Allegra L, Blasi F, de Bernardi B, Cosentini R, Tarsia P
Institute of Respiratory Diseases, Department of Emergency Medicine, Milan, Italy.
Pulm Pharmacol Ther. 2001;14(2):149-55. doi: 10.1006/pupt.2001.0289.
The study was designed to extend retrospectively the analysis of a previously reported study on chronic bronchitis patients with acute exacerbations treated with amoxicillin-clavulanic acid or matched placebo. We retrospectively re-clustered patients on the basis of severity of baseline lung function: Cluster 1 (104 patients) mean screening FEV(1)32.67+/-6.83 (SD); Cluster 2 (109 patients) mean screening FEV(1)54.12+/-5.56; Cluster 3 (122 patients) mean screening FEV(1)71.54+/-5.51. The success rate in the antibiotic group was significantly greater compared to the placebo group (P<0.001). When clinical improvement was analysed on the basis of patient re-clustering, 31.4% of Cluster 1 (severe COPD) patients treated with amoxicillin/clavulanate showed clinical improvement, whereas success was recorded in 58.8%. Conversely, 13.2% of Cluster 1 patients receiving placebo improved and 17% successfully recovered (P<0.001). Mild and moderate COPD patients (Clusters 2 and 3) were grouped together. In these two groups, 31.2% and 53.6% of patients receiving antibiotic treatment showed improvement or recovery, respectively, compared to 29.2% improvements and 30.2% successful recoveries among placebo-treated patients (P<0.001). In placebo-treated patients the improvement/success vs. failure rate was significantly different in Cluster 1 patients compared to Cluster 2+3 subjects (P<0.01, (2)test). The differences in final FEV(1)values in the treatment group and placebo group were significantly different (P<0.01) in favour of the active treatment group. Among more severe patients (Cluster 1), the comparison between screening and follow up FEV(1)values showed an improvement following antibiotic treatment and worsening after placebo (P<0.01). In Clusters 2 and 3 the difference between screening and follow up FEV(1)values was not significant for both treatment groups. Our patients with severe functional impairment and higher number of exacerbations per year are those who derive the greatest benefit from antibiotic treatment.
该研究旨在回顾性地扩展先前一项关于使用阿莫西林-克拉维酸或匹配安慰剂治疗慢性支气管炎急性加重患者的研究分析。我们根据基线肺功能的严重程度对患者进行回顾性重新分组：第1组（104例患者），平均筛查FEV(1)为32.67±6.83（标准差）；第2组（109例患者），平均筛查FEV(1)为54.12±5.56；第3组（122例患者），平均筛查FEV(1)为71.54±5.51。抗生素组的成功率显著高于安慰剂组（P<0.001）。当根据患者重新分组分析临床改善情况时，接受阿莫西林/克拉维酸治疗的第1组（重度慢性阻塞性肺疾病）患者中有31.4%显示临床改善，而记录的成功率为58.8%。相反，接受安慰剂的第1组患者中有13.2%有所改善，17%成功康复（P<0.001）。轻度和中度慢性阻塞性肺疾病患者（第2组和第3组）合并在一起。在这两组中，接受抗生素治疗的患者分别有31.2%和53.6%显示改善或康复，而安慰剂治疗患者的改善率为29.2%，成功率为30.2%（P<0.001）。在安慰剂治疗的患者中，第1组患者的改善/成功率与失败率与第2 + 3组受试者相比有显著差异（P<0.01，卡方检验）。治疗组和安慰剂组最终FEV(1)值的差异有显著统计学意义（P<0.01），有利于活性治疗组。在病情较重的患者（第1组）中，筛查和随访FEV(1)值的比较显示抗生素治疗后有所改善，安慰剂治疗后则恶化（P<0.01）。在第2组和第3组中，两个治疗组筛查和随访FEV(1)值的差异均无统计学意义。我们那些功能严重受损且每年急性加重次数较多的患者是从抗生素治疗中获益最大的患者。
