Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome.
China ; Clinical Trials as Topic ; standards ; Cohort Studies ; Endpoint Determination ; Humans ; Research Design ; standards ; Spinal Fusion ; instrumentation

Objective To explore the importance of pre hospital emergency care for patients with hypertensive cerebral hemorrhage.Methods A total of 85 patients with hypertensive cerebral hemorrhage transferred by ambulance were considered as the observation group and 51 patients with hypertensive cerebral hemorrhage transferred by family members were considered as the control group.Patients in observation group were given first aid at the scene,transit and hospital,and patients in control group were given first aid after admission in hospital.Effective transit time,complications,and mortality were compared between the two groups.Results Effective transit time was shorter in observation group than in control group [(0.92±0.17) h vs.(1.31±0.39) h,t=8.05,P＜0.001].The complication incidence was lower in observation group than in control group (14.12％ vs.47.06％,x2 =17.77,P＜0.001).The mortality rate was lower in observation group than in control group (15.29 ％ vs.37.25 ％,x2 =8.54,P ＜ 0.01).Conclusions Pre-hospital emergency care could shorten the effective transit time,reduce the complication incidence and improve the survival rate in patients with hypertensive cerebral hemorrhage

Objective To explore the application and implementation of narrow band imaging (NBI) in fiberscope.Methods NBI color filter in the light source gifted the host machine with NBI function,and the application of DBI technique in fiberscope was implemented with a compatible HD camera.Results NBI technique involved in fiberscope decreased the costs in hospital and departments,relieved patient pain and increased the diagnosis rate.Conclusion NBI technique can be applied to electron mirror and fiberscope,and gains advantages in the future.

In recent years, a rapid development has been achieved in the clinical prevention of hepatocellular carcinoma recurrence after liver transplantation, especially in perioperative management, which are supported by the results of evidence-based studies.However, due to the complicated procedures and varied risk factors for liver transplantation, the prevention of postoperative carcinoma recurrence remains a challenge and a focus of research in liver transplantation.This study reviews the perioperative measures for the prevention of hepatocellular carcinoma recurrence after liver transplantation, aiming to shed some light on this aspect for graduates and clinicians of surgery.

OBJECTIVE: To study the effects of Tangmaikang granules on blood sugar and sugar tolerance in diabetic mice and on the sugar tolerance of normal rats.METHODS: The diabetic mouse model was induced by alloxan,and the effects of different dosage of Tangmaikang granules on blood sugar and sugar tolerance in experimental diabetic mice and on the sugar tolerance of normal rats were observed.RESULTS: Tangmaikang granules(Medium-dose and high-dose) could downregulate the blood sugar level of experimental diabetic mice and inhibited the glucose-induced increase of the blood sugar level,showing significant differences as compared with the model group(P

Pancreatic cancer is a kind of high degree of malignant gastrointestinal tumor,and its incidence has increased significantly in recent years.Due to the low early diagnosis rate,and the extreme low middile or late resection rate of pancreatic cancer,Pancreatic cancer's prognosis is poor.Therefore,improving the early diagnostic rate of pancreatic cancer has very important significance for improving the prognosis.Early diagnosis of pancreatic cancer is dependent on tumor markers detection to a great extent.And proteomics progress rapidly in recent years and has been widely applied in clinical research.It provides an effective way to find markers.Among all of the spec imens,secrum is easy to obtain,and it allows repetitive detection.What is more,secmm is also renewable.So it is the most ideal for biological specimens.In this review,the proteomics technology role in pancreatic cancer patients serum detection were summarized.

How to choose an appropriate experimental design type to arrange research factors and their levels is an important issue in experimental research. Choosing an appropriate design type is directly related to the accuracy and reliability of the research result. When confronting a practical issue, how can researchers choose the most appropriate design type to arrange the experiment based on research objective and specified situation? This article mainly introduces the related contents of the single-group design and the paired design through practical examples.

The general problems existing in the clinical trials of investigational new drugs involve some key aspects such as the guiding principles, research designs, quality controls and statistical analyses. This paper explores the eight general issues in the clinical trials of investigational new drugs and presents precautionary measures with high operability. Research on the clinical trials of investigational new drugs is a complex project, which should be carried out strictly according to the policies, laws, criteria and operating rules set by related agencies. The neglect of research designs and data analyses will lead clinical trials to failure.

Three-factor designs that are unable to examine the interactions include crossover design and Latin square design, which can examine three factors, namely, an experimental factor and two block factors. Although the two design types are not quite frequently used in practical research, an unexpected research effect will be achieved if they are correctly adopted on appropriate occasions. Due to the limit of space, this article introduces two forms of crossover design.