Brambilla C, Benhamou D, Guérin J C, Kelkel E, Muir J F, Prud'homme A, Taytard A, Fauche A
CHRU Grenoble, France.
Pathol Biol (Paris). 1995 Nov;43(9):815-24.
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.
为比较头孢曲嗪(头孢哌酮)和头孢泊肟酯(奥复星)治疗成人继发性感染慢性阻塞性肺疾病(COPD)的临床疗效和安全性,60名全科医生进行了一项多中心、随机、开放研究,将患者分为两个平行组,均患有合并急性重叠感染(安东尼森2期和3期)的COPD。在核实入选标准、获得书面同意并进行随机分组后,患者接受为期10天的治疗,一组患者每日服用1g头孢曲嗪,另一组患者每日服用400mg头孢泊肟酯。给患者发放了一份自我评估表。计划在第3天进行电话随访。在第11天±1天的最终随访评估临床疗效(成功或失败)和安全性。研究人群由250名患者组成,平均年龄为59.9±15.9岁(男女比例为1.5)。COPD的主要病因是,67.5%的患者为慢性支气管炎,24.5%的患者为长期哮喘,6.8%的患者为肺气肿。疾病平均病程为13.0±10.8年。73.6%的患者安东尼森评分为2分,8.8%的患者为3分,17.6%的患者为1分。两个研究组在这些标准方面未观察到显著差异。两组的临床成功率相当。直到第六天(主要在第4天和第6天之间),接受头孢曲嗪治疗的患者临床症状消退时间往往更短(p=0.09;无统计学意义)。临床安全性良好,两个研究组相当。本研究得出结论,在全科医疗中,头孢曲嗪和头孢泊肟酯治疗COPD重叠感染的临床疗效相当(分别为97.5%和99%),安全性令人满意且相当,但头孢曲嗪的治疗成本低得多。在可参照医学文献的背景下,这一结论尤为重要,因为尽管经常建议使用第二代和第三代头孢菌素治疗COPD重叠感染,但开具成本较低的头孢菌素似乎更合适。