By means of literature review of existing laws and regulations,an analysis was made on main setbacks found in the clinical trials and regulation of medical devices in China.The authors proposed to enact and improve such laws and regulations as soon as possible.

Objective To investigate the relationship between CYP2J2*7 mutation(G-76T) and coronary heart disease (CHD) in Chinese Hanpopulation and to study the effects of CYP2J2 geneover-expressionon the proliferation and migrationof aortic smooth muscle cells of ApoE-/- mice. Methods CYP2J2*7 genotype was detectedin 500 patients with CHD and 478 controlsubjects by the Polymerase Chain Reaction-Restriction Frag-ment Length Polymorphism (PCR-RFLP). Culturedaortic smooth muscle cells of ApoE-/- mice were divided into control group, sham transfectiongroup and CYP2J2 over-expression group. Cell proliferation and migration were investigated after CYP2J2 over-expressionby MTS and Transwell assay. Results The frequency of CYP2J2*7 in CHD group was significantly higher than that incontrol group (10.00% vs. 6.49%, P = 0.046). Same is the case in female cases(P = 0.026). Compared with these of aortic smooth muscle cells incontrol group and sham trans-fectiongroup, the cell proliferation in 24, 48, 72 h, and the cell migration in 48 h after CYP2J2 over-expression in CYP2J2 group were significantly suppressed. Conclusions CYP2J2*7 mutation might increase the risk of CHD in Chinese Han population. CYP2J2 over-expression can suppress the proliferation and migration of aortic smooth muscle cells and CYP2J2 might have the effect of anti-atherosclerosis.

Objective Evaluate the performance of the encephalon state index(ESI)in depth of anesthesia monitoring during clinical surgery,compared with the bispectral index(BIS).Methods ESI and BIS data were collected from 60 patients in a single-center clinical trial to compare their efficacy in measuring the depth of anesthesia.Results Consistency analysis revealed mean differences and standard deviations of-0.18±5.42 and-0.11±6.51 between ESI and BIS for awake and anesthetized states,respectively.Correlation analysis showed a correlation coefficient of 0.92 throughout the operative period.Prediction probability analysis indicated that both ESI and BIS had prediction probabilities of 0.97,effectively predicting anesthesia status.Conclusion ESI and BIS show good equivalence in monitoring depth of anesthesia during clinical surgery,which meet the requirements of clinical anesthesia.

OBJECTIVE: Reduce the number of false alarms and measurement time caused by movement interference by the sync waveform of the movement. METHODS: Vital signal monitoring system based on motion sensor was developed, which collected and processed the vital signals continuously, optimized the features and results of vital signals and transmitted the vital signal results and alarms to the interface. RESULTS: The system was tested in many departments, such as digestive department, cardiology department, internal medicine department, hepatobiliary surgery department and emergency department, and the total collection time was 1 940 h. The number of false electrocardiograph (ECG) alarms decreased by 82.8%, and the proportion of correct alarms increased by 28%. The average measurement time of non-invasive blood pressure (NIBP) decreased by 16.1 s. The total number of false respiratory rate measurement decreased by 71.9%. CONCLUSIONS False alarms and measurement failures can be avoided by the vital signal monitoring system based on accelerometer to reduce the alarm fatigue in clinic.
Humans ; Monitoring, Physiologic ; Electrocardiography ; Arrhythmias, Cardiac ; Blood Pressure ; Accelerometry ; Clinical Alarms