• Tuberculosis and Respiratory Diseases
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• v.55 no.1
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• pp.69-87
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• 2003

Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.

• Radiation Oncology Journal
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• v.19 no.3
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• pp.275-286
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• 2001

Purpose : To setup procedures of quality assurance (OA) for implementing intensity modulated radiation therapy (IMRT) clinically, report OA procedures peformed for one patient with prostate cancer. Materials and methods : $P^3IMRT$ (ADAC) and linear accelerator (Siemens) with multileaf collimator are used to implement IMRT. At first, the positional accuracy, reproducibility of MLC, and leaf transmission factor were evaluated. RTP commissioning was peformed again to consider small field effect. After RTP recommissioning, a test plan of a C-shaped PTV was made using 9 intensity modulated beams, and the calculated isocenter dose was compared with the measured one in solid water phantom. As a patient-specific IMRT QA, one patient with prostate cancer was planned using 6 beams of total 74 segmented fields. The same beams were used to recalculate dose in a solid water phantom. Dose of these beams were measured with a 0.015 cc micro-ionization chamber, a diode detector, films, and an array detector and compared with calculated one. Results : The positioning accuracy of MLC was about 1 mm, and the reproducibility was around 0.5 mm. For leaf transmission factor for 10 MV photon beams, interleaf leakage was measured $1.9\%$ and midleaf leakage $0.9\%$ relative to $10\times\;cm^2$ open filed. Penumbra measured with film, diode detector, microionization chamber, and conventional 0.125 cc chamber showed that $80\~20\%$ penumbra width measured with a 0.125 cc chamber was 2 mm larger than that of film, which means a 0.125 cc ionization chamber was unacceptable for measuring small field such like 0.5 cm beamlet. After RTP recommissioning, the discrepancy between the measured and calculated dose profile for a small field of $1\times1\;cm^2$ size was less than $2\%$. The isocenter dose of the test plan of C-shaped PTV was measured two times with micro-ionization chamber in solid phantom showed that the errors upto $12\%$ for individual beam, but total dose delivered were agreed with the calculated within $2\%$. The transverse dose distribution measured with EC-L film was agreed with the calculated one in general. The isocenter dose for the patient measured in solid phantom was agreed within $1.5\%$. On-axis dose profiles of each individual beam at the position of the central leaf measured with film and array detector were found that at out-of-the-field region, the calculated dose underestimates about $2\%$, at inside-the-field the measured one was agreed within $3\%$, except some position. Conclusion : It is necessary more tight quality control of MLC for IMRT relative to conventional large field treatment and to develop QA procedures to check intensity pattern more efficiently. At the conclusion, we did setup an appropriate QA procedures for IMRT by a series of verifications including the measurement of absolute dose at the isocenter with a micro-ionization chamber, film dosimetry for verifying intensity pattern, and another measurement with an array detector for comparing off-axis dose profile.