Cranberry is a popular ingredient in dietary supplements in the U. S. and is commonly used for preventing urinary tract infections. Because of its popularity in dietary supplements, the U. S. Pharmacopeial Convention has developed quality standards for cranberry ingredients. The purpose of this review was to determine if there are safety issues that should preclude the admission of cranberry ingredients from the development of U. S. Pharmacopeial Convention quality standards. Based on the totality of the data, the U. S. Pharmacopeial Convention concluded that cranberry ingredients are not known to be associated with serious risks to human health when consumed properly in dietary supplements and therefore were admitted for standard development. Although published clinical and animal data indicated that cranberry is not associated with serious adverse effects, interactions with warfarin and kidney stone formation were identified as potential risks. Studies have reported contradictory data regarding the role of cranberry in kidney stone formation, with some reports suggesting cranberry is associated with a reduced risk of kidney stones. Interactions with warfarin were not associated with moderate intakes of cranberry juice (240 – 480 mL). Some reports suggested that the potential for warfarin interactions requires excessive intakes of cranberry juice (1 – 2 L/day) or cranberry extracts (3000 mg/day). Cases of warfarin interactions with cranberry have mostly involved patients with serious illnesses and/or individuals taking concomitant medications. Based on these findings, the U. S. Pharmacopeial Convention concluded that the use of cautionary labeling statements regarding interactions with warfarin or kidney stone formation is not necessary in the development of quality standards for cranberry ingredients.

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蔓越莓的安全性：肾结石形成和植物药物相互作用的证据评估

蔓越莓是美国膳食补充剂中的一种流行成分，通常用于预防尿路感染。由于其在膳食补充剂中的流行，美国药典公约制定了蔓越莓成分的质量标准。本次审查的目的是确定是否存在安全问题，以排除蔓越莓成分被纳入美国药典公约质量标准的制定。根据所有数据，美国药典公约得出结论，蔓越莓成分在膳食补充剂中正确食用时不会对人类健康造成严重风险，因此被批准用于标准制定。尽管已发表的临床和动物数据表明蔓越莓与严重不良反应无关，但与华法林和肾结石形成的相互作用被确定为潜在风险。研究报告了关于蔓越莓在肾结石形成中的作用的相互矛盾的数据，一些报告表明蔓越莓与肾结石风险降低有关。与华法林的相互作用与适量摄入蔓越莓汁（240 – 480 毫升）无关。一些报告表明，华法林相互作用的可能性需要过量摄入蔓越莓汁（1-2 升/天）或蔓越莓提取物（3000 毫克/天）。华法林与蔓越莓相互作用的案例主要涉及患有严重疾病的患者和/或同时服用药物的个体。基于这些发现，美国