Mycobacterium vaccae immunotherapy for treating tuberculosis

 

Abstract

Background

Some authorities have advocated Mycobacterium vaccae immunotherapy for treating tuberculosis and other infections caused by mycobacteria.

Objectives

To evaluate M. vaccae immunotherapy as an adjunct to chemotherapy in people with tuberculosis.

Search methods

In October 2002, we searched the Cochrane Infectious Diseases Group Specialized Register, Cochrane Controlled Trials Register (The Cochrane Library 2002, Issue 3), MEDLINE, EMBASE, LILACS, and reference lists of articles. We also contacted organizations and individuals working in the field.

Selection criteria

Randomized and quasi-randomized controlled trials of inoculation with whole killed M. vaccae versus placebo for people with tuberculosis.

Data collection and analysis

Both authors assessed trial quality and extracted data. Dichotomous outcomes were analysed with risk ratio (RR) and 95% confidence intervals (CI).

Main results

Eight trials involving 2140 adults met the inclusion criteria. M. vaccae immunotherapy had no significant effect on the number of deaths (RR 1.09, 95% CI 0.83 to 1.42; 1741 participants, 4 trials). Meta-analysis suggested small effects on the number of people who were sputum smear negative and sputum culture negative at two months, but these apparent effects were not present in sensitivity analyses that only included adequately concealed trials. Most immunotherapy recipients experienced local adverse reactions (RR 18.82, 95% CI 5.47 to 64.77; 131 participants, 2 trials), some of which progressed to ulceration and scarring.

Authors' conclusions

M. vaccae immunotherapy does not benefit people with tuberculosis. No further trials are warranted and, as a result, the authors do not intend to update this review.

 

Plain language summary

No benefit from immunotherapy with Mycobacterium vaccae in people with tuberculosis

Injections that aim to influence a person's immune system have been used by doctors to lessen the chance of a person developing a disease, or sometimes to reduce the damage the disease does to the body. M. vaccae is a type of bacterium related to the one that causes tuberculosis. Scientists have wondered if injections of this could reduce the damage done to someone when they are infected with tuberculosis, and some early trials suggested this might be true. However, this overview involving eight trials identified that the research does not show any consistent effect of this injection on death or the course of tuberculosis illness. It may be that the early trials had methodological problems that led to false optimism about this intervention.

 

摘要

背景

為了治療肺結核所用的牝牛分枝桿菌(Mycobacterium vaccae)免疫療法

對於肺結核以及其他種因為分枝桿菌所引起的感染症而言，有許多的當局機構已經提倡使用牝牛分枝桿菌來治療它們。

目標

評估將牝牛分枝桿菌當作化學藥物治療肺結核之輔助劑的效應。

搜尋策略

我們搜尋Cochrane Infectious Diseases Group trials register (2002年9月)、Cochrane Controlled Trials register (Issue3, 2002)、 MEDLINE (1966年 – 2002年10月)、EMBASE (1980年−2002年9月)、以及文章的參考資料清單。我們也與本領域相關機構與研究人員聯絡。

選擇標準

以死亡後之整株牝牛分枝桿菌治療肺結核的隨機與半隨機試驗。

資料收集與分析

由1位審稿者評估了試驗的品質並擷取出資料。

主要結論

共有7項試驗符合了收集的標準。在死亡率方面，並沒有影響(4項試驗，Peto odds ratio 1.09，95% CI 0.79到1.49)。在痰的陰性反應或是痰的培養方面，並沒有呈現出一致的結果。大多數接受了免疫療法的患者，都會經歷到局部的不良反應(2項試驗，Peto odds ratio 18.19，95% CI 8.96到36.95)，而且其中有些人的狀況還演變成潰瘍與疤痕。

作者結論

牝牛分枝桿菌並不會為肺結核病患者帶來任何助益。

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

使用牝牛分枝桿菌對患有肺結核病的人們進行免疫療法並沒有任何好處。為了要影響某人的免疫系統而打上幾針，已經是許多醫生所採用的方式，可以用來降低人們得到病症的機會，或是有時候還可以用來降低疾病對身體所造成的傷害。牝牛分枝桿菌是1種跟肺結核有關的細菌。科學家們懷疑對於某些受到肺結核感染的人們來說，把這種桿菌拿來注射了幾次之後，是否就可以降低感染對於他們所造成的傷害，而且有些早期的試驗也認為這樣的懷疑是對的。然而，本篇回顧研究顯示，對於肺結核病症的死亡或是過程方面，打了這樣的針之後並無一致的效應。可能的原因是早期的試驗在方法學方面有所瑕疵導致人們對於這樣的醫療介入產生了錯誤的樂觀看法。