Objective To investigate the serum concentrations of connective tissue growth factor (CTGF) and serum cystatin C(CysC) in diabetic nephropathy(DN) patients and its clinical significance. Methods 82 cases of diabetic nephropathy patients were divided into three groups by urinary albumin excretion rate(UAER):normal al-buminuric group(group 1),microalbuminuric group(group 2),macroalbuminuric group(group 3). Serum concentra-tions of CTGF and CysC were determined by ELISA, which was compared with 20 cases of control group. Results CTGF and CysC were markedly higher in the three groups than that in healthy controls [CTGF: (87.65±6.09)、 (105.36±7.78)、(129.05±5.12) ng/L and (68.29±5.90) ng/L;CysC: (0.99±0.10)、(1.59±0.14)、 (2.53±0.27) mg/L and (0.82±0.56) mg/L, P<0.05]. CTGF, CysC were all positively correlated with UAER (r=0.80、0.21, P<0.05), all negatively correlated with glomerular filtration rate (eGFR) (r=-0.85、-0.88, P<0.01). Conclusions The serum concentrations of CTGF and CysC may be early markers in predicting diabetic nephropathy and assessing its severity.

[Objective] To introduce a modified method for immunoblotting in detecting protein and to show all the details needing to be paid attention to. We take COX-2 for example. [Method] Total proteins were extracted and quantified. Denatured proteins were separated by SDS-PAGE and were transferred semi-dryly to NC membrane, then the latter was bound with specific antibody. Finally, protein expression was detected by ECL.[Result] The method was concise and easy to manipulate. The method had been successfully used to detect COX-2 protein in our lab and the pictures were reproducible. [Conclusion] Every step of the method is described in detail. It is helpful for novice to carry out immunoblotting. This established method is worthy to be recommended.

Distress thermometer (DT) is a widely used rating scale for testing distress severity in cancer patients in recent years.Recent studies have indeed showed that DT is worth being used in oncology clinic because of its acceptable validation.More and more studies have demonstrated the important role of DT on exploring distress.It may provide important basis for improving the distress in cancer patients.

Objective To compare the effectiveness of the forced-air warming system and the conventional warming care practice in preventing hypothermia in patients undergoing major surgeries.Methods A total of 62 patients were enrolled in this study. Patients of both sexes,aged≥18 years,and with an ASA physical status Ⅰ-Ⅲ were included and allocated randomly into intervention group(n=30)or control group(n=32). Patients in the intervention group were provided forced-air warming,either prior to induction or during the surgery procedure depending on core temperature monitoring results. In the control group,patients were warmed with conventional warming care without any intervention. Core temperature was measured by Spot-On sensor and tympanic membrane thermometer,blood pressure,the electrocardiogram,heart rate,pulse oxygen staturation,and partial pressure of end-tidal COwere also monitored continuously in the two groups.Crystalloid,colloid,and allogeneic blood were also recorded by strict protocol. Results Intraoperative hypothermia monitored with tympanic thermometer was observed in 23 patients(71.87%)in the control group,which was significantly higher than that (0) in the intervention group(P=0.00). In addition,the incidence of hypothermia monitored by Spot-On sensor was 81.25%(n=26)in control group and 13.33%(n=4)in intervention group(P=0.00). Conclusion Compared with the conventional warming care,forced-air warming system is more effective in preventing hypothermia during major surgeries.

Objective To study the effect of follicle stimulating hormone(FSH)on the secretion of anti-mullerian hormone(AMH)in granulosa cells in patients with polycystic ovarian syndrome(PCOS).Methods From Aug.2008 to Dec.2009,33 patients with PCOS in Reproductive Medicine Research Center,Sixth Affiliated Hospital of Sun Yat-sen University were collected from 8-10 mm antral follicles and classified into the following three groups: FSH-unstimulated granulosa cells(unstimulated group,n =12),exogenous FSH-stimulated granulosa cells(exo-stimulated group,n =12)and internal FSH-stimulated granulosa cells(int-stimulated group,n =21).ELISA and real-time PCR were relatively used to measure protein and mRNA level of AMH.Luciferase reporting vector was constructed to detect the promoter activity of AMH.Results The levels of AMH secretion in PCOS granulosa cells were(11.4 ± 4.0)μg/L in unstimulated group,(7.9 ± 1.1)μg/L in exo-stimulated group and(5.6 ± 1.7)μg/L in int-stimulated group.Both the external and internal stimulation of FSH may suppress AMH secretion significantly(P ＜0.05).The mRNA level of AMH in PCOS granulosa cells were 2.5 ± 1.2 in unstimulated group,which were higher than 1.5 ± 0.5 in exo-stimulated group and 1.1 ± 0.7 in int-stimulated group significantly(P ＜0.05).The luciferase activity of AMH in PCOS granulosa cells were 11.5 ± 2.3 in unstimulated group,8.7 ± 2.4 in exo-stimulated group and 6.8 ± 2.4 in int-stimulated group.The luciferase activity of AMH in unstimulated group was significantly higher than those in exo-stimulated and int-stimulated groups(P ＜0.05).Conclusion FSH may inhibit the excessive secretion of AMH and stimulate follicle growth in PCOS granulosa cells by suppressing activity and expression of promoter.

Objective To investigate the concentration changes and clinical significance of hepatocyte growth factor (HGF) during the development of acute kidney injury (AKI). Methods The serum concentrations of HGF in 62 patients with AKI were measured every two days, and the relation between HGF and glomerular filtration rate (eGFR) ,the renal failure index,course of diseases,numbers of viscera injury,and short-term prognosis were an-alyzed. Results The serum concentrations of HGF were progressively rising along with the course of diseases and the amount of viscera injury (P=0.000), reached peak at the 9th day, and then decreased, which was was elevated in the death group than renal function failure group, but which in the latter group was elevated than in renal function recovery group (P<0.05 for each). AKI with liver injury patients were obviously higher than without liver injury pa-tients(P<0.05 for each). The serum concentrations of HGF were positively correlated with the renal failure index (r=0.580～0.821) but negatively correlated with eGFR(r=-0.943～-0.703) (P<0.05 for each). Conclu-sion The serum concentrations of HGF are abnormally rising in the patients of AKI ,which reflects the state of dis-ease and short-term prognosis of AKI.

OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.

Objective: To analyze and estimate the risks of failure modes in a pharmaceutical Co.Ltd.in Nanjing producing solid preparations by collinear production, and come up with measurements to improve the quality level accordingly.Methods: The quality risk level evaluation table for the failure modes in the various steps of collinear production was obtained through the failure mode and effects analysis (FMEA).The risk control measurements were put forward in order to control and improve different failure modes with various unacceptable risk levels.Results: The risks of solid preparations by collinear production were greatly reduced through FMEA.Conclusion: The FMEA method is an effective way to improve the quality level of collinear products.Meanwhile, there are limitations of FMEA, and other risk management methods should be combined to control the overall risk of drug production.Moreover, the failure modes at the same risk level with different properties should be analyzed and controlled accordingly.The above methods can improve the risk management level of a company and reduce the risks of cross-contamination, mistakes and air-transferring in order to enhance the efficiency of quality management system and produce safe and effective drugs.

Objective To compare the clinical curative effect of partial hepatectomy combined with biliary intestinal anastomosis and T tube drainage in the treatment of intrahepatic stones.Methods 72 patients with intrahe-patic stones were selected and randomly divided into observation group and control group.The observation group received lobectomy of liver +bile duct jejunum anastomosis,the control group received lobectomy of liver +T tube drainage treatment.The operation time,intraoperative blood loss,functional exercise time,length of hospital stay, recurrence rate,clinical efficacy and complications were observed.Results The patients were followed up for 6 -12months.The operative time,blood loss,ambulation exercise time,length of hospital stay in the observation group were (158.29 ±32.53)min,(161.42 ±11.75)mL,(3.61 ±0.28)d,(5.31 ±1.17)d,which were significantly more than those in the control group[(127.57 ±26.38)min,(78.29 ±8.36)mL,(2.25 ±0.56)d,(4.86 ± 2.39)d].The recurrence rate of stone of the observation group during the postoperative follow -up was 5.56%, which was significantly lower than 16.67% of the control group (t =4.328,7.196,2.174,2.259,1.862,all P <0.05).The excellent and good rate of the observation group was 94.44%,which was higher than 83.33% of the control group,the difference was statistically significant (χ2 =1.257,P <0.05).6 cases in the observation group had complications (16.67%),including 1 case of incision infection,subphrenic infection in 2 cases,bile leakage in 2 cases,1 case of pulmonary infection.15 cases in the control group had postoperative complications (41.67%), including 3 cases of wound infection,bile leakage in 4 cases,3 cases of biliary tract bleeding,abdominal bleeding in 1 case,2 cases of pulmonary infection,subphrenic infection in 1 case,pleural effusion in 1 case,the difference between the two groups was significant (χ2 =2.291,P <0.05).Conclusion Liver resection is an effective method for treatment of intrahepatic bile duct stones,on the basis of liver resection by intestinal anastomosis in the treatment of intrahepatic bile duct stone long -term effect is better,which can effectively prevent recurrence of the intrahepatic bile duct stone and bile duct cancer,widely used in patients with indications for clinical physicians.

Objective:To study the content in the new version of EU-GMP ANNEX 15 (draft) to find the changes of the new and the old version and help the domestic pharmaceutical enterprises meet the requirements of the EU-GMP and complete verification and validation activities.Methods:The new version and the old version of EU-GMP ANNEX 15 were compared,and the changes in the new ANNEX 15 were analyzed in order to understand the changes deeply.Combined with the current implementation status of verification and validation activities in domestic pharmaceutical enterprises,some suggestions on qualification and validation work were provided for domestic pharmaceutical enterprises.Results and Conclusion:The new revision of EU-GMP ANNEX 15 (draft) emphasizes qualification and validation activities during the life cycle of products,and processes,and risk management methods should be used in qualification and validation activities.