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在一项为期48周的随机研究中,关于齐多夫定/拉米夫定继续用药或换用替诺福韦酯/恩曲他滨(均联合依非韦伦)的抗逆转录病毒疗法、治疗依从性和生活质量的相关信念。

Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz.

作者信息

Cooper Vanessa, Moyle Graeme J, Fisher Martin, Reilly Geraldine, Ewan Jacqueline, Liu Hui C, Horne Rob

机构信息

Department of Practice and Policy, Centre for Behavioural Medicine, The School of Pharmacy, University of London, London, UK.

出版信息

AIDS Care. 2011 Jun;23(6):705-13. doi: 10.1080/09540121.2010.534433.

DOI:10.1080/09540121.2010.534433
PMID:21476152
Abstract

Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects. The study aim was to assess the effect of switching zidovudine plus lamivudine twice-daily (Combivir, CBV) to once-daily tenofovir DF plus emtricitabine (Truvada, TVD), each plus efavirenz (EFZ), on adherence, beliefs about ART and quality of life (QoL). Subjects stable on CBV + EFV were randomised 1:1 to continue this regimen or switch to TVD + EFV. Adherence was measured using the Medication Adherence Self-Report Inventory at 4, 12, 24 and 48 weeks. Beliefs about ART (perceptions of necessity and concerns about adverse effects), treatment intrusiveness and QoL were measured by questionnaire at baseline 4, 12, 24 and 48 weeks. Viral load was assessed at each visit. Two hundred and thirty-four subjects initiated treatment. At week 48, the proportion of subjects reporting high adherence (≥95% taken as prescribed) was significantly greater in the TVD arm (p=0.049). Low adherence (reporting taking <95% as prescribed, discontinuing the study or having missing data) was associated with doubts about necessity (p=0.020), stronger concerns about adverse effects (p=0.010), greater treatment intrusiveness (p=0.010) and poorer mental health related QoL (p=0.008). At week 48, both concerns about ART (p=0.038) and treatment intrusiveness (p=0.004) were lower among those who switched to TVD. Furthermore, there was a decline in both concerns about ART (p=0.007) and treatment intrusiveness (p=0.057) over the 48 weeks among those who switched to TVD. There were no significant differences in necessity beliefs, QoL or viral load between randomised groups. Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.

摘要

通过减少抗逆转录病毒疗法(ART)的认知和实际障碍,可能有助于提高依从性。实际障碍包括每日给药的复杂性,而认知障碍包括对治疗必要性的认知以及对不良反应的担忧。本研究的目的是评估将齐多夫定加拉米夫定每日两次(Combivir,CBV)换成替诺福韦酯加恩曲他滨每日一次(Truvada,TVD),每种方案均加用依非韦伦(EFZ),对依从性、关于ART的信念以及生活质量(QoL)的影响。在CBV + EFV方案下病情稳定的受试者按1:1随机分组,继续该方案或换用TVD + EFV。在第4、12、24和48周时,使用药物依从性自我报告量表测量依从性。通过问卷在基线、第4、12、24和48周时测量关于ART的信念(对必要性的认知和对不良反应的担忧)、治疗干扰性和QoL。每次就诊时评估病毒载量。234名受试者开始治疗。在第48周时,TVD组中报告高依从性(≥95%按规定服药)的受试者比例显著更高(p = 0.049)。低依从性(报告服药<95%按规定,停止研究或有缺失数据)与对必要性的怀疑(p = 0.020)、对不良反应的更强担忧(p = 0.010)、更大的治疗干扰性(p = 0.010)以及较差的心理健康相关QoL(p = 0.008)相关。在第48周时,换用TVD的受试者中对ART的担忧(p = 0.038)和治疗干扰性(p = 0.004)均较低。此外,换用TVD的受试者在48周内对ART的担忧(p = 0.007)和治疗干扰性(p = 0.057)均有所下降。随机分组之间在必要性信念、QoL或病毒载量方面无显著差异。从CBV换用TVD可能会改善患者报告的结局,包括依从性略有提高、对不良反应的担忧减少更多以及治疗干扰性更小。

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