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 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 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 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 assess the association between serum γ-glutamyltransferase (γGT) levels and the risk of metabolic syndrome (MS),so as to provide a reference for prevention and diagnosis of MS.Methods Ten papers about the relationship between γGT level and incident MS published in Pubmed,Embase,and the Institute for Scientific Information (ISI),China Academic Journal Full-text Database,China National Knowledge Infrastructure Database and Wan Fang Digital Periodicals Database from January 2000 to April 2014 were retrieved and analysed.Results A total of 65 331 participants from the ten studies were included in the rmeta-analysis.The pooled RR was 2.06 (95％ CI 1.63-2.49) when the incidence of MS was compared between the highest and the lowest groups of γGT levels.A subgroup analysis was made in Asian and western populations.The pooled RR of MS in Asian population was 2.26 (95 ％ CI 1.65-2.87) and in western population it was 1.70 (95 ％ CI 1.15-2.25).Sensitivity analysis confirmed the stability of results.No publication bias was found in our meta-analysis by Egger's and Begg's test.Conclusion Current evidences from prospective studies indicate that risk of metabolic syndrome is increased in correlation with an increase in serum γGT,and serum γGT seems to be an important predictor for MS.

Objective To explore the effects of ligustrazine (TMP) on acute drug -induced free radical for-mation in guinea pig cochlear ,and to explore possible mechanisms of TMP on gentamycin(GM)-induced ototoxici-ty .Methods Sixty guinea pigs were randomly divided into four groups ,control group ,GM group ,TMP group and TMP+GM group .GM group were injected with GM 120 mg/kg per day .TMP group were injected with TMP 40 mg/kg per day .TMP+GM group were injected with GM and TMP at the same dosage .Control group were injected with normal saline .All groups were injected for consecutive 10 days .Before injection and one day after the last injec-tion ,ABR thresholds were measured .Biochemical assays of Superoxide Dismutase (SOD1 ,SOD2 ,T -SOD) activity and ma1ondia1dehyde(MDA) content in guinea pig cochlear were detected by TBA .Results After the injection , ABR thresholds in GM group were significantly increased compared with those of in control group (P<0 .01) ,with significant difference between GM +TMP and GM group(P<0 .01) .Before and after the experiment ,ABR thresholds in control group were almost unchanged(P>0 .05) .SOD activity was significantly decreased while MDA content was increased in cochlear tissues after GM injection (P<0 .05) .Co -treatment with TMP evidently enhanced SOD activity and decreased MDA content (P<0 .05) .Conclusion TMP may enhance SOD activity and prevent lipid per-oxidation ,thus alleviate GM ototoxicity ,and improve auditory function .