OBJECTIVE:To establish a method to determine the content of ferulic acid in Tianwang buxin pills. METHODS:HPLC was performed on the column of Diamonsil C18 with the mobile phase of acetonitrile-1% glacial acetic acid solution(15∶85, V/V)at the flow rate of 1.0 ml/min,the detection wavelength was 323 nm,the temperature was room temperature,and the volume was 20 μl. RESULTS:The linear range of ferulic acid was in the range of 0.091 2-2.28 μg/ml(r=0.999 8);the RSDs of precision, stability and reproducibility tests were less than 2.0%,and the average recovery was 98.96%(RSD=0.26%,n=9). CONCLU-SIONS:The method is simple,accurate and reliable,and can be used as the quality control method of ferulic acid in Tianwang buxin pills.

Objective To establish a method of TRFIA with high sensitivity and broad detecting range for serum HBV large surface protein (HBV-LP).Methods The monoclonal antibody of HBV-LP was covered on the microwell plate and incubated with HBV-LP in blood sample,then Eu3+ labeled antibody of HBs was added.HBV-LP in standard substance,blood samples of 66 chronic hepatitis B patients and 30 healthy controls was detected by the TRFIA and ELISA.x2 test and linear correlation analysis were used for data analysis.Results The dose-response curve of standard substance with TRFIA had good linear correlation (r=0.999).Normal reference range was established at 0-1.36 mg/L based on the ELISA results of 30 healthy controls.The sensitivity was 0.10 mg/L.The specificity was 100％ (30/30).Correlation coefficient between the TRFIA and the ELISA was 0.800 9 (P＜0.001).The positive detecting rates of the 2 methods were significantly different (89.4％(59/66) vs 77.3％(51/66),x2 =6.13,P＜0.01).The recovery rate for HBV-LP was between 95.93％-107.62％.The effective detecting range(CV＜10％) of TRFIA was 1.35-2 764.00 mg/L,and that of ELISA was 10.8-691.0 mg/L.Conclusion The TRFIA was established for HBV-LP detection with higher sensitivity and wider detecting range compared to ELISA.It has potential value for HBV screening and monitoring of antiviral therapy.

Objective To investigate the clinical procedural performance of CT-guided needle biopsy for peritoneal lesions.Methods CT-guided needle biopsy was performed in 84 consecutive patients (M : F=26 : 58) with peritoneal lesions.Results Among 84 cases,60 lesions were malignant (55 metastatic tumor,4 mesothelioma,1 lymphoma) and 24 were benign (11 tuberculosis, 13 inflammation).3 cases failed to get clear pathologic diagnosis because of lost data.Diagnostic accuracy was 91.7% (77/84).The major complications were noted in 3 patients(1 with bleeding,2 ascites exosmosis).Conclusion CT-guided needle biopsy for retroperitoneal lesions is highly practical and useful,should be considered complementary in the investigation of abdominal lesions.

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.

Objective To evaluate the prognostic values of common definition compared to traditional definition of contrast-induced nephropathy (CIN) in patients with normal serum creatinine (SCr). Methods Patients undergoing percutaneous coronary angiology or intervention with normal baseline SCr were enrolled prospectively. Those who were diagnosed as CIN according to common definition were divided into two groups based on the peak increase from baseline in the SCr concentration within 48 ~ 72 hours after the procedure: ≥ 44.2 μmol/L (CIN44.2 group, in common with traditional definition), ≥25% of baseline to < 44.2 μmol/L (CIN25%-44.2 group, interval between the two definitions). Hospital stay and long-term outcomes were compared among CIN44.2, CIN25%-44.2, and non-CIN groups. Results Of all 3,044 patients enrolled, 302 (9.9%) patients developed CIN according to common definition including CIN44.2 occurred in 56 (1.8%) patients and CIN25%-44.2 in 246 (8.1%) patients. Patients in CIN44.2 group indicated significant longer hospital stay and long-term outcomes compared with non-CIN group (P < 0.05). However, patients in CIN25%-44.2 group had similar in-hospital mortality and long-term cumulative risk of major clinical adverse events (MACE) and death with non-CIN group (all, P = 1.00). Multivariate Cox proportional hazard analyses also demonstrated that CIN25%-44.2 did not associate with long-term MACE (HR 1.16, P = 0.645) and death (HR 0.98, P = 0.964) after adjusting for potential confounding factors. Conclusions For patients with normal baseline SCr, common definition based on traditional definition of CIN is unreasonable and overestimates the incidence of CIN, whose extension of traditional denifition proves no significant clinical value.

Objective To analyze the mammographic findings of triple-negative breast cancer [TNBC,which is estrogen receptor (ER) negative,progesterone receptor (PR) negative,and human epidermal growth factor receptor 2 ( HER2 ) negative ] and triple-positive breast cancer ( TPBC,which is ER positive,PR positive,and HER2 positive ),and to evaluate the relationship of immunohistochemologic receptor status and mammographic findings.MethodsThe immunohistochemistry results of 631 cases with breast cancers were reviewed,including 117 cases of TNBC and 44 cases of TPBC.All of the patients took mammography at initial diagnosis.We retrospectively evaluated the visibility,morphology,distribution and size of the lesion (masses and calcifications) and breast density on mammography of TNBC,and compared them with those of TPBC.The age onset and tumor sizes of TNBC and TPBC were compared by using Chi-square test and t test.ResultsThe visibility rate of TNBC and TPBC on mammography were 88.0％(103/117) and 90.9％ (40/44),and the difference between them was insignificant ( x2 =0.055,P ＞0.05).TNBC was more frequently associated with merely a mass (56/103) than TPBC (12/40) (x2 =6.860,P＜0.01 ),and the mean diameter of the mass of TNBC [ ( 2.6 ± 1.4 ) cm ] was larger than that of TPBC [(2.0 ± 0.6) cm](t =2.087,P ＜ 0.05). TNBC were less frequently associated with microcalcifications (37/103) than TPBC ( 24/40 ) ( x2 =7.423,P ＜ 0.01 ).Mammographic density and lesion visibility were similar between the two different immunophenotypes of breast cancers.The mean age of TNBC (52±9) was more than that of TPBC (48 ±8) (t =2.759,P ＜0.01).Infiltrating ductal carcinoma was the main pathologic type of both groups.Basal-like breast cancer accounted for 49％ (57/117 ) of TNBC while none happened in TPBC.ConclusionsTNBC shows merely a mass with indistinct margins,lager size and is less associated with microcalcifications.These mammographic features might be useful in diagnosing triple negative breast cancer.

Objective To discuss the effectiveness of the second surgical procedure of adjacent segment degeneration after the first spinal fusion.Method 35 patients who had been performed spinal fusion in our hospital or had symptoms recurred or aggravated after 12 ～ 114 (42 ±35) months of the prior surgery were enrolled in this study.A second surgery was performed and intraoperative the intradiscal pressure of adjacent segments of degeneration and normal segments was measured.The VAS score systems were compared among prior surgery,3 months later and 2 years after the second surgery.Result The intradiscal pressure of adjacent segments after the cervical vertebra and lumbar vertebra fusion were [ (15 ± 4.6)cmH2O,(23 ±5.2)cmH2O],much higher than normal segments [ (3 ±2.3)cmH2O,(8 ±4.1)cmH2O](P ＜0.01).The VAS score systems of 3 months later and 2 years after the second surgery were [ (2.9 ±0.7),(2.0 ± 0.6) ],which were dramatically lower than the prior (7.8 ± 1.2) (P ＜ 0.01).In 12 ～ 46(31 ± 12) months of follow-up after the second procedure,X-ray and MRI showed that fusion segments reached nearly bone fusion,well decompressed and without nerve compression or other complications.Conclusion If recurrence of symptoms after spinal fusion were caused by adjacent segment degeneration,reoperation would guarantee good clinical outcome.

Recent research based on various animal models has shown the neuroprotective effects of erythropoietin (EPO). However, few studies have examined such effects of EPO in the clinic. In this study we enrolled patients with spinal cord ischemia-reperfusion (I-R) injury to investigate the clinical application of EPO and methylprednisolone (MP) for the neuroprotection against spinal cord I-R injury. Retrospective analysis of 63 cases of spinal cord I-R injury was performed. The Frankel neurological performance scale was used to evaluate the neurological function after spinal cord injury (SCI), including 12 cases of scale B, 30 cases of scale C, and 21 cases of scale D. These cases were divided into 2 groups: group A (27 cases) got treatment with both EPO and MP; group B (36 cases) got treatment with MP only. The neurological function of patients after treatment was evaluated by American Spinal Cord Injury Association (ASIA) index score, and activity of daily living (ADL) of the patients was also recorded. All patients got follow-up and the follow-up period ranged from 24 to 39 months (mean 26 months). There was no significance difference in neurological function between groups A and B before the treatment (P>0.05). However, the neurological function and ADL scores were significantly improved 1 week, 1 year or 2 years after the treatment compared to those before the treatment (P<0.05), and the improvement was more significant in group A than in group B (P<0.05). It is suggested that the clinical application of EPO and MP provides the neuroprotection against spinal cord I-R injury.

Objective To make a comparison between the plain radiograph, CT, and MR findings of gouty arthritis and to analyse the relationship between clinical data and imaging findings. Methods Fifty-four joints of 33 patients with a confirmed diagnosis of gouty arthritis were included in this study. In the morning, the blood uric acid level of patients was tested before meal. In the afternoon, their clinical data were recorded and joints were examinated by plain radiography, CT, and MRI. The imaging findings were evaluated by tophi, bone erosion, soft tissue swelling, hydrarthrosis, synovial thickness, and bone oedema. The data was analyzed by Chi-square test, indepentdent-samples t test, and logistic regression. Results The Chi-square test was utilized to evaluate number of joints with tophi(CT>plain radiography, MR>plain radiography, P<0. 01), soft tissue swelling (MR>CT>plain radiography, P<0. 01), hydrarthrosis(MR>CT, P<0. 01). In addition, 35 joints had bone oedema and 50 joints had synovial thickness. The course of disease(tophi positive group vs tophi negative group, P<0. 01) was analyzed by indepentdent-samples t test. The tophi's causative agents including bone erosion and course of disease were analysed by logistic regression(P<0. 01). Conclusions MRI is superior to CT and plain radiography on the early diagnosis of gout. Tophi and bone erosion may not affect the blood uric acid level. With the progression of disease, the probability of tophi formation increases. The relationship between the formation of tophi and bone erosion may be interpromotied.

Objective To investigate the predictive value of preprocedural cystatin C level for contrast-in-duced acute kidney injury (CI-AKI) and poor long-term outcome after cardiac catheterization. Methods One thou-sand one hundred and fifty-four patients underwent cardiac catheterization were enrolled in Guangdong general hos-pital. The level of serum cystatin C was determined at 24 hours pre-operation. A 2-year follow up was performed for each patient. Preprocedural cystatin C level was compared between patients with or without CI-AKI. The cystatin C quartiles were compared between patients with incidence of CI-AKI and patients with adverse in-hospital outcomes. Analyses of the receiver operating characteristic curves (ROC) were performed to evaluate the predictive value and cutoff level of cystatin C level for CI-AKI. The log-rank test and Cox regression analyses were also performed to in-vestigate the correlation between cystatin C level and poor long-term outcomes. Results CI-AKI occurred in 42 patients (3.6%). The cystatin C level was significantly higher in the CI-AKI group than that in the non-CI-AKI gu-oup (1.76 ± 1.05 vs 1.20 ± 0.50 mg/L, P=0.001). Patients with higher cystatin C level also had higher risk of CI-AKI and adverse in-hospital outcomes. ROC and Youden index showed that 1.3 mg/L cystatin C of was a fair dis-criminator for CI-AKI, but not significantly different from the Mehran CI-AKI score (AUC, 0.75 vs 0.76, P =0.874). After adjusting for other known CI-AKI risk factors, cystatin C level over 1.3 mg/L remained significantly associated with CI-AKI. During the long-term follow-up , the patients with cystatin C level over 1.3 mg/L were at a higher risk of all-cause mortality and MACEs (P < 0.001). Concusions A preprocedural cystatin C level over 1.3 mg/L was a good predictor of CI-AKI and poor long-term outcomes after cardiac catheterization.