Intervention Review

Unit-dose packaged drugs for treating malaria

  1. Lois C Orton1,*,
  2. Guy Barnish2

Editorial Group: Cochrane Infectious Diseases Group

Published Online: 20 APR 2005

Assessed as up-to-date: 24 MAR 2009

DOI: 10.1002/14651858.CD004614.pub2


How to Cite

Orton LC, Barnish G. Unit-dose packaged drugs for treating malaria. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD004614. DOI: 10.1002/14651858.CD004614.pub2.

Author Information

  1. 1

    University of Manchester, School of Nursing, Midwifery and Social Work, Manchester, UK

  2. 2

    Liverpool School of Tropical Medicine, Disease Control Strategy Group, Liverpool, Merseyside, UK

*Lois C Orton, School of Nursing, Midwifery and Social Work, University of Manchester, University Place, Oxford Road, Manchester, M13 9PL, UK. Lois.Orton@manchester.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 APR 2005

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Unit-dose packaging of antimalarial drugs may improve the success of malaria treatments by making it easier for patients to take them correctly.

Objectives

To summarize the effects of unit-dose packaged treatment on treatment failure and treatment adherence in people with uncomplicated malaria.

Search methods

We searched the Cochrane Infectious Diseases Group Specialized Register (February 2009); CENTRAL (The Cochrane Library Issue 1, 2009); MEDLINE (1966 to February 2009); EMBASE (1980 to February 2009); LILACS (February 2009); conference proceedings, and reference lists of articles. We also contacted pharmaceutical companies, organizations, and researchers in the field.

Selection criteria

Randomized controlled trials (RCTs), cluster-RCTs and quasi-RCTs of unit-dose packaged drugs for treating uncomplicated malaria.

Data collection and analysis

We independently assessed trial eligibility and risk of bias, and extracted data for an intention-to-treat analysis, where possible. We combined binary data using risk ratio (RR) and the fixed-effect model, and presented them with 95% confidence intervals (CI). We attempted to contact trial authors for additional information.

Main results

One RCT (203 participants), three quasi-RCTs (895 participants), and one cluster-RCT (six health facilities) met the inclusion criteria. Trials were generally of poor methodological quality, and none adequately assessed treatment failure. Unit-dose packaged drugs (in conjunction with prescriber training and patient information) appeared to be associated with higher participant-reported treatment adherence in all trials.

A meta-analysis of two trials (596 participants) showed that participant-reported treatment adherence was slightly higher with blister-packed tablets compared with tablets in paper envelopes (RR 1.18, 95% CI 1.12 to 1.25). Two trials using tablets in sectioned polythene bags as the intervention also noted an increase in participant-reported treatment adherence: the cluster-RCT (six clusters) compared it with tablets in paper envelopes, and the other trial compared it with syrup in bottles (RR 2.15, 95% CI 1.76 to 2.61; 299 participants).

Authors' conclusions

There is insufficient evidence to know if the effects of unit-dose packaged antimalarial drugs reduce treatment failure. Unit-dose packaging, supported by prescriber training and patient information, appears to improve participant-reported treatment adherence, but these data come from trials with methodological limitations.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Unit-dose packaging of drugs for treating malaria

Malaria is a parasitic disease spread by mosquitoes in areas such as sub-Saharan Africa, South-East Asia and South America. Millions of people are infected with malaria each year. It is thought that packaging a course of treatment in units of a single dose may better ensure the correct dosage is taken, thus increasing the success of treatment. The review found insufficient good quality evidence from randomized controlled trials to determine if unit-dose packaging of drugs saves lives, but there is some indication that it might improve treatment adherence. More research is needed.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

針對治療瘧疾所使用的單位劑量包裝型藥物

抗瘧疾藥物的單位劑量包裝方法或許可以提高瘧疾的治癒情況,因為它可以讓患者們更容易就能正確地服用他們的藥物。

目標

對於沒有併發症的瘧疾的人們而言,要整理出單位劑量包裝型的治療方式對於治癒與治療依從行為的影響。

搜尋策略

我們搜尋Cochrane Infectious Diseases Group Specialized Register (2004年11月)、 CENTRAL (Cochrane Library Issue 4, 2004)、 MEDLINE (1966年−2004年11月)、 EMBASE (1980年 – 2004年11月)、 LILACS (2004年11月)、研討會手冊,以及文章的參考資料清單。我們也與本領域藥廠、相關機構以及研究人員聯絡。

選擇標準

對於治療沒有併發症的瘧疾而言,屬於單位劑量包裝型藥物的隨機對照試驗(RCTs)、群集式的隨機對照試驗、半隨機對照試驗,以及對照型的之前與之後研究。

資料收集與分析

我們獨立地評估了研究的合格度與方法學的品質,並且儘可能針對意圖治療分析擷取出資料。我們使用了相對風險(RR)與固定效果模型來合併二元性的資料,並且以95%信賴區間(CI)的方式來表達它們。為了取得更多的資訊,我們曾經試著與研究的作者們取得聯繫。

主要結論

有3項半隨機對照試驗(895名參與者)與1項群集式的隨機對照試驗(6種衛生設施)符合了收集的標準。這些試驗在方法方面的品質都不盡理想,而且沒有任何1項曾經適當地評估治療失敗的情形。在所有的試驗當中,單位劑量包裝型藥物(連同開立處方者的訓練與病患的資訊)看起來會使得參與者報告所提到的治療依從行為變得比較高。有1份來自2項試驗(596名參與者)的統合分析顯示,跟裝在紙製信封袋當中的錠劑(RR 1.18,1.12到1.25)比較起來,使用吸塑包裝型的錠劑可以使得參與者報告所提到的治療依從行為變得比較高。有2項試驗使用了裝在分段式之聚乙烯袋當中的錠劑來當作介入行為,也發現到參與者報告所提到的治療依從行為升高了:這份群集式的隨機對照試驗(6個群集)將它與裝在紙製信封袋當中的錠劑進行了比較,至於其他的試驗則將它與裝在瓶子裡面的糖漿進行了比較(RR 2.15,1.76到2.61;299名參與者)。

作者結論

關於單位劑量包裝型的抗瘧疾藥物對於治療失敗情況所造成的影響,並沒有充分的證據能夠確認。開立處方者的訓練與病患的資訊都支持使用單位劑量的包裝方式,而這樣的方式看起來可以提高參與者報告所提到的治療依從行為,但是這些資料的來源卻是在方法學有所瑕疵的試驗。

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

對抗瘧疾藥物採取單位劑量的包裝方式,或許可以提高治療依從行為,但是關於它是否可以提升治療的功效,幾乎沒有品質良好的證據能夠加以說明。瘧疾是1種寄生蟲疾病,在例如撒哈拉以南的非洲、東南亞,以及南美洲等區域之中,會由蚊子來進行傳播。每年都有上百萬人會受到瘧疾的感染。人們認為,將1個治療的療程包裝在某種單1劑量的單位裡面,或許能夠更為妥善地確保患者能夠服用到正確的劑量,因此也就能夠提高治療的成功率。本篇回顧發現,從這些隨機對照試驗當中並沒有辦法得到足夠的且具有良好品質的證據,所以無法確認藥物的單位劑量包裝方式是否可以拯救這些生命,但是有某種跡象顯示,這樣的方式或許能夠提高治療依從行為。更多的研究有其必要。