Andrade Adriana S A, McGruder Henraya F, Wu Albert W, Celano Shivaun A, Skolasky Richard L, Selnes Ola A, Huang I-Chan, McArthur Justin C
Division of Infectious Diseases, Department of Medicine, The Johns Hopkins University, School of Medicine, Baltimore, Maryland 21205, USA.
Clin Infect Dis. 2005 Sep 15;41(6):875-82. doi: 10.1086/432877. Epub 2005 Aug 5.
Background. Patients cite "forgetting" as a reason for nonadherence to highly active antiretroviral therapy (HAART). We measured the effect of a memory-prompting device on adherence to HAART in memory-intact and memory-impaired human immunodeficiency virus (HIV)-infected subjects.Methods. The study was a prospective, randomized, controlled trial involving 64 HIV-infected adults. The intervention was the Disease Management Assistance System (DMAS) device, combined with monthly adherence counseling. Control subjects received only adherence counseling. The DMAS was programmed with HAART regimen data to provide verbal reminders at dosing times. Adherence was measured for 24 weeks using electronic drug exposure monitor (eDEM) caps.Results. A total of 58 subjects completed the 24-week study period; 28 were HAART naive (12 DMAS users and 16 control subjects). Mean adherence scores did not differ significantly between DMAS users (80%) and control subjects (65%). Post hoc analysis of 31 memory-impaired subjects (14 DMAS users and 17 control subjects) revealed significantly higher adherence rates among DMAS users (77%), compared with control subjects (57%) (P=.001). However, analysis of memory-intact subjects showed that adherence was not significantly improved for DMAS users (83%), compared with control subjects (77%) (P=.25). At week twelve, 38% of the DMAS users and 14% of the control subjects had an undetectable plasma HIV RNA load (P=.014), and at week 24, the plasma HIV RNA load was undetectable for 34% of the DMAS users and 38% of the control subjects (P=.49). CD4(+) cell counts did not differ between the study arms. Virological and immunological responses were not related to DMAS use in memory-impaired subjects.Conclusion. The DMAS prompting device improved adherence for memory-impaired subjects but not for memory-intact subjects.
背景。患者将“遗忘”作为不坚持高效抗逆转录病毒治疗（HAART）的一个原因。我们在记忆力正常和记忆力受损的人类免疫缺陷病毒（HIV）感染受试者中，测量了一种记忆提示装置对HAART依从性的影响。
方法。该研究是一项前瞻性、随机、对照试验，涉及64名HIV感染的成年人。干预措施是疾病管理辅助系统（DMAS）装置，结合每月的依从性咨询。对照受试者仅接受依从性咨询。DMAS被编入HAART治疗方案数据，以便在给药时间提供语音提醒。使用电子药物暴露监测器（eDEM）帽测量24周的依从性。
结果。共有58名受试者完成了24周的研究期；28名受试者初治HAART（12名DMAS使用者和16名对照受试者）。DMAS使用者（80%）和对照受试者（65%）的平均依从性得分无显著差异。对31名记忆力受损受试者（14名DMAS使用者和17名对照受试者）的事后分析显示，与对照受试者（57%）相比，DMAS使用者（77%）的依从率显著更高（P = 0.001）。然而，对记忆力正常受试者的分析表明，与对照受试者（77%）相比，DMAS使用者（83%）的依从性没有显著提高（P = 0.25）。在第12周时，38%的DMAS使用者和14%的对照受试者血浆HIV RNA载量不可检测（P = 0.014），在第24周时，34%的DMAS使用者和38%的对照受试者血浆HIV RNA载量不可检测（P = 0.49）。研究组之间的CD4(+)细胞计数无差异。记忆力受损受试者的病毒学和免疫学反应与DMAS的使用无关。
结论。DMAS提示装置提高了记忆力受损受试者的依从性，但对记忆力正常受试者无效。
