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

Two-factor designs are quite commonly used in scientific research. If the two factors have interactions, research designs like the factorial design and the orthogonal design can be adopted; however, these designs usually require many experiments. If the two factors have no interaction or the interaction is not statistically significant on result in theory and in specialty, and the measuring error of the experimental data under a certain condition (usually it is one of the experimental conditions which is formed by the complete combination of the levels of two factors) is allowed in specialty, researchers can use random block design without repeated experiments, balanced non-complete random block design without repeated experiments, single factor design with a repeatedly measured factor, two-factor design without repeated experiments and two-factor nested design. This article introduced the first three design types with examples.

Objective To investigate the status of metabolic syndrome(MS),chronic metabolic disease and insulin resistance(IR) in dwellers over twenty years old in Wulian County,Shandong province.Method 2 127 dwellers over twenty years old were investigated in three towns with multistage stratified sampling and cross sectional methods.Questionnaire was delivered to all the subjects,while physical examination and biochemical test were carried out.Result The prevalent rate of chronic metabolic diseases in dwellers over twenty years old in Wulian County was 64.34%.The prevalent rate of overweight/obesity,diabetes,hypertension and hyperlipemia were 36.24%,3.24%,38.98% and 31.26,respectively.The prevalence of MS having more than three above diseases was 7.9%.The prevalent rate of IR in obesity,diabetes,hypertension,dyslipidemia and MS patients were 43.34%,78.26%,29.79%,33.23% and 64.28%,respectively.Conclusion Near two-thirds of the dwellers over twenty years old in Wulian suffered chronic metabolic disease.IR was common in MS and chronic metabolic disease,especially in diabetes and MS.

Objective To explore the difference between pressure-regulated volume controlled ventilation (PRVCV) and volume controlled ventilation (VCV) during videothoracoscopic bhb excision.Methods Consecutive 20 patients scheduled to undergo videothoracoscopic bleb excision were enrolled into the study.After induction, endotracheal blocker was advanced into endotracheal tube to establish one-lung ventilation,each patient was randomly assigned to receive successively PRVCV and VCV for 20 minutes.Ventilatory variables were kept constantly(tide volume 6 ml/kg, respiratory rate 15 breaths/min and I: E ratio 1: 2).Heart rate,blood pressure,peak airway pressure and blood gas parameters were compared.Results Peak airway pressure was significantly lower with PRVCV than that with VCV [(12.7±3.6 ) cmH_2O(1 cm H_2O =0.098 kPa) vs (18.2±4.3) cm H_2O,P < 0.01].However,there was no significant difference in arterial oxygen tension,arterlal partial pressure of carbon dioxide,heart rate and blood pressure between PRVCV and VCV.Conclusion During one-lung ventilation in videothoracoscopic bleb excision, PRVCV offers lower peak inspiratory airway pressures while maintaining equal oxygenation compared with VCV.

Objective To study the effect of endotracheal tube's resistance on the respiratory systolic variation test(RSVT).Methods The RSVT,a test to predict fluid responsiveness was performed in 20 patients.The test consisted of the delivery of three congecutive pressure-controlled breaths with incremental peak inspiratory pressures of 10,20 and 30 cm H2O(1 cm H2O=0.098 kPa).The minimal values of the systolic arterial pressure following each of these three breaths were measured and plotted against their respective airway pressures,producing the RSVT slope.RSVT slope were compared between normal airway resistance and increased resistance circumstances,and the latter was simulated by advancing a Cooperdech bronchial blocker into endotracheal tube.Results Under normal resistance,RSVT slope was(0.39±0.21) volumes were(461.5±95.9),(891.5±149.8)and(1207.5±159.1)ml,when peak inspiratory pressures of 10,20 and 30 cm H2O were dehvered.When bronchial blocker was advanced into endotrecheal tube, (0.27±0.17)mm Hg,cm H2O significantly(P<0.01),and tidal volumes decreased to(434.5±92.8), (796.5±96.6)and(1097.5±68.4)ml(P<0.05 or<0.01).Conclusion Changes in endotraeheal tube's resistance can distort the RSVT slope.

Objective To study the effect of humic acid (HA) and soil on dissolution performance of depleted uranium (DU).Methods Using the static dissolve-adsorption experiment and inductively coupled plasma-mass spectrometry(ICP-MS) to determine uranium concentration and 235U/238U isotope ratios of the samples at different time and study the dissolution of DU in water.Results The solubility of DU in water was reduced by 90％ by adding HA.Soil could increase the solubility of DU in water by nearly 25％,adding an appropriate amount of HA could play a supporting role on the dissolution of DU,in this experiment adding 5％ of HA was best.Conclusions Soil and HA could produce positive and negative impact on the solubility of DU in water,and the combined effect of the two relied on the complex absorption and complexation reactions of soil,HA and dissolved uranium ions.

ObjectiveTo observe the dose of methadone and the compliance of patients to the methadone maintenance treatment(MMT).MethodsWe analyzed the status of 69 patients who were addicted to opiate medication and 44 patients who dropped out in our clinic until July 31,2010.ResultsThere was no significant relationship between patients' urine test and the dose.Crime caused the patients who dropped out.The percentage of positive urine did not decline as the dose increased,but the rate of patients who dropped and the number of positive urine test showed a significant correlation( r =0.523 P =0.000).Crime was the main reason that affected the compliance to MMT and caused dropping out.ConclusionThe use of MMT dose should be individualized.

Objective To compare the expression changes of neuropeptide Y (NPY) receptor Y1 in different stages of osteoblast differentiation of rat bone marrow mesenchymal stem cells (BMSCs).Methods The rBMSCs were isolated in vitro from Sprague-Dawley (SD) rats using whole bone marrow adherence method and cultured. Then, the rBMSCs were divided into osteoblast-induced group and noninduced group. In different periods of culture at 1, 2 and 3 weeks, identification of the osteoblasts was performed by using immunocytochemistry and Western blot. Expressions of mRNA and protein of Y1 receptor were detected by real time reserve transcriptase-polymerase chain reaction (RT-PCR) and Western blot. Results RT-PCR demonstrated that osteoblast-induced group had a lower expression of Y1 receptor than non-induced group at the same time point and the expression of Y1 receptor was increased in a time-dependent manner in both groups. Western blot demonstrated higher expression of Y1 receptor in osteoblast-induced group compared with non-induced group at the same time point and a decreased expression of Y1 receptor in a time-dependent manner in both groups. Conclusions During the process of osteoblastic differentiation of rat BMSCs, the expressions of mRNA and protein of NPY Y1 receptor show different trends, when NPY may mediate the inhibition of osteoblastic differentiation of BMSCs through Y1 receptor pathway.

Objective To investigate the effects and mechanism of calcitonin gene-related peptide (CGRP) and substance P (SP) on proliferation of rat bone marrow mesenchymal stem cells. Methods The rBMSCs were isolated using whole bone marrow adherence method. In the different periods of culturing (1, 2,and 3 weeks), expressions of the neuropeptide receptors were detected by Western Blot and reserve transcriptase-polymerase chain reaction (RT-PCR). The BMSCs were treated with CGRP and SP at concentration 10-8 mol/L at different time (1,3,5,7,9 days), cell proliferation was detected with MTT assay, the protein expressions of cyclin D1 ,cyclin E and p53 were examined using Western Blot. Results The CGRP receptor and SP receptor were expressed in BMSCs. The expression of CGRP receptor was statistically higher than that of SP receptorat the same time point. The growth curves of BMSCs cultured by both neuropeptides had similar appearance. CGRP and SP stimulated the proliferation of BMSCs significantly at 9 days and 7 and 9 days. In this process, the expressions of cyclinDl and cyclinE were up-regulated by CGRP, SP only enhanced the expression of cyclinE; these effects all reached a peak at 5 days. The expression of p53 was down-regulated by both neuropeptides. Conclusion CGRP and SP had direct effects on the proliferation of BMSCs, the regulation of cell cycle proteins is one of the mechanisms.

Aim To observe the effects of liver cirrho-sis on the expression of transforming growth factor-β1 ( TGF-β1 ) and ColⅠin rat myocardium and interven-tion of erythropoietin ( EPO ) . Methods Thirty-six male Sprague-Dasley rats were randomly divided into three groups:control group, liver cirrhosis group and EPO group, then the cardic hemodynamic parameters in vivo and levels of serum lactate dehydrogenase ( LDH ) as well as creatine kinase isoenzyme ( CK-MB) were measured. With Masson′s trichrome stain, changes of collagen formation of myocardial tissue in different groups were observed. Also the mRNA ex-pressions of TGF-β1 and ColⅠin myocardium were de-tected by RT-PCR. Results In contrast to control group, rats in liver cirrhosis group showed a decline in systolic and diastolic function of left ventricule, rising myocardial enzyme, a distinct increase of cardiac colla-gen deposition, as well as an elevation of TGF-β1 and ColⅠmRNA expressions. In contrast to liver cirrhosis group, rats in EPO group demonstrated an improve-ment in systolic and diastolic function of left ventricule as well as in cardiac collagen deposition, and a de-crease in both myocardial enzyme and TGF-β1 and ColⅠmRNA expressions. Conclusion Liver cirrhosis can lead to the changes of myocardial structure and function in rats,and it can accelerate myocardial inter-stitial fibrosis; EPO can protect the myocardial injury in liver cirrhosis rats.