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中成药和保健品掺假:香港一所三级毒理学实验室的经验。

Adulteration of proprietary Chinese medicines and health products with undeclared drugs: experience of a tertiary toxicology laboratory in Hong Kong.

机构信息

Hospital Authority Toxicology Reference Laboratory, Princess Margaret Hospital, Hong Kong.

出版信息

Br J Clin Pharmacol. 2018 Jan;84(1):172-178. doi: 10.1111/bcp.13420. Epub 2017 Oct 4.

Abstract

AIMS

Proprietary Chinese medicines (pCMs) and health products, generally believed to be natural and safe, are gaining popularity worldwide. However, the safety of pCMs and health products has been severely compromised by the practice of adulteration. The current study aimed to examine the problem of adulteration of pCMs and health products in Hong Kong.

METHODS

The present study was conducted in a tertiary referral clinical toxicology laboratory in Hong Kong. All cases involving the use of pCMs or health products, which were subsequently confirmed to contain undeclared adulterants, from 2005 to 2015 were reviewed retrospectively.

RESULTS

A total of 404 cases involving the use of 487 adulterated pCMs or health products with a total of 1234 adulterants were identified. The adulterants consisted of approved drugs, banned drugs, drug analogues and animal thyroid tissue. The six most common categories of adulterants detected were nonsteroidal anti-inflammatory drugs (17.7%), anorectics (15.3%), corticosteroids (13.8%), diuretics and laxatives (11.4%), oral antidiabetic agents (10.0%) and erectile dysfunction drugs (6.0%). Sibutramine was the most common adulterant (n = 155). The reported sources of these illicit products included over-the-counter drug stores, the internet and Chinese medicine practitioners. A significant proportion of patients (65.1%) had adverse effects attributable to these illicit products, including 14 severe and two fatal cases. Psychosis, iatrogenic Cushing syndrome and hypoglycaemia were the three most frequently encountered adverse effects.

CONCLUSIONS

Adulteration of pCMs and health products with undeclared drugs poses severe health hazards. Public education and effective regulatory measures are essential to address the problem.

摘要

目的

人们普遍认为,中药成药(pCM)和保健品天然且安全,因此在全球范围内越来越受欢迎。然而,pCM 和保健品的安全性因掺假问题而受到严重损害。本研究旨在调查香港地区 pCM 和保健品掺假问题。

方法

本研究在香港一家三级转诊临床毒理学实验室进行。回顾性分析了 2005 年至 2015 年间所有涉及使用 pCM 或保健品且随后证实含有未申报掺杂物的病例。

结果

共发现 404 例涉及 487 种掺假 pCM 或保健品的使用,共有 1234 种掺杂物。这些掺杂物包括已批准药物、禁用药物、药物类似物和动物甲状腺组织。检测到的六种最常见掺杂物类别为非甾体抗炎药(17.7%)、食欲抑制剂(15.3%)、皮质类固醇(13.8%)、利尿剂和泻药(11.4%)、口服降糖药(10.0%)和勃起功能障碍药物(6.0%)。西布曲明是最常见的掺杂物(n = 155)。这些非法产品的来源包括非处方药商店、互联网和中医从业者。相当一部分患者(65.1%)出现了与这些非法产品相关的不良反应,包括 14 例严重病例和 2 例死亡病例。精神错乱、医源性库欣综合征和低血糖是最常遇到的三种不良反应。

结论

含有未申报药物的 pCM 和保健品掺假对健康造成严重危害。开展公众教育和采取有效监管措施对于解决这一问题至关重要。

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