Regimens of less than six months for treating tuberculosis

 

Abstract

Background

WHO recommends 6 months of treatment in TB programmes.

Objectives

The purpose of this review is to assess the effects of regimens lasting less than 6 months compared with longer regimens in the treatment of active TB.

Search methods

Search strategy: MEDLINE 1955 to October 2005, Cochrane Infectious Diseases Specialized Register, existing reviews, and researchers in the field. Date of the most recent search: May 2004.

Selection criteria

Randomized trials comparing two or more TB drug regimens, in which at least one regimen was <6 months and it was compared with at least one regimen that lasted longer, in any patients with active TB.

Data collection and analysis

One reviewer extracted data and assessed trial quality.

Main results

Seven trials with a total of 9 comparisons of <6 months (range: 2-5 months) versus longer treatment were included. About 2200 patients were in the shorter regimens and about 1900 in the longer regimens (the same comparison groups were used for more than one shorter regimen, in two studies).

Relapse rates were consistently higher after shorter duration treatment regimens, regardless of the comparison made, though they were all relatively low. Results were significantly better in the longer groups in the meta-analyses of 2, 3, and 4 months of treatment vs longer treatment (Peto OR = 6.1 [95%CI 2.19,17.01], 3.67 [2.42,5.58], 3.64 [1.71,7.75] but not in the single trial of 5 vs. 7 months (Peto OR = 2.24 [0.90,5.59].

Relapse rates after longer (comparison) regimens ranged from 0-7% at one year (or more), and in the shorter treatment arms, they ranged from 1-9% in 8 trials, and18% relapsed in the one remaining.

There was little or no difference in the rates of adverse reactions or toxicity requiring a change of regimen or discontinuation of treatment. The "sterilizing efficacy" at the end of treatment varied little among treatments, providing no predictive value for relapse rates. Few or no deaths were reported in the individual trials, and in no case did enough deaths occur for a comparison of short vs. long regimens.

Authors' conclusions

Longer periods of treatment (at least up to 6 months) result in higher success rates in patients with active TB, but the differences are small. Under field conditions, where adherence to treatment is a big problem, and shorter regimens might improve adherence, these differences may not be evident. A comparison of <6 months vs. 6 months of treatment under programme conditions would be needed to determine this.

 

Plain language summary

Regimens of less than six months for treating tuberculosis

Plain language summary pending

 

摘要

背景

治療結核病短於六個月的處方

世界衛生組織建議結核病的治療計畫為期六個月

目標

這一個回顧的目的為評估治療活動性肺結核處方中短於六個月的及長於六個月的處方療效的比較

搜尋策略

檢索策略:從1955年至2004年5月MEDLINE的資料，Cochrane Infectious Diseases Specialized Register,現存的文獻回顧，以及相關領域的研究者。最近一次檢索時間為2004年5月。

選擇標準

針對活動性肺結核病患，隨機試驗比較兩個或多個結核病藥物處方，其中至少有一個處方是短於6個月，它與至少一個長於6個月的處方療程比較。

資料收集與分析

一位審核者摘要研究數據和評估試驗品質。

主要結論

七個臨床試驗，共有9個短於6個月(範圍：2 – 5個月)的處方與長期治療處方被包括在內。約2200個病人，使用短期處方而1900個病人使用長期處方(在兩個研究中，相同的對照組被用於與多個短於6個月的處方作比較)。無論與任何對照組比較，使用短期處方的復發率始終高於長期處方，雖然復發率都很低。整合分析的結果顯示使用2，3，4個月的治療處方比上長期處方，長期處方明顯優於短期處方(Peto OR = 6.1 [95%CI 2.19,17.01],3.67 [2.42,5.58], 3.64 [1.71,7.75])，但在一個臨床試驗中5個月與 7個月處方的比較則並未有同樣結論(Peto OR = 2.24 [0.90,5.59])。在一年(或以上)時(相對)較長期的處方，復發率介於0 – 7％，而在8個臨床試驗中較短期處方則介於1 – 9％，餘下唯一的臨床試驗復發率則是18％。兩種處方間很少或根本沒有不良反應或毒性的差別，並未因此有需要改變處方或停止治療的。殺菌功效在治療結束時差異極小，不能作為預測復發率的指標。在個別試驗中很少或根本沒有死亡的個案報導，在這種情況下沒有足夠的死亡事件足以比較長與短期處方的差異。

作者結論

治療時間較長(至少達6個月)，為活動性結核患者帶來更高的成功率，但差異很小。在臨床實際狀況，如何持續服藥是個大問題，而縮短療程可以提高順從性，但這些差異可能並不明顯。比較短於6個月與 6個月的治療處方的設定下，將需要確定這一點。

翻譯人

本摘要由三軍總醫院林斈府翻譯。

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

總結

概要仍在準備之中。