Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):75-86. doi: 10.4269/ajtmh.14-0544. Epub 2015 Apr 20.
Ensuring that artemisinin-containing antimalarials (ACAs) are of good quality is a key component of effective malaria treatment. There are concerns that a high proportion of ACAs are falsified or substandard, though estimates are rarely based on representative data. During a nationally representative survey in Tanzania, ACAs were purchased from private retail drug outlets, and the active pharmaceutical ingredient (API) was measured. All 1,737 ACAs contained the labeled artemisinin derivative, with 4.1% being outside the 85-115% artemisinin API range defined as acceptable quality. World Health Organization (WHO) prequalified drugs had 0.1 times the odds of being poor quality compared with non-prequalified ACAs for the artemisinin component. When partner components of combination therapies were also considered, 12.1% were outside the acceptable API range, and WHO prequalified ACAs had 0.04 times the odds of being poor quality. Although the prevalence of poor quality ACAs was lower than reported elsewhere, the minority of samples found to be substandard is a cause for concern. Improvements in quality could be achieved by increasing the predominance of WHO prequalified products in the market. Continued monitoring of quality standards is essential.
确保含青蒿素抗疟药（ACAs）质量良好是有效治疗疟疾的关键组成部分。有人担心很大一部分ACAs是伪造的或不合格的，不过相关估计很少基于具有代表性的数据。在坦桑尼亚进行的一项全国代表性调查中，从私人零售药店购买了ACAs，并对活性药物成分（API）进行了测量。所有1737种ACAs都含有标签所示的青蒿素衍生物，其中4.1%超出了定义为可接受质量的85 - 115%青蒿素API范围。与未通过世界卫生组织（WHO）预认证的ACAs的青蒿素成分相比，WHO预认证药物质量差的几率为其0.1倍。当同时考虑联合疗法的其他成分时，12.1%超出了可接受的API范围，而WHO预认证的ACAs质量差的几率为其0.04倍。尽管质量差的ACAs的流行率低于其他地方报告的情况，但发现的少数不合格样本令人担忧。通过提高市场上WHO预认证产品的占比可以实现质量的提升。持续监测质量标准至关重要。
