1.The Solomon Four-Group Design:Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
Wenqian ZHANG ; Yufei LI ; Tong LIN ; Xintong WEI ; Yingjie WANG ; Jianping LIU ; Ying ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1649-1655
		                        		
		                        			
		                        			The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine (TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, know-ledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research. 
		                        		
		                        		
		                        		
		                        	
2.The renoprotective effect of Salvia miltiorrhiza injection on HBOC-CHP01 resuscitated haemorrhagic shock rats
Shasha HAO ; Xintong XIE ; Shen LI ; Honghui ZHANG ; Hong WANG ; Chengmin YANG ; Wentao ZHOU ; Jiaxin LIU
Chinese Journal of Blood Transfusion 2025;38(2):172-180
		                        		
		                        			
		                        			[Objective] To investigate the protective effect of Salvia miltiorrhiza injection (SMI) on the kidneys of HBOC-CHP01 resuscitated haemorrhagic shock rats. [Methods] A 50% haemorrhagic shock rat model was established, with 12 rats divided into two groups: SMI + HBOC-CHP01 group and HBOC-CHP01 group, with 6 rats in each group. The rats in the SMI+ HBOC-CHP01 group were given an equal volume of HBOC-CHP01 for resuscitation after haemorrhagic shock, and an 8 mL/kg dose of SMI. Rats in the HBOC-CHP01 group were resuscitated by administering an equilibrium blood loss volume of HBOC-CHP01 and given an 8 mL/kg dose of 0.9% NaCl solution. Blood was taken from rats at five points: before bloodletting (baseline), during haemorrhagic shock (HS), immediately after resuscitation (RS0h), 1 h after resuscitation (RS1h), and 24 h after resuscitation (RS24h). A blood gas analyser was used to detect the lactate level (Lac), glucose content (Glu), residual base (BEecf), pH, bicarbonate (HCO3-), high iron haemoglobin (MetHb). White blood cells (WBC), platelets (PLT), haemoglobin content (Hb), carboxyhaemoglobin (COHb) were detected using a quintuple classification. Blood creatinine (SCr), uric acid (UA), kidney-related indexes were detected using biochemistry instrument. Kidney tissues of the rats were taken after 24 h of resuscitation and after execution, and the inflammation of kidneys of the rats of the two groups was analyzed using HE staining. Fluorescence staining was used to detect the level of ROS in the kidneys of rats in both groups. [Results] At RS 0h, the Beecf, Glu and Lac levels of rats in the SMI+HBOC-CHP01 group were significantly lower than those of rats in the HBOC-CHP01 group, and the pH level of rats in the SMI+HBOC-CHP01 group was significantly higher than that of rats in the HBOC-CHP01 group, and the Glu levels of rats in the SMI+HBOC-CHP01 group were significantly lower than those of rats in the HBOC-CHP01 group at RS 1h. At RS 0h, the WBC, PLT and COHb contents of rats in the SMI+HBOC-CHP01 group were all significantly higher than those of rats in the HBOC-CHP01 group, and at RS 1h, the WBC content of rats in the SMI+HBOC-CHP01 group was significantly higher than that of rats in the HBOC-CHP01 group; at RS 1h, the UA content of rats in the SMI+HBOC-CHP01 group was significantly lower than that of rats in the HBOC-CHP01 group; at RS 24h, the SCr content of rats in the SMI+HBOC-CHP01 group was significantly lower than that of rats in the HBOC-CHP01 group; at RS 24h, the inflammation level of kidney tissues of rats in the SMI+HBOC-CHP01 group was significantly lower than that of rats in the HBOC -CHP01 group rats, and the ROS and MPO levels in the kidney tissues of rats in the SMI+HBOC-CHP01 group were significantly lower than those of rats in the HBOC-CHP01 group. [Conclusion] The combination of Salvia miltiorrhiza injection during the resuscitation of rats with severe haemorrhagic shock by HBOC-CHP01 can alleviate renal injury by reducing inflammatory response and oxidative stress.
		                        		
		                        		
		                        		
		                        	
3.Effect of anterior segment parameters on the rotational stability of Toric intraocular lens
Gengqi* TIAN ; Su* XU ; Yuhang ZHANG ; Yizhuo HU ; Wei SI ; Yifan YANG ; Xintong LI ; Fengyan ZHANG
International Eye Science 2025;25(6):993-998
		                        		
		                        			
		                        			 AIM: To explore the effects of preoperative anterior segment parameters on the rotational stability of Toric intraocular lens(Toric IOL).METHODS:Prospective study. A total of 41 cataract patients(54 eyes)with combined corneal regular astigmatism from March to December 2023 were included and treated with cataract phacoemulsification combined with plate loop Toric IOL implantation in the Department of Ophthalmology of the First Affiliated Hospital of Zhengzhou University. The rotation degree of Toric IOL and uncorrected distance visual acuity(UCDVA)were evaluated at 1 d, 2 wk, and 1 mo postoperatively, the corrected distance visual acuity(CDVA)was evaluated at 2 wk and 1 mo after surgery, and the decentration and tilt of the Toric IOL were assessed at 2 wk postoperatively.RESULTS:A total of 33 patients(40 eyes)were included in this study. The UCDVA(LogMAR)of 1 d, 2 wk and 1 mo postoperatively were 0.10(0.10, 0.30), 0.05(0, 0.10)and 0(0, 0.10), respectively, which was improved compared with the preoperative levels of [0.80(0.49, 1.00)](P<0.001). The CDVA(LogMAR)of 2 wk and 1 mo postoperatively were 0.05(0, 0.15)and 0(0, 0.138), respectively, which was improved compared with preoperative levels of [0.52(0.40, 0.80)](P<0.001). The residual astigmatism of 2 wk and 1 mo postoperatively were 0.625(0.25, 0.75)D and 0.50(0.25, 0.75)D, respectively, which was significantly reduced compared with preoperative astigmatism of [1.82(1.31, 2.59)D](P<0.001). The preoperative anterior segment length(ASL), and lens thickness(LT)were positively correlated with Toric IOL rotation degree at 1 d(rs=0.463, P=0.003; rs=0.340, P=0.032)and 2 wk(rs=0.520, P=0.001; rs=0.409, P=0.009)postoperatively. At 1 mo postoperatively, only ASL was positively correlated with Toric IOL rotation degree(rs=0.463, P=0.003). The results of linear regression analysis showed that preoperative ASL was a predictor of rotation degree at 1 d, 2 wk and 1 mo after surgery(F1 d=10.098, P1 d=0.003; F2 wk=16.915, P2 wk<0.001; F1 mo=10.957, P1 mo=0.002). The rotation degree of Toric IOL was positively correlated with lens decentration(rs=0.360, P=0.043).CONCLUSION:The early postoperative rotation of Toric IOL is positively correlated with ASL, and the rotation is also positively correlated with lens decentration. 
		                        		
		                        		
		                        		
		                        	
4.The curative effect of interventional embolization of middle meningeal artery for chronic subdural hematoma
Fei DING ; Zhenbao LI ; Zihuan ZHANG ; Xintong ZHAO ; Jiaqiang LIU ; Feiyun QIN ; Liying HU ; Gang ZHOU
Journal of Interventional Radiology 2024;33(1):12-16
		                        		
		                        			
		                        			Objective To evaluate the safety and efficacy of interventional embolization of middle meningeal artery(MMA)for the treatment of chronic subdural hematoma(CSDH).Methods The clinical data of 14 patients with CSDH(17 lesions in total),who were treated with simple embolization of MMA at the Yijishan Hospital of Wannan Medical College of China between July 2021 and July 2022,were retrospective analyzed.After superselective catheterization of MMA using a microcatheter was accomplished,Onyx-18 glue,a liquid embolization agent,was used to embolize the main trunk and the branches of MMA.Imaging follow-up was adopted at 30 days and 90 days after discharge from hospital to evaluate the absorption of hematoma,and the improvement of clinical symptoms was defined as the modified Rankin Scale score(mRS)being decreased≥1 point from the baseline value.Results Successful embolization of MMA was accomplished for all the 17 lesions in the 14 patients,and no procedure-related complications occurred.During the follow-up period,the clinical symptoms and signs were remarkably improved in all patients.The postoperative 90-day hematoma volume was reduced by more than 90%in 11 patients and by more than 40%in one patient,and in 2 patients the postoperative 30-day hematoma volume was reduced by more than 30%.Complete absorption of hematoma was seen in 11 patients,and partial absorption of hematoma was observed in 3 patients.Conclusion For the treatment of newly-developed or recurrent CSDH,interventional embolization of MMA is clinically safe and effective.(J Intervent Radiol,2024,32:12-16)
		                        		
		                        		
		                        		
		                        	
5.Serum levels of procalcitonin,interleukin-6 and interleukin-8 in patients with COVID-19 infection at admis-sion and their significance in patient prognosis
Sibo LONG ; Yan CHEN ; Xintong ZHANG ; Yanjun YIN ; Limei YANG ; Maike ZHENG ; Chaohong WANG ; Qing SUN ; Jun YAN ; Yiheng SHI ; Guangli SHI ; Yan ZHAO ; Guirong WANG
The Journal of Practical Medicine 2024;40(4):471-475
		                        		
		                        			
		                        			Objective To analyze the predictive value of serum levels of procalcitonin(PCT)and cytokines on the prognosis of patients with COVID-19 at admission.Methods From November 2022 to February 2023,patients diagnosed with COVID-19 who were admitted to Beijing Chest Hospital were enrolled.Chemiluminescence was used to detect serum PCT levels,and flow microsphere array was used to detect serum cytokines IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17A,IL-17F,IL-22,TNF-α,TNF-β,IFN-γ level.ICU admission,mechanical ventilation and in-hospital death were defined as poor prognosis.After excluding patients with bacterial infection,the relationship between serum PCT and cytokine levels at admission and the prognosis of COVID-19 patients was analyzed.After excluding patients with bacterial infection,the relationship between serum PCT and cytokine levels at admission and the prognosis of COVID-19 patients was analyzed.Results A total of 176 patients with complete data were included,including 134 in the PCT-normal group and 42 in the PCT-elevated group,with a median age of 71.50 years and 71.59%males.Patients in the PCT elevated-group had significantly higher rates of ICU admission(38.41%vs.13.11%,P<0.05),mechanical ventilation(76.92%vs.24.59%,P<0.001)and in-hospital mortality(38.46%vs.6.56%,P<0.001)were significantly higher than those in the PCT-normal group.Serum levels of cytokines IL-6(7.40 pg/mL vs.4.78 pg/mL,P = 0.033 4)and IL-8(10.97 pg/mL vs.5.92 pg/mL,P<0.001)were significantly higher in patients with poor prognosis than in those with good prognosis.The area under the curve for PCT,IL-6,and IL-8 to predict poor prognosis in COVID-19 patients was 0.687,0.660,and 0.746,respectively;sensitivity was 52.78%,55.17%,and 72.41%,respectively;and specificity was 81.58%,74.19%,and 74.19%,respectively,as calculated from the ROC curve.When PCT,IL-6 and IL-8 jointly predict the prognosis of COVID-19 patients,the area under the curve is 0.764,the sensitivity is 70.00%,and the specificity is 80.00%.Conclusion Serum PCT and cytokines IL-6 and IL-8 could be used as predictive markers for poor prognosis in patients with COVID-19.
		                        		
		                        		
		                        		
		                        	
6.Effects of Modified Gegen Qinlian Decoction (葛根芩连汤) on Intestinal Mucosal Barrier and Epithelial Mesenchymal Transition in Ulcerative Colitis Model Mice
Lihui FANG ; Jiaqi ZHANG ; Lanshuo HU ; Xintong WANG ; Shan LIU ; Yuedan WANG ; Jinke HUANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2024;65(24):2580-2588
		                        		
		                        			
		                        			ObjectiveTo investigate the possible mechanism of modified Gegen Qinlian Decoction (葛根芩连汤) in treatment of ulcerative colitis (UC) from the view of intestinal mucosal epithelial barrier damage and epithelial mesenchymal transition. MethodsSixty male C57BL/6J mice were divided into blank group, model group, western medicine control group, and low-, medium-, and high-dose modified Gegen Qinlian Decoction groups, with 10 mice in each group. Except for the blank group, 3% dextran sodium sulfate (DSS) was used to induce colitis model by free drinking for 7 days, and on the first day of modelling, 6, 12, and 24 g/(kg·d) of modified Gegen Qinlian Decoction were given to the low-, medium-, and high-dose groups respectively, 5-aminosalicylic acid (5-ASA) 100 mg/(kg·d) given by gavage to western medicine control group, and 10 ml/kg distilled water were given to blank and model group by gavage, once a day for 7 days. Body mass of mice was recorded and disease activity index (DAI) scores were performed daily. The mice were anesthetized after 24h of the last administration and the colon was taken to observe the length of colon, HE staining was applied to observe the damage of colonic mucosa and score pathological states, Masson staining to detect the deposition of colonic collagen fibers, immunofluorescence to observe the distribution of F-actin in colonic mucosal epithelium, and immunohistochemistry to detect the expression of tight junction protein ZO-1, Occludin, E-cadherin and Vimentin. ResultsCompared with the blank group at the same time, the percentage of body mass of mice in the model group on day 7 of modelling significantly reduced and the DAI score was significantly increased (P<0.01); compared with the model group at the same time, the body mass of mice in the western medicine control group and all of modified Gegen Qinlian Decoction groups decreased, and the DAI scores of mice in the western medicine control group and the high-dose modified Gegen Qinlian Decoction group decreased (P<0.05 or P<0.01); compared with the same time of mice in the low-dos Gegen Qinlian Decoction group, the body mass of mice in the high-dose Gegen Qinlian Decoction group and the western medicine control group significantly elevated (P<0.05). Compared with the blank group, the length of the colon of mice in the model group was significantly shortened, the pathological score and the percentage of collagen area were significantly increased, the average fluorescence intensity of F-actin was reduced, the protein levels of ZO-1, Occludin and E-cadherin in the colon tissue decreased, and the protein level of Vimentin elevated (P<0.01). Compared with the model group, the length of colon significantly increased, patholo-gical score, collagen area percentage decreased, ZO-1, Occludin, E-cadherin protein levels increased and Vimentin levels decreased in all medicated groups; the average fluorescence intensity of F-actin increased in the western medicine control group and the middle- and high-dose Gegen Qinlian Decoction groups (P<0.05 or P<0.01). Compared with the low-dose Gegen Qinlian Decoction group, the proportion of collagen fibre area in the middle-dose Gegen Qinlian Decoction group and the western medicine control group reduced; the mean fluorescence intensity of F-actin increased in the middle-dose Gegen Qinlian Decoction group; the protein levels of ZO-1 and E-cadherin increased in the western medicine control group, and the protein levels of ZO-1 increased in the high-dose Gegen Qinlian Decoction group (P<0.05). Compared with the medium-dose Gegen Qinlian Decoction group, the protein levels of ZO-1 elevated in the high-dose Gegen Qinlian Decoction group (P<0.05). Comapred with the high-dose Gegen Qinlian Decoction group, level of E-cadherin and Vimentin protein of the western medicine control group increased (P<0.05). ConclusionModified Gegen Qinlian Decoction was able to reduce colonic inflammation and mucosal barrier damage and inhibit the process of epithelial mesenchymal transition in mice models of ulcerative colitis, which may be one of its action mechanisms . 
		                        		
		                        		
		                        		
		                        	
7.Implementation logic and suitable disease analysis of Internet first visit of common diseases
Xintong ZHANG ; Jin JIANG ; Yan ZHANG ; Ran WEI
Chinese Journal of Hospital Administration 2024;40(4):292-297
		                        		
		                        			
		                        			There is still a certain gap between the supply of medical resources and the health needs of the people, and the difficulty of seeking medical treatment remains an important problem plaguing the residents. As an application mode of the new generation of information technology deeply integrated with medical services, Internet first visit provides a new way and possibility to solve the above problem. This study took the Internet first visit for common diseases as an entry point, analyzed the diagnosis and treatment needs of common diseases at the grassroots level and the service capacity of mainstream online consultation methods, put forward the remote first visit realization logic of " type of disease-first consultation method-meeting the minimum requirements for diagnosis and treatment", and analyzed the common diseases suitable for Internet first visit. It is suggested that all parties should jointly promote the standardization of the Internet first visit guideline, promote the integration of online and offline services of Internet first visit, and avoid the risks from technical and legal ways, so as to provide a theoretical basis for the future Internet first visit.
		                        		
		                        		
		                        		
		                        	
8.Expression of TRAP1 in colon cancer tissues and its relationship with clinicopathological features and patient prognosis and the possible molecular mechanisms
CHANG Jingjia ; WU Hao ; ZHANG Wentao ; ZHANG Xintong ; HU Yanfen ; LIU Ming ; LI Li ; ZHU Jianjun
Chinese Journal of Cancer Biotherapy 2023;30(1):42-49
		                        		
		                        			
		                        			[摘  要]  目的:探讨肿瘤坏死因子受体相关蛋白1(TRAP1)在结肠癌组织和细胞中的表达及其与临床病理特征和患者预后的关系和相关分子机制。方法:通过TCGA和GEO数据全面分析TRAP1在结肠癌中的表达及其与临床病理特征和患者预后的关系,选取2020年10月至2021年03月间在山西医科大学第一医院手术切除的10例结肠癌组织及相应癌旁组织标本,用IHC染色法检测中国人结肠癌组织中TRAP1的表达进行验证,运行R包(survival和survminer)进行Kaplan-Meier生存分析;在线分析TRAP1蛋白的信号肽及穿膜结构域,通过基因富集分析软件进行GO分析和KEGG分析。培养结肠癌SW480和SW620细胞,将si-NC和si-TRAP1转染结肠癌细胞,实验分为空白对照组、si-NC组和si-TRAP1组,采用qPCR法检测转染后各组结肠癌细胞中TRAP1的表达,FCM检测转染后各组细胞的细胞周期和凋亡情况。结果:与癌旁组织比较,TRAP1在结肠癌组织中呈高表达(P<0.01),TRAP1表达水平与淋巴结转移有关联(P<0.05),TRAP1高表达组结肠癌患者5年OS率较低(P<0.05)。TRAP1蛋白属于细胞质蛋白,功能富集结果显示TRAP1及其相关分子与细胞周期、核糖体生物发生等信号通路有关(均P<0.01),TRAP1高表达组的结肠癌代谢重编程基因簇和线粒体蛋白输入基因簇水平升高(均P<0.01)。敲减TRAP1后,结肠癌细胞周期阻滞于G1期,细胞凋亡水平显著升高(均P<0.01)。结论:TRAP1在结肠癌组织中呈高表达,且与患者淋巴结转移和低OS率相关联,敲减TRAP1可阻滞结肠癌细胞周期并促进其凋亡。
		                        		
		                        		
		                        		
		                        	
9.Research progress of tumor immunomodulation strategies based on nanodrug delivery system
Yanhong LIU ; Liqing CHEN ; Xintong ZHANG ; Zhonghao GAO ; Wei HUANG
Journal of China Pharmaceutical University 2023;54(1):5-14
		                        		
		                        			
		                        			Tumor immunotherapy is a therapeutic modality that uses immunological principles and methods to activate and enhance the body''s immune system to generate immune response for the removal of tumour cells. Many new immunotherapeutic agents have demonstrated effective anti-tumour capabilities, yet their clinical use is challenging due to the complex mechanisms of tumour immune escape. Meanwhile, these drugs would accumulate in different tissues and organs in the human body and be unable to achieve precise and specific targeting therapeutic effects, resulting in serious immune-related adverse effects, which greatly hinders the clinical potential of immunotherapy.Nanodrug delivery systems can deliver immunotherapeutic drugs to target tissues or specific immune cells precisely, thereby enhancing immune effects and reducing side effects.This paper reviews the research progress of nanodrug delivery systems in tumour immunotherapy in recent years based on the regulatory mechanism of the anti-tumour immune response, with a prospect of the challenges and development in this field.
		                        		
		                        		
		                        		
		                        	
10.Role of selenoprotein M knockdown in the melatonin antagonism of nickel-induced apoptosis and endoplasmic reticulum stress in mouse heart.
Xintong ZHANG ; Xiaoxue GAI ; Lihua XU ; Wenxue MA ; Qiaohan LIU ; Bendong SHI ; Cheng FANG ; Jingzeng CAI ; Ziwei ZHANG
Journal of Zhejiang University. Science. B 2023;24(5):406-417
		                        		
		                        			
		                        			The aim of this study was to investigate the role of selenoprotein M (SelM) in endoplasmic reticulum stress and apoptosis in nickel-exposed mouse hearts and to explore the detoxifying effects of melatonin. At 21 d after intraperitoneal injection of nickel chloride (NiCl2) and/or melatonin into male wild-type (WT) and SelM knockout (KO) C57BL/6J mice, NiCl2 was found to induce changes in the microstructure and ultrastructure of the hearts of both WT and SelM KO mice, which were caused by oxidative stress, endoplasmic reticulum stress, and apoptosis, as evidenced by decreases in malondialdehyde (MDA) content and total antioxidant capacity (T-AOC) activity. Changes in the messenger RNA (mRNA) and protein expression of genes related to endoplasmic reticulum stress (activating transcription factor 4 (ATF4), inositol-requiring protein 1 (IRE1), c-Jun N-terminal kinase (JNK), and C/EBP homologous protein (CHOP)) and apoptosis (B-cell lymphoma-2 (Bcl-2), Bcl-2-associated X protein (Bax), Caspase-3, Caspase-9, and Caspase-12) were also observed. Notably, the observed damage was worse in SelM KO mice. Furthermore, melatonin alleviated the heart injury caused by NiCl2 in WT mice but could not exert a good protective effect in the heart of SelM KO mice. Overall, the findings suggested that the antioxidant capacity of SelM, as well as its modulation of endoplasmic reticulum stress and apoptosis, plays important roles in nickel-induced heart injury.
		                        		
		                        		
		                        		
		                        			Animals
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		                        			Male
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		                        			Mice
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		                        			Antioxidants/pharmacology*
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		                        			Apoptosis
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		                        			Endoplasmic Reticulum Stress
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		                        			Melatonin/pharmacology*
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		                        			Mice, Inbred C57BL
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		                        			Nickel/adverse effects*
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		                        			Selenoproteins/genetics*
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		                        			Heart/drug effects*
		                        			
		                        		
		                        	
            
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