This paper analyzed ethical and legal issues related to gene therapy.Based on the insufficiency in present Chinese legislation on gene therapy rules and regulations and comparing with foreign counterparts,a Chinese "Gene Therapy" regulation is suggested to formulate to provide a batter service of gene therapy for the whole population.

Diabetes mellitus is a systemic and chronic disease induced by abnormal carbohydrate metabolism,and hyperglycemia,hyperlipidemia and hypertension are main clinical characteristics.Long-term high blood glucose level causes the disorders of microvessels and macrovessels in human tissue and organ,resulting in serious complications and extremely high morbidity and mortality worldwide.Diabetes mellitus increases the risk of eye complications,and the incidence of diabetic eye complications is gradually increased in recent years,which is one of important problems that should not be ignored.Diabetic ocular complications include diabetic retinopathy (DR),diabetic optic neuropathy (DN),glaucoma,cataracts,diabetic ocular surface diseases,etc.So the prevention,early diagnosis and effective management for diabetic eye diseases are challenges.Ophthalmologists should pay more attention to diabetic ocular complications and keep a watchful eye on the renewal of managing guidelines of diabetic eye diseases to reduce the blinding rate and economic cost by early detection and timely treatment.

There are many topics in clinical studies of diabetic retinopathy (DR).The current hot topics include the relationship between DR and systemic diseases,major factors for initiation and progression of DR,early DR screening strategies,DR prevention strategies and how to improve the therapeutic effects of DR.However,due to the complexity of DR pathogenesis,multiple risk factors,long cycle of DR prevention and control,it is difficult to exclude all the confounding factors in the DR clinical research.From the long-term perspective,delaying the occurrence and progression of DR and establishing an efficient and practical prevention and control system is the focus of the future DR research in China.

Refractory macular hole (MH) has lower surgical anatomical closure rate and poor recovery of visual acuity due to its clinical characteristics.Refractory macular hole includes unclosed MH,reopening MH,large MH,high myopic MH,traumatic MH and secondary MH.Some modified surgeries were employed to improve the surgical results.Inverted internal limiting membrane flap,autologous transplantation of the internal limiting membrane,laser photocoagulation,extended internal limiting membrane peeling,arcuate retinotomy,lens capsular flap transplantation and mesenchymal stem cell transplantation can improve the prognosis partially.Loosening MH traction,providing a scaffold for Müller cell proliferation and promoting photoreceptor reconstruction will be the key points in future.

Informed consent right is not just for basic ethical consideration, but is important for protect-ing patient’s right by law, which is expressed through informed consent contract. The appraised individ-uals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

Objective To investigate the diagnostic value of serum proadrenomedullin( pro-ADM)in catheter related blood stream infection( CRBSI). Methods Prospective diagnostic test was performed with 76 cases patients with clinically suspected diagnosis of CRBSI,and the patients were divided into CRBSI group( n=25)and non-CRBSI group. Serum pro-ADM,procalcitonin( PCT),C-reactive protein( CRP)and white blood cell( WBC)levels were measured at the study entry and on the day of CRBSI suspicion. Results On the day of CRBSI suspicion,the levels of pro-ADM,PCT,CRP and WBC in the CRBSI group were(5. 17 ± 1. 28)nmol/L, 2. 29(1. 47-4. 28)μg/L,(102. 04 ± 51. 00)μg/L and(14. 66 ± 5. 09)× 109/L respectively,significantly higher than those in the non-CRBSI group((2. 83 ± 1. 25)nmol/L,2. 29(1. 4-4. 28)μg/L,(61. 43 ± 53. 52) mg/L and(11. 78 ± 3. 52)× 109/L respectively;t or Z=7. 636,-4. 777,3. 156,2. 882;P﹤0. 05). For the diagnosis of CRBSI,the area under the curve(AUC)of pro-ADM,PCT,CRP and WBC were 0. 89(95%CI 0. 82-0. 97),0. 84(95%CI 0. 75-0. 93),76(95%CI 0. 65-0. 86)and 0. 68(0. 54-0. 81)respectively. Taking pro-ADM with 4. 31 nmol/L as the cutoff value,the sensitivity,specificity,positive predictive value and negative predictive value were 76. 0%,84. 3%,70. 4% and 87. 8% respectively. Simultaneously,taking procalcitonin with 1. 52 μg/L as the cutoff value, the sensitivity and specificity was 81. 8% and 87. 0%respectively. Conclusion Serum level of pro-ADM in the diagnosis of CRBSI has good specificity. Simultaneous surveillance of serum pro-ADM and PCT may be helpful for the diagnosis of CRBSI in the early stage.

Objective:To investigate the mechanism of histone deacetylase (HDAC) inhibitor in down-regulating the expression of HER-2 in breast cancer cells and to provide an innovative therapeutic option to overcome the disadvantages of anti-HER-2 therapy. Meth-ods:HER-2-positive breast cell lines were treated with HDAC inhibitors. The changes in the gene and protein levels of HER-2 were de-tected by qPCR and Western blot. MiRNA microarray was used to identify the HDAC inhibitors, whereas qPCR was used to verify the miRNA expression. Results:In vitro cell experiments confirmed that the HDAC inhibitors TSA and SAHA can down-regulate the expres-sion of HER-2 in breast cancer cell lines. TSA can down-regulate the expression of HER-2 gene in BT474 and decrease the concentra-tions of 100 nmol by 10.7%and 200 nmol by 38.9%(P<0.05). TSA had no effect on the primary cells. The expression of HER-2 gene of BT474 was down-regulated by 93.9%(P<0.05) in the 5μmol/L group but not in the 1μmol/L group. SAHA significantly affected the pri-mary cells at a concentration of 1μmol/L and reduced the cells at 87.1%at a concentration of 5μmol/L. Seven miRNAs were identified from the miRNA microarray. MiR-762 was used as a basis to identify the changes in miRNA. The miRNA sputum identified by miRNA microarray and qPCR may be associated with the down-regulation of HER-2 by HDAC inhibitors. Conclusion: HDAC inhibitors may down-regulate the expression of HER-2 in breast cancer cells by changing some miRNAs.

Objective To investigate the effect of Clostridium butyricum on the intestinal permeability and expression of tight junction proteins in rats with intrahepatic cholestasis.Methods Forty SD rats were random-ly divided into normal control group(Con),model group(Mod),group with low(CBL)and high dose(CBH)of Clostridium butyricum. Animal models of intrahepatic cholestasis were induced by alpha-naphthylisothiocyanate. Then different drugs were administrated via oral gavage for 7 days after modeling.After the last administration,the activities of serum alanin aminotransferase(ALT),aspartate aminotransferase(AST),diamineoxidase(DAO)and the contents of total bilirubin(T-BIL)in serum were detected. Pathological changes of liver tissue were observed. The expression level of Occludin and ZO-1 in small intestine was analysed by Western blot. Results Compared with the normal control group,the levels of ALT,AST,DAO,and T-BIL in mordel group were significantly in-creased. The expression of Occludin and ZO-1 in small intestine was reduced(P < 0.05). Compared with the mordel group,the levels of ALT,AST,DAO,and T-BIL and the expression of Occludin and ZO-1 decreased sig-nificantly(P<0.05)and the liver pathologic changes were improved in CBL and CBH group.Conclusions Clos-tridium butyricum can protect the liver and improve the intestinal permeability in rats with intrahepatic cholestasis, and he mechanism may be related with upregulation of Occludin and ZO-1.

Objective To investigate the relationship between the polymorphism of human multidrug resistance 1 gene(MDR1)polymorphism and early MMF pharmacokinetics.Methods Twenty-eight Chinese primary renal transplant recipients were emrolled.On day 14 post-transplant,patients took the MMF orally on fast.Whole blood samples(2 ml)were obtained at the following time points:predose(G0)and 0.5,1,1.5,2,4,6,8,10 and 12 h(C0.5,C1,C1.5,G2,C4,C6,C8,C10,C12,respectively)postdose during the dosing interval.The MPA plasrna concentration was assayed by high performance liquid chromatography (HPLC).Pharmacokinetie parameters were determined by WINNOLIN 3.1.Three major single nucleotide polymorphisrrls(SNP),C1236 T,G2677 T/A,C3435 T of MDR1 were analyzed by PCR-RFLP.Pharmacokinetie parameters of MPA were compared between different MDR1 genotype and haplotype groups.Ailele frenqueneis were also compared in high(MPA area under concentratation-time curve 0～12 h,frequencies of 1236 TT,2677 TT/AA,3435 TT in three major MDR1 SNP positions,exons 12,21 and 26,were 0.368,0.184 and 0.211,respectively.MPA AUC was significantly higher in 1236 TT group than in 1236 CC/CT group(65.36±11.51 vs 53.33±13.77,P=0.032).On C1236 T SNP,TT genotype frequency showed significant difference between MPA high and low exposure groups(66.7%vs 15.4%,P=0.013,OR=2.526).T allele frequency was marginally higher in MPA high exposure group than that in low exposure group(83.3%vs 53.3%,P=0.072).Conclusion TT genotype on 1236 of MDR1 indicates a risk of early high exposure to MPA in Chinese renal transplant patients given by oral MMF,

By skin prick test,three kinds of mite allergens(Dermatophagoides pteronyssinus,Dermatophagoides farinae,Blomia tropicalis)were tested in a group of asthma children in Jinhua area from Oct 2005 to Sep 2006.The pos-itive rate to allergen from D.pteronyssinus and D.farinae was 80.6% and 77.8% respectively,higher than that of Blomia tropicalis(61.1%)(?2=21.39,P