Directly observed therapy for treating tuberculosis.
Directly observed therapy for treating tuberculosis.
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DOI：
10.1002/14651858.cd003343.pub4
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发表时间：
2015-05-29
影响因子：
8.4
通讯作者：
Garner, Paul
中科院分区：
文献类型：
--
作者：
Karumbi, Jamlick;Garner, Paul
关键词：
结核病 (TB) 需要至少六个月的治疗。如果治疗不彻底，患者可能无法治愈，并且可能产生耐药性。直接观察治疗 (DOT) 是世界卫生组织认可的一项具体策略，通过要求卫生工作者、社区志愿者或家庭成员观察和记录服用每次剂量的患者来提高依从性。对正在接受活动性结核病治疗或预防活动性疾病的患者进行比较，评估 DOT 与自我治疗的比较。我们还比较了不同形式的 DOT 的效果。我们检索了截至 2015 年 1 月 13 日为止的以下数据库： Cochrane 传染病组专业登记库； Cochrane 对照试验中央登记册 (CENTRAL)，在 Cochrane 图书馆出版；医学线；电子数据库；紫丁香和 mRCT。我们还检查了文章参考列表并联系了相关研究人员和组织。随机对照试验 (RCT) 和半随机对照试验将 DOT 与在家中常规自我治疗或预防进行比较。两位综述作者独立评估了每项纳入试验的偏倚风险并提取数据。我们使用风险比 (RR) 和 95% 置信区间 (CI) 来比较干预措施。如果荟萃分析合适但存在异质性（I2 统计量> 50%），我们使用随机效应模型。我们使用 GRADE 方法评估了证据的质量。包括 5662 名参与者在内的 11 项试验符合纳入标准。 DOT 是由一系列人员（护士、社区卫生工作者、家庭成员或前结核病患者）在各种环境（诊所、患者家或社区志愿者家）进行的。 DOT 与自我管理疗法 来自南非、泰国、台湾、巴基斯坦和澳大利亚的六项试验比较了 DOT 与自我管理疗法的治疗效果。试验包括由家庭成员、社区卫生工作者（通常受到监督）在家进行 DOT；由医护人员在家中进行 DOT；卫生机构的 DOT。所有研究中自我给药的结核病治愈率较低（范围为 41% 至 67%），直接观察并没有显着改善这一情况（RR 1.08，95% CI 0.91 至 1.27；五项试验，1645 名受试者，证据质量中等）。在按自我治疗组中卫生服务机构之间的接触频率进行分层的亚组分析中，与自我管理治疗相比，每日 DOT 可能会改善结核病治愈率，自我管理组中的患者每月仅去诊所就诊（RR 1.15，95% CI 1.06 至 1.25；两项试验，900 名受试者）；但随着对照组的接触变得更加频繁，这种微小的影响并不明显（每两周：RR 0.96，95％CI 0.83至1.12；一项试验，497名受试者；每周：RR 0.90，95％CI 0.68至1.21；两项试验，248名受试者）。自我治疗组的治疗完成率显示出类似的模式，从 59% 到 78% 不等，直接观察并没有改善这一情况（RR 1.07，95% CI 0.96 到 1.19；六项试验，1839 名受试者，证据质量中等）。在家中进行的 DOT 与在医疗机构中进行的 DOT 在四项试验中，将家庭成员或社区卫生工作者在家中进行的 DOT 与卫生机构中卫生工作者进行的 DOT 进行比较，发现治愈或治疗完成情况几乎没有差异（治愈：RR 1.02，95% CI 0.88 至 1.18，四项试验，1556 名受试者，证据质量中等；治疗完成：RR 1.04，95% CI 0.91 至 1.18）。 1.17，三项试验，1029 名受试者，证据质量中等）。家庭成员 DOT 与社区卫生工作者 DOT 两项试验比较了家庭成员在家 DOT 和社区卫生工作者在家 DOT。治愈或治疗完成情况也几乎没有差异（治愈：RR 1.02，95% CI 0.86至1.21；两项试验，1493名受试者，中等质量证据；完成：RR 1.05，95% CI 0.90至1.22；两项试验，1493名受试者，低质量证据）。特定患者类别 美国一项针对 300 名静脉注射吸毒者的试验评估了直接观察，但没有观察结核病预防措施以预防活动性疾病，显示治疗完成情况差异不大（RR 1.00，95% CI 0.88 至 1.13；一项试验，300 名受试者，低质量证据）。从现有试验来看，DOT 并未为结核病治疗依从性差的问题提供解决方案。鉴于 DOT 对资源和成本的巨大影响，政策制定者可能需要重新考虑依赖于直接观察的策略。其他选择可能会考虑到护理的财务和后勤障碍；激励患者和工作人员的方法；以及违约者的后续行动。 2019 年 4 月 15 日 更新待定 研究等待评估 CIDG 目前正在审查截至 2018 年 7 月 5 日进行的潜在相关研究的检索。这些研究尚未纳入本 Cochrane 综述。直接观察结核病患者服用药物以帮助他们完成治疗 本 Cochrane 综述总结了评估直接观察治疗 (DOT) 治疗结核病 (TB) 患者或预防活动性疾病患者与自我治疗相比效果的试验。在搜索了截至 2015 年 1 月 13 日的相关试验后，我们纳入了 1995 年至 2008 年间进行的 11 项随机对照试验，纳入了 5662 名结核病患者。什么是 DOT 以及它如何改善结核病患者的治疗结果 DOT 是确保结核病患者服用所有药物的一种策略。患者和卫生系统可接受的“观察员”观察患者服用每一剂药物，并记录下来以供卫生系统进行监控。世界卫生组织目前建议结核病患者接受至少六个月的治疗才能治愈。对于患者来说，这些长时间的治疗可能很难完成，尤其是当他们康复并需要重返工作岗位时。未能完成治疗可能会导致个体复发甚至死亡，并且还会产生重要的公共卫生后果，例如结核病传播增加和耐药性的产生。研究内容 总体而言，自我治疗组和 DOT 组的治愈率和治疗完成率都很低，而 DOT 并没有实质性改善这一情况。在一个研究亚组中观察到了较小的影响，其中自我治疗组的监测频率低于 DOT 组。当在家或诊所进行直接观察时，结核病治愈或治疗完成可能没有差异（中等质量证据）。由社区卫生工作者或家庭成员进行的结核病治愈直接观察（中等质量证据）可能几乎没有差异，并且治疗完成情况也可能几乎没有差异（低质量证据）。直接观察可能对注射吸毒者的治疗完成影响很小或没有影响（低质量证据）。作者得出的结论是，DOT 本身可能无法解决人们服用结核病药物依从性差的问题。
Tuberculosis (TB) requires at least six months of treatment. If treatment is incomplete, patients may not be cured and drug resistance may develop. Directly Observed Therapy (DOT) is a specific strategy, endorsed by the World Health Organization, to improve adherence by requiring health workers, community volunteers or family members to observe and record patients taking each dose. To evaluate DOT compared to self‐administered therapy in people on treatment for active TB or on prophylaxis to prevent active disease. We also compared the effects of different forms of DOT. We searched the following databases up to 13 January 2015: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; EMBASE; LILACS and mRCT. We also checked article reference lists and contacted relevant researchers and organizations. Randomized controlled trials (RCTs) and quasi‐RCTs comparing DOT with routine self‐administration of treatment or prophylaxis at home. Two review authors independently assessed risk of bias of each included trial and extracted data. We compared interventions using risk ratios (RR) with 95% confidence intervals (CI). We used a random‐effects model if meta‐analysis was appropriate but heterogeneity present (I2 statistic > 50%). We assessed the quality of the evidence using the GRADE approach. Eleven trials including 5662 participants met the inclusion criteria. DOT was performed by a range of people (nurses, community health workers, family members or former TB patients) in a variety of settings (clinic, the patient's home or the home of a community volunteer). DOT versus self‐administered Six trials from South Africa, Thailand, Taiwan, Pakistan and Australia compared DOT with self‐administered therapy for treatment. Trials included DOT at home by family members, community health workers (who were usually supervised); DOT at home by health staff; and DOT at health facilities. TB cure was low with self‐administration across all studies (range 41% to 67%), and direct observation did not substantially improve this (RR 1.08, 95% CI 0.91 to 1.27; five trials, 1645 participants, moderate quality evidence). In a subgroup analysis stratified by the frequency of contact between health services in the self‐treatment arm, daily DOT may improve TB cure when compared to self‐administered treatment where patients in the self‐administered group only visited the clinic every month (RR 1.15, 95% CI 1.06 to 1.25; two trials, 900 participants); but with contact in the control becoming more frequent, this small effect was not apparent (every two weeks: RR 0.96, 95% CI 0.83 to 1.12; one trial, 497 participants; every week: RR 0.90, 95% CI 0.68 to 1.21; two trials, 248 participants). Treatment completion showed a similar pattern, ranging from 59% to 78% in the self‐treatment groups, and direct observation did not improve this (RR 1.07, 95% CI 0.96 to 1.19; six trials, 1839 participants, moderate quality evidence). DOT at home versus DOT at health facility In four trials that compared DOT at home by family members, or community health workers, with DOT by health workers at a health facility there was little or no difference in cure or treatment completion (cure: RR 1.02, 95% CI 0.88 to 1.18, four trials, 1556 participants, moderate quality evidence; treatment completion: RR 1.04, 95% CI 0.91 to 1.17, three trials, 1029 participants, moderate quality evidence). DOT by family member versus DOT by community health worker Two trials compared DOT at home by family members with DOT at home by community health workers. There was also little or no difference in cure or treatment completion (cure: RR 1.02, 95% CI 0.86 to 1.21; two trials, 1493 participants, moderate quality evidence; completion: RR 1.05, 95% CI 0.90 to 1.22; two trials, 1493 participants, low quality evidence). Specific patient categories A trial of 300 intravenous drug users in the USA evaluated direct observation with no observation in TB prophylaxis to prevent active disease and showed little difference in treatment completion (RR 1.00, 95% CI 0.88 to 1.13; one trial, 300 participants, low quality evidence). From the existing trials, DOT did not provide a solution to poor adherence in TB treatment. Given the large resource and cost implications of DOT, policy makers might want to reconsider strategies that depend on direct observation. Other options might take into account financial and logistical barriers to care; approaches that motivate patients and staff; and defaulter follow‐up. 15 April 2019 Update pending Studies awaiting assessment The CIDG is currently examining a search conducted up to 5 Jul, 2018 for potentially relevant studies. These studies have not yet been incorporated into this Cochrane Review. Directly observing people with TB take their drugs to help them complete their treatment This Cochrane Review summarises trials evaluating the effects of directly observed therapy (DOT) for treating people with tuberculosis (TB) or people on prophylaxis to prevent active disease compared to self‐administered treatment. After searching for relevant trials up to 13 January 2015, we included 11 randomized controlled trials, enrolling 5662 people with TB, and conducted between 1995 and 2008. What is DOT and how might it improve treatment outcomes for people with TB DOT is one strategy to ensure that patients with TB take all their medication. An 'observer' acceptable to the patient and the health system observes the patient taking every dose of their medication, and records this for the health system to monitor. The World Health Organization currently recommends that people with TB are treated for at least six months to achieve cure. These long durations of treatment can be difficult for patients to complete, especially once they are well and need to return to work. Failure to complete treatment can lead to relapse and even death in individuals, and also has important public health consequences, such as increased TB transmission and the development of drug resistance. What the research says Overall, cure and treatment completion in both self‐treatment and DOT groups was low, and DOT did not substantially improve this. Small effects were seen in a subgroup of studies where the self‐treatment group were monitored less frequently than the DOT group. There is probably no difference in TB cure or treatment completion when the direct observation was conducted at home or at the clinic (moderate quality evidence). There is probably little or no difference in TB cure direct observation is conducted by a community health worker or family member (moderate quality evidence) and there may be little or no difference in treatment completion either (low quality evidence). Direct observation may have little or no effect on treatment completion in injection drug users (low quality evidence). The authors conclude that DOT on its own may not offer the solution to poor adherence in people taking TB medication.