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

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.

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

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

Aim To discuss the effect of Danhong in-jection(DHI) on hyperlipidemia in rats and its possible mechanism. Methods The hyperlipidemia model of rats were induced by high fat diet. The protein expres-sion of adenosine 5'-monophosphate-activated protein kinase(AMPK), p-AMPK, cholesterol-binding ele-ment binding protein (SREBP-1), adenylate-activated protein kinase carboxylasecetyl-CoA(ACC) and p-ACC in liver were detected using Western blot. Results The protein expression levels of AMPK, SREBP-1 and ACC significantly decreased (P<0.05), but the pro-tein expression levels of p-ACC and p-AMPK signifi-cantly increased (P<0.05). Conclusions Danhong injection can reduce the activity of SREBP-1 and ACC by enhancing the activation of AMPK, and effectively reduce the blood lipid level of hyperlipidemic rats by promoting fatty acid oxidation and reducing lipid depo-sition.