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

Objective To observe the incidence of phlebitis in patients with PICC through peripheral vein and its nursing effect, in order to aLleviate the patients' suffering. Methods The 60 volunteers were divided into three groups randomly, who were received PICC through basilie vein, vena mediana and cephalic vein, the incidence of of phlebitis and therapeutic effieaey were analyzed. Results 2 patients appeared phlebitis in 20 cases received PICC through basilic vein, 3 patients in 20 eases through eubital vein, and all cured;11 patients in 20 eases through cephalic vein, while 9 patients were cured and 2 patients were detubated in cephalic vein group. Conclusions It' s suggested that the prevalence of phlebitis with PICC through cephalic vein is high, with long treat time and low cure rate. It' s likely to reduce the phlebitis occurrence and patients relief from pain through eephalic vein.

BACKGROUNDPulmonary atresia with ventricular septal defect (PA-VSD) and major aortopulmonary collateral arteries (MAPCAs) remains a challenging complex congenital heart disease nowadays. In the present study, we aimed to develop a two-stage surgical method and to evaluate outcomes of this method in managing PA-VSD and MAPCAs.

METHODSBetween December 2003 and December 2008, 7 female and 4 male patients between the age of 5 and 10 years who were suffering from PA-VSD and MAPCAs were selected and recruited. The native pulmonary artery trunks were absent in all patients; the lungs were solely supplied by major aortopulmonary collaterals, and the numbers of supplied lung segments ranged from 15 to 20 (17.9 +/- 1.6). There were a total of 43 MAPCAs in all the patients (3 - 5 (3.9 +/- 0.7) MAPCAs per patient). The accumulated Nakata index was (222.9 +/- 29.9) mm(2)/m(2) (ranged from 182 to 272). All the patients underwent two sequential operations. Stage one included left major aortopulmonary collateral unifocalization and modified Blalock-Taussig shunt from left posterior lateral thoracotomy; stage two comprised right unifocalization, ligation of the shunt, followed by ventricular septal defect closure and right ventricular outflow tract reconstruction assisted with cardiopulmonary bypass from midline sternotomy.

RESULTSAll the patients survived the initial surgery, but one of them died of low cardiac output syndrome on the third day after the second operation. Postoperative complications included pneumonia in one case and capillary leak syndrome in another. Postoperative oxygen saturation maintained about 95% - 100%, which was significantly higher than pre-operation (P < 0.01). During the follow-up period of 3 - 51 (25.4 +/- 15.2) months, there were no late death and no need for re-intervention. All the patients enjoyed their lives with good conditions.

CONCLUSIONSThis two-stage complete repair strategy was well-tolerated and effective with good outcome, thus offering an alternative surgical approach in the treatment of PA-VSD and MAPCAs.

Child ; Child, Preschool ; Female ; Heart Defects, Congenital ; surgery ; Heart Septal Defects, Ventricular ; surgery ; Humans ; Male ; Pulmonary Artery ; abnormalities ; Pulmonary Atresia ; surgery ; Thoracotomy ; Treatment Outcome

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.
Acupuncture Therapy ; standards ; China ; Humans ; Quality Control ; Randomized Controlled Trials as Topic ; standards ; Research Design ; standards

OBJECTIVETo determine the effect of activation of lambda-opioid receptor with U50, 488H, a selective kappa-opioid receptor agonist, on the changes in electrical coupling during prolonged ischemia and to explore the possible mechanism.

METHODSThe isolated rat heart was perfused in a Langendorff apparatus. The effect of U50, 488H on electrical coupling parameters including onset of uncoupling, plateau time, slope and fold increase in r(t) was observed in isolated perfused rat heart subjected to global no-flow ischemia. The effect of U50, 488H on connexin 43 (Cx43) expression of ventricular muscle during ischemia was determined by immunohistochemistry.

RESULTSIn the prolonged ischemia model, U50, 488H concentration dependently delayed the onset of uncoupling, increased time to plateau, and decreased the maximal rate of uncoupling during ischemia. The effect of U50, 488H on electrical uncoupling parameters during ischemia was abolished by a selective kappa-opioid receptor antagonist nor-BNI or a PKC inhibitor chelerythrine. The amount of Cx43 immunoreactive signal in ventricular muscle was greatly reduced after ischemia. U50, 488H markedly increased Cx43 expression during ischemia and its effect was also attenuated by nor-BNI or chelerythrine.

CONCLUSIONThese results demonstrated that U50, 488H delayed the onset of uncoupling and plateau time, decreased the maximal rate of uncoupling and increased Cx43 expression of ventricular muscle during ischemia, and these effects of U50, 488H were mediated by kappa-opioid receptor, in which activation of PKC was involved. The effect of U50, 488H on electrical coupling during ischemia was probably correlated with preservation of Cx43 in cardiac muscle.

3,4-Dichloro-N-methyl-N-(2-(1-pyrrolidinyl)-cyclohexyl)-benzeneacetamide, (trans)-Isomer ; pharmacology ; Animals ; Benzophenanthridines ; pharmacology ; Connexin 43 ; metabolism ; Female ; Heart ; drug effects ; In Vitro Techniques ; Myocardial Ischemia ; metabolism ; physiopathology ; Myocardium ; metabolism ; Naltrexone ; analogs & derivatives ; pharmacology ; Rats ; Rats, Sprague-Dawley ; Receptors, Opioid, kappa ; metabolism ; Signal Transduction ; drug effects

Objective Analyze the reasons of PICC catheter displacement and gave nursing countermeasure, to reduce the incidence of its complication. Methods Retrospective analysis was implemented on the 2 cases with PICC catheter displacement in our hospital. Results Repeated and excessive outreach of limbs was the inductive factor of the catheter displacement. Conclusions Nurses would identify the content and method of health education, study and research how to improve the compliance the patients. Nurses should adjust and reset the catheter timely when catheter displacement occurs.

OBJECTIVETo investigate the difference in the CD4+T lymphocytes activation between long term non progressors (LTNP) and typical progressors (TP) of HIV-1 infected patients.

METHODSTwenty-four HIV-1 infected patients and 15 heathy control adults were tested and flow cytometry was used to detect the activation marker CD38 and CD4 count in blood samples taken from the patients and control. bDNA method was used to test the virus load in the plasma of patients.

RESULTSThe activation of CD4+T cells was positively correlated with virus load and negatively correlated with CD4 counts. Compared with normal controls, the activation of CD4+T cells was obviously increased in TP patients but not obviously changed in LTNP patients.

CONCLUSIONCompared with healthy controls, the activation of CD4+T cells in LTNP did not obviously increase. This maybe partially accounts for LTNP patients keeping a good state for a long time.

ADP-ribosyl Cyclase 1 ; analysis ; Adult ; CD4 Lymphocyte Count ; CD4-Positive T-Lymphocytes ; cytology ; immunology ; Female ; Flow Cytometry ; HIV Infections ; blood ; immunology ; virology ; HIV-1 ; genetics ; physiology ; Host-Pathogen Interactions ; Humans ; Lymphocyte Activation ; immunology ; Male ; Middle Aged ; RNA, Viral ; blood ; Time Factors ; Viral Load ; Young Adult

OBJECTIVETo create transgenic mice expressing hamster- and human-PRNP as a model for understanding the physiological function and pathology of prion protein (PrP), as well as the mechanism of cross-species transmission of transmissible spongiform encephalopathies (TSEs).

METHODSHamster and human-PRNP transgenic mice were established by conventional methods. The copy number of integrated PRNP in various mouse lines was mapped by real-time PCR. PRNP mRNA and protein levels were determined by semi-quantitative RT-PCR, real-time RT-PCR, and western blot analysis. Histological analyses of transgenic mice were performed by hematoxylin and eosin (H & E) staining and immunohistochemical (IHC) methods.

RESULTSIntegrated PRNP copy number in various mouse lines was 53 (Tg-haPrP1), 18 (Tg-huPrP1), 3 (Tg-huPrP2), and 16 (Tg-huPrP5), respectively. Exogenous PrPs were expressed at both the transcriptional and translational level. Histological assays did not detect any abnormalities in brain or other organs.

CONCLUSIONWe have established one hamster-PRNP transgenic mouse line and three human-PRNP transgenic mouse lines. These four transgenic mouse lines provide ideal models for additional research.

Animals ; Blotting, Western ; Cricetinae ; DNA ; genetics ; Disease Models, Animal ; Humans ; Immunohistochemistry ; Mice ; Mice, Inbred C57BL ; Mice, Transgenic ; Organ Specificity ; Plasmids ; Prion Diseases ; genetics ; Prion Proteins ; Prions ; genetics ; Real-Time Polymerase Chain Reaction ; Transcription, Genetic

This study was aimed to investigate the relevance of nilotinib in combination with tetrandrine (Tet) on reversing multidrug resistance and inducing apoptosis of K562/A02 cell line and its mechanism. Methyl-thiazol tetrazolium (MTT) assay was employed to examine the pharmacological effect of nilotinib or Tet alone on K562/A02 cell line, the IC(50) of daunorubicin (DNR) on K562/A02 cell line treated with nilotinib and Tet was calculated; the flow cytometry (FCM) was employed to detect the apoptosis rate of K562/A02. The expression of bax/survivin mRNA was determined by RT-PCR, and the expression of bax/survivin protein was assayed by Western blot. The results showed that after being treated by 5 nmol/L nilotinib or 1.0 µml/L Tet for 48 hours, IC(50) of DNR to K562/A02 was 5.71 ± 0.72 mg/L or 6.52 ± 0.43 mg/L, respectively, while in their combined treatment, IC(50) decreased to 3.12 ± 0.13 mg/L. Nilotinib or Tet alone could increase DNR-inducing apoptosis rate of K562/A02 cell, while the apoptosis rate of K562/A02 increased remarkably in combination treatment of nilotinib with Tet. After being treated with 5 nmol/L nilotinib or 1.0 µml/L Tet alone for 48 hours, the expressions of bax mRNA and BAX protein was up-regulated, while both effects were more obvious in combination treatment of nilotinib with Tet. Treatment with 5 nmol/L nilotinib or 1.0 µmol/L Tet alone for 48 hours down-regulated the expression of survivin mRNA and its protein, while treatment of nilotinib in combination with Tet had more significant effect on down-regulation of their expression. It is concluded that the K562/A02 cells are resistant to DNR, nilotinib or Tet alone both can partially reverse resistance of K562/A02 cells to DNR, increase the apoptosis rate of K562/A02 cells. Combination of nilotinib with Tet shows obvious synergistic action, mechanism of which may associate with up-regulation of bax mRNA and BAX protein expressions and down-regulation of survivin mRNA and its protein expressions.
Apoptosis ; drug effects ; Benzylisoquinolines ; administration & dosage ; pharmacology ; Daunorubicin ; pharmacology ; Drug Resistance, Multiple ; Drug Resistance, Neoplasm ; Gene Expression Regulation, Leukemic ; Humans ; Inhibitor of Apoptosis Proteins ; genetics ; K562 Cells ; Pyrimidines ; administration & dosage ; pharmacology ; bcl-2-Associated X Protein ; genetics

OBJECTIVETo prepare the PrP specific monoclonal antibodies (mAbs) that can be used for the detection of mammalian prions and study of pathogenesis of prion diseases.

METHODSSeveral BALB/c mice were immunized with recombinant hamster prion protein (HaPrP). Three hybridoma cell lines designated as B7, B9, and B10, secreting monoclonal antibodies against HaPrP, were established by hybridoma technique. The mAbs reactivities were evaluated with ELISA, Western blot, and immunohistochemistry.

RESULTSThe mAbs produced by these cell lines reacted well with different recombinant hamster PrP proteins. Western blot analyses showed that mAbs B7 and B9 reacted with PrPSc from the scrapie-infected animals after proteinase K digestion with three glycosylated forms. The mAbs exhibited cross-reactivity with various PrPC from several other mammalian species, including humans and cattles. Immunohistochemistry assays confirmed that mAbs B7 and B9 could recognize not only extracellular but also intracellular PrPsSc.

CONCLUSIONThe mAbs of prion protein are successfully generated by hybridoma technique and can be applied for the diagnosis of prion associated diseases.

Animals ; Antibodies, Monoclonal ; immunology ; Blotting, Western ; Brain ; metabolism ; Cell Line, Tumor ; Cricetinae ; Enzyme-Linked Immunosorbent Assay ; Female ; Immunization ; Immunohistochemistry ; Mice ; Mice, Inbred BALB C ; PrPC Proteins ; genetics ; immunology ; PrPSc Proteins ; genetics ; immunology ; Recombinant Proteins ; immunology