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OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.
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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.
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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.
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China , Consumer Product Safety , Equipment and Supplies , Safety ManagementABSTRACT
Aim To investigate the effect of Panax Quinquefolium Saponin (PQS) on the cell immune system of the patients with Chronic Pulmonary Heart Disease (CPHD) and then to find out the relationship between the immune system and the mechanism of CPHD. Methods The T lymph subgroup and NK (CD3 -/CD16+56 +) cells in patients’ peripheral blood were detected by flow cytometry, and the expression of IL 2, IFN? mRNA were analyzed by RT PCR. Results CD3 +, CD4 + and CD4/CD8 in patients with CPHD were significantly lower than those in the control, while CD8 + higher ( P
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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.
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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.
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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.