There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.
Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

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

Adenocarcinoma, Papillary ; blood supply ; metabolism ; pathology ; Adult ; Aged ; Carcinoma, Pancreatic Ductal ; blood supply ; metabolism ; pathology ; Chemokine CXCL12 ; metabolism ; Female ; Gene Expression Regulation, Neoplastic ; Humans ; Lymph Nodes ; metabolism ; Lymphatic Metastasis ; Male ; Microvessels ; pathology ; Middle Aged ; Neoplasm Staging ; Neovascularization, Pathologic ; metabolism ; pathology ; Pancreas ; metabolism ; Pancreatic Neoplasms ; blood supply ; metabolism ; pathology ; Receptors, CXCR4 ; metabolism

The paper is to systematically evaluate the effect and safety of Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy for non-small cell lung cancer (NSCLC). Randomized controlled trials (RCTs) on Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy (experiment group) and chemotherapy alone group ( control group) were electronically retrieved from Medline, EMbase, Clinical Trials, Cochrane Library, CBM, CNKI, VIP, and Wanfang Data base. All trials were assessed for quality according to the Cochrane Reviewer's Handbook for Systematic Reviews of Intervention and then Meta-analysis was performed withRevMan5. 2 Software. A total of 43 RCTs (3433 patients) were included after screening and selecting. Results of Meta-analysis showed that: Objective remission rate (ORR): ORR of experimental group was about 20% higher than that of control group [RR = 1.23, 95% CI (1.11,1.35), P < 0.0001]. Disease control rate (DCR):DCR of SFI combined with first-line chemotherapy was 11% higher than that of first-line chemotherapy alone [RR = 1.11, 95% CI (1.07, 1.16), P < 0.000 01]. Life quality evaluated by Kosovan performance status (KPS) showed that: life quality improvement rate of experimental group was about twice of that in control group [RR = 2.02, 95% CI (1.81, 2.26), P < 0.000 01]. Toxic and side reaction analysis showed that: the incidence of side reactions in experimental group was about 50% lower than that in control group [RR = 0.59, 95% CI (0.53, 0.66), P < 0.000 01]. Immune function test showed that: the function of experimental group was 3.2 (standard deviations) times greater than that of control group [MD = 3.23, 95% CI (2.86, 3.60), P < 0.000 01]. We can see that SFI combined with first-line chemotherapy for NSCLC can increase objective efficacy, improve life quality, decrease toxic and side reactionsinduced by chemotherapy, and improve the immune functions. As most of the included studies in this systematic evaluation had poor quality, the evidence to support conclusion was weak, so it was necessary to conduct more multi-center clinical trials with high quality methods and rigorous design.
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; Young Adult

Objective advance“equal pay for equal work” standard for contract nurses,and approach for effective means of stabilizing nursing staff.Methods in order to improve of nursing staff's ideological understanding,personnel department and nursing department utilize their advantages of political work in the the Communist Party,the Communist Youth League and the Labor Unions,and bridge the cap between contract and staff nurses in clinical department in terms of welfares and promotion to realize the goal of “equal pay for equal work”.Results all contract nurses join the Labor Union.contract nurses play active role in the Commtmist Youth League.Salaries,insurance and other welfares for contract nurses are guaranteed.Contract nurses enjoy equal opportunity of promotion in technical positions and of open recruitment as registered nurses.Conclusion treatment disparity has been effectively alleviated between contract and staff nurses,so that the nursing staff becomes stable.

Objective To understand the effect of vanadium to liver ultramicro structure in SD rats.Methods One hundred and fifty generaMevel SD rats of 2 months were randomly divided into control groups,30 in each,the males and females were equivalent,treated with ammonium metavanadate at doses of 0,10,20,40,60 mg/L through drinking water.After 2,6 and 10 weeks of treatment,6 rats from each group were weighed and the changes of ultramicro-structure in the liver were examined with electron microscope.Results As the increasing of dose,the increase in body weight showed a downward trend,but the coefficient of liver showed a increasing trend,the consistent performance was seen in male and female rat.After two weeks of exposure,the rats acted,ate and drank less,hair roughing and no shining,often getting together were seen.After 10 weeks,the rats had not the basic activities,the hair was disheveled and loose,some died,the structure of mitochondria and endoplasmic reticulum was normal in the 10,20,40 mg/L group,the number of endoplasmic reticulum increased,in 60 mg/L group,the rough endoplasmic reticulum vanished,the liver cytoplasm had a swelling phenomenon,the mitochondria reduced.Conclusion Vanadium have little effect on the liver cells of rats in low exposure level,but high level exposure may damage the liver cells in rats.

Adolescent ; Adult ; Aged ; China ; epidemiology ; Dust ; Female ; Humans ; Lung Diseases ; epidemiology ; prevention & control ; Male ; Middle Aged ; Occupational Diseases ; epidemiology ; prevention & control ; Pneumoconiosis ; prevention & control ; Young Adult

The paper is to systematically evaluate the efficacy and safety of Deng Zhan Xi Xin injection ( DZXXI) as an adjuvant treatment for patients with angina pectoris. The Cochrane Library, Medline, EMbase, CBM, CNKI, VIP, and Wan fang Data base were searched. Randomized controlled trials (RCTs) of DZXXI combined with western medicine routine treatment versus western medicine routine treatment alone for angina pectoris patients were all included. All trials were assessed according to the Cochrane Reviewer' s Handbook 5.1 for Systematic Reviews of Intervention and Meta analyses were performed by RevMan 5. 2 Software. A total of 30RCTs (3 086 patients including 1 572 patients of treatment group and 1 514 patients of control group) were included. Meta-analysis of treatment group compared with control group showed superior effect over reducing cardiovascular events ( OR = 0.33; 95% CI: [0.16, 0.67], P = 0.002, improving effective rate of DZXXI as adjuvant treatment for angina pectoris patients (OR = 3.97; 95% CI: [3.15, 5.02]; P < 0.000 010 and electrocardiogram curative effect (OR = 2.21; 95% CI; [1.83, 2.68]; P < 0.000 010. Funnel figure seemed that there was publication bias. The current limited evidence showed that when compared with the control group, treatment group was superior in improving patients with angina pectoris. But based on the limitations of the study, rigorous design with long follow up clinical trials are necessary for further evidence.
Adjuvants, Pharmaceutic ; Adult ; Aged ; Angina Pectoris ; drug therapy ; physiopathology ; Drugs, Chinese Herbal ; administration & dosage ; Electrocardiography ; Female ; Heart ; physiopathology ; Humans ; Injections ; Male ; Middle Aged ; Randomized Controlled Trials as Topic

Objective To explore the morphological changes of human mesenchymal stem cells(hMSCs) after exposure to extracorporeal shock wave(ESW).Methods An optimal experimental energy dose of ESW was applied to hMSCs of passage one.The morphological changes were examined by using inverted phase contrast microscope(IPCM),transmission electron microscope and cytochemical staining.Results ESW of 5kV and 100 times could raise the viability and proliferation of the cells.In the hMSCs of passage 3-5,the multiplicative division was speeded up,and the cells in the nuclear fission phase were increased.In the hMSCs of passage 7-9,the volume of the cells increased,and the endoplasmic reticulum was expanded.The Golgi's apparatus was developed and the matrix of the cells was bunchy.In the hMSCs of passage 11,the multiplicative division was also detected.Conclusion The proliferation and differentiation of the hMSCs can be improved by the treatment of ESW.

Objective: To investigate the developmental toxicity of 2,4-dinitrochlorobenzene in zebrafish embryos. Methods: AB wild-type male and female zebrafish were selected to mate and spawn, then the eggs were cultured with Holt buffer solution. Six dose groups ( 0.4, 0.8, 1.0, 1.2, 1.6, 2.0 μg/mL ), a solvent control group and a cosolvent control group, were set up with 20 embryos each. Malformations and death of embryos were observed at 48, 72 and 96 hpf ( hours post fertilization ), the mortality and 50% lethal concentration ( LC50 ) were also calculated. Results: At 48, 72 and 96 hpf, the LC50 of 2,4-dinitrochlorobenzene on zebrafish embryos were 1.668, 1.043 and 0.895 μg/mL, respectively, with a downward trend. After 72 hpf, when the concentration reached 2.0 μg/mL, all the zebrafish died. In the range of 0.4-2.0 μg/mL, the mortality of zebrafish at 48, 72 and 96 hpf increased with the increase of 2,4-dinitrochlorobenzene concentration ( all P<0.05 ); the malformation rate of zebrafish embryos at 48 hpf increased with the increase of 2,4-dinitrochlorobenzene concentration ( P<0.05 ). Zebrafish embryos exposed to 2,4-dinitrochlorobenzene led to yolk sac edema, pericardial edema and spinal curvature. Conclusion 2,4-dinitrochlorobenzene can affect the development of zebrafish embryos, which will lead to lethal and teratogenic effects.