Walley J D, Khan M A, Newell J N, Khan M H
Nuffield Institute for Health, University of Leeds, UK.
Lancet. 2001 Mar 3;357(9257):664-9. doi: 10.1016/S0140-6736(00)04129-5.
DOTS is the control strategy for tuberculosis promoted by WHO. Pakistan is currently developing its National Tuberculosis Programme, and requires guidance on types of direct observation of treatment appropriate for the local conditions. We did a randomised trial to assess the effectiveness of different packages for tuberculosis treatment under operational conditions in Pakistan.
We enrolled 497 adults with new sputum-positive tuberculosis. 170 were assigned DOTS with direct observation of treatment by health workers; 165 were assigned DOTS with direct observation of treatment by family members; and 162 were assigned self-administered treatment. The trial was done at three sites that provide tuberculosis services strengthened according to WHO guidelines for the purposes of the research, with a standard daily short-course drugs regimen (2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol, followed by 6 months of isoniazid and ethambutol). The main outcome measures were cure, and cure or treatment completion. Analysis was by intention to treat.
Within the strengthened tuberculosis services, the health-worker DOTS, family-member DOTS, and self-administered treatment strategies gave very similar outcomes, with cure rates of 64%, 55%, and 62%, respectively, and cure or treatment-completed rates of 67%, 62%, and 65%, respectively.
None of the three strategies tested was shown to be superior to the others, and direct observation of treatment did not give any additional improvement in cure rates. The effectiveness of direct observation of treatment remains unclear, and further operational research is needed.
直接观察短程治疗（DOTS）是世界卫生组织推广的结核病控制策略。巴基斯坦目前正在制定其国家结核病规划，需要针对适合当地情况的不同治疗直接观察类型提供指导。我们进行了一项随机试验，以评估在巴基斯坦实际操作条件下不同结核病治疗方案的效果。
我们招募了497名新的痰涂片阳性成年结核病患者。170人被分配接受由卫生工作者直接观察治疗的DOTS方案；165人被分配接受由家庭成员直接观察治疗的DOTS方案；162人被分配接受自我给药治疗。该试验在三个根据世界卫生组织指南强化了结核病服务的地点进行，以用于研究目的，采用标准的每日短程药物治疗方案（2个月的异烟肼、利福平、吡嗪酰胺和乙胺丁醇，随后6个月的异烟肼和乙胺丁醇）。主要结局指标为治愈，以及治愈或完成治疗。分析采用意向性分析。
在强化的结核病服务中，卫生工作者DOTS、家庭成员DOTS和自我给药治疗策略产生了非常相似的结果，治愈率分别为64%、55%和62%，治愈或完成治疗率分别为67%、62%和65%。
所测试的三种策略均未显示出优于其他策略，并且治疗直接观察并未在治愈率方面带来任何额外改善。治疗直接观察的有效性仍不明确，需要进一步开展实际研究。
