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.Timing of stage Ⅱ vitrectomy in patients with open ocular trauma
Chunxia* MA ; Xiaxia* YANG ; Chaowei TIAN ; Manhong LI ; Dan HU ; Yusheng WANG ; Zifeng ZHANG
International Eye Science 2024;24(4):630-633
AIM:To observe the clinical efficacy of vitrectomy at different times for open ocular trauma and explore the timing of stage Ⅱ vitrectomy.METHODS: Retrospective case series study. A total of 60 cases(60 eyes)with open ocular trauma who visited our ophthalmology department from June 2022 to February 2023 were included. They were divided into treatment group A(interval ≤14 d)and treatment group B(interval >14 d)based on the interval between the stage Ⅰ emergency treatment surgery and the stage Ⅱ vitreoretinal surgery. Among the 32 cases(32 eyes)in the treatment group A, 16 eyes(50%)had eyeball rupture, 13 eyes(41%)had penetrating injury, and 3 eyes(9%)had perforating injury. Among the 28 cases(28 eyes)in the treatment group B, 15 eyes(54%)had eyeball rupture, 12 eyes(43%)had penetrating injury, and one eye(4%)had perforating injury. The two groups of patients were followed-up for 6 mo after surgery, and the treatment effects were compared.RESULTS:There was no statistically significant difference in visual acuity between the two groups of patients before vitrectomy(P>0.05). In the treatment group A, 10 eyes(31%)had significantly improved visual acuity, 21 eyes(66%)had effectively enhanced visual acuity, and 1 eye(3%)had no improvement in visual acuity at 6 mo after surgery. Among the 28 eyes in the treatment group B, 5 eyes(18%)had significantly improved vision, 16 eyes(57%)had effectively enhanced vision, and 7 eyes(25%)had no change in vision, with statistically significant difference between the two groups(U=322.5, P=0.032). There was no significant difference between the treatment group A and the treatment group B in complications such as secondary glaucoma, silicone oil dependence, vitreous hemorrhage, and eyeball atrophy(P>0.05). There was no evidence of traumatic proliferative vitreoretinopathy(TPVR)in the treatment group A during postoperative follow-up, which was significantly lower than that of the treatment group B(P<0.05).CONCLUSION:The prognosis of the stage Ⅱ vitrectomy for open ocular injury is relatively good after completing the stage Ⅰ surgery within 2 wk.
4.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.
5.18F-FDG PET/CT combined with CT three-dimensional reconstruction in the differentiation of benign and malignant pulmonary nodules: A retrospective cohort study
Yong CHEN ; Jun WU ; Shichun LU ; Chao SUN ; Yusheng SHU ; Xiaolin WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(03):357-363
Objective To investigate the accuracy of 18F-FDG positron emission tomography/computed tomography (PET/CT) combined with CT three-dimensional reconstruction (CT-3D) in the differential diagnosis of benign and malignant pulmonary nodules. Methods The clinical data of patients who underwent pulmonary nodule surgery in the Department of Thoracic Surgery, Northern Jiangsu People's Hospital from July 2020 to August 2021 were retrospectively analyzed. The preoperative 18F-FDG PET/CT and chest enhanced CT-3D and other imaging data were extracted. The parameters with diagnostic significance were screened by the area under the receiver operating characteristic (ROC) curve (AUC). Three prediction models, including PET/CT prediction model (MOD PET), CT-3D prediction model (MOD CT-3D), and PET/CT combined CT-3D prediction model (MOD combination), were established through binary logistic regression, and the diagnostic performance of the models were validated by ROC curve. Results A total of 125 patients were enrolled, including 57 males and 68 females, with an average age of 61.16±8.57 years. There were 46 patients with benign nodules, and 79 patients with malignant nodules. A total of 2 PET/CT parameters and 5 CT-3D parameters were extracted. Two PET/CT parameters, SUVmax≥1.5 (AUC=0.688) and abnormal uptake of hilar/mediastinal lymph node metabolism (AUC=0.671), were included in the regression model. Among the CT-3D parameters, CT value histogram peaks (AUC=0.694) and CT-3D morphology (AUC=0.652) were included in the regression model. Finally, the AUC of the MOD PET was verified to be 0.738 [95%CI (0.651, 0.824)], the sensitivity was 74.7%, and the specificity was 60.9%; the AUC of the MOD CT-3D was 0.762 [95%CI (0.677, 0.848)], the sensitivity was 51.9%, and the specificity was 87.0%; the AUC of the MOD combination was 0.857 [95%CI (0.789, 0.925)], the sensitivity was 77.2%, the specificity was 82.6%, and the differences were statistically significant (P<0.001). Conclusion 18F-FDG PET/CT combined with CT-3D can improve the diagnostic performance of pulmonary nodules, and its specificity and sensitivity are better than those of single imaging diagnosis method. The combined prediction model is of great significance for the selection of surgical timing and surgical methods for pulmonary nodules, and provides a theoretical basis for the application of artificial intelligence in the pulmonary nodule diagnosis.
6.Research progress of SARS-CoV-2 vaccine-related ocular adverse events
Yusheng ZHU ; Tong WANG ; Xiaodong CHEN
International Eye Science 2024;24(6):925-929
Since 2019, severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection has been widespread in the world, causing about 770 million infecting and 6.9 million deaths. Vaccines against SARS-CoV-2 infection have become the main way to prevent the severe SARS-CoV-2. The use of SARS-CoV-2 vaccine has substantial protection against the serious consequences of SARS-CoV-2 infection, but multiple systemic adverse reactions can occur after the use of SARS-CoV-2 vaccine. More and more studies have shown that SARS-CoV-2 vaccine caused lesions of ocular conjunctiva, cornea, sclera, uvea, retina and optic nerve tissue and resulted in damage to visual function. In this paper, the classification and characteristics of SARS-CoV-2 vaccines and related studies on ocular tissue lesions were reviewed, hoping to better understand the ocular adverse reactions of SARS-CoV-2 vaccine and provide some theoretical guidance for the prevention and treatment of ocular tissue damage caused by SARS-COV-2 vaccine.
7.Construction of Meridian and Collateral Homeostasis Model from Phenomics
Jiaqi SUN ; Luxia JIANG ; Zheng YU ; Zhenmei DU ; Shengyan ZHANG ; Yusheng TANG ; Ziqian WANG ; Xianfeng CAO ; Chuanbiao WEN
Journal of Traditional Chinese Medicine 2024;65(10):990-995
By applying "homeostasis" to the study of the meridian and collateral system, the concept of meridian and collateral homeostasis has been proposed which refers to a balanced and stable state of meridian and collateral system, and plays an important role in maintaining body health and can provide a reference for the diagnosis and treatment of diseases. Phenomics realizes the cross-scale correlation from micro-phenotypic data, such as genome, proteome, and metabolome, to macro-phenotypic data, such as physiological state, behavioral activities, and external manifestations. From the perspective of phenomics, this paper proposes a meridian and collateral homeostasis dynamic mapping model of "macroscopic signs and microscopic expression". This model combines macro signs such as the four examinations of traditional Chinese medicine (TCM), biophysical indicators of acupoints, and micro expression information such as genes, proteins, and metabolism, and systematically investigates the relationship between meridian and collateral homeostasis and health and disease, thereby providing ideas and references for the identification of pre-disease states as well as precise diagnosis and treatment in TCM.
8.Clinical features and impact factors in patients with open ocular trauma
Xiaxia* YANG ; Chunxia* MA ; Pengfei LIU ; Chaowei TIAN ; Manhong LI ; Dan HU ; Yusheng WANG ; Zifeng ZHANG
International Eye Science 2024;24(11):1846-1850
AIM:To summarize the clinical features and prognostic factors of patients with open ocular trauma in northwest China, and to explore the application of ocular trauma score(OTS)in open ocular trauma.METHODS:The clinical data of 91 patients(91 eyes)with open ocular trauma admitted to Xijing Hospital from June 2021 to June 2023 were retrospectively analyzed. The correlation analysis of visual acuity prognosis was carried out by age, treatment time, initial visual acuity, trauma zone and other factors, and the relationship between different OTS and prognostic visual acuity was discussed.RESULTS:Univariate analysis showed that age(0-20 years), treatment time(<24 h), initial visual acuity, trauma zone, trauma type(penetrating injury), anterior chamber hematoma, vitreous hematoma were correlated with prognostic visual acuity(all P<0.1); multivariate Logistic regression analysis showed that initial visual acuity and treatment time(<24 h)were risk factors(both P<0.05). There was a significant correlation between different OTS and prognostic visual acuity(rs=0.639,P<0.001).CONCLUSION:Patients with open ocular trauma should be diagnosed and treated as early as possible. The main factors influencing the visual prognosis are age, treatment time, initial visual acuity, trauma zone, trauma type, anterior chamber hematoma and vitreous hematoma. OTS has good application value in visual acuity evaluation of open ocular trauma prognosis.
9.The application of percutaneous puncture renal fascia suspension in laparoscopic partial nephrectomy
Qi LI ; Pei ZHENG ; Yusheng WANG ; Guangyuan JING ; Mingrui WANG ; Bo ZHAO ; Tengfei XU ; Xiaoli WANG ; Kaidong WANG ; Xiao PAN ; Fen YIN
Chinese Journal of Urology 2024;45(1):53-54
When partial nephrectomy is performed by posterior abdominal approach, the surgical field is poorly exposed, resulting in increased surgical difficulty and risk of injury.In this study, 28 patients with T 1a stage kidney tumors underwent retroperitoneal laparoscopic partial nephrectomy. Intraoperatively, exposure of the surgical field was achieved using the percutaneous puncture of the renal fascia suspension technique. There were no dissatisfactory exposures due to peritoneal damage during the surgery, no additional tubes were inserted, and no conversions to open surgery were needed. The operation time was (76.5±20.3) minutes, blood loss was (92.1±18.7) ml, renal artery clamping time was (19.5±4.3) minutes. Postoperatively, there were no complications such as bleeding, infection, or hematuria.
10.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.

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