BACKGROUND An inadequate combination of prescription drugs with food or medicinal plants could cause adverse effects in patients or produce negative therapeutic results. Therefore, this generic systematic review protocol aims to identify and synthesize the literature on clinical characteristics and safety issues of these types of pharmacological interactions occurring in children, adolescents, adults, pregnant/lactating women, and older adults. METHODS/DESIGN This generic protocol follows the stated guidelines from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement. A literature search will be performed in PubMed, Scopus, and Virtual Health Library (VHL) electronic databases from 1960 till present for studies reporting clinical characteristics and safety issues associated with pharmacological interactions occurring between prescription drugs and food or medicinal plants in participants from birth-age to ≥ 65-year-old, including pregnant/lactating women. Lateral searching will be carried out in PubMed via related citation. Two reviewers will carry out an independent evaluation of eligible studies as well as the corresponding data extraction of the selected ones. Subsequently, the methodological quality evaluation of the selected articles will be completed using the corresponding Joanna Briggs Institute Checklists. Moreover, the quality of evidence will be graded according to the criteria of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group. Quantitative research in humans comprising clinical trials and clinical, comparative and, observational studies will be included. The main outcomes of this protocol involve reported potential food-drug and herb-drug interactions, associated safety issues, and adverse reactions along with the generic name of the prescribed drug and the scientific name of the food and medicinal plants involved in these types of pharmacological interactions. Finally, findings extracted from the selected studies will be summarized in a narrative synthesis. DISCUSSION This generic systematic review protocol seeks to synthesize and critically evaluate current knowledge besides to identify any comprehension gaps in the concurrent administration of prescription drugs with food and herbs. By achieving a better understanding of this topic, this information will allow healthcare professionals to develop useful strategies to recognize, manage, and prevent these types of pharmacological interactions at different age stages, including pregnant/lactating women. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42018117308.

中文翻译：

---

与处方药和食品或药用植物同时给药相关的临床相关性的相互作用：系统评价方案。

背景技术处方药与食物或药用植物的不充分组合可能会对患者造成不良影响或产生负面的治疗结果。因此，本通用系统评价方案旨在识别和综合有关儿童、青少年、成人、孕妇/哺乳期妇女和老年人中发生的此类药理相互作用的临床特征和安全性问题的文献。方法/设计 该通用方案遵循系统评价和荟萃分析方案的首选报告项目 (PRISMA-P) 声明中规定的指南。将从 1960 年至今的 PubMed、Scopus 和虚拟健康图书馆 (VHL) 电子数据库中进行文献检索，以查找报告临床特征和安全问题的研究，这些问题与参与者从出生起处方药与食品或药用植物之间发生的药理相互作用相关。年龄≥65岁，包括孕妇/哺乳期妇女。将通过相关引文在 PubMed 中进行横向检索。两名评审员将对符合条件的研究进行独立评估，并对所选研究进行相应的数据提取。随后，将使用相应的乔安娜·布里格斯研究所检查表完成所选文章的方法学质量评估。此外，证据的质量将根据建议、评估、制定和评价（GRADE）工作组的分级标准进行分级。将包括人体定量研究，包括临床试验以及临床、比较和观察研究。该协议的主要成果涉及报告的潜在食品-药物和草药-药物相互作用、相关安全问题和不良反应，以及处方药物的通用名称以及参与这些类型药理学的食品和药用植物的学名互动。最后，从选定的研究中提取的结果将以叙述性综合的形式进行总结。讨论除了确定处方药与食物和草药同时给药方面的任何理解差距之外，本通用系统评价方案还旨在综合和严格评估当前的知识。通过更好地理解这一主题，这些信息将使医疗保健专业人员能够制定有用的策略来识别、管理和预防不同年龄阶段（包括孕妇/哺乳期妇女）的这些类型的药理学相互作用。系统审查注册 PROSPERO CRD42018117308。