1.Analysis of Subject Related Costs in Medical Research
Jiajing ZHANG ; Keying LI ; Zhendong WEI ; Jinhai YAN
Chinese Medical Ethics 2024;35(4):415-420
The development of medical research is completed by the cooperation of sponsors, investigators, subjects, and ethics committees. Clinically, it mainly includes clinical trials of medical devices, clinical medicine and new technology research. This paper analyzed the game and the relationship between rights, responsibilities and interests of relevant parties in medical research, combined with the relevant costs and sharing principles involved in medical research, and found that the use of the word "free" in the informed consent is easy to cause misunderstanding and the lack of relevant compensation costs in the informed consent, while the compensation and insurance costs had some problems, such as the imperfect subject compensation mechanism and the insufficient insurance purchase by the sponsor, which can not protect the basic rights and interests of the subjects. Therefore, in order to standardize the cost management of clinical medical research, it is necessary to standardize the process and content of informed consent, strengthen the supervision of medical research process, establish medical research damage compensation fund and research damage insurance system, so as to better protect the rights and interests of subjects.
2.Research on the Technology for Enzymatic Preparation of Scutellarein
Yujie CHENG ; Yunhua LIU ; Zhifang HUANG ; Yan CHEN ; Yuhong LIU ; Jinhai YI
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(2):274-279
Objective Scutellaria baicalensis stems and leaves glucuronic hydrolase(sbsl GUS)was used to enzymatically hydrolyze scutellarin in Erigeron breviscapus(Vant.)Hand.Mazz.to prepare scutellarein,and the high-purity scutellarein was obtained through separation and purification.Methods Orthogonal experiments were used to optimize the process parameters for the extraction of Erigeron breviscapus(Vant.)Hand.Mazz..Using the rate of enzymatic hydrolysis conversion of scutellarin as the index,the amount of enzyme,pH,temperature,time and antioxidant were investigated,and the preparation process parameters of scutellarein were optimized.Ethanol extraction,activated carbon decolorization,and fractional crystallization were used to purify the crude extract.Results The extraction process was determined to be:segments of Erigeron breviscapus were decocted twice with 10 times water for 1 hour each time.The preparation process of scutellarein was as follows:the amount of sbsl GUS extract and Erigeron breviscapus decoction was 1∶10 based on crude drugs,0.5%sodium metabisulfite was added,pH value was about 6.0,the temperature was about 45℃,and the time was 20 hours.The crude extract of scutellarein with the content more than 60%was obtained.The crude extract was purified by fractional crystallization,refluxed with 80%ethanol,decolorized with activated carbon,concentrated and crystallized,and the scutellarein extract with content more than 85%was obtained.Conclusion sbsl GUS enzymatic hydrolysis technology,which was used to prepare scutellarein,is simple and feasible.This study provides a new way for the manufacture of scutellarein.
3.Analysis and research on implementation status of informed consent in surgery
Chinese Medical Ethics 2024;37(2):163-167
Objective:Investigating the content and signing status of the informed consent form for surgery,as well as the signing status of the power of attorney to understand the current implementation of informed consent for surgery in medical institutions.Methods:A stratified random sampling method was used to investigate the signing status of surgical consent and power of attorney on 276 surgical records from a tertiary A hospital in the first half year of 2022.Results:The signatures of both patients and doctors were relatively complete.The medical teams had provided sufficient information to patients regarding the main preoperative diagnosis,surgical name,possible complications during or after the surgery,and surgical risks.However,there was inadequate information on the patient's own high-risk factors,as well as alternative treatment plans and their advantages and disadvantages.The signing of surgical consent and power of attorney signed by non-patients was not standardized.Conclusion:The implementation of informed consent for surgery in medical institutions is relatively good,but there are still some shortcomings.Medical institutions can ensure the implementation of informed consent by strengthening legal and regulatory training,clarifying the scope of authorization,strengthening the surgeon's notification and signing,as well as implementing supervision and inspection,so as to protect the unity of rights and obligations of doctors and patients,effectively avoid medical risks,and promote the construction of a harmonious doctor-patient relationship.
4.Salmonella-mediated blood‒brain barrier penetration, tumor homing and tumor microenvironment regulation for enhanced chemo/bacterial glioma therapy.
Ze MI ; Qing YAO ; Yan QI ; Jinhai ZHENG ; Jiahao LIU ; Zhenguo LIU ; Hongpei TAN ; Xiaoqian MA ; Wenhu ZHOU ; Pengfei RONG
Acta Pharmaceutica Sinica B 2023;13(2):819-833
Chemotherapy is an important adjuvant treatment of glioma, while the efficacy is far from satisfactory, due not only to the biological barriers of blood‒brain barrier (BBB) and blood‒tumor barrier (BTB) but also to the intrinsic resistance of glioma cells via multiple survival mechanisms such as up-regulation of P-glycoprotein (P-gp). To address these limitations, we report a bacteria-based drug delivery strategy for BBB/BTB transportation, glioma targeting, and chemo-sensitization. Bacteria selectively colonized into hypoxic tumor region and modulated tumor microenvironment, including macrophages repolarization and neutrophils infiltration. Specifically, tumor migration of neutrophils was employed as hitchhiking delivery of doxorubicin (DOX)-loaded bacterial outer membrane vesicles (OMVs/DOX). By virtue of the surface pathogen-associated molecular patterns derived from native bacteria, OMVs/DOX could be selectively recognized by neutrophils, thus facilitating glioma targeted delivery of drug with significantly enhanced tumor accumulation by 18-fold as compared to the classical passive targeting effect. Moreover, the P-gp expression on tumor cells was silenced by bacteria type III secretion effector to sensitize the efficacy of DOX, resulting in complete tumor eradication with 100% survival of all treated mice. In addition, the colonized bacteria were finally cleared by anti-bacterial activity of DOX to minimize the potential infection risk, and cardiotoxicity of DOX was also avoided, achieving excellent compatibility. This work provides an efficient trans-BBB/BTB drug delivery strategy via cell hitchhiking for enhanced glioma therapy.
5.Bioinformatic analysis of the expression of KIF14 and its clinical significance and biological functions in clear cell renal cell carcinoma
Mengzhao ZHANG ; Yangyang YUE ; Yunzhong JIANG ; Yan LI ; Jinhai FAN
Journal of Modern Urology 2023;28(6):519-528
【Objective】 To investigate the expression of Kinesin family member 14 (KIF14), and its correlation with clinical prognosis and immune cell infiltration of clear cell renal cell carcinoma (ccRCC). 【Methods】 The correlation between KIF14 expression in ccRCC and different clinicopathological features were analyzed with TCGA, GEO and Ualcan databases. The correlation between KIF14 expression and prognosis was analzyed with Kaplan-Meier method. The correlation between KIF14 expression and immune cell infiltration was analzyed with TIMER. The protein-protein interaction network of KIF14 was conducted with Genemania. The co-expression genes of KIF14 in TCGA-KIRC were picked out in Linkedomics database and were used to perform GO annotations and KEGG pathway enrichment analysis with R software. The biological functions of KIF14 were verified with in vitro functional assay. 【Results】 KIF14 was highly expressed in ccRCC tissue and was positively correlated with clinical stage, pathological grade, and lymphatic metastasis, but negatively correlated with clinical prognosis. KIF14 expression was an independent risk factor for overall survival of ccRCC patients. GO annotations showed that KIF14 was involved in DNA replication, nuclear division, organelle fission, and cell adhesion. KEGG pathway enrichment analysis showed that KIF14 participated in cell cycle and p53 signaling pathway. Genemania analysis indicated KIF14 interacted with CENPE, CIT, KIF23, and other proteins. Timer showed that KIF14 was positively correlated with immune cell infiltration. Knockdown of KIF14 expression suppressed cell proliferation, migration, and invasion of ccRCC. 【Conclusions】 KIF14 may serve as a novel prognostic marker and a potential therapeutic target of clear cell renal cell carcinoma.
6.Comparison between endoscopic surgery and glucocorticoid therapy for traumatic optic neuropathy: a meta-analysis
Jinhai YU ; Yan WU ; Yaohua WANG ; Qihua XU ; Chao XIONG ; Hongfei LIAO
Chinese Journal of Experimental Ophthalmology 2023;41(1):42-46
Objective:To systematically analyze the efficacy of nasal endoscopic transsphenoidal decompression and glucocorticoid pulse therapy for traumatic optic neuropathy (TON).Methods:PubMed, Web of Science, Cochrane Library, ClinicalTrial.gov, CNKI, Wanfang, China Biomedical and other databases were searched to retrieve clinical studies on endoscopic surgery and hormone therapy for TON since their establishment to November 1, 2020.Two researchers screened the literature and evaluated the quality of the included literatures.The improvement of visual acuity before and after treatment was taken as an effective indicator.RevMan 5.3 statistical software was used for meta-analysis.The sensitivity of the results was analyzed atfer literature exclusion.The publication bias of each study was double checked by funnel plot and Begg test.Results:Eight studies were included, including 7 cohort studies and 1 randomized controlled trial.There was no significant difference between the endoscopic decompression group and glucocorticoid group in the efficiency of visual acuity improvement in the treatment of TON [odds ratio ( OR)=1.65, 95% confidence interval ( CI)∶0.75-3.66, P=0.22], neither in TON patients with residual vision before surgery ( OR=2.17, 95% CI: 0.94-4.98, P=0.07). For nasal endoscopic decompression surgery, early surgery (disease course<7 days) was more effective than late surgery (disease course>7 days) ( OR=4.73, 95% CI: 2.55-8.78, P<0.01). Sensitivity analysis suggested that the results of this literature analysis were not robust.The Begg test showed that there was no literature publication bias. Conclusions:There is no significant difference between nasal endoscopic surgery and glucocorticoid therapy in the treatment of TON.Early endoscopic surgery may help improve visual acuity in patients with residual vision.
7.Ethical Analysis of the Medical Science Experiments Targeting Humans
Jiajing ZHANG ; Keying LI ; Zhendong WEI ; Jinhai YAN
Chinese Medical Ethics 2023;36(3):277-283
With the continuous progress of medical technology, some violations of ethical principles often occur in science experimental research targeting humans. Taking the type of human experimental research as the starting point, through ethical analysis and evaluation of different types of human experimental research, this paper concluded that in human experimental research, it was necessary to adhere to humanitarian principles of human experimental research, fully respect the research participants’ right to informed consent, select research participants fairly, fully protect the research participants’ rights and interests, and supervise the whole research process. So as to better regulate the behavior of medical researchers in human experimental research and protect the rights and interests of research participants.
8.Analysis on Hospice Care Cognition Status and Influencing Factors among High School Students in Guangzhou
Chinese Medical Ethics 2023;36(3):298-304
【Objective:】 To investigate the cognition, attitude and influencing factors of hospice care among high school students in Guangzhou, and to provide basis for improving the understanding level of hospice care and death education among adolescents. 【Methods:】 A total of 226 questionnaires were collected by convenient sampling and questionnaire survey. The questionnaire covered two parts: basic information of the respondents, cognition and attitude towards hospice care (including four dimensions: basic knowledge of hospice care, knowledge of pain control, attitude and thought of hospice care, and attitude towards hospice care education). Excel software was used to preliminary screen, preprocess and establish database of data. SPSS21.0 was used for statistical analysis. T-test and ANOVA were used for difference analysis, multiple linear regression was used for correlation analysis. 【Results:】 High school students had a basic understanding of hospice care. Among the four dimensions of basic knowledge of hospice care, knowledge of pain control, attitude and thought of hospice care, and attitude towards hospice care education, the cognition of "knowledge of pain control" dimension was the weakest link, and the entry of "attitude and thought of hospice care" had the highest score, which was the strong cognitive link. 【Conclusion:】 The main influencing factors of high school students’ cognition of hospice care were family structure, family residence and whether they have understood hospice care. This paper recommended that schools should add medical humanities education courses related to hospice and death education, and cooperate with hospice care centers to carry out hospice care experience practices. It was also suggested that relevant departments or organizations should make full use of mainstream media, such as online media and WeChat public accounts, to strengthen the popularity and popularization of hospice care education and science popularization from multiple channels and aspects, and improve the level and quality of hospice care education for young people.
9.Acceptance of pre-exposure prophylaxis and post-exposure prophylaxis against HIV and related factors in men who have sex with men in Shandong Province
Xiaonan ZHANG ; Ke YAN ; Xiangdong YOU ; Jinhai LI ; Na ZHANG ; Guoyong WANG ; Meizhen LIAO ; Wei MA
Chinese Journal of Epidemiology 2023;44(9):1352-1357
Objectives:To understand the use of pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) and related factors in men who have sex with men (MSM) in Shandong Province, and provide reference for the promotion of PrEP and PEP in MSM.Methods:From April to July in 2022, MSM were recruited from 7 sentinel surveillance sites in Shandong Province for a questionnaire survey, and the sample size of each city site was 400. The information about sociodemographic characteristics, sexual behaviors, the uses of PrEP and PEP and others were collected from the MSM, and blood samples were collected from them for HIV and syphilis testing.Results:A total of 2 815 MSM were investigated, the majority of them were aged less than 30 years (55.7%, 1 569/2 815), unmarried (68.6%, 1 931/2 815) and had education background of college and above (56.5%, 1 590/2 815). Only 9.2% (258/2 815) had used PrEP and 10.8% (305/2 815) had used PEP. Multivariate logistic regression showed that factors associated with high likelihood of PrEP use in MSM included age ≤30 years (a OR=4.04, 95% CI:1.25-13.01), self-perceived lower risk of HIV infection (a OR=1.76, 95% CI:1.16-2.68), group sex and commercial sex in the past six months (a OR=1.51, 95% CI: 1.10-2.09; a OR=1.69, 95% CI: 1.16-2.47), new-type drug use (a OR=1.53, 95% CI: 1.11-2.11), receiving peer education (a OR=1.56, 95% CI: 1.03-2.37), other people using PrEP (a OR=3.29, 95% CI: 2.48-4.36), and being HIV negative (a OR=8.40, 95% CI:1.12-63.12). Factor associated with low likelihood of PrEP use in MSM was anal sex with casual partner (a OR=0.67, 95% CI:0.49-0.90). Factors associated with high likelihood of PEP use in MSM included age under 50 years (≤30 years old: a OR=2.41, 95% CI:1.02-5.69; 31-49 years old: a OR=3.33, 95% CI:1.42-7.85), no self-perceived risk for HIV infection (a OR=1.87, 95% CI:1.12-3.11), group sex in the past six months (a OR=1.68, 95% CI:1.23-2.29), new-type drug use (a OR=3.86, 95% CI:2.94-5.07) and receiving no peer education (a OR=1.54, 95% CI:1.12-2.12). Conclusions:In Shandong, a higher proportion of MSM used PrEP and PEP. Peer education and self-perceived HIV infection risk education should be strengthened to increase the rates of PrEP and PEP use in MSM.
10.A multicenter study to test the reliability and validity of the frailty assessment scale for elderly patients with inguinal hernia and to evaluate the value of clinical application
Xian LI ; Jia ZHENG ; Shibo WEI ; Hangyu LI ; Lei JIANG ; Lei DONG ; Jiang WANG ; Chongzhu TAO ; Yuhao YAN ; Lihui SUN ; Lunbo CUI ; Jinhai HUANG ; Yuxuan FANG ; Chengxin TANG
Chinese Journal of Surgery 2023;61(12):1080-1085
Objectives:To verify the reliability and validity of the frailty assessment scale for elderly patients with inguinal hernia and to evaluate the value of its clinical application.Methods:A convenience sampling method was used to collect 129 geriatric patients who underwent inguinal hernia surgery from January 2018 to January 2023 in nine hospitals in Liaoning Province. There were 120 males and 9 females, of whom 89 patients were 60 to <75 years old, 33 patients were 75 to <85 years old and 7 patients were ≥85 years old. The 129 patients included 11 elderly patients with inguinal hernia who had recovered from preoperative infection with COVID-19. Statistical methods such as Cronbach′s coefficient, Kaiser-Meyer-Olkin test, Bartlett′s test, Pearson′s correlation analysis, etc. were calculated to verify the reliability indexes such as feasibility, content validity, structural validity, criterion-related validity, internal consistency reliability, and re-test reliability. Taking the 5-item modified frailty index (5-mFI) as the gold standard, the area under the curve was used to analyze the ability of the two scales to predict the occurrence of postoperative acute urinary retention, postoperative delirium, poor incision healing, operative hematoma seroma, and postoperative complications.Results:The frailty assessment scale for elderly patients with inguinal hernia showed good reliability and validity (valid completion rate of 99.2%; item content validity index of 1.000, and the scale content validity index of 1.000; exploratory factor analysis extracted a total of 1 principal component, and factor loadings of each item of 0.565 to 0.873; the AUC for frailty diagnosis using 5-mFI as the gold standard of 0.795 ( P<0.01) Cronbach′s coefficient of 0.916, retest reliability coefficient of 0.926), it could effectively predict postoperative acute urinary retention, delirium, hematoma seroma in the operative area and total complications (AUC of 0.746, 0.870, 0.806, and 0.738, respectively; all P<0.05), and prediction efficiency was higher than that of 5-mFI (AUC of 0.694, 0.838, 0.626 and 0.641, P<0.05 for delirium only), but both scales were inaccurate in predicting poor incision healing (AUC of 0.519, P=0.913 for the frailty assessment scale and 0.455, P=0.791 for the 5-mFI). Conclusions:The frailty assessment scale for elderly patients with inguinal hernia is reliable and significantly predicts the occurrence of postoperative adverse events in elderly inguinal hernia patients. The scale can also be used for preoperative frailty assessment in elderly patients with inguinal hernia after rehabilitation from COVID-19 infection.

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