Isoniazid for preventing tuberculosis in non-HIV infected persons

 

Abstract

Background

Although isoniazid (INH) is commonly used for treating tuberculosis (TB), it is also effective as preventive therapy.

Objectives

The objective of this review was to estimate the effect of six and 12 month courses of INH for preventing TB in HIV-negative people at increased risk of developing active TB.

Search methods

We searched the Cochrane Infectious Diseases Group Specialized Register (May 2003), CENTRAL (The Cochrane Library 2003, Issue 2), Science Citation Index (1955 to 1993), Cumulated Index Medicus (1960 to 1970), MEDLINE (1966 to May 2003), EMBASE (1974 to May 2003), and reference lists of articles.

Selection criteria

Randomized controlled trials of INH preventive therapy for six months or more compared with placebo. Follow up for a minimum of two years. Trials enrolling patients with current or previously treated active TB or with known HIV infection were excluded. Criteria were applied by two reviewers independently.

Data collection and analysis

Trial quality was assessed by two reviewers independently, and data extracted by one reviewer using a standardized extraction form.

Main results

Eleven trials involving 73,375 patients were included. Trials were generally of high quality. Treatment with INH resulted in a risk ratio (RR) of developing active TB of 0.40, (95% confidence interval (CI) 0.31 to 0.52), over two years or longer. There was no significant difference between six and 12 month courses (RR 0.44, 95% CI 0.27 to 0.73 for six months, and 0.38, 95% CI 0.28 to 0.50 for 12 months). Preventive therapy reduced deaths from TB, but this effect was not seen for all-cause mortality. INH was associated with hepatotoxicity in 0.36% of people on six months of treatment and in 0.52% of people treated for 12 months.

Authors' conclusions

Isoniazid prevents active TB in diverse at-risk patients, and six- and 12-month regimens have a similar effect. The most recent trial included in the review was published in 1994, and we have not identified any relevant trials up to 2003. We therefore do not plan to update this review.

 

Plain language summary

Isoniazid is effective in helping to prevent tuberculosis in people not infected with HIV

Tuberculosis (TB) is a serious bacterial infection and it is estimated that about a third of the world's population is infected with TB. There are a number of types, such as pulmonary TB (bacteria residing in a person's lungs) and spinal TB (in the spine). Some bacteria can be drug resistant and some people may have the infection alongside another medical condition. People suffer from severe cough, weakness and sweats, and some people still die from TB even though effective drug treatment has been around for many years. The incidence of TB has reduced in areas where the drugs are readily available. Preventing people from contracting TB in high-risk areas is a goal worth pursuing. The review of trials using isoniazid for a six- to 12-month period in people without HIV infection (HIV infected people were studied in another review) identified 11 trials involving over 90,000 people. Isoniazid was effective in preventing TB in 60% of people, although some did develop hepatitis. The findings showed that one person can be saved from getting TB when 35 people take isoniazid for six months, and one in every 200 treated will get hepatitis. The balance of benefits and harms need to be carefully considered for each setting where intervention is being considered.

 

摘要

背景

對於未受到愛滋病病毒感染的人們給予Isoniazid以預防結核病

雖然說isoniazid(INH)很常被用來治療結核病(TB)，但是它在預防療法中也很有效。

目標

針對那些對愛滋病病毒呈現陰性反應的人們而言，當他們所處的風險逐漸提高，而有可能演變成開放性的肺結核時，可以使用為期6個月與12個月的INH療程來預防結核病，而本篇回顧的目的就是要評估這種作法所帶來的影響。

搜尋策略

我們搜尋Cochrane Infectious Diseases Group Specialized Register (2003年5月)、 CENTRAL (Cochrane Library 2003, Issue 2)、 Science Citation Index (1955 to 1993)、 Cumulated Index Medicus (1960年−1970年)、 MEDLINE (1966年−2003年5月)、 EMBASE (1974年−2003年5月)、以及文獻參考資料清單。

選擇標準

跟安慰劑比較起來，以INH之預防療法進行了6個月或是更久的隨機對照試驗且至少追蹤病人2年。試驗所收集的病患，不論是目前或是過去曾經接受過開放性肺結核治療的對象，或是屬於已知的愛滋病病毒感染者，都會被排除在外。共有2位審稿者獨立地使用了這些標準。

資料收集與分析

有2位審稿者獨立地評估了試驗的品質，而有1位審稿者使用了1種標準化過的擷取表格來進行資料擷取。

主要結論

其中共收集了包含73,375名病患在內的11項試驗。這些試驗通常都具備了很高的品質。若是以INH來進行治療，經過2年或是更長的追蹤時間之後，會使得演變成開放式肺結核的相對風險(RR)變成0.40，(95% 信賴區間(CI)0.31到0.52)。在6個月與12個月的療程之間，並沒有顯著的差異(對於6個月而言，RR 0.44，95% CI 0.27到0.73，而對於12個月而言，RR 0.38，95% CI 0.28 到0.50)。預防療法可以降低因為結核病而死亡之人數，但是考慮所有造成死亡的因素時，並未發現這樣的影響。INH會對肝臟產生毒性，對於6個月的治療來說，有0.36%的人們會有此現象，而對於12個月的治療來說，則有0.52%的人們會有此現象。

作者結論

在各種處於風險之中的病患身上，Isoniazid都可以預防開放式的肺結核。6個月與12個月的療法得到類似的效果。在本篇回顧當中所收集到的試驗，最近期的1篇是在1994年發表，而且直到2003年為止，我們都沒有確認到任何相關的試驗。因此，我們並沒有對本篇回顧進行即時更新的計畫。

翻譯人

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

總結

Isoniazid對尚未被愛滋病病毒感染的人們身上可有效地預防結核病。結核病(TB)是1種嚴重的細菌性感染症，據估計全世界大約有3分之1的人口受到了肺結核的感染。結核病有很多種類型，像是肺部的結核病(細菌寄居在某人的肺部當中)，以及脊髓的結核病(在脊髓之中)。某些細菌可能會變成對藥物具有抵抗力，而有些人則可能會因為其他種類的醫學症狀而受到感染。人們會苦惱於嚴重的咳嗽、虛弱，以及盜汗，而且即便是有效的藥物治療已經問世了好多年，有某些人們還會因為結核病而死亡。在某些已經隨時準備好藥物的地區之中，結核病的發生率已經下降了。我們有1個值得追求的目標，那就是在高風險的地區之中，要預防人們受到結核病的感染。在未受到愛滋病病毒感染的人們(關於受到愛滋病病毒感染的人們，有另外1篇回顧撰述)，本篇研究回顧了使用為期6個月到12個月isoniazid的11份試驗，包含了超過90,000個人在內。對於60%的人們來說， 雖然有些人得到了肝炎，但是Isoniazid仍然可以有效地預防結核病。這些發現顯示若是有35個人接受了6個月的 isoniazid之後，就有1個人可以免於結核病，另外，在每200名接受治療的人們當中，有1人會得到肝炎。當我們在考慮醫療介入行為的時候，對每1種情況都必須謹慎地考量優點與危害之間的平衡。