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 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.

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.

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.

Objective To analyze the changes of schistosomiasis endemic situation in Anhui Province from 2004 to 2014, so as to provide the evidence for formulating“The thirteenth five year”schistosomiasis control plan. Methods The information for schistosomiasis control and the data of the endemic surveillance of schistosomiasis were collected and analyzed for the chang?es of schistosomiasis endemic situation in Anhui Province from 2004 to 2014. Results The Oncomelania hupensis snail areas presented on a rising trend,and reached to the largest area with about 3.1 billon m2 in 2011. However,the snail areas decreased from 2012,and reduced by 10.55%in 2012 compared with the areas in 2011,and reduced to the lowest level in 2014 in recent 10 years. The density of living snails presented a fluctuation situation from 2004 to 2008,and on a decreasing trend from 2008, and the density of living snails was below 1 snail/0.1 m2 after 2011. The infection rate of snails remained stagnant state from 2004 to 2011,and decreased rapidly in 2012,and no schistosome infected snails were found in 2013 and 2014. The schistosome in?fection rate of residents decreased gradually,and the number of acute schistosomiasis was under 50 cases with scattered distribu?tion after 2006,and no acute cases occurred in 2013 and 2014. The infection rate of livestock was above 1%from 2004 to 2011, and reduced to 0.55%in 2012,and it was the first time that the infection rate of livestock was lower than that of residents in the same year in 2014. The progress for achieving the goal of schistosomiasis transmission control accelerated after 2011,and the number of counties that reached the standard of schistosomiasis transmission controlled from 2012 to 2014 was 4,9 and 14 and the number of townships was 33,76 and 32,respectively. Conclusion Schistosomiasis control has achieved remarkable effec?tiveness in Anhui Province,but there still exists hard work to consolidate the achievement and reach schistosomiasis transmis?sion interrupted.

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.

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.

This study aimed to analyze the effect of the external method of tonifying kidney and promoting blood circulation on endometrial morphology of rats with kidney deficiency and blood stasis model. A total of 50 normal healthy unmated female SD rats of proestrus were selected with vaginal smear. Rats were randomly divided into the blank group, model group, high dose group and low dose group with the prescription of tonifying kidney and promoting blood circulation and theWu-Zi (WZ) group. Except the blank group, intragastric administration of hydroxyurea was given to other group to establish the kidney deficiency model. Meanwhile, clyster of distilled water was given to the blank group and the model group. And clyster of high dose and low dose prescription of tonifying kidney and promoting blood circulation was given to the high dose and low dose group, respectively. The intragastric administrations ofWu-Zi Yan-Zong(WZYZ) pills were given to theWu-Zi (WZ) group. On the 4th day of pregnancy, 10% of the macromolecule dextran was quickly injected to the caudal vein to induce blood stasis model 1 hour after the last medication administration. The uterus tissue section was observed by HE dyeing. The results showed that the thickness of covering epithelium of endometrium in the model group was lower than the blank group (P < 0.05). There were significant differences on the thickness of covering epithelium of endometrium in the high dose group and low dose group with the prescription of tonifying kidney and promoting blood circulation, the WZ group and the model group (P < 0.01). The sum of gland number and gland area as well as the maximum diameter / minimum diameter of the model group was significantly lower than that of the blank group (P< 0.05, orP < 0.01). The shape factor was the closest to “1”, which had significant difference compared with the blank group (P < 0.01). Compared with the model group, the sum of gland number and glandular lumen of the high dose and low dose group were increased at different levels (P < 0.05, orP < 0.01). The sum of gland number, glandular lumen area, shape factor, and maximum diameter / minimum diameter of WZ group had significant difference compared with the model group (P < 0.05, orP < 0.01). The sum of interstitial cells’ nucleus area, integral optical density of interstitial cells’ nucleus and number of interstitial blood vessels in the high dose and low dose group were significantly higher compared to the model group (P < 0.05, orP < 0.01). The sum of interstitial cells’ nucleus area and the integral optical density of interstitial cells’ nucleus in the WZ group were obviously higher than the model group (P < 0.01). It was concluded that the external method of tonifying kidney and promoting blood circulation can effectively improve the endometrial morphology of kidney-deficiency and blood-stasis rat model, promote the synchronous development of endometrial gland and stroma, in order to play a role to improve the endometrial receptivity.