1.Analysis of the protection of compensation rights for research participants
Aijuan SHENG ; Xiaoqi WANG ; Liyan SUN ; Dongxiang ZHENG ; Fang LIU
Chinese Medical Ethics 2024;37(5):507-513
Life science and medical research involving human beings cannot be separated from the support of research participants.The safety,health,and rights and interests of research participants are the primary considerations in clinical research,and their rights and interests include the right of compensation,privacy protection,health and so on.Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel.Based on laws and regulations and literature review,and combined with practical experience,this paper made an in-depth discussion on compensation rights.It puts forward the types of compensation(conventional compensation,research-related damage compensation),compensation principles(necessity,timeliness,appropriateness,fairness),compensation elements(method,amount,plan,consent,notification,and reference of compensation),compensation under special circumstances(compensation for participants without or with limited informed consent ability and withdraw from the study midway),protection measures of compensation right(sponsor/contract research organizations,research institutions,research management departments,(main)researchers and research teams,ethics(review)committee).The compensation rights should be implemented to protect research participants.
2.Analysis of drug resistance characteristics and influencing factors of rifampicin resistance in high-risk populations for drug-resistant pulmonary tuberculosis in Qingdao from 2018 to 2022
SONG Song ; XU Honghong ; WANG Zhongdong ; LI Xuekui ; SUN Haiyan ; CHEN Meng ; ZHANG Menghan ; ZHANG Huaqiang ; DAI Xiaoqi
China Tropical Medicine 2024;24(2):190-
bjective To analyze the drug resistance screening status and drug resistance influencing factors of high-risk groups of drug-resistant pulmonary tuberculosis in Qingdao, and to understand the inclusion of rifampicin patients in treatment, so as to provide a reference for the prevention and treatment of drug-resistant pulmonary tuberculosis. Methods The medical records of 726 cases of drug-resistant pulmonary tuberculosis among high-risk populations registered in Qingdao from 2018 to 2022 were obtained from the National Health Insurance Information System of the China Center for Disease Control and Prevention. The drug resistance to five anti-tuberculosis drugs, namely isoniazid (INH), rifampicin (RFP), ethambutol (EMB), levofloxacin (Lfx), and amikacin (Am), in the high-risk populations of drug-resistant pulmonary tuberculosis was analyzed. Univariate and multivariate logistic regression were used toidentify factors influencing rifampicin resistance, and the detection and inclusion of treatment for rifampicin-resistant patients were evaluated. Results Of the 726 subjects, 278 were drug-resistant, with a total drug resistance rate of 38.29%. The drug resistance for the five anti-tuberculosis drugs in descending order was: INH 25.90%(188/726), RFP 22.87%(166/726), Lfx 14.19%(103/726), EMB 11.29%(82/726), Am 2.48%(18/726). Analysis of the drug resistance spectrum showed that among those resistant to one drug, RFP was most common, accounting for 13.67% (38/278); among those resistant to two drugs, INH+RFP was predominant, accounting for 15.83% (44/278); among those resistant to three drugs, INH+RFP+Lfx was most frequent, at 7.19% (22/278); and among those resistant to four drugs, INH+RFP+EMB+Lfx was highest, at 6.12% (17/278). Multivariate logistic regression analysis of rifampicin resistance showed that compared with patients under 25 years of age, the risk of developing rifampicin resistance was lower in the groups aged 45 to under 65 and those aged 65 and above (OR=0.356, 95%CI: 0.181-0.700; OR=0.352, 95%CI: 0.170-0.729). Compared with migrant patients in other provinces, local patients from within the same county or district had a lower risk of developing rifampicin resistance (OR=0.599, 95%CI:0.383-0.962). Compared with patients who were smear-positive at the end of the second month of initial treatment, the risk of developing rifampicin resistance was higher in patients with relapse/return, failure of retreatment/chronic, and other categories of patients (OR=9.380, 95%CI:3.717-23.671;OR=25.749, 95%CI:8.037-82.490; OR=36.651, 95%CI:8.438-159.201). Conclusions The situation of drug-resistant pulmonary tuberculosis in Qingdao cannot be ignored. Individuals under 25 years old, migrants from other provinces, and patients with relapse/return, failure of retreatment/chronic, and other categories are significant risk factors for developing rifampicin resistance in the high-risk groups of drug-resistant pulmonary tuberculosis.
3.Epidemiological characteristics of pulmonary tuberculosis in Huzhou City from 2014 to 2023
JIN Meihua ; WANG Ziyi ; REN Feilin ; LIU Xiaoqi ; SUN Xiuxiu ; YANG Zhongrong ; MAO Guangyun
Journal of Preventive Medicine 2024;36(10):856-860
Objective:
To investigate the epidemilogical characteristics of pulmonary tuberculosis in Huzhou City, Zhejiang Province from 2014 to 2023, so as to provide the basis for formulating prevention and control measures for the construction of "TB-free city".
Methods:
The data of pulmonary tuberculosis cases in Huzhou City from 2014 to 2023 was collected through the Infectious Disease Reporting Management System of Chinese Disease Prevention and Control Information System. The onset time, region, and population distribution characteristics of the cases were described.
Results:
A total of 11 598 cases of pulmonary tuberculosis were reported in Huzhou City from 2014 to 2023, with an average annual incidence of 37.42/105. The reported incidence decreased from 47.50/105 in 2014 to 28.36/105 in 2023 (P<0.05), with an annual decline rate of 5.57%. There were 6 304 etiological positive cases, accounting for 54.35%. The peak season for pulmonary tuberculosis cases was from March to September, with the highest seasonal ratio of 112.48% in May. The average annual reported incidence rates in Anji County and Changxing County were relatively high (46.14/105 and 41.15/105). The reported incidence rate of pulmonary tuberculosis in Huzhou City increased with age (P<0.05), peaking at 97.36/105 in the group aged 75 to <80 years. There were 7 991 male pulmonary tuberculosis cases and 3 607 female cases, with a male-to-female ratio of 2.22∶1. The average annual incidence rates of pulmonary tuberculosis was higher in males than in females (50.39/105 vs. 23.87/105). Farmers were the primary occupation affected, with 6 350 cases accounting for 54.75%.
Conclusions
The reported incidence rate of pulmonary tuberculosis in Huzhou City decreased from 2014 to 2023, with a high incidence in spring and summer. The incidence rates in Anji County and Changxing County were higher than Huzhou City's average. Male, elderly residents and farmers were the key populations for pulmonary tuberculosis prevention and control.
4.Clinicopathological and molecular genetic features of neuromuscular choristoma-associated desmoid type fibromatosis
Rongfang DONG ; Wen GUO ; Nan LI ; Ziyi WANG ; Xiaoqi SUN ; Yi DING
Chinese Journal of Pathology 2024;53(7):685-690
Objective:To investigate the clinicopathological and genetic characteristics of neuromuscular choristoma-associated desmoid type fibromatosis (NMC-DF).Methods:The clinical morphological and immunohistochemical features of 7 NMC-DF cases diagnosed from January 2013 to January 2023 in Beijing Jishuitan Hospital were retrospectively analyzed. A series of neuromuscular choristoma and neuromuscular choristoma-associated desmoid type fibromatosis were evaluated for CTNNB1 mutations, and hotspot mutations for CTNNB1 were tested in 4 NMC-DF cases using Sanger sequencing.Results:The tumors were collected from 3 females and 4 males, aged 1 to 22 years (mean 7.1 years), involving the sciatic nerve ( n=4), brachial plexus ( n=2) or multiple nerves ( n=1). The course of the disease spanned from 3 months to 10 years. Two cases were recurrent tumors. All the 7 NMC cases showed endoneurial intercalation of mature skeletal muscle fibers among the peripheral nerve fascicles, and the histologic features of the NMC-DF were strikingly similar to the conventional desmoid-type fibromatosis. By immunohistochemistry, all NMC and NMC-DF cases showed aberrant nuclear staining of β-catenin (7/7), the muscle cells in NMC were intensely immunoreactive for desmin, and the admixed nerve fibers were highlighted by NF and S-100 (7/7). Four NMC and NMC-DF had CTNNB1 mutations, 3 c.121A>G (p.T41A) and 1 c.134C>T (p.S45F). Follow-up of the 7 cases, ranging from 22 to 78 months, showed tumor recurrence in 2 patients at 3 and 8 months respectively after the first surgical resection, of which 1 patient underwent above-knee amputation. No recurrence occurred in other cases with tumor excision and neurological reconstruction surgery. There was no metastasis occurred in the 7 cases. Conclusions:NMC is a rare congenital lesion with differentiated mature skeletal muscle tissue found in peripheral nerve fascicles, and approximately 80% of patients with NMC develop a soft tissue fibromatosis. CTNNB1 mutation in the Wnt signaling pathway may be involved in the pathogenesis of NMC and NMC-DF, and S45F mutations seems to have a higher risk of disease progression.
5.Implementation status of intracardiac electrocardiogram positioning technology in localizing peripherally inserted central catheter tip position in 199 hospitals
Jing SHI ; Lei WANG ; Xiaoqi WU ; Wei GAO ; Hong SUN ; Yuan SHENG ; Yan WU
Chinese Journal of Modern Nursing 2024;30(4):494-499
Objective:To investigate the implementation status of peripherally inserted central catheter (PICC) tip intracardiac electrocardiogram positioning technology in the hospitals, so as to provide reference for promoting the development of intracardiac electrocardiogram positioning technology.Methods:This study was a cross-sectional survey. Using the convenient sampling method, members of Intravenous Infusion Committee of Chinese Nursing Association selected PICC/ intravenous therapy leaders meeting the inclusion criteria from 5 to 10 hospitals in their work area as the research objects from December 2022 to January 2023. The self-made PICC Tip Intracardiac Electrocardiogram Positioning Technology Implementation Status Questionnaire was used to investigate the PICC/intravenous therapy leaders. A total of 205 questionnaires were distributed in 28 provinces/autonomous regions/municipalities directly under the Central Government, and 199 valid questionnaires were collected, with an effective recovery rate of 97.1%. Results:Among 199 hospitals, 63.3% (126/199) of them successfully implemented PICC tip intracardiac electrocardiogram positioning technology. Among the 126 hospitals that implemented PICC tip intracardiac electrocardiogram positioning technology, only 20 hospitals included it in their charging items. A total of 50.3% (100/199) of hospitals established a unified intracardiac electrocardiogram guided PICC catheterization procedure; 47.7% (95/199) of hospitals organized/participated in training programs on PICC tip intracardiac electrocardiogram positioning technology, and 57.3% (114/199) of hospital PICC/intravenous therapy leaders participated in training programs related to PICC tip intracardiac electrocardiogram positioning technology. In terms of the relevant achievements of 199 research hospitals, 56 papers, seven utility model patents and 28 awards were issued.Conclusions:The application, training and achievement output of PICC tip intracardiac electrocardiogram positioning technology need to be further improved. It is suggested to sink high-quality resources, formulate implementation procedures and evaluation standards, standardize nursing service project management, increase training efforts, and improve scientific research thinking of intravenous therapy nurses, so as to promote the standardization development of new technologies.
6.Clinical application of mammogram microcalcification detection model based on Attention U-Net
Xiaoqi SUN ; Siqing CAI ; Yannan REN
Chinese Journal of Medical Physics 2024;41(6):716-723
Objective To develop a mammogram microcalcification detection model(DL model)based on Attention U-Net for realizing the efficient detection of microcalcifications,and to investigate the effects of breast density and microcalcification type on the microcalcification detection performance of the DL model.Methods A retrospective analysis was performed on 694 images from 347 patients undergoing mammography.Through the independent image diagnosis by junior physicians and review by senior physicians,the reference standard for microcalcification detection was established.Neural network training was performed to establish a DL model.The performance of the model for microcalcification detection was evaluated using precision rate,recall rate,intersection over union(IoU)and F1-score which were calculated based on calcification area or quantity;and the effects of microcalcification type(benignvsmalignant)and breast density(a+bvsc+d)on the model performance were also analyzed.Results For detecting microcalcifications by the DL model,the precision rate,recall rate,IoU and F1-score were 85.12%±18.39%,78.18%±19.25%,68.29%±21.39%and 78.96%±17.70%when the calculation was based on calcification area,and those were 76.72%±19.85%,85.12%±18.39%,67.13%±23.84%and 77.65%±9.37%when the calculation was based on calcification quantity.The differences in precision rate,recall rate,IoU,F1-score of DL model in different microcalcification types(benignvsmalignant)and breast densities(a+bvsc+d)were insignificant.Conclusion The developed mammogram microcalcification detection model based on Attention U-Net can effectively detect breast microcalcifications and is conducive to the quantitative research on breast microcalcifications.Meanwhile,the model exhibits high stability,and the breast density and microcalcification type have trivial effects on the microcalcification detection performance of the model.
7.Research on risk management model of ECG monitoring equipment in emergency department based on particle swarm optimization algorithm
Baiming ZHENG ; Xiaoqi SUN ; Zheng CHEN ; Jia WANG
China Medical Equipment 2024;21(6):143-148
Objective:To construct equipment risk management model based on particle swarm optimization(PSO)algorithm,and to discuss its application value in the management of ECG monitoring equipment in emergency department.Methods:The operation risk data of ECG monitoring equipment in the hospital were collected and normalized,and the PSO algorithm was used to optimize the neural network model to construct the risk management model of ECG monitoring equipment.30 ECG monitoring equipment in clinical use in the emergency department of Beijing Puren Hospital from November 2021 to October 2023 were selected and according to different equipment management modes,the backpropagation(BP)neural network model(referred to as the conventional BP model)and the PSO algorithm equipment risk management model(referred to as the PSO algorithm model)were used to manage the equipment respectively.The equipment risk fault identification effect,alarm risk control effect and equipment fault maintenance diagnosis time were compared between two management models.Results:The area under the curve(AUC)of the receiver operating characteristic(ROC)value,accuracy,sensitivity,and specificity of risk fault data identification in the test set using the PSO algorithm were 0.869,93.6%,92.8 and 95.1%,respectively,the AUC value,accuracy,sensitivity,and specificity of risk fault data identification in the training set were 0.839,95.6%,97.9%and 96.7%,respectively,which were higher than those of the conventional BP model,and the difference was statistically significant(x2test=3.691,4.023,3.557,3.409,x2training=6.884,5.962,5.334,3.215,P<0.05).The pass rate of ECG monitoring equipment alarm threshold and the average pass rate of equipment maintenance using PSO algorithm were(98.61±3.07)%and(98.79±3.11)%,respectively,which were higher than those of the conventional BP mode,and the alarm mute rate was(1.14±0.27)%,which was lower than that of the conventional BP mode,and the differences were statistically significant(Z=11.831,10.020,21.141,P<0.05).The internal repair time,external repair time,fault diagnosis time and total repair time of ECG monitoring equipment using PSO algorithm were(1.21±0.96)min,(3.18±1.09)min,(5.08±1.93)min and(10.95±2.81)min,respectively,which were all less than those of the conventional BP mode,the difference was statistically significant(t=15.404,19.020,16.694,25.511,P<0.05).Conclusion:The application of the risk management model of ECG monitoring equipment based on PSO algorithm can improve the sensitivity,specificity and accuracy of risk fault data identification of ECG monitoring equipment,improve the qualified rate of alarm threshold and equipment maintenance,reduce the silence rate of alarm,and shorten the time of fault diagnosis and repair.
8. Curative effect of fuzheng xiaoliu granules in the treatment of primary liver cancer and analysis of serum metabolomics
Dandan SHI ; Yiyao SUN ; Xiaoqi CHEN ; Fangming YANG ; Chuanlei ZHANG ; Xinting WANG ; Changwei YUAN ; Xinju CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(11):1247-1262
AIM: To observe the clinical efficacy of Fuzheng Xiaoliu Granules in the treatment of stage II primary liver cancer and to explore its mechanism of action from the perspective of metabolomics. METHODS: Sixty patients with stage II primary liver cancer who achieved complete remission (CR) after comprehensive interventional therapy were randomly divided into treatment group and placebo group, with 30 patients in each group. They were treated for one year and observed for one year. The one-year recurrence rate, traditional chinese medicine (TCM) syndrome score, alpha-fetoprotein and child-pugh grade were compared between the two groups. The serum metabolites of the two groups before and after treatment were screened by ultra-high liquid chromatography-mass spectrometry technology, and the metabolic pathways and related biological pathways were analyzed. RESULTS: The one-year recurrence rate of the treatment group was significantly lower than that of the placebo group, and the overall improvement rate of TCM syndrome score was significantly better than that of the placebo group (P<0.05). There was no statistical significance in the comparison of alpha-fetoprotein and child-pugh grade between the two groups after treatment (P>0.05). Metabolomics results showed that there were 39 and 33 different metabolites in the treatment group before and after treatment and in the two groups after treatment, respectively. After enrichment analysis and topological analysis of the different metabolites, it was found that Fuzheng Xiaoliu Granules could affect amino acid metabolism, fatty acid metabolism and purine metabolism and other metabolic pathways. Before and after treatment in the treatment group and after treatment in the two groups, there were the same differential metabolites and metabolic pathways in the two comparison results. The same differential metabolites with FOLD CHANGE>1 include Stearic acid, Hypoxanthine, Kynurenic acid, Arachidonic acid, and N-Arachidonoyl Dopamine. The same metabolic pathways with Impact>0.1 include Arachidonic acid metabolism and Histidine metabolism. CONCLUSION: Fuzheng xiaoliu granules can effectively reduce the recurrence rate of stage II liver cancer patients after comprehensive intervention and improve the TCM syndrome. It may inhibit the activation of PI3K/Akt and ERK signaling pathways by regulating the content of metabolites involved in metabolic pathways such as amino acids and fatty acids, thereby delaying tumor recurrence.
9.Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans
Aijuan SHENG ; Meixia WANG ; Qiang LIU ; Zhongguang YU ; Hu CHEN ; Hui JIANG ; Jiyin ZHOU ; Xiaoqi WANG ; Haibin YU ; Mingjie ZI ; Yifeng JIANG ; Lei XU ; Tao SHI ; Guizhen SUN ; Dongxiang ZHENG
Chinese Medical Ethics 2023;36(5):492-498
The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
10.Single-cell analyses reveal cannabidiol rewires tumor microenvironment via inhibiting alternative activation of macrophage and synergizes with anti-PD-1 in colon cancer
Xiaofan SUN ; Lisha ZHOU ; Yi WANG ; Guoliang DENG ; Xinran CAO ; Bowen KE ; Xiaoqi WU ; Yanhong GU ; Haibo CHENG ; Qiang XU ; Qianming DU ; Hongqi CHEN ; Yang SUN
Journal of Pharmaceutical Analysis 2023;13(7):726-744
Colorectal tumors often create an immunosuppressive microenvironment that prevents them from responding to immunotherapy.Cannabidiol(CBD)is a non-psychoactive natural active ingredient from the cannabis plant that has various pharmacological effects,including neuroprotective,antiemetic,anti-inflammatory,and antineoplastic activities.This study aimed to elucidate the specific anticancer mechanism of CBD by single-cell RNA sequencing(scRNA-seq)and single-cell ATAC sequencing(scATAC-seq)technologies.Here,we report that CBD inhibits colorectal cancer progression by modulating the suppressive tumor microenvironment(TME).Our single-cell transcriptome and ATAC sequencing results showed that CBD suppressed M2-like macrophages and promoted M1-like macrophages in tumors both in strength and quantity.Furthermore,CBD significantly enhanced the interaction between M1-like macrophages and tumor cells and restored the intrinsic anti-tumor properties of macrophages,thereby preventing tumor progression.Mechanistically,CBD altered the metabolic pattern of macro-phages and related anti-tumor signaling pathways.We found that CBD inhibited the alternative acti-vation of macrophages and shifted the metabolic process from oxidative phosphorylation and fatty acid oxidation to glycolysis by inhibiting the phosphatidylinositol 3-kinase-protein kinase B signaling pathway and related downstream target genes.Furthermore,CBD-mediated macrophage plasticity enhanced the response to anti-programmed cell death protein-1(PD-1)immunotherapy in xenografted mice.Taken together,we provide new insights into the anti-tumor effects of CBD.


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