Development of an evidence evaluation and synthesis system for drug-drug interactions, and its application to a systematic review of HIV and malaria co-infection.
Development of an evidence evaluation and synthesis system for drug-drug interactions, and its application to a systematic review of HIV and malaria co-infection.
复制标题
DOI：
10.1371/journal.pone.0173509
复制
发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Khoo SH
中科院分区：
文献类型：
--
作者：
Seden K;Gibbons S;Marzolini C;Schapiro JM;Burger DM;Back DJ;Khoo SH
在所有情况下，安全治疗多病多药患者都存在挑战。因此，描述、理解和限制药物使用造成的危害的需要变得越来越重要。药物-药物相互作用（ddi）在服用抗逆转录病毒药物（ARVs）的患者中很普遍，如果不加以管理，可能对治疗结果构成相当大的风险。预防ddi的最大挑战之一是理论与临床实践之间的巨大差距。尽管信息来源多种多样，但目前还没有发表可靠的方法来正式评估与ddi有关的证据质量。我们定义了一个透明的、结构化的过程来开发证据质量总结，以指导治疗决策。这适用于对具有重大公共卫生意义的DDI数据的系统审查：艾滋病毒和疟疾。这是对抗逆转录病毒药物和用于预防和治疗疟疾的药物之间的DDI数据的系统审查。这些数据包括所有评估抗逆转录病毒药物与抗疟疾药物联合使用时药代动力学数据和/或相关不良事件的人类原始研究，包括健康志愿者、艾滋病毒和/或疟疾患者、观察性研究和病例报告。数据综合包括1987年至2016年8月期间通过PubMed和会议网站/摘要书籍发表的36篇文章和会议演讲。HIV蛋白酶抑制剂（NNRTIs）和含青蒿素的抗疟方案之间存在显著的ddi风险。对于许多抗逆转录病毒药物，缺乏针对抗疟药物的DDI研究，而且大多数研究质量为中等至极低。证据的质量和推荐类别的强度是专门为关于ddi的建议定义和制定的。抗逆转录病毒药物和抗疟药物之间的DDIs有很大的潜力。将证据质量和推荐标准的强度应用于DDI数据是可行的，并允许对DDI的评估是稳健的、一致的、透明的和基于证据的。
In all settings, there are challenges associated with safely treating patients with multimorbidity and polypharmacy. The need to characterise, understand and limit harms resulting from medication use is therefore increasingly important. Drug-drug interactions (DDIs) are prevalent in patients taking antiretrovirals (ARVs) and if unmanaged, may pose considerable risk to treatment outcome. One of the biggest challenges in preventing DDIs is the substantial gap between theory and clinical practice. There are no robust methods published for formally assessing quality of evidence relating to DDIs, despite the diverse sources of information. We defined a transparent, structured process for developing evidence quality summaries in order to guide therapeutic decision making. This was applied to a systematic review of DDI data with considerable public health significance: HIV and malaria. This was a systematic review of DDI data between antiretrovirals and drugs used in prophylaxis and treatment of malaria. The data comprised all original research in humans that evaluated pharmacokinetic data and/or related adverse events when antiretroviral agents were combined with antimalarial agents, including healthy volunteers, patients with HIV and/or malaria, observational studies, and case reports. The data synthesis included 36 articles and conference presentations published via PubMed and conference websites/abstract books between 1987-August 2016. There is significant risk of DDIs between HIV protease inhibitors, or NNRTIs and artemesinin-containing antimalarial regimens. For many antiretrovirals, DDI studies with antimalarials were lacking, and the majority were of moderate to very low quality. Quality of evidence and strength of recommendation categories were defined and developed specifically for recommendations concerning DDIs. There is significant potential for DDIs between antiretrovirals and antimalarials. The application of quality of evidence and strength of recommendation criteria to DDI data is feasible, and allows the assessment of DDIs to be robust, consistent, transparent and evidence-based.