口服糖皮质激素治疗慢性阻塞性肺疾病急性加重的疗效和疗程研究

The effects and therapeutic duration of oral corticosteroids in patients with acute exacerbation of chronic obstructive pulmonary diseases

目的观察口服糖皮质激素（简称激素）对COPD急性加重（AECOPD）的疗效以及7d和14d疗程的疗效。方法2002年7月至2005年1月对130例住院的AECOPD患者按随机数字表法分为3组：7d治疗组：44例（男32例，女12例），平均年龄（70±8）岁，泼尼松30mg／d连续7d，然后安慰剂7d；14d治疗组：43例（男34例，女9例），平均年龄（72±7）岁，泼尼松30mg／d连续10d，然后15mg／d连续4d；安慰剂组：43例（男32例，女11例），平均年龄（734-7）岁，口服安慰剂14d。试验前后观察肺功能、血气分析、住院天数、症状得分、治疗失败率、激素不良反应和复发率。用SPSS11．0软件包对数据进行分析，计量资料数据以面x±s表示，治疗前后比较采用配对t检验，计数资料数据采用x^2检验，多组间比较采用方差分析，其中多重比较采用SNK法，对治疗失败率、复发率和安全性评价采用Fisher精确概率检验。结果7d治疗组的FEV。为（0．87±0．23）L，较安慰剂组的（0．74±0．32）L明显提高（q=3．67，P〈0．05）；14d治疗组的FEV1为（0．93±0．30）L，较安慰剂组的（0．74±0．32）L也明显提高（q=4．43，P〈0．01）。7d治疗组的PaO2为（79±9）mmHg（1mmHg=0．133kPa），较安慰剂组的（73±12）mmHg明显提高（q=6．31，P〈0．01）；14d治疗组的PaO2为（80±10）mmHg，较安慰剂组的（73±12）mmHg也明显提高（q=7．07，P〈0．01）。7d治疗组的住院天数为（12．5±3．5）d，较安慰剂组的（13．5±3．6）d明显缩短（q=3．03，P〈0．05）；14d治疗组的住院天数为（12．4±4．1）d，较安慰剂组的（13．5±3．6）d也明显缩短（q=3．42，P〈0．05）。7d治疗组与14d治疗组比较，各项指标无明显差别。激素组和安慰剂组的症状得分、治疗失败率、不良反应和复发率也无明显差别。结论口服激素可以改善AECOPD的肺功能，改善PaO2和缩短住院时间，7d和14d疗程的疗效相同，建议采用口服激素治疗AECOPD的疗程为7d。

Objective To observe the clinical efficacy and therapeutic duration of oral corticosteroids in patients with acute exacerbations of chronic obstructive pulmonary diseases （AECOPD）. Methods A randomized, double-blinded, placebo-controlled clinical study was designed. One hundred and thirty hospitalized patients with AECOPD were randomly divided into three groups： group 1 （n = 44 ） received 30 mg,/d of prednisone for 7 days and then placebo for another 7 days ; group 2 （ n = 43 ） received 30 mg,/d of prednisone for 10 days, then tappered to 15 mg/d for 4 days; group 3 （n =43） received placebo for 14 days. The lung functions, arterial blood gas, length of stay, symptom scores, failure rate of treatment, side-effect of corticosteroids and the rate of relapse were evaluated before and after treatments. The results were analyzed by statistical package for social science （ SPSS version 11.0）. Measurement data were expressed by x ± s, and t test was used for the comparison of the data before and after treatments. Chisquare test was used for the comparison of count data. Analysis of variance was applied to test for differences between the three groups. Multiple comparison was analyzed by SNK test. Fisher exact test was used for the comparision of the failure rate of treatment, the rate of relapse and safety evaluation. Results Compared with the placebo group [ group 3, （0. 74± 0. 32） L ], the FEV1 in [ group 1 （0. 87± 0. 23） L and in group 2（0.93 ±0.30） L] were significantly increased （F=4.53, P〈0.05）. The PaO2 in group 1 （79 ＋9） mm Hg （ 1 mm Hg =0. 133 kPa） and in group 2 （80 ± 10） mm Hg were also increased significantly [group 3 was （73±12） mm Hg] （F=3.98, P〈0.05）. The length of stay （LOS） in group 1 （12.5 ±3.5） d and in group 2 （ 12.4 ± 4. 1 ） d were shortened [ group 3 was （ 13.5 ± 3.6） d ] （ F = 3. 82, P 〈 0. 05 ）. However, no difference of FEV1, PaO2 and LOS was found between 7-day and 14-day durations of corticosteroids therapy. There were no differences in symptom scores, failure rate of treatment, side-effect of corticosteroids and the rate of relapse among the 3 groups. Conclusions Oral prednisone results in improvement of FEV1, PaO2 and LOS in hospitalized patients with AECOPD. A 7-day or 14-day duration of oral prednisone is of the same clinical efficacy. From these results, we recommend that 30 mg/d of prednisene for a 7-day duration is appropriate for the treatment of AECOPD.