Clinical evaluation of oral levofloxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China

doi:10.1007/s10156-009-0713-9

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	Clinical evaluation of oral levofloxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China
	Zhang, YY; Huang, HH; Ren, ZY; Zheng, HG; Yu, YS; Lu, XJ; Xiao, ZK; Yang, HF; Xiu, QY; Chen, BY
刊名	JOURNAL OF INFECTION AND CHEMOTHERAPY
	2009-10
卷号	15 期号:5 页码:301-311
关键词	Lower respiratory tract infection Urinary tract infection Levofloxacin Clinical study
ISSN号	1341-321X
DOI	10.1007/s10156-009-0713-9
文献子类	Article
英文摘要	Levofloxacin (LVFX), a fluoroquinolone agent, has a broad spectrum that covers Gram-positive and -negative bacteria and atypical pathogens. It demonstrates good clinical efficacy in the treatment of various infections, including lower respiratory tract infections (LRTIs) and urinary tract infections (UTIs). To evaluate the efficacy and safety of oral LVFX 500 mg once daily, a large open-label clinical trial was conducted in 1266 patients (899 with LRTIs and 367 with UTIs) at 32 centers in China. In the per-protocol population, the clinical efficacy rate (cure or improvement) at 7 to 14 days after the end of treatment was 96.4% (666/691) for LRTIs and 95.7% (267/279) for UTIs. In 53 patients diagnosed with atypical pneumonia the treatment was effective. The bacteriological efficacy rate was 96.6% (256/265) for LRTIs and 93.3% (126/135) for UTIs. The eradication rate of the causative pathogens was 100% (33/33) for Haemophilus influenzae and 96.0% (24/25) for Streptococcus pneumoniae in LRTIs, and 94.1% (80/85) for Escherichia coli in UTIs. The overall efficacy rates were 89.3% (617/691) for LRTIs and 87.8% (245/279) for UTIs. The incidence of drug-related adverse events (ADRs) was 17.3% (215/1245), and the incidence of drug-related laboratory abnormalities was 15.7% (191/1213). Common ADRs were dizziness, nausea, and insomnia. Common laboratory abnormalities included "WBC decreased", "alanine aminotransferase (ALT) increased", "aspartate aminotransferase (AST) increased", and "lactate dehydrogenase (LDH) increased". All of these events were mentioned in the package inserts of fluoroquinolones including LVFX, and most events were mild and transient. Thirty-four patients (2.7%) were withdrawn from the study because of the ADRs. No new ADRs were found. This study concluded that the dosage regimen of LVFX 500 mg once daily was effective and tolerable for the treatment of LRTIs and UTIs.
学科主题	Infectious Diseases ; Pharmacology & Pharmacy
出版地	TOKYO
项目编号	Daiichi Pharmaceutical Co., Ltd, Beijing, China
语种	英语
WOS记录号	WOS:000271106500006
内容类型	期刊论文
源URL	[http://ir.lzu.edu.cn/handle/262010/125689]
专题	第一临床医学院_期刊论文
通讯作者	Zhang, YY (reprint author), Fudan Univ, Inst Antibiot, Huashan Hosp, 12 Wulumuqi Zhong Lu, Shanghai 200040, Peoples R China.
推荐引用方式 GB/T 7714	Zhang, YY,Huang, HH,Ren, ZY,et al. Clinical evaluation of oral levofloxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China[J]. JOURNAL OF INFECTION AND CHEMOTHERAPY,2009,15(5):301-311.
APA	Zhang, YY.,Huang, HH.,Ren, ZY.,Zheng, HG.,Yu, YS.,...&Zhang, YY .(2009).Clinical evaluation of oral levofloxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China.JOURNAL OF INFECTION AND CHEMOTHERAPY,15(5),301-311.
MLA	Zhang, YY,et al."Clinical evaluation of oral levofloxacin 500 mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China".JOURNAL OF INFECTION AND CHEMOTHERAPY 15.5(2009):301-311.