The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results

OBJECTIVETo evaluate the monitoring of ultrasonography in artificial vascular graft for arteriovenous fistula and its complications in patients with chronic renal failure.

METHODSEighteen cases of artificial vascular graft arteriovenous fistula after four to six weeks were enrolled. The diameter, the peak velocity and blood flow were examined in arterial fistula. And the artificial vascular diameter, the peak velocity and blood flow of artificial vessels next to artery were all examined and analyzed. And the patients with symptoms in the upper extremity were tested by ultrasound.

RESULTSIntravascular blood showed good filling in fistula and artificial blood vessels in four to six weeks after artificial vascular graft for arteriovenous fistula by color doppler ultrasonography. The arterial fistula diameter, the peak velocity and blood flow were (3.61 +/- 0.68) mm and (298.56 +/- 93.42) cm/s and (583.62 +/- 216.77) ml/min. Artificial vascular diameter in (4.47 +/- 0.61) mm, the peak velocity and blood flow were (219.37 +/- 68.42) cm/s and (325.23 +/- 117.12) ml/min in the artificial blood vessels next to artery. Seven patients with upper extremity discomfort were examined by ultrasonography. One case was serum swollen. Three cases were thrombosis in artificial vessels. One case was pseudoaneurysm. Two cases were edema.

CONCLUSIONSUltrasonography plays a significant clinic role in testing artificial vascular graft for arteriovenous fistula and its complications.

Aged ; Arteriovenous Shunt, Surgical ; Blood Vessel Prosthesis Implantation ; Female ; Follow-Up Studies ; Hemodynamics ; Humans ; Male ; Middle Aged ; Postoperative Complications ; diagnostic imaging ; Postoperative Period ; Ultrasonography, Doppler, Color

Objective To study the effects of angiotensin converting enzyme inhibitor benazepri1 on apoptosis and the expression of Fas and FasL in the kidney of rats with adriamycin-indued nephritic glomeruosclerosis.Methods After uninephrectomy and the injection of adriamycin induced rats model with glomerulosclerosis, benazapril(6 mg/kg) was delivered daily by gavage to the rats in therapeutic groups for 12 weeks.Apoptosis was examined by means of terminal-deoxynucleotidyl trans ferase mediated d-UTP nick end label ling(TUNEL) and immunohistochemistry was utlized to detect the expression of Fas and FasL.Software of pathological analysis quantitated the level of Fas and FasL.Results Compared with those of the control group, the kidney of model group had moresevere glomerulosclerosis, much more apoptotic cells and higher level of exprssion of Fas and FasL. The degree of glomeruloscleroais, the nuxner of apoptotic cells and the level of expression of Fas and FasL were ameliofated by benazepril treatment.Conclusion Benazepril may suppress the excessive apoptosis of kidney cell by lowering the expression of the protin correlatng apoptosis Fas and FasL,so as to postpone the process of glomeruosclerosis.

The crude toxin was extracted from hypha and culture solution of Phyllosticta commelimecola through three different polarity solvent: benzinum, puncificatum ethyl acetate and chloroform. The result indicated that the toxin secreted by Phyllosticta commelimecola not only was in hypha but also in culture solution and the extracting effect of ethyl acetate was the best. The soybean median and PSK media can be respectively used as solid and liquid culture media to produce toxin and grow mycelium. The optimal cultural conditions for producing toxin were temperature 32℃,cultured period 14d, cultured ways shaking of 150r/min.

OBJECTIVETo explore the values of tissue factor (TF) and vascular endothelial growth factor (VEGF) expressions on peripheral CD14+ monocytes in disease assessment, prognosis, and short-term efficacy evaluation of non-Hodgkin lymphoma (NHL) patients.

METHODSTF and VEGF expressions on CD14+monocytes in 47 NHL patients (disease group) before chemotherapy and after 4 chemotherapy cycles and in 30 healthy subjects (control group) were detected by flow cytometry, and the potential relationship among TF, VEGF, International Prognostic Index (IPI), and short-term efficacy were analyzed.

RESULTSTF and VEGF expressions on CD14 + monocytes in disease group were significantly higher than those in control group ( all P <0. 01) and positive correlation was showed between them (r = 0. 708, P = 0.00). TF and VEGF expressions in Ann Arbor stage III and IV (n = 22 and 19) , symptomatic (n = 22) , lactate dehydrogenase (LDH) increased (n = 21) , Eastern Cooperative Oncology Group (ECOG) score 2-4 (n = 12) and extranodal lesions >1 (n = 16) groups were significantly higher than those in Ann Arbor stage II (an = 6) , asymptomatic (an =25) , LDH normal (n = 26) , ECOG score 0-1 ( n = 35) and extranodal lesions ~1 ( na = 31) groups, respectively (all P <0.05). The expressions of TF and VEGF on CD14 + monocytes in high-risk (n = 7) or high-middle-risk (n = 11) groups were significantly increased compared with low-risk (n = 15) or low-middle-risk(n = 14) groups, respectively (all P <0. 01). TF and VEGF expressions in non-remission group before chemotherapy (n = 11) were both obviously higher than those in remission group (an = 36, all P <0. 01) , and after chemotherapy their expressions in remission group were significantly lower than those before chemotherapy (all P <0. 01) , while such significant changes were not observed in the non-remission group ( all P > 0. 05).

CONCLUSIONThe high expressions of TF and VEGF on peripheral CD14 + monocytes can be useful markers in dis-ease assessment, prognosis evaluation and short-term efficacy observation of NHL patients.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Case-Control Studies ; Child ; Female ; Humans ; Lipopolysaccharide Receptors ; Lymphoma, Non-Hodgkin ; blood ; Male ; Middle Aged ; Monocytes ; metabolism ; Prognosis ; Thromboplastin ; metabolism ; Vascular Endothelial Growth Factor A ; blood ; Young Adult

Objective To explore the effects of stimulating vagus nerve with pulse current on peripheral blood CD4+T lymphocyte of rats with collagen induced arthritis and its mechanism.Methods To duplicate model rats of experimental arthritis(EA)by intradermal injection of Ⅱtype collagen,divide the rats into 2 groups:vagus nerve stimulation(VNS)group and sham operated group.Rats in VNS group were stimulated at the left cervical vagus nerves for 30 minutes a day with constant square wave,pulse current with intra train of 16 Hz,pulse duration of 1.0 ms,train duration of 10 s,interstimulus interval of 1.5 min and intensities of 3.0 mA.Then flow cytometry and immunofluorescence methods were used to detect the activation of CD4+T lymphocytes(expressing CD71)and the expression of nicotinic acetylcholine receptors alpha 7(nAChR?7)and choline acetyltransferase(ChAT)in peripheral blood CD4+T lymphocytes.Results In VNS group,the expression of nAChR?7 and ChAT were significantly raised in CD4+ T cells at 1st weekend(Pa

OBJECTIVETo study, the high polar media-water extraction process of Herba epimedii with the microwave technology.

METHODThe single parameters of extraction process was investigated with dry extract yield and extraction efficiency of icariin as content index.

RESULTThrough studying the single parameter, the optimal conditions are as follows: 70% ethanol as wetting solvent, volume of solvent to weight of material equal to 6:1 in wetting, 30 min wetting time, 2.5 min microwave irradiation time, volume of solvent to weight of material equal to 50:1 in extraction process, 10 min microwave-assisted extraction time.

CONCLUSIONCompared with conventional methods, microwave-assisted extraction (MAE) after Microwave Pretreament (MP) of raw material was higher extraction efficiency and time-saving.

Drugs, Chinese Herbal ; analysis ; isolation & purification ; Epimedium ; chemistry ; Flavonoids ; analysis ; isolation & purification ; Microwaves ; Plants, Medicinal ; chemistry ; Solvents ; Technology, Pharmaceutical ; methods

OBJECTIVETo observe the therapeutic effect of Qingfei Huatan Quyu method (QHQ, a Chinese medicinal therapy for clearing Fei-heat and dissolving phlegm-stasis) combined with hormone-antibiotic therapy (HAT) on radiation pneumonia (RP).

METHODSEighty-one patients with RP were randomized into two groups, 41 patients in the control group and 40 in the treatment group were treated with HAT alone and HAT combined with QHQ respectively for 21 days. The severity of RP was evaluated before and after treatment according to the criteria of the radiation therapy oncology group. The effect on TCM symptoms and chest roentgenogram, as well as on plasma levels of interleukin-6 ( IL-6) and transform growth factor-beta (TGF-beta) were detected.

RESULTSAfter treatment, number of patients with RP graded as 0, 1, 2, 3, and 4 in the treatment group was 23, 10, 4, 2, and 1, respectively, while in the control group, 14, 9, 11, 4, and 3, respectively. The combined therapy showed effects in improving RP grading (P <0.01) and TCM syndromes were superior to those of HAT respectively (P < 0.05). Besides, levels of IL-6 and TGF-beta were lowered after treatment in the treatment group, showing a significant difference to those in the control group (P <0.05).

CONCLUSIONQHQ combined with HAT has a definite therapeutic effect on RP. It could efficiently decrease the plasma levels of IL-6 and TGF-beta in patients with RP.

Anti-Bacterial Agents ; therapeutic use ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Interleukin-6 ; blood ; Medicine, Chinese Traditional ; Radiation Pneumonitis ; drug therapy ; Transforming Growth Factor beta ; blood