[The efficacy and safety of moxifloxacin in the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease].

Objective: To compare the effectiveness and safety of moxifloxacin and cefoperazone-sulbactam therapy in acute exacerbation of chronic obstructive pulmonary disease (COPD).

Methods: This was a prospective, randomized, multicentre study conducted between December 2011 and December 2012 involving 21 hospitals in Fujian. A total of 202 patients with AECOPD requiring antibiotic therapy were enrolled. Of these patients randomized to either treatments, 102 patients [male 60, female 42, (69.8 ± 6.5) y] received moxifloxacin (400 mg qd) and 100 [male 56, female 44, (69.6 ± 6.7) y] received cefoperazone-sulbactam (3.0 q 8 h). Clinical effectiveness, bacterial eradication and drug safety were evaluated.

Results: The clinical effectiveness rate was 90.2% (92/102) in the moxifloxacin group and 88.0% (88/100) in the cefoperazone-sulbactam group. The bacterial eradication rate was 51.9% (14/27) and 48.3% (14/29) in the 2 groups respectively. The differences between groups were not statistically significant in terms of clinical and microbiological effectiveness (χ² = 0.251, χ² = 0.072, both P > 0.05). The length of hospital stay and antibiotic-days were shorter in the moxifloxacin group [(8.7 ± 2.4) vs (11.7 ± 3.0) d; (6.7 ± 2.2) vs (8.7 ± 2.3) d], the differences being significant between the 2 arms. (t = 6.360, t = 7.732, P < 0.05). Both drugs were well tolerated with no significant differences in numbers of drug-related adverse events (P > 0.05).

Conclusions: Moxifloxacin was equivalent to cefoperazone-sulbactam therapy for clinical success, bacteriologic eradication and showed superiority over the control group in shortening the length of hospital stay and antibiotic-days. Additionally, the drug safety of moxifloxacin was good.