Anti-malarial medicine quality field studies and surveys: a systematic review of screening technologies used and reporting of findings.
Anti-malarial medicine quality field studies and surveys: a systematic review of screening technologies used and reporting of findings.
复制标题
DOI：
10.1186/s12936-017-1852-6
复制
发表时间：
2017-05-15
期刊：
影响因子：
3
通讯作者：
Kaur H
中科院分区：
文献类型：
--
作者：
Lalani M;Kitutu FE;Clarke SE;Kaur H
在中低收入国家评估药品质量主要依赖于现有的人员检查和筛选技术。实地研究和调查经常利用筛选试验来分析在保健设施和医药销售点等护理点取样的药品，以便对某一特定地理区域的药品质量进行简要了解。本综述概述了调查中通常用于评估抗疟疾药物质量的筛选试验，总结了所使用的分析方法，如何报告研究结果，并为未来的研究提出了报告模板。系统检索了1990-2016年期间公共领域（包括国家和多国药品质量调查）可获得的同行评议文献和灰色文献。如果研究使用了筛选技术来评估抗疟疾药物的质量，那么这些研究就被包括在内。由于没有一套标准化的药物质量调查方法和报告指南，因此根据新提出的标准清单对纳入的研究进行了标准评估。筛选了4621条记录的标题和摘要，发现只有39条符合资格标准。这39项研究利用目视检查、崩解、比色法和薄层色谱法（TLC）作为全球制药健康基金（GPHF） MiniLab®的组成部分或作为单独的测试。总体而言，39项研究中有30项报告采用了国际药典中描述的确认性检测，通过筛选试验验证抗疟疾药物后评估的质量。作者为每项研究的报告标准的23个标准分配了分数。研究设计存在相当大的异质性，药品质量实地调查报告也不一致。药物质量研究的设计和报告缺乏标准化，增加了偏倚和错误的风险，影响了研究结果的普遍性和可靠性。本综述中提出的研究标准报告标准可与现有的药品质量调查指南结合使用，作为设计和报告研究结果的检查清单。审查方案已在PROSPERO注册（CRD42015026782）。本文的在线版本（doi:10.1186/s12936-017-1852-6）包含补充材料，可供授权用户使用。
Assessing the quality of medicines in low-middle income countries (LMICs) relies primarily on human inspection and screening technologies, where available. Field studies and surveys have frequently utilized screening tests to analyse medicines sampled at the point of care, such as health care facilities and medicine outlets, to provide a snap shot of medicine quality in a specific geographical area. This review presents an overview of the screening tests typically employed in surveys to assess anti-malarial medicine quality, summarizes the analytical methods used, how findings have been reported and proposes a reporting template for future studies. A systematic search of the peer-reviewed and grey literature available in the public domain (including national and multi-national medicine quality surveys) covering the period 1990–2016 was undertaken. Studies were included if they had used screening techniques to assess the quality of anti-malarial medicines. As no standardized set of guidelines for the methodology and reporting of medicine quality surveys exist, the included studies were assessed for their standard against a newly proposed list of criteria. The titles and abstracts of 4621 records were screened and only 39 were found to meet the eligibility criteria. These 39 studies utilized visual inspection, disintegration, colorimetry and Thin Layer Chromatography (TLC) either as components of the Global Pharma Health Fund (GPHF) MiniLab® or as individual tests. Overall, 30/39 studies reported employing confirmatory testing described in international pharmacopeia to verify the quality of anti-malarials post assessment by a screening test. The authors assigned scores for the 23 criteria for the standard of reporting of each study. There is considerable heterogeneity in study design and inconsistency in reporting of field surveys of medicine quality. A lack of standardization in the design and reporting of studies of medicine quality increases the risk of bias and error, impacting on the generalizability and reliability of study results. The criteria proposed for reporting on the standard of studies in this review can be used in conjunction with existing medicine quality survey guidelines as a checklist for designing and reporting findings of studies. The review protocol has been registered with PROSPERO (CRD42015026782). The online version of this article (doi:10.1186/s12936-017-1852-6) contains supplementary material, which is available to authorized users.