Bacterial diversity in the indoor air of pharmaceutical environment.

AIMS: To monitor bacterial diversity of ISO Class 8 pharmaceutical clean room environment using conventional culture-based methods and pyrosequencing analysis. METHODS AND RESULTS: Bacterial isolates were obtained through viable particulate air monitoring, passive air monitoring and surface-monitoring procedures. A total of 157 bacterial isolates were obtained and assigned to four different phyla, Actinobacteria, Firmicutes, Proteobacteria and Deinococcus-Thermus, encompassing 52 species of 24 genera based on 16S rRNA gene sequence analysis. The genera Micrococcus and Staphylococcus were found as the main bacterial groups among the isolates. However, a big discrepancy was found between the culture based and pyrosequencing results. A total of 11 409 quality reads were obtained from the pyrosequencing analysis, and the subsequent phylogenetic analysis indicated that Proteobacteria was the most abundant group at phylum level, followed by Actinobacteria and Firmicutes. Bacillus, Propionibacterium and Acinetobacter were identified as the most abundant genera by the pyrosequencing analysis. CONCLUSIONS: The culture-based results were in line with previous reports on the airborne bacterial composition of various environments, but the pyrosequencing analysis revealed a unique diversity of bacteria in this case. No significant pathogens above Riskgroup 2 were found from either culture based or pyrosequencing studies. SIGNIFICANCE AND IMPACT OF THE STUDY: The presence of various bacterial taxa including a number of groups, whose presence in air is previously unknown, was confirmed through this analysis. The main source of bacteria in the indoor air environment of pharmaceutical processes is likely human, but no significant primary pathogens were detected. Culture-based analysis may give limited information on the bacterial diversity of air environment.

Assessment of the value of preoperative serum levels of CA 242 and CEA in the staging and postoperative survival of colorectal adenocarcinoma patients.

INTRODUCTION: CEA is the most frequently used tumor marker in colorectal cancer. There may be an improvement in its efficacy when used in association with CA 242. AIM: The purpose of this study was to evaluate the efficacy of preoperative serum levels of the tumor markers CA 242 and CEA in the staging and postoperative follow-up of colorectal adenocarcinoma patients. PATIENTS AND METHODS: Of a series of 134 patients with colorectal adenocarcinomas 90 underwent radical surgery and 44 palliative surgery. The control group consisted of 22 organ donors. The cutoff serum levels utilized were 5 ng/mL for CEA and 20 U/mL for CA 242. The mortality during follow-up was recorded in order to determine the duration of survival. The data were submitted to statistical analysis using diagnostic tests, the chi-square test, survival analysis (Kaplan and Meier) and ROC curves. A significance level of p < or = 0.05 was applied. RESULTS: The sensitivity of CEA in Dukes' stages A, B, C and D was 27.8%, 32.4%, 32.1% and 66.7%, respectively. The sensitivity of CA 242 was 11.1%, 16.2%, 30.8% and 50%. When both markers were combined, the sensitivity was 33.3%, 48.6%, 40.7% and 72.5%. In the group of patients who underwent radical surgery the mean survival was 60.47 months for those with high preoperative CEA levels, 52.22 months for those with high preoperative CA 242 levels, and 44.80 months for those with elevated levels of both markers. There was a statistically significant difference in survival between patients undergoing radical surgery with elevated CA 242 levels, especially when CEA was also elevated, and patients without elevated CA 242. CONCLUSION: Preoperative serum levels of CA 242 showed less efficacy than CEA levels for the staging of colorectal adenocarcinoma patients. Elevated preoperative serum levels of CA 242 alone were related to poor survival, especially in association with high levels of CEA.

The possible cost effectiveness of peripheral blood stem cell mobilization with cyclophosphamide and the late addition of G-CSF.

The purpose of this study was to develop a cost-effective protocol for the mobilization of peripheral blood stem cells (PBSC) in patients with malignancy. Thirty consecutive patients were randomized to mobilize PBSC with the late addition of a standard 250 microg dose of G-CSF (Neutrogen) from day 8 or early addition of the same dose of G-CSF from day 2, following cyclophosphamide (CY) 4 g/m2. The median yield of CD34+ cells from evaluated patients was 7.87 x 10(6)/kg (range, 2.06-27.25), collected in a median of four apheresis (range, 2-9). Target CD34 + cell doses > or = 2.0 x 10(6)/kg were achieved in all patients able to be evaluated. There were no statistically significant differences in CD34+ cell yields or toxicities. Overall engraftment occurred with median days to neutrophils > or = 0.5 x 10(9)/L or platelets > 20 x 10(9)/L of 11 and 17 days, respectively. However, the duration of G-CSF administration was markedly shorter in the late use of G-CSF group than in the early use of G-CSF group, with a median of 9 days compared with 15 days (p<0.001). PBSC harvesting after priming with CY plus delayed use of G-CSF made it a safe and cost-effective procedure.