.2 mL/10 g)].Glucose intake was measured by glucose oxidase method.The fluorescence intensity of Glut2 protein was detected by immunofluorescence.The expression of insulin signaling pathway protein was detected by Western blot.Test oral glucose tolerance(OGTT)and insulin tolerance(ITT).Results The glucose intakes of the normal low-glucose culture group,the M-BMSC-CS experimental group and the high-glucose and high-lipid control group were(2.96±0.05),(1.64±0.28)and(1.42±0.32)mmol·L-1,respectively;the fluorescence expressions of glucose transporter 2(Glut2)were 53.21±2.70,30.95±3.39 and 34.96±7.60,respectively;the protein expression levels of phosphorylated insulin receptor substrate 1-ser307(p-IRS-1ser307)were 0.46±0.21,1.09±0.24 and 0.91±0.16,respectively;phosphorylated protein kinase(p-AKT)protein expression levels were 0.94±0.05,0.59±0.06 and 0.53±0.05;Glut2 protein expression levels were 1.08±0.14,0.58±0.14 and 0.62±0.09,respectively.The above indexes in M-BMSC-CS experimental group were statistically significant compared with those in normal low-glycemic culture group(all P<0.05).Fasting blood glucose levels in the normal group and M-BMSC-CS-m group were(5.23±0.57)and(9.30±1.14)mmol·L-1;p-AKT protein expression level were 1.27±0.21 and 0.51±0.19;Glut2 protein expression level were 1.17±0.17 and 0.79±0.09,respectively.The above indexes in M-BMSC-CS-m group were significantly different from those in normal mouse group(P<0.05).Conclusion BMSC culture supernatant from diabetic mice induced insulin resistance of normal HepG2 hepatocytes in vitro and normal mice in vivo.
7.High glucose and high fat can induce bone marrow mesenchymal stem cells damage and abnormal ferroptosis signaling pathway
ABUDOULA·Mi-re-he-mai-ti ; ZULIHUMA·Re-he-man ; Bao-Juan LI ; Yu-Meng YE ; Yan-Zhi ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(17):2508-2512
Objective To investigate the relationship between the injury and ferroptosis of bone marrow mesenchymal stem cells(BMSCs)induced by high glucose and high fat.Methods BMSCs were divided into normal group(5.50 mmol·L-1 glucose)and high glucose and high fat(HGHF)group(25.00 mmol·L-1 glucose+0.25 mmol·L-1 palmitic acid).Assessment of cellular aging via β-galactosidase staining;enzyme linked immunosorbent assay(ELISA)were used to detect tumor necrosis factor-α(TNF-α),interleukin-10(IL-10)release levels;glutathione(GSH),malondialdehyde(MDA)and ferrous ion(Fe2+)detection kits were used to detect ferroptosis related indicators;Western blotting was used to detect the expression of ferroptosis related signaling pathway protein acyl-CoA synthetase long chain family member 4(ACS14)/arachidonate 15-lipoxygenase(ALOX15)/glutathione peroxidase 4(GPX4).Results The senescence rates of normal group HGHF group were(6.80±1.60)%and(13.00±1.58)%;the levels of TNF-α were(122.54±3.94)and(169.77±2.89)pg·mL-1;the levels of IL-10 were(155.16±3.97)and(105.15±7.30)pg·mL-1;GSH levels were 4.30±0.33 and 1.55±0.14;MDA levels were 2.94±0.10 and 5.84±0.10;Fe2+levels were 6.22±0.35 and 16.13±0.36;the relative expression levels of ACSL4 protein were 0.42±0.05 and 0.84±0.10;the relative ALOX15 protein were 0.61±0.25 and 1.06±0.11;the relative expression levels of GPX4 protein were 1.13±0.17 and 0.33±0.08,respectively.The above indexes in the HGHF group were significantly different from those in the normal group(all P<0.05).Conclusion 25 mmol·L-1 glucose combined with 0.25 mmol·L-1 palmitic acid for 24 h can be used as a suitable condition to induce BMSCs injury.ferroptosis plays an important role in BMSCs injury induced by high glucose and high fat.
8.Prediction method for weaning outcomes based on machine learning and electrical impedance tomography
Pu WANG ; Zhan-Qi ZHAO ; Meng DAI ; Yi-Fan LIU ; Jian-An YE ; Xiang TIAN ; Ti-Xin HAN ; Feng FU
Chinese Medical Equipment Journal 2023;44(10):1-6
Objective To propose a method for predicting weaning outcomes based on machine learning and electrical impedance tomography(EIT).Methods Firstly,EIT image features were extracted from a total of 84 samples from 30 patients,and the important features screened with the extreme gradient boosting(XGBoost)algorithm were used as inputs to the model.Secondly,the prediction model was built with six machine learning methods,namely random forest(RF),support vector machines(SVM),XGBoost,gradient boosting decision tree(GBDT),logistic regression(LR)and decision tree(tree).Then the prediction model had its prediction performance evaluated by AUC,accuracy,sensitivity and specificity under imbalanced dataset,over-sampling balanced dataset and random under-sampling balanced dataset.Results In terms of AUC,accuracy and specificity,the model under the over-sampling balanced dataset and the random under-sampling balanced dataset behaved better than that under the imbalanced dataset(P<0.05);in terms of sensitivity,the difference in model performance between the over-sampling balanced dataset and the imbalanced dataset was not statistically significant(P>0.05),and the model performance under the random under-sampling balanced dataset decreased when compared with that under the imbalanced dataset(P<0.05).There were no significant differences between the model performance under the over-sampling balanced dataset and that under the random under-sampling balanced dataset(P>0.05).The model based on XGBoost behaved the best under the over-sampling balanced dataset,with an AUC of 0.769,an accuracy of 0.808,a sensitivity of 0.938 and a specificity of 0.600.Conclusion The method based on machine learning and EIT predicts weaning outcomes of patients with prolonged mechanical ventilation,and thus can be used for auxiliary decision support for clinicians to determine the appropriate timing of weaning.[Chinese Medical Equipment Journal,2023,44(10):1-6]
9.Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies.
Jun LIU ; Nian WANG ; Hai-Xia DANG ; Bing-Wei CHEN ; Li ZHANG ; Chong ZOU ; Cheng-Liang ZHONG ; Ju-Kai HUANG ; Qiong LIU ; Ya-Nan YU ; Meng JIANG ; Wei-Xiong LIANG ; Qi-Guang CHEN ; Yong-Yan WANG ; Chun-Ti SHEN ; Zhong WANG
Chinese journal of integrative medicine 2021;27(7):483-489
Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.
10.Right ventricular decompression for pulmonary atresia with intact ventricular septum
Yunxing TI ; Yuanxiang WANG ; Huaipu LIU ; Pengcheng WANG ; Junrong HUANG ; Baoying MENG ; Qing ZHANG ; Yiqun DING
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(01):75-80
Objective To summarize the experience and lessons of right ventricular decompression in children with pulmonary atresia and intact ventricular septum (PA/IVS) and to reflect on the strategies of right ventricular decompression. Methods The clinical data of 12 children with PA/IVS who underwent right ventricular decompression in our hospital from March 2015 to December 2019 were reviewed retrospectively. There were 10 males and 2 females with a median age at the time of surgery was 5 d (range, 1-627 d). Correlation analysis between the pulmonary valve transvalvular pressure gradient and changes in Z score of tricuspid valves after decompression was performed. Results One patient died of refractory hypoxemia due to circulatory shunt postoperatively and family members gave up treatment. There were 2 (16.67%) patients received postoperative intervention. The pulmonary transvalvular gradient after decompression was 31.95±21.75 mm Hg. Mild pulmonary regurgitation was found in 7 patients, moderate in 2 patients, and massive in 1 patient. The median time of mechanical ventilation was 30.50 h (range, 6.00-270.50 h), and the average duration of ICU stay was 164.06±87.74 h. The average postoperative follow-up time was 354.82±331.37 d. At the last follow-up, the average Z score of tricuspid valves was 1.32±0.71, the median pressure gradient between right ventricle and main pulmonary artery was 41.75 mm Hg (range, 21-146 mm Hg) and the average percutaneous oxygen saturation was 92.78%±3.73%. Two children underwent percutaneous balloon pulmonary valvoplasty at 6 and 10 months after surgery, respectively, with the rate of reintervention-free of 81.8%. There was no significant correlation between pulmonary transvalvular gradients after decompression and changes in Z score of tricuspid valves (r=–0.506, P=0.201). Conclusion For children with PA/IVS, the simple pursuit of adequate decompression during right ventricular decompression may lead to severe pulmonary dysfunction, increase the risk of ineffective circular shunt, and induce refractory hypoxemia. The staged decompression can ensure the safety and effectiveness for initial surgery and reduce the risk of postoperative death.

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