1.Discussion of the methodology and implementation steps for assessing the causality of adverse event
Hong FANG ; Shuo-Peng JIA ; Hai-Xue WANG ; Xiao-Jing PEI ; Min LIU ; An-Qi YU ; Ling-Yun ZHOU ; Fang-Fang SHI ; Shu-Jie LU ; Shu-Hang WANG ; Yue YU ; Dan-Dan CUI ; Yu TANG ; Ning LI ; Ze-Huai WEN
The Chinese Journal of Clinical Pharmacology 2024;40(2):299-304
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.
2.The diagnostic value of miR-571 levels in blood from the peripherals in liver fibrosis
Juan TANG ; Yi LI ; Liqiong ZHAI ; Shaowen LIU ; Yong SHEN ; Shuo CONG ; Yongmei LIU
The Journal of Practical Medicine 2024;40(5):653-657
Objective To study the diagnostic value of miR-571 for liver fibrosis by detecting miR-571 expression in the peripheral blood of patients with liver fibrosis.Methods From December 2022 to September 2023,40 patients with liver fibrosis,40 patients with chronic hepatitis,and 40 healthy controls were chosen as research subjects.The expression level of miR-571 in peripheral blood was detected using a real-time quantitative polymerase chain reaction,and the relative expression of miR-571 in each group was evaluated.The Spearman correlation method was utilized to examine the relationship between miR-571 and clinical detection indices.To assess the capacity of miR-571 and the multivariate diagnostic model to identify liver fibrosis,binary logistic regression was used to create a multivariate diagnostic model,and ROC curves were generated.Results The expression of miR-571 was significantly higher in the liver fibrosis group than in the healthy control and hepatitis groups,and the difference was statistically significant(P<0.001).The expression level of miR-571 was positively connected with ALT,APRI score,and FIB-4 index(r = 0.23,0.30,0.22,P<0.05)and negatively correlated with PLT(r =-0.19,P<0.05)according to Spearman correlation analysis.Logistic regression research revealed that miR-571 and the FIB-4 index were independent risk factors for liver fibrosis.The AUC for miR-571 to diagnose fibrosis was 0.91(95%CI:0.85~0.96),while the AUC for miR-571 paired with the FIB-4 index was 0.94(95%CI:0.90~0.98).Conclusion MiR-571 expression was shown to be considerably higher in the peripheral blood of hepatic fibrosis patients,and the combined FIB-4 index offers some clinical diagnostic value for hepatic fibrosis.
3.Low-dose CT reconstruction based on high-dimensional partial differential equation projection recovery
Shanzhou NIU ; Shizhou TANG ; Shuyan HUANG ; Lijing LIANG ; Shuo LI ; Hanming LIU
Journal of Southern Medical University 2024;44(4):682-688
Objective We propose a low-dose CT reconstruction method using partial differential equation (PDE) denoising under high-dimensional constraints. Methods The projection data were mapped into a high-dimensional space to construct a high-dimensional representation of the data, which were updated by moving the points in the high-dimensional space. The data were denoised using partial differential equations and the CT image was reconstructed using the FBP algorithm. Results Compared with those by FBP, PWLS-QM and TGV-WLS methods, the relative root mean square error of the Shepp-Logan image reconstructed by the proposed method were reduced by 68.87%, 50.15% and 27.36%, the structural similarity values were increased by 23.50%, 8.83% and 1.62%, and the feature similarity values were increased by 17.30%, 2.71% and 2.82%, respectively. For clinical image reconstruction, the proposed method, as compared with FBP, PWLS-QM and TGV-WLS methods, resulted in reduction of the relative root mean square error by 42.09%, 31.04%and 21.93%, increased the structural similarity values by 18.33%, 13.45% and 4.63%, and increased the feature similarity values by 3.13%, 1.46% and 1.10%, respectively. Conclusion The new method can effectively reduce the streak artifacts and noises while maintaining the spatial resolution in reconstructed low-dose CT images.
4.Accuracy of digital guided implant surgery:expert consensus on nonsurgical factors and their treatments
Shulan XU ; Ping LI ; Shuo YANG ; Shaobing LI ; Haibin LU ; Andi ZHU ; Lishu HUANG ; Jinming WANG ; Shitong XU ; Liping WANG ; Chunbo TANG ; Yanmin ZHOU ; Lei ZHOU
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(5):321-329
The standardized workflow of computer-aided static guided implant surgery includes preoperative exami-nation,data acquisition,guide design,guide fabrication and surgery.Errors may occur at each step,leading to irrevers-ible cumulative effects and thus impacting the accuracy of implant placement.However,clinicians tend to focus on fac-tors causing errors in surgical operations,ignoring the possibility of irreversible errors in nonstandard guided surgery.Based on the clinical practice of domestic experts and research progress at home and abroad,this paper summarizes the sources of errors in guided implant surgery from the perspectives of preoperative inspection,data collection,guide de-signing and manufacturing and describes strategies to resolve errors so as to gain expert consensus.Consensus recom-mendation:1.Preoperative considerations:the appropriate implant guide type should be selected according to the pa-tient's oral condition before surgery,and a retaining screw-assisted support guide should be selected if necessary.2.Da-ta acquisition should be standardized as much as possible,including beam CT and extraoral scanning.CBCT performed with the patient's head fixed and with a small field of view is recommended.For patients with metal prostheses inside the mouth,a registration marker guide should be used,and the ambient temperature and light of the external oral scan-ner should be reasonably controlled.3.Optimization of computer-aided design:it is recommended to select a handle-guided planting system and a closed metal sleeve and to register images by overlapping markers.Properly designing the retaining screws,extending the support structure of the guide plate and increasing the length of the guide section are methods to feasibly reduce the incidence of surgical errors.4.Improving computer-aided production:it is also crucial to set the best printing parameters according to different printing technologies and to choose the most appropriate postpro-cessing procedures.
5.Research on regulatory countermeasures for local human genetic resources in China
Shuo GU ; Tao XUE ; Yue TANG ; Jinping ZHAO ; Xiaowei ZHANG ; Jun FENG
Chinese Medical Ethics 2024;37(4):441-447
Human genetic resources are an indispensable part of national natural science and technology resources,as well as an important strategic resource for safeguarding national security,public health,and social public interests.To promote the effective protection and rational utilization of human genetic resources,as well as improve and optimize the local human genetic resources management system in China,this paper summarized the current situation of administrative approval and supervision of national human genetic resources from 2004 to 2021 by sorting out the national human genetic resources management policies and regulations.Furthermore,the current situation and progress of local human genetic resources management in China were understood from three aspects,including development planning and programs of human genetic resources,administrative licensing and penalties,and the construction of management expert committees.The main problems of local human genetic resources management in China were discussed and analyzed,such as unclear supervision,difficulty in supervision and inspection,and capacity for services.Based on the causes of the problems and the local management work,specific countermeasures and suggestions were put forward from the perspective of clarifying the regulatory policies and procedures for human genetic resources,improving the supervision and inspection mechanisms,and improving the management and service capabilities.
6.Low-dose CT reconstruction based on high-dimensional partial differential equation projection recovery
Shanzhou NIU ; Shizhou TANG ; Shuyan HUANG ; Lijing LIANG ; Shuo LI ; Hanming LIU
Journal of Southern Medical University 2024;44(4):682-688
Objective We propose a low-dose CT reconstruction method using partial differential equation (PDE) denoising under high-dimensional constraints. Methods The projection data were mapped into a high-dimensional space to construct a high-dimensional representation of the data, which were updated by moving the points in the high-dimensional space. The data were denoised using partial differential equations and the CT image was reconstructed using the FBP algorithm. Results Compared with those by FBP, PWLS-QM and TGV-WLS methods, the relative root mean square error of the Shepp-Logan image reconstructed by the proposed method were reduced by 68.87%, 50.15% and 27.36%, the structural similarity values were increased by 23.50%, 8.83% and 1.62%, and the feature similarity values were increased by 17.30%, 2.71% and 2.82%, respectively. For clinical image reconstruction, the proposed method, as compared with FBP, PWLS-QM and TGV-WLS methods, resulted in reduction of the relative root mean square error by 42.09%, 31.04%and 21.93%, increased the structural similarity values by 18.33%, 13.45% and 4.63%, and increased the feature similarity values by 3.13%, 1.46% and 1.10%, respectively. Conclusion The new method can effectively reduce the streak artifacts and noises while maintaining the spatial resolution in reconstructed low-dose CT images.
7.Mixed reality combined with surgical navigation technology assisted in parapharyngeal space tumors surgery: a clinical study
Zunan TANG ; Leihao HU ; Shuo LIU ; Yao YU ; Wenbo ZHANG ; Xin PENG
Chinese Journal of Stomatology 2024;59(11):1107-1113
Objective:To assess the feasibility and application of mixed reality combined with surgical navigation technology in parapharyngeal space tumor surgery, and to provide a reference for the development and promotion of this technology.Methods:In this study, retrospective data collection was conducted on 16 patients with parapharyngeal space tumors who were treated at the Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology from June 2020 to June 2023. The patient′s age was (39.6±17.8) years, with 4 males and 12 females. Mixed reality combined with surgical navigation technology was utilized to assist physicians in the treatment of these patients. Mixed reality combined with surgical navigation technology was used to assist physicians in treatment of these patients. The application steps included acquisition of image data, processing of image data [three-dimensional (3D) reconstruction, image fusion, and virtual surgical design], development of surgical navigation plan, connection of mixed reality and navigation system, automatic registration and intraoperative guidance and validation. In the preoperative plan, landmark points were placed on the virtual tumor and surrounding important structures reconstructed using digital software, serving to guide the localization of crucial anatomical structures. Intraoperative positioning deviation, surgical time, intraoperative blood loss, and postoperative complications were recorded and analyzed to evaluate the clinical application effectiveness of mixed reality combined with surgical navigation technology.Results:With the assistance of mixed reality combined with surgical navigation technology, 16 patients successfully underwent tumor resection. All patients were accurately diagnosed preoperatively by 3D reconstruction and image fusion technology, and a comprehensive preoperative plan was formulated; intraoperatively, mixed reality combined with surgical navigation technology was utilized for the localization of important structures. The average localization deviation of 38 landmark points during the operation were (4.43±1.96) mm, with 62% (26/42) of the points having a deviation of ≥0 and<5 mm. The average duration of the operation was (149.6±53.9) min and the blood loss was 70 (45, 150) ml. The average postoperative follow-up was 16 months, and five patients experienced postoperative complications involving facial paralysis, hoarseness, and choking.Conclusions:Mixed reality combined with surgical navigation technology can achieve the three-dimensional visualization of oral and maxillofacial anatomical structures to achieve precise preoperative diagnosis. During surgery, the technology can real-time display the relationship between soft tissue tumors and the surrounding important anatomical structures, guide surgical operation, and enhance the safety of surgery.
8.Analysis on association between serum homocysteine and inflammatory response and oxidative stress in patients with acute ischemic stroke
Jing TANG ; Huan LI ; Shuo ZHANG ; Ligang JING
Journal of Jilin University(Medicine Edition) 2024;50(3):786-790
Objective:To discuss the correlation between homocysteine(Hcy)and inflammatory responses as well as oxidative stress,and to analyze its role in the occurrence and development of acute ischemic stroke(AIS).Methods:Thirty-eight patients with their first incidence of AIS were selected as AIS group,and according to the principles of case-control study,45 healthy individuals undergwent routine health examination during the same period were selected as control group.The levels of homocysteine and inflammatory cytokine interleukin(IL)-6,and tumor necrosis factor α(TNF-α)in serum of the subjects in two groups were detected by enzyme-linked immunosorbent assay(ELISA)method;the level of highly sensitive C-reactive protein(hs-CRP)of the subjects in two groups was detected by immunoturbidimetry;the levels of malondialdehyde(MDA)and activities of superoxide dismutase(SOD)in serum of the subjects in two groups were detected by chemical colorimetry;Pearson's correlation analysis was used to analyze the correlation between serum Hcy level and levels of inflammatory markers and oxidative stress indicators of the AIS patients.Results:Compared with control group,the levels of Hcy,hs-CRP,TNF-α,IL-6,and MDA in serum of the patients in AIS group were significantly increased(P<0.05),while the activity of SOD was significantly decreased(P<0.05).The level of Hcy in serum of the AIS patients was positively correlated with the levels of hs-CRP,TNF-α,IL-6,and MDA(r=0.615,P<0.05;r=0.632,P<0.05;r=0.598,P<0.05;r=0.612,P<0.05),and negatively correlated with the activity of SOD(r=-0.325,P<0.05).Conclusion:The Hcy level in serum of the AIS patients is closely associated with the inflammatory factors and oxidative damage.Hcy can promote the production of oxidative free radicals and inflammatory factors and cause damage to the endothelial cells and play a significant clinical role in the occurrence and development of AIS.
9.Evaluation of reaction inhibition among military university students by multitasking operation based on Go/No-Go paradigm
Qian ZHANG ; Kejia WU ; Hongqi ZHAO ; Shuo FAN ; Nannan JIANG ; Chuanrui YANG ; Lulu TANG ; Hao YU
Academic Journal of Naval Medical University 2024;45(9):1185-1189
Objective To explore the characteristics of response inhibition of military university students during multitasking operation. Methods Repeated measures of ANOVA as well as distribution test were employed to explore how the performance of 127 military university students in Go/No-Go test was affected by simulated driving task. Results The test results of 127 participants showed that there was a interaction between the interference task and the Go trial proportion on the hit rate and false alarm rate,that is,no significant difference was observed between the 60% and 40% of trial proportion without interference task (both P>0.05),but the hit rate and false alarm rate in the 60% trial proportion condition were significantly higher than those in the 40% trial proportion condition under interference task (both P<0.01).In addition,significant main effects of interference task were observed on hit rate,false alarm rate,and discrimination index d' (all P<0.01),that is,the interference task reduced the hit rate and discrimination,but increased the false alarm rate.Moreover,individual differences existed in the discrimination index d' changes,and the participants were divided into easily disturbed group (n=23,18.11%),undisturbed group (n=20,15.75%),and intermediate group (n=84,66.14%) by adding or subtracting 1 standard deviation from the mean of the difference. Conclusion The interference tasks increase the psychological load of military university students during multitasking operation,and impair the response inhibition;and individual differences exist in response inhibition.
10.Bioinformatics analysis and experimental validation of ferroptosis in peri-implantitis
Zhewei ZHANG ; Jiaohong WANG ; Wei WU ; Shuo DONG ; Guoqing LI ; Chunbo TANG
STOMATOLOGY 2024;44(7):527-535
Objective To investigate the key genes associated with ferroptosis in peri-implantitis and explore the potential mecha-nisms regulating peri-implantitis.Methods Several datasets were obtained from the GEO database.Differential expressed genes were screened,and GO and KEGG analyses were performed.A PPI network was constructed using the STRING website.Key genes were val-idated using a test set,and the diagnostic value of key genes was determined.The content and proportion of 22 immune cells in peri-im-plantitis tissues were obtained through immune infiltration analysis.Key genes were validated by qRT-PCR and Western Blot(WB).Results There were 1 138 differential genes between peri-implantitis tissues and normal gingival tissues,of which 29 were related to ferroptosis.The gene expression in peri-implantitis tissues mainly involved processes such as immune response activation.Five key genes in the ferroptosis-related differential genes,namely SOX2,GJA1,IL1B,GPX2 and CHAC1,were differentially expressed in peri-implantitis tissues and had high diagnostic value.Immune infiltration analysis showed significant changes in immune cells such as memory B cells and plasma cells in peri-implantitis tissues.qRT-PCR and WB confirmed significant differential expression of mRNA and the protein transcribed by key genes.Conclusion Differential genes between peri-implantitis and ferroptosis are screened using bioinformatics analysis and biological validation,providing new insights into the study on peri-implantitis.


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