Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Medicine Quality Research Group, Laboratory of Microbiology, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
Nuffield Department of Medicine, Medicine Quality Research Group, University of Oxford Centre for Tropical Medicine and Global Health, Oxford, UK.
BMJ Glob Health. 2022 Aug;7(8). doi: 10.1136/bmjgh-2022-008587.
Antimicrobial resistance (AMR) is a significant global health threat with substandard and falsified (SF) antibiotics being neglected contributing factors. With their relationships poorly understood, more research is needed in order to determine how interventions to reduce SF antibiotics should be ranked as priorities in national AMR action plans. We assessed the evidence available on the global prevalence of SF antibiotics, examined the quality of the evidence and discussed public health impact.
MATERIALS/METHODS: We searched PubMed, Embase, Google and Google Scholar for publications on antibiotic quality up to 31 December 2020. Publications reporting on the prevalence of SF antibiotics were evaluated for quantitative analysis and assessed using the Medicines Quality Assessment Reporting Guidelines.
Of the 10 137 screened publications, 648 were relevant to antibiotic quality. One hundred and six (16.4%) surveys, published between 1992 and 2020 and conducted mainly in low-income and middle-income countries (LMICs) (89.9% (480/534) of the data points), qualified for quantitative analysis. The total number of samples tested for quality in prevalence surveys was 13 555, with a median (Q1-Q3) number of samples per survey of 47 (21-135). Of the 13 555 samples, 2357 (17.4%) failed at least one quality test and the median failure frequency (FF) per survey was 19.6% (7.6%-35.0%). Amoxicillin, sulfamethoxazole-trimethoprim and ciprofloxacin were the most surveyed antibiotics, with FF of 16.1% (355/2208), 26.2% (329/1255) and 10.4% (366/3511), respectively. We identified no SF survey data for antibiotics in the WHO 'Reserve' group. The mean Medicine Quality Assessment Reporting Guidelines score was 11 (95% CI 10.1 to 12.2) out of 26.
SF antibiotics are widely spread with higher prevalence in LMICs. The quality of the evidence is poor, and these data are not generalisable that 17.4% of global antibiotic supply is SF. However, the evidence we have suggests that interventions to enhance regulatory, purchasing and financial mechanisms to improve the global antibiotic supply are needed.
CRD42019124988.
抗生素耐药性（AMR）是一个严重的全球健康威胁，而劣质和假冒（SF）抗生素是被忽视的促成因素。由于人们对它们之间的关系了解甚少，因此需要更多的研究来确定减少 SF 抗生素的干预措施应如何在国家 AMR 行动计划中被列为优先事项。我们评估了全球 SF 抗生素流行率的现有证据，检查了证据的质量并讨论了公共卫生影响。
材料/方法：我们在 PubMed、Embase、Google 和 Google Scholar 上搜索了截至 2020 年 12 月 31 日有关抗生素质量的出版物。对报告 SF 抗生素流行率的出版物进行了定量分析，并使用《药品质量评估报告指南》进行了评估。
在筛选出的 10137 篇论文中，有 648 篇与抗生素质量相关。106 项调查（1992 年至 2020 年期间发表，主要在中低收入国家（LMICs）进行）（7.6%-35.0%）。在 13555 个接受质量检测的样本中，每个调查的中位数（Q1-Q3）样本数为 47（21-135）。在 13555 个样本中，有 2357 个（17.4%）至少有一个质量检测失败，每个调查的失败频率（FF）中位数为 19.6%（7.6%-35.0%）。阿莫西林、磺胺甲恶唑-甲氧苄啶和环丙沙星是调查最多的抗生素，FF 分别为 16.1%（355/2208）、26.2%（329/1255）和 10.4%（366/3511）。我们没有发现世卫组织“储备”组抗生素的 SF 调查数据。《药品质量评估报告指南》的平均得分为 11 分（95%CI 10.1 至 12.2），共 26 分。
SF 抗生素广泛传播，在 LMICs 中更为普遍。证据的质量很差，而且这些数据并不能说明全球抗生素供应中有 17.4%是 SF。然而，我们现有的证据表明，需要加强监管、采购和财务机制的干预措施，以改善全球抗生素供应。
PROSPERO 注册号：CRD42019124988。
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