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.The effect of virtual reality balance training on the balance and the ability in the activities of daily living of children with cerebral palsy
Qinan YU ; Meixia YANG ; Jianming FU
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(11):992-996
Objective:To observe the effect of virtual reality (VR) balance training on the balance and ability in the activities of daily living (ADL) of children with cerebral palsy.Methods:Forty children with spastic cerebral palsy were divided at random into an intervention group (21 cases) and a control group (19 cases). All received 30 minutes of daily routine rehabilitation training, including therapeutic exercise, occupational therapy and home rehabilitation training. Everyone also received 20 minutes of balance training 5 days a week for 3 months. That included sitting and standing balance training and training in transferring the center of gravity. Beyond that the intervention group additionally trained on the Biomaster virtual reality training system doing image matching, playing football and skiing. Before the experiment and after 1 and 3 months, both groups′ balance trajectory length, peripheral area, and the unit area the trajectory length were documented and also using the Berg balance scale (BBS). ADL ability was quantified using the modified Barthel index (MBI).Results:①After the 3 months of training there was a significant improvement in the average trajectory length, peripheral area and unit area trajectory length of both groups sitting and standing. The average values of the intervention group were, however, significantly superior to the control group′s averages. ②After the 3 months there were also significant improvements in the groups′ average BBS and MBI scores, again with significantly greater improvement in the intervention group.Conclusion:Virtual reality balance training can significantly improve the balance function and ADL ability of children with cerebral palsy.
3.Clinical Efficacy of Xiaoyaosan Combined with Paroxetine Tablets in Treatment of Migraine with Liver Depression and Blood Deficiency Syndrome and Depression Based on Transcranial Doppler
Meng ZHANG ; Meixia WANG ; Qian ZHAO ; Yu ZHANG ; Yimin CHEN ; Yanyun ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(2):113-118
ObjectiveBased on the hemodynamic indicators of transcranial Doppler (TCD),this study aimed to analyze the correlations of visual analogue scale(VAS) and Hamilton depression rating scale 24-item(HAMD-24) scores with mean blood velocity (Vm) of the anterior cerebral artery (ACA),the middle cerebral artery (MCA), and the posterior cerebral artery (PCA),and the correlation between VAS score of headache and HAMD-24 score,and explore the clinical efficacy of Xiaoyaosan combined with paroxetine tablets in the treatment of migraine with liver depression and blood deficiency syndrome and depression. MethodSixty-two outpatients treated in the encephalopathy department, the First Afffiliated Hospital of Anhui University of Chinese Medicine between January 2019 to June 2020 who were in line with the diagnostic criteria were enrolled and divided into a treatment group (32 cases) and a control group (30 cases). All patients were treated with paroxetine tablets,while those in the treatment group received additional Xiaoyaosan. The changes in relevant indicators in the two groups before and after treatment were observed. The effects of Xiaoyaosan on the TCD indicators (VmACA, VmMCA, and VmPCA), scores of migraine and depression [including VAS score, Headache Impact Test-6 (HIT-6) score,and HAMD-24 score], and the traditional Chinese medicine (TCM) syndrome score were analyzed. ResultVAS and HAMD-24 scores were positively correlated with VmACA, VmMCA, and VmPCA (P<0.01). VAS scores were positively correlated with HAMD-24 scores. Compared with the conditions before treatment, the levels of TCD indicators (VmACA, VmMCA, and VmPCA) in the two groups decreased after treatment (P<0.01), and the scores of HIT-6, VAS, and HAMD-24 in the two groups were significantly improved (P<0.01). Compared with the control group after treatment, the treatment group showed decreased levels of TCD indicators (VmACA, VmMCA, and VmPCA) (P<0.01) and superior improvement of HIT-6, VAS, and HAMD-24 scores (P<0.01). The effective rate in the treatment group was 90.6% (29/32), higher than 63.3% (19/30) in the control group (χ2=5.13,P<0.05). There was no significant difference in adverse reactions between the two groups. ConclusionTCD indicators can effectively reflect the cerebral blood flow of patients with migraine and depression co-morbidity,and migraine is correlated with the onset and severity of depression. The comprehensive analysis showed that the efficacy of Xiaoyaosan combine paroxetine tablets was better than that of paroxetine tablets alone in the treatment of migraine with liver depression and blood deficiency syndrome and depression. This therapeutic protocol can significantly improve cerebral blood flow and the symptoms and degree of migraine and depression and can provide references for clinical treatment.
4.Clinical Efficacy of Gandouling Combined with Short-term Decoppering on Hepatic Fibrosis of Wilson's Disease Based on Transient Elastography
Yu ZHANG ; Meixia WANG ; Jing ZHANG ; Qian ZHAO ; Meng ZHANG ; Yiming CHEN ; Zhonglei LI
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(13):123-129
ObjectiveTo explore the accuracy of clinical common serum fibrosis indexes hyaluronic acid (HA), type Ⅳ collagen (CⅣ), laminin (LN), and type Ⅲ procollagen peptide (PⅢNP), in combination with liver stiffness measurement (LSM, measured by transient elastography) and non-invasive markers of fibrosis aspartate aminotransferase to platelet ratio index (APRI) and fibrosis-4 (FIB-4) in the prediction of the hepatic fibrosis of Wilson's disease (WD) and to observe the clinical effect of Gandouling (GDL). MethodThe data of 76 WD patients were collected and the LSM, serum fibrosis indexes (HA, PⅢNP, CⅣ, LN), APRI, and FIB-4 before treatment were recorded. The correlation of LSM with serum fibrosis indexes, APRI, and FIB-4 was discussed via Pearson′s correlation analysis. According to the therapeutic schemes, patients were classified into the control group (36 cases) and treatment group (40 cases). Patients in control group were treated with sodium dimercaptopropylsulfonate (DMPS), while those in the treatment group received GDL in addition to the western medicine therapy. The treatment lasted 6 courses (8 days/course) and the influence of GDL on the indictors was evaluated. ResultHA, CⅣ, LN, PⅢNP, APRI, and FIB-4 were in positive correlation with LSM (r=0.517, 0.438, 0.281, 0.457, 0.778, 0.847, P<0.01). HA, CⅣ, LN, and PⅢNP in the treatment group were lower after treatment than before treatment (P<0.05, P<0.01). HA, CⅣ, and LN in the control group were lower after treatment than before treatment (P<0.05, P<0.01), and PⅢNP showed no significant difference. LSM, FIB-4, and APRI in both groups decreased after treatment (P<0.05). After treatment, LSM, FIB-4, APRI, HA, and PⅢNP in the treatment group were lower than those in the control group (P<0.05, P<0.01), but CⅣ and LN demonstrated no significant difference from the control group. ConclusionLSM in combination with serum fibrosis indexes (HA, PⅢNP, CⅣ, LN), FIB-4, and APRI can help accurately identify the level of the hepatic fibrosis in WD. Moreover, on the basis of decoppering by western medicine, GDL can significantly improve the liver function and hepatic fibrosis of WD patients.
5.Association between previous bleeding and 90-day mortality and rebleeding in patients with acute upper gastrointestinal bleeding: a real-world study
Shuang LIU ; Xiaoming ZHANG ; Meixia YANG ; Yage CHAI ; Rui HUANG ; Danwen ZHENG ; Xuezhong YU ; Huadong ZHU
Chinese Journal of Emergency Medicine 2021;30(5):593-601
Objective:To investigate the relationship between previous bleeding history and poor prognosis of patients with acute upper gastrointestinal bleeding.Methods:This study was a prospective multicentre real-world study (Acute Upper Gastrointestinal Real-word study, AUGUR study). The data of patients with UGIB who were admitted to the emergency department of 20 tertiary hospitals in China from June 30, 2020 to February 10, 2021 were collected. According to the number of previous bleeding history, the patients were divided into three groups (0 time, 1-3 times, and≥4 times). Based on the patient’s demographic data, clinical characteristics, laboratory data, treatment, and outcomes, univariate and logistic regression analysis were performed to investigate the correlation between the number of previous bleeding and the 90-day mortality and rebleeding of patients with gastrointestinal bleeding.Results:A total of 1 072 patients with acute UGIB were included in this study. The all-cause mortality and rebleeding rate of all patients were 10.9% (117/1 072) and 11.8% (129/1 072), respectively. Among them, 712 patients (66.42%) had no previous bleeding, 297 patients (27.71%) had previous bleeding 1-3 times, and 63 patients (5.88%) had previous bleeding≥4 times. In univariate analysis, age, vital signs and consciousness on admission, history of liver cirrhosis, onset with hematemesis, admission hemoglobin, varicose veins bleeding, peptic ulcer bleeding, red blood cell infusion, tracheal intubation and the use of vasopressors after admission were risk factors for the 90-day mortality and rebleeding rate. Multivariate logistic regression analysis showed that patients with previous bleeding≥4 times had a higher risk of the 90-day mortality ( OR=2.17, 95% CI: 1.04-4.57, P=0.040) and rebleeding ( OR=2.32, 95% CI: 1.19-4.53, P=0.013). Conclusions:The history of previous bleeding≥ 4 times can be used as an independent risk factor for the 90-day mortality and rebleeding in patients with acute UGIB.
6.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.
7.Epidemiological analysis of 1 940 cases of brucellosis in Hohhot
Ruiping YU ; Meixia WANG ; Mengguang FAN ; Litao SONG ; Na TA ; Xiaoyan LI ; Jingchuan MI
Chinese Journal of Endemiology 2019;38(4):306-309
Objective To understand the epidemiological characteristics of recent brucellosis in Hohhot.Methods Clinical data of patients with brucellosis in Hohhot City were retrospectively analyzed,and the patients were diagnosed in the outpatient clinic of Comprehensive Center for Disease Prevention and Control of Inner Mongolia Autonomous Region from 2014 to 2017.To analyze the patient's area,age,gender,occupation and time distribution of the disease.Results A total of 1 940 patients with brucellosis were diagnosed in Hohhot from 2014 to 2017,with an average age of 50.8 years old.There were 1 464 males with an average age of 50.4 years old and 476 females with an average age of 51.9 years old;the male-female ratio was 3:1.The number of cases of brucellosis in 2014-2017 was 612,649,402,and 277,respectively.Brucellosis was mainly distributed in three districts including Horinger County (937 cases),Tumd Left Banner (236 cases) and Tuoketuo County (191 cases),accounting for 70.31% (1 364/1 940) of the total number of cases in the city.The age of onset was at least 1 year old,the oldest age was 86 years old,and most cases were in the 45-< 65 age group,the total number of cases was 1 046,accounting for 53.92% (1 046/1 940) of the total number of cases in the city;the occupational distribution was mainly farmers (1 795 cases),herders (13 cases) and veterinarians (17 cases),with a total of 1 825 cases,accounting for 94.07% (1 825/1 940).The time distribution was mainly concentrated in March-July,and the number of cases was 1 157 cases.Conclusions The number of brucellosis cases in Hohhot area of Inner Mongolia is mainly from Horinger County,Tumd Left Banner and Tuoketuo County;the cases occur frequently in Spring and Summer;the age of onset is mainly between 45-< 65 years old,they are mainly male farmers.
8.Distribution and drug resistance analysis of carbapenems-resistant Klebsiella pneumoniae
Yongchun RUAN ; Yiqing ZHOU ; Lixia YU ; Haiwang ZHANG ; Jianyong MA ; Meixia SU ; Dongfang HAN ; Wei HE ; Minghui LI
Chinese Journal of General Practitioners 2018;17(10):789-793
Objective To investigate the clinical distribution and drug resistance of carbapenemsresistant Klebsiella pneumoniae (CRKP).Methods A total of 134 clinical strains of CRKP were collected from inpatients in our hospital from January 2014 to December 2016.VITEK-2 compact automatic microbiological analyzer was used to identify the bacteria and the supporting gram-negative bacterial drug susceptibility card was used for susceptibility testing.The sensitivity of other clinical commonly used antimicrobial agents was measured by K-B method.And the clinical distribution of CRKP and its resistance to antimicrobial agents were investigated and analyzed.Results The clinical strains of CRKP were isolated mainly from urine (n=70,52.2%) and sputum (n=38,28.4%).Klebsiella pneumoniae was identified in samples from the department of neurosurgery,including neurosurgery ICU (47.8%,64/134),ICU (23.9%,32/134),department of hepatobiliary surgery (8.2%,11/134) and department of urology (6.0%,8/134).Among all 22 antimicrobial agents tested,the resistant rates of CRKP to 16 antimicrobial agents were >90%,especially for ampicillin it was 100%,and those to 19 antibiotics were >80%,only for tigecycline it was 23.1%.There were 16 strains of CRKP with positive extended spectrum β-lactamases (ESBLs) (11.9%).All the CRKP strains were resistant to more than three kinds of antimicrobial agents,except one strain that was resistant to two kinds.Conclusion There is a wide range of clinical distribution of CRKP,which is resistant to most of antimicrobial agents,while tigecycline still has a strong antibacterial activity to CRKP.
9.Clinical application of high-frequency electric snare in treatment of airway neoplasm
Haiwang ZHANG ; Meixia SU ; Lixia YU ; Yefeng CHEN ; Yongchun RUAN ; Jianyong MA ; Minghui LI ; Wei HE
China Journal of Endoscopy 2017;23(8):95-98
Objective To investigate the clinical efficacy and safety of high-frequency electric snare for the treatment of main airway neoplasm through bronchoscopy. Methods The clinical datas of 18 patients from July 2013 to April 2016, who had main airway neoplasm and were treated with high-frequency electric snare through bronchoscopy, were retrospectively analyzed. Meanwhile, the interventional bronchoscopic techniques partly included argon plasma coagulation and cryoablation. After operarion, the relief of symptoms and complications were observed. Results After operarion, the clinical symptoms, shortness of breath, dyspnea index score and the degree of airway stenosis were improved significantly. No serious complications such as massive hemoptysis occurred in all patients. Conclusion High-frequency electric snare is an effective and safe approach for the treatment of main airway neoplasm.
10.Effect of eletroacupuncture for Z syndrome without organic lesion and serum leptin.
Minghui LI ; Juxin SHEN ; Yongchun RUAN ; Luojie CAI ; Hua WANG ; Meixia SU ; Lixia YU
Chinese Acupuncture & Moxibustion 2016;36(4):376-378
OBJECTIVETo explore the effect and mechanism of electroacupuncture (EA) for Z syndrome without organic lesion (metabolic syndrome combined with obstructive sleep apnea hypopnea syndrome).
METHODSFifty-eight patients with Z syndrome were divided into three groups according to mild,moderate and severe degree. Acupuncture and EA were used at Daimai (GB 26), Zhongwan (CV 12), Xiawan (CV 10), Zusanli ST 36), Qihai (CV 6) and Huaroumen (ST 24), etc., once a day and five times a week. The treatment of ten times was a course, and two courses were acquired continuously. Sleep respiration monitoring (PSG) was done before EA and in one week after treatment respectively. Triacylglycerol (TG) fasting blood glucose (FBG) fasting insulin (INS) and serum leptin (Lep) were tested before and after treatment in the three groups.
RESULTSAfter treatment apnea hypopnea index (AHI) and the percentage of the time of arterial oxygen saturation (SaO₂) less than 90% taken in the total sleep time (SLT 90%) were improved apparently than those before treatment in the three groups (all P < 0.05). The levels of TG, FPG, INS and Lep were decreased after treatment in all groups (all P < 0.05).
CONCLUSIONEA can improve AHI and nocturnal hypoxia of Z syndrome, and the mechanism may be related to decreasing the indices of metabolism syndrome and leptin.
Acupuncture Therapy ; Adult ; Female ; Humans ; Insulin ; blood ; Leptin ; blood ; Male ; Metabolic Syndrome ; blood ; physiopathology ; therapy ; Middle Aged ; Sleep ; Sleep Apnea, Obstructive ; blood ; physiopathology ; therapy ; Treatment Outcome ; Triglycerides ; blood ; Young Adult


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