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The clinical efficacy and safety of intravenous levofloxacin in the treatment of 4888 patients with bacterial infections: a multi-center trial

Cooperation Group for Phase IV Clinical Study of Levofloxacin

Zhonghua nei ke za zhi, 2009

Abstract

OBJECTIVE: To evaluate the clinical efficiency and safety of intravenous levofloxacin in the treatment of bacterial infections at a dose of 500 mg once a day.

METHODS: Randomized, prospective, multicenter, open-label study.

RESULTS: The total effective rate of levofloxacin was 90.8% (4103/4521). The effective rates of levofloxacin in the treatment of bacterial infections of respiratory tract, urinary tract, digestive tract and gynecologic infections and infections complicated with hematological disease were 90.2% (2884/3198), 92.3% (810/878), 91.9% (203/221), 94.5% (120/127), 88.7% (86/97), respectively. The bacterial eradication rate was 80.3% (677/843). The most common adverse drug reactions were gastrointestinal disorders (3.9%, 193/4888) and local irritation (1.7%, 84/4888), which were mild and disappeared after stopping administration.

CONCLUSION: Intravenous levofloxacin with a dose of 500 mg once a day is effective and safe in treating bacterial infections with low adverse reactions.

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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