Niki Yoshihito, Yoshida Koichiro, Miyashita Naoyuki, Oka Mikio, Hara Hiroki, Kishimoto Michihiro, Okimoto Niro, Kawanishi Masayoshi, Uno Masatoshi, Kamao Takayuki, Yoneyama Hirohide, Nakamura Junichi, Kimura Makoto, Watanabe Masatoshi, Tanimukai Takeshi, Moriya Osamu, Matsushima Toshiharu
School of Medicine, Department of Clinical Infectious Diseases, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan.
J Infect Chemother. 2008 Aug;14(4):296-304. doi: 10.1007/s10156-008-0625-0. Epub 2008 Aug 17.
The efficacy and safety of gatifloxacin (GFLX) was evaluated for elderly patients with respiratory infections. Each patient received one-half (100 mg b.i.d.) or one-quarter (100 mg q.d.) of the conventional dosage of 200 mg b.i.d., after a tentative clinical dosage for GFLX was estimated based on the patient's age and body weight. The subjects were 34 patients aged 65 years or older with mild to moderate acute bronchitis, pneumonia, or chronic respiratory tract infections. The serum concentration of GFLX was measured for each patient, and population and pharmacokinetic (PPK) analysis was performed, using the Bayesian method, to calculate the AUC and maximum drug concentration (Cmax). The overall efficacy rate of GFLX for 33 patients was 87.9% (29/33 patients). GFLX was effective for 75.0% (6/8 patients) in the 100-mg dosage group and 92.0% (23/25 patients) in the 200-mg dosage group. The clinical efficacy was 90.0% (9/10 patients) for acute bronchitis, 86.7% (13/15 patients) for pneumonia, and 87.5% (7/8 patients) for chronic respiratory tract infections. The bacterial eradication rate was 85.7% (12/14 patients). No adverse events or laboratory abnormalities were observed. The AUC values were 11.2-37.5 microg.h/ml and 12.7-111 microg.h/ml for the 100-mg and 200-mg dosage groups, respectively, and the Cmax values were 1.28-3.02 microg/ml and 0.72-6.35 microg/ml, respectively, for the two groups. These results suggest that the dosage of GFLX examined in this study is clinically useful in elderly patients aged 65 or older with acute bronchitis, pneumonia, or chronic respiratory tract infections. The results of PPK analysis with the dosage management also support the efficacy of GFLX.
对老年呼吸道感染患者评估了加替沙星（GFLX）的疗效和安全性。根据患者年龄和体重估算出GFLX的暂定临床剂量后，每位患者接受常规剂量200mg每日两次的一半（100mg每日两次）或四分之一（100mg每日一次）。研究对象为34例65岁及以上患有轻至中度急性支气管炎、肺炎或慢性呼吸道感染的患者。测定了每位患者的GFLX血清浓度，并采用贝叶斯方法进行群体药代动力学（PPK）分析，以计算AUC和最大药物浓度（Cmax）。33例患者中GFLX的总有效率为87.9%（29/33例患者）。100mg剂量组中GFLX对75.0%（6/8例患者）有效，200mg剂量组中对92.0%（23/25例患者）有效。急性支气管炎的临床有效率为90.0%（9/10例患者），肺炎为86.7%（13/15例患者），慢性呼吸道感染为87.5%（7/8例患者）。细菌清除率为85.7%（12/14例患者）。未观察到不良事件或实验室异常。100mg和200mg剂量组的AUC值分别为11.2 - 37.5μg·h/ml和12.7 - 111μg·h/ml，两组的Cmax值分别为1.28 - 3.02μg/ml和0.72 - 6.35μg/ml。这些结果表明，本研究中所检测的GFLX剂量对65岁及以上患有急性支气管炎、肺炎或慢性呼吸道感染的老年患者在临床上是有用的。剂量管理的PPK分析结果也支持GFLX的疗效。
