Objective To observe the clinical effect of treating chronic renal failure with herbal retention-enema.Methods 23 cases with chronic renal failure were randomly recruited into a control group and a treatment group. The control group was treated with routine western medicine (low salt, low fat, and low protein diet, and correcting disturbance of water-electrolyte and acid-base balance), and the treatment group was treated with herbal retention-enema (Rhubarb, Concha ostreae, Dandelion, and Processing aconite). The clinical effect was observed in both groups. Results The clinical effect in the treatment group was significantly higher than that of the control group (χ2=3.456, P＜0.05). Conclusion The treatment of chronic renal failure with herb retention-enema is better than routine western medicine.

Objective To approach effect of glucosidorum tripterygll totorum on chronic glomerulonephritis.Methods A total of 182 cases of chronic glomerulonephritis were randomly recruited into a treatment group (103 cases) and a control group (79 cases). The control group was treated with valsartan capsule, 80mg per time, once daily, and prednisone for those cases of intractable proteinuria, 1 mg/kg, once daily. The treatment group was treated with glucosidorum tripterygll totorum the basis of the control group. Therapeutic effects in both groups were evaluated. Results The total effective rate was 83.5% in treatment group and 65.8% in control group, showing significant difference (t=2.0134, P=0.0785) Conclusion Glucosidorum tripterygll totorum has sound therapeutic effects on chronic glomerular nephritis.

Objective:To construct and identify the recombinant eukaryotic plasmid PcDNA3.1-MxA encoding MxA with the eukaryotic plasmid PcDNA3.1.Methods:Recombinant plasmid PAdTrack-MxA constructed before and PcDNA3.1 were amplified in Escherchia coli JM109.Plasmids were double-digested with restrictive endonucleases NotⅠ and XbaⅠ after extracted,and then ligated to construct recombinant eukaryotic plasmid PcDNA3.1-MxA.The recombinant plasmid was selected for Ampicillin resistance and then confirmed by digestion with NotⅠ and XbaⅠ,PCR and sequencing.The sequence was homology-analysed compared with the sequence of MxA gene in PAdTrack-MxA and the sequence of MxA gene published in Genebank(NM_002462) with sofeware DNAssist 2.0.Results:The restrictive endonuclease and PCR analysis confirmed that the recombinant eukaryotic plasmid PcDNA3.1-MxA was constructed successfully.Sequencing analysis revealed that the cloned segment was 2012bp including MxA gene sequence,and the nucleotide sequence of MxA gene was same to that in PAdTrack-MxA exactly.There were five variations in nucleotide sequence compared with published sequence in Genebank,which caused only one amino acid residue replaced from isoleucine to valine.This replaced amino acid residue was located in the non functional area of MxA protein.Conclusions:The recombinant eukaryotic plasmid PcDNA3.1-MxA is constructed successfully,which lays foundation for the further study on anti-HBV effects of MxA.

Dipeptidyl Peptidase-4 inhibitor (DPP-4 inhibitor),a new kind of oral anti-diabetic medicine,has been widely used for the treatment of type 2 diabetes (T2DM) during the last decades.Recent evidence showed that DPP-4 inhibitor may have renal protective effects beyond glycemic control.Some clinical studies revealed that the reduction of HbA1c by DPP-4 inhibitor was paralleled by an improvement of albuminuria and renal function.Experimental studies indicated that the renal protection mechanism of DPP-4 inhibitor may be involved in its multiple effects including anti-inflammatory,anti-oxidation and improvement of endothelial function.However,the evidence of decreasing albuminuria for DPP-4 inhibitor mainly comes from animal models and some clinical trials with small sample size.More large randomized controlled trials (RCT) will be needed to certify the renal protection effect of DPP-4 inhibitor.In this review,the role of DPP-4 inhibitor on albuminuria will be considered and discussed from both experimental and clinical perspectives.

In this study, the ultrastructural changes of skeletal muscle of hindlimbs in rats were observed. Skeletal muscle of 5 h ischemia showed diminished glycogen granules, swelling of mitochondria, clearing of mitochondrial matrix, breakage of mitochondrial crista and dilatation of sarcoplasmic reticulum. Skeletal muscle of 5 h ischemia and 1/2 h or 12 h reperfusion showed high amplitude swelling of mitochondria with rupture of mitochondrial membrane, dense granules in mitochondrial matrix and complete loss of normal organization of myofibrils. The results demonstrate that reperfusion after prolonged ischemia exaggerates tissue injury.

[Objective] To ensure the safety of preoperative autologous blood donation in late pregnancy through a series of nursing measures.[Methods]From January 2010 to November 2011, 52 cases of pregnant women in late pregnancy took storage autotransfusion. After prenatal guardianship, psychological care, health education, blood were col ected before and after care, custody and from the blood transfusion care; record blood col ection process pregnant women with maternal-fetal reaction, the vital signs of pregnant women, birth outcomes, since the amount of al ogeneic blood transfusion, and achieve satisfactory re-sults.[Results] 52 cases of pregnant women with the blood col ection process were good, normal, with stable vital signs, abnormal fetal heart rate monitoring, one case of fetal moved too much, given the oxygen, improved with the left lateral decubitus position. In the process of self-blood transfusion, there's no ma-ternal discomfort, but with safe motherhood. [Conclusion] Effective care measures and storage of a pregnant woman autologous transfusion are relatively safe, economical and effective in the transfusion way, achieve good results, and help to improve the quality of obstetric care.

OBJECTIVE:To identify Salvia miltiorrhiza,Rehmannia,Chuangxion rhizome,rhubarb and to determine the content of tanshinone Ⅱ A,as an efficacious composition,in Shendi Tangmaining capsules.METHODS:TLC and SPE-UV were used.The SPE-UV method was performed with silica gel column(1.1cm).The mobile phase consisted of dichloromethane-me_thanol(8∶2).The detected wavelength was 280nm.RESULTS:In the SPE-UV method,the standard curve for tanshinone Ⅱ A was linear in the range of 1.6～8?g/ml(r=0.9 999).The average recovery was 96.13% with RSD=0.80%.CONCLUSION:The method is simple,rapid and reliable for quality control of the capsules.

Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.
China ; Data Collection ; standards ; Drug Evaluation ; standards ; Information Storage and Retrieval ; standards ; Internet

Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.

Objective To study the correlation between hand, foot and mouth disease (HFMD) in lung-spleen damp-heat syndrome, syndrome of stagnation and steaming due to damp-heat, and syndrome of stirring wind due to toxic-heat with IL-6, PCT, CRP, CD3+, CD4+, CD8+ and NK cells.Methods Ninety patients with HFMD were randomly selected, dividing into lung-spleen damp-heat syndrome, syndrome of stagnation and steaming due to damp-heat, and syndrome of stirring wind due to toxic-heat, 30 cases for each syndrome. IL-6, PCT, CRP, CD3+, CD4+, CD8+ and NK cells were detected, and the distribution of above indicators in the three syndromes were analyzed.Results Levels of IL-6, PCT and CRP in syndrome of stirring wind due to toxic-heat were significantly higher than those in lung-spleen damp-heat syndrome and syndrome of stagnation and steaming due to damp-heat, with statistical significance (P<0.01); There was statistical significance in absolute value counting of CD3+, CD4+, CD8+ and NK cells among the three syndromes (P<0.01); There was statistical significance in the percentage of CD3+ cells in syndrome of stirring wind due to toxic-heat and lung-spleen damp-heat syndrome (P<0.01) and syndrome of stagnation and steaming due to damp-heat (P<0.05); There was statistical significance in the percentage of CD4+ cells syndrome of stirring wind due to toxic-heat and lung-spleen damp-heat syndrome (P<0.05) and syndrome of stagnation and steaming due to damp-heat (P<0.01); There was statistical significance in the percentages of CD8+ and NK cells in the three syndromes (P<0.01).Conclusion Proinflammatory cytokines, proinflammatory markers, and T cell sub-group related to HFMD in lung-spleen damp-heat syndrome, syndrome of stagnation and steaming due to damp-heat, syndrome of stirring wind due to toxic-heat are not only correlative with morbidity, but also with the severity of diseases and prognosis, which can relatively effectively evaluate the state of diseases and judge prognosis.