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Background/Purpose
Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP.Methods
A phase 3, multicenter, randomized (2:1) controlled trial was conducted in adult CAP patients receiving nemonoxacin 500 mg or levofloxacin 500 mg orally once daily for 7–10 days. Clinical, microbiological response and adverse events were assessed. Non-inferiority was determined in terms of clinical cure rate of nemonoxacin compared with that of levofloxacin in a modified intention-to-treat (mITT) population. NCT registration number: NCT01529476.Results
A total of 527 patients were randomized and treated with nemonoxacin (n = 356) or levofloxacin (n = 171). The clinical cure rate at test-of-cure visit was 94.3% (300/318) for nemonoxacin and 93.5% (143/153) for levofloxacin in the mITT population [difference (95% CI), 0.9% (?3.8%, 5.5%)]. The microbiological success rate was 92.1% (105/114) for nemonoxacin and 91.7% (55/60) for levofloxacin in the bacteriological mITT population [difference (95% CI), 0.4% (?8.1%, 9.0%)]. The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) (P > 0.05).Conclusion
Nemonoxacin 500 mg once daily for 7–10 days is as effective and safe as levofloxacin for treating adult CAP patients in terms of clinical cure rates, microbiological success rates, and safety profile.ClinicalTrials.gov identifier: NCT01529476. 相似文献Patients diagnosed with chronic functional diarrhoea (Rome II criteria), exclusion of blood, ova/parasites in the stool and a normal colonoscopy were included. After a 1-week period of baseline without any medication, they were prescribed three sachets of dioctahedral smectite 3 g, administered 1 h after the meals (Group A), or two capsules of Bifico 210 mg (Group B) for 28 consecutive days. Efficacy of the treatments was assessed on frequency of bowel movements and consistency of stool, as compared to baseline.
Four hundred and ten patients were included (258 males, 152 females; mean age 43.8 ± 13.9 years): 208 in Group A and 202 in Group B. In Group A, the mean number of stool per day decreased from 3.5 ± 1.0 at baseline to 2.0 ± 0.9 and from 3.3 ± 1.0 to 2.2 ± 0.9 in Group B (z = 2.699; P = 0.007). Decrease in stool number was significant with both treatments but more important with smectite at week 2 and remained significant throughout the treatment period. Stool consistency, assessed by the Bristol scale, also improved significantly over the treatment period, as compared to baseline (z = 3.310, P = 0.001).
Dioctahedral smectite appeared in this study to be an effective and safe treatment of chronic functional diarrhoea, its effect starting during the first week of treatment and consisting in a decrease in the frequency of daily bowel movements and improvement of stool consistency. Moreover, dioctahedral smectite displays a prolonged action after disruption of the treatment that may interfere with the natural course of the disease. 相似文献