The time-to-event index is a kind of common evaluation index. It measures the speed of intervention effect. It is different from other index in research design, source material filling, data checking and statistical analysis. To obtain the time-to-event index, investigators can fill in the table directly and statistical analyst can compute after clinical observation. When filling in the source material or data checking, it is should be noticed that the logical relation between the time-to-event index and the visiting point and between the time-to-event index and the correlative other indicator. When statistical analyzing, it is an important issue how to deal with the cases whose time-to-event index does not appear till the observation period ends. Understanding the difference clearly can make the time-to-event index evaluate the effect of the intervention truly and make the clinical observation results reliable.
Clinical Trials as Topic ; Female ; Humans ; Male ; Observational Studies as Topic ; Research ; Research Design

Objective T_O analyze the electrophysiological features of shoulder-hand syndrome(SHS)fol- lowing stroke and investigate the relationships between peripheral nerve damage and the factors causing SHS.Meth- ods Fifty-eight stroke patients were divided into an SHS group(39 patients with shoulder-hand syndrome)and a model group(19 patients without shoulder-hand syndrome).Standard sensory and motor nerve conduction studies were performed with 58 of the patients,including sensory nerve conduction velocity(SCV),amplitude of the sensory nerve action potential(SNAP),distal motor latency(DMI)and the amplitude of the compound muscle action poten- tial(CMAP)of the median nerve.A needle electromyogram(EMG)test was performed on the abductor pollicis of the affected side with both groups.Results The needle EMG showed abnormal insertion potential,fibrillation po- tential and positive sharp waves in all 39 cases of the SHS group,which was significantly higher than in the model group.The amplitude of the sensory nerve action potential(7.77?4.34 mV)and the amplitude of the compound muscle action potential(10.13?3.15 mV)were significantly lower than those of the model group.Abnormal ampli- tude was more severe in sensory nerves than in motor nerves.Conclusion Peripheral nerve damage was found in the shoulder-hand syndrome patients,and this damage was mainly the dystrophy of axonal neuropathy.The damage severity was more in sensory nerves than in motor nerves.The study could offer an useful clue of prevention and treat- ment of shoulder-hand syndrome.

Apnea ; epidemiology ; pathology ; therapy ; Birth Weight ; China ; epidemiology ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Infant, Very Low Birth Weight ; Male ; Risk Factors ; Time Factors

Humans ; Hyperthyroidism ; Infant, Newborn

Chondrodysplasia Punctata ; congenital ; Humans ; Infant, Newborn ; Male

ObjectiveTo understand the status and requirement of the clinical researchers in Guang’anmen Hospital of China Academy of Chinese Medical Sciences (hereinafter referred to as Guang’anmen Hospital).MethodsSelf-filling questionnaire was used. All medical care personnel in the clinical specialty with the GCP qualification were set as respondents. The three aspects of recognition degree of clinical trials quality, initiative of participation and knowledge demand for GCP were investigated. Data were analyzed through SPSS11.5.Results 95.6% of clinical researchers considered that the course of clinical trial was legal;89.9% of clinical researchers believed that the quality of clinical trial was good. Most clinical researchers participated in the clinical trials actively (86.9%) and they considered that the trials were helpful for them to enhance research ability and to issue paper.Conclusion Clinical researchers are familiar with GCP knowledge and can participate in the clinical trials actively. They still expect to learn more.

Objective To analyze the central effect of Qi-Yin Deficiency Syndrome (QYDS) scoring in clinical trials of diabetes.Methods Dispensation degree analysis and multiple linear regression analysis were adopted to compare the differences of central effects among the Qi-Yin deficiency syndrome scoring,fasting plasma glucose (FPG) level and 2-hour postprandial blood sugar (2 hPG)level before and after treatment in the suited databases from two phase Ⅲclinical trials of type two diabetes performed in 2004～2005.Results The variation coefficients of QYDS scoring treated with drug A and drug B varied from one tenth to half times of those of FPG and 2 hPG levels before and after treatment.And the influence of centers on QYDS is weaker than those on blood sugar levels (FPG &2 hPG) either referring to the numbers of significant centers or referring to the absolute values of standard regression coefficients in multiple linear regression equation.Conclusion There exists a central effect in QYDS scoring before and after treatment,and the central effect of QYDS scoring is weaker than that of blood sugar levels (FPG &2 hPG) in clinical trials of diabetes.

The liver is an important organ of the body,with an extraordinary capacity for responding to physical or chemical injuries by regenerating. The mechanisms behind liver regeneration are very complicated as hundreds of substances are involved.However,most of them are not liver-specific,such as HGF,EGF etc. We recently isolated a pure protein with hepatic stimulatory activity from the extract of a weanling calf liver and named its hepatopoietin Cn (HPPCn).This paper,with reference to our own work, mainly reviews the development and bioactivity about hepatic stimulator substance(HSS),augmenter of liver regeneration(ALR),hepassocin(HPS) and HPPCn,which are liver-specific biologically active peptides.

This paper intends to explore a method which can arouse the students'interests,improve their study efficiency and develop their creativity by applying the delightful teaching mode during the pharmacology teaching in medical vocational colleges.When applying the de-lightful teaching mode,it is important for us to take advantage of different delightful materials,use various flexible teaching skills and emphasize the attractive education,and only in this way can we obtain good results.

Objective To study the effect of fusion protein FADDDEL-GFP in the treatment of type 1 diabetes by murine islet cell transplantion.Methods After transfecting the recombinate FADDDEL-GFP into mouse insulinoma cells NIT-1,insulin level secreted by the cells was examined.Type 1 diabetes was induced by STZ as animal model.NIT-fg cells,the NIT-1 cells modified by FADDDEL-GFP,were transplanted into the diabetic mice.Then the effects of islet cell transplantation on diabetic mice were checked.Results GFP was expressed in NIT-1 cells transfected with FADDDEL-GFP.Diabetic mice reached normoglycemia and prolonged the life span,which was obviously different from the control group.Conclusion FADDDEL-GFP may enhance the capability of resisting allogeneic transplantation rejection.