There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; standards

OBJECTIVETo explore the effect of Danshensu on the lipid metabolism of hyperlipidemic rats.

METHODSixty clean male SD rats were selected. Twelve of them were selected in the basic control group and fed with common foods, and the remaining rats were fed with the high-fat feeds. After the successful modeling, they were randomly divided into the high-fat control group and low dose (10 mg x kg(-1) x d(-1)), medium dose (20 mg x kg(-1) x d(-1)) and high dose (40 mg x kg(-1) x d(-1)) Danshensu (dissolved in saline) groups. Both of the two groups were abdominally injected with the same volume of normal saline once a day for consecutively 30 days. The serum TG, TC, HDL-C and liver ACC1, FAS, HMGR, CPT-I mRNA expressions were detected.

RESULT AND CONCLUSIONDanshensu could inhibit the LDL-C level, timely clear redundant cholesterol and effectively regulate the lipid metablism of hyperlipidemic rats by reducing the TC content, decrease the fatty acid by reducing the FAS mRNA expression, and reduce the synthesis levels of endogenous cholesterol by inhibit the HMGR mRNA expression.

Animals ; Hyperlipidemias ; drug therapy ; metabolism ; Lactates ; pharmacology ; Lipid Metabolism ; drug effects ; Male ; Rats ; Rats, Sprague-Dawley

Objective To investigate the correlation between α1-adrenergic receptor and the pathological behavior of cholangiocarcinoma, and the effects of norepinephrine (NE) on the proliferation of cholangiocarcinoma cell line QBC939. Methods Thirty-six samples of cholangiocarcinoma were resected in Southwest Hospital from August 2002 to March 2008. The expression of α1-adrenergic receptor in the 36 samples of cholangiocarcinoma tissue and 4 samples of normal bile duct tissue were detected by SABC technique. The proliferation of cholangio-carcinoma cell line QBC939 was detected after processing the cells with NE, phentolamine and prazosin. All the data were analyzed by chi-square test. Results The high positive expression rate of α1-adrenergic receptor was 68% (17/25) in patients with lymph node metastasis, which was significantly higher than 9% (1/11) in patients without lymph node metastasis (χ2=10.604, P<0.05). The high positive expression rate of α1-adrenergic receptor was 85% (11/13) in patients with middle and low positioned cholangiocarcinoma, which was significantly higher than 30% (7/23) in patients with hilar cholangiocarcinoma (χ2=9.753, P<0.05). NE promoted the proliferation of cholangiocarcinoma cell line QBC939 by stimulating the expression of α1-adrenergic receptor, and in a concentration-dependent manner. The proliferative effect was weakened as time passed by, and it was eliminated by phentolamine and prazosin. Conclusions The expression of α1-adrenergic receptor is diverse due to lymph node metastasis and the location of the tumor, α1-adrenergic receptor with high expression may play an important role in the proliferation and metastasis of cholangiocarcinoma.

Taking application of some isolation and purification technologies, such as solvent extraction, preliminary solvent isolation, column chromatographies over silica gel and Sephadex LH-20 gel and preparative HPLC, 10 compounds were obtained from Gynura nepalensis cultivated in the suburban area of Beijing. Their structures were identified by spectroscopic methods and comparison with literature as (3R) -3-hydroxy-β-ionone (1), (3S,5R, 6S, 7E) -5, 6-epoxy-3-hydroxy-7-megastigmen-9-one (2), (+) -boscialin (3), 3, 6-trans-3-hydroxy-α-ionone (4), 3, 6-cis-3-hydroxy-α-ionone (5), 3, 4-cis-3, 4-dihydroxy-β-ionone (6), ethyl caffeate (7), loliolide (8), 1H-indole-3-carbaldehyde (9), and 3-(hydroxyacetyl)indole (10), respectively. All compounds were isolated from the title plant for the first time, and with compounds 1, 2, 4-7, 9 and 10 being isolated from Gynura species for the first time. Structurally, the above compounds 1-6 belong to C13 nor-sesquiterpenoids, sharing the same carbon skeleton of megastigmane. According to this study, they are one of major kinds of chemical constituents of Gynura nepalensis and have important reference value for the investigation on phytotaxonomy of this species.
Asteraceae ; chemistry ; Caffeic Acids ; chemistry ; Cyclohexanones ; Drugs, Chinese Herbal ; chemistry ; Glucosides ; Indoles ; chemistry ; Mass Spectrometry ; Molecular Structure ; Norisoprenoids ; chemistry

Taking application of some isolation and purification technologies, including crushing, solvent extraction, preliminary solvent isolation, column chromatographies over silica gel and Sephadex LH-20 gel and preparative HPLC, 8 compounds were obtained from the seeds of Jufeng grape sourced from market. Their structures were identified by spectroscopic methods and comparison with literature values as Catechin (1), Epicatechin (2), quercetin (3), ethylgallate (4), rel-(2S, 3R) -2-(4-hydroxy-3-methoxyphenyl) -3- (hydroxymethyl)-5-(3-hydroxypropyl)-2,3-dihydrobenzofuran-7-ol (5), rel-(2α, 3β)-7-O-methylcedrusin (6), rel-(1R,2S)-1-(4-hydroxy-3-methoxyphenyl) -2-(4-(3-hydroxypropyl) -2-methoxyphenoxy) propane-1,3-diol (7), and (+) -isolariciresinol (8), respectively. Compounds 5-8 were serial lignans isolated from the seeds of grape for the first time. Structurally, 5 and 6 belong in benzofuran-8,3'-neolignans, 7 in 8,4'-oxyneolignan, and 8 in 8,8' :2,7'-cyclolignan. According to in vitro activity evaluation conducted in cell model, compound 6 showed significant anti-oxidative ability, with the activity of RAW264. 7 cell superoxide dismutase being raised evidently in the test as compared with the positive anti-oxidative agents, compounds 1 and 2.
Antioxidants ; chemistry ; isolation & purification ; Magnetic Resonance Spectroscopy ; Plant Extracts ; chemistry ; isolation & purification ; Seeds ; chemistry ; Vitis ; chemistry

Ongoing study on the chemical constituents of the roots of Macleaya microcarpa led to the isolation of eight compounds of derivatives of triterpenes and organic acids in addition to some previously identified benzophenanthridines. The eight compounds were identified by spectroscopic methods as well as comparison with literature values as 1-oxo-2, 22 (30)-hopandien-29-oic acid (1), 3-oxo-12-oleanen-30-oic acid (2), 3α-hydroxy-12-oleanen-30-oic acid (3), 3β-hydroxy-12-oleanen-30-oic acid (4), ferulic acid (5), ferulic acid 4-O-β-D-glucoside (6), 3-O-feruloylquinic acid (7), and methyl 3-O-feruloylquinate (8). Of which, 1 is a new triterpenoid of hopanes and 2-8 are isolated from M microcarpa for the first time. In order to discover natural active compounds as potential agents of anti-ulcerative colitis (UC), an in vitro drug high-throughput screening model targeted x-box-binding protein 1 (xbp1) was employed to evaluate the activity of the major chemical constituents of M microcarpa. The result confirmed that two dihydrobenzophenanthridines, dihydrosanguinarine (9) and dihydrochelerythrine (10), showed a certain activity on activating the transcription of xbpl, a transcription factor (TF) associated with the occurrence, development, and potential treatment of UC, with their relative activating ratios being 1.76 and 1.77 times, respectively, as compared with control group.
Anti-Ulcer Agents ; chemistry ; Benzophenanthridines ; chemistry ; DNA-Binding Proteins ; genetics ; Isoquinolines ; chemistry ; Papaveraceae ; chemistry ; Plant Roots ; chemistry ; Regulatory Factor X Transcription Factors ; Transcription Factors ; genetics ; Transcription, Genetic ; Triterpenes ; chemistry

Background:Accumulating studies on computational fluid dynamics (CFD) support the involvement of hemodynamic factors in artery stenosis.Based on a patient-specific CFD model,the present study aimed to investigate the hemodynamic characteristics of transplant renal artery stenosis (TRAS) and its alteration after stent treatment.Methods:Computed tomography angiography (CTA) data of kidney transplant recipients in a single transplant center from April 2013 to November 2014 were reviewed.The three-dimensional geometry of transplant renal artery (TRA) was reconstructed from the qualified CTA images and categorized into three groups:the normal,stenotic,and stented groups.Hemodynamic parameters including pressure distribution,velocity,wall shear stress (WSS),and mass flow rate (MFR) were extracted.The data of hemodynamic parameters were expressed as median (interquartile range),and Mann-Whitney U-test was used for analysis.Results:Totally,6 normal,12 stenotic,and 6 stented TRAs were included in the analysis.TRAS presented nonuniform pressure distribution,adverse pressure gradient across stenosis throat,flow vortex,and a separation zone at downstream stenosis.Stenotic arteries had higher maximal velocity and maximal WSS (2.94 [2.14,3.30] vs.1.06 [0.89,1.15] m/s,256.5 [149.8,349.4] vs.41.7 [37.8,45.3] Pa at end diastole,P =0.001;3.25 [2.67,3.56] vs.1.65 [1.18,1.72] m/s,281.3 [184.3,3 64.7] vs.65.8 [61.2,71.9] Pa at peak systole,P =0.001) and lower minimal WSS and MFRs (0.07 [0.03,0.13] vs.0.52 [0.45,0.67] Pa,1.5 [1.0,3.0] vs.11.0 [8.0,11.3] g/s at end diastole,P =0.001;0.08 [0.03,0.19] vs.0.70 [0.60,0.81] Pa,2.0 [1.3,3.3] vs.16.5 [13.0,20.3] g/s at peak systole,P =0.001) as compared to normal arteries.Stent implantation ameliorated all the alterations of the above hemodynamic factors except low WSS.Conclusions:Hemodynamic factors were significantly changed in severe TRAS.Stent implantation can restore or ameliorate deleterious change of hemodynamic factors except low WSS at stent regions.

OBJECTIVETo investigate the features of intraductal papilloma of the breast in mammography and magnetic resonance imaging (MRI) and assess the diagnostic values of the two imaging modalities.

METHODSFifteen patients with intraductal papilloma of the breast confirmed surgically and pathologically underwent X-ray examination of the breast, and 11 of them also received enhanced MRI. The imaging findings by mammography and MRI were compared.

RESULTSEnhanced MRI clearly displayed the location and morphology of the intraductal papilloma, and 7 patients showed smooth tumor margins and 2 showed irregular margins. On T(1)WI, the lesions were isointense or slightly hypointense, and appeared isointense or slightly hyperintense on T(2)WI. Some of the intraductal papillomas were seen encapsulated in the dilated ductal. The varying enhancement features of the lesions increased the difficulty in distinguishing from carcinoma. Mammography identified intraductal papillomas only in 2 of the 15 cases (13%) with lesion feature similar to that found by MRI. Fine cluster calcification was found in 1 case.

CONCLUSIONMRI can more accurately define the location of the lesion than X-ray. In spite of some resemblance in the MRI findings between intraductal papillomas and breast carcinoma, MRI still serves as a useful diagnostic modality for intraductal papilloma that shows some characteristic findings.

Adult ; Aged ; Breast Neoplasms ; diagnostic imaging ; pathology ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Mammography ; Middle Aged ; Papilloma, Intraductal ; diagnostic imaging ; pathology ; Sensitivity and Specificity

OBJECTIVETo observe the effect of laparoscopy-assisted and open distal gastrectomies on the perioperative levels of C-reactive protein (CRP) and visceral proteins in patients with gastric cancer.

METHODST Fifty-three patients with gastric cancer were randomized into two groups to receive laparoscopic surgery (n=26) or open surgery (n=27). The CRP levels were measured preoperatively and at 1, 2, 3 and 7 days after the operation. The levels of the visceral proteins including albumin (ALB), prealbumin (PRE), transferrin (TRF) and retinal-binding protein (RbP) were assayed before and at 3 and 7 days after the operation.

RESULTSCompared with the preoperative levels, the CRP levels in both groups were significantly increased on days 1, 2, and 3 after the operation (P<0.05), with the highest level occurred on day 2 postoperatively. The postoperative CRP levels were significantly lower in the laparoscopic group than in the open surgery group (P<0.01). The levels of ALB, PRE, TRF, and RbP were significantly decreased after operation in both groups (P<0.01) without significant differences between the two groups (P>0.05).

CONCLUSIONCompared with open surgeries, laparoscopy-assisted distal gastrectomy for gastric cancer causes minimal surgical trauma and mild inflammatory responses to allow the recovery of the levels of the visceral proteins.

Adult ; Aged ; C-Reactive Protein ; metabolism ; Female ; Gastrectomy ; Humans ; Intraoperative Period ; Laparoscopy ; Male ; Middle Aged ; Stomach Neoplasms ; blood ; metabolism ; surgery ; Young Adult

Plateau zokor (Myospalax baileyi) and plateau pika (Ochotona curzniae) are native to the Qinghai-Tibet plateau. To study their adaptive mechanisms, the ratios of heart weight to body weight (HW/BW) and right to left ventricular plus septum weights [RV/(LV+S)] were determined; the microvessel density (MVD) of cardiac muscle were measured by immunohistochemical staining; the numerical density on area (N(A)), volume density (V(V)), specific surface (δ), and surface density (S(V)) of mitochondria were obtained by microscopy and stereology; the contents of myoglobin (Mb) and lactic acid (LD), and the activity of lactate dehydrogenase (LDH) in cardiac muscle were analyzed by spectrophotometer. The results showed that the HW/BW of plateau zokor [(4.55±0.26)%] and plateau pika [(4.41±0.38)%] was significantly greater than that of Sprague-Dawley (SD) rat [(3.44±0.41)%] (P<0.05), but the RV/(LV+S) [(22.04±1.98)%, (25.53±3.41)%] was smaller than that of SD rats [(44.23±3.87)%] (P<0.05). The MVD and N(A) of cardiac muscle were 1688.631±250.253 and 0.768±0.123 in SD rat, 2002.888±367.466 and 0.868±0.159 in plateau pika and 2 990.643±389.888 and 1.012±0.133 in plateau zokor. The V(V) of mitochondria in plateau zokor (0.272±0.045) was significantly lower than that in plateau pika (0.343±0.039) and SD rat (0.321±0.048) (P<0.05), while the δ of mitochondria in plateau zokor (9.409±1.238) was higher than that in plateau pika (6.772±0.892) and SD rat (7.287±1.373) (P<0.05). The S(V) of mitochondria in plateau pika (2.322±0.347) was not obviously different from that in plateau zokor (2.468±0.380) and SD rat (2.227±0.377), but that in plateau zokor was significantly higher than that in SD rat (P<0.05). The contents of Mb in cardiac muscle of plateau zokor [(763.33±88.73) nmol/g] and plateau pika [(765.96±28.47) nmol/g] were significantly higher than that of SD rat [(492.38±72.14) nmol/g] (P<0.05), the content of LD in plateau zokor [(0.57±0.06) mmol/L] was obviously higher than that in plateau pika [(0.45±0.06) mmol/L] and SD rat [(0.48±0.02) mmol/L] (P<0.05), and the activity of LDH in plateau zokor [(16.90±2.00) U/mL] and plateau pika [(20.55±2.46) U/mL] were significantly lower than that in SD rat [(38.26±6.78) U/mL] (P<0.05). The percentage of LDH-H in cardiac muscle decreased in order in plateau zokor, plateau pika and SD rat. In conclusion, plateau zokor and plateau pika adapt better to hypoxia than SD rat by increasing the SV of mitochondria, MVD and content of Mb in the cardiac muscle. However, the parameters of mitochondria in the two high-altitude animals are different possibly because of the differences of habitats and habits.
Adaptation, Physiological ; Animals ; Heart ; physiology ; Hypoxia ; metabolism ; Isoenzymes ; metabolism ; L-Lactate Dehydrogenase ; metabolism ; Lagomorpha ; physiology ; Rats ; Rats, Sprague-Dawley ; Tibet