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临床试验中定量吸入器的依从性

Metered-dose inhaler adherence in a clinical trial.

作者信息

Rand C S, Wise R A, Nides M, Simmons M S, Bleecker E R, Kusek J W, Li V C, Tashkin D P

机构信息

Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.

出版信息

Am Rev Respir Dis. 1992 Dec;146(6):1559-64. doi: 10.1164/ajrccm/146.6.1559.

Abstract

We studied patterns of inhaler usage in a sample of participants from two centers in the Lung Health Study clinical trial. The inhaler, containing either ipratropium bromide or a placebo, was prescribed to be taken as two inhalations three times daily. For 4 months we recorded adherence by both self-report (n = 95) and canister weight change (n = 70). We compared these results with data obtained from a microprocessor monitoring device, the Nebulizer Chronolog (NC), which records the date and time of each inhaler actuation. Seventy-three percent of the participants reported using the inhaler an average of three times daily; however, NC data showed that only 15% of the participants actually used the inhaler an average of 2.5 or more times per day. Canister weight overestimated adherence because only 62% of the NC sets contained the prescribed two actuations. Fourteen percent showed a pattern of actuation of their inhalers more than 100 times in a 3-h interval. We interpret this usage pattern to reflect deliberate emptying of inhalers to appear to be in good compliance with the prescribed program. We conclude that self-report and weighing of inhaler canisters overestimate adherence to the prescribed regimens. Furthermore, a substantial number of monitored inhaler users appear to deliberately dump their medication prior to follow-up visits.

摘要

我们在肺部健康研究临床试验中,对来自两个中心的参与者样本的吸入器使用模式进行了研究。吸入器中含有异丙托溴铵或安慰剂,规定每日三次,每次吸入两下。在4个月的时间里,我们通过自我报告(n = 95)和药罐重量变化(n = 70)记录依从性。我们将这些结果与通过微处理器监测设备——雾化器时间记录器(NC)获得的数据进行比较,该设备可记录每次吸入器启动的日期和时间。73%的参与者报告称平均每天使用吸入器三次;然而,NC数据显示,只有15%的参与者实际每天平均使用吸入器2.5次或更多次。药罐重量高估了依从性,因为只有62%的NC装置有规定的两次启动。14%的人在3小时内出现吸入器启动超过100次的模式。我们将这种使用模式解释为反映了故意排空吸入器,以显示出良好地遵守规定方案。我们得出结论,自我报告和吸入器药罐称重高估了对规定治疗方案的依从性。此外,大量接受监测的吸入器使用者似乎在随访前故意丢弃他们的药物。

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