Clinical evaluation of oral levofloxacin 500mg once-daily dosage for treatment of lower respiratory tract infections and urinary tract infections: a prospective multicenter study in China
| Autor: | Min-hua Shi, Jian Duan, Zu-ke Xiao, Guo-hua Ding, Hong-mei Yue, Qi-hao Li, Zhen-yi Ren, Hong-guang Zheng, Xiao-ju Lü, Huayin Li, Qing-lin Hao, Dong-yang Guo, Heping Yang, Tie-ying Sun, Hui Ma, Bin Si, Wanzhen Yao, Huahao Shen, Guo-ming Wu, Sheng-hua Sun, Bao-yuan Chen, Qian-ming Xia, Jun-ming Gu, Qingyu Xiu, Yingyuan Zhang, Jian-an Huang, Yun-song Yu, Wei Xiao, Wei Zhang, Ke-jing Ying, Hai-hui Huang, Ao Liu, Hui-fen Yang |
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| Rok vydání: | 2009 |
| Předmět: |
Male
Microbiology (medical) China Ofloxacin medicine.medical_specialty Adolescent medicine.drug_class Antibiotics Population Administration Oral Levofloxacin medicine.disease_cause Dizziness Drug Administration Schedule Sleep Initiation and Maintenance Disorders Internal medicine Lower respiratory tract infection Streptococcus pneumoniae medicine Humans Pharmacology (medical) Prospective Studies education Adverse effect Respiratory Tract Infections Aged education.field_of_study Respiratory tract infections business.industry Nausea Middle Aged medicine.disease Haemophilus influenzae Anti-Bacterial Agents Surgery Treatment Outcome Infectious Diseases Withholding Treatment Atypical pneumonia Urinary Tract Infections Female business medicine.drug |
| Zdroj: | Journal of Infection and Chemotherapy. 15:301-311 |
| ISSN: | 1341-321X |
| DOI: | 10.1007/s10156-009-0713-9 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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