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Objective To evaluate the performance of GenoType®MTBDRplus VER2.0 kit for detecting Mycobacterium tuberculosis complex (MTBC) in sputum. Methods Sputum samples from 177 patients with suspected tuberculosis were collected, and tested by smear, MGIT liquid culture and GenoType® MTBDRplus VER2.0. When the liquid culture was positive, identification of strains was carried out. The results were statistically analyzed using SPSS 22.0, and the consistency of the count data was compared using the Kappa test. Good consistency was defined as K≥0.75. The sensitivity and specificity were applied to evaluate the performance of GenoType® MTBDRplus VER2.0 kit for detecting MTBC in sputum. Results Based on the MGIT liquid culture results,，the sensitivity, specificity, positive predictive value, negative predictive value and total coincidence rate of the GenoType® MTBDRplus VER2.0 kit was 91.67%, 95.58%, 91.67%, 95.58% and 94.22%，respectively．The Kappa test was performed on both methods, K=0.872 (P® MTBDRplus VER2.0 kit had high sensitivity and specificity for detecting MTBC in sputum, and it has good application value for early diagnosis of tuberculosis.
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OBJECTIVE: To study the bioequivalence of tegaserod maleate dispersible tablets in healthy volunteers.METHODS: A single oral dose of 6mg test or reference preparations of tegaserod maleate was given to 22 healthy volunteers in a randomized crossover study.The plasma concentrations of tegaserod were determined by LC/MS/MS assay.RESULTS: The main pharmacokinetic parameters of test and reference products were as follows: tmax(0.86? 0.22) and(1. 01? 0.24) h;Cmax(2.21? 0.69) and(2.05? 0.64) ng? mL1;AUC0～ 17(6.35? 2.48) and(6.47? 1.99) ng? h? mL-1,AUC0～ ∞(6.69? 2.59) and(6.70? 2.03) ng? h? mL-1,respectively.The relative bioavailability of test to reference preparation was(98.2? 22.1) %.CONCLUSION: The reference preparation and the test preparation are bioequivalent.
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Objective To understand the distribution,variation and prevalence of virulence-related gene of the V.cholerae at the molecular level.Methods PCR technique was applied to detect ctxAB,and zot gene of CTX? genetic element,cri gene of TLC cluster of the 176 strains of V.cholerae isolated from 1964 to 2008.Results One hundred and thirty-one strains of V.cholerae carry ctxAB and zot of CTX? genetic element in 176 strains,the positive rates were 72.72%(128/176 strain) and 73.30%(129/176 strain) respectively.69.00%(69/100 strain) of V.cholerae O1 strains isolated from 1964 to 1996 carried cri gene,however the rate was only 1.33%(1/75) in the strains isolated from 1998 to 2008.ctxAB,zot and cri in V.cholerae O139 were all positive.Conclusion Detection of virulence-related genes can reflect the molecular characteristics of strains,and it is important to the molecular epidemiology of V.cholerae research.
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OBJECTIVE:To study the bioequiavailability of two sertraline hydrochloride formulations in healthy volunteers.METHODS:A randomized, crossover study of 22 healthy volunteers receiving single oral dose of 50mg sertraline hydrochloride solution(test preparation) or sertraline hydrochloride tablets(comparator preparation) was conducted and the blood concentrations determined by LC/MS/MS.RESULTS: The pharmacokinetic parameters for the test sertraline and the comparator sertraline were as follows:t1/2 were (27.3?5.2)h and (26.3?3.0)h,respectively;Cmax were(9.56?2.49)?g?L-1 and(9.43?2.91)?g?L-1,respectively;tmax were(5.18?1.47)h and(6.00?1.07)h,respectively;AUC0～108 were(329?112)?g?h?L-1 and (297?111)?g?h?L-1,respectively;AUC0～∞ were(354?127)?g?h?L-1 and (316?122)?g?h?L-1,respectively.There were no significant differences in main pharmacokinetics parameters between the 2 preparations,except in tmax from analysis of variance and one-side & two-sides t tests.The relative bioavailability of the test sertraline was(115.5?26.7)%.CONCLUSION:These two sertraline hydrochloride formulations are bioequivalent.