Randomised controlled trial of self-supervised and directly observed treatment of tuberculosis
Randomised controlled trial of self-supervised and directly observed treatment of tuberculosis
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DOI：
10.1016/s0140-6736(98)04022-7
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发表时间：
1998-10-24
期刊：
影响因子：
168.9
通讯作者：
Tatley, M
中科院分区：
文献类型：
--
作者：
Zwarenstein, M;Schoeman, JH;Tatley, M
背景在南非，结核病是一个主要的公共卫生问题，由于治疗的不良坚持和频繁中断，情况变得更糟。对结核病患者服药的直接观察(DO)被认为是提高治疗完成率和结果的关键。我们比较了DO和自我监督，在自我监督中，没有观察到服用相同药物方案的患者服用药物，以评估各自对结核病治疗成功的影响。方法我们在两个结核病病例量较大的社区进行了一项无盲法随机对照试验。这项试验包括216名首次开始肺结核治疗的成年人，或接受第二疗程治疗的成年人(再次治疗的患者)。除了随机化外，没有对现有的治疗方案进行任何改变。分析采用意向治疗。来自两个社区的个体患者数据被结合在一起。自我监督患者(60%的患者)比接受DO治疗的患者(54%，两组之间的差异6%[90%CI-5.1至17.0])更成功地发现了结核病的治疗。再治疗患者自我监督(74%的患者)的治疗结果显著高于DO(42%的患者，两组之间的差异为32%[11%-52%])。在治疗中断率较高的情况下，自我监督以较低的成本获得与临床DO相同的结果。自我监督对复治患者取得了较好的效果。支持性的患者-护理者关系，而不是DO中隐含的专制监督，可能会改善治疗结果，并有助于控制结核病。
Background Tuberculosis is a major public-health problem in South Africa, made worse by poor adherence to and frequent interruption of treatment. Direct observation (DO) of tuberculosis patients taking their drugs is supposed to improve treatment completion and outcome. We compared DO with self-supervision, in which patients on the same drug regimen are not observed taking their pills, to assess the effect of Each on the success of tuberculosis treatment.Methods We undertook an unblinded randomised controlled trial in two communities with large tuberculosis caseloads. The trial included 216 adults who started pulmonary tuberculosis treatment for the first time, or who had a second course of treatment (retreatment patients). No changes to existing treatment delivery were made other than randomisation. Analysis was by intention to treat. Individual patient data from the two communities were combined.Findings Treatment for tuberculosis was more successful among self-supervised patients (60% of patients) than among those on DO (54% of patients, difference between groups 6% [90% CI -5.1 to 17.0]). Retreatment patients had significantly more successful treatment outcomes if self supervised (74% of patients) than an DO (42% of patients, difference between groups 32% [11%-52%]).Interpretation At high rates of treatment interruption, self-supervision achieved equivalent outcomes to clinic DO at lower cost. Self-supervision achieved better outcomes far retreatment patients. Supportive patient-carer relations, rather than the authoritarian surveillance implicit in DO, may improve treatment outcomes and help to control tuberculosis.