Background

The concurrent use of conventional drugs and herbal medicines is becoming popular among patients with cancer. However, the potential risk of herb-drug interactions (HDI) remains under-addressed in the literature. Previous reviews have mainly focused on the prevalence of interactions, with less attention paid to the methods used by pharmacoepidemiological studies on evaluating HDI. This scoping review aims to summarize the existing pharmacoepidemiological studies that evaluate HDI using real-world data and to identify gaps to be addressed in future research.

Methods

A comprehensive search was performed in nine English- and Chinese-language databases from their inception to May 2021. Gray literature and manual searches were conducted to identify additional studies. The recommended components of the pharmacoepidemiological studies and key findings related to HDI were summarized. The proportion (%) of patients with cancer at risk of HDI was estimated by combining data from eligible studies.

Results

Twenty-eight studies were included in the review. More than half of these studies were cross-sectional studies (n=18, 64.3%), followed by retrospective cohort studies (n=5, 17.9%) and prospective cohort studies (n=2, 7.1%). The three cancer drugs most commonly studied for their interaction potential with herbs were tamoxifen (n=11, 39.3%), cyclophosphamide (n=6, 21.4%), and paclitaxel (n=6, 21.4%). Most cross-sectional studies identified potential HDI using tertiary databases and primary literature searches. Conversely, prospective and retrospective studies mainly investigated actual clinical outcomes, such as adverse events and secondary cancer occurrences. Most interaction outcomes identified using real-world data did not lead to negative clinical consequences. Collectively, 45.4% of herbal medicine users of the included studies were found to be at risk of HDI. We infer from this review that the common limitations of these studies were limited sample size, lack of data on herbal medicine use and details of HDI, and lack of evidence of HDI. Based on the study limitations, several recommendations to enrich the data sources and optimize the study designs were proposed.

Conclusions

There is a high demand for pharmacoepidemiological research on HDI, considering the increasing popularity of herbal medicine among patients with cancer. It is anticipated that emerging real-world data in this field can guide the development of safe and effective approaches to integrative oncology.

中文翻译：

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肿瘤学中草药-药物相互作用的真实数据：药物流行病学研究的范围审查

背景

常规药物和草药的同时使用在癌症患者中变得越来越流行。然而，文献中仍然没有提到草药-药物相互作用 (HDI) 的潜在风险。以前的评论主要集中在相互作用的普遍性，较少关注药物流行病学研究用于评估 HDI 的方法。该范围审查旨在总结使用真实数据评估 HDI 的现有药物流行病学研究，并确定未来研究中需要解决的差距。

方法

从开始到 2021 年 5 月，在九个英文和中文数据库中进行了全面搜索。进行了灰色文献和手动搜索以确定其他研究。总结了药物流行病学研究的推荐组成部分和与 HDI 相关的主要发现。通过结合符合条件的研究的数据估计有 HDI 风险的癌症患者的比例 (%)。

结果

该评价纳入了 28 项研究。这些研究中有一半以上是横断面研究（n=18, 64.3%），其次是回顾性队列研究（n=5, 17.9%）和前瞻性队列研究（n=2, 7.1%）。最常研究与草药相互作用的三种抗癌药物是他莫昔芬（n=11, 39.3%）、环磷酰胺（n=6, 21.4%）和紫杉醇（n=6, 21.4%）。大多数横断面研究使用三级数据库和主要文献搜索确定了潜在的 HDI。相反，前瞻性和回顾性研究主要调查实际临床结果，例如不良事件和继发性癌症发生。使用真实世界数据确定的大多数交互结果并未导致负面的临床后果。总的来说，45。纳入研究的 4% 的草药使用者被发现存在 HDI 的风险。我们从这篇综述中推断，这些研究的共同局限性是样本量有限、缺乏关于草药使用的数据和 HDI 的详细信息，以及缺乏 HDI 的证据。基于研究局限性，提出了一些丰富数据源和优化研究设计的建议。

结论

考虑到草药在癌症患者中的日益普及，对 HDI 的药物流行病学研究有很高的需求。预计该领域新兴的真实世界数据可以指导开发安全有效的综合肿瘤学方法。