一项在乌干达注册药店引入快速诊断检测的整群随机试验：对疟疾适当治疗的影响
A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria.
作者信息
Mbonye Anthony K, Magnussen Pascal, Lal Sham, Hansen Kristian S, Cundill Bonnie, Chandler Clare, Clarke Siân E
机构信息
Ministry of Health, Box 7272, Kampala, Uganda; School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.
Centre for Medical Parasitology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
PLoS One. 2015 Jul 22;10(7):e0129545. doi: 10.1371/journal.pone.0129545. eCollection 2015.
BACKGROUND
Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops.
METHODS
A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT.
FINDINGS
A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 - 50·9), p<0·001. The majority of patients with fever in the intervention arm accepted to purchase an mRDT (97·8%), of whom 58·5% tested mRDT-positive. Drug shop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7- 98·4), p<0·001) compared to drug shop vendors using presumptive diagnosis (control arm).
CONCLUSION
Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate treatment of malaria with ACT.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01194557.
背景
疟疾治疗不当的情况屡见不鲜，尤其是在那些难以获得医疗设施的地区，人们最常见的就医方式是自行购买抗疟药物治疗发烧。本研究的主要目的是考察在乌干达注册药店引入疟疾快速诊断检测（mRDTs）的影响，旨在增加在药店寻求治疗发烧的患者中使用以青蒿素为基础的联合疗法（ACT）进行疟疾恰当治疗的比例。
方法
在乌干达中部穆科诺区的20个地理集群的药店中开展了一项在注册药店引入mRDTs的整群随机试验。10个集群被随机分配到干预组（通过mRDT确诊疟疾后给予ACT），10个集群被分配到对照组（用ACT对发烧进行推定治疗）。提供者的治疗决策通过在咨询时采集的参考血涂片进行显微镜检查来验证。主要结局是接受ACT恰当治疗的发热患者比例，定义为：外周血涂片经显微镜确认有寄生虫的疟疾患者接受ACT或直肠用青蒿琥酯治疗，以及没有疟原虫的患者不给予ACT治疗。
研究结果
2011年1月至12月期间，共有15517名符合条件的患者（8672名干预组患者和6845名对照组患者）接受了发烧治疗。接受ACT恰当治疗的发热患者比例在干预组为72.9%，而在对照组为33.7%；差异为36.1%（95%CI：21.3 - 50.9），p<0.001。干预组中的大多数发烧患者接受购买mRDT（97.8%），其中58.5%的检测结果为mRDT阳性。与使用推定诊断的药店供应商（对照组）相比，药店供应商遵循mRDT结果，将疟疾过度治疗减少了72.6%（95%CI：46.7 - 98.4），p<0.001）。
结论
与在注册药店实施的发烧推定治疗相比，使用mRDT进行诊断检测显著改善了用ACT对疟疾的恰当治疗。
试验注册
ClinicalTrials.gov NCT01194557 。
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