Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 399 45 2012 11 5 LVFX 500 mg 1 1 20 Chlamydia trachomatis C. trachomatismycoplasma genitalium M. genitalium LVFX 1 500 mg 1 1 7 22 22 C. trachomatis 17 M. genitalium 4 C. trachomatis M. genitalium 1 2 4 86.4% 19/22 C. trachomatis M. genitalium C. trachomatis M. genitalium 94.1% 16/17 50.0% 2/4 100% 1/1 3 2 490.9% 20/22 C. trachomatis M. genitalium C. trachomatis M. genitalium 100% 17/17 50.0% 2/4 100% 1/1 M. genitalium P 0.0071 22 LVFX 500 mg 1 1 2008 1
400 46 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 LVFX 100 mg 3 / 7 150 mg 2 / 7 2 2006 2008 9 LVFX PK PD 2009 7 100 mg 1 3 500 mg 1 1 AUC/MIC Cmax/MIC 1 AUC Cmax LVFX 500 mg1 1 Mycoplasma genitalium LVFX 500 mg 1 1 2,3 LVFX 500 mg 1 1 20 I. 1. 2010 6 2012 5 20 C. trachomatis M. genitalium 1 2 mg/dl 2. 500 mg LVFX 500 mg 250 mg LVFX 250 mg 1 500 mg 1 250 mg 2 1 1
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 401 47 7 3. 4. G-CSF NSAID 2 5. Fig. 1 1 STI Fig. 1.
402 48 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 7 1 2 2 3 2 3 2 3 2 3 3 5 4 C. trachomatis TMA, SDA, PCR Neisseria gonorrhoeae, M. genitalium PCR 4 5 AST GOT ALT GPT -GTP LDH ALPCK CPK BUN Na, K, Cl CRP 6 6. 1 5 2 2 4 1 C. trachomatis M. genitalium 2
Table 1. Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 403 49
404 50 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 C. trachomatis M. genitalium C. trachomatis M. genitalium 2 2 7. 3 2 2 8. 2 5% II. 1. 24 C. trachomatis M. genitalium 2 22 2. Table 1 22 C. trachomatis 17 M. genitalium 4 C. trachomatis M. genitalium 1 38.2 10.3 9.6 4.7 11.9 10.7 STI 5 1 32 14 3 2 14 1 1 1 4/hpf 1000 Table 2.
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 405 51 5/hpf 1000 C. trachomatis M. genitalium Table 2 C. trachomatis 17 C. trachomatis 15 C. trachomatis Ureaplasma parvum C. trachomatis Ureaplasma urealyticum 1 M. genitalium 4 M. genitalium 3 M. genitalium U. urealyticum 1 C. trachomatis M. genitalium C. trachomatis M. genitalium U. parvum 3. 2 4 Table 3 86.4% 19/22 C. trachomatis M. genitalium C. trachomatis M. genitalium 94.1% 16/17 50.0% 2/4 100% 1/1 3 P 0.0633 81.8% 18/22 Table 4 C. trachomatis M. genitalium C. trachomatis M. genitalium82.4% 14/17 75.0% 3/4 100% 1/1 P 0.8393 4. 2 4 Table 5 90.9% 20/22 C. trachomatis M. genitalium C. trachomatis M. genitalium 100% 17/17 50.0% 2/4 100% 1/1 M. genitalium P 0.0071 95.5% 21/22 C. trachomatis M. genitalium C. trachomatis M. genitalium 100% 17/17 75.0% 3/4 Table 3. 2 4 Table 4.
406 52 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 Table 5. 2 4 Table 6. 100% 1/1 P 0.0947 5. 22 III. C. trachomatis M. genitalium LVFX 500 mg 1 1 C. trachomatis 1 5 2 4 94.1% 16/17 100% 17/17 C. trachomatis LVFX 500 mg 1 1 7 S. TAKAHASHI 6 M. genitalium 2 4 50.0% 2/4 50.0% 2/4 C. trachomatis M. genitalium 1 2 4 C. trachomatis M. genitalium M. genitalium 7 LVFX 100 mg 3 / M. genitalium 7 33.3% 4/12 7 14 50% 8/16 8 LVFX M. genitalium
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 407 53 500 mg 1 1 M. genitalium LVFX MIC 0.125 2 g/ml 9 50.0% 4 2 4 3 C. trachomatis 1 C. trachomatis 2 4 C. trachomatis PCR C. trachomatis 2 4 PCR PCR 10 2 4 M. genitalium 2 M. genitalium 1 2 4 M. genitalium 2 4 M. genitalium 1 2 4 22 LVFX 500 mg 1 1 1 300 mg 500 mg 22 LVFX 500 mg 1 1 1.61% 482/29,880 11 1.26% 203/ 16,117 12 LVFX 500 mg1 1 C. trachomatis LVFX 500 mg 1 1 7 M. genitalium 4 LVFX 1 2008 19: 57 60, 2008 2 Levo oxacin 500 mg 1 1 57 S-2 : 34 46, 2009 3 ZHANG, Y. Y.; H. H. HUANG, Z. Y. REN, et al.: Clinical evaluation of oral levo oxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China. J. Infect. Chemother. 15: 301 311, 2009 4 YOSHIDA, T.; S. MAEDA, T. DEGUCHI, et al.: Phylogeny-based rapid identification of Mycoplasma and Ureaplasma from urethritis. J. Clin. Microbiol. 40: 105 110, 2002 5
408 54 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 1 57: 511 525, 2009 6 TAKAHASHI, S.; K. ICHIHARA, J. HASHIMOTO, et al.: Clinical ef cacy of levo oxacin 500 mg once daily for 7 days for patients with nongonococcal urethritis. J. Infect. Chemother. 17: 392 396, 2011 7 15: 139 143, 2004 8 M. genitalium M. genitalium 12: 74 78, 2002 9 HAMASUNA, R.; J. S. JENSEN & Y. OSADA: Antimicrobial susceptibilities of Mycoplasma genitalium strains examined by broth dilution and quantitative PCR. Antimicrob. Agents Chemother. 53: 4938 4939, 2009 10 7 Polymerase Chain Reaction 13: 81 86, 2002 11 Levo oxacin 500 mg 1 1 59: 614 633, 2011 12 YAMAGUCHI, H.; H. KAWAI, T. MATSUMOTO, et al.: Post-marketing surveillance of the safety of levo oxacin in Japan. Chemotherapy 53: 85 103, 2007 Ef cacy and safety of levo oxacin to non-gonorrheal urethritis SHOICHI ONODERA Fuji City General Hospital YASUHIKO ONOE Miyamotocho Central Clinic TAKAHIDE HOSOBE Hosobe Clinic TETSURO KATO and MASAKI YOSHIDA Department of Infectious Diseases and Infection Control, The Jikei University School of Medicine We investigated the efficacy and safety of levofloxacin LVFX 500 mg once a day in patients with non-gonorrheal urethritis. Men, aged 20 years or older, with urethritis symptoms, and detection of Chlamydia trachomatis C. trachomatis or Mycoplasma genitalium M. genitalium by a microbiological examination were eligible for this study. Patients were administered LVFX 500 mg, orally, once a day and the dosage period was seven days. We assumed 22 patients for a safety and ef cacy analysis. In 22 patients, 17 patients had urethritis with C. trachomatis, 4 patients urethritis with M. genitalium, and one patient mixed infection of C. trachomatis and M. genitalium. In the clinial study, the primary endpoint was set as the bacteriological eradication rate at two to four weeks after completion of treatment. The
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 409 55 bacterial eradication rate in the urethritis was 86.4% 19/22. The bacterial eradication rate in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 94.1% 16/17, 50.0% 2/4, 100% 1/1, respectively. A signi cant difference was not recognized among the three groups. The clinical efficacy at two to four weeks after completion of treatment was 90.9% 20/22. The clinical ef cacy rates in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 100% 17/17, 50.0% 2/4, 100% 1/1, respectively. The efficacy rate of urethritis with M. genitalium was signi cantly low. No adverse drug reactions were observed. These results suggest that once-a-day levofloxacin 500 mg is effective and safe treatment for non-gonorrheal urethritis.