OBJECTIVE:To provide reference for the standardization of the instructions of felodipine.METHODS:The instructions of felodipine in China were compared with the national regulation as well as foreign instructions of felodipine.The problems of Chinese instructions of felodipine were analyzed to put forward revision measures.RESULTS & CONCLUSIONS:The problems of Chinese instructions of felodipine are items shortage or missing,lacking of warnings for drug safety.It is suggested that related administration departments and enterprises should revise and improve the instructions of felodipine.

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

OBJECTIVE: To probe into the regularity of drug consumption and to provide evidence for drug price control.METHODS: The actual purchase price,selling price,consumption sum and consumption quantity of all the drugs used in our hospital from 2003 to 2007 were taken as primary data to analyze the variation of drug price and consumption sum as well as the effect of the factor of drug price variation on drug consumption.RESULTS: The price fluctuation has big impact on the drug consumption,especially on the application structure of drugs characterized by the disappearance of the low price drugs from the market and substituting them with the "new drugs" which were prepared by altering dosage form,specification,package or brand name.CONCLUSION: It is advisable to adopt comprehensive measures rather than simple price reduction policy to control the artificial high price of drugs.

Objective To characterize the CT and MRI features of Osgood-Schlatter disease (OSD),and explore the feasibility of staging OSD by using CT and MRI.Methods The imaging data of the 27 cases with OSD were retrospectively analyzed,and fea-tures of MRI and CT were characterized.Results All 27 cases with OSD were featured with different extent of edema within the pa-tellar tendon.The portion already exhibited edema in the secondary ossification center in 5 cases,which showed high signal intensity on the T2 WI.There were 1 5 cases which exhibited ossified or tears in the secondary ossification center,and 5 of them were featured with opened shell-like separation on sagittal radiograph.Seven cases had isolated solitary ossicles located at the lower part of the pa-tellar ligament,which is also thickening.Among the 7 cases,one showed hypertrophy in the tibial tuberosity.Three cases examined with CT scan,exhibited ossified nodules located at the lower part of the patellar ligament.Conclusion OSD has characteristic CT and MRI features,and MRI scan is an important imaging method to show edema and morphological changes of patellar tendon in OSD,which could help to identify the stage of OSD and predict the prognosis.

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 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.

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.

The finite element method was used for simulating the mechanical performance and fatigue safety of three different structures of Nitinol stent. According to the actual situation, after proposing reasonable assumptions and simplification, the geometry model and finite element model establishment, material mode selection and boundary condition setting are completed. The strain and fatigue life of different stent edges wide (omega) or strut angle (theta) are computed. The result can provide a valuable reference for the optimal design of stent.
Alloys ; Finite Element Analysis ; Prosthesis Design ; Stents

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.

In this study,we summarized the results from the retrospective investigation on endemic situation of schistosomia-sis that was implemented in nine provinces(autonomous region),China in 2009,demonstrated the role of these retrospective in-vestigations in accelerating the progress of schistosomiasis control in China,and clarified the great significance of the investiga-tion for summarizing the experiences for the control of schistosomiasis,and analyzing the changing patterns and affecting factors of endemic status of schistosomiasis in China. In addition,these retrospective investigations provide reliable evidence for revis-ing the Criteria of Schistosomiasis Control and Elimination,and for the more accurate and scientific assessment of the effec-tiveness of schistosomiasis control in China.