A series of laws and regulations are the essential legal requirement in the field of clinical trial of medical device currently in China, especially the Provision for Clinical Trial of Medical Device. On the basis of current situation of medical device clinical trial, systemic analysis on the hot spot topics in the regulations was conducted to explore the way of improving the control system of clinical trial of medical device in China, which will provide the reference for medical device industry and the investigators of the clinical trial of medical device.
China ; Device Approval ; legislation & jurisprudence

Oncomelania hupensis which plays an important role in the transmission of schistosomiasis japonica is the only intermediate host of Schistosoma japonicum and carrying out studies on its subspecies differentiation and genetic variation will have an important significance for schistosomiasis control. In this paper the research progress of taxonomy and discrimination techniques of O. hupensis is reviewed at four levels namely the morphological level the cellular level the protein level and the DNA molecule level and DNA sequencing technology is considered as the ideal taxonomy and discrimination technique of O. hupensis and the future research emphasis.

Objective To investigate the effects of spleen preservation on hepatic fibrosis and relevant cytokine in rabbits with advanced schistosomiasis. Methods After hepatic cirrhosis was induced by infecting Schistosoma japonicum cercariae in rabbits, total splenectomy (TSG), subtotal splenectomy (SSG) or sham operation (model control group, MCG) were performed respectively on these rabbits. Meanwhile,a normal control group (NCG) was established. The serum levels of tumor necrosis factor alpha (TNF-α) , interleukin-6 (IL-6) and interleukin-1 beta (IL-lβ) were detected respectively by radioimmunoassay(RIA) at the 8th, 15th and 21st week post-infection. The expressions of transforming growth factor betal (TGF-β1), type Ⅰ and type Ⅲ collagen in liver tissues were determined by immunohistochemistry before and after the operations. Results Compared with NCG, the serum levels of TNF-α, IL-6 and IL-1β of MCG rabbits increased significantly at the 8th week post-infection (P <0.01). However, the levels of them decreased to a lower level at the 15th week. At the 6th week after operation,no significant difference was found among the three model groups ( MCG, TSG, SSG) (P > 0.05). The expressions of TGF-β1, type Ⅰ and type Ⅲ collagen in liver tissue of MCG rabbits were significantly higher than those of NCG rabbits before the operation (P < 0. 01). No significant difference was found among the three model groups at the 6th week after the operation ( P > 0.05). Conclusion The residual splenic tissue after subtotal splenectomy does not aggravate the hepatic fibrosis at advanced schistosomiasis. The mechanism may be that the relevant cytokines of hepatic fibrosis (TGF-β1, TNF-a, IL-6, IL-1β) decreased to a lower level at this time,and splenectomy does not influence the levels of them.

Objective To investigate the status of Cryptosporidium infection in the population in the local area of Anhui Prov?ince,and discuss the risk factors of the infection,so as to provide the evidence for the prevention and treatment of cryptosporidi?osis. Methods Qianshan County and Lingbi County of Anhui Province were selected as investigation spots,and the oocysts of Cryptosporidium in the feces of the investigation objects and the specific IgG antibody against Cryptosporidium in the serum were checked by using the pathogenic modified acid fast staining method and ELISA,respectively,so as to determine the status of Cryptosporidium infection in these investigation objects. At the same time,the questionnaire surveys were conducted in the inves?tigation objects so as to know about the risk factors of Cryptosporidium infection. Results A total of 668 people were investigat?ed in the two counties,635 people received etiological examinations,and 15 people were positive with the positive rate of 2.36%;642 people received serological examinations,and 140 people were positive with the positive rate of 21.81%;628 peo?ple received pathogenic and serological examinations at the same time,and the examination results of the both methods showed that 12 people were positive(there were 4 people in Qianshan County and 8 people in Lingbi County),and the positive rate was 1.94%. The rates of Cryptosporidium infection in the population of Qianshan County and Lingbi County were 1.24%(4/322)and 2.71%(8/295)respectively,and the difference had no statistical significance(P>0.05). The single factor analysis found that the rate of Cryptosporidium infection was higher in the children and diarrhea patients;the multivariate logistics regression analy?sis indicated that the rate of Cryptosporidium infection was higher in the people who bred poultry and the diarrhea patients. Con?clusions The positive rate of serum antibody of Cryptosporidium in the population of the local area of Anhui Province is higher, which indicates that the previous infection is serious,and the rate of Cryptosporidium infection in human is relative to the age, diarrhea and whether there are poultries to be bred in the family,which is worthy of attention in the future prevention and treat?ment.

Objective To understand the variation rules of schistosomiasis endemic situation before and after schistosomia-sis transmission controlled or interrupted,so as to provide the evidence for the consolidation of control achievements. Meth-ods In Anhui Province,3 counties reaching the criteria of schistosomiasis transmission controlled or interrupted were selected and their historical endemic data were collected and analyzed statistically from 10 years before the schistosomiasis transmission controlled to 2008. Results In Tianchang City,the Oncomelania hupensis snail area was 3.54 hm2 in a part of the lake marsh-land in the year reaching the criteria of transmission controlled(1998),and no snails were found in the year of transmission in-terrupted(2008). No stool-test-positive resident was detected except there were 58 acute schistosomiasis cases in 1993,and the sero-test-positive rate of local residents remained at low levels(0-1.55%). In Taihu County,the snail area was 0.84 hm2 account-ing for 0.06%of its historical accumulative snail areas in the year of transmission controlled(1971),and no snails were found three years before the transmission interrupted (1983). However,the schistosomiasis endemic rebounded 12 years later (1995),there was an outbreak of acute schistosome infections(73 cases),and the snail area increased again to 133.7 hm2 ac-counting for 2.91%of historical accumulative snail areas. After that,the snail area kept on rising and the infection rates of resi-dents and bovine remained higher than 1%. In Guangde County,the snail area was 32.4 hm2 accounting for 1.90%of its histori-cal accumulative snail areas in the year of transmission controlled(1995). After that,the snail area increased progressively, and the schistosomiasis endemic rebounded and there were acute schistosome infections 5 years later. The Spearman tests showed that the sero-test-positive rate(Tianchang City)and the stool-test-positive rates of residents and bovine(Taihu County)had positive correlations with the snail areas(r=0.582,0.401,0.596,all P<0.05). Conclusion The snail status is a key for the consolidation of schistosomiasis transmission controlled and interrupted. Therefore,a valid surveillance system of snail situa-tion should be established as quickly as possible.

Phase Ⅰ Clinical trial of new drugs is key for clinical drug development. In this article,we describe our experience and reflection on phase Ⅰ clinical trials of new drugs at the First Affiliated Hospital of Nanjing Medical University.

With the aid of scientific research management information system, we established an in-formation management for the scientific research funds. The structure,function and application of the system were introduced in this paper.

This article presented the idea of implementation for the general hospital scientific research management information system.Based on the network and database,the scientific research management information system was constructed by analysis on the operation process of it;the information management of the scientific research management was implemented.This modern scientific research management information would improve the hospital scientific research management level.

Objective To explore the expression feature of long non-coding RNA (lncRNA) 1010001N08Rik in hyperoxia-induced bronchopulmonary dysplasia (BPD) and predict the mechanism that 1010001N08Rik might be involved in the occurrence and development of BPD by a series of bioinformatics analysis.Method The sequence,genomic position and structure characteristics of 1010001N08Rik were acquired from UCSC genome browser,and its target gene was predicted by Ensemble database.We successfully established the animal model of BPD by making newborn C57BL/6J mice exposed to 95％ concentrations of ambient oxygen for seven days.The expression of 1010001N08Rik and Gata 6 were detected using real-time quantitative polymerase chain reaction (PCR).Student's t test was used to compare their expression levels during the BPD process.Result The relative expression of 1010001N08Rik in BPD process at d1,d3,d5,d7 was 1.21 ± 0.33,2.02 ± 0.41,2.95 ± 0.45,4.20-± 0.48 respectively,and there were significant difference between adjacent time points (P ＜ 0.05).The relative expression of Gata 6 mRNA was 0.92 ±0.30,1.10 ± 0.31,0.86 ± 0.24,0.45-± 0.08 respectively,and there was significant difference between d5 and d7 (P ＜0.05).1010001N08Rik had highly conserved property among different species.The chromosomal regions of 1010001N08Rik existed transcriptional factors binding locations and epigenetic regulation clues,and its possible candidate target gene was Gata 6.Conclusion The expression of 1010001N08Rik increased during the formation process of BPD.Bioinformatics analysis and preliminary experiment results suggested that 1010001N08Rik might participate in the process of BPD by down-regulating Gata 6 expression.

This study retrospectively reviewed the experimental clinical programs at The First Affiliated Hospital of Nanjing Medical University. Experience was summarized, and methods for improving clinical pharmaceutical research were discussed including recruiting talent people, managing resources and trail results, and establishing international cooperations.