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背景关于慢性阻塞性肺疾病(COPD)对吸入疗法的依从性以及对死亡率和发病率的影响了解甚少。方法我们所用的数据来自某药物依从性随机双盲试验,TORCH(注:TO wards a Revolution in COPD Health)研究将吸入剂沙美特罗(salmeterolβ2促效剂)50μg+丙酸氟替卡松(fluticasone propionate)500μg每日2次与安慰剂进行比较,将每种药分别用于患有中或重度COPD病程3年余的6112例病人。将所有原因死亡和因病情加重而住院作为一级或二级终点。依从性研究作为补充研究并不具有先验特异性。结果其中4880例病人(79.8%)用研究药达>80%即定义为依从性良好,11.3%死亡,而1232例(20.2%)依从性不良的病人,26.4%死亡。因病情加重需住院治疗年度率分别为0.15和0.27。依从性与死亡率相关不变,修正预后相关的其他因素后统计学意义显著,校正风险比0.40[95%CI(0.35,0.46),P<0.001]。仅做治疗死亡病例分析就呈强相关。同样,依从性和住院治疗相关不变,而多元分析呈显著相关,比率0.58[95%CI(0.44,0.73),P<0.001];增强依从性与减少死亡和减少住院的相关不依赖于研究治疗。与那些依从性不良者比较,依从性好的病人治疗效果更为显著。结论COPD对吸入药物治疗的依从性与减少死亡率和因病情加重需要住院治疗的风险密切相关。为了能更好地理解这些强相关还需做进一步研究。
Background Little is known about the compliance of inhalation therapy with chronic obstructive pulmonary disease (COPD) and its impact on mortality and morbidity. Methods We used data from a randomized, double-blind, drug-adherent trial. TORCH (TO wards a Revolution in COPD Health) studied inhaled salmeterol 2 agonist 50 μg + fluticasone propionate 500 μg 2 times a day compared with placebo, each drug was used for 6112 patients with moderate or severe COPD duration of more than 3 years. All causes of death and hospitalization as a result of exacerbations were considered as primary or secondary end points. Compliance studies do not have a priori specificity as a supplementary study. RESULTS: 4880 patients (79.8%) were defined as having good compliance and 11.3% with 80% of the study medication, while 12.3% (20.2%) of the patients with poor compliance died of the disease. Due to exacerbations, the annual rates of hospitalization were 0.15 and 0.27, respectively. The correlation between compliance and mortality was unchanged, and other factors related to prognosis were statistically significant after adjustment for the adjusted risk ratio of 0.40 [95% CI (0.35,0.46), P <0.001]. Only the treatment of death case analysis was strongly related. Similarly, compliance and hospitalization remained unchanged, whereas multivariate analysis was significantly associated with a ratio of 0.58 [95% CI (0.44, 0.73), P <0.001]; increased adherence was associated with less death and fewer hospitalizations independent of the study treatment. Compared with those with poor compliance, patients with good compliance were more effective in treatment. CONCLUSIONS: The adherence of COPD to inhaled drug therapy is closely related to the reduction of mortality and the risk of hospitalization due to increased illness. In order to better understand these strong correlation needs further study.