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
机构：[1]Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Wulumuqi Zhong Lu, Shanghai 200040, China[2]Department of Respiratory Medicine, First People’s Hospital of Hangzhou, Hangzhou, China[3]Department of Nephrology, The Military General Hospital of Shenyang, Shenyang, China[4]Department of Infectious Diseases, First Hospital, Zhejiang University, Hangzhou, China内科系统感染病科浙江大学医学院附属第一医院[5]Department of Infectious Diseases, Huaxi Hospital, Sichuan University, Chengdu, China四川大学华西医院[6]Department of Respiratory Medicine, The People’s Hospital of Jiangxi Province, Nanchang, China[7]Department of Infectious Diseases, Second Hospital, Tianjin Medical University, Tianjin, China[8]Department of Respiratory Medicine, Shanghai Changzheng Hospital, Shanghai, China[9]Department of Respiratory Medicine, Tianjin Medical University General Hospital, Tianjin, China[10]Department of Respiratory Medicine, First Hospital, Lanzhou University, Lanzhou, China[11]Department of Respiratory Medicine, First Hospital, Kunming Medical University, Kunming, China内科科室呼吸内科昆明医科大学附属第一医院[12]Department of Respiratory Medicine, First Hospital, Suzhou University, Suzhou, China[13]Department of Respiratory Medicine, The People’s Hospital of Gansu Province, Lanzhou, China[14]Department of Respiratory Medicine, Qilu Hospital, Shangdong University, Jinan, China[15]Department of Nephrology, The Military General Hospital of Chengdu, Chengdu, China[16]Department of Respiratory Medicine, The Military General Hospital of Wuhan, Wuhan, China[17]Department of Respiratory Medicine, Xiangya Third Hospital, Zhongnan University, Changsha, China[18]Department of Respiratory Medicine, First Hospital, Nanchang University, Nanchang, China[19]Department of Respiratory Medicine, Second Hospital, Kunming Medical University, Kunming, China[20]Department of Respiratory Medicine, Second Hospital, Zhejiang University, Hangzhou, China[21]Department of Nephrology, The Military General Hospital of Kunming, Kunming, China[22]Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China[23]Department of Respiratory Medicine, Peking University Third Hospital, Beijing, China[24]Department of Respiratory Medicine, Second Hospital, Dalian Medical University, Dalian, China[25]Department of Respiratory Medicine, The Military General Hospital of Chengdu, Chengdu, China[26]Department of Respiratory Medicine, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, China[27]Department of Respiratory Medicine, The Military General Hospital of Kunming, Kunming, China[28]Department of Respiratory Medicine, First Hospital, Third Military Medical University, Chongqing, China[29]Department of Respiratory Medicine, Second Hospital, Suzhou University, Suzhou, China[30]Department of Respiratory Medicine, Beijing Hospital, Beijing, China[31]Department of Nephrology, The People’s Hospital, Wuhan University, Wuhan, China[32]Department of Respiratory Medicine, Second Hospital, Third Military Medical University, Chongqing, China
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.
第一作者机构：[1]Institute of Antibiotics, Huashan Hospital, Fudan University, 12 Wulumuqi Zhong Lu, Shanghai 200040, China
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Ying-yuan,Huang Hai-hui,Ren Zhen-yi,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.doi:10.1007/s10156-009-0713-9.
APA：
Zhang, Ying-yuan,Huang, Hai-hui,Ren, Zhen-yi,Zheng, Hong-guang,Yu, Yun-song...&Wu, Guo-ming.(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)
MLA：
Zhang, Ying-yuan,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
