Zwarenstein M, Schoeman J H, Vundule C, Lombard C J, Tatley M
Health Systems Division, Medical Research Council, Tygerberg, South Africa.
Lancet. 1998 Oct 24;352(9137):1340-3. doi: 10.1016/S0140-6736(98)04022-7.
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.
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.
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 on DO (42% of patients, difference between groups 32% [11%-52%]).
At high rates of treatment interruption, self-supervision achieved equivalent outcomes to clinic DO at lower cost. Self-supervision achieved better outcomes for retreatment patients. Supportive patient-carer relations, rather than the authoritarian surveillance implicit in DO, may improve treatment outcomes and help to control tuberculosis.
结核病是南非的一个主要公共卫生问题，治疗依从性差和治疗频繁中断使情况更加恶化。对结核病患者服药进行直接观察（DO）理应能提高治疗完成率和治疗效果。我们将直接观察与自我监督进行了比较，自我监督是指对采用相同药物治疗方案的患者服药时不进行观察，以评估二者对结核病治疗成功率的影响。
我们在两个结核病病例负担较重的社区开展了一项非盲随机对照试验。该试验纳入了216名首次开始接受肺结核治疗或正在接受第二疗程治疗的成年人（复治患者）。除了随机分组外，未对现有的治疗方式做出其他改变。分析采用意向性分析。将两个社区的个体患者数据合并。
自我监督组的结核病治疗成功率（60%的患者）高于直接观察组（54%的患者，组间差异为6%[90%CI -5.1至17.0]）。复治患者若接受自我监督，其治疗成功结局显著多于接受直接观察的患者（74%的患者对比42%的患者，组间差异为32%[11%-52%]）。
在治疗中断率较高的情况下，自我监督以较低成本取得了与诊所直接观察相当的治疗效果。自我监督对复治患者取得了更好的治疗效果。支持性的患者-照顾者关系，而非直接观察中隐含的专制监督，可能会改善治疗效果并有助于控制结核病。
