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假冒抗疟药物是反人类罪:科学证据的系统综述。

The counterfeit anti-malarial is a crime against humanity: a systematic review of the scientific evidence.

作者信息

Karunamoorthi Kaliyaperumal

机构信息

Unit of Medical Entomology and Vector Control, Department of Environmental Health Sciences and Technology, College of Public Health & Medical Sciences, Jimma University, Jimma, Ethiopia.

出版信息

Malar J. 2014 Jun 2;13:209. doi: 10.1186/1475-2875-13-209.

Abstract

BACKGROUND

The counterfeiting of anti-malarials represents a form of attack on global public health in which fake and substandard anti-malarials serve as de facto weapons of mass destruction, particularly in resource-constrained endemic settings, where malaria causes nearly 660,000 preventable deaths and threatens millions of lives annually. It has been estimated that fake anti-malarials contribute to nearly 450,000 preventable deaths every year. This crime against humanity is often underestimated or ignored. This study attempts to describe and characterize the direct and indirect effects of counterfeit anti-malarials on public health, clinical care and socio-economic conditions.

METHODS

A search was performed using key databases, WHO documents, and English language search engines. Of 262 potential articles that were identified using a fixed set of criteria, a convenience sample of 105 appropriate articles was selected for this review.

RESULTS

Artemisinin-based combination therapy (ACT) is an important tool in the fight against malaria, but a sizable number of patients are unable to afford to this first-line treatment. Consequently, patients tend to procure cheaper anti-malarials, which may be fake or substandard. Forensic palynology reveals that counterfeits originate in Asia. Fragile drug regulations, ineffective law-enforcement agencies and corruption further burden ailing healthcare facilities. Substandard/fake anti-malarials can cause (a) economic sabotage; (b) therapeutic failure; (c) increased risk of the emergence and spread of resistant strains of Plasmodium falciparum and Plasmodium vivax; (d) an undermining of trust/confidence in healthcare stakeholders/systems; and, (e) serious side effects or death.

CONCLUSION

Combating counterfeit anti-malarials is a complex task due to limited resources and poor techniques for the detection and identification of fake anti-malarials. This situation calls for sustainable, global, scientific research and policy change. Further, responsible stakeholders in combination with the synthesis and supply of next generation malaria control tools, such as low-cost anti-malarials, must promote the development of a counterfeit-free and malaria-free future.

摘要

背景

抗疟药物的假冒伪劣是对全球公共卫生的一种攻击形式,假药和不合格抗疟药实际上成为了大规模杀伤性武器,尤其是在资源匮乏的疟疾流行地区,每年疟疾导致近66万人可预防死亡,并威胁数百万人的生命。据估计,假冒抗疟药每年导致近45万人可预防死亡。这种反人类罪行常常被低估或忽视。本研究试图描述并刻画假冒抗疟药对公共卫生、临床护理和社会经济状况的直接和间接影响。

方法

使用关键数据库、世界卫生组织文件和英文搜索引擎进行检索。在根据一组固定标准识别出的262篇潜在文章中,选取了105篇合适文章作为本综述的便利样本。

结果

以青蒿素为基础的联合疗法(ACT)是抗击疟疾的一项重要工具,但相当多的患者负担不起这种一线治疗。因此,患者往往会购买更便宜的抗疟药,而这些药可能是假药或不合格产品。法医孢粉学显示,假药源自亚洲。脆弱的药品监管、执法机构效率低下以及腐败给本就不堪重负的医疗设施雪上加霜。不合格/假冒抗疟药可导致:(a)经济破坏;(b)治疗失败;(c)恶性疟原虫和间日疟原虫耐药菌株出现和传播的风险增加;(d)对医疗利益相关者/系统的信任/信心受损;以及(e)严重副作用或死亡。

结论

由于检测和识别假冒抗疟药的资源有限且技术欠佳,打击假冒抗疟药是一项复杂的任务。这种情况需要可持续的全球科学研究和政策变革。此外,责任利益相关者必须与下一代疟疾控制工具(如低成本抗疟药)的合成与供应相结合,推动实现无假冒药品和无疟疾的未来。

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