OBJECTIVE:To emphasis the importance to unceasingly upgrading of drug quality standard for drug quality and to arouse the attention of the related enterprises, medical institutions and governmental department to this matter. METHODS: The correlation between quality standard and drug quality was expounded systematically by citing examples and reviewing the pertinent literature, and the current status of drug quality standard in China was analyzed briefly. RESULT & CONCLUSION: Great importance should be attached to the evaluation of drug quality standard to improve drug quality standard level step by step and to ensure efficacy and safety of drugs.

Objective To compare the results between laparoscopic repair and surgical procedures in perforation of duodenal ulcer. Methods Fifteen p atients were operated on perforation of duodenal were by laparoscopic repair, an d thirty patients performed open repair or partial gastrectomy at the same peri od were chosen as control groups. Results The operating time in laparoscopic group and other two surgical groups were 59 min, 84 min and 204 min; postoperati ve requirement of analgesic was 7％(1/15), 73％(11/15) and 80％(12/15) in three groups respectively. The recovery time of gastrointestinal function was 25 h, 56 h, and 72 h. the mean time of hospitalization was 6 d, 8 d and 10 d. The differ ences among groups were significant (P

1 cm. Postoperative pathological findings showed negative cut surface. No hemorrhage or bile leakage were seen after operation. The abdominal drainage tube was indwelled for 3~4 d. The postoperative hospital stay was 3~5 d. Follow-up checkups for 1~20 months (mean, 12.5 months) revealed no tumor recurrence or incision implantation. All the patients survived. Conclusions Laparoscopic regular hepatic left lateral lobectomy can be carried out safely and effectively in clinically selected patients.

Objective To investigate the effect of standardization regional lymphadenectomy in radical resection of ductal adenocareinoma in the pancreatic head.Methods On the basis of routine panereaticoduodenectomy(whipple proceduce),we performed the standardization regional lymphadenectomy,the emphasis of the procedure was the resection of wide nodes,particularly the mesenteric root lymph nodes(14abcd),the paraaortic lymph nodes(16a2b1),the hepatoduodenal ligament lymph nodes(12abpeh),hepatic artery(Group 8)and coeliacus lymph nodes(Group 9). Results Eleven patients underwent this procedure,there was no operative mortality,1 case occurred pancreatic fistula,the lymph nodes metastasis occurred in 7(63.6%)patients,the posterior pancreaticoduodenal lymph nodes(Groupl3)and superior mensenteric artery(Groupl4)was the predominant metastatic site of the tumor,the rate of the second site metastasis to lymph nodes was 57.1%.of the 11 cases follow-up 1 died. Conclusion The radical pancreaticoduodenectomy combined with wide resection of standardization regional lymph nodes is a safe and effective procedure of the treatment of adenocarcinoma of the head of the pancreas.but the long-term survivalrate must be valued objectively with many cases.

Objective To construct a recombinant adenovirus vector encoding for indoleamine 2,3-dioxygenase(IDO)and chimetric albumin promoter,evaluate the mRNA and protein expression levels in Hepa 1-6cell.Methods Full-length mouse derived IDO cDNA was subeloned into pAdTraek-ALB shuttle Plasmid.The product was linearized to homologous recombination with AdEasy-l vector in BJ5183 bacteria.The positive clone was identified by restriction endonuclease digestion and further confirmed by sequencing.The recombined adenoviruses DNA were transfected into AD-293 cells for packaging and amplification of Ad-ALB/IDO.The expression of IDO was monitored by RT-PCR and EGFP fluorescence in infected cells.The recombinant viruses with Hepa 1-6 cells were cultured and the mRNA and protein expression levels monitored bv RT-PCR and Western blot, respectively. Results Construction of recombinant andenoviruses containing IDO and albumin promoter was confirmed by restriction endonuclease digestion and sequencing.The expression of IDO was identified by RT-PCR in transfected AD-293 cell.The virus titer was 2.9×10~6 pfu/ml.The IDO mRNA and protein expression levels were detectable after transfected Hepa 1-6 cells by RT-PCR and Western blot. Conclusion A recombinant adenovirus Ad-ALB/IDO was susceessfullyconstructed.

Objective To investigate the mutations of basal core promoter (BCP) and precore (PreC) region of hepatitis B virus (HBV) and the association with the development of hepatocellular carcinoma in patients with chronic HBV infection.Methods Totally 381 untreated HBV patients were recruited from the Department of Infectious Diseases,People's Hospital of Shangyu from Jan 2003 to Dec 2010,which included patients with chronic hepatitis B (CHB,n =166),cirrhotic hepatocellular carcinoma (cirrhotic-HCC,n =158) and noncirrhotic hepatocellular carcinoma (noncirrhotic-HCC,n=57).The mutations in HBV BCP and PreC and the genotypes of HBV were determined by polymerase chain reaction (PCR) and direct sequencing.Data were analyzed by chi square test and Logistic regression.Results The HBV genotype of most cases was genotype B (CHB,n =124;cirrhotic-HCC,n=126 ; noncirrhotic-HCC,n=50).In univariant analysis,BCP V1753 (x2 =7.927,P=0.005),BCP T1762/A1764 (x2 =12.796,P＜0.01),PreC A1896 (x2 =6.890,P=0.009) and PreC A1899 (x2=11.850,P =0.001) mutations were more frequently detected in cirrhotic-HCC patients than those in CHB patients.PreC A1896 (x2 =27.310,P＜0.01) and A1899 (x2=7.575,P=0.006) mutations were highly detected in noncirrhotic-HCC patients than those in CHB patients.Multivariate Logistic regression analysis revealed that in HBeAg positive patients,BCP T1762/A1764 (wald=6.180,P=0.016,OR=8.883) and PreC A1899 (wald=10.279,P=0.001,OR=7.475) mutations were independently associated with the development of cirrhotic-HCC; PreC A1896 (wald=4.324,P=0.038,OR=4.439) and PreC A1899 (wald=4.850,P=0.028,OR=6.010)mutations were independently associated with the development of noncirrhotic-HCC.While in HBeAg negative patients,PreC A1896 mutation (wald=15.448,P＜0.01,OR=12.128) was independently associated with the development of noncirrhotic-HCC.Conclusions BCP T1762/A1764 mutations are associated with the development of cirrhotic-HCC in HBeAg positive patients.PreC A1896 mutation is associated with the development of noncirrhotic-HCC in HBeAg positive and HBeAg negative patients.PreC A1899 mutation is associated with the development of cirrhotic-HCC and noncirrhotic-HCC in HBeAg positive patients.

Objective To investigate the expression of hypoxia inducible factor-1α(HIF-1α) and vascular endothelial growth factor C(VEGF-C) in colon carcinoma,and their relation with clinical pathological parameters and prognosis. Methods Immunohistochemistry was used to detect the expression of HIF-1α and VEGF-C in 65 tissues of colon carcinoma. Results In all cases,the expression of HIF-1α had a positive correlation with the expression of VEGF-C(r= 0.638,P＜0.01).The expressions of HIF-1α and VEGF-C had significant correlation with clinical stage and nodal metastasis(P＜0.05) ,but had no relationship with sex,age and tumor size(P＞0.05). Conclusion The expression of HIF-1α and VEGF-C was correlated with nodal metastasis, tumorigenesis and prognosis of colon/carcinoma.

Objective To investigate the effectiveness and technical points of anatomical liver resection by trans-Glisson Sheath methylene blue staining in treatment of hepatolithiasis of right posterior lobe.Methods The clinical data of 12 cases of hepatolithiasis of right posterior lobe treated with anatomical liver resection by Glisson sheath methylene blue staining were retrospectively analyzed.Result 6 of 12 patients had undergone more than 2 previous biliary surgeries.All patients underwent contrast-enhanced CT scan and portography,hepatolithiasis of segment Ⅵ in 4 cases,right posterior lobe in 8 cases,accompanied by left lateral lobe bile duct stones in 2 cases,the right caudate lobe bile duct stones in 1 case.Methylene blue was injected into the portal vein,the methylene blue interface of segment Ⅵ or right posterior lobe displays well.Methylene blue interface was larger than the ischemia interface,which is in accordance with the anatomy.Along the methylene blue interface,hepatic resection was performed including right posterior lobe resection (n =9),segment Ⅵ resection (n =3),and combined with left lateral lobe resection (n =2) and the right caudate lobe resection (n =1).There was no postoperative mortality.Incision infection occurred in 5 cases,4 had right pleural effusion and 2 had a biliary fistula that were treated conservatively.With a mean follow-up period of 3.2 years,all patients are symptoms free and stone free.Conclusions Anatomical liver resection by methylene blue staining is a safe and effective treatment for hepatolithiasis of right posterior lobe.

Objective To investigate the effect of postoperative anti-viral therapy using adefovir dipivoxil in recurrence of hepatocellular carcinoma HCC with HBV infection. Methods Sixty HCC patients with HBV infection were randomized into two groups:Group A (n=23) received hepatectomy only, and Group B (n=37) received hepatectomy and postoperative therapy using adefovir dipivoxil. The changes in liver func-tion, the suppression of HBV-DNA, HBeAg seroconversion rate, tumor recurrence rate and median survival in the two groups were observed and compared. Results In Group B, serum albumin, total bilirubin, AST and ALT were significantly improved compared with Group A (P < 0.05). Furthermore, the rate of 6-month and 1-year HBV-DNA suppression, the rate of 6-month and 1-year HBeAg seroconversion were significantly improved compared with Group A (P < 0.05). In Group A and Group B the tumor recurrence rate was 82. 6% (19/23) vs 78.4% (29/37) (P > 0.05), the recurrence time was 7.3 vs9.6 months (P > 0.05) and the median survival time was 17.4 vs 24.9 months (P < 0.01). Conclusion The results suggest that an-ti-viral therapy using adefovir dipivoxil postoperatively may improve the remnant liver function, suppress the HBV reaction, prolong the survival for patients with HCC with HBV infection.

Objective To report the cloning, expression and identification of the tumor-associated antigen G250/MN/CA Ⅸ. Methods The total RNA was extracted from renal cell carcinoma tissue samples from 54 male patients. Gene fragments encoding G250 was obtained by RT-PCR,and was cloned into prokaryotic expression vector pET22b(+) and expressed in E.coli BL21(DE3);and the results were examined by SDS-PAGE gel electrophoresis. The recombinant protein was studied by Western blot test. Results DNA sequence analysis showed that the obtained sequence was the same as that showed in GenBank.Gene of G250 was expressed in E.coli BL21 successfully. Western blot analysis showed that the recombinant protein could be specially recognized by monoclonal antibody. It had better antigenicity and specificity. Conclusions This study provides experimental basis for the purification of G250/MN/CA Ⅸ protein and the further study of G250/MN/CA Ⅸ function and preparation of antibody.