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.

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 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.

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.

Acromegaly is mostly caused by a pituitary adenoma secreting growth hormone ( GH ) , which leads to a wide range of endocrine morbidities, with an insidious onset and slow progression.A long-term overproduction of GH results in elevated insulin-like growth factor-1 ( IGF-1 ) level, which in turn, would cause target organ damage and an increased risk for mortality and decreased quality of life.Herein, the literature regarding the progress of drug therapy for acromegaly in recent five years is reviewed.

Objective To observe the curative effect of acupuncture on insulin receptor substrate 1 ( IRS-1) , IRS-2 and glucose transporter 4 (GLUT4) in skeletal muscle of experimental rats with insulin resistance (IR) . Methods Thirty-two rats were randomly divided into normal group, model group, acupuncture normal group and acupuncture model group. The fasting plasma glucose ( FPG) level was detected with glucose oxidase method, fasting insulin and C-peptide ( C-P) were examined with enzyme linked immunosorbent assay ( ELISA) , insulin sensitivity index ( ISI) was calculated, and IRS-1 mRNA, IRS-2 mRNA and GLUT4 mRNA of skeletal muscle were observed by real-time PCR-based fluorescent assay in each group. Results Compared to the normal group, the FPG, FINS, C-P levels were increased dramatically (P<0.01), ISI, IRS-1 mRNA, IRS-2 mRNA and GLUT4 mRNA of the model group declined remarkably ( P<0.01). Compared to the model group, the FPG, FINS, C-P levels declined evidently ( P<0.05 or P<0.01) , and ISI, IRS-1 mRNA, IRS-2 mRNA and GLUT4 mRNA of the acupuncture model group were increased dramatically ( P<0.01). Conclusion The curative mechanism of acupuncture for insulin resistance is probably related to the increase of IRS-1 mRNA, IRS-2 mRNA and GLUT4 mRNA expression in skeletal muscle which contributes to the improvement of PI3K signal pathway.

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.

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 discuss the regulation requirements of software based on the analysis of software-related recalls of medical devices. Methods:The data of software-related recalls of medical devices in America were collected and processed, and the type, situation, cause and trend of software-related recalls were analyzed, then the suggestions on the regulation requirements of software were proposed. Results:During the four periods from 1983 to 2011, the percentage of software-related recalls vs medical device recalls in America increased from 6%to 19%, and the year-on-year growth rate of software-related recalls rose by 47%to 164%, significantly higher than medical device recalls in the same period (from 13%to 54%). Especially, the problem of software-related recalls in radiology medical devices was the most serious. Conclusion: The regulatory situation of software is more complicated and severe, so the regulation requirements of software, including software validation, adverse event monitoring and usability design, need to be further strengthened according to the particularity of software.