OBJECTIVE:To provide reference for improving registration regulation of medical institution preparation and pro-moting the development of it. METHODS:According to sorting out and summarizing the Medical Institution Preparation Registra-tion Management Approach(trail)contents,for its shortcomings in terms of medical institution preparation definitions,related im-provement suggestions were put forward. RESULTS & CONCLUSIONS:The Medical Institution Preparation Registration Manage-ment Approach(trail)has promulgated for 12 years from 2005 till now,existing shortcomings were that the definition of medical institution preparations was too wide,requirement on data of application and registration was less rigorous,regulation of clinical re-search was vague,clinical application re-evaluation was inadequate,disapproved case was lacked. In view of the above shortcom-ings,it is suggested to narrow the definition of medical institution preparations,modify the requirement on data of application and registration specify the regulation of clinical research,add monitoring period for the new preparation and update the disapproved case,so as to improve the registration regulation of medical institution preparations and promote the development of preparations in medical institutions.

Differentiated cells can be induced into pluripotent stem cell by reprogramming with defined fators. The new method of stem cell technology marks a major breathrough. This paper reviews the establishment, identification and research progress about induction of pluripotent stem cell.

Hepatocellular carcinoma (HCC)is a common malignant tumor in the world,and surgical resection and liver transplantation are two radical treatment modalities,but only 10%-20%of all patients can receive such treatments.In recent years,local therapies including radiofrequency ablation,microwave ablation,cryoablation,and the irreversible electroporation ablation which appeared recently have gradu-ally become the alternative therapies for the patients who are unable to undergo surgery.In addition to local tumor growth control and im-provement in survival outcomes,the ablation technology also helps to downgrade tumor for secondary resection.This article focuses on the re-search progress in radiofrequency ablation alone and in combination with other therapies in the treatment of HCC,compares radiofrequency ablation with other local ablative therapies,and briefly introduces the application of intelligent navigation technology in adjuvant ablation. With the development of medical imaging and progress in related fields,the ablation technology will be widely applied in clinical practice in the future.

Pituitary adenoma, a benign intracranial tumor, is the third most common brain tumor, second only to glioma and me-ningioma. Pituitary adenoma has been defined as a benign tumor, but some pituitary adenomas can invade the surrounding tissue. This tumor is difficult to resect and can easily recur after surgery. RWD-containing sumoylation enhancer (RSUME) can stabilize the activity of hypoxia-inducible factor-1α and inhibitor kappaB by the small ubiquitin-related modifiers. This phenomenon indicates the impor-tance of RSUME in pituitary adenoma because it promotes the invasiveness of the tumor. However, the correlation between RSUME and the invasion of pituitary adenoma remains unclear. In this study, the roles of RSUME on HIF-1α/VEGF signaling pathway and IκB/NF-κB compomers in the invasiveness of pituitary adenoma were reviewed.

Objective To investigate the effects of sulfur dioxide(SO2) pollution in different concentrations on activity of SOD,levels of GSH and MDA in heart and lung tissue of exercised rats,in order to elucidate the toxicological mechanism of SO2 pollution.Methods Forty-eight SD rats were randomly divided into eight groups:a rest group(RG),an exercise group(EG),a low pollution exercise group(LEG),a low pollution rest group(LRG),a moderate pollution exercise group(MEG),a moderate pollution rest group(MRG),a high pollution exercise group(HEG) and a high pollution rest group(HRG).All groups,except RG and EG,were exposed to SO2 with different concentrations(5 mg/m3,10 mg/m3,15 mg/m3),meanwhile exercised rats run in a motor-driven wheel at a speed of 8 m/min,2 h/d for 10 days.Rats were sacrificed at 24 h after treatment and the anti-oxidative enzymes activity and lipid peroxidation(LPO) levels were measured.Results Compared with RG,SOD activity of lung tissue significantly decreased in HEG,MEG,LEG(P

Objective To investigate the difference of clinical characteristics and treatment outcome between pituitary apoplexy with and without inducing factors. Methods The clinical characteristics and treatment outcome between 12 pituitary apoplexy with inducing factors and 30 pituitary apoplexy without ones. Results Compared with the patients of pituitary apoplexy without inducing factors, the patients of pituitary apoplexy with inducing factors more frequently occurred visual dysfunction(P=0.020) and visual field defection(P=0.046), and the diagnosis of pituitary apoplexy was also delayed in the latter (P=0.015). Conclusion Inducing factors of pituitary apoplexy often aggravated the apoplexy, delayed its diagnosis and treatment due to atypical clinical symptoms, and caused worse restoration of visual function. Headache patients with abrupt visual deterioration should be considered suffering from pituitary apoplexy.

Objective To study the clinical effect of the combination of cataract ultrasonic emulsification and multifocal aspherical intraocular lens in cataract patients through evaluating different intraocular lenses elimi-nating spherical aberration. Methods 180 patients(180 eyes)with senile cataract were included between,2001 and 2005.The patients were divided into three group (n = 60 each),based on the admition time. Implantion of ReSTOR-SN60D3 is multifocal aspherical intraocular lens(SN60D3),implantion of SN60AT lens is single spheri-cal intraocular lens (SN60AT),and implantion of SN60WF lens is single aspherical intraocular lens (SN60WF group). Three months after operation,the refractive state,focus depth,modulation transfer function(MTF),and higher-order aberrations were measured ,and the visual quality were investigated. Results There was no signifi-cant difference in vision in three groups before operation(P > 0.05). After operation,the UCNVA of SN60D3 group was significantly better than the SN60AT group and SN60WF group(P < 0.05). Under 3 mm pupil diame-ter,spherical aberration of SN60D3 group and SN60WF Z(4,0)were less than SN60AT group(P < 0.05), SN60D3 group and SN60WF only under 5 CPD spatial frequency MTF(HOA)value was superior to the SN60AT group(P<0.05);The score of near vision,reliance on vision correction and limitation of operation of patients in SN60D3 group were higher than other two groups(P<0.05). Visual clarity and day vision fluctuations of patients in SN60D3 group is better than single focal sphere group(P<0.05). Conclusion In multifocal aspherical intra-ocular lens,general spherical aberrations and higher-order aberrations is smaller,effect of naked near vision is bet-ter and the rest of the vision is stable ,which can bring good visual quality for cataract patients after operation.

Objective To study the risk values of glycosylated hemoglobin ( HbA1c) screening patients with diabetes mellitus(DM) and pre-diabetes(PreD) in different age and sex.Methods HbA1c results from10 840 in Taizhou Hospital in 2012 were retrospectively collected , and CHAID analysis of decision tree was used in preliminary hierarchy .Age was further divided into five groups according to the preliminary results , then one-way ANOVA and linear regression were utilized to determine the differences between age groups and the prediction intervals (PI) of HbA1c,respectively.The upper limit value of 95%PI of HbA1c was set as diabetes risk values ( DRVs).By comparison of the sensitivity of DM patients screening by DRVs in 1 889 cases whose HbA1c were between 6.0%to 6.5%and the upper limit value of traditional HbA1c reference intervals to verify the screening value ofDRVs .Then the DRVs of HbA1c were utilized to screen DM in the population whose HbA 1c is were 6.0%-6.5% in 2008,and followed their re-examination records toverify the screening value of the DRVs toin PreD patients. Results (1) On the basis of the initially root of decisiontree by age , the populationwas divided into 9 groups ( P =0.000, F =231.462).By calculatingthe 95% confidence interval(CI) of each group and merging reasonably,it was finally divided into 5 groups:20-30years,31-40years,41-50years,51-60years and >60years (F=434.342, P=0.000).(2)Using the method of linear regression , the 95% PI of HbA1c of the 5 groups showed as following:20-30 years, males 4.6%-5.9%, females 4.6%-5.9%.31-40 years, males 4.8%-6.0%, females 4.7%-6.0%.41-50 years, males 4.9%-6.2%, females 4.8%-6.1%.51-60 years, males 5.0%-6.3%, females 4.9%-6.2%.>60 years, males 5.1%-6.4%, females 5.0%-6.3%.The traditional HbA1c reference interval was4.8%-6.3%.(3) The screening sensitivity of DM by the upper limit value of traditional HbA1c reference interval and DRVs in group which HbA1c was between 6.0%-6.5% were 34.5%and 48.1%,respectively.(4) Reviewing of the group with HbA1c between 6.0%-6.5% and not diagnosed as DM in 2008, 49 hadnegative DM screening results by using the upper limit value of traditional HbA1c reference interval but were positive in our setting DRVs , and 13 have developed to DM now , which accounted for 26.5%.Conclusion HbA1c DRVs need to be set hierarchically between different age and sex groups as a supplement to the traditional reference interval , which has a great significance for the diagnosis and treatment of DM and also forthe screening and intervention of PreD patients.

Objective To investigate the relationship between the single nucleotide polymorphisms of exon 6 C161→T of peroxisome proliferators activated receptor γ(PPART)gene and osteoporosis in elderly male. Methods Polymerase chain reaction restriction-fragment length polymorphism(PCR-RFLP)was used to analyze the gene frequency distribution in the groups of nonosteoporosis and osteoporosis in elderly male.Bone mineral density of lumbar and hip(neck of femur,greater trochanter,Ward's triangle)were measured by dual energy X-ray absorptiometry.Serum osteocalcin level was measured by enzyme-labeled immunosorbent assay(ELISA). Results The exon 6 of PPARγ had 3 genotypes(CC,CT and TT).The frequency of T allele in osteoporosis was higher than that in non-osteoporosis.Compared with the control group,serum bone glaprotein level and bone mineral density was lower in osteoporosis group.The bone mineral density in the genotype of CT and TT groups were lower than that in the genotype of CC group. Conclusions The study shows that the single nucleotide polymorphisms of 6th exons of PPARγ may relate to osteoporosis in elderly male.T allele of PPARγ may be a predisposing factor of osteoporosis in elderly male.PPARγmay be a candidate gene of osteoporosis in elderly males.

Objective To evaluate the clinical value of serum procalcitonin (PCT) in the diagnosis of bacte-rial infections in the critically ill patients. Methods A loud d 100 cases of critical patients were divided into bacteri-al infection group(56 cases) and non-bacterial infection group(44 cases). Serum PCT was measured by immunolu-minometric assay. Results The concentration of PCT in bacterial infection group(21.54 ±5.72) μg/L, was signifi-cantly higher than non-bacterial infection group (11. 95±4. 58)μg/L (t =2.291,P<0.05);The APACHE Ⅲ score of bacterial infection group(62. 44 ± 19. 55) cent was significantly higher than non-bacterial infection group(44. 56 ± 25. 88) cent(t = 2. 195 ,P < 0. 05). The concentration of PCT of 1.0μg/L and 2. 0 p.g/L compared to the former sensitivity (96. 5) % higher than the latter (55.2) % (X2 = 3. 94, P < 0. 05), the former specificity (41.7) % lower than the latter (95.8)% (X2 = 4. 02 ,P < 0. 05);1.5μg/L as a positive standard Youden index and the Agreement (83.0 % ,0. 65), were significantly higher than 1 μg/L and 2 μg/L(71.7%, 0. 38 ;73.6% ,0. 51) (X2 = 3.84, X2=3. 90,X2 = 3.992 = 3.91 ,P < 0. 05);The concentration of PCT in death group (38. 9 ±12. 6)μg/L was signifi-canfly higher than the survival group(11.8± 8. 3) μg/L(t =2. 398 ,P <0. 05). Conclusion Serum PCT has clinical values in the diagnosis and therapy of bacterial infections in the critical patients.