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 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.

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 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 seek approach for the protection of domestic pharmaceutical enterprises with immature creativity and to ensure drug accessibility. METHODS: An analysis was performed applying the theory of demand elasticity by comparing the attributes of health right and patent right etc based on TRIPS protocol and the related practice abroad. RESULTS & CONCLUSIONS: For a developing country, China should give top priority to the short-term urgent needs, such as to meet people's medication demands, followed by meeting the long-term demands, such as to encourage independent intellectual property rights. Hence, drug accessibility-related system in drug patent system should be evolved step by step.

OBJECTIVE: To provide references for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.METHODS: FDA's CGMP Warning Letters on medical products issued by the USA during 2002～2006 were analyzed statistically,and FDA's emphasis and intent on quality management system of medical products was discussed.RESULTS & CONCLUSIONS: The contents stated in FDA Warning Letters are of great importance for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level.Chinese enterprises can probe into the problems and solutions of quality management of medical products by analyzing FDA's emphasis and intent on quality management system of medical products as well as field investigation.

The professionalism view of qualified person and some reasonable proposals for the promotion of the professionalism are put forward. The necessity of the professionalization of qualified person and the effective measures of perfecting the professionalization are studied by the comparative analysis between home and abroad combined with the game model analysis. Under the current national conditions, qualified person are repositioned, and after learning the advanced experience of the EU, the registration system is strictly carried out, which can promote the professionalism of qualified person and make relevant measures in order to restrict the behavior of qualified person.

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 provide reference for small interfering ribonucleic acid (SiRNA) R&D and registration in China. METHODS:The situation of SiRNA R&D at home and abroad were introduced,and problems encountered in the evaluation and approval process were summed up to put forward suggestions. RESULTS & CONCLUSIONS:SiRNA has developed slowly in Chi-na,with a gap of 5-10 years at least compared with foreign developed countries. The registration category of SiRNA is not clear;applicants lack of guidance documents;production workshop which meet requirement is in shortage;the efficiency of drug registra-tion allows of no optimism. It is recommended that pharmaceutical registration departments carry out the pilot reform for SiRNA registration,publish SiRNA registration guide,relax regulations for IND gradually,encourage applicants to participate in the inter-national multicenter clinical trials in order to improve the efficiency of SiRNA evaluation and approval efficiency.