Objective To examine the change of bilirubin level in neonates and infants after administration of fusidic acid.Methods The data of serum bilirubin,alanine aminotransferasese (ALT),aspartate aminotransferase (AST) and adverse drug reaction were collected retrospectively in neonates and infants and compared statistically before and after administration of fusidic acid.Results Emerging jaundice or exacerbation of the existing jaundice was not found in all the 138 patients after administration of fusidic acid in this analysis.Biochemical markers were measured before and after use of fusidic acid in 64 of the patients.ALT,AST and albumin did not show significant difference before and after use of fusidic acid.However,the ratio between indirect bilirubin and total bilirubin decreased by about 8％ after use of fusidic acid.Conclusions Fusidic acid did not show significant effect on serum bilirubin level in the neonates and infants following fusidic acid treatment.

OBJECTIVE To study the resistant characteristics and the resistant mechanisms of Gram-negative bacilli(G-) to ?-lactam antibiotics in the local nosocomial infections.METHODS The effects of efflux pump inhibitor on MICs were determined.Phenotypes and isoelectric points of ?-lactamases(Bla) were determined.Bla Genes were amplified and sequenced.RESULTS Of all tested isolates,the resistant rates to the most antibiotics were high.Besides 10.5% isolates with the efflux pumps,all tested isolates produced Bla,among which extended spectrum ?-lactamases(ESBLs),cephalosporin ?-lactamase(AmpC Bla) and metallo-?-lactamase were responsible for 42.1%,17.5% and 7.0% isolates,respectively.The complete nucleotide sequences of the ampC genes in 8 Enterobacter cloacae isolates had very high homology with the ampC gene in E.cloacae ECLC074.CONCLUSIONS The production of Bla is the main resistant mechanism of G-to ?-lactam antibiotics.ESBLs are the most frequent Bla.All of the ampC genes of AmpC Bla-producing E.cloacae originate from the ampC gene in E.cloacae ECLC074.Imipenen is the best choice for the treatment of the infections caused by multidrug resistant G-.Piperacillin/tazobactam and cefoperazone/sulbactam can be used to treat the infections caused by drug-resistant non-fermentative bacilli.Amikacin is effective to treat the infections caused by AmpC Bla-producing E.cloacae.

The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
China ; Consumer Product Safety ; Equipment and Supplies ; Safety Management

BACKGROUND: Heal-all oral biofilm is a material utilized in repairing oral mucosa and soft tissues defects and characterized by degradation, easily preparation, long preserved duration, convenient transportation and good ossification, which has been widely used in dental implant as guided bone regeneration materials.OBJECTIVE: To check the clinical effective of Heal-all oral biofllm on guided bone regeneration in dental implant.METHODS: A total of 72 patients with bone defects in the implantation area were selected as subjects, who were divided into control group and experimental group at random. Bone defects around implants were repaired by guided bone regeneration technique with BME-10X medical collagen membrane and Heal-all oral biofilm respectively. X-ray and clinical examination were taken at 1 and 3 months after implantation. The amount of new.formed bone tissue was evaluated when stage Ⅱ operation was performed.RESULTS AND CONCLUSION: In stage Ⅱ operation, osseointegration was formed between implants and bone tissue in all 72 patients. The average rate of bone formation was 92% in the experimental group while 91% in the control group. All implants were successfully repaired with implant denture. Occlusal function was restored successfully with all 72 implants during the follow-up period of 3-24 months after restoration. As an alternative option of BME-10X medical collagen membrane, Heal-all oral biofilm can be used in guided bone formation clinically.

Aim To compare the relative bioavailabilities of domestic acyclovir chewabletablets and normal tablets. Methods A single oral dose of 800 mg acyclovir chewable tablets or normal tablets was given to 8 volunteers respectively in a randomized, cross-over study, acyclovir serum concentration was determined by high performance liquid chromatography. Results The AUC of chewable and normal tablets was respectively 0.42 and 0.40 μg · ml · h-1, and the relative bioavailability of a cyclovir chewable tablets was (105.8 + 13.1) %. Conclusion The chewable tablets and reference tablets is bioequivalent in AUC.

AIM: To study the inhibitory effects of 10-23 deoxyribozyme (10-23 DRz) on Escherichia coli ?-lactamase gene expression. METHODS: According to the gene sequence of Escherichia coli ?-lactamase gene blashv-5, 10-23 DRz and antisense oligonucleotides (As-ODN) were designed and synthesized. 10-23 DRz, As-ODN or control oligonucleotides were respectively introduced into Escherichia coli by the method of electroporation. Following electroporation, bacterial viability in liquid medium contained ceftazidime was detected, bacterial ?-lactamase expression was analysed by using IEF-PAGE and the ?-lactamase band was measured with gel documentation-analyzing system. RESULTS: A_ 600 in 10-23 DRz transfected Escherichia coli was lower compared with that in As-ODN transfected Escherichia coli (P

Objective To explore the value of CT venography in the surgical treatment of falcotentorial junction meningiomas. Methods CT venography was carried out in 25 patients with falcotentorial junction meningiomas. 2-D and 3-D images were reformatted at the workstation. The classification and relationship between the tumors and veins were determined, and the degree of venous stenosis and collateral were assessed. The safe surgical pathway was chosen to avoid the injury of main draining vein. Results Falcotentorial junction meningiomas were divided into 5 types according to the relationship between the tumors and veins and the direction of the tumors. There were 5 cases of forward type, 4 cases of backward type, 3 cases of inferior type, 6 cases of superior type and 7 cases of lateral type in this group. The relationship between tumors and veins was accordant with the findings in surgery. Of all 25 cases, 19 underwent total removal, 6 underwent subtotal removal and all of the main driving veins were reserved. There were 3 cases of quadrantanopsia or hemianopsia after the operation, and all of them recovered after 3 months of follow-up. Conclusion CTV technique can classify the falcotentorial junction meningioma and is helpful for choosing the appropriate surgical approaches.

AIM: To verify the bioequivalence between sustained released tablet of nepopam and normal one. METHODS: 18 volunteers were randomly devided into two groups. Double periodical crossed design was used, and poly dose of nefopam was administered to 18 volunteers following single dose after one week interval. The concentration of nefopam hydrochloride in serum was determinated by HPLC, and the related parameters came out through 3p97 programme. RESULTS: In the single dose test the drug concentration of sustained released tablet maitained 2040 mg?L -1 for 10 h ,c max was ( 45.8 ?15.7) mg?L -1 ,t peak was ( 3.4 ? 0.8) h , and the corresponding parameters of normal tablet were over 20 mg?L -1 for 7.5 h ,( 72.7 ?26.0) mg?L -1 ,and ( 1.6 ? 0.6) h . The AUC was ( 363.4 ? 107.1 ) and ( 374.8 ?125.7) mg?h?L -1 respectively, and F was ( 1.02 ? 0.25 ). In the poly dose test the c max of sustained released and normal one was ( 31.50 ? 12.65 ) and ( 33.68 ?10.51) mg?L -1 ,c min was ( 13.4 ? 4.4 ) and ( 10.9 ?5.4) mg?L -1 , t peak was ( 2.6 ? 0.6 ) and ( 1.22 ? 0.46) h , and FI was ( 0.77 ? 0.26 ) and ( 1.04 ? 0.18 ) respectively. CONCLUSION: The sustained released tablet is credible and the two types of tablet are equieffective in AUC.

AIM: To compare the bioequivalence of glimepiride tables and capsules with a single dose. METHODS: Twenty Chinese healthy male volunteers were enrolled in a randomized crossover study with a single oral dose 3 mg of two formulations respectively. The blood drug concentration in serum was measured by HPLC, and the pharmacokinetic parameters were calculated by 3p97 software and compared by two one side t test. RESULTS: The parameters of the tables and the capsules were( 1.23 ? 0.19 ) and ( 1.31 ? 0.22 ) mg?h?L -1 at AUC (0-t) ,( 1.32 ? 0.20 ) and ( 1.45 ? 0.24 ) mg?h?L -1 at AUC (0-inf) ,( 0.30 ? 0.05 ) and ( 0.30 ? 0.06 ) mg?L -1 at C max ,( 6.6 ? 2.5 ) and ( 9.3 ? 7.9 ) h the peak time (T peak ), respectively. There were no significant differences between the two formulations. F was 96.4 ? 21.1 calculated by AUC (0-t) and 96.4 ? 21.1 by AUC (0-inf) . CONCLUSION: Glimepiride tables and capsules are of bioequivalence.

OBJECTIVE:To study the characteristics of ceftazidime-resistant?-lactamase produced by Escherichia coli.METHODS:The types of2strains of drug fast?-lactamase produced by Escherichia coli were determined initially by K-B slip diffusion method and ampholine electrophoresis method;The plasmid was extracted by alkaline lysis and the PCR ampli?fication and sequencing were conducted;?-Lactamase was counter-extracted by saturated ammonium sulfate,filtrated by Sephadex G-75gel and purified by DE-52anion exchange chromatography;The molecular weight of which was determined by SDS-PAGE and the enzyme kinetics parameters of?-lactamas were determined by ultraviolet spectrophotometry.RE?SULTS:The2strains produced a super-broad spectrum?-lactamase(CTX-M-1V)with isoionic point at8.7and the molecular weight at29kDa,which can hydrolyze cefotaxim and aztreonam but imipenem and which was sensitive to sulbactam(IC 50 =94nmol/L)and tazobactam(IC 50 =5nmol/L).CONCLUSION:CTX-M-1V is a CTX-M type super-broad spectrum?-lactamase sensitive to suppressants.