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

BackgroundRetinitis pigmentosa (RP) has the genetic and phenotype heterogeneity.To determine the disease-causing gene is a foundation of gene therapy.Objective This study was to localize the pathogenic gene and screen the gene mutation associated with Han Nationality autosomal dominant retinitis pigmentosa (ADRP) in a Chinese family.MethodsTwenty-one families enrolled this study,including 12 patients with ADRP and 9 individuals with normal phenotype.Perimetry,fundus examination,electrooculogram ( EOG ) and electroretinogram (ERG) were performed in 12 patients.Genetic linkage analysis was performed on the subjects in all known genetic loci related to ADRP with a panel of microsatellite markers.Subsequently,the mutation screening of rhodopsin gene was screened by direct DNA sequencing.This study was approved by Ethic Committee of Zhongnan Hospital of Wuhan University.Informed consent was obtained from each subject.ResultsThe fundus appearance of the proband was in accordance with the ADRP,and the EOG and ERG showed undetectable.Contractive visual field also was exhibited in the proband.Linkage analysis showed that the maximum logarithm of the odds(LOD) score reached 3.6671 at marker D3S1292 at recombination fraction θ =0.0.The results of direct DNA sequencing revealed a C→ G transversion mutation at codon 53 in exon 1 of rhodopsin gene,which resulted in a proline to arginine change (Pro53Arg) in 12 patients.However,no similar mutation was found in the unaffected members of this family.ConclusionsThe missence mutation Pro53Arg in rhodopsin gene cosegregate with the RP disease.It is determined to be a pathogenic factor of this ADRP family.

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.

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

In order to develop characteristic folk medicine resources in Jiangxi, a pharmacognostical study was systematically performed for four different origin plants of Sikuaiwa, the result of study provides the microscopic features of powder and tissue of the crude drug. The research provided reference for the identification of Sikuaiwa, as well as a theoretical basis for the further development and the formulation of quality standards.
Magnoliopsida ; anatomy & histology ; chemistry ; growth & development ; Medicine, Traditional ; Plants, Medicinal ; anatomy & histology ; chemistry ; growth & development

Animals ; China ; epidemiology ; Epidemiologic Studies ; Molecular Epidemiology ; Rickettsia ; genetics ; isolation & purification ; Rickettsia Infections ; epidemiology ; transmission ; Ticks ; microbiology

The type of basic media and the contents of plant growth substances were investigated by orthogonal design experiment,and also the effects of different culture conditions on the growth of suspension cells and the accumulation of total flavonoids in Eucommia ulmoides were studied.The results showed that B5 medium supplemented with 0.5mg/L NAA,0.6mg/L 6-BA and 30g/L sucrose,at initial pH 5.0～5.5,20g(FW)/L inoculation quantity and 110 r/min of rotation speed was a preferable culture conditions for E.ulmoides suspension cells growth and flavonoids synthesis.The results of metabolic kinetics analysis for E.ulmoides cell suspension culture showed that the logistic and Luedeking-Piret equations can be used for describing the kinetics of cell growth,sucrose consumption and flavonoids production during the process.The maximum specific growth rate(?m),the actual growth yield based on sucrose(YG) and maintenance coefficient(m) were 0.417/d,0.619g/g and 0.0206g/(g?d-1) respectively.All these outcomes could give a basis for establishing the suspension cell culture of E.ulmoides and production of the natural active components in large-scale.

Objective To compare the therapeutic effect of the combination of ~(99m)Tc-methnetium methylene diphosphunate and colloidal chromic,phosphate ~(32)p with the monotherapies in rats with adjuvant arthritis(AA).Methods In this study,50 Sprague-Dawley rats were randomly divided into five groups with 10 rats in each:normal control group(arthritis induced and treated with the same volume of normal saline via the same administration route),AA control group(arthritis induced with adjuvant and treated with normal sa- line),~(32)p colloid group(arthritis induced with adjuvant and treated with single intra-articular injection of col- luidal chromic phosphate ~(32)p 0.74 MBq and intra-peritoneal injection of normal saline every other clay),~(99m)Tc- MDP group(arthritis induced with adjuvant and treated with intra-peritoneal injection of ~(99m)Tc-MDP 2.5?10~(-3)?g/kg every other day and single intra-articular injection of normal saline),combination group(arthritis in- duced with adjuvant and treated with the combination of the two drugs).The diameter of the left hind ankle, serum levels of turnout necrosis factor(TNF)and interleukin-1?(IL-1?),and the pathological changes of an- kle joints were tested at different time points.Results The diameter of the left hind ankle at week 4 was smaller in the combination group than that of the ~(32)p colloid treatment alone group [(7.11?0.34)mm vs(7.57?0.29)mm,P

In this study,nearly 200 endophytic bacteria were isolated from different part of Huperzia serrata, over 60 bacterium with clear antifungal activity were selected from those cultures.Among them,strain H-6 exhibited the highest antifungal activity which was strongly inhibits the growth of many plant pathogenic fungi such as Sclerotinia scleroliorum,Fusarium graminearumt,Sclerotinia libertiana,Phytophthora capsici Leonia and Sesame fusarium wilt.According to the characteristics of morphology,physiology and biochem- istry tests and the comparison of 16S rDNA sequence,the strain H-6 was similar to the Burkholderia.So strain H-6 was identified as Burkholderia sp.H-6.The results also showed that Burkholderia sp.H-6 was markedly different from Burkholderia cepacia that was applied widely in agriculture as antagonistic bacteria. The medium and culture conditions of the strain all were optimized by single factor and orthogonal experiments.In the investigation of the culture condition,growth was carried out in a basal medium(potato juice)and gradually supplemented with the various ingredients to be investigated.The major ingredients be- ing investigated included carbon sources and nitrogen sources.The optimal antifungal activity production condition is growth in a medium(potato juice with 2.5%mannitol and 0.1%NaNO3),initial pH 4.0 at 28℃.

Objective This objective of the study was to analyze the factors related to being recaptured and condom use among low-fee female sex workers (FSWs) to provide reference in developing human immunodeficiency virus (HIV) intervention strategy. Methods Physical examination certificates were designed by Zhongshan County Center for Disease Control and Prevention to record HIV and syphilis test results for low-fee FSWs from 2013 to 2015. Low-fee FSWs were asked to show physical examination certificates in the next intervention and test. Multivariate Logistic regression was used to analyze factors associated with being captured with physical examination certificates. Generalized linear mixed model was used to analyze factors associated with condom use with clients. Results A total of 220 low-fee FSWs were recruited by using physical examination certificates and received 389 interviews from 2013 to 2015. The proportions of HIV positive and syphilis positive were 4.2% (9/213) and 30.0% (64/213) respectively among those who had HIV and syphilis test. Results of multivariate Logistic regression analysis showed that low-fee FSWs who had been FSWs for more than 4 years (OR=2.95, 95% CI：1.35-6.45), and worked in the local county in the past 30 days (OR=11.74, 95% CI: 5.26-26.20), were more likely to be captured with physical examination certificates. Results of generalized linear mixed model showed that those who were captured at least once (OR=3.33, 95% CI: 1.34-8.27), had junior middle school education and above (OR=22.79, 95% CI: 3.75-138.57), had high HIV knowledge (OR=3.57, 95% CI: 1.52-8.38), and charged more than 30 yuan for vaginal sex (OR=30.68, 95% CI: 12.57-74.90), were more likely to use condom consistently. Conclusions Physical examination certificates could be used for low-fee FSWs surveillance and intervention and tracking their HIV and syphilis status. The intervention strategy should take these into consideration.