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 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.

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 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.

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 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 investigate the application value of transversus abdominis muscle release technique in giant ventral hernia repair.Methods:The retrospective and descriptive study was conducted. The clinical data of 72 patients with giant ventral hernia who were admitted to Beijing Chaoyang Hospital of Capital Medical University from January 2017 to January 2020 were collected. There were 47 males and 25 females, aged from 29 to 79 years, with a median age of 56 years. All patients underwent ventral hernia repair with transversus abdominis muscle release technique and preperitoneal/retro-muscular polypropylene mesh reinforcement. Observation indicators: (1) surgical situations; (2) postoperative complications; (3) hernia-related quality of life. Follow-up was conducted using outpatient examination and telephone interview to detect postoperative complications at postoperative 1, 6 and 12 months. Follow-up was up to January 2021. Measurement data with normal distribution were represented as Mean± SD, and comparison within groups was analyzed using the paired t test. Measurement data with skewed distribution were represented as M (range). Count data were described as absolute numbers. Results:(1) Surgical situations: all 72 patients underwent ventral hernia repair with transversus abdominis muscle release technique and preperitoneal/retro-muscular polypropylene mesh reinforcement successfully. The operation time, volume of intraoperative blood loss and mesh size of the 72 patients were (105±46)minutes, (55±15)mL and (680±225)cm 2, respectively. (2) Postoperative complications: 72 patients were followed up for 12 to 48 months, with a median follow-up time of 16 months. During the follow-up, 7 of the 72 patients were diagnosed with seroma by abdominal computed tomography (CT) scan at postoperative 1 week, the size of which was (460±130)mm 2. The 7 patients with seroma were followed up and results of abdominal CT scan at postoperative 6 months showed that the seroma was completely absorbed. Two of the 72 patients had postoperative intestinal obstruction, which was considered as postoperative paralytic ileus. After conservative treatment, the 2 patients were improved 2 weeks after operation. None of the 72 patients had surgical site infection, intestinal fistula or hernia recurrence. (3) Hernia-related quality of life: the score of hernia-related quality of life of 72 patients before operation and at postoperative 12 months were 40±12 and 73±17, respectively, showing a significant difference ( t=12.527, P<0.05). Conclusion:Transversus abdominis muscle release technique in the giant ventral hernia repair is safe and effective, which can improve hernia-related quality of life of patients.

Cancer immunotherapy can effectively inhibit cancer progression by activating the autoimmune system, with low toxicity and high effectiveness. Some of cancer immunotherapy had positive effects on clinical cancer treatment. However, cancer immunotherapy is still restricted by cancer heterogeneity, immune cell disability, tumor immunosuppressive microenvironment and systemic immune toxicity. Cell membrane-coated nanoparticles (CMCNs) inherit abundant source cell-relevant functions, including "self" markers, cross-talking with the immune system, biological targeting, and homing to specific regions. These enable them to possess preferred characteristics, including better biological compatibility, weak immunogenicity, immune escaping, a prolonged circulation, and tumor targeting. Therefore, they are applied to precisely deliver drugs and promote the effect of cancer immunotherapy. In the review, we summarize the latest researches of biomimetic CMCNs for cancer immunotherapy, outline the existing specific cancer immune therapies, explore the unique functions and molecular mechanisms of various cell membrane-coated nanoparticles, and analyze the challenges which CMCNs face in clinical translation.

Objective:To explore the effect of moderate intensity physical exercise on depression, anxiety and cognitive function of schizophrenic patients and its possible biochemical mechanism.Methods:Totally 148 patients with schizophrenia who were hospitalized in hospital from March 2019 to March 2021 were randomly divided into control group ( n=75) and exercise group ( n=73). The patients of the two groups were given drug treatment and routine exercise according to clinical practice, and the patients in exercise group were given additional medium-intensity physical exercise.Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) were used to evaluate the poor mental state of the subjects.The verbal fluency task(VFT), digital span test(DST), trail making test-A(TMT-A) and the positive and negative symptom scale (PANSS) were used to evaluate cognitive function.The levels of endocannabinoids (eCBs) receptors were detected by high performance liquid chromatography, and the levels of monoamine neurotransmitters and eCBs in the patients' serum were determined by enzyme-linked immunosorbent assay (ELISA). SPSS 19.0 software was used for statistical analysis.The measurement data between the two groups were compared by t-test and the counting data between the two groups were compared by χ2 test. Results:(1) After effective intervention, the scores of SAS, SDS, TMT-A and PANSS of the two groups were significantly lower than those before intervention, and the difference before and after intervention between the two groups was statistically significant( t=6.00, 6.52, 25.79, 17.03, all P<0.01). The scores of SAS, SDS, TMT-A and PANSS after intervention in the exercise group were significantly lower than those in the control group( t=4.66, 20.88, 6.61, 8.95; all P<0.01). The number of VFT and DST in the two groups after intervention were significantly higher than those before intervention, and the differences before and after intervention between the two groups were statistically significant( t=13.78, 22.76, both P<0.01). After effective intervention, the number of VFT and DST in exercise group were significantly higher than those in the control group( t=5.02, 5.15, both P<0.01). (2) After effective intervention, the contents of monoamine neurotransmitters and eCBs in serum of the two groups were significantly higher than those before intervention, and HVA level ((63.68±6.99) pg/mL), MHPG level ((175.90±16.22) pg/mL), 5-HIAA level ((29.94±4.19) pg/mL) and CBR1 level ((6.70±1.40)μg/L), 2-AG level ((61.90±5.73)pmol/g) and AEA level ((76.48±6.59) pmol/g) in exercise group were significantly higher than those in the control group ((52.97±5.37)pg/mL, (138.50±11.52)pg/mL, (23.87±3.15)pg/mL, (5.71±1.29)μg/L, (52.13±5.14)pmol/g, (67.66±5.88)pmol/g)( t=10.43, 16.21, 10.91, 8.65, all P<0.01). Conclusion:Moderate intensity physical exercise can significantly improve their depression, anxiety and cognitive function, which may be related to regulating the levels of ECBS and their receptors in patients with chronic schizophrenia to increase monoamine neurotransmitters.