The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.
China ; Device Approval ; Humans

Objective:To explore the difference of blood pressure compliance rate in patients with continuous ambulatory peritoneal dialysis (CAPD) in the internet of things (IoT) follow-up and conventional care.Methods:CAPD patients from 3 peritoneal dialysis centers from May 2019 to October 2019 were included in this retrospective cohort study. They were divided into IoT group and conventional care group according to the way of follow-up. The difference in blood pressure compliance rate during 1 year of follow-up between the two groups was observed. The primary outcome was defined as the proportion of patients with blood pressure compliance rate≥85%.Results:A total of 75 patients were included in this study, in during 32 patients in IoT group and 43 patients in conventional care group. The comparison of baseline data between the two groups showed that the dialysis age of patients in IoT group was shorter ( P<0.01). After a median of 9(9, 12) months follow-up, the median blood pressure compliance rate was 85.2% (65.2%, 95.1%), and 25 patients (65.6%) in IoT group had met the target of blood pressure compliance rate≥85%, which was significantly higher than that in the conventional care group (17 cases, 39.5%) ( χ2=4.996, P=0.025). The cumulative probability of the target of blood pressure compliance rate≥85% was 97%, 90%, 90% and 52%, respectively in IoT group, while 95%, 86%, 55% and 34%, respectively in conventional care group after 3, 6, 9 and 12 months of follow-up, and the different between the two groups was significant (Log-rank χ2=4.774, P=0.029). Adjusted for age, sex and dialysis age, the multivariate Cox proportional risk regression model showed that serum creatinine level(for every 1 μmol/L increase, HR=1.002, 95% CI 1.000-1.003, P=0.033), follow-up mode (IoT follow-up vs conventional care, HR=0.023, 95% CI 0.003-0.210, P=0.001), follow-up times (for each additional time, HR=0.879, 95% CI 0.823-0.939, P<0.001) and the rate of weight compliance (for each increase of 1%, HR=0.964, 95% CI 0.939-0.991, P=0.008) was the independent influencing factors for the blood pressure compliance rate<85%. The results of subgroup analysis showed that patients with shorter dialysis age (<10 months) and in the centers where the nurses finished the PD follow-up work as part-time job had better blood pressure control in IoT follow-up. Conclusions:IoT follow-up is helpful to improve CAPD patients' blood pressure compliance rate. Elevated serum creatinine level at baseline is the independent risk factor associated with poor blood pressure compliance. However, IoT follow-up, more follow-up times and the elevated rate of weight compliance are the protective factors for blood pressure compliance. IoT follow-up mode is more recommended for patients with short dialysis age and for dialysis centers where most of the nurses are part-time.

Objective: In view of the difficulty of the shortage of new coronavirus nucleal acid test in the early COVID-19 outbreak, to explore the application value of chest CT in screening COVID-19 patients. Methods: Retrospective analysis was performed on the data of patients with fever who received chest CT and new coronavirus nucleal acid test during January 25, 2020 to February 2, 2020 in Zhongnan Hospital of Wuhan University. A total of 587 patients were enrolled, including 290 males and 297 females, aged from 11.0 to 96.0 (51.3±17.1) years old. Take the nucleic acid test results as the gold standard, the sensitivity, specificity and rate of missed diagnosis of CT screening COVID-19 were calculated. Results: Among the 587 patients, there were 433 positive cases (73.8%, 433/587) and 154 negative cases (26.2%, 154/587) of novel coronavirus nucleic acid test. Using CT screening, 494 cases (84.2%, 494/587) were positive and 93 cases (15.8%, 93/587) were negative. The sensitivity of CT screening COVID-19 was 97.7% (423/433), specificity was 53.9% (83/154) and rate of missed diagnosis was 2.3% (10/433). Conclusions In the early COVID-19 outbreak, CT screening has the advantages of high sensitivity and low rate of missed diagnosis of COVID-19, which can compensate for the shortage of new coronavirus nucleal acid test and can be used as the basis for rapid screening for early prevention and control of COVID-19 outbreak.

OBJECTIVE: To carry out G-banded chromosomal karyotyping and chromosomal microarray analysis (CMA) for a fetus featuring multiple malformations. METHODS: The fetus was found to have increased nuchal thickness, generalized edema, asymmetric lower limbs, tetralogy of Fallot, nasal bone anomaly and cleft palate. Following amniocentesis, G-band karyotyping and CMA were carried out. RESULTS: The fetus had a karyotype of 47,XX,+i(12)(p10) [14]/46,XX[6]. CMA has identified a 33.9 Mb duplication at 12p13.33-p11.1, which was suggestive of tetrasomy 12p. CONCLUSION Combined chromosomal karyotyping and CMA can delineate the origin of abnormal chromosomal fragments during prenatal diagnosis. The fetus was diagnosed with Pallister-Killian syndrome.

To improve the water solubility of daidzein, solid inclusion complexes of daidzein with two amino-modified β-cyclodextrins (ACDs), i.e., mono-6-amino-6-deoxy-β-cyclodextrin (NCD) and mono-6-ethylenediamino-6-deoxy-β-cyclodextrin (ENCD), were prepared by the saturated solution method in water under the preparation conditions as follows: the ratio of daidzein/ACD was 3∶1 and the stirring time was 72 h (83% and 67% yields, respectively).The formation of two inclusion complexes was confirmed by x-ray diffractometry (XRD) and themogravimetric (TG) analysis.The inclusion stoichiometry of the inclusion complexes was 1∶1 from the Job plot and their complexation stability constants (KS) were 899.2 and 203.8 L/mol from fluorescence titration, respectively.After formation of inclusion complexes with NCD and ENCD, the water solubility of daidzein was dramatically raised from 8.31 μg/mL to 15.2 and 13.2 mg/mL at 25℃, increasing by 1800-fold and 1500-fold.

Objective To investigate relation of anxiety, depression and quality of life for patients with anus-saving surgery of rectal cancer. Methods Sixty patients with rectal cancer accepted anus-saving surgery were investigated with self-designed survey, hospital anxiety and depression scale(HADS)and the MOS 36 items short form health survey(SF-36). The correlation between patients with anxiety and depression and the quality of life used pearson correlation analysis. Results Colorectal cancer confirmed anal postoperative elderly patients with anxiety and depression and quality of life were negatively correlated (r value of 0.312 and 0.495 respectively, P<0.05). The postoperative SF-36 was (64.2 ± 11.76), 36.67%and 36.00%patients were evaluated to anxiety and depression respectively . Conclusion In order to reduce patients' anxiety and depression and improve their quality , nursing staff should actively protect elderly patients with anal rectal cancer, psychological emotional support, guide them to adopt measures, such as relaxation therapy so as to improve their quality of life.

OBJECTIVETo compare two different routes of totally implantable venous access ports (TIVPs) from the upper arm vein and the subclavian vein in terms of complications for patients with gastrointestinal malignancy.

METHODSPatients who underwent implantations of TIVPs from September 2013 to January 2015 were retrospectively evaluated. The outcome measurements were rates and types of postprocedural early-stage and long-term complications.

RESULTSA total of 208 patients(upper arm vein group, 86; subclavian vein group, 122) were included in this study. All TIVPs were implanted successfully. The rate of catheter displacement was higher in upper arm vein group(14.0% vs 5.7%, P=0.04), while other postprocedural early-stage complications had no significant difference between the two groups. The occurrence of transfusion obstacle and rates of overall postprocedural long-term complications were significantly lower in upper arm vein group than that in subclavian vein group(1.2% vs. 9.8%, P=0.02; 7.0% vs. 27.0%, P=0.01, respectively).

CONCLUSIONCompared with subclavian vein group, upper arm vein group has lower postprocedural long-term complication rates and is recommended as a safe and comfortable choice for port implantation.

Purpose To investigate the expression of polo-like kinase 1 (Plk1) and Cyclin B1, p21WAF1in cervical carcinoma, and to determine the relationship between the expression of the three proteins and tumor clinicopathological features. Methods The expres-sion of Plk1, Cyclin B1 and p21WAF1 was detected in 102 cases of cervical carcinoma, 20 cases of (cervical intraepithelial neoplasia, CIN) , and 20 cases of nomal cervical tissues by the technique of tissue chip and immunohistochemical staining of EliVision. Statistical analyses of the data were performed with SPSS 19. 0 software. Results The positive rates of Plk1 in cervical carcinoma and CIN were 70. 5%, 55. 0%, respectively, which were significantly higher than normal cervical tissues (10%) (P<0. 01);The positive rates of Cyclin B1 in cervical carcinoma and CIN were 52. 9% and 30. 0%, respectively, which were significantly higher than normal cervical tissues (10%)(P <0.01); The positive rates of p21WAF1 in cervical carcinoma and CIN were 23.5% and 10.0%, respectively, which were significantly higher than normal cervical tissues ( 0 ) ( P<0. 01 ) . There were no significant differences between cervical carcinoma and CIN in the positive rates of Plk1, Cyclin B1 and p21WAF1. The expression of Plk1 was associated with the depth of carci-noma invasion (P<0. 05), that of Cyclin B1 was associated with lymph node metastases and the depth of carcinoma invasion (P<0. 05)and that of p21WAF1 in cervical carcinoma was associated with histological grade (P<0. 05). In cervical carcinoma, the expres-sion of Plk1 was positively correlated with Cyclin B1 (rs =0. 297, P=0. 002) and negatively correlated with p21WAF1(rs = -0. 403, P<0. 001). Conclusion The expression of Plk1, Cyclin B1 and p21WAF1 is involved in the occurrence and development of cervical carcinoma, and the former two are also related with prognosis of cervical carcinoma. The combination of the three would provide a new target for clinical treatment.

Objective To compare two different routes of totally implantable venous access ports﹙TIVPs) from the upper arm vein and the subclavian vein in terms of complications for patients with gastrointestinal malignancy. Methods Patients who underwent implantations of TIVPs from September 2013 to January 2015 were retrospectively evaluated. The outcome measurements were rates and types of postprocedural early-stage and long-term complications. Results A total of 208 patients﹙upper arm vein group, 86; subclavian vein group, 122) were included in this study. All TIVPs were implanted successfully. The rate of catheter displacement was higher in upper arm vein group ﹙14.0% vs 5.7%, P=0.04), while other postprocedural early-stage complications had no significant difference between the two groups. The occurrence of transfusion obstacle and rates of overall postprocedural long-term complications were significantly lower in upper arm vein group than that in subclavian vein group﹙1.2% vs. 9.8%, P=0.02; 7.0% vs. 27.0%, P=0.01, respectively). Conclusion Compared with subclavian vein group, upper arm vein group has lower postprocedural long-term complication rates and is recommended as a safe and comfortable choice for port implantation.

Objective To compare two different routes of totally implantable venous access ports﹙TIVPs) from the upper arm vein and the subclavian vein in terms of complications for patients with gastrointestinal malignancy. Methods Patients who underwent implantations of TIVPs from September 2013 to January 2015 were retrospectively evaluated. The outcome measurements were rates and types of postprocedural early-stage and long-term complications. Results A total of 208 patients﹙upper arm vein group, 86; subclavian vein group, 122) were included in this study. All TIVPs were implanted successfully. The rate of catheter displacement was higher in upper arm vein group ﹙14.0% vs 5.7%, P=0.04), while other postprocedural early-stage complications had no significant difference between the two groups. The occurrence of transfusion obstacle and rates of overall postprocedural long-term complications were significantly lower in upper arm vein group than that in subclavian vein group﹙1.2% vs. 9.8%, P=0.02; 7.0% vs. 27.0%, P=0.01, respectively). Conclusion Compared with subclavian vein group, upper arm vein group has lower postprocedural long-term complication rates and is recommended as a safe and comfortable choice for port implantation.