PubMed · 6771537
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F Daschner. 1980-04-11. [Chronic bronchitis].. https://pubmed.ncbi.nlm.nih.gov/6771537/
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OBJECTIVE: To assess the efficacy and pitfalls of a protocol of generalized screening for group B Streptococcus (GBS) and intra-partum treatment of all carriers in a clinical setting. DESIGN: A descriptive study and comparison with an historical group. SETTING: A tertiary perinatal center. POPULATION: All women attending prenatal care in our center and delivered after 37 weeks were eligible. Study period ranged from January 1994 to September 1996. Comparison group consisted in deliveries of years 1992 and 1993. METHODS: Vaginal cultures were performed at 36 weeks on non-selective medium followed by intra-partum treatment of all carrier mothers. Rate of carriage, incidence of neonatal GBS sepsis, influence of risk factors and the reasons for failures were analysed. Comparison was made with an historical group. Statistical analysis was performed using a Chi-square test. RESULTS: There were 5374 term deliveries during the study. 3906 were screened (72.7%) and 559 of them found positive for GBS (14.3%). We observed 46 early-onset GBS diseases (0.86% of term-births). 43.5% of infections occurred in babies born from mothers without risks factors at delivery. Negative GBS cultures at sampling accounted for 43.5% of protocol failures. Comparison of the incidence of early-onset GBS disease with the previous two years showed a significant drop (1.45-0.86%, P<0.05). CONCLUSIONS: Our protocol revealed feasible and effective in reducing the incidence of early-onset GBS disease. Improvements must be studied particularly as to the predictive value of screening cultures.
Considering a variable mixing/stirring and flow pattern in a drug dissolution vessel as a likely source of high variability in results, experiments were conducted using USP paddle apparatus by placing (aligned to the walls) a metal strip (1.7 mm thickx6.4 mm wide) in a dissolution vessel. The metal strip forces the undisintegrated tablet to settle about 3 mm away from the centre, facilitates spread of disintegrated material and diminishes the cone formation at the bottom of the vessel. To assess the impact of this altered environment in the vessel, but still maintaining the vessel dimensions within required specifications, drug release characteristics were evaluated for products having different formulation/manufacturing attributes. Tests were conducted with calibrator tablets (USP prednisone and salicylic acid tablets and FDA proposed NCDA No. 2 prednisone tablets) and two commercially available products (250 mg amoxicillin capsules and 5 mg glibenclamide tablets). Except for the glibenclamide tablet product, all products gave significantly (P<0.01) higher dissolution results with vessels containing metal strip than without. The extent of increased dissolution with the metal strip varied from product to product i.e. USP prednisone tablet was the smallest (14.4%) and NCDA No. 2 was the largest (88.4%). Based on the results obtained from this study, it is concluded that employing the current apparatuses, in many cases products will provide lower than anticipated results which may not be reflective of the product drug release characteristics. Test-to-test variability, within or between laboratories, can also be very high depending on the settling position of the product once dropped in the vessel and/or due to slight aberration in the walls of the vessel by altering the extent of spread of disintegrated material at the bottom of the vessel. Thus, dissolution testing will require wider tolerances to be useful for comparison of batch-to-batch or interlaboratory results.
An experimental Streptococcus pneumoniae pneumonia model in rabbits was used to assess the efficacy of amoxycillin, erythromycin and a new ketolide, telithromycin (HMR 3647). The MICs of amoxycillin, erythromycin and HMR 3647 for the three clinical S. pneumoniae strains used were, respectively, (mg/L): 0.01, 16 and 0.02 (strain 195); 2, 0.25 and 0.02 (strain 16089); 8, >64 and 0.02 (strain 11724). Antibiotic therapy reproduced human serum pharmacokinetics (amoxycillin 1 g iv tds or erythromycin 500 mg qds or HMR 3647 800 mg bd). Forty-eight hours of therapy with HMR 3647 and amoxycillin resulted in significant bacterial clearance in the lungs and spleen of rabbits infected by S. pneumoniae strain 195 and strain 16089 (at least 3 log(10) cfu/g decrease, P < 0.001). Erythromycin was active against only the erythromycinsusceptible strain (3 log(10) cfu/g decrease at 48 h, P < 0.001). None of the antibiotics showed significant efficacy with strain 11724. All agents produced significant bacterial clearance when time above MBC was >33%, and microbiological failure when it was <25%, whereas MIC was not correlated with microbiological outcome with HMR 3647. Our findings suggest that pharmacodynamic data integrating MBC may be predictive of microbiological success or failure with greater accuracy than with MIC. HMR 3647 produced significant bacterial clearance in both penicillin- and erythromycin-resistant pneumonia, but was less effective against the highly erythromycin-resistant S. pneumoniae strain.