泰利霉素在哮喘急性发作治疗中的作用
2007/03/09
该研究共纳入278个确诊为哮喘的成人患者，所有患者24小时内均因哮喘急性加重而需要短期住院。研究对象随机分为两组，一组在常规治疗的基础上口服泰利霉素（800mg/天）10天，另一组则在常规治疗的基础上口服安慰剂。疗效评估的指标是经过治疗期后患者症状的改变（通过患者日记卡上的记录来显示）和自行在家监测晨间呼气峰流速的变化。此外通过血清学抗体的检测、PCR和病原体培养等来确定是否合并有衣原体肺炎和支原体肺炎。
研究结果显示，相对安慰剂组，口服泰利霉素组哮喘症状的改善更明显。以症状评分制（实行7分制，0分表示没有症状，6分表示最严重的症状）来评估哮喘的症状。口服泰利霉素组基线的评分是3.0±1.4、治疗后的评分是1.7±1.1；安慰剂组基线的评分是2.8±1.3、治疗后的评分是2.0±1.0。口服泰利霉素组患者治疗后症状评分平均减少了1.3分，而安慰剂组则只减少了1.0分（相差0.3；95％可信区间是相差0.1-0.5；P=0.004）。
在清晨呼气峰流速的变化上，两组间无显著性差异。
口服泰利霉素患者较安慰剂组容易出现恶心症状(P=0.01)。
虽然检查表明61％的病人合并有衣原体肺炎或支原体肺炎或两者均有，但细菌感染与药物对哮喘患者治疗的疗效并不相关。
该研究证明口服泰利霉素对哮喘急性加重患者的治疗是有益的，但其作用机制仍不清楚。
RESULTS: Of the two prespecified primary outcomes, only asthma symptoms showed a significantly greater reduction among patients receiving telithromycin than among those receiving placebo. Mean (+/-SD) scores on a test of asthma symptoms (on a 7-point scale, with 0 denoting no symptoms and 6 denoting severe symptoms) were 3.0+/-1.4 at baseline and 1.7+/-1.1 at the end of treatment for the telithromycin group and 2.8+/-1.3 at baseline and 2.0+/-1.0 at the end of treatment for the placebo group. The mean decrease in symptom scores during the treatment period was 1.3 for telithromycin and 1.0 for placebo (mean difference, -0.3; 95 percent confidence interval, -0.5 to -0.1; P=0.004). There was no significant treatment effect on the other primary outcome measure, a change in morning peak expiratory flow. Nausea was more common among patients in the telithromycin group than in the placebo group (P=0.01). Although 61 percent of patients had evidence of infection with C. pneumoniae, M. pneumoniae, or both, there was no relationship between bacteriologic status and the response to asthma treatment.
CONCLUSIONS: This study provides evidence of the benefit of telithromycin in patients with acute exacerbations of asthma; the mechanisms of benefit remain unclear.
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