1.Exploration on Surrogate Outcome Measures in Clinical Trials of Traditional Chinese Medicine for Diabetic Kidney Disease
Can CAO ; Weiwei SUN ; Tong MA ; Yaoxian WANG
Journal of Traditional Chinese Medicine 2025;66(8):790-794
Traditional Chinese medicine (TCM) has unique advantages in alleviating the symptoms of diabetic kidney disease (DKD) and slowing its progression. However, traditional clinical trials often use the occurrence of end-stage renal disease as the end point, requiring long-term follow-up, which increases trial complexity and costs, thereby limiting the feasibility of TCM clinical studies. This paper suggested that in clinical trials of TCM for DKD, both the estimated glomerular filtration rate (eGFR) change rate (≥30%) and eGFR slope can serve as potential surrogate outcome measures. If the intervention course is short (<1 year), the eGFR change rate (≥30%) is recommended as a surrogate outcome measure, whereas in long-term interventional studies (≥1 year), the eGFR slope may be more appropriate. Furthermore, based on biochemical indicators such as eGFR slope and urinary albumin-to-creatinine ratio (UACR) change rate, integrating TCM symptom evaluation, TCM syndrome evaluation, and quality of life scales can help develop internationally recognized patient-reported outcome measures (PROMs) for TCM clinical trials, which will be a key step in enhancing the evaluation system for the effectiveness of TCM in treating DKD.
2.Inhibitory effect of bovine serum albumin-chitosan nanoparticles loaded with EPZ6438 on osteosarcoma
Chang LIU ; Wen ZHANG ; Can ZHU ; Jie SUN ; Yicheng DING ; Qin SHI
Chinese Journal of Tissue Engineering Research 2024;28(10):1512-1518
BACKGROUND:The most prominent transcription factor activated by tumor stem cells in osteosarcoma is EZH2,and silencing of EZH2 has been reported to inhibit osteosarcoma cell growth.Studies have confirmed that bovine serum albumin-chitosan nanoparticles are a drug delivery vector with excellent biocompatibility and biodegradability,and the albumin carrier can provide tumor-targeted drug delivery function. OBJECTIVE:To investigate the effect and mechanism of bovine serum albumin-chitosan nanoparticles loaded with EPZ6438(EZH2 inhibitor)for the treatment of osteosarcoma. METHODS:(1)Bovine serum albumin-chitosan nanoparticles loaded with and without EPZ6438 were prepared.The drug encapsulation rate and drug release rate of serum albumin-chitosan nanoparticles loaded with EPZ6438 were detected.(2)MG-63 cells were divided into four groups and added with PBS(control group),serum albumin-chitosan nanoparticle extract solution(blank nanoparticle group),EPZ6438 solution(free drug group),and serum albumin-chitosan nanoparticle extract loaded with EPZ6438(drug-loaded nanoparticle group),respectively.After 3 days of culture,cell apoptosis was detected by flow cytometry and the expression of caspase-3 mRNA was detected by RT-PCR.(3)Twelve nude mice were selected and the subcutaneous tumor-bearing mouse model was established by injecting MG-63 cell suspension under the armpit.After successful modeling,the mice were randomly divided into four groups for intervention.Normal saline(control group),serum albumin-chitosan nanoparticle solution(blank nanoparticle group),EPZ6438 solution(free drug group)and serum albumin-chitosan nanoparticle solution loaded with EPZ6438(drug-loaded nanoparticle group)were injected into tumor tissues,with three animals in each group.After 7 days of injection,the tumor volume and frozen sections of tumor tissue were observed by TUNEL staining. RESULTS AND CONCLUSION:(1)The drug encapsulation rate of the nanoparticles was about 8.8%,and the nanoparticles had a good drug release effect in pure water.The drug release amount was(34.72±1.93)μg at 24 hours,(48.58±1.10)μg at 72 hours,(49.18±1.24)μg at 120 hours,and(50.25±1.13)μg at 168 hours.The drug release reached the plateau at 120 hours,and the release rate was about 97.9%.(2)After 3 days of cell culture with MG-63,the apoptotic rate in the control group and blank nanoparticle group was lower than that in the free drug group and drug-loaded nanoparticle group(P<0.001),and the expression of caspase 3 mRNA was lower than that in the free drug group and drug-loaded nanoparticle group(P<0.000 1).(3)After 7 days of injection,the tumor volume of nude mice in the drug-loaded nanoparticle group was smaller than that in the other three groups(P<0.05),and the percentage of TUNEL-positive cells in tumor tissue was higher than that in the other three groups(P<0.000 1).(4)The results verify that serum albumin-chitosan nanoparticles loaded with EPZ6438 can inhibit the growth of osteosarcoma by inducing apoptosis of tumor cells.
3.Advances in near-infrared brain functional imaging of emotional tasks in affective disorder
Can GUO ; Chunxia YANG ; Ning SUN
Chinese Journal of Nervous and Mental Diseases 2024;50(1):54-59
Emotional task is one of the main methods to study the attention bias and emotional function of affective disorder.Functional near-infrared spectroscopy(fNIRS)studies based on emotional tasks in patients with affective disorders have shown that facial emotion recognition task,the emotional stroop effect,and the emotion induction task combined with fNIRS technology have clinical value in the diagnosis and treatment of affective disorders.The defects of attention function and emotional processing in patients with affective disorders are related to abnormal activation of the left prefrontal cortex,especially the differences in brain activation patterns are related to depressive symptoms in patients with depressive disorders.The future direction of using fNIRS to study emotional tasks is to combine a variety of neuroimaging methods to conduct large-sample longitudinal cohort studies to obtain more objective bases for diagnosis and treatment,and to compare the differences in activation areas of different emotional stimulation materials.
4.Effects of Bushen Zhuyun Prescription on Endometrial Angiogenesis by Regulating Mitochondrial Function
Yuling ZHOU ; Jinglei ZHANG ; Can CAO ; Ying SUN ; Ruobing NIU ; Yingmei ZHANG ; Shuchan HU ; Lin LUO ; Ming HE
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(1):91-96
Objective To observe the effects of Bushen Zhuyun Prescription on regulating mitochondrial function and endometrial angiogenesis;To explore its mechanism of improving endometrial receptivity.Methods The mouse model of controlled ovarian hyperstimulation(COH)was established,and the mice were randomly divided into normal group,model group,and Bushen group,with 20 mice in each group.Bushen group received Bushen Zhuyun Prescription for gavage for 11 d,and the normal group and model group received normal saline for gavage.The number of embryo implantation was counted,the endometrial morphology was observed by HE staining,α-smooth muscle actin(α-SMA)expression was observed by immunofluorescence staining.Human endometrial microvascular endothelial cells(HEMECs)were cultured in vitro,they were divided into control group,VEGFA group,Bushen group and VEGFA + Bushen group,and were intervened with VEGFA and/or Bushen Zhuyun Prescription medicated serum.The activities of mitochondrial respiratory chain complexes Ⅰ-Ⅳ,the content of ATP,the expression of PCNA and Caspase-3 were detected.Results Animal experiment showed that,compared with the normal group,the number of embryo implantation in model group significantly decreased(P<0.05),α-SMA protein expression in endometrial tissue significantly decreased(P<0.05);compared with the model group,the number of embryo implantation in Bushen group significantly increased(P<0.05),α-SMA protein expression in endometrial tissue significantly increased(P<0.05).Cell experiment showed that,Bushen Zhuyun Prescription medicated serum could increase the activity of mitochondrial respiratory chain complexes Ⅰ-Ⅳ and ATP content in HEMECs,promote PCNA protein expression,and inhibit Caspase-3 protein expression(P<0.05,P<0.01).Conclusion Bushen Zhuyun Prescription can promote endometrial angiogenesis through improving mitochondrial function.
5.Four cases of occupational heatstroke among sanitation workers working in high temperature weather
Can MA ; Xin ZUO ; Ran SUN ; Yongmei ZHAO
Chinese Journal of Industrial Hygiene and Occupational Diseases 2024;42(8):621-623
Through the report of 4 cases of occupational heatstroke among sanitation workers working in high-temperature weather, this study analyzes the risk of occupational heatstroke among workers in the environmental sanitation industry working in high-temperature weather, and provides scientific suggestions for standardizing occupational health management, safeguarding the health rights and interests of workers, and preventing the occurrence of occupational heatstroke in summer. Through case analysis, we aim to raise high awareness of the occupational health of sanitation workers in the whole society, in order to provide a scientific and healthy working environment for sanitation workers and promote their physical and mental health.
6.Changes and predictive value of serum IL-1,IL-12 and IFN-α levels in early pregnancy in hepatitis B pregnant women with abnormal liver function
Can YANG ; Yue WANG ; Weize SUN ; Hongyan JIA ; Wei WANG
International Journal of Laboratory Medicine 2024;45(14):1710-1714,1719
Objective To explore the changes and predictive value of serum interleukin-1(IL-1),interleu-kin-12(IL-12)and interferon α(IFN-α)levels in early pregnancy in hepatitis B pregnant women with abnor-mal liver function.Methods A total of 100 hepatitis B pregnant women with normal liver function in early pregnancy in Shijiazhuang Maternal and Child Health Hospital from January 2022 to May 2022 were selected,and were divided into normal liver function group(52 cases)and abnormal liver function group(48 cases)ac-cording to whether there was abnormal liver function in middle and late pregnancy,and another 50 healthy pregnant women of the same gestational week in the same period in Shijiazhuang Maternal and Child Health Hospital were selected as the control group.The general information,liver function indicators[alanine amin-otransferase(ALT),aspartate aminotransferase(AST),glutamine transferase(GGT)],serum interleukin(IL)-1,IL-12,and interferon α(IFN-α)levels among the three groups were compared.The serum levels of IL-1,IL-12,IFN-α in pregnant women with different degrees of liver dysfunction in the liver dysfunction group were compared,and the relationship between the serum levels of IL-1,IL-12,IFN-α and the degree of liver dysfunction was analyzed,as well as the value of predicting liver dysfunction in pregnant women with hepatitis B in the middle and late pregnancy.Results The serum levels of ALT,AST,GGT,IL-1 and IL-12 in early pregnancy from high to low in three groups were liver dysfunction group,normal liver function group,and control group(P<0.05),while the level of IFN-α in early pregnancy from low to high in three groups were liver dysfunction group,normal liver function group,and control group(P<0.05).In the abnormal liver func-tion group,there were 12 cases with abnormal concentration values of 3 enzymes,16 cases with abnormal con-centration values of 2 enzymes,and 20 cases with abnormal concentration values of 1 enzyme.The levels of IL-1 and IL-12 from high to low were pregnant women with 3 abnormal values of enzyme,2 abnormal values of enzyme,and 1 abnormal value of enzyme(P<0.05).The level of IFN-α from low to high were pregnant women with 3 abnormal values of enzyme,2 abnormal values of enzyme,and 1 abnormal value of enzyme(P<0.05).The levels of serum IL-1 and IL-12 in the abnormal liver function group were positively correlated with the degree of liver function abnormality(r=0.771,0.793,P<0.05),while the levels of IFN-α were negatively correlated with the degree of liver function abnormality(r=-0.755,P<0.05).The area under the curve of serum IL-1,IL-12 and IFN-α in the early pregnancy for predicting abnormal liver function of hep-atitis B pregnant women in the middle and late pregnancy was 0.936(95%CI:0.869-0.976,P<0.05).Conclusion The levels of serum IL-1,IL-12 and IFN-α in early pregnancy of hepatitis B pregnant women are closely related to the degree of liver dysfunction in the middle and late pregnancy,and the combined detection of the three serum indicators has a high predictive value for predicting the liver dysfunction in the middle and late pregnancy of hepatitis B pregnant women.
7.Microbiomes combined with metabolomics reveals the changes of microbial and metabolic profile of articular cavity effusion in rheumatoid arthritis, urarthritis and osteoarthritis patients
Hanzhi Yi ; Wukai Ma ; Minhui Wang ; Chunxia Huang ; Guangzhao Gu ; Dan Zhu ; Hufan Li ; Can Liu ; Fang Tang ; Xueming Yao ; Liping Sun ; Nan Wang ; Changming Chen
Acta Universitatis Medicinalis Anhui 2024;59(12):2237-2245
Objective:
To investigate the changes of microorganisms and metabolites in joint effusion of patients with Rheumatoid arthritis(RA), Osteoarthritis(OA) and Urarthritis(UA). To provide new ideas for the study of the effect of microbiota on the pathogenesis of arthritis.
Methods:
Joint effusion samples were collected from 20 patients with RA, 20 patients with OA, and 20 patients with UA. 16S rRNA gene sequencing and untargeted ultra-high performance Liquid chromatography-mass spectrometry(LC-MS) were used to explore the differences in microorganisms and metabolites among the three groups. Pearson correlation analysis was used to detect the correlation between effusion microbiota and metabolites.
Results:
There were differences in microbial diversity and microbiota composition among the three groups. Combined with VIP>1 from OPLS-DA andP<0.05 from two-tailed Students t-test, 45 differential metabolites(Between RA and OA groups), 38 differential metabolites(Between UA and OA groups) and 16 differential metabolites(Between RA and UA groups), were identified. GO analysis and KEGG pathway analysis showed that the differential metabolic pathways among the three groups were mainly concentrated in citric acid cycle(TCA cycle), nucleotide metabolism, amino acid metabolism and glycolysis pathway. Correlation analysis of joint effusion microbiota and metabolites suggested that bacteria enriched in the three groups of joint effusion, such asPrevotella,Clostridium ruminosus,Prevotellaceae_UCG-001, were related to many key metabolites such as lysozyme, uric acid, glucose, and L-glutamine.
Conclusion
This study shows that there are a variety of bacterial flora in joint cavity effusion of RA, OA, and UA patients, and the differential metabolites produced by them are involved in the pathogenesis of the three types of arthritis by affecting a variety of metabolic pathways.
8.CT and MRI features of Kimura disease in parotid region
Can WANG ; Bocheng WANG ; Bingbing SUN ; Chunye ZHANG ; Xiaofeng TAO ; Ling ZHU
Chinese Journal of Radiology 2024;58(12):1402-1407
Objective:To analyze the CT and MRI imaging features of Kimura disease in parotid region.Methods:This study was a cross-sectional study. From January 2018 to June 2023, a total of 40 patients with Kimura disease in parotid region who were initially diagnosed and confirmed by postoperative pathology were retrospectively collected in the Ninth People′s Hospital, School of Medicine, Shanghai Jiao Tong University. There were 36 male patients and 4 female patients, with an age of (46±19) years, ranging from 8 to 74 years old. The clinical data, preoperative CT and MRI findings were analyzed. For patients undergoing MRI examination, the apparent diffusion coefficient (ADC) value of the lesion was measured, and the type of time-signal intensity curve (TIC) was analyzed.Results:The ratio of male to female patients was 9∶1, with a long clinical history (1 month to 20 years). And 37 cases (37/40, 92.5%) were associated with elevated peripheral blood eosinophils. Among the 40 cases, there were 4 cases of nodular type, 34 cases of diffuse type, and 2 cases of intermediate type. Nodular type: All lesions were located in the superficial lobe of unilateral parotid gland, and 3 cases had multiple lesions. The lesions were round, well-defined, and homogeneous in density or signal intensity. Two lesions showed hyperintensity on T 2WI and obvious homogeneous enhancement. The TIC was plateau type, and the ADC values were 0.74×10 -3 mm 2/s and 0.82×10 -3 mm 2/s. Diffuse type: The 22 cases had multiple lesions, and 20 cases had subcutaneous lesions in other parts of the head and neck. The lesions were irregular in shape and ill-defined in boundary. The adjacent subcutaneous tissue and skin were involved in 33 cases. The density or signal intensity of the lesions was heterogeneous, and among the 15 patients who underwent MRI, 14 cases showed uneven slightly hyperintensity with hypointense strips on T 2WI, moderate or significant enhancement. TIC showed a persistent pattern in 9 cases, and a plateau pattern in 6 cases. The ADC value was (0.99±0.21)×10 -3 mm 2/s. Intermediate type: The 2 cases were single, irregular in shape, without involvement of adjacent subcutaneous tissue and skin, with obvious enhancement and no necrosis. And 28 cases of diffuse type and 2 cases of nodular type were accompanied by ipsilateral or bilateral cervical lymphadenopathy. The enlarged lymph nodes had clear boundaries, homogeneous density or signal intensity, and homogeneous enhancement. Conclusions:The Kimura disease in parotid region has a long clinical course and elevated peripheral blood eosinophils. The diffuse type is more common in the morphology, with multiple ill-defined lesions in and around the parotid gland, and can be accompanied by similar subcutaneous lesions in other parts of the head and neck with obvious enhancement, accompanied by cervical lymph node enlargement. TIC shows persistent pattern or plateau type, and the ADC value is low. The nodular type and intermediate type are rare.
9.Comparative Analysis of the Efficacy of Thoracoscopic Intrathoracic Fixation Versus Traditional Thoracotomy for Multiple Rib Fractures
Can SUN ; Bingchun LIU ; Chunbo ZHAI ; Jianpeng CHE ; Wei LI
Chinese Journal of Minimally Invasive Surgery 2024;24(7):488-493
Objective To explore the clinical efficacy of video-assisted thoracoscopic intrathoracic fixation in the treatment of multiple rib fractures.Methods Clinical data of 93 cases of multiple rib fractures in our department from August 2019 to April 2022 were retrospectively compared.They were divided into thoracoscopic group(n=50)and traditional group(n=43)according to surgical methods.In the thoracoscopic group,the memory alloy rib plate was used for thoracoscopic intrathoracic fixation,and in the traditional group,the memory alloy rib plate was used for traditional thoracotomy to treat multiple rib fractures.The operation time,intraoperative blood loss,postoperative hospital stay,postoperative catheter duration,postoperative pain time,postoperative drainage volume,and postoperative complications were compared between the two groups.Results As compared with the traditional group,the thoracoscopic group had significantly shorter operation time[(96.1±24.7)min vs.(110.2±29.1)min,t=-2.526,P=0.013],less intraoperative blood loss[(76.0±38.4)ml vs.(140.2±80.8)ml,t=-4.767,P=0.000],shorter postoperative catheter duration[(3.9±1.6)d vs.(6.2±1.8)d,t=-2.739,P=0.008],less postoperative drainage volume[(132.4±53.9)ml vs.(157.9±50.5)ml,t=-2.345,P=0.021],shorter postoperative hospital stay[(5.8±2.5)d vs.(9.7±2.5)d,t=-4.397,P=0.000],and shorter pain time[(4.9±1.2)d vs.(5.8±1.4)d,t=-2.199,P=0.030].The incidence of postoperative pneumonia,atelectasis,and pleural effusion in the thoracoscopic group was significantly lower than that in the traditional group(P<0.05).Follow-ups at 1,3,and 12 months after surgery showed that the rib plate was firmly fixed without any displacement,deformation,or detachment.Conclusion Video-assisted thoracoscopic intrathoracic fixation in the treatment of multiple rib fractures has advantages of less trauma,less pain,faster recovery,and definite clinical results,which is worthy of clinical application and promotion.
10.Evaluation of prophylactic use of metal clips after cold resection of 6-10 mm intestinal polyps
Zhongxin SUN ; Can WU ; Mei YANG ; Li LIU ; Liu LIU ; Zhengkui ZHOU ; Weidong XI ; Jing SHAN ; Lin JIANG ; Yu LEI ; Xiaobin SUN
Chinese Journal of Digestive Endoscopy 2024;41(7):550-554
Objective:To investigate whether prophylactic use of metal clips is necessary after cold snare polypectomy (CSP) of colorectal polyps of 6-10 mm.Methods:A total of 200 patients with 6-10 mm polyps that met the criteria of cold snare resection in Chengdu Third People's Hospital from 15 February 2022 to 30 May 2022 were randomly divided into two groups: a group that received preventive metal clip treatment and an observation group. Age, gender, body mass index (BMI), Boston score, endoscopy entry time, wound size, operation time, intraoperative bleeding time, postoperative delayed bleeding rate and cost between the two groups were compared and analyzed.Results:Ninety-eight patients in the metal clip group had 122 polyps removed, and 97 patients in the observation group had 119 polyps removed. There was no significant difference in the age, gender, BMI, Boston score, endoscopy entry time or wound size between the two groups. There were significant differences in the operation time (171.03±90.78 s VS 69.81±43.26 s, t=2.266, P=0.010), intraoperative bleeding time (19.98±17.37 s VS 29.16±17.56 s, t=-2.875, P=0.006) and surgery cost (571.63±110.92 yuan VS 366.32±13.2 yuan, t=18.102, P<0.001) between the metal clip group and the observation group. There was no significant difference in the delayed bleeding incidence[0.0%(0/98)VS 1.0%(1/97), P=0.497]between the two groups. Conclusion:For patients with continuous bleeding time <60 seconds after CSP of 6-10 mm colonic polyps, the prophylactic use of metal clips may reduce the bleeding time, but may increase the operation time and cost. Metal clips have little effect on preventing postoperative complications.


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