1.Study of Abnormal Heart Rate Variability and Its Acupuncture Intervention in Anxiety Disorder
Xia XIAO ; Wei HE ; Yanfei JIA ; Mengmeng YANG ; Jingjin WEI ; Hong YAO ; Qizhi ZHOU
Shanghai Journal of Acupuncture and Moxibustion 2015;(6):592-594
Heart rate variability (HRV) is a reliable, innocuous and sensitive new index to measure cardiac autonomic nervous function. Anxiety disorder is often accompanied by autonomic nerve dysfunction and its main sign is abnormal HRV. Acupuncture can affect HRV indices, correct abnormal HRV and improve cardiac autonomic nerve dysfunction to relieve anxiety. This article sorts out and analyzes recent years’ studies on abnormal HRV in anxiety disorder, the effect of acupuncture on HRV and acupuncture regulation of abnormal HRV in anxiety disorder to provide a therapeutic basis for clinical acupuncture intervention in abnormal HRV in anxiety disorder.
2.Protection of Subjects' Rights and Interests during the Implementation of Informed Consent in Psychiatric Clinical Researches
Jingjin JIA ; Changqing HU ; Yimin ZHAI ; Xiaoting WANG ; Lei FENG ; Weiwei WANG ; Honghong TENG
Chinese Medical Ethics 2017;30(5):567-571
With the widely development of psychiatric clinical researches,the ethical issue has been concerned gradually.Although the ethical review has strict rules on informed consent,there are many problems and challenges on informed consent implementation because of the special mental illness population.According to the relevant laws and regulations,combined with the characteristics of clinical psychiatric researches,this paper discussed the protection of subjects' fights and interests during the implementation of informed consent in psychiatric clinical researches,from the following aspects:providing a quiet,comfortable,and relatively independent environment for the participants to ensure informed consent,guaranteeing full informed consent time,choosing qualified researchers for informed consent,ensuring the effective process of informed consent,and guiding the subjects to correctly sign their names and the date.
3.Pay attention to ethical detail management for the better protection of subjects' rights and interests
Jingjin JIA ; Honghong TENG ; Changqing HU ; Xuequan ZHU ; Le XIAO ; Yimin ZHAI ; Ye ZHAO
Chinese Journal of Medical Science Research Management 2018;31(1):73-77
Objective To promote the Institutional Review Board(IRB) construction and development via paying more attention to the detail management and providing better protection of subjects' rights and interests in ethical review of clinical trials and scientific research projects.Methods Assessment criteria were established according to the domestic and international laws and regulations on the management of ethical and scientific research project.Ethical site visit was performed on the 37 clinical trials/scientific research projects approved by IRB during the year 2012-2015.Results Clinical trials/scientific research projects were divided into tree types:the registered clinical trials,the post-marketing clinical trials and the researcher initiated scientific research project.All the types met with the following assessment criteria:satisfy the requirement of equipment,facilities and qualifications of drug preservation required for conducting clinical research;subjects were given compensation according to the protocol;informed consent were obtained.Among them,the registered clinical trials meet more criteria than other research types.Regarding to the standard of informed consent implementation,all types met with the following assessment criteria:all the subjects enrolled signed informed consent forms,informed consent forms are well documented;investigators and subjects/ the guardian signed the forms.However,during the site visit,some other criteria were also neglected more or less.Particularly,only few project recorded the consent process and time spots singed the forms.Conclusions Investigators should pay more attention to the activities and behaviors taken place during the research implementation process.Researchers and management staffs should pay attention to ethical detail management to guarantee better protection of subjects' rights and interests.
4.Elevated level of high-sensitivity cardiac troponin I as a predictor of adverse cardiovascular events in patients with heart failure with preserved ejection fraction.
Hongyu HU ; Jingjin LI ; Xin WEI ; Jia ZHANG ; Jiayu WANG
Chinese Medical Journal 2023;136(18):2195-2202
BACKGROUND:
The relationship between the elevation of cardiac troponin and the increase of mortality and hospitalization rate in patients with heart failure with reduced ejection fraction is clear. This study investigated the association between the extent of elevated levels of high-sensitivity cardiac troponin I (hs-cTnI) and the prognosis in heart failure with preserved ejection fraction patients.
METHODS:
A retrospective cohort study consecutively enrolled 470 patients with heart failure with preserved ejection fraction from September 2014 to August 2017. According to the level of hs-cTnI, the patients were divided into the elevated level group (hs-cTnI >0.034 ng/mL in male and hs-cTnI >0.016 ng/mL in female) and the normal level group. All of the patients were followed up once every 6 months. Adverse cardiovascular events were cardiogenic death and heart failure hospitalization.
RESULTS:
The mean follow-up period was 36.2 ± 7.9 months. Cardiogenic mortality (18.6% [26/140] vs. 1.5% [5/330], P <0.001) and heart failure (HF) hospitalization rate (74.3% [104/140] vs. 43.6% [144/330], P <0.001) were significantly higher in the elevated level group. The Cox regression analysis showed that the elevated level of hs-cTnI was a predictor of cardiogenic death (hazard ratio [HR]: 5.578, 95% confidence interval [CI]: 2.995-10.386, P <0.001) and HF hospitalization (HR: 3.254, 95% CI: 2.698-3.923, P <0.001). The receiver operating characteristic curve demonstrated that a sensitivity of 72.6% and specificity of 88.8% for correct prediction of adverse cardiovascular events when a level of hs-cTnI of 0.1305 ng/mL in male and a sensitivity of 70.6% and specificity of 90.2% when a level of hs-cTnI of 0.0755 ng/mL in female were used as the cut-off value.
CONCLUSION
Significant elevation of hs-cTnI (≥0.1305 ng/mL in male and ≥0.0755 ng/mL in female) is an effective indicator of the increased risk of cardiogenic death and HF hospitalization in heart failure with preserved ejection fraction patients.
Humans
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Male
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Female
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Troponin I
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Stroke Volume
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Retrospective Studies
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Biomarkers
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Heart Failure
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Prognosis