1.Advances in Sequential Multiple Assignment Randomized Trial Methodology and Considerations for Its Application in Traditional Chinese Medicine
Wenxin MA ; Xuehui WANG ; Yuyi WANG ; Yuan SUN ; Yike SONG ; Zhijun BU ; Zeyang SHI ; Jianping LIU ; Zhaolan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1530-1539
Traditional Chinese Medicine(TCM)emphasizes syndrome differentiation and treatment,characterized by"maintaining the prescription if effective"and"changing the prescription if ineffective".Traditional randomized controlled trials(RCTs)are inadequate for evaluating the efficacy of dynamic treatment adjustments.The Sequential Multiple Assignment Randomized Trial(SMART)is an emerging adaptive research design that incorporates randomization at multiple stages,allowing for adjustments in subsequent interventions based on treatment responses.This approach is suitable for evaluating dynamic treatment regimens while retaining the low bias risk of traditional RCTs,making it highly promising for clinical research in TCM.This paper summarizes recent methodological advancements in SMART design,including different sample size estimation and statistical analysis methods for primary effect objectives,embedded adaptive intervention objectives,and optimization objectives,along with providing corresponding operational software.Additionally,it offers considerations for applying SMART design in TCM research,such as the selection of disease types,interventions,decision points,tailoring variables,sample size calculation,statistical methods,the importance of pilot trials,ethical considerations,and limitations.The aim is to promote the exploration and practice of this method in the field of TCM,thereby contributing to the generation of high-quality evidence-based evidence for TCM.
2.Analysis of clinical features of nasal pleomorphic adenoma
Shengnan ZHANG ; Lin WANG ; Xuehui LI ; Longgang YU ; Xudong YAN ; Junfeng WEN ; Zhaoxia WEI ; Yan JIANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(1):42-46
Objective:To analyze the clinical features of nasal pleomorphic adenoma and to share clinical insights into its diagnosis and treatment.Methods:This was a case series study. Clinical data of 12 patients with nasal pleomorphic adenoma, confirmed by histopathology, admitted to the Department of Otorhinolaryngology Head and Neck Surgery, Affiliated Hospital of Qingdao University from 2014 to 2023, were retrospectively analyzed. This cohort included 3 males and 9 females, aged 12-84 years old. The pathogenesis, clinical manifestations, imaging features, pathological features, treatment methods and prognosis were analyzed.Results:Among the 12 patients with nasal pleomorphic adenoma, the most common symptom was nasal obstruction (8 cases), and the most common site was nasal septum (7 cases). Of the 12 patients, 9 had benign tumors, and 3 had malignant tumors. Postoperative follow-up ranged from 10 months to 9 years. One benign case recurred at 5 years after surgery and was left untreated after recurrence. The remaining 11 cases had shown no recurrence to date.Conclusions:Nasal pleomorphic adenoma is rare in clinical practice, typically occurring in the nasal septum. The primary symptom is nasal obstruction. Diagnosis is primarily based on histopathology, and surgical resection is the primary treatment.
3.Mechanism of Yishen Tongluo Formula regulating the TLR4/MyD88/NF-κB signaling pathway to ameliorate pyroptosis in diabetic nephropathy mice
Yifei ZHANG ; Zijing CAO ; Zeyu ZHANG ; Xuehui BAI ; Jingyi TANG ; Junyu XI ; Jiayi WANG ; Yiran XIE ; Yuqi WU ; Xi GUO ; Zhongjie LIU ; Weijing LIU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(1):21-33
Objective:
To investigate the mechanism of Yishen Tongluo Formula in ameliorating renal pyroptosis in diabetic nephropathy mice by regulating the toll-like receptor 4 (TLR4)/myeloid differentiation factor 88 (MyD88)/nuclear factor-κB (NF-κB) signaling pathway.
Methods:
Sixty C57BL/6 male mice were randomly divided into control (10 mice) and intervention groups (50 mice) using random number table method. The diabetes nephropathy model was established by intraperitoneally injecting streptozotocin(50 mg/kg). After modeling, the intervention group was further divided into model, semaglutide (40 μg/kg), and high-, medium-, and low-dose Yishen Tongluo Formula groups (15.6, 7.8, and 3.9 g/kg, respectively) using random number table method. The high-, medium-, and low-dose Yishen Tongluo Formula groups were administered corresponding doses of medication by gavage, the semaglutide group received a subcutaneous injection of semaglutide injection, and the control group and model groups were administered distilled water by gavage for 12 consecutive weeks. Random blood glucose levels of mice in each group were monitored, and the 24-h urinary protein content was measured using biochemical method every 4 weeks; after treatment, the serum creatinine and urea nitrogen levels were measured using biochemical method. The weight of the kidneys was measured, and the renal index was calculated. Hematoxylin and eosin, periodic acid-Schiff, periodic Schiff-methenamine, and Masson staining were used to observe the pathological changes in renal tissue. An enzyme-linked immunosorbent assay was used to detect urinary β2-microglobulin (β2-MG), neutrophil gelatinase-associated lipocalin (NGAL), and kidney injury molecule-1 (KIM-1) levels. Western blotting and real-time fluorescence PCR were used to detect the relative protein and mRNA expression levels of nucleotide-binding domain leucine-rich repeat and pyrin domain-containing receptor 3 (NLRP3), Caspase-1, gasdermin D (GSDMD), interleukin-1β (IL-1β), and interleukin-18 (IL-18) in renal tissue. Immunohistochemistry was used to detect the proportion of protein staining area of the TLR4, MyD88, and NF-κB in renal tissue.
Results:
Compared with the control group, the random blood glucose, 24-h urinary protein, serum creatinine, urea nitrogen, and renal index of the model group increased, and the urine β2-MG, NGAL, and KIM-1 levels increased. The relative protein and mRNA expression levels of NLRP3, Caspase-1, GSDMD, IL-1β, and IL-18 in renal tissue increased, and the proportion of TLR4, MyD88, and NF-κB protein positive staining areas increased (P<0.05). Pathological changes such as glomerular hypertrophy were observed in the renal tissue of the model group. Compared with the model group, the Yishen Tongluo Formula high-dose group showed a decrease in random blood glucose after 12 weeks of treatment (P<0.05). The Yishen Tongluo Formula high- and medium-dose groups showed a decrease in 24-h urinary protein, creatinine, urea nitrogen, and renal index, as well as decreased β2-MG, NGAL, and KIM-1 levels. NLRP3, Caspase-1, GSDMD, IL-1 β, and IL-18 relative protein and mRNA expression levels were also reduced, and the proportion of TLR4, MyD88, and NF-κB protein positive staining areas was reduced (P<0.05). Pathological damage to renal tissue was ameliorated.
Conclusion
Yishen Tongluo Formula may exert protective renal effects by inhibiting renal pyroptosis and alleviating tubular interstitial injury in diabetic nephropathy mice by regulating the TLR4/MyD88/NF-κB signaling pathway.
4.Clinical value of quality control circle activities in preventing deep vein thrombosis in military hospitals
Xile WEI ; Xuehui HU ; Hange SONG ; Meixia ZHANG ; Guang CHENG ; Heng LUO ; Desheng WANG
Journal of Navy Medicine 2025;46(2):150-155
Objective To explore the clinical effect of quality control circle(QCC)activities on the prevention of postoperative deep vein thrombosis(DVT)in inpatients in military hospitals.Methods A total of 318 patients who were diagnosed and treated in The First Affiliated Hospital of Air Force Medical University from January to December 2021 and 40 medical staff were enrolled in this study.Routine care was performed in 158 patients from January to June 2021,and QCC care was implemented in 160 patients from July to December 2021.The awareness of DVT prevention in medical staff and patients(or their famiy members)before and after QCC activities,lower limb DVT preventive measures taken by medical staff,and the occurrence of DVT were compared.Results The scores of the cause,clinical manifestations,nursing measures and preventive measures of DVT after QCC activities were significantly higher than those before QCC activities in both medical staff and patients(or their families)(P<0.05).The overall implementation rate of preventing lower limb DVT after QCC activities was significantly higher than that before QCC activities(94.14%vs.46.20%,P<0.05).The incidence of DVT after QCC activities was significantly lower than that before QCC activities(0.62%vs.5.06%,P<0.05).Conclusion Implementing QCC activities can improve the cognitive ability of military medical staff and patients(or family members)in DVT prevention,increase the implementation rate of DVT prevention measures,and reduce the incidence of DVT.
5.Study on the mechanism of lnRNA HOTAIR targeting TSC1 to regulate podocyte injury in diabetic nephropathy
Qiuxia NIU ; Weili LIU ; Xuehui LI ; Qian ZHANG ; Shuangli WANG
Chongqing Medicine 2025;54(8):1787-1792
Objective To explore the regulatory effect of long non-coding RNA HOX transcript anti-sense RNA(lnRNA HOTAIR)targeting tuberous sclerosis complex 1(TSC1)on podocyte injury in diabetic nephropathy(DN).Methods Mice podocyte MPC5 were divided into 6 groups:the control group,the high glucose group(the HG group),the HG+si-NC group,the HG+si-HOTAIR group,the HG+si-HOTAIR+sh-NC group,and the HG+si-HOTAIR+sh-TSC1 group.qPCR was used to detect the levels of lnRNA HO-TAIR and TSC1 mRNA.Cell viability was detected by cell counting kit-8(CCK-8),and apoptosis was detec-ted by flow cytometry.ELISA was used to detect the levels of inflammatory factors[IL-6,tumor necrosis fac-tor-α(TNF-α)]and the levels of oxidative stress indicators[reactive oxygen species(ROS),malondialdehyde(MDA),superoxide dismutase(SOD)]were detected by corresponding reagent kit.Results Compared with the control group,the levels of lnRNA HOTAIR,apoptosis rate,IL-6,TNF-α,ROS and MDA in the HG group were significantly increased(P<0.05),while the levels of TSC1 mRNA,cell viability and SOD were significantly decreased(P<0.05).Compared with the HG+si-NC group,the levels of lnRNA HOTAIR,ap-optosis rate,IL-6,TNF-α,ROS and MDA in the HG+si-HOTAIR group significantly decreased(P<0.05),the levels of TSC1 mRNA,cell viability and SOD were significant increased(P<0.05).Compared with the HG+si-HOTAIR+sh-NC group,the levels of apoptosis rate,IL-6,TNF-α,ROS and MDA in the HG+si-HOTAIR+sh-TSC1 group were significantly increased(P<0.05),the levels of TSC1 mRNA,cell viability and SOD were significantly decreased(P<0.05).Conclusion Silencing lnRNA HOTAIR can target TSC1 to regulate the activity,apoptosis rate,inflammatory level and oxidative stress levels of podocyte injury in DN,thereby alleviating podocyte damage in DN.
6.Correlation between fat infiltration in the hip abductor muscles and cartilage damage in hip osteoarthritis evaluated by MR least squares estimation method of iterative water-fat separation technique
Zhuoli ZENG ; Jifeng DANG ; Guohua WANG ; Xuehui ZHANG ; Xiaoming HUANG
Journal of Practical Radiology 2025;41(2):262-266
Objective To quantify the mean fat fraction(FF)values of hip abductor muscles using the MR least squares estimation method of iterative water-fat separation(IDEAL-IQ)technique and to analyze the correlation between muscle fat infiltration and cartilage damage in hip osteoarthritis(HOA),age and gender.Methods Ninety-five patients with clinical symptoms of hip joint(HOA group)and volunteers(control group)underwent MRI conventional sequence and IDEAL-IQ sequence scans of the hip joint were selected.Hip cartilage damage was graded based on conventional MRI sequences(mild HOA group and severe HOA group),and the FF values of hip abductor muscles were measured for each group.ANOVA analysis and Pearson correlation tests were used to compare the differences between the groups and correlation analyses were performed.Results The FF values of hip abductor muscles in the mild HOA group and severe HOA group were significantly higher than those in the control group,with statistically significant differences(P<0.05).There were correlations between the FF values of hip abductor muscles and the degree of HOA cartilage damage,age and gender(r=0.677,0.566,0.311).Conclusion The IDEAL-IQ technique can be used for quantitative research on muscle fat infiltration,and fat infiltration in hip abductor muscles is an important risk factor for HOA cartilage damage.
7.Sero-epidemiological investigation and analysis of akabane disease and bluetongue of cattle of Guizhou Province
Tingting XU ; Hao WANG ; Qiuyu WU ; Xingwei NI ; Yuqi ZUO ; Jiafu SHANG ; Yanyan LIU ; Xuehui ZHOU ; Xiaowei YANG ; Guangwei ZHAO ; Xia LIU
Chinese Journal of Veterinary Science 2025;45(9):1895-1901
To investigate the infection status of two arboviruses,akabane orthobunyavirus(AKAV)and bluetongue virus(BTV),in cattle herds of Guizhou Province,we employed the indirect ELISA method to detect AKAV and BTV antibody levels in the present experiment.A total of 1504 bovine serum samples from 37 large-scale farms and 88 free-range households from 26 districts or coun-ties of 7 cities(prefectures)of Guizhou Province were collected to detect AKAV antibody levels.Additionally,1 241 serum samples from 30 large-scale farms and 15 free-range households in 19 districts or counties of 3 cities(prefectures)were tested for BTV antibody levels.Moreover,two influencing factors,breeding mode and sampling season,were statistically analyzed for their effects.The results showed that the overall positive rate of AKAV antibodies was 11.64%(175/1 504),with individual positive rates of 13.20%(123/934)and 9.12%(52/570)in large-scale farms and free-range households,respectively.No significant differences were observed between the two groups.However,the farm positive rate(64.86%,24/37)in large-scale farms was significantly higher than that(26.14%,23/88)in free-range households.Seasonal statistics showed that the positive rate was highest during the summer season at 60.00%(12/20).The total positive rate of BTV antibodies was 25.42%(222/1 241).The farm positive rate and individual positive rate in free-range households were 66.67%(10/15)and 41.91%(57/136),respectively.For large-scale farms,these rates were 60.00%(18/30)and 14.93%(165/1 105),respectively.The individual pos-itive rate in free-range households was significantly higher than that in large-scale farms.Seasonal statistics showed that the positive rates in summer and autumn seasons were 50.00%(5/10)and 72.41%(21/29),respectively,both of which were significantly higher than those in winter and spring seasons.All these findings indicated that both AKAV and BTV were present to a certain ex-tent in Guizhou Province,with seasonality.Furthermore,differences were observed between the different breeding modes.Our results could provide a data reference for the formulation of preven-tion and control measures for the two insect-borne diseases.
8.Establishment and application of an RPA-LFD method for detection of Akabane virus
Jiafu SHANG ; Xuehui ZHOU ; Yanyan LIU ; Xia LIU ; Xingwei NI ; Tingting XU ; Zhiguo ZHAO ; Yan WANG ; Zhenjun WANG ; Xiaowei YANG ; Guangwei ZHAO
Chinese Journal of Veterinary Science 2025;45(8):1601-1608
To establish a rapid visual detection method for Akabane virus(AKAV)on site,specific primers and probes based on the S fragment of AKAV were designed in this experiment.Corre-sponding groups were added to the primers or probes to fulfil the requirement of the combination of recombinase polymerase amplification(RPA)with lateral flow dipstick(LFD).The reaction temperature and time,concentrations of the primer and probe were optimized to establish the RPA-LFD method for detecting AKAV.After that,the specificity,sensitivity and clinical reliability of the method were evaluated.The results showed that after 20 minutes of reaction at 37 ℃,the test results could be read on LFD paper.There was no cross reaction against blue tongue virus,Pasteurella multocida,bovine infectious rhinotracheitis virus and bovine Mycoplasma bovis,and the detection limit was 2.5 × 100 copies/μL of standard plasmid.Detection of clinical samples showed a consistent results with that by RT-PCR method.These findings indicated that the RPA-LFD method established had the advantages of good specificity,high sensitivity,simple operation and visualization,and could be applied to clinical detection,which provides new technical support for the rapid diagnosis and prevention and control of AKAV.
9.Sero-epidemiological investigation and analysis of akabane disease and bluetongue of cattle of Guizhou Province
Tingting XU ; Hao WANG ; Qiuyu WU ; Xingwei NI ; Yuqi ZUO ; Jiafu SHANG ; Yanyan LIU ; Xuehui ZHOU ; Xiaowei YANG ; Guangwei ZHAO ; Xia LIU
Chinese Journal of Veterinary Science 2025;45(9):1895-1901
To investigate the infection status of two arboviruses,akabane orthobunyavirus(AKAV)and bluetongue virus(BTV),in cattle herds of Guizhou Province,we employed the indirect ELISA method to detect AKAV and BTV antibody levels in the present experiment.A total of 1504 bovine serum samples from 37 large-scale farms and 88 free-range households from 26 districts or coun-ties of 7 cities(prefectures)of Guizhou Province were collected to detect AKAV antibody levels.Additionally,1 241 serum samples from 30 large-scale farms and 15 free-range households in 19 districts or counties of 3 cities(prefectures)were tested for BTV antibody levels.Moreover,two influencing factors,breeding mode and sampling season,were statistically analyzed for their effects.The results showed that the overall positive rate of AKAV antibodies was 11.64%(175/1 504),with individual positive rates of 13.20%(123/934)and 9.12%(52/570)in large-scale farms and free-range households,respectively.No significant differences were observed between the two groups.However,the farm positive rate(64.86%,24/37)in large-scale farms was significantly higher than that(26.14%,23/88)in free-range households.Seasonal statistics showed that the positive rate was highest during the summer season at 60.00%(12/20).The total positive rate of BTV antibodies was 25.42%(222/1 241).The farm positive rate and individual positive rate in free-range households were 66.67%(10/15)and 41.91%(57/136),respectively.For large-scale farms,these rates were 60.00%(18/30)and 14.93%(165/1 105),respectively.The individual pos-itive rate in free-range households was significantly higher than that in large-scale farms.Seasonal statistics showed that the positive rates in summer and autumn seasons were 50.00%(5/10)and 72.41%(21/29),respectively,both of which were significantly higher than those in winter and spring seasons.All these findings indicated that both AKAV and BTV were present to a certain ex-tent in Guizhou Province,with seasonality.Furthermore,differences were observed between the different breeding modes.Our results could provide a data reference for the formulation of preven-tion and control measures for the two insect-borne diseases.
10.Establishment and application of an RPA-LFD method for detection of Akabane virus
Jiafu SHANG ; Xuehui ZHOU ; Yanyan LIU ; Xia LIU ; Xingwei NI ; Tingting XU ; Zhiguo ZHAO ; Yan WANG ; Zhenjun WANG ; Xiaowei YANG ; Guangwei ZHAO
Chinese Journal of Veterinary Science 2025;45(8):1601-1608
To establish a rapid visual detection method for Akabane virus(AKAV)on site,specific primers and probes based on the S fragment of AKAV were designed in this experiment.Corre-sponding groups were added to the primers or probes to fulfil the requirement of the combination of recombinase polymerase amplification(RPA)with lateral flow dipstick(LFD).The reaction temperature and time,concentrations of the primer and probe were optimized to establish the RPA-LFD method for detecting AKAV.After that,the specificity,sensitivity and clinical reliability of the method were evaluated.The results showed that after 20 minutes of reaction at 37 ℃,the test results could be read on LFD paper.There was no cross reaction against blue tongue virus,Pasteurella multocida,bovine infectious rhinotracheitis virus and bovine Mycoplasma bovis,and the detection limit was 2.5 × 100 copies/μL of standard plasmid.Detection of clinical samples showed a consistent results with that by RT-PCR method.These findings indicated that the RPA-LFD method established had the advantages of good specificity,high sensitivity,simple operation and visualization,and could be applied to clinical detection,which provides new technical support for the rapid diagnosis and prevention and control of AKAV.


Result Analysis
Print
Save
E-mail