In the recent 2 decades,the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based mode,ie,evidence-based medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject,including protocol design,staff training,manual formulating,organization,data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol,the results are reliable and protect the human rights of participants.

BACKGROUND: Stroke-prone spontaneously hypertensive rat(SHRsp) is an animal model of hypertensive stroke commonly used. The species is hard to be maintained due to hypertension and easily affected by environmental factors, therefore the characteristics of stroke are always aberrated.OBJECTIVE: To observe the abilities of reproduction and maintaining the characteristics of hypertensive stroke in SHPsp.DESIGN: Observational controlled study based on rats.SETTING: Cardiovascular Disease Institute and Fuwai Hospital of Chinese Academy of Medical Sciences.MATERIALS: The experiment was conducted Cardiovascular Disease Institute and Fuwai Hospital of Chinese Academy of Medical Sciences during September 1999 to December 2001. Totally 93 pairs(186) strain SHRsp, 48stroke-prone spontaneously hypertensive rats of 8 weeks age as well as 98pairs(196) rats of normal blood pressure [Wistar Kyoto rat (WKY) ] were selected.METHODS: Brother sister mating method was used. And the conception rate, number of litter size(only calculating the litter size of mother rat not eating neonatal rats), rate of eating neonatal rats by mother rats were recorded and compared with those of WKY. The systolic pressure and heart rate of strain rat were measured when they were 12, 16 and 20 weeks old. In addition, 488-week SHRsp were loaded 10 g/L salty water to accelerate the occurrence of stroke and hypertension and executed when they naturally dead or 12 weeks after salty water load. The brain tissue was processed by H-E staining and observed under microscope to detect the incidence of stroke.MAIN OUTCOME MEASURES: Conception rate of female rats within 2years; litter rate of pregnant rats; eating, rate of eating neonatal rats by mother rats; systolic pressure of strain rat; heart rate; detection rate of stroke.RESULTS: Totally 93 pairs(186) strain rats of SHRsp, 98 pairs(196) WKY and 48 SHRsp of 8 weeks old entered the final analysis. In the first year there were 2 generations delivered, the average conception rate( 100% ) and average litter number (10.3 rats) of SHRsp were higher than those of WKY of the same term(90%, P ＜ 0. 001; 6. 5 rats, P ＜ 0. 001) . In the second year, there were 2 generations of which the conception rate and average litter number(89%, 8.2 rats) of SHRsp were higher than those of WKY(59%, P ＜ 0. 001; 4. 3 rats, P ＜ 0. 001). There were 87 SHRsp female rats and 67normal blood pressure rats pregnant within 2 years, the rate of eating neonatal rats within 4 weeks postnatal was 6% (5/87) which was lower than that of WKY(18%, 12/67), P ＞ 0.05. The systolic pressure of 12weeks old male rats and female rats was 191.6-223.8 mm Hg and 174. 2-196. 3 mm Hg respectively, while that of 16-week old and 20-week male rats were 219.0 -224. 9 mm Hg and 232.0 -242.6 mm Hg respectively. The blood pressure of SHRsp increased with the advancing of age. The heart rate of 12-week old male and female rats was 388-428 times per minute and 373-417times/minute respectively while that of 16-week and 20-week male rats were 392 -410 times per minute and 404-425 times per minute respectively. The pathological detection rate of 48 SHRsp was 81% (39/48).CONCLUSION: The reproduction ability of SHRsp is similar to normal rats. The blood pressure, heart rate and pathological examination of brain tissue of them all maintain the characteristics of hypertension and stroke so that they can be used as qualified experimental model.

Objective This study aims to examine expression of Caveolin -1 in non smoking cell lung cancer(NSCLC)and to discusses the relationship between expression of Caveolin -1 and the Epidermal growth factor receptor mutations .Methods Immunohistochemical staining was used to determine the Caveolin -1 ex-pression and ARMS-qPCR was used to measure EGFR mutations in 40 cases of lung cancer tissue .The clinical pathological characteristics and correlations in patients were analyzed .Results The expression of Caveolin -1 in human lung cancer was significantly lower than that in normal lung tissue ,and negatively correlated with EGFR mutations ,which was statistically significant .Conclusion Caveolin -1 expression is negatively correlated with EGFR mutations in non-small cell lung cancer and related to the histologic type .Caveolin-1 may be a molecu-lar target for diagnosis and judgment of NSCLC .

Objective:To preliminarily study the characteristics of ventricular synchronicity in patients of idiopathic pulmonary arterial hypertension (IPAH) with different heart function.
Methods:Our research included in 2 groups:IPAH group, n=40 patients intermittently collected in our hospital from 2010-10 to 2014-12 and Control group, n=23 normal subjects from the same period of time. Tissue Doppler echocardiography was conducted to compare interventricular systolic and diastolic time to peak (Ts and Te), their differences (Te-Ts) and (Te-Ts) of left ventricle (LV), right ventricle (RV), interventricular septum (IVS) between 2 groups.
Results:Ts and Te of RV were longer than Ts and Te of LV and IVS in both groups, P<0.05. Compared with Control group, by heart function reducing, IPAH group showed different Ts and Te of LV and IVS, P<0.05 and Ts was gradually prolonged, Te was gradually shorter;while Te of RV became longer firs tand then became shorter thereafter. In IPAH group, the patients with heart function grade IV had the longer Ts of LV and IVS than those with heart functionII, III;the patients with heart function IV had the shorter Te of LV, RV and IVS than those with heart function II, III, all P<0.05. In IPAH group with different heart function, Te between RV-IVS and RV-LV were different from Control group, all P<0.05;Te between LV-IVS in heart function IV patients had the largest difference from Control group, P<0.05. Compared with Control group, IPAH group had gradually decreased Te-Ts of LV and IVS by heart function reducing asgrade II>III>IV, all differences had statistic meaning.
Conclusion:IPAH patients with different right heart function may have interventricular systolic and diastolic de-synchronicity;by reduced heart function, interventricular Te-Ts could be specifically shortened.

Objective To observe the effect of somatosensory interactive technology of Kinect on post-stroke depression (PSD). Methods 60 patients with PSD were divided into control group (n=30) and experimental group (n=30), who accepted routine rehabilitation and Kinect in addition, respectively. They were assessed with Zung's Self-rating Depression Scale (SDS) before and 4 weeks after intervention. Results The scores of SDS was (43.25±10.11) in the experimental group, which was less than that in the control group (55.67±8.80) after intervention (P<0.01). Conclusion Rehabilitation with somatosensory interactive technology of Kinect may improve the efficiency on PSD.

OBJECTIVETo explore the effect of Zhenqing Recipe (ZQR) on renal structure and expressions of matrix metalloproteinase-9 (MMP-9), tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) in experimental type 2 diabetic rats.

METHODSThe rat models of type 2 diabetic were set up by intraperitoneally giving small-dose streptozotocin (STZ) after fed with high carbohydrate and high fat diets for one month. The model rats were randomly divided into the model group,the high and low dose ZQR-treated groups,and the enalapril-treated group; a normal control group was also established. The course of treatment continued 8 weeks. The expressions of MMP-9, TIMP-1, and fibronectin (FN) in renal tissues were detected by immunohistochemistry. The morphological changes of glomeruli and renal tubules were checked by microscopy.

RESULTSCompared with the normal control group, the expression of TIMP-1 and FN increased and MMP-9 decreased in the model group; the treated groups could decrease the expressions of TIMP-1 and FN, and increase the expression of MMP-9, especially the high-dose ZQR group had the best effect. The morphological changes of renal tubules and glomerulus in the treated groups were improved better as compared with the model group.

CONCLUSIONThe protective effect of ZQR on renal structure may be achieved by modulating the expressions of MMP-1 and TIMP-1.

Animals ; Diabetes Mellitus, Experimental ; enzymology ; metabolism ; prevention & control ; Diabetes Mellitus, Type 2 ; enzymology ; metabolism ; prevention & control ; Drugs, Chinese Herbal ; pharmacology ; Fibronectins ; metabolism ; Kidney ; metabolism ; Matrix Metalloproteinase 9 ; metabolism ; Protective Agents ; pharmacology ; Rats ; Tissue Inhibitor of Metalloproteinase-1 ; metabolism

OBJECTIVETo study the effects of Zhenqing Recipe (ZQR) and earthworm on the expressions of transforming growth factor-beta1 (TGF-beta1) and plasminogen activator inhibitor-1 (PAI-1) in renal tissues of type 2 diabetes mellitus (T2DM) rats.

METHODSThe T2DM model rats induced by high sucrose/fat feeding and low dose streptozotocin injecting were randomly divided into the model group, the ZQR group, and the earthworm group. A normal control group was also set up. ZQR extract was given at the daily dose of 24 g/kg body weight by gastrogavage to rats in the ZQR group. The earthworm extract was given at the daily dose of 2.6 g/kg body weight by gastrogavage to rats in the earthworm group. Equal volume of distilled water was given to rats in the normal control group and the model group by gastrogavage. The medication was once daily for 8 successive weeks. The fasting blood glucose (FBG), serum PAI-1, 24-h urinary albumin excretion (UAE), and endogenous creatinine clearance rate (CCr) were detected. The structural changes of renal tissues stained with Periodic Acid-Schiff were observed by light microscope. The expressions of TGF-beta1 and PAI-1 were analyzed by immunohistochemistry. And the mRNA and protein expressions of TGF-beta1 and PAI-1 in the renal cortex were detected by Real-time PCR and Western blot respectively.

RESULTSCompared with the normal control group, the FBG, serum PAI-1, UAE, the mRNA and protein expressions of TGF-beta1, and PAI-1 significantly increased in the model group, and CCr obviously decreased (P<0.01). Compared with the model group, FBG, serum PAI-1, UAE obviously decreased (P<0.01) and CCr obviously increased (P<0.05) in the ZQR group. FBG was not obviously lowered in the earthworm group. The serum PAI-1 and UAE both decreased obviously (P<0.05, P<0.01) and CCr increased (P<0.05) in the earthworm group. The effects of ZQR were superior to the earthworm. The renal pathological changes got improved in the ZQR group and the earthworm group. The mRNA and protein expressions of TGF-beta1 and PAI-1 significantly decreased in the ZQR group and the earthworm group, especially in the ZQR group.

CONCLUSIONSEarly application of ZQR and earthworm in treatment of T2DM rats with nephropathy was effective in protecting the kidney. Its mechanism may possibly be correlated with inhibition of TGF-beta1 expression, resulting in down-regulation of PAI-1 expression. ZQR showed better effects than earthworm.

Animals ; Diabetes Mellitus, Experimental ; metabolism ; Diabetes Mellitus, Type 2 ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; Kidney ; drug effects ; metabolism ; Male ; Oligochaeta ; Plasminogen Activator Inhibitor 1 ; metabolism ; Rats ; Rats, Wistar ; Transforming Growth Factor beta1 ; metabolism

Objective To investigate the correlation between the degree of liver fibrosis and Aspartate aminotransferase-to-Platelet Ratio Index ( APRI ) in children with biliary atresia ( BA ) , and evaluate the clinical significance of liver fibrosis in biliary atresia.Methods A total of 97 patients with diagnosed BA were recruited between January 2010 and June 2013.AST, PLT and APRI were determined one week before laparotomy.The severity of hepatic tibrosis was.Judged by Metavir system the correlation among AST, PLT, APRI and severity of liver fibrosis were evaluated, and their diagnostic value for degree of liver fibrosis was analyzed by ROC.Results Sera AST levels and PLT counts of BA patients were found to be positively(r=0.367, P<0.01) and negatively(r=-0.403, P<0.01) correlated with Metavir scores of liver fibrosis, respectively.There existed positive correlation between APRI and the severity of hepatic fibrosis (r=0.541, P<0.01).The area under ROC curve of APRI to diagnose none or mild fibrosis and moderately severe fibrosis was 0.78, with sensitivity of 77.9%and specificity of 62.1%at the optimal cut-off value of 0.75; the area under ROC curve of APRI to diagnose moderately severe fibrosis with liver cirrhosis arrived 0.85, with sensitivity of 75.0% and specificity of 89.4% at the optimal cut-off value of 1.77.The accuracy of none or mild fibrosis, moderate fibrosis and cirrhosis diagnosed by APRI were 73.2%, 64.9%, 87.6%, respectively.Conclusion APRI can be used as a non-invasive parameter to assess the severity of hepatic fibrosis with BA.

Objective:To investigate the assisted pregnancy clinical effect of autologous peripheral blood mononuclear cells (PBMCs) combined with low molecular weight heparin (LMWH) on patients with intrauterine adhesion separation.Methods:Nine patients with intrauterine adhesion separation were treated with intrauterine perfusion of PBMCs 48 hours before transplantation. The low molecular weight heparin 3 200 IU injected daily subcutaneously were carried out on the day of transplantation. Measurement of endometrial thickness and observation of pregnant outcome were perfomed.Results:After 9 patients were injected into the uterine cavity with autologous PBMCs. It was found that, compared to the previous, the thickness of the endometrium was increased, and the morphology of the endometrium was improved in 6 cases. After transplantation, 7 cases of the patients were clinically pregnant, 1 of the patients was biochemically pregnant, and 1 of the patients was not pregnant; among the 7 clinical pregnancy cases, 1 case was intrauterine compound pregnancy (operation on the affected side of fallopian tube pregnancy had been performed), another 2 cases had embryo termination at the 7-8th week of gestation by B-scan ultrasonography analysis. However, 3 cases of clinical pregnancy in 4 patients with repeated implantation failure. At present, 2 cases were in live labor, and the other three cases were in normal continuous pregnancy.Conclusions:Intrauterine perfusion of human PBMCs combined with low molecular weight heparin is beneficial to the improvement of endometrial receptivity and the pregnancy outcome of some patients after the separation of intrauterine adhesions.

This study was designed to detect the impact of Valerian Ligusticum Pill (VLP) on cerebral ischemia reperfusion injury in rats, and explore the mechanism of angiogenesis. Sixty SD male rats were randomly divided into five groups, including sham operation group, model group, VLP-low (30mg·kg^-1) group, VLP-high (50mg·kg^-1) group and nimodipine (10mg·kg^-1) group. The ischemia reperfusion injury model was induced by occlusion of middle cerebral artery with suture embolus, reperfusion after 30 minutes' ischemia. When the rats were awake, the first neurological function scores was determined with modified neurological severity score (mNSS). The rats were given VLP (30mg·kg^-1, 50mg·kg^-1) and nimodipine (10mg·kg^-1) through intragastric administration at 2 mL, once a day for a total of 7 days, while an equal amount of distilled water was used in the sham operation group and model control group. After 7 days, the rats were given second neurological function scores, and improvement of neurological function=[the first score]-[the second score]. The rats were sacrificed to investigate the infarction volume percentage with 2,3,5-triphenyl tetrazolium chloride method; do the qualitative and half quantitative analyses for protein vascular endothelial growth factor receptor 2 (VEGFR2) in the tissue of cortex infarction around by Western blot; detect the new blood vessels of cortex infarction around by ki67/lectin immunofluorescence double staining method. Results suggest that VLP could significantly improve the neurological function, reduce the percentage of infarct volume, increase the expression of VEGFR2 and number of new blood vessels in the cortex infarction around compared with model group. In conclusion, VLP may relive the acute cerebral ischemia reperfusion injury in rats by inducing angiogenesis.