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对德国市场上销售的紫锥菊制剂的批判性分析。

Critical analysis of Echinacea preparations marketed in Germany.

作者信息

Groß Carina, Seifert Roland

机构信息

Institute of Pharmacology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.

出版信息

Naunyn Schmiedebergs Arch Pharmacol. 2025 May;398(5):5743-5756. doi: 10.1007/s00210-024-03634-2. Epub 2024 Nov 28.

Abstract

Colds are the most common cause of incapacity to work in 2023 and therefore have a significant impact on the German economy. Echinacea preparations are considered a non-specific immune stimulant that is used as a phytotherapeutic agent for the treatment and prevention of colds. In the 2021 ZEIT ranking of the best-selling pharmacy-only medicines in Germany, four Echinacea preparations were among the top ten, and they experienced a new hype during the SARS-CoV-2 pandemic. In this study, 22 Echinacea monopreparations, which are approved as herbal medicinal products, were analyzed based on their package inserts. The preparations used in clinical studies were compared with the preparations available on the market with regard to the criteria of plant species used, plant part used, preparation (extract or pressed juice), drug-extract ratio, single dose administered, standardization of the preparations, prior performance of an ingredient analysis, galenics, dosage, duration of administration, and daily dose administered. The analysis revealed that the preparations available on the market are very heterogeneous. The composition can vary considerably in terms of ingredients. For customers, these products appear homogeneous in terms of their presentation on the market. The legal framework conditions promote this situation. The clinical studies are also unable to adequately reflect the market situation. New studies based on market reality, with an analysis of ingredients in the preparations used, a standardized study design, and the inclusion of hematological and biochemical parameters in the evaluation should improve this situation. Days of incapacity for work as an outcome parameter could be well suited.

摘要

感冒是2023年导致无法工作的最常见原因,因此对德国经济产生重大影响。紫锥菊制剂被认为是一种非特异性免疫刺激剂,用作治疗和预防感冒的植物治疗剂。在2021年德国仅在药店销售的畅销药品的《时代》排名中,四种紫锥菊制剂位列前十,并且在SARS-CoV-2大流行期间经历了新一轮热潮。在本研究中,对22种被批准为草药药品的紫锥菊单一制剂的包装说明书进行了分析。将临床研究中使用的制剂与市场上现有的制剂在所用植物种类、所用植物部位、制剂(提取物或压榨汁)、药物-提取物比例、单次给药剂量、制剂标准化、成分分析的预先进行情况、盖伦制剂学、剂量、给药持续时间和每日给药剂量等标准方面进行了比较。分析表明,市场上现有的制剂非常不均一。其成分在成分方面可能有很大差异。对消费者而言,这些产品在市场上的呈现方式看起来是同质的。法律框架条件助长了这种情况。临床研究也无法充分反映市场情况。基于市场实际情况进行的新研究,包括对所用制剂中的成分进行分析、采用标准化的研究设计以及在评估中纳入血液学和生化参数,应该会改善这种情况。将无法工作的天数作为一个结果参数可能会很合适。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/749f/11985562/7cb7c1ce8909/210_2024_3634_Fig1_HTML.jpg

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