1.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.
2.Diagnostic value of transcranial substantia nigra ultrasound in Parkinson's disease and analysis of clinical characteristics of patients with different substantia nigra echoes
Meixia ZHANG ; Lu QIAO ; Shuyun HU
China Modern Doctor 2023;61(34):60-62,99
Objective To explore the diagnostic value of transcranial substantia nigra ultrasound in Parkinson's disease(PD)and the clinical characteristics of patients with different substantia nigra(SN)echoes.Methods Sixty patients with PD admitted to Yichun Hospital of Traditional Chinese Medicine from October 2020 to January 2023 were included in study group,and another 60 normal persons who received health examination in our hospital during the same period were included in control group.Both groups were examined by transcranial substantia nigra ultrasound.The SN high-echo area and ratio of total area of hyperechoic substantia nigra to total area of mesencephalon(S/M)of two groups were compared,and the positive rate of PD diagnosed by transcranial substantia nigra ultrasound was calculated.According to the intensity of SN echo,PD patients were divided into PD-SN-group and PD-SN+ group,and the clinical characteristics of patients with different SN echo were compared.Results The SN high-echo area and S/M of study group were significantly higher than those of control group(P<0.05).Transcranial substantia nigra ultrasound showed PD-SN-in 10 cases and PD-SN+ in 50 cases.The positive rate of PD diagnosed by transcranial substantia nigra ultrasound was 83.33%(50/60).There were statistically significant differences between PD-SN+ group and PD-SN-group in gender,age,H-Y stage,age of onset,score of mini mental status examination and score of Montreal cognitive assessment(P<0.05).Conclusion Transcranial substantia nigra ultrasound can better help clinical screening and detection of PD,and improve the positive detection rate of PD.
3.Relationship between blood pressure variability and neurological deterioration occurring within 24 h following ischemic stroke with intravenous thrombolysis
Meixia ZHANG ; Chuanchen HU ; Wen YANG
Journal of Apoplexy and Nervous Diseases 2022;39(11):986-989
Abstract: Objective To investigate the impacts of blood pressure (BP) variability on neurological deterioration in patients with acute ischemic stroke after intravenous thrombolysis (IVT). Methods The clinical data of 134 patients after IVT in Department of Neurology, Affiliated jinhua Hospital, Zhejiang University School of Medicine from January 2020 to September 2020 were retrospectively analyzed, including hour-to-hour BP measurements. BP variability profiles, including average squared difference between successive measurements (sv), standard deviation (sd) were calculated. Early neurological deterioration (END) was defined as the National Institutes of Health Stroke Scale > 4 or death within 24 hour after IVT. The binary logistic-regression model was performed to determine the independent risk factors of END. Results Among134 patients, with mean age 67 year and median NIHSS 5,11 (8. 2%) patients achieved END. Compared with non-END group, END group has higher systolic BP sd (18 vs 14, t=-2.567,P=0.011),systolic BP sv (22 vs 17, t= -1.988, P=0.049). diastolic BP sd (13 vs 9.8.t= -2.431, P=0.016). Systolic BP sd, systolic BP sv and diastolic BP sd were related to the occurring of END independently. Conclusions SP variability is negatively associated with neurological deterioration occurring within 24h following ischemic stroke with intravenous thrombolysis.
4.The effects of observing good swallowing on the swallowing ability of stroke survivors
Ming ZENG ; Jingmei MA ; Xudong GU ; Yunhai YAO ; Meihong ZHU ; Minmin JIN ; Meixia YANG ; Bihua ZHU ; Fang SHEN ; Shuzhen HU ; Jianming FU
Chinese Journal of Physical Medicine and Rehabilitation 2021;43(2):116-121
Objective:To observe the effect of observing good swallowing on the swallowing action of stroke survivors with dysphagia.Methods:Eighteen stroke survivors with dysphagia were randomly divided into a treatment group ( n=9) and a control group ( n=9). In addition to routine swallowing rehabilitation therapy, the treatment group was asked to simulate swallowing after watching a video of normal people′s swallowing action. They did so 5 times a week for 10 minutes, while the control group just watched landscape videos at the same time. The treatment lasted 8 weeks. Before and after the treatment, both groups were assessed using the eating assessment tool (EAT-10), the functional oral intake scale (FOIS) and the penetration and aspiration scale (PAS). Functional magnetic resonance imaging (fMRI) was also used to observe their swallowing action. Results:There was no significant difference between the two groups in any of the measurements before the treatment. After the 8 weeks of treatment the average EAT-10, FOIS and PAS scores of the treatment group were all significantly better than before the treatment and better than the control group′s averages at the time. fMRI showed significantly more areas activated in the precuneus, parietal lobe, posterior central gyrus, BA7, BA5, frontal lobe and paracentral lobule in the treatment group compared with before the intervention and also more than in the control group.Conclusions:Observing proper swallowing action can improve dysphagia and activation of the swallowing-related brain areas of stroke survivors.
5.Cross-sectional investigation of nosocomial infection in a tertiary general hospital and construction of a prediction model
Meixia WANG ; Hongfei MI ; Xiaodong GAO ; Bijie HU ; Yu PAN
Journal of Public Health and Preventive Medicine 2021;32(5):56-60
Objective To understand the prevalence of nosocomial infection and its potential risk factors through a cross-sectional study, to construct a predictive model of the probability of nosocomial infection, and to provide a basis for nosocomial infection management. Methods The prevalence rate of nosocomial infection and potential risk factors of all inpatients in a tertiary general hospital were investigated on a certain day. The possible risk factors of nosocomial infection were analyzed, and a nomogram prediction model on the probability of nosocomial infection was established. The calibration curve and ROC curve were used to evaluate the predictive efficiency of the model. Results A total of 419 hospitalized patients were investigated, and the prevalence rate of nosocomial infection was 3.58%. The top three nosocomial infections were in ICU, neurosurgery, and cardiac surgery. The top three infection sites were surgical site infections, lower respiratory tract infections, and urinary tract infections. The results of univariate analysis showed that the length of hospital stay, surgery, antimicrobial use and underlying diseases were statistically related to the occurrence of nosocomial infections (all P<0.05). Logistic regression analysis showed that compared with the length of stay (LOS)<14, the risk of nosocomial infection in patients with long LOS (≥14) was 5.48 (95% CI: 1.68-19.16). The risk of nosocomial infection in patients with two basic diseases was 7.61 times that (95%CI: 1.50-44.79) of patients without underlying diseases. The risk of nosocomial infection in patients with surgery was 4.88 times that of patients without surgery (95%CI: 1.47-19.6). According to the coefficients of the related risk factors calculated by logistic regression, a nomogram model of the occurrence probability of nosocomial infection was established. The C-index of the model was 0.839, and the area under the ROC curve for predictive efficiency was 0.809 (95%CI: 0.740-0.942). Conclusion Nosocomial infection control and management should be strengthened. Individual risk assessment of patients' nosocomial infection should consider about the age, underlying diseases, surgical status, glucocorticoid or immunosuppressive agents, and antimicrobial drug use. It is essential to identify the high-risk groups as soon as possible and take prevention and control measures to reduce the prevalence rate of nosocomial infection.
6.Case-control study on association of female reproductive factors with risk of papillary thyroid cancer
Tianfeng WU ; Meixia LIU ; Pinqing BAI ; Zhengyuan WANG ; Jiajie ZANG ; Changyi GUO ; Xueying CUI ; Hui HU ; Xiaodong JIA ; Fan WU
Journal of Environmental and Occupational Medicine 2021;38(11):1173-1178
Background Papillary thyroid cancer is the result of a variety of pathogenic factors. The prevalence of papillary thyroid cancer varies greatly in different regions, and the disease is more harmful to women. Objective This study aims to explore the relationship between reproductive factors and papillary thyroid cancer, and to provide basic data for prevention and control of the disease. Methods A 1∶1 age (±3 years) matched case-control study was conducted in 331 pairs of newly confirmed papillary thyroid cancer cases and controls from two hospitals in Shanghai from November 2012 to December 2013. Comparisons were made in the history of menstruation, pregnancy, gynecological and breast diseases, and other variables between the two groups. Results The results of univariate analysis indicated that the proportions of education below bachelor degree, married, and mainly manual workers in the case group were significantly higher than those in the control group (P<0.05); the proportion of those with a family history of thyroid diseases in the case group was significantly higher than that in the control group (P<0.05); the proportions of the cases with irregular menstruation (77.34%), a history of using oral contraceptive or hormone drugs (24.77%), a history of benign gynecological diseases (31.72%), and a history of gynecological surgery (9.67%) were significantly higher than the proportions in the control group (P<0.05). After adjusting potential confounding factors such as history of CT examination, age, kinds of family salt, total iodine intake every day, education level, occupation, marital status, body mass index, and family history of thyroid diseases, the results of multiple logistic regression analysis showed that irregular menstruation (OR=1.767, 95%CI: 1.122-2.782; P=0.014), surgical menopause (OR=12.787, 95%CI: 3.202-51.057; P<0.001), pregnancy >1 time (OR =2.490, 95%CI: 1.196-5.184; P=0.015), and the history of using oral contraceptive or hormone drugs (OR=2.389, 95%CI: 1.338-4.268; P=0.003) were the risk factors of papillary thyroid cancer. Conclusion Irregular menstruation, surgical menopause, history of pregnancy, and history of using oral contraceptive or hormone drugs might be the risk factors of papillary thyroid cancer. To reduce the incidence of papillary thyroid cancer, strengthened health education and rational use of contraceptives are recommended.
7.Investigation and Analysis of Current Situation of Human Research Ethical Management in Beijing Medical and Health Institutions
Zhengjuan HU ; Shuang MU ; Meixia WANG ; Xueqin WANG ; Mingjie ZI ; Zhuoran ZHANG ; Yingwei SUN ; Xiaolong MA ; Fang LIU ; Yiting LI
Chinese Medical Ethics 2018;31(2):230-235
Through the questionnaire survey on the current situation of human research ethical management in Beijing medical and health institutions, this paper analyzed the problems existing in ethical management of Beijing medical and health institutions and put forward corresponding countermeasures and suggestions. The results showed that overall status of human research ethical management in Beijing medical and health institutions was satisfying. But the ethical management levels of different types of medical and health institutions were quite different, and medical and health institutions, health family planning administration departments and academic teams should all make corresponding contributions.
8.Determination of polymethoxylated flavones in Citri Reticulatae Pericarpium from eleven cultivar origins
Hujie LUO ; Yiting YANG ; Xiaowei LI ; Meixia LUO ; Pingjun HU ; Hao CHEN ; Guodong ZHENG
Chinese Traditional Patent Medicine 2017;39(3):565-569
AIM To determine the contents of polymethoxylated flavones in Citri Reticulatae Pericarpium from eleven cultivar origins.METHODS HPLC was applied to screening extraction solvents (methanol,anhydrous ethanol,95% ethanol,ethyl acetate and petroleum ether).Ultraviolet-visible spectrophotometry was adopted in the content determination of polymethoxylated flavones in eighteen batches of samples,nobiletin was taken as a reference substance,and the detection wavelength was set at 330 nm.RESULTS Ethyl acetate exhibited the best extraction effect,so it was selected as extraction solvent.Nobiletin showed a good linear relationship within the range of 3.024-13.104 μg/mL (R2 =0.999 8),whose average recovery was 101.37% with the RSD of 1.34%.The contents of polymethoxylated flavones had obvious differences among samples from different cultivar origins,which were relatively high from Citrus reticulata ‘ Chachi’,Citrus reticulata ‘ Dahongpao’,Citrus reticulata ‘ Tangerina’,Citrus reticulata ‘ Ponkan’,Citrus reticulata ‘ Kinokuni’and Citrus reticulata ‘ Shiyueju’(more than 0.4%).CONCLUSION This simple and accurate method can effectively eliminate the interference of another flavonoids,which is suitable for the content determination of polymethoxylated flavones in Citri Reticulatae Pericarpium.
9.Thoughts on Application of Evaluation Index System on Human Research Ethics Management in Beijing Medical Institutions
Zhengjuan HU ; Yiting LI ; Fang LIU ; Xiaoxia PENG ; Yingwei SUN ; Xiaolong MA ; Mingjie ZI ; Zhuoran ZHANG ; Meixia WANG ; Shuang MU
Chinese Medical Ethics 2017;30(6):737-741
Objective:This thesis aims to construct the evaluation index system ethics management in Beijing medical institutions for application research.Method:The author applied the evaluation system which was agreed and adjusted by expert groups in four medical and health institutions.Result:After three rounds of expert groups have reached the agreement,the Evaluation Index System on Human Research Ethics Management in Beijing Medi-cal Institutions is established,which contains 6 first-class indicators,16 second-class indicators and 39 third-class indicators.The application on four medical and health institutions show that the evaluation index system is practical,operable and is of high degree of distinction.Conclusion:The evaluation index system is scientific,rea-sonable,practical and is of high degree of validity,credibility and distinction.
10.Study on curative effect of Yishen recipe combined with progesterone in the treatment of recurrent spontaneous abortion
Meixia WANG ; Huijuan HU ; Yihong XIE ; Haobo CHEN
Chinese Journal of Biochemical Pharmaceutics 2017;37(5):101-102,105
Objective To analyze and research the Chinese medicine of tonifying kidney recipe on the mechanism of recurrent spontaneous abortion IL-4, IFN-gamma cytokine.Methods60 patients in accordance with the inclusion criteria with recurrent miscarriage from January 2013 to December 2015 were selected, according to the random number table method, the patients were randomly divided into Chinese medicine group, Western medicine group,Combine traditional Chinese and western medicine group, Chinese medicine group treated with traditional Chinese medicine of tonifying kidney recipe, Western Medicine group were given intramuscular injection of progesterone injection,combining traditional Chinese and Western medicine group was treated with acupuncture combined with progesterone Chinese medicine.The course of treatment was 15 days, before and after treatment in patients with pregnancy outcome and IL-4, IFN-gamma levels.ResultsThere was no significant difference between the three groups before treatment with IL-4 and IFN-.After treatment,compared with the traditional Chinese and Western medicine group, western medicine group, Chinese medicine group of IL-4, IFN-, respectively, showed a rise and fall, the difference was statistically significant(P<0.05).After treatment, compared with the traditional Chinese medicine group, the IL-4 and IFN-of the western medicine group were increased and decreased, respectively, and the difference was statistically significant (P<0.05).Combination of traditional Chinese and Western medicine to obtain a higher clinical cure rate.ConclusionThe combination of TCM and Western medicine for improving the efficacy of pregnancy outcome of recurrent spontaneous abortion and exact expression may obviously improve the IL-4 and IFN-gamma, help to improve the IL-4, reduce the expression of IFN-gamma, improve the outcome of pregnancy.


Result Analysis
Print
Save
E-mail