Vol.65 No.3 May 2017

Clinical study on levofloxacin injection in gynecological infection

Hiroshige Mikamo¹⁾, Yuka Yamagishi¹⁾, Keiji Oe²⁾, Yasuyuki Okuda²⁾, Mutsuo Ishikawa³⁾, Kazuo Sengoku⁴⁾, Tsuyoshi Yamashita⁵⁾, Chisato Kinoshita⁶⁾, Tatsuro Furui⁷⁾, Koji Izumi⁸⁾, Yasuyuki Noguchi⁹⁾, Kazuhiro Iwasaku¹⁰⁾ and Hiroyuki Yamashita¹¹⁾

¹⁾Department of Clinical Infectious Diseases, Aichi Medical University Hospital, 1-1 Karimata, Yazako, Nagakute, Aichi, Japan
²⁾R&D Division, Daiichi Sankyo Co., Ltd.
³⁾Ai Women's Clinic
⁴⁾Department of Obstetrics and Gynecology, Asahikawa Medical University
⁵⁾Department of Obstetrics and Gynecology, Hakodate Municipal Hospital
⁶⁾Seijo Kinoshita Hospital
⁷⁾Department of Obstetrics and Gynecology, Gifu University Hospital
⁸⁾Izumi Ladies Clinic
⁹⁾Department of Obstetrics and Gynecology, Aichi Medical University School of Medicine
¹⁰⁾Kyoto Prefectural University of Medicine, School of Nursing Division of Obstetrics and Gynecology
¹¹⁾Department of Gynecology, Kokura Memorial Hospital

Abstract

We evaluated the efficacy and safety of levofloxacin (LVFX) injection 500 mg once-daily by intravenous infusion for 3 days to 14 days in patients with gynecological infections. The usefulness of sequential therapies, from LVFX injection to LVFX oral agent, for the treatment of gynecological infection was evaluated. Additionally, the drug penetration into vaginal discharge after administrating 500 mg of LVFX by injection was determined in patients with gynecological infections.
Clinical efficacy: The clinical efficacy rates at test of cure (primary endpoint) in patients with intrauterine infection and patients with uterine adnexitis were 85.7% (6/7) and 80.0% (8/10), respectively. The clinical efficacy rates in the patients with intrauterine infection and patients with uterine adnexitis receiving the sequential therapy were 100.0% (5/5) and 87.5% (7/8), respectively.
Microbiological efficacy: The microbiological efficacy rates at the end of treatment in patients with intrauterine infection and patients with uterine adnexitis were 42.9% (3/7) and 81.8% (9/11), respectively.
Pharmacokinetics: The mean value of LVFX concentration in vaginal discharge 3 h-7 h after starting infusion was 9.4 μ g/g (range: 7.5 μg/g-13.9 μg/g). The mean value of the vaginal discharge to plasma concentration ratio was 1.46 (range: 1.17-2.21).
Safety: The incidence rates of adverse events (AEs) and adverse drug reactions (ADRs) were 76.2% (16/21) and 38.1% (8/21), respectively. Serious adverse events or adverse events that led to treatment discontinuation were not observed.
From these results, LVFX injection 500 mg once-daily was shown to be useful for the treatment of intrauterine infection and uterine adnexitis, and it was demonstrated that there were no significant problems with its safety. Also, it was suggested that the sequential therapy, from LVFX injection to LVFX oral agent, contributes to reducing time spent in the hospital and medical care costs, and improves the quality of life (QOL) of patients.

Key word

levofloxacin, intrauterine infection, uterine adnexitis, sequential therapy

Received

July 8, 2016

Accepted

January 10, 2017

Jpn. J. Chemother. 65 (3): 469-483, 2017