Objective:To investigate overall quality status of rose bengal agar culture medium for drug control in China to provide technical support for the drug standard revision. Methods:Four quality control microorganisms, namely Aspergillus niger, Candida al-bicans, Staphylococcus aureus and Escherichia coli, were used to evaluate the quality of rose bengal agar culture medium from 7 domes-tic and foreign manufacturers. Results:Including the control medium, the pH value of all the 8 media was different. The growth rate of Aspergillus niger and Candida albicans in the seven tested media were all above 0. 7 without significant difference (P>0. 05). The selectivity factors of Staphylococcus aureus in the seven media and the control medium was more than 6. The eight media showed differ-ences in the selectivity factors of Escherichia coli. Among them, A, B, C, E, G and the control medium had no inhibitory ( selectivi-ty) , while D and F showed certain selectivity. Conclusion:The rose bengal agar media from different manufacturers for drug control show similar growth-promoting ability with different pH value and selectivity to Escherichia coli.

Objective To explore the risk factors of diabetic nephropathy.Methods According to the excretion rate of proteinuria,90 patients were divided into 3 groups:normal diabetic proteinuria group (DM),diabetic micro-proteinuria group (DN1),and clinical diabetic proteinuria group (DN2).We compared patients'ages,diabetic course,cholesterol,triglyceride,glycosylated hemoglobin,high density lipoprotein cholesterol (HDL),low density lipoprotein cholesterol (LDL),serum p-selectin,serum C-reactive protein,urinary monocyte chemotactic protein,and proteinuria excretion rate.Logistic regression analysis was used to analyze the relation between DN and various factors.Results Differences among these groups were statistically significant in type 2 diabetic course,HDL,LDL,p-selectin,C-reactive protein,glycosylated hemoglobin,and urinary monocyte chemotactic protein (P ＜ 0.05).Logistic regression analysis showed that diabetic course,LDL,C-reactive protein,p-selectin,and urinary monocyte chemotactic protein were independent risk factor (OR values were 2.238,1.062,6.723,1.166,and 1.046).Conclusions Occurrence and severity of DN had relationship with course of diabetes,microvascular lesions,and inflammatory reaction.Emphasis on monitoring and evaluation of the DN-related factors would contribute to the prevention and treatment of DN.

Objective To investigate the value of quantitative analysis in the diagnosis of renal lesions with contrast-enhanced ultrasound.Methods Sixty cases with renal lesions confirmed by surgery and pathology underwent contrast-enhanced ultrasound preoperatively and quantitative analysis retrospectively.The Sonoliver software was applied in the analysis of CEUS imaging and in the recoustruction of quantitative parameter,s.Five parameters were calculated,including the maximum intensity (IMAX),rise time (RT),time to peak (TTP),mean transit time (mTT) and area under the curve (AUC).Results There were statistically differences in parameters RT,mTT and AUC ( P ＜ 0.05) and significant differences in parameter IMAX ( P ＜0.01).In malignant tumors,the RT and mTT were less than that of the benign while IMAX and AUC were more than that of the benign.Conclusions Contrast-enhanced ultrasound using a quantitative parametric analysis offers more information and is a promising tool in the diagnosis and differentiation of renal masses.

The paper introduces the status of TCM symptoms information application,constructs the symptoms knowledge classification system by taking the TCM Diagnostics as the knowledge source,constructs the symptoms knowledge representation model based on the classification and coding technologies,and draws a conclusion that the data analysis result is consistent with the actual clinical situation based on collecting symptom data in the Electronic Medical Records (EMR) and correlation analysis using this model.

Objective:To provide the basic data for the further revision of mycoplasma test method described in Chinese Pharma-copoeia and some references for the operation standardization of drug mycoplasma test. Methods:Two incubation conditions,namely aerobic conditions and microaerophilic conditions,were compared with respect to the growth status of mycoplasma in liquid and solid media. Results:The growth of mycoplasma was obvious difference between the two incubation conditions,and the microaerophilic con-ditions were better than the aerobic conditions. Conclusion:The microaerophilic conditions can be used in the incubation of mycoplas-ma test,which should be defined and standardized in the future Chinese Pharmacopoeia.

Microbiological data deviations ( MDD) investigation differs from out of the standard ( OOS) investigation in chemical inspection items. Investigating Out-of-Specification( OOS) Test Results for Pharmaceutical Production issued by FDA specifically ex-cludes microbiological and other biological assays. Until recently, there is not a definitive guideline for MDD investigation in the world. Some institutions and experts have explored the practice and theory of MDD investigation. Referred to the existing practical experience and theoretical achievement and based on the provisions of Chinese GMP (2010 revision) and the requirements of Chinese Pharmaco-poeia Ⅱ(2010 edition) Appendix XIX Q, the article discussed the methods for MDD laboratory investigation.

Objective:To investigate the growth-promoting properties and applicability of the mycoplasma test culture media pre-scribed in Chinese pharmacopoeia, and provide reference for the standardization of the drug mycoplasma test method. Methods: Re-spectively using four quantitative detection methods including sensitivity, degree of color change, colony counts and colony diameter, and mycoplasma media widely used in the world as the reference media, the growth-promoting properties of 4 batches of mycoplasma broth and 4 batches of arginine mycoplasma broth from four domestic manufacturers were investigated. Results:The results of sensitivity assay and absorbance detection showed that all the media inoculated with below 100 CFU test microorganisms exhibited visible color change. Furthermore, the results of color change degree and colony diameter showed that there were significant differences among the media products from different manufacturers(P<0. 01). Conclusion:Mycoplasma broth and arginine mycoplasma broth both can sup-port the growth of below 100 CFU test microorganisms. Due to the difference in the growth-promoting properties among the media prod-ucts from different manufacturers, the drug mycoplasma test workers should use more sensitive methods to examine the applicability of the media.

Objective To summarize the safety and efficacy of low dose of hepatitis B immunoglobulin (HBIG) for prevention of de novo hepatitis B infection after renal transplantation.MethodsThe clinical data of 138 patients who received renal transplantation without hepatitis B infection between January 2007 and June 2010 were retrospectively studied (study group).All the patients in study group were given low dose of HBIG injection before transplantation.The HBsAb titer was monitored regularly after transplantation,and the dosage of HBIG adjusted according to the level of the HBsAb titer.HBIG was implied to all patients in the study group for more than one year.The clinical data of 196 patients who received renal transplantation without hepatitis B infection between January 2004 and December 2006 served as the control group.These 196 patients were not treated with HBIG.The incidence of de novo hepatitis B infection,and acute rejection of these two groups was analyzed.The one-year graft and patients survival rate was also investigated.Results During the follow- up period of 12 months,only one case in the study group had de novo hepatitis B infection (0.7％) 6 months after renal transplantation,while 11 cases (5.6％) in the control group had de novo hepatitis B infection,in which 2 cases were died from acute hepatic failure.The incidence of de novo hepatitis B infection had statistically difference between the two groups (P＜0.05).The incidence of acute rejection in the study and control groups was 13.8％ and 17.3％ respectively (P＞0.05).The one-year graft and patient survival rate in the study and control groups was 96.4％ and 97.8％,and 90.3％ and 91.8％ respectively (P＜0.05).ConclusionLow dose of HBIG is effective and safe for prevention of de novo hepatitis B infection after renal transplantation.

Objective To investigate the relationship between hemodynamic parameters from quantitative analysis of contrast-enhanced ultrasonography (CEUS) on hepatocellular carcinoma (HCC) and pathological tumor differentiated grades. Methods Seventy-seven HCC lesions were examinated and off-line analyzed with dynamic images. Quantitative parameters such as slope of decrease to half of peak (SD), increased signal intensity (ISI), area under the curve (AUC) and blood flow coefficient (BF) were acquired, and the standardized values (sISI, sAUC and sBF) included the ratio of parameters from tumor to those from hepatic parenchyma. These quantitative parameters were correlated with tumor grades according to Edmonson criteria. Results There was significant difference (P＜0.05) of SD, AUC and BF, as well as standardized values (sISI, sAUC and sBF) between different grades of HCC. AUC, BF, sISI, sAUC and sBF were negative correlated with differentiated grades, respectively (P＜0.05). Well-differentiated HCC had significantly higher perfusion values than HCC of other grades (P＜0.05). Conclusion Quantitative analysis of CEUS can assess differentiation of HCC indirectly, and might reveal biological behavior of malignant tumors.

Objective To explore the diagnostic value of contrast-enhanced ultrasonography (CEUS) in ureteral lesions.Methods The ultrasonogram of conventional ultrasound and CEUS were retrospectively analyzed in 19 confirmed ureteral lesions cases by operation and pathology.The size,inner echoes,boundary and color blood signal of ureteral lesions were observed by conventional ultrasound.The modality and phases of enhancement,including arrival time,peak time,washout time and appearance of internal structure,were observed by CEUS.Results The 19 ureteral tumors were of maximum widths between 2.1 to 7.7 cm.Conventional ultrasound showed 7 hypoechoic masses,10 isoechoic masses,1 hyperechoic mass and 1 unclear mass.Color Doppler flow imaging showed fairly rich blood signal in 8 tumors,a small amount of blood signal around tumor in 6 tumors and no blood signal in the rest.In early phase,CEUS showed enhancement in all 19 ureteral lesions,including synchronously enhancement in 8 tumors and delayed enhancement in 11 tumors.In peak time,hypoechogenicity compared to the normal renal cortex was shown in 3 tumors,hyperechogenicity in 11 tumors and isoechogenicity in 5 tumors.In late phase,fast wash-out was displayed in 16 tumors,isochronously wash-out in 1 tumor,delayed wash-out in 1 tumor and unclear in 1 tumor.The detection rates of blood supply and clear boundary in ureteral lesions and the diagnostic sensitivity for ureteral cancer were 74% (14/19),16% (3/19),50% (8/16) by conventional ultrasound respectively.The detection rates of blood supply and clear boundary in ureteral lesions and the diagnostic sensitivity for ureteral cancer were 100% (19/19) ,58% (11/19) ,94% (15/16) by CEUS respectively.The change of these performances was statistically significant between conventional ultrasound and CEUS.Conclusions CEUS can improve blood supply,boundary and the diagnostic sensitivity of ureteral lesions.