[Comparative trial of the clinical efficacy and tolerance of cefatrizine (Cefaperos) and cefpodoxime proxetil (Orelox) in superinfections of chronic obstructive bronchopneumopathies in adults in urban practice].
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| Abstract |
In order to compare the clinical efficacy and safety of cefatrizine (Cefaperos) and cefpodoxime proxetil (Orelox) in the treatment of secondarily infected chronic obstructive pulmonary disease (COPD) in adults, a multicentre, randomized, open study was conducted by 60 general practitioners in two parallel groups of patient suffering from COPD complicated by an acute episode of superinfection (Anthoniesen stages 2 and 3). After verification of the eligibility criteria, written consent and randomization, the patients received, for 10 days, either cefatrizine at the dose of 1 g/day or cefpodoxime proxetil at the dose of 400 mg/day. A self-assessment form was given to the patient. A telephone visit was planned for D3. The final visit on D11 +/- 1 evaluated clinical efficacy (success or failure) and safety. The study population was composed of 250 patients with a mean age of 59.9 +/- 15.9 years (sex ratio M/F = 1.5). The principal etiology of COPD was chronic bronchitis in 67.5% of patients, longstanding asthma in 24.5% and emphysema in 6.8%. The mean history of the disease was 13.0 +/- 10.8 years. The Anthoniesen score was equal to 2 in 73.6% of patients, 3 in 8.8% of patients and 1 in 17.6% of patients. No significant difference concerning these criteria was observed between the two study groups. The clinical success rate was equivalent in the two groups. The time to regression of clinical signs tended to be shorter, up until the sixth day (mainly between D4 and D6) for patients treated with cefatrizine (p = 0.09; NS). The clinical safety was considered to be good and was comparable in the two study groups. This study concluded on the equivalent clinical efficacy of cefatrizine and cefpodoxime proxetil in the treatment of superinfections of COPD in general practice (97.5% and 99%, respectively), with a satisfactory and comparable safety, but with a much lower cost of treatment for cefatrizine. This conclusion is particularly important in the context of opposable medical references, as, although the treatment of superinfections of COPD by second and third generation cephalosporins is frequently proposed, the prescription of a less expensive cephalosporin appears to be more relevant.
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| Authors | C Brambilla, D Benhamou, J C Guérin, E Kelkel, J F Muir, A Prud'homme, A Taytard, A Fauche |
| Journal | Pathologie-biologie (Pathol Biol (Paris)) Vol. 43 Issue 9 Pg. 815-24 (Nov 1995) ISSN: 0369-8114 [Print] France |
| Vernacular Title | Essai comparatif de l'efficacité et de la tolérance clinique entre la céfatrizine (Cefaperos) et le cefpodoxime proxétil (Orelox) dans les surinfections des bronchopneumopathies chroniques obstructives de l'adulte en médecine de ville. |
| PMID | 8746104 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial) |
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