2008The Chinese Journal of Clinical PharmacologyRequires access

Randomized controlled clinical trial of moxifloxacin versus levofloxacin injection in the treatment of community acquired pneumonia

Hao Feng-lan

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Abstract

Objective To evaluate the efficacy and safety of moxifloxacin for the treatment on the patients with community acquired pneumonia.Methods A randomized controlled,parallel,block,open clinical trial was conducted.Patients were randomized into each group in the study.Trial group patients received moxifloxacin 400 mg once daily,and control group patients received levofloxacin 200 mg twice daily by intravenous infusion.The duration was 7~14 days in both groups.Ninety-two cases in the ITT analysis,46 patients in trial group received moxifloxacin treatment,and 46 in control group received levofloxacin treatment;73 cases in the PP analysis,37 patients in moxifloxacin group,and 66 patients in levofloxacin group;73 cases in PP/MBE,34 patients in moxifloxacin group and 39 patients in levofloxacin group;62 cases in the PP/MBE,31 patients in each group.The overall efficacy rates of each group in ITT were 76.1%.Results The overall efficacy rates in PP were 89.2% and 88.9%,respectively.The bacterial eradication rates of each group in ITT/MBE were 88.2% and 82.1%,and in PP/MBE were 90.3% and 90.6%,respectively.The adverse drug reaction was evaluated in 92 cases.The adverse drug reaction rates,which related to study drug of each group were 10.3% and 8.7%,respectively.The results showed that there were no statistical differences between these two groups(P0.05).Conclusion Moxifloxacin was effective and safe as levofloxacin in the treatment of community acquired pneumonia.

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Objective To evaluate the efficacy and safety of moxifloxacin for the treatment on the patients with community acquired pneumonia.Methods A randomized controlled,parallel,block,open clinical trial was conducted.Patients were randomized into each group in the study.Trial group patients received moxifloxacin 400 mg once daily,and control group patients received levofloxacin 200 mg twice daily by intravenous infusion.The duration was 7~14 days in both groups.Ninety-two cases in the ITT analysis,46 patients in trial group received moxifloxacin treatment,and 46 in control group received levofloxacin treatment;73 cases in the PP analysis,37 patients in moxifloxacin group,and 66 patients in levofloxacin group;73 cases in PP/MBE,34 patients in moxifloxacin group and 39 patients in levofloxacin group;62 cases in the PP/MBE,31 patients in each group.The overall efficacy rates of each group in ITT were 76.1%.Results The overall efficacy rates in PP were 89.2% and 88.9%,respectively.The bacterial eradication rates of each group in ITT/MBE were 88.2% and 82.1%,and in PP/MBE were 90.3% and 90.6%,respectively.The adverse drug reaction was evaluated in 92 cases.The adverse drug reaction rates,which related to study drug of each group were 10.3% and 8.7%,respectively.The results showed that there were no statistical differences between these two groups(P0.05).Conclusion Moxifloxacin was effective and safe as levofloxacin in the treatment of community acquired pneumonia.

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Available abstract

Objective To evaluate the efficacy and safety of moxifloxacin for the treatment on the patients with community acquired pneumonia.Methods A randomized controlled,parallel,block,open clinical trial was conducted.Patients were randomized into each group in the study.Trial group patients received moxifloxacin 400 mg once daily,and control group patients received levofloxacin 200 mg twice daily by intravenous infusion.The duration was 7~14 days in both groups.Ninety-two cases in the ITT analysis,46 patients in trial group received moxifloxacin treatment,and 46 in control group received levofloxacin treatment;73 cases in the PP analysis,37 patients in moxifloxacin group,and 66 patients in levofloxacin group;73 cases in PP/MBE,34 patients in moxifloxacin group and 39 patients in levofloxacin group;62 cases in the PP/MBE,31 patients in each group.The overall efficacy rates of each group in ITT were 76.1%.Results The overall efficacy rates in PP were 89.2% and 88.9%,respectively.The bacterial eradication rates of each group in ITT/MBE were 88.2% and 82.1%,and in PP/MBE were 90.3% and 90.6%,respectively.The adverse drug reaction was evaluated in 92 cases.The adverse drug reaction rates,which related to study drug of each group were 10.3% and 8.7%,respectively.The results showed that there were no statistical differences between these two groups(P0.05).Conclusion Moxifloxacin was effective and safe as levofloxacin in the treatment of community acquired pneumonia.

Key concepts: Moxifloxacin, Levofloxacin, Medicine, Community-acquired pneumonia, Pneumonia, Randomized controlled trial, Adverse effect, Internal medicine

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