Directly observed therapy for treating tuberculosis

 

Abstract

Background

Using a pilot system we have categorised this review as: Current question - no update intended (Results conclusive) Please see "Published notes" section of the review for more details.

For tuberculosis treatment, policies have been introduced to encourage adherence to treatment regimens. One such policy is directly observed therapy (DOT), which involves people directly observing patients taking their antituberculous drugs.

Objectives

To compare DOT with self administration of treatment or different DOT options for people requiring treatment for clinically active tuberculosis or prevention of active disease.

Search methods

In May 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 2), MEDLINE, EMBASE, LILACS, and mRCT. We also checked article reference lists and contacted relevant researchers and organizations.

Selection criteria

Randomized and quasi-randomized controlled trials comparing a health worker, family member, or community volunteer routinely observing people taking antituberculous drugs compared with routine self administration of treatment at home. We include people requiring treatment for clinically active tuberculosis or medication for preventing active disease.

Data collection and analysis

Both authors independently assessed trial methodological quality and extracted data. Data were analysed using relative risks (RR) with 95% confidence intervals (CI) and the fixed-effect model when there was no statistically significant heterogeneity (chi square P > 0.1). Trials of drug users were analysed separately.

Main results

Eleven trials with 5609 participants met the inclusion criteria. No statistically significant difference was detected between DOT and self administration in terms of cure (RR 1.02, 95% CI 0.86 to 1.21, random-effects model; 1603 participants, 4 trials), with similar results for cure plus completion of treatment. When stratified by location, DOT provided at home compared with DOT provided at clinic suggests a possible small advantage with home-based DOT for cure (RR 1.10, 95% CI 1.02 to 1.18; 1365 participants, 3 trials). There was no significant difference detected in clinical outcomes between DOT at a clinic versus by a family member or community health worker (2 trials), or for DOT provided by a family member versus a community health worker (1326 participants, 1 trial). Two small trials of tuberculosis prophylaxis in intravenous drugs users found no statistically significant difference between DOT and self administration (199 participants, 1 trial) or a choice of location for DOT for completion of treatment (108 participants, 1 trial).

Authors' conclusions

The results of randomized controlled trials conducted in low-, middle-, and high-income countries provide no assurance that DOT compared with self administration of treatment has any quantitatively important effect on cure or treatment completion in people receiving treatment for tuberculosis.

 

Plain language summary

Directly observing people taking their tuberculosis drugs did not improve the cure rate compared with people without direct monitoring of treatment

Using a pilot system we have categorised this review as: Current question - no update intended (Results conclusive). Please see "Published notes" section of the review for more details.

Tuberculosis is a very serious health problem with two million people dying each year, mostly in low-income countries. Effective drugs for tuberculosis have been available since the 1940s, but the problem still abounds. People with tuberculosis need to take the drugs for at least six months, but many do not complete their course of treatment. For this reason, services for people with tuberculosis often use different approaches to encourage people to complete their course of treatment. This review found no evidence that direct observation by health workers, family members, or community members of people taking their medication showed better cure rates that people having self administered treatment. The intervention is expensive to implement, and there appears to be no sound reason to advocate its routine use until we better understand the situations in which it may be beneficial.

 

摘要

背景

直接監視治療治療肺結核的效果評估

對於結核病的治療，在治療方針上是鼓勵接受持續治療計畫，其中一個治療方針是直接監視治療(directly observed therapy，DOT)，監視病人直接服用抗結核藥物。

目標

比較DOT與自我治療，或是比較不同的DOT方案用於需要治療活躍性肺結核，或是需要預防活躍性肺結核的人其效果差異。

搜尋策略

在2007年5月，我們搜尋了Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 2)、MEDLINE、 EMBASE、LILACS、及 mRCT。我們還找了文章的參考文獻，並聯繫相關研究人員和組織。

選擇標準

隨機和半隨機對照試驗中涉及到比較包括健康工作者、家庭成員、或社區志工定期監視病人服用抗結核藥物，與在家中定期自我服藥治療的差異。我們納入的對象包括需要治療的活動性肺結核，或需服藥來預防疾病活化的病人。

資料收集與分析

兩位作者獨立評估試驗的方法學質量和提取數據。當沒有統計學上的意義時(chisquare P>0.1)，數據使用relative risks (RR)的95 ％ CI) 和fixedeffect model 來進行分析，試驗中藥物的使用者被個別的進行分析。

主要結論

11個試驗中有5609參與者符合納入標準，在DOT與自我用藥的治療比較，在治癒率上並無統計顯著差異(RR 1.02 ， 95 ％ CI為0.86至1.21，隨機效應模型;4個試驗1603個參與者)，與類似的結果為治愈合併完成治療。以觀查的位置來作比較，在家裡做DOT與在門診做DOT相比，可能有小的優勢(RR 1.10 ， 95 ％CI為1.02至1.18; 3個試驗，1365個參與者)。在門門診做DOT與家庭成員或社區衛生工作者來做DOT相比，臨床療效方面沒有顯著差異(2個試驗)或家庭成員做DOT與社區衛生工作者做DOT相比也沒有顯著差異(1個試驗，1326個參與者)。兩個靜脈注射毒品使用者預防結核病的小試驗，發現無統計學顯著性差異在DOT和自我用藥(1個試驗，199參與者)或DOT選擇完成治療的位置(1個試驗，108參與者)。

作者結論

在低、中、高收入國家所進行隨機對照試驗的結果顯示，與自我給藥相較下DOT並不保證病人在接受完整結核藥物治療後在量性上有任何重要的治癒效果。

翻譯人

本摘要由三軍總醫院楊登和翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

相較於沒有直接監測的情況相比，直接觀測病人抗結核藥物的服用並無法改善治癒率。結核病是一個非常嚴重的健康問題，每年有200萬人瀕臨死亡，主要是在低收入國家；自1940年代以來已開始使用有效的抗結核病藥物，但問題仍然存在。結核病人需要採取至少6個月的藥物，但許多人沒有完成他們的療程。基於這個原因，服務結核病人的機構往往採用不同的辦法，鼓勵病人完成他們的療程。這個回顧沒有發現任何證據顯示由衛生工作者、家庭成員或社區成員直接監視病人服藥與病人自我管理服藥，有較好的治癒率。DOT應用起來過於昂貴，似乎沒有很強的理由主張常規地使用DOT，除非我們了解在何種情況下它可能是有益的。