Good clinical practice should be based on evidence. Evidence quality should be based on critical appraisal in evidence based medicine (EBM). Evaluation of evidence quality plays an important role in evidence level clarifying, which is the core of EBM. Different recommendations for clinical practice often derive from evidence levels. Thus evidence quality evaluation is the first and most important step in EBM. There are lots of standards to evaluate evidence quality in the world. However there are two aspects of the evaluation, one is methodological evaluation and the other is reporting evaluation. This article collected a series of standards for clinical trials quality evaluation according to different research designs. It is hoped that the resource and introduction about the quality evaluation of clinical trials be helpful for medical researchers in China. Only being familiar with all kinds of standards of methodology and reporting, researchers could publish high quality scientific papers.
Biomedical Research ; Evidence-Based Medicine ; Guidelines as Topic ; Humans ; Meta-Analysis as Topic ; Randomized Controlled Trials as Topic

OBJECTIVEObserve and analyze the informations of western medicine and traditional Chinese medicine in patients with coronary heart disease (CHD), in order to provide reference for clinical treatment.

METHODSelect patients with CHD in diagnosis of the first place in 17 hospitals, drug informations of these patients were analyzed using frequency method and association rules.

RESULTIn 84 697 patients,there were 47 564 males and 32 882 females. The median age was 71 years old, 76 172 patients have medicine records, including 278 kinds of western medicine and 331 kinds of traditional Chinese medicine. Aspirin was the most common used western medicine (51 132 patients, 67.08%), followed by isosorbide dinitrate, clopidogrel etc. The most common used traditional Chinese medicine was danhong injection, followed by shuxuetong injection. After classified the drugs, at the forefront of western medicine were antiplatelet drugs, nitrates drugs, statins, beta blockers, calcium antagonists, ACEI; the most used in traditional Chinese medicine was injection of blood-activating and stasis-resolving, followed by oral preparations of blood-activating and stasis-resolving medicine, Fuzheng class oral medicine, purgation medicine etc. After association rules, combination therapy among western medicine was the most common, combination of western medicine with blood-activating and stasis-resolving was very commonly, especially antiplatelet drugs and nitrates drugs.

CONCLUSIONWestern medicine in the treatment of patients with CHD was in accordance with the guidelines recommend, but with the lower utilization rate. Traditional Chinese medicine has become an important method for the treatment of CHD, promoting blood circulation and removing blood stasis is an important part of traditional Chinese medicine treatment in patients with CHD.

Adrenergic beta-Antagonists ; therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Animals ; Aspirin ; therapeutic use ; Combined Modality Therapy ; Coronary Disease ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; therapeutic use ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Nitrates ; therapeutic use ; Platelet Aggregation Inhibitors ; therapeutic use

Objective To investigate the prevalence of subclinical hypothyroidism and its relation to serum total cholesterol (TC),triglyceride (TG) levels and non-alcoholic fatty liver.Methods Serum levels of TC,TG, TSH,TT_3 and TT_4 were determined in 1 602 subjects which were divided into groups by sex and age (20-39,40- 59 and≥60 years).Fatty liver was diagnosed by type B ultrasonography.Restults ( 1 ) Prevalence of subclinical hypothyroidism was 6.6% in this population.(2) The mean levels of serum TC and TG in subclinical hypothyroidism group and normal group showed no significant difference ( both P＞0.05 ).(3) On the whole,the prevalences of subclinical hypothyroidism in hypercholesterolemia group and normal cholesterolemia group showed significant difference (P＜0.01 ).(4) In the three age groups of male and few.ale examinees,the prevalences of subclinical hypothyroidism in hypercholesterulemla group and normal cholesterolemia group showed no significant difference ( all P＞0.05 ).In the multiple regression analysis,TSH level was not related with raised TC level.(5) In the three age groups of male,there was no significant difference between the prevalences of subclinical hypothyroidism in hypertriglyceridemla group and normal triglyceridemia group ( all P＞0.05 ).In female,expect for the elderly group (＞60 years old ),the prevalence of subclinical hypothyroidism was higher in hypertriglyceridemia group than that in normal triglyceridemia.However,in the multiple regression analysis, increased TSH level was positively associated with increased serum TG level ( OR = 1.072,P=0.013 and OR = 1.102,P = 0.03 ).(6) The prevalence of subclinical hypothyroidism in non-alcobolic fatty liver group and normal group showed no significant difference ( P＞0.05 ).In the multiple regression analysis,TSH level was not the independent risk factor of non-alcoholic fatty liver (P＞0.05 ).Conclusion Subclinical hypothyroidism is not asseciated with serum TC level but positively associated with serum TG level.Subclinical hypothyroidism does not apparently increase the prevalence of non-alcoholic fatty liver.

Objective To verify whether the storage bag can reach the use requirement of cord blood freezing storage by conduc-ting a series of tests before staring use of new type cryopreservation bag for cord blood.Methods According to the standard opera-tion procedure,28 new type cryopreservation bags were extracted.The cord blood units were performed the cryostorage and thaw for rewarming according to the standard operating procedures.Then the physical integrity and various quality indicators of cord blood in bag were detected,including the nucleated cell viability,cell recovery rate,CD34-positive cell,colony-forming cultivation of stem cells,sterility test and verification of actual load volume.Results All the tested storage bags passed the integrity test,and the various testing indicators of the preserved cells conformed to the use requirements.Conclusion The new type storage bag has the same performance and effect to original bag,it is verified that the maximum loading volume of 50 mL(for 50 mL specification of storage bag)and 80mL(for 250mL specification of storage bag)is safe.

OBJECTIVETo investigate the estrogenic activity of icariin and genistein with estrogen-dependent human breast cancer (MCF-7) cells.

METHODMCF-7 cells were incubated with media containing 5% charcoal dextran-treated FBS in phenol red-free media for 48 h. CCK-8 kit was used to study the impact of defferent concentration of icariin and genistein on MCF-7 proliferation in vitro. Optimal concentration icariin and genistein were added into medium and total RNA was isolated after 12, 24, 36, 48 h. The gene expression of ERalpha, ERbeta, PS2, and PR were investigated by Real-time RT-PCR Total protein was also isolated and secretion of ERalpha, ERbeta, PS2, and PR were examined by Western blot.

RESULT10 micromol x L(-1) icariin and genistein could promote the proliferation of MCF-7 evidently. However, the ability of genistein to promote the proliferation was better than icariin. With the concentration of 10 micromol x L(-1), genistein group had a stronger expression of ERa, PS2 and PR mRNA levels than icariin while ERbetaexpression had no significant difference in two group. The same effects were detected by western blotting.

CONCLUSIONBoth genistein and icariin have a strong estrogen-like effect, but the estrogenic activity of genistein is stronger than icariin. It showed that the activity of icariin is stron-ger than genistein to promote ROB maturation. So it must be that icariin promotes the maturation of osteoblasts in vitro by a estogen-independent mechanism.

Cell Proliferation ; drug effects ; Estrogen Receptor alpha ; genetics ; metabolism ; Estrogen Receptor beta ; genetics ; metabolism ; Estrogens ; pharmacology ; Flavonoids ; pharmacology ; Gene Expression Regulation ; drug effects ; Genistein ; pharmacology ; Humans ; MCF-7 Cells ; Osteoblasts ; cytology ; drug effects ; metabolism ; Presenilin-2 ; metabolism

In order to understand the clinical characteristics of patients with coronary heart disease (CHD) in real world and provide reference for clinical prevention and treatment, this study analyzed informations of patient with CHD in hospital information system. Data from 17 national hospitals were collected. Select patients with coronaryheart disease in diagnosis of the first place in 17 hospitals, general informations and traditional Chinese medicine (TCM) syndrome, complications, medicine were analyzed using frequency method and association rules. This study included 84 697 patients with CHD, the majority of men and in the elderly. The average age of patients was 71 years. The proportion of men to women was about 1. 45: 1. Hospital stay time ranged from 8 to 14 d. The most common total hospitalization cost distribution was 5 000-20 000 RMB. Young patients have a rising trend year by year. The death of patients increased with increasing age. Common complications were hypertension, diabetes, cerebral infarction and hyperlipidemia, 57.24 percent of the CHD patient complicated with hypertension, 21.94 percent patients complicated with diabetes. Among TCM syndrome types, Qi-Yin deficiency and qi deficiency blood stasis were the most common syndromes. Blood stasis was the highest syndrome elements, accounted for 79.97%, followed by Qi deficiency, phlegm, Yin deficiency, and so on. The most common western medicine was aspirin, followed with isosorbide dinitrate, clopidogrel. The most common used traditional Chinese medicine was danhong injection, followed by shuxuetong injection. Combined with removing blood stasis drugs has been more common at present clinical treatment, there were 43.46 percent of patients combined with anti-platelet western drug and injection of removing blood stasis.
Adult ; Aged ; Aged, 80 and over ; Aspirin ; therapeutic use ; Coronary Disease ; complications ; drug therapy ; epidemiology ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Isosorbide Dinitrate ; therapeutic use ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Ticlopidine ; analogs & derivatives ; therapeutic use

OBJECTIVETo establish osteoblast model, primary cilla model was removed by chloral hyrate, observe effects of osteoblast primary cilla moved on enhancing ALP staining and calcified nodules staining in electromagnetic field.

METHODSThree 3-day-old male SD rats weighed between 6 and 9 g were killed, cranial osteoblast was drawed and adherencing cultured respectively. Cells were subcultured and randomly divided into 4 groups until reach to fusion states. The four groups included chloral hydrate non-involved group (control group), 2 mM, 4 mM and 8 mM chloral hydrate group, and cultured in 37 °C, 5% CO2 incubator for 72 h. Morphology of primary cilla was observed by laser confocal scanning microscope, and incidence of osteoblast primary cilia was analyzed by Image-Pro Plus 6.0 software. Cells in the correct concentration group which can removed cillia most effectively were selected and divided into 3 groups, including control group (C), Electromagnetic fields group (EMFs), and EMFs with 4 mM chloral hydrate group. DMEM nutrient solution contained 10%FBS were added into three groups and cultured for 9 days and formation of ALP were observed by histochemical staining of alkaline phosphatase. After 12 days' cultivation, formation of mineralization nodes was observed by alizarin red staining.

RESULTSCompared with control group and 2mM chloral hydrate group,4 mM chloral hydrate group could effectively remove osteoblast primary cilla (P<0.01). Removal of osteoblast primary cilla could weaken the formation of ALP and mineralization nodes in osteoblast in EMFS. Compared with EMFs group, the area of ALP and mineralization nodes in EMFs with 4 mM chloral hydrate group were decreased obviously (P<0.01).

CONCLUSION4mM chloral hydrate could effectively remove osteoblast primary cilia. Primary cilla participate in EMFs promoting formation of ALP and mineralization nodes in osteoblast and provide new ideas for exploring mechanism of EMFs promoting osteoblast maturation and mineralization.

Alkaline Phosphatase ; metabolism ; Animals ; Cell Culture Techniques ; instrumentation ; methods ; Cells, Cultured ; Chloral Hydrate ; pharmacology ; Cilia ; drug effects ; enzymology ; physiology ; Male ; Osteoblasts ; cytology ; enzymology ; Rats ; Rats, Sprague-Dawley

ObjectiveTo investigate the histological features as well as the factors influencing liver disease progression in Chinese patients with chronic hepatitis C (CHC). MethodsA total of 102 CHC patients who underwent percutaneous liver biopsy between August 2007 and May 2010 were recruited. Age, gender, body mass index (BMI) and transmission route of recruited patients were recorded. Serum levels of alanine transaminase (ALT) and aspartate transaminase (AST), HCV genotypes, HCV viral load and liver histological changes were detected. Statistical analysis was done by t test and Logistic regression. ResultsThe serum levels of ALT and AST in CHC patients with histological activity index (HAI) ≥4 were much higher, while platelet (PLT) counts were lower than those with HAI ＜4(t=2.209, 2. 298 and 2. 565, respectively; all P＜0.05). Likewise, in patients with F≥3, the serum levels of ALT and AST as well as the mean age and the duration of infection were significantly elevated compared with F ＜ 3 group ( t = 3.497, 2. 758, 2. 340 and 2. 570,respectively; all P＜0. 05), while PLT counts were much lower (t = 2. 761, P=0. 007). The unvariate predictors for HAI≥4 were female, ALT＞1 × upper limits of normal (ULN), AST level,F≥3, HCV RNA≥6 lgIU/mL and PLT counts. By mutivariate analysis, the Ishak stage score was the only independent predictor for HAI≥4 (OR 3.098, 95％CI 1.884-5. 092; P＜0.01). Finally,the univariate predictors for F≥3 were age, BMI≥24 kg/m2 , ALT＞1 × ULN, AST level, HAI≥4,PLT counts and duration of infection≥ 15 years. Multivariate analysis revealed that age (OR 1. 074,95％CI 1.006-1. 146; P=0.033), ALT level (OR 1. 035, 95％CI 1.015－1.055; P＜0.01), ASTlevel (OR 0. 969, 95％CI 0. 948－0. 990; P=0. 005), the duration of infection ≥15 years (OR 37. 215, 95％CI 5. 816－238. 127; P＜0.01) and HAI≥4 (OR 1. 939, 95％CI 1. 426－2. 636; P＜0.01) were independent predictors for F≥ 3. ConclusionAge, ALT level, AST level, duration of infection≥15 years, HAI≥4 are independent predictors for liver fibrosis.

OBJECTIVETo investigate the expressions of matrix metalloprotein-2 (MMP-2) and tissue inhibitor of metallopeptidase inhibitor-1 (TIMP-1) in the renal allografts of patients with chronic active antibody-mediated rejection (ABMR), and explore their role in the pathogenesis of ABMR.

METHODSImmunohistochemistry and computer-assisted image analysis were used to detect the expression of MMP-2 and TIMP-1 in the renal allografts of 46 patients with interstitial fibrosis and tubular atrophy (IF/TA), with 15 normal renal tissue specimens as the control. The association of MMP-2 and TIMP-1 with the pathological grade of IF/TA in ABMR was analyzed.

RESULTSThe expressions of MMP-2 and TIMP-1 significantly increased in the renal tissues of the patients as compared with the normal renal tissues (P<0.05). MMP-2 expression tended to decrease, while TIMP-1 and serum creatinine increased with the pathological grades of IF/TA (P<0.05). In IF/TA group, the expression of TIMP-1 was positively correlated to serum creatinine level (r=0.718, P=0.00<0.05).

CONCLUSIONAbnormal expressions of MMP-2 and TIMP-1 can promote the development of renal fibrosis in chronic ABMR.

Adult ; Antibody Formation ; Complement C4b ; metabolism ; Female ; Fibrosis ; etiology ; Graft Rejection ; immunology ; Humans ; Kidney ; metabolism ; Kidney Diseases ; pathology ; Kidney Transplantation ; adverse effects ; immunology ; Male ; Matrix Metalloproteinase 2 ; genetics ; metabolism ; Middle Aged ; Peptide Fragments ; metabolism ; Tissue Inhibitor of Metalloproteinase-1 ; genetics ; metabolism

The tumor multidrug resistance reversal effect of NPB304, a novel taxane, was studied. MTT assay was used to determine the IC50 of chemotherapy drugs. Western blotting assay was applied to analyze the expression of P-glycoprotein (P-gp). The effect of compounds on the P-gp function and P-gp ATPase activity was determined by rhodamine 123 (Rh123) accumulation assay and analysis kit, respectively. Molecular docking was employed to predict the binding force between compounds and P-gp. Transmembrane transport of NPB304 was analyzed using MDCK II and MDR1-MDCK II cell model. NPB304 displayed multidrug resistance reversal effect on KBV cells and MCF-7/paclitaxel cells, NPB304 collaborative with P-glycoprotein (P-gp) inhibitors verapamil enhanced the reversal activity, specifically, 10 μmol x L(-1) verapamil in combination with paclitaxel reversed resistance by 56.5-fold, while combined with NPB304 increased the reversal fold; NPB304 synergistically increased Rh123 accumulation in the resistant cells when combined with verapamil, and NPB304 at 0-1 μmol x L(-1) enhanced the ATPase activity activated by verapamil was observed. NPB304 existed the hydrophobic interactions with the TM regions of P-gp, and the binding force between NPB304 and the A chain of the TM region was stronger. P-gp ATPase activity assay demonstrated NPB304 at lower concentrations (0-1.5 μmol x L(-1)) could activate the P-gp ATPase, playing a role on inhibition of P-gp function. However, NPB304 did not have an obvious feature of P-gp substrate. NPB304 exerted itself and synergy with verapamil activity on reversing tumor resistance via inhibiting the P-gp function.
ATP-Binding Cassette, Sub-Family B, Member 1 ; metabolism ; Antineoplastic Agents ; pharmacology ; Biological Transport ; Drug Resistance, Multiple ; Drug Resistance, Neoplasm ; Drug Synergism ; Humans ; MCF-7 Cells ; Rhodamine 123 ; Taxoids ; pharmacology ; Verapamil ; pharmacology