Nakonezny Paul A, Hughes Carroll W, Mayes Taryn L, Sternweis-Yang Kathryn H, Kennard Betsy D, Byerly Matthew J, Emslie Graham J
Division of Biostatistics, Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, Texas 75390-8828, USA.
J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.
In this study, we examined antidepressant (fluoxetine) medication adherence in children and adolescents with major depressive disorder (MDD). Using electronic monitoring (EM) as the "reference standard," we compared various methods of measuring antidepressant medication adherence (including EM, pill counts, and medication diaries) among children and adolescents with MDD and examined the relationship between EM medication adherence and depression severity across time. We then suggested recommendations for clinical researchers and practicing clinicians regarding medication adherence assessment.
Thirty-one child and adolescent outpatients with MDD who enrolled in a 12-week open trial of fluoxetine had their antidepressant medication adherence assessed at each visit, using EM, pill counts, and parent and patient medication diaries. Depression severity was assessed by the Children's Depression Rating Scales-Revised at each visit.
Twelve-week least squares mean estimates of medication adherence for the entire sample was high, regardless of the adherence assessment method, although the overall adherence among the four methods (EM, pill, parent diary, patient diary) was significantly different (87.5% vs. 90.6% vs. 93.1% vs. 93.3%, respectively, p=0.0002). Adjusted mean symptom severity was significantly lower for the EM "adherent" group than for the EM "nonadherent" group over the 12 weeks of treatment (35.6 vs. 43.8, p=0.008).
Overall, EM medication adherence for the depressed youth in this study is high. Compared with EM, there is a tendency of pill counts and medication diaries to overestimate medication adherence. However, pill count adherence better approximates EM adherence, and compliance with returning medication diaries is poor. Youth who are adherent to fluoxetine treatment have lower symptom severity over the course of treatment. Recommendations are provided.
在本研究中,我们调查了患有重度抑郁症(MDD)的儿童和青少年对抗抑郁药(氟西汀)的服药依从性。以电子监测(EM)作为“参考标准”,我们比较了测量MDD儿童和青少年抗抑郁药服药依从性的各种方法(包括EM、药片计数和用药日记),并研究了EM服药依从性与抑郁严重程度随时间的关系。然后,我们针对服药依从性评估向临床研究人员和执业临床医生提出了建议。
31名参加氟西汀12周开放试验的患有MDD的儿童和青少年门诊患者,在每次就诊时使用EM、药片计数以及家长和患者用药日记来评估他们的抗抑郁药服药依从性。每次就诊时通过修订版儿童抑郁评定量表评估抑郁严重程度。
整个样本12周的服药依从性最小二乘均值估计值较高,无论依从性评估方法如何,尽管四种方法(EM、药片、家长日记、患者日记)的总体依从性存在显著差异(分别为87.5%、90.6%、93.1%和93.3%,p = 0.0002)。在12周的治疗过程中,EM“依从”组的调整后平均症状严重程度显著低于EM“不依从”组(35.6对43.8,p = 0.008)。
总体而言,本研究中抑郁青少年的EM服药依从性较高。与EM相比,药片计数和用药日记有高估服药依从性的倾向。然而,药片计数依从性更接近EM依从性,而交回用药日记的依从性较差。坚持氟西汀治疗的青少年在治疗过程中症状严重程度较低。本研究提供了相关建议。