Maglione Margaret, Miotto Karen, Iguchi Martin, Hilton Lara, Shekelle Paul
RAND, 1776 Main Street, Mailstop M4W, Santa Monica, CA 90401, USA.
Expert Opin Drug Saf. 2005 Sep;4(5):879-84. doi: 10.1517/14740338.4.5.879.
The objective of this review is to describe psychiatric adverse events occurring after ingestion of dietary supplements containing herbal ephedra and to assess the possible relationship between supplement use and the events. The authors reviewed all adverse event reports related to dietary supplements containing herbal ephedra from US FDA MedWatch files as of 30 September, 2001. Psychosis, mania or severe agitation, severe depression, hallucinations, delusions, suicide attempts, paranoia and violent behaviour were classified as serious psychiatric events. Events were categorised based on the amount of information supporting a causal relationship. Out of almost 1800 total adverse events, 57 were classified as both psychiatric in nature and serious. Two-thirds of these psychiatric cases involved patients with pre-existing psychological/psychiatric conditions and/or use of other mood-altering medications or illicit substances. The majority of case reports were insufficiently documented to make an informed judgment about a relationship between the use of ephedra and the adverse event in question. The case reports evaluated do not prove a definitive causal link between ephedra and psychiatric complications. However, they do raise concern that such a relationship may exist.
本综述的目的是描述摄入含麻黄属植物的膳食补充剂后发生的精神科不良事件，并评估补充剂使用与这些事件之间可能存在的关系。作者查阅了截至2001年9月30日美国食品药品监督管理局（FDA）MedWatch档案中所有与含麻黄属植物的膳食补充剂相关的不良事件报告。精神病、躁狂或严重激动、重度抑郁、幻觉、妄想、自杀未遂、偏执和暴力行为被归类为严重精神科事件。根据支持因果关系的信息量对事件进行分类。在近1800起不良事件中，57起被归类为具有精神科性质且严重。这些精神科病例中有三分之二涉及已有心理/精神疾病和/或使用其他改变情绪的药物或非法物质的患者。大多数病例报告记录不足，无法就麻黄使用与相关不良事件之间的关系做出明智判断。所评估的病例报告并未证明麻黄与精神科并发症之间存在明确的因果联系。然而，它们确实引发了人们对这种关系可能存在的担忧。
