1.Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina
Jingui WANG ; Haining ZHANG ; Shun FAN ; Yusheng LI ; Hongyi WANG ; An BAO ; Wei ZHANG ; Huanan LI
Journal of Traditional Chinese Medicine 2025;66(11):1128-1132
The rationale for the design of control groups in tuina clinical trial is the foundation for rigorously validating the effectiveness and safety of this therapy. This article reviewed the current state of the design of tuina placebo in control groups of clinical trials, pointed out the necessity of setting up tuina placebo in clinical trials of tuina, analyzed the challenges in implementing blinding of tuina manipulation, and concluded that tuina placebo is still challenged by the placebo effect, the diversification of tuina manipulation but the lack of standardization, and the difficulty of implementing blinding due to the high level of public awareness of tuina. This article also summarized the design of placebo manipulation in three types of clinical trials, including spinal manipulation, acupressure, and paediatric tuina, and proposed four strategies for designing placebo tuina manipulation-controlling placebo effects, developing operational standards for placebo tuina manipulation, ensuring the rigor of blinding implementation, and applying new technologies to enhance the standardization and blinding capacity of placebo tuina methods. So the article is aimed at improving the methodological quality of tuina clinical trial designs, and promoting the standardization and scientificity of tuina clinical trial design.
2.The causal relationship between neuroticism and gastroesophageal reflux disease: A bidirectional Mendelian randomization study in the European population
Siding ZHOU ; Hongbi XIAO ; Mingjun GAO ; Mengmeng WANG ; Xiaolin WANG ; Yusheng SHU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):814-818
Objective To analyze the relationship between neuroticism and gastroesophageal reflux disease (GERD) using the Mendelian randomization (MR) method. Methods Exposure and outcome data were downloaded from the Integrative Epidemiology Unit (IEU) database in August 2023, including summary statistics from genome-wide association studies (GWAS) for neuroticism (n=374 323) and GERD (n=602 604). MR was conducted using the weighted median method, MR-Egger method, inverse variance weighted method, weighted mode method, and simple mode method. The causal relationship between the two was assessed using odds ratio (OR), and sensitivity analyses were performed to ensure the accuracy of the results. Results Neuroticism was associated with an increased risk of GERD [OR=1.229, 95%CI (1.186, 1.274), P<0.001]. Similarly, GERD was associated with an increased risk of neuroticism [OR=1.786, 95%CI (1.623, 1.965), P<0.001]. Conclusion There is a bidirectional causal relationship between neuroticism and gastroesophageal reflux disease.
3.Study on the aging change of postural control reaction time and movement time during adaptive balance
Yusheng WANG ; Zishan JIA ; Gongzi ZHANG
Chinese Journal of Rehabilitation Medicine 2024;39(5):675-680,686
Objective:To observe the aging-related trends and age-sensitive changes in postural control reaction time(RT)and movement time(MT)during the adaptive balance after instability. Method:A total of 97 healthy adult subjects aged 20-79 were tested for posture control time using the DE-A somatosensory balance detection system.The test included postural adjustment RT and MT during the adaptive balance(e.g.forward,backward,left and right)tilts of the support surface under static and dynamic balance states.The subjects were sequentially divided into six age groups based on 10-year age intervals,with 16 in Group 1(20-29 years),10 in Group 2(30-39 years),17 in Group 3(40-49 years),18 in Group 4(50-59 years),31 in Group 5(60-69 years)and 5 in Group 6(70-79 years).The age-related trends and age-sensitive changes in postural control RT and MT were observed and analyzed. Result:The postural control RT and MT increased with age.In static balance,all RT and MT indicators were longer in group 6 than in groups 1 to 5,with significant differences compared with groups 1 to 4(P<0.05)but no significant differences compared to group 5(P>0.05).All RT and MT indicators were longer in group 5 than in groups 1 to 4,and there were significant differences(P<0.05).All RT and MT indicators were lon-ger in group 4 than in groups 1 to 3,with a significant difference compared with group 1 in RT when the support surface was tilted to the right(P<0.05),but no significant differences between groups for the remain-ing indicators(P>0.05).All RT and MT indicators were longer in group 3 than in groups 1 to 2,with a sig-nificant difference compared with group 1 in MT when the support surface was tilted to the left(P<0.05),but no significant differences between groups for the remaining indicators(P>0.05).There was no significant difference(P>0.05)between group 2 in all RT and in MT compared with group 1.In dynamic balance,all RT and MT indicators were longer in group 6 than in groups 1 to 5,with significant differences compared with groups 1 to 4(P<0.05)but no significant differences compared with group 5(P>0.05).All RT and MT indicators were longer in group 5 than in groups 1 to 4,but there were no significant differences(P>0.05).All RT indicators were longer in group 4 than in groups 1 to 3,with no significant differences compared with group 1 in RT when the support surface was tilted to the left(P>0.05),while there were significant dif-ferences between groups for the remaining RT indicators(P<0.05).All MT indicators were longer in group 4 than in groups 1 to 3,with significant differences compared with group 2 in MT when the support surface was tilted to the back and left(P<0.05),while there were no significant differences between groups for the remaining RT indicators(P>0.05).All RT indicators were longer in group 3 than in groups 1 to 2,with no significant differences compared with group 1(P>0.05).All MT indicators were longer in group 3 than in groups 1 to 2,with significant differences compared with group 1(P<0.05).There was no significant differ-ence between group 2 in all RT and in MT compared with group 1(P>0.05). Conclusion:The postural control RT and MT during the adaptive balance after instability gradually increase with aging.The deterioration of postural control response time and motion time in static balance may start to become evident around the age of 60,while in dynamic balance,these deteriorations may begin to appear around the ages of 50 and 40,respectively.
4.Risk prediction models for recurrence of diabetic foot ulcers: a systematic review
Yusheng XIE ; Rongrong HUANG ; Yuhong LUO ; Qiansha WANG ; Yue MING ; Yi XU
Chinese Journal of Modern Nursing 2024;30(11):1414-1421
Objective:To systematically evaluate the recurrence risk prediction model of diabetic foot ulcers (DFU) .Methods:Research on DFU recurrence risk prediction models was electronically searched in PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Wanfang Data, and China Biomedical Service System. The search period was from database establishment to July 20, 2023. Two researchers independently screened literature and conducted data extraction and quality evaluation using the prediction model research data extraction table and the Prediction Model Risk of Bias Assessment Tool (PROBAST) .Results:A total of 8 articles were included, including 14 models. The area under the receiver operating characteristic (ROC) curve included in the model ranged from 0.660 to 0.940. The most common five predictors in the model were ulcers location, glycosylated hemoglobin, smoking, combined peripheral neuropathy and diabetes course. All 8 articles had a high risk of bias, mainly due to insufficient sample size, improper handling and reporting of missing data, and a lack of internal validation, which might lead to overfitting of the model. Only one article was subjected to external validation.Conclusions:The research on DFU recurrence risk prediction models is still in the development stage, and the predictive performance of various studies is still acceptable, but there is a high risk of bias. Future research still needs to use rigorous statistical analysis methods to construct new risk prediction models and improve internal and external validation.
5.Evidence summary of enteral and parenteral nutrition support in adult patients with severe burns
Yusheng XIE ; Rongrong HUANG ; Xue ZHAO ; Lei MA ; Yan HU ; Qian YANG ; Qiansha WANG ; Yue MING
Chinese Journal of Nursing 2024;59(9):1106-1113
Objective To systematically retrieve and integrate the best evidence of enteral and parenteral nutrition support in adult patients with severe bums.Methods 2 nursing master students who had studied evidence-based nursing systematically searched the clinical decisions,recommended practices,guidelines,expert consensuses,systematic reviews,evidence summaries and other evidences on enteral and parenteral nutrition support for adult patients with severe bums in domestic and foreign guideline networks,relevant institutional websites and databases.The retrieval time was from the establishment of the databases to April 2023.2 researchers who had obtained master's degrees and undergone systematic evidence-based training in Fudan University used the appraisal of guidelines for research and evaluation n and JBI critical appraisal tools to evaluate the methodological quality,and extracted and summarized the evidence according to the theme.Results A total of 28 articles were included,including l clinical decision,9 guidelines,3 expert consensuses,9 systematic reviews,and 6 evidence summaries.A total of 20 pieces of evidence were summarized from 6 aspects:nutritional risk screening and assessment,energy requirement calculation,timing and route of nutritional support,nutrient intake,nutritional support monitoring and effect evaluation.Conclusion The best evidence of enteral and parenteral nutrition support for adult patients with severe burns summarized in this study is more comprehensive and scientific.It is suggested that in clinical application,targeted screening should be carried out according to the promotion and hindering factors of evidence,so as to scientifically carry out nutritional support for adult patients with severe burns.
6.A real-world study evaluating the safety and efficacy of envafolimab-containing regimens in the treatment of digestive adenocarcinoma patients
Jiaxue WU ; Jian ZHAO ; Yusheng WANG
Modern Interventional Diagnosis and Treatment in Gastroenterology 2024;29(7):778-783,788
Objective To retrospectively analyze the safety and efficacy data of envafolimab-containing treatment regimens for digestive adenocarcinoma in the real world.Methods Treatment information of 35 patients with digestive adenocarcinoma who received envafolimab-containing regimens at Shanxi Provincial Cancer Hospital from December 2021 to July 2023 was retrospectively collected.Data were analyzed using IBM SPSS Statistics 27.Descriptive statistics were used to present quantitative data as mean±standard deviation or median,and qualitative data as frequency and percentage.Survival status was analyzed using the Kaplan-Meier(KM)method,and graphs were created using GraphPad Prism 9.5.1.Results Among 108 patients,35 met the inclusion criteria.Twenty-four(68.6%)experienced grade 1-3 adverse events(AEs),with no grade 4 or 5 AEs.The incidence rate of immune-related AEs was 31.4%.The median time to overall AE occurrence was 4.8 months.Twenty-three of the 35 patients underwent at least one efficacy evaluation,with 5 achieving partial response(PR)and 15 achieving stable disease(SD).No patients achieved complete response(CR).The objective response rate(ORR)was 21.7%,and the disease control rate(DCR)was 87.0%.Among the six patients with deficient mismatch repair/microsatellite instability-high(dMMR/MSI-H)lesions,the ORR was 50%,and the DCR was 100%.Among the 17 patients with proficient mismatch repair/microsatellite stable(pMMR/MSS)lesions,the ORR was 11.8%,and the DCR was 82.4%.Conclusion Envafolimab-containing regimens demonstrate good safety and favorable efficacy in the real-world treatment of digestive adenocarcinoma.
7.Refractive prediction error in vitrectomy combined with phacoemulsification and intraocular lens implantation for patients with macular disease and cata-ract
Jiayi KONG ; Zifeng ZHANG ; Manhong LI ; Chaowei TIAN ; Yusheng WANG
Recent Advances in Ophthalmology 2024;44(5):370-375
Objective To analyze the refractive prediction error(PE)in combined vitrectomy,phacoemulsification,and intraocular lens(IOL)implantation for patients with macular disease and cataract.Methods This study encom-passed 96 patients(96 eyes)diagnosed with macular disease and cataract,who underwent combined vitrectomy,phacoe-mulsification and IOL implantation at the Department of Ophthalmology in Xijing Hospital,Air Force Military Medical Uni-versity from May 2014 to November 2022.The best corrected visual acuity(BCVA)and actual spherical equivalent(SE)were studied,PE and absolute refractive error(ARE)were calculated,and the correlations between PE and axial length(AL),anterior chamber depth(ACD),lens thickness(LT),flat keratometry(Kf),steep keratometry(Ks),mean kera-tometry(Km),corneal astigmatism degree(cylinder,Cyl),intraocular pressure(IOP),BCVA,corneal astigmatism axis,the classification of macular diseases,and the type of intraoperative vitreous fillers were analyzed.Results In the early postoperative period(within 3 days after surgery),no statistically significant disparity in BCVA was observed compared to preoperative data among the 96 patients studied(P>0.05).The ARE was determined to be(1.47±2.54)D,indicating a substantial deviation between the actual SE and preoperative predictive refraction of the 96 patients(P<0.05).Among them,61 patients had a myopic shift,35 patients had a hyperopic shift,and the values of PE were(-1.81±3.07)D and(0.87±0.96)D,respectively.At the 1-month mark after surgery,there was no statistically significant difference in BCVA compared to the preoperative data of 12 follow-up patients(P>0.05).Similarly,no statistically significant differences were found between every two of the three data,namely the actual SE one month after surgery,the preoperative predictive refraction,and the actual SE in the early postoperative period of the 12 follow-up patients(all P>0.05).Also,no disparity was observed in BCVA at the last follow-up(P>0.05)among the 6 patients who were followed up for over 1 year(long-term postoperative follow-up).The correlation analysis revealed that,in the early postoperative period,the PE of patients with myopic shift was negatively correlated with both preoperative AL and Cyl measurements(both P<0.05).The early postoperative PE of patients with myopic shift was associated with the diagnostic classification of macular diseases(P<0.05),and the degree of myopic shift was observed to be significantly greater in patients with pathological myopia macular holes compared to those with other macular diseases(P<0.05).Additionally,the early postoperative PE of patients with myopic shift was uncorrelated with preoperative ACD,TL,Kf,Ks,Km,IOP,BCVA,the type of intraoperative vitreous fillers and the corneal astigmatism axis(all P>0.05).In contrast,for patients exhibiting hyperopic shift,the PE observed in the early postoperative period exhibited a positive correlation with preoperative Cyl(P<0.05).PE was also correlated with the type of intraoperative vitreous fillers(P<0.05),and the degree of hyperopic shift was notably enhanced when the intraoperative vitreous cavity was filled with silicone oil(P<0.05).The PE of patients with hyperopic shift observed in the early postoperative period exhibited no correlation with preoperative AL,ACD,TL,Kf,Ks,Km,IOP,BCVA,the diagnos-tic classification of macular diseases or the astigmatism axis(all P>0.05).Conclusion Refractive prediction error may occur in patients with macular disease and cataract in the initial postoperative period after the vitrectomy combined with phacoemulsification and IOL implantation,predominantly caused by myopic shift.However,over time,there is a signifi-cant reduction in the magnitude of this refractive error.The direction and extent of diopter drift appear to be influenced by preoperative AL,Cyl,the specific diagnosis of macular disease,and the type of vitreous cavity filler utilized in the surgical procedure.
8.Optical coherence tomography imaging features of Coats disease and their correlation with macular fibrosis
Ziyi ZHOU ; Guorui DOU ; Hongxiang YAN ; Guoheng ZHANG ; Jinting ZHU ; Dongjie SUN ; Zifeng ZHANG ; Manhong LI ; Yusheng WANG
Chinese Journal of Experimental Ophthalmology 2024;42(5):436-441
Objective:To analyze the optical coherence tomography (OCT) imaging characteristics in patients with Coats disease and their value in predicting macular fibrosis.Methods:A nested case-control study was performed.A total of 43 patients (43 eyes) diagnosed with Coats disease through color fundus photography, ocular B-scan ultrasonography, fundus fluorescein angiography, and spectral-domain OCT examination were enrolled from January 2008 to October 2021 at the Xijing Hospital.Among them, there were 40 males and 3 females, aged from 2 to 60 years old, with a median age of 13 years.Macular fibrosis was used as an indicator of poor prognosis, and patients were divided into two groups based on whether macular fibrosis occurred at the end of follow-up.The differences in OCT characteristics between two groups were compared and logistic regression analysis was used to identify the risk factors for macular fibrosis.This study adhered to the Declaration of Helsinki and was approved by the Ethics Committee of Xijing Hospital of Fourth Military Medical University (No.KY20202009-C-1).Results:The OCT clinical features of 43 cases of Coats disease included intraretinal hard exudates in 43 eyes (100%), subretinal fluid in 21 eyes (48.8%), macular cysts in 17 eyes (27.9%), subretinal exudates in 9 eyes (20.9%), anterior retinal hyperreflective dots in 7 eyes (16.3%), epiretinal membrane in 21 eyes (48.8%), and intraretinal fluid in 22 eyes (51.2%).In color fundus photos of 41 eyes, 38 eyes (93.0%) had hard exudates distributed in the posterior pole and 27 eyes (65.9%) had the mid-peripheral region.OCT examination showed that hard exudates were distributed in the inner nuclear layer in 35 eyes (81.4%) and the outer nuclear layer in 33 eyes (76.7%).Among 21 eyes with exudative retinal detachment detected by OCT, 9 eyes (42.9%) were detected by fundus photography and 18 eyes (85.7%) were detected by B-scan ultrasonography.The proportions of eyes with subretinal fluid and subretinal exudates were higher in the macular fibrosis group than in the non-macular fibrosis group, and the differences were statistically significant ( χ2=20.755, P<0.001; χ2=6.133, P=0.013).Logistic regression analysis showed that the presence of subretinal fluid was a risk factor for macular fibrosis (odds ratio=48.345, 95% confidence interval: 4.272-547.066, P=0.002). Conclusions:OCT examination can detect subretinal fluid, subretinal exudates, macular cysts, macular exudates, and hyperreflective spots in the retina of patients with Coats disease.Subretinal fluid is a risk factor for macular fibrosis.
9.The ergonomic requirements of liquid crystal displays in airborne environments
Shaoheng LI ; Tao CHEN ; Yuting SU ; Yusheng WANG ; Zuoming ZHANG
China Medical Equipment 2024;21(10):183-189
Special flight missions cover vast areas,involve urgent tasks,and often require long hours,leading to visual issues for crew,especially during night flights.These problems affect flight parameters and information access.Current special aircraft cockpit displays have low technical standards and limited product sources,restricting design choices.The absence of visual ergonomics evaluation tools and methods in the aviation industry significantly contributes to the shortcomings in military aircraft cockpit design.Considering the General Specification for Airborne Liquid Crystal Displays(GJB8187-2015)and other relevant standards,this covers modern cockpit display requirements,current cockpit display status,screen light source modification technology,and visual ergonomics assessment for cockpit displays.To determine if the visual clarity,color accuracy,and other attributes of current special aircraft airborne displays during flight meet the needs for long-duration operations,and if the operational environment ensures visual comfort and ergonomics to minimize visual fatigue.We seek to enhance the evaluation of visual ergonomics satisfaction for flight crews in current special aircraft cockpits and offers new approaches to optimize cockpit display technology,reducing visual issues from prolonged screen use during flights.
10.Effect of early postoperative comprehensive rehabilitation on children and youth with supracondylar fracture of humerus complicated with ulnar nerve injury
Lihua LUO ; Yusheng WANG ; Jianfeng LI ; Jige DONG
Chinese Journal of Rehabilitation Theory and Practice 2024;30(1):105-110
ObjectiveTo observe the therapeutic effect of early postoperative comprehensive rehabilitation on elbow joint dysfunction and ulnar nerve injury in children and adolecents with supracondylar fracture of humerus complicated with ulnar nerve injury. MethodsA total of 49 children with supracondylar fracture of humerus complicated with ulnar nerve injury after operation were selected from January, 2016 to December, 2021 in Wangjing Hospital, which were randomly divided into control group (n = 24) and treatment group (n = 25). The control group accepted wax therapy and acupuncture, and the treatment group accepted medicine fumigation, joint mobilization and electromyographic biofeedback, for twelve weeks. They were assessed with The Hospital for Special Surgery Elbow score (HSS) and Medical Research Neurotrauma Society Report (MCRR) before and after treatment. ResultsAfter treatent, the HSS scores increased in both groups (|t| > 8.345, P < 0.001). The HSS score was significantly higher in the treatment group than in the control group (t = 4.536, P < 0.001). The d-value of HSS scores before and after treatment was significantly higher in the treatment group than in the control group (t = 3.717, P < 0.05). The rate of excellent recovery of ulnar nerve function was significantly higher in the treatment group than in the control group (χ2 = 5.975, P < 0.05). ConclusionEarly postoperative comprehensive rehabilitation could romote the recovery of elbow function and ulnar nerve injury in children and youth with supracondylar fracture of humerus complicated with ulnar nerve injury.

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