OBJECTIVE:To provide reference for drug registration declaration. METHODS:The disapproval comments of Chi-na Food and Drug Administration on the declared drugs in Guangdong Province in 2015 were collected,existing problems in cur-rent drug registration declaration in clinical trials stage and registered production stage were analyzed. And suggestions were put for-ward based on relevant policies and regulations. RESULTS & CONCLUSIONS:Reasons for the rejection of declaring chemical drugs in clinical trials stage mainly focused on that there had been imported drugs applied for registration or new drugs entering monitoring period. While pharmacy research quality defects,especially insufficient research in impurities and relevant materials, are the main problems of declaring clinical trials and production. In terms of clinical trail declaration,applicant should respond to new drug registration classification reform,strengthen original innovation development;the development of biological products should establish comprehensive and effective evaluation system to form superior technology and products. In terms of drug registra-tion production declaration,related departments or drug manufacturers should enhance the evaluation for drug form and specifica-tions design,and generic drugs should pay attention to the consistency evaluation with the original research drugs. Besides,the above problems can be solved by conducting scientific and feasible research methods for impurities and related material,and pay at-tention to enlarging research of forward-looking production technology.

Objective To compare the lymph node dissection of left chest single incision and neck-right chest-abdomen incision in esophageal cancer surgery,and to explore the reasonable range of lymph node dissection in esophageal cancer surgery.Methods We retrospectively analyzed the clinical data of 72 patients with esophageal cancer radical surgery.According to the surgical approach,the patients were divided into left chest single-incision group (32 cases) and three-incision group (40 cases).The surgery time,number of lymph node resected,drainage tube time,length of hospital stay,lymph node dissection status and incidence of postoperative complications were analyzed.Results In left chest single-incision group and three-incision group,the operative time [(225.44 ± 11.98) min vs (265.42 + 13.15) min],lymph node dissection number[(8.031 ± 1.153) vs (11.821 ± 1.138)],length of stay [(13.212 ± 1.294) d vs(15.691 ± 1.404) d] and other aspects had statistically significant differences (t =24.201,25.302,14.010,all P ＜ 0.05).There were no significant differences between two groups in the chest tube indwelling time and the incidence of postoperative complications (P ＞ 0.05).Conclusion Both surgical radical resection of esophageal cancer have their own characteristics in terms of surgical difficulty,risks,efficacy and complications.In clinical,these must be carefully evaluated in patients with lesions and body affordability flexibility to choose the surgical approach in order to achieve the best therapeutic effect.

Objective To observe the effect of Shenxian Yiganling Tablets ( SYT) , a Chinese herbal recipe with the actions of tonifying kidney and removing toxicity, combined with HBsAg gene-modified dendritic cells (DC/HBsAg) on immune response and hepatocyte damage of hepatitis B virus (HBV) transgenic mice. Methods HBV transgenic mice ( Tg mice) were immunized with injection of DC/HBsAg ( 100 μg every three weeks) through caudal vein, and then were given intragastric administration of SYT in the dosage of 12.8, 23.5, and 47.0 mg/d for four weeks. HBV Tg mice splenic T cell cytokines of interleukin 2 ( IL-2) and interferon gamma ( IFN-γ) levels as well as serum alanine aminotransferase ( ALT) and aspartate aminotransferase ( AST) conents were detected by enzyme-linked immunosorbent assay ( ELISA) . Lactate dehydrogenase ( LDH) release assay was used to detect the in-vitro cytotoxic activity of splenic HBsAg specific T lymphocytes. Serum HBsAg level of HBV Tg mice was detected by ELISA after immunization. Results Compared with DC/HBsAg administration alone, DC/HBsAg combined with SYT could significantly increase HBV Tg mice splenic T cells cytokines IL-2 and IFN-γ levels ( P<0.05 or P<0.01) , increase the cytotoxic activity of HBsAg-specific T lymphocytes ( P<0.05 or P<0.01), increase the inhibition rate of HBsAg expression (P<0.05 or P<0.01), and reduce hepatocyte damage. Conclusion SYT could enhance the immune response of Tg mice to DC/HBsAg immunization, and relieve the hepatic damage, which enable the HBV clearance process out of hepatic damage in the case of anti-HBV activity of IFN-γbeing unaffected.

Objective To study the mental status of dento-maxillofacial deformities patients for orthognathic-orthodontic treatment,assess the testing results,and provide reference for doctors and nurses to evaluate mental features of patients.Methods 79 patients from a three-level and first-class hospital in Shanghai were collected from February 2011 to January 2012,who were to undergo orthognathic-orthodontic treatment.All the subjects filled in MMPI questionnaire before the operation.Results Scores of F and Pa subscales in male were significantly lower than the national norm.Scores of K and Mf subscales in female were significantly higher than the national norm.Scores of L,F,Hs,D,Pd,Pa,Pt,Sc,Si subscales were significantly lower than the national norm.Scores of F,Pa,Sc,Ma subscales in male were significantly higher than female.Scores of Mf subscales in female were significantly higher than male.Conclusions The whole personality of dento-maxillofacial deformities patients are normal.However,individualized personality deviation and psychological problems exist,including personality characteristics among different genders.

Background and purpose: Ductal carcinoma in situ (DCIS), is precursor lesions of invasive breast cancer, belongs to non-systemic ductal lesions, which is similar to other ductal lesions on imaging. This study aimed to investigate the differential diagnostic value of MRI in DCIS between DCIS with microinvasion (DCIS-MI) and breast intraductal papilloma (BIDP). Methods:All the cases were surgico-pathologically conifrmed. Twenty-four patients were DCIS, 9 patients were DCIS-MI, and 20 patients were BIDP. The MRI charateristics of DCIS, DCIS-MI and BIDP were analyzed and compared. Results:DCIS and DCIS-MI’s performance in the form of MRI is dififcult to differentiate (P<0.05). Compared with BIDP, the ductal and segmental enhancement, typeⅢtime-signal intensity curve (TIC), and the red pseudo-color image were associated with the DCIS. The local area enhancement, typeⅡTIC, and no-red pseudo-color image were associated with BIDP. Conclusion:MRI is a useful for differentiate between DCIS and BIDP, but is dififcult for DCIS and DCIS-MI.

Objective To investigate the nutrition statuses of thiamine and riboflavin and their relationship with the antioxidant capacity and blood glucose and lipids levels in the middle-aged and elderly. Methods Totally 314 subjects aged above 40 years old from communities in Shanghai were enrolled. The 3-day survey of 24-hour's diet recall was made to evaluate the daily nutrient intakes using a nutrition assessment software provided by CDC China. Thiamine and riboflavin levels were detected by urine load test. Fasting blood glucose ( FBG), total choles-terol (TC), triglyceride (TG), superoxide dismutase (SOD) activity and malondialdehyde (MDA) were deter-mined by commercial kits. Results The average daily intakes of thiamine and riboflavin were (0. 82 + 0. 36) and (0. 91 +0.48) rag, respectively. The middle-aged and elderly whose intakes of thiamine and riboflavin reached recommended nutrient intake (RNI) level accounted for 11.8% and 17.2%, while those lower than 60% RNI ac-counted for 51.3% and 49. 4%, respectively. Urine load test showed the deficiency rates of thiamine and ribofla-vin were 65.0% and 58.6%, respectively. Compared with the normal group, plasma MDA, FBG, TC, and TG levels progressively increased and SOD activity decreased in insufficient and deficient groups; the plasma MDA, FBG, and TC levels were significantly different between normal group and thiamine deficient group ( P < 0. 05 ).The FBG and TC levels were negatively correlated with the status of thiamine ( r = - 0. 246, r = - 0. 154, P <0. 05). The MDA and TG levels were negatively correlated with the status of riboflavin ( r = - 0. 136, r =-0. 297, P <0. 05). Conclusions The nutrition statuses of thiamine and riboflavin are poor in the middle-aged and elderly in Shanghai. The nutritional statuses of thiamine and riboflavin are positively correlated with the antioxi- dant capacities and are negatively correlated with the level of FBG, TC, and TG.

Objective To study the relationship between trace elements and blood lipids and glucose in Shanghai adults. Methods Totally 245 subjects aged above 18 years from two communities in Shanghai were en-rolled into this study. Blood trace elements (Fe, Zn, Cu, Mg, Pb, Mn, and Cd) were examined with atom ab-serption spectrophotometry. Body mass index (BMI), waist hip rate (WHR), and blood pressure (SBP, DBP)were also determined. Results Compared with the normal control group, plasma Fe and Mn levels were signifi-cantly lower while Zn and Zn/Cu levels were significantly higher in hyperlipemia group (P <0.05 or P <0. 01 ) ;plasma Zn, Zn/Cu, and Mn levels were significantly lower while Cu and Pb levels were significantly higher in dia- betes mellitus group (P <0. 05 or P <0. 01 ) . A tendency of lower Mg and higher Cd levels were also found in both disease groups, but there were no statistical significance ( P >0. 05 ). Conclusions The metabolism of trace elements is abnormal in patients with hyperlipemia and diabetes mellitus. Intervention of these trace elements disor-der may be valuable in the prevention and treatment of these diseases.

Objective To evaluate the value of computed tomography(CT)in diagnosing abdominal tuberculosis.Methods CT features of abdominal tuberculosis proven histopathologically or by antituberculous therapy in 16 cases were retrospectively analysed.There were 8 men and 8 women,the age ranged from 20 to 66 years,mean age was 36.4 years.Results The most common CT features of abdominal tuberculosis were:lymphadenectasis(n=11),mesenteric masses(n=6),ascites(n=6,all were loculated),omental thickening(n=7),bowel wall thickening(n=6),pleural fluid(n=2),and pancreatic involvement(n=1).Tuberculous lymphadenosis(mainly the mesentery and peripancreatic lymph nodes involved)had typical CT findings including circular or multilocular enhancement,calcification of lymph nodes,abdominal lymph nodes involved more than that of retroperitoneum and peritonitis(high dense ascites,patchy or nodular lesions in the mesentery and omentum,and intestinal adhesion).Conclusion CT findings in combination with clinical symptoms and laboratory test can improve the diagnosis of abdominal tuberculosis.

Objective:To determine the content of all-trans-retinyl palmitate in multivitamin preparations. Methods: HPLC was used and the chromatographic column was Apollo Silica (250 mm × 4. 6 mm, 5 μm). The mobile phase consisted of hexane-isopro-panol (999. 5:0. 5) and the column temperature was 30 ℃. The detection wavelength was 325 nm and the flow rate was 1. 0 ml· min-1 . The injection volume was 100 μl. Results:The calibration curve of all-trans-retinyl palmitate was linear within the concentra-tion range of 0. 2260-0. 6780 IU·ml-1(0. 1243-0. 3729 μg·ml-1, r=0. 9999). The average recovery was 99. 86%, and RSD was 0. 64%(n=9). Conclusion:The method is simple,accurate,sensitive,reproducible and universal, which can be used for the con-tent determination of all-trans-retinyl palmitate in multivitamin preparations.

OBJECTIVE:To compare the pharmacoeconomic efficacies of 5 drug therapeutic regimens for children pneumonia.METHODS:Using retrospective study and cost-effectiveness analysis to compare the pharmacoeconomic efficacies among the following 5 regimens in treating children pneumonia:amoxicillin sodium/clavulanate potassium(Group A),cefotaxime sodium(Group B),cefoperazone sodium/sulbactam sodium(Group C),cefuroxime sodium(Group D),and azithromycin(Group E).RESULTS:The effective rates of the 5 groups(A,B,C,D and E) were 80.43%,76.09%,65.12%,77.27%,and 91.30%,respectively,and the cost-effectiveness ratios were 1 595.06,1 225.38,1 669.69,1 284.83,and 697.84,respectively.CONCLU-SION:The regimen of azithromycin(group E) is the optimal one among the 5 groups for children pnemonia.