The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy

Pulmonary alveolar proteinosis (PAP) is a rare disease clinically, and at present no western medicine can effectively cure the disease. After the analysis of literatures related to Traditional Chinese Medicine (TCM) for treatment of the disease in the China National Knowledge Internet Database, it was discovered that the syndrome differentiation showed the disease closely associated with phlegm, blood stasis and yin deficiency. In this study, from view point of pulmonary gangrene TCM theory and treatment combined with PAP pathophysiological characteristics, it is emphasized that phlegm accumulation, blood stasis and yang deficiency are the key pathological manifestations of PAP, thus Yanghe decoction, Tounong powder, Kongxian pellet were used for treatment of one such case, the rational thinking in diagnosis and treatment of this patient being consistent with the idea learning western medicine for China use.

Objective To study the effects of found in inflammatory zone 1(FIZZ1) on the migration of cul- tured mouse vascular smooth muscle cell(VSMC) and the potential mechanism.Methods Using Boyden chamber, immunofluorescence and Western blot,the migratory effects,F-actin content and Akt/Akt1 expression were deter- mined in VSMC after stimulation by FIZZ1.Results FIZZ1 markedly increases the migratory ratio,F-actin con- tent and the Akt1 expression of VSMC.Ly294002,a PI3K inhibitor,attenuated migratory ratio,F-actin content and the Akt1 expression of VSMC promoted by FIZZ1 in a dose-dependent manner (10-30 ?mol/L).Conclusion Our data demonstrated FIZZ1 by activating PI3K/Akt1 pathway induced the expression of F-actin of VSMC,and promoted the migration of VSMC.

In this paper is summarized and classified the recent great progress in the research of spine biomechanics analysis, In addition, the relevant clinical significance as well as some possible research trends of finite element model establishment are also clarified. As a theoretical method, only by close links with clinical practice can finite element analysis really help explain the onset and development of diseases and forecast the curative effects.

OBJECTIVETo investigate the change and correlation of carbon monoxide/heme oxygenase and nitrogen monoxide/nitric oxide synthase system in atherosclerosis and the influence of the two systems on atherosclerotic progress.

METHODSThe rabbits received 1% cholesterol diet (chol group, n = 8), or 1% cholesterol diet plus L-arginine (L-arg group, n = 8) or L-NAME (L-NAME group, n = 8) by drinking water, or 1% cholesterol diet plus heme-L-lysinate (Heme group, n = 8) or ZnPP-IX (ZnPP group, n = 8) by injection in abdominal cavity for 10 weeks.

RESULTSCompared with those in control group, aortic NO production and expression of NOS decreased markedly; while CO production (P < 0.01) and HO-1 activity increased obviously in chol group. The aortic plaques area was (40.2 +/- 8.9)% in chol group. Compared with those in chol group, aortic areas [(26.6 +/- 9.2)%] reduced distinctly in heme group, aortic CO production and NOS activity increased obviously (P < 0.01) in L-arg group. However, compared with those in control group, HO-1 expression and CO production decreased markedly (P < 0.01) in heme group, while they were not different from those in chol group. Compared with those in chol group, aortic cNOS activity and NO production increased obviously and aortic plaques area [(28.1 +/- 7.7)%] greatly reduced (P < 0.01) in L-arg group. However, HO-1 expression and CO production of L-arg group decreased distinctly compared with those of control group, but they were similar to those of chol group. The aortic c-myc and c-fos expressions in both heme group and L-arg group reduced markedly compared with those in chol group, while they were similar to those in ZnPP and L-NAME group.

CONCLUSIONThe reciprocal relationship between heme oxygenase/carbon monoxide and nitric oxide synthase/nitrogen monoxide system in atherosclerosis may play the inhibitory role against atherosclerotic lesion.

Animals ; Atherosclerosis ; metabolism ; pathology ; physiopathology ; Carbon Monoxide ; metabolism ; Heme Oxygenase-1 ; metabolism ; Male ; Nitric Oxide ; metabolism ; Nitric Oxide Synthase ; metabolism ; Rabbits

Background: Previous study has found that ursolic acid (UA) inhibited the proliferation of gastric cancer cells by the down-regulation of cyclooxygenase-2 (COX-2) expression.However,its molecular mechanism is not fully clear.Aims: To investigate the role of adenosine monophosphate-activated protein kinase (AMPK)/signal transducer and activator of transcription 3 (STAT3)/COX-2 signaling pathway in UA-mediated inhibition of gastric cancer cells proliferation.Methods: AMPK-pLVX,AMPK-shRNA,STAT3-pLVX,STAT3-shRNA plasmids were constructed,and then were transfected into human gastric cancer cell lines SGC-7901 and MKN-45,respectively.Gastric cancer cells were cultured with different concentrations of UA for different times.The expressions of phosphorylated AMPK (p-AMPK),phosphorylated STAT3 (p-STAT3) and COX-2 were measured by Western blotting,and cell proliferation was detected by CCK-8 assay.Results: UA dose-and time-dependently increased p-AMPK expression,inhibited p-STAT3 and COX-2 expressions in SGC-7901 and MKN-45 cells.Knockdown of AMPK blocked UA-induced inhibition of STAT3 phosphorylation and COX-2 expression.Overexpression of STAT3 blocked UA-induced down-regulation of COX-2 expression.Knockdown of AMPK and overexpression of STAT3 blocked UA-induced inhibition of proliferation of gastric cancer cells.Conclusions: UA may inhibit the proliferation of gastric cancer cells via down-regulation of COX-2 expression through AMPK/STAT3 pathway.

Objective To identify and monitor potential risk areas of schistosomiasis in Dongting Lake area. Methods With remote sensing (RS)and geographic information system(GIS) technology, potential risk areas of schistosomiasis in Dongting Lake area were extracted by using spectral characteristics and environmental factors. Based on epidemiological data and land use data, the regional epidemic index and environmental susceptibility index were fused with potential epidemic risk areas in the grid system of Dongting Lake area to form the epidemic risk surveillance map of schistosomiasis in Dongting Lake area from 2006 to 2016. Results From 2006 to 2016, the high risk areas of schistosomiasis epidemic in Dongting Lake area were concentrated in the central and Northern lakeside areas of Changde City (Annual average epidemic index R-=0.330 5, Regional average susceptibility index Y-=2.458 2), the sensitive land types were Lake area (Sensitivity coefficient β=1.236 6), the surrounding area of Datong Lake in Nanxian and Northern Yuanjiang City (R-=0.426 0, Y-=0.836 8), paddy field area (β=0.202 1) and other construction land (β=0.308 0). The extremely high risk areas were concentrated in some lake-facing areas in Jinshi (R-=0.449 1, Y-=3.917 0) and the sensitive land type is woodland(β=1.234 5). The risk of river basin from high to low was respectively the Lishui River, the Yuanjiang River, the Zijiang River and the Xiangjiang River. Conclusions The high-risk and extremely high-risk areas should be the focus of future epidemic control. The snail control and environmental renovation of epidemic-sensitive areas such as sparse woodland, grassland with high coverage, reservoir pits and ponds should be done well in Dongting Lake area.

OBJECTIVETo probe the function of interleukin-17 (IL-17) in rheumatoid arthritis (RA) patients of accumulated dampness-heat obstruction in joints syndrome (ADOJS) by detecting levels of IL-17 in serum and the synovial fluid and analyzing its correlation with erythrocyte sedimentation rate (ESR) and C reactive protein (CRP).

METHODSFrom January 2011 to January 2013, recruited were 90 RA inpatients of ADOJS at Department of Integrative Medical Rheumatism, General Hospital of Chengdu Military Region, of which 28 patients had knee joint effusion. Besides, 30 healthy volunteers who received physical examination at our hospital were recruited as the normal control group, and 30 patients with osteoarthritis (OA) who had knee joint effusion were recruited as the synovial fluid control group. The expression levels of IL-17 in serum and the synovial fluid were detected by enzyme linked immunosorbent assay (ELISA), and contents of ESR and CRP were detected in RA patients. Then correlation analyses were performed between levels of IL-17 and contents of ESR and CRP.

RESULTSCompared with the normal serum control group, the expression levels of IL-17 in serum of RA patients significantly increased (P < 0.05). Compared with the serum of RA patients and the synovial fluid of OA patients, the expression levels of IL-17 in the synovial fluid of RA patients significantly increased (P < 0.05). The expression levels of IL-17 in serum of RA patients were not correlated with ESR or CRP (r = 0.092, -0.082; P > 0.05), and the expressional levels of IL-17 in the synovial fluid of RA patients were not correlated with ESR or CRP (r = 0.113, -0.034; P > 0.05).

CONCLUSIONSIL-17 was the main effector cytokine of Th17 cells. The expressional levels of IL-17 significantly increased in serum and the synovial fluid of RA patients of ADOJS, but with no correlation to ESR or CRP. It indicated that IL-17 participated in the occurrence and development of RA. Concrete mechanisms needed to be further proved in larger samples.

Aged ; Arthritis, Rheumatoid ; blood ; diagnosis ; metabolism ; Blood Sedimentation ; C-Reactive Protein ; metabolism ; Case-Control Studies ; Female ; Humans ; Interleukin-17 ; blood ; metabolism ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Synovial Fluid ; metabolism

OBJECTIVETo screen the proteins interacting with FXR1P for functional investigation of FXR1P.

METHODSThe yeast strain AH109 transformed with the recombinant expression vector pGBKT7/FXR1 was mated with the yeast strain Y187 pretransformed with human fetal brain cDNA library. The positive clones were screened and identified by sequence analysis.

RESULTSThe recombinant expression vector pGBKT7/FXR1 was constructed successfully. Five proteins binding to FXR1P were screened from human fetal brain cDNA library using the yeast two-hybrid system, including CMAS, FTH1, GOLGA4, HSD17B1 and CSH1.

CONCLUSIONSThese results provide new clues for investigating the biological functions of FXR1P and the pathogenesis of Fragile X syndrome.

Autoantigens ; genetics ; metabolism ; Estradiol Dehydrogenases ; genetics ; metabolism ; Ferritins ; genetics ; metabolism ; Gene Library ; Humans ; Membrane Proteins ; genetics ; metabolism ; Protein Binding ; Protein Interaction Domains and Motifs ; genetics ; RNA-Binding Proteins ; genetics ; metabolism ; Two-Hybrid System Techniques

OBJECTIVETo study the effect of bitter-cold herbs easing dampness method (BCHEDM) plus Sanhuang Yilong Decoction (SYD) combined with methotrexate (MTX) on expression levels of interleukin-1 (IL-1), IL-6, and IL-17 in rheumatoid arthritis (RA) patients of accumulated dampness-heat syndrome (ADHS).

METHODSFrom January 2011 to January 2013 recruited were 90 RA inpatients of ADHS at Department of Integrative Medicine on Rheumatoid Disease, General Hospital of Chengdu Military Region. They were assigned to the treatment group (45 cases) and the control group (45 cases) according to the random digit table produced by SPSS 11.5 Software. Patients in the treatment group were treated by heavy bitter-cold herbs plus SYD combined with MTX, while those in the control group were treated by MTX alone. Expressional levels of IL-1, IL-6, and IL-17 in serum were detected by enzyme linked immunosorbent assay (ELISA) before treatment, at week 2 and 4 after treatment. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and disease activity score in 28 joints (DAS28) were detected as well.

RESULTSAfter two or four weeks of treatment, ESR, CRP, and DAS28 decreased more in the treatment group than in the control group with statistical difference (P < 0.05, P < 0.01). After four weeks of treatment, IL-1, IL-6, IL-17, ESR, CRP, and DAS28 in the treatment group were all lower than before treatment and those of the control group at corresponding time points with statistical difference (P < 0.01).

CONCLUSIONSYD combined MTX could play roles of improving inflammatory indices within 2 weeks, and inhibiting the expression of IL-1, IL-6, and IL-17 within 4 weeks.

Arthritis, Rheumatoid ; blood ; drug therapy ; immunology ; Blood Sedimentation ; C-Reactive Protein ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Hot Temperature ; Humans ; Interleukin-1 ; blood ; Interleukin-17 ; blood ; Interleukin-6 ; blood ; Methotrexate ; therapeutic use ; Syndrome ; Treatment Outcome