Objective: To help medical device registration applicant understand the content of clinical evaluation, guided on the clinical evaluation method, and also putted forward several suggestions of the improvement scheme for our country registered clinical assessment and review of the work. Methods:Described the Global Harmonization Task Force (GHTF) medical device registration guidance for clinical evaluation, combined with the status quo of supervision in China, and made some specific scheme on China's medical device of clinical evaluation work. Results: Introduced the contents of the clinical evaluation and the relationships between the factors, in order to help the medical device registration applicant and Chinese regulators to do clinical evaluation work of scientific and reasonable. Conclusion:The definition of medical device registration clinical evaluation should clear the clinical evaluation, and to develop guidance for clinical evaluation of the corresponding.

This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
Equipment and Supplies ; standards ; Risk Assessment ; United States ; United States Food and Drug Administration

Objective: To evaluate the relevance of diabetes mellitus and hepatitis B virus(HBV) infection in people by Meta-analysis. Methods: Databases we searched included CNKI, VIP China Science and Technology Journal Database, Wanfang Data Knowledge Service Platform, PubMed, Cochrane Library and Web of Science Core Collection database. Publication time was from January 1997 to May 2017. The Languages were limited to Chinese and English. English search terms include: diabetes, diabetes mellitus, hepatitis B and risk. Chinese search terms include: diabetes mellitus, hepatitis B and risk. We included all observational studies on diabetes and HBV infection. Firstly, the Newcastle-Ottawa Scale and the evaluation criteria of Cross-sectional study recommended by Agency for Healthcare Research and Quality were used to evaluate the quality of articles. Secondly, RevMan 5.3 software was used for heterogeneity testing. Subgroup analysis, random effects model and Mantel-Haenszel method were used to calculate the combined OR value. Finally, Stata 14.0 software was used to conduct the sensitivity analysis, and Begg rank correlation method was used to detect the publication bias. Results: A total of 12 studies were included, comprising 6 cross-sectional studies and 6 case-control studies. But the 12 articles were heterogeneous (χ²=42.10, P<0.001). After subgroup analysis, cross-sectional studies of diabetes and HBV infection were still heterogeneous (χ²=28.21, P<0.001), whose combined odds ratio (OR) was 1.36 (95%CI: 1.03-1.80). But the heterogeneity of case-control studies was not statistically significant (χ²=10.32, P=0.070), whose combined odds ratio (OR) was 1.55 (95%CI: 1.10-2.17). After the sensitivity analysis, the 95%CI of the combined OR of the 7 studies did not fluctuate, and the lower limit was above 1.07. No publication bias was detected in the cross-sectional study subgroup (Z=1.35, P=0.176) and the case-control study subgroup (Z=1.69, P=0.091). Conclusion Patients with diabetes are more likely to be infected with HBV than those without diabetes. Diabetes mellitus is likely to be a risk factor for HBV infection.

Objective To verify the feasibility of discriminating tissue types in the anterior approach of the cervical spine by the Electrical impedance (EI) and decrease the rate of severe complications.Methods Six New Zealand white rabbits and 6 mini-pigs were performed standard anterior cervical surgery.The esophagus,carotid artery,tracheal cartilage,annular ligaments of trachea,longus colli muscle and anterior longitudinal ligament are classified as the prevertebral group;The cortical bone,cancellous bone,anulus fibrosus and nucleus pulposus are classified as the vertebral group.Once all the tissues were exposed completely,over the frequency range of 200-3 000 kHz (the frequency points were 200 kHz,400 kHz,600 kHz,800 kHz,1 000 kHz,2 000 kHz,3 000 kHz),the in vivo EI of prevertebral group and vertebral group were measured by a probe and a precision inductance-capacitance-resistance (LCR) meter;then the data were analyzed with IBM SPSS Statistics 22 software.At every frequency,Kruskal-Wallis test followed by all pairwise multiple comparisons was applied for all the four groups (the prevertebral group of rabbits,the vertebral group of rabbits,the prevertebral group of mini-pigs,and the vertebral group of mini-pigs),respectively.P values ＜ 0.05 were considered statistically significant.Results At every frequency,the results of Kruskal-Wallis test for all the four groups were significant,and the results of multiple comparisons were as follows.(1) In both miniature experimental animals and large experimental animals,the EI of the vertebral group tissues was significantly different at every investigated frequency (multiple comparisons).(2) In the miniature experimental animals,the EI between longus colli muscle and esophagus,carotid artery and annular ligaments of trachea,and tracheal cartilage and anterior longitudinal ligament had no significant difference at any frequency (multiple comparisons);significant difference could not be detected in the EI between anterior longitudinal ligament and annular ligaments of trachea at the frequencies of 2000-3 000 kHz (multiple comparisonsk) and could be detected at the frequencies of 200-1 000 kHz (multiple comparisons);for comparison of all other paired tissues of prevertebral group there were significant differences at all frequencies (multiple comparisonsk).(3) In the large experimental animals,the EI between longus colli muscle and esophagus,carotid artery and annular ligaments of trachea,and tracheal cartilage and anterior longitudinal ligament had no significant difference at any frequency (multiple comparisons),the same was true for the EI between annular ligaments of trachea and esophagus,carotid artery and anterior longitudinal ligament,and longus colli muscle and annular ligaments of trachea at the frequencies of 800-3 000 kHz,3 000 kHz and 3 000 kHz (multiple comparisons),respectively;for comparison of all other paired tissues of prevertebral group there were significant differences at all frequencies (multiple comparisons).Conclusion At certain frequencies,the EI among tissues was significantly different and could discriminate tissues in the anterior approach of the cervical spine.

Objective To evaluate the clinical effect of retrievable esophageal covered metal internal stent in treating patients with achalasia.Methods Under DSA guidance,peroral"Z-type"double horn covered metal internal stent implantation was performed in 16 patients with achalasia.Esophagography was carried out about 28 days after the procedure and the stent was retrieved.Results Of 16 cases,the stent fell off into the stomach two weeks after the operation in one.And the stent was successfully replaced after it was taken out.The placed stent was successfully retrieved in all cases 28 days after the treatment.No serious complications occurred.All the patients were followed up for 3 months to 3 years.During the follow-up period restenosis of the esophagus developed in two cases(at one and 1.5 years respectively),and the restenosis degree was relived after balloon dilation.Clinically,no esophageal symptoms,such as dysphagia,occurred in all patients.Conclusion As a simple and safe technique,the retrievable esophageal covered metal internal stent implantation is very effective with fewer complications for the treatment of achalasia.Moreover,the technique carries lower restenosis occurrence.

This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.

This paper introduced the significance parameters of the quality control of cold light source of endoscope, expounded the importance and necessity of quality control of cold light source; it investigated several manufacturers, analyzed and discussed the main causes of the cold light source uneven, in order to realized the standard management and effective supervision on the cold light source, at the end, the next step quality control work was brought out, which provide technical support for quality supervision of cold light source.
Endoscopes ; standards ; Light ; Quality Control

Objective:This study intended to explore the current sexual and childbearing stigma, experienced by chronic hepatitis B patients in China, and to develop related preventive strategies.Methods:We used a self-made questionnaire to investigate the sexual and childbearing stigma suffered by chronic hepatitis B patients in four provinces of China. Analysis of variance and chi-square test were used to compare the differences on sexual and childbearing stigma indexes between different demographic variables.Results:We surveyed 797 chronic hepatitis B patients in four provinces. Among them, 4.15 % (28/675) of the patients were persuaded not to give birth to children, and 4.67 % (10/210) of patients were told to stop pregnancy, by their medical care takers or by members from the family planning institutions. 3.62 % (25/690) and 3.48 % (24/690) of the patients were not able to enjoy the family planning or reproductive health services as they were stigmatized,suffered, as having HBV infection. Among the male chronic hepatitis B patients, the under 30 years group suffered less sexual and childbearing stigma than those who were aged 31- ( P=0.011) or 51 and above year-olds ( P=0.009). Among female chronic hepatitis B patients, the 31- year-olds group suffered less sexual and childbearing stigma than those under 30 years group but higher than those aged 41- ( P=0.001) or 51 and above ones ( P<0.001). Patients with knowledge on route of sexual transmission for HBV, were more likely to practice less related sexual behaviors than those without such knowledge ( P=0.022). Patients who were aware or not that condoms could reduce the risk of HBV infection did not show statistically significant difference on sex behaviors ( P=0.612). Conclusions:Chronic hepatitis B patients did suffer from sexual and childbearing related stigma, with women aged 31-40 years old the most. It is necessary to advocate on the advantage of condom use for prevention of HBV transmission among pregnant women, both horizontally and vertically. Strategies on protection the rights of patients with hepatitis B should be developed and strengthened.

Objective To explore the efficacy of memantine-assisted deep brain stimulation in adolescents with refractory obsessive-compulsive disorder and its effect on serum neurofactors and inflammatory cytokines.Methods A total of 115 adolescents with refractory obsessive-compulsive disorder were randomly divided into the control group(n = 57)and the study group(n = 58).The control group was treated with sertraline combined with deep brain stimulation for 3 months,while the study group was treated with memantine combined with deep brain stimulation for 3 months.The efficacy,adverse reactions,serum neurofactors(including 5-hydroxytryptamine[5-HT],brain-de-rived neurotrophic factor[BDNF],and glial neurotrophic factor[GDNF]),inflammatory cytokines(including tumor necrosis factor-α[TNF-α],interleukin[IL]-2,and IL-6),mental state,psychosocial functioning,and quality of life before and after treatment were compared between the two groups.Results The total effective rate in the study group was significantly higher than that in the control group(96.55%and 84.21%,P＜0.05).Compared with the control group,the serum 5-HT and BDNF levels at 1-and 3-month post-treatment were signifi-cantly higher in the study group,while the levels of serum GDNF,TNF-α,IL-2,and IL-6 were significantly lower(P＜0.05).The scores of Hamilton Anxiety Scale and Hamilton Depression Scale were significantly lower and the scores of Chinese Version of the Personal and Social Performance Scale,and TDL Quality of Life Assessment Scale were significantly higher in the study group than in the control group(P＜0.05).The incidence of adverse reactions between the two groups were similar(P＞0.05).Conclusion Our results support the efficacy of memantine-assisted deep brain stimulation for refractory obsessive-compulsive disorder in adolescents.In particular,the treatment can regulate neurofactor and inflammatory cytokine levels,relieve anxiety and depression,improved psychosocial function and quality of life,and is safe.

Objective:To analyze epidemic trends of other infectious diarrhea in Jiangxi Province from 2017 to 2022, and explore the application of autoregressive integrated moving average (ARIMA) model in the prediction of the incidence of other infectious diarrhea in Jiangxi Province, providing reference for the prediction and prevention and control of other infectious diarrhea.Methods:To conduct a descriptive epidemiological analysis of other infectious diarrhea cases in Jiangxi Province from 2017 to 2022, and establish an ARIMA model to predict the number of other infectious diarrhea cases in 2023.Results:From 2017 to 2022, Jiangxi Province reported 204 842 cases of other infectious diarrhea. The annual average reported incidence rate was 74.32/100 000. The cases were reported in each age group with obvious seasonal characteristics of the main peak. There were two peak periods of incidence in winter and spring (from January to March) and in summer and autumn (from July to September) and the peak value was higher in winter and spring. All parameters of the model ARIMA (0,1,2)(2,1,0) 12 and ARIMA (1,0,0)(2,1,0) 12 were statistically significant ( P<0.05), and the minimum values of Bayesian information criterion were 13.83 and 9.12, respectively. The residual series were all white noise ( P>0.05); The predicted value of the model is in good agreement with the actual value, and the predicted trend is consistent with the actual trend. The model has a good prediction effect. Conclusions:The other infectious diarrhea occurred in 2017-2022 was still the first case of notifiable disease in Jiangxi Province. The prevention and control situation cannot be ignored. Disease monitoring and health education for families of children under 3 years of age and scattered children among key populations for prevention and control should be strengthened during the epidemic season. The ARIMA model can be used for short-term prediction and trend analysis of other infectious diarrhea outbreaks in Jiangxi Province.