Hospital Authority Toxicology Reference Laboratory, Princess Margaret Hospital, Lai Chi Kok, Hong Kong, China.
Br J Clin Pharmacol. 2012 May;73(5):795-800. doi: 10.1111/j.1365-2125.2011.04135.x.
The current study aims to examine the problem of adulteration of herbal antidiabetic products with undeclared pharmaceuticals, including both registered and banned drugs.
All cases involving use of adulterated herbal antidiabetic products referred to a tertiary centre for clinical toxicology analysis from 2005 to 2010 inclusive were retrospectively reviewed. The patients' demographic characteristics, clinical presentations, medical history, drug history and the analytical findings of the herbal antidiabetic products were studied.
A total of 27 cases involving use of 29 adulterated herbal antidiabetic products were identified. Seventeen of the patients (63%) had clinical toxicities associated with the illicit products. Hypoglycaemia was the most common adverse effect, followed by lactic acidosis. Analysis of the 29 illicit herbal antidiabetic products revealed eight undeclared registered or banned oral antidiabetic agents, namely glibenclamide (n= 22), phenformin (n= 18), metformin (n= 6), rosiglitazone (n= 6), gliclazide (n= 2), glimepiride (n= 2), nateglinide (n= 1) and repaglinide (n= 1). Non-antidiabetic drugs were also detected in some products. Up to four adulterants were detected within the same product.
Adulteration of herbal antidiabetic products with undeclared pharmaceuticals is a significant yet under-recognized problem. Patients taking these illicit products could be at risk of potentially fatal adverse effects. It is important to educate the public to avoid taking pCMs of dubious source. Effective regulatory measures should be put in place to address the problem.
本研究旨在调查含有未申报药物(包括已注册和禁用药物)的掺假草药抗糖尿病产品的问题。
回顾性分析了 2005 年至 2010 年期间所有因使用掺假草药抗糖尿病产品而被送到三级临床毒理学分析中心的病例。研究了患者的人口统计学特征、临床表现、病史、药物史以及草药抗糖尿病产品的分析结果。
共发现 27 例 29 种掺假草药抗糖尿病产品,其中 17 例(63%)患者与非法产品相关的临床表现为毒性作用。低血糖是最常见的不良反应,其次是乳酸性酸中毒。对 29 种非法草药抗糖尿病产品进行分析,发现 8 种未申报的已注册或禁用口服抗糖尿病药物,即格列本脲(n=22)、苯乙双胍(n=18)、二甲双胍(n=6)、罗格列酮(n=6)、格列齐特(n=2)、格列美脲(n=2)、那格列奈(n=1)和瑞格列奈(n=1)。一些产品中还检测到非抗糖尿病药物。同一产品中最多可检测到四种掺杂物。
含有未申报药物的草药抗糖尿病产品掺假是一个重大但未被充分认识的问题。服用这些非法产品的患者可能存在潜在致命不良反应的风险。重要的是要教育公众避免服用来源可疑的 pCMs。应采取有效的监管措施来解决这个问题。