Myers Stephen P, Cheras Phillip A
ACCMER, PO Box 157, Lismore NSW 2480, Australia.
Med J Aust. 2004 Aug 16;181(4):222-5.
Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.
大多数消费者认为补充和替代医学（CAM）产品本质上是安全的。澳大利亚消费者同时使用CAM产品和药品的情况日益增多，这增加了CAM与药物相互作用的风险。治疗用品管理局（TGA）对治疗用品有一个基于风险的两级监管系统——CAM产品被作为低风险产品进行监管，并对其质量和安全性进行评估；产品赞助商必须掌握任何关于其功效声明的证据。对CAM产品的不良反应可分为内在的（产品固有的）或外在的（风险与产品本身无关，而是由于良好生产规范的失败导致）。对CAM疗法的不良反应可分为实施风险（包括停止医学治疗）和遗漏风险（包括在适当的时候未能转诊）。虽然关于CAM不良事件的系统研究很少，而且漏报情况可能存在，但大多数CAM产品和疗法似乎并没有带来高风险；需要从更广泛的安全问题角度看待它们的安全性。研究的一个优先事项是严格界定与CAM产品和疗法相关的风险，以便能够评估它们对公众健康的潜在影响。
