阿莎丽根与肝癌上市后 8 年监测：全国基于人群的证据否定其关联性。
8 years post-marketing surveillance between Asari Radix and hepatocellular carcinoma: Nationwide population-based evidence against an association.
机构信息
Department of Public Health, China Medical University, Taichung, Taiwan; Taiwan Association for Traditional Chinese Medicine of Family, Taiwan.
School of Post-Baccalaureate Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan; Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.
出版信息
J Ethnopharmacol. 2019 Oct 28;243:112094. doi: 10.1016/j.jep.2019.112094. Epub 2019 Jul 16.
ETHNOPHARMACOLOGICAL RELEVANCE
Asari Radix (Xixin, Asarum heterotropoides Fr. Schmidt var. mandshuricum Kitag., Asarum sieboldii Miq., or Asarum sieboldii Miq. var. seoulense Nakai, Asarum spp.) is the only herbal medicine containing aristolochic acid that can be used in medical practice. However, scientific evidence regarding its safe use in relation to hepatocellular carcinoma (HCC) is lacking.
AIM OF THE STUDY
The aim of this study was to use post-marketing surveillance to provide a scientific understanding of the relationship between Asari Radix and the development of HCC and suggest the maximum allowable amount of Asari Radix.
MATERIALS AND METHODS
A retrospective, population-based cohort study was conducted, with patients randomly selected and divided into three cohorts: a non-hepatitis B virus (HBV)/hepatitis C virus (HCV) cohort, a HBV cohort, and a HCV cohort. Data were retrieved from the National Health Insurance Research Database of Taiwan from January 1, 1997 to December 31, 2013. The study period covered the initial 10 years of exposure to persistent HBV or HCV, followed by exposure to Asari Radix for an additional 8 years.
RESULTS
After propensity score matching, 106,942, 3818, and 928 patients were included in the non-HBV/HCV, HBV, and HCV cohorts, respectively. These cohorts included 75, 50, and 42 HCCs and 1,564,943, 30,956, and 6938 person-years, respectively. All hazard ratios of exposure to 1-30 g, 31-60 g, 61-100 g, and 101-200 g of Asari Radix in these three cohorts showed negative associations between Asari Radix exposure and HCC development. Furthermore, the three cohorts demonstrated that exposure to under 200 g of Asari Radix was safe.
CONCLUSIONS
Post-marketing surveillance showed that Asari Radix has no relationship with HCC development at an intake of under 200 g. The study is persuasive in furthering our knowledge of the maximum allowable amount of Asari Radix.
民族药理学相关性
细辛（细辛、细辛 Fr. Schmidt var. 细辛 Kitag.、细辛、细辛或细辛。米克 var. 汉城 Nakai、细辛属植物）是唯一可用于医疗实践的含有马兜铃酸的草药。然而，关于其在肝细胞癌（HCC）方面的安全使用的科学证据尚缺乏。
研究目的
本研究旨在通过上市后监测，提供对细辛与 HCC 发生发展之间关系的科学认识，并提出细辛的最大允许用量。
材料与方法
进行了一项回顾性、基于人群的队列研究，随机选择患者并分为三组：非乙型肝炎病毒（HBV）/丙型肝炎病毒（HCV）组、HBV 组和 HCV 组。数据来自台湾全民健康保险研究数据库，时间范围为 1997 年 1 月 1 日至 2013 年 12 月 31 日。研究期间涵盖了持续 HBV 或 HCV 暴露的最初 10 年，随后再暴露于细辛 8 年。
结果
经过倾向评分匹配后，非 HBV/HCV 组、HBV 组和 HCV 组分别纳入了 106942、3818 和 928 例患者。这些队列包括 75、50 和 42 例 HCC 病例，以及 1564943、30956 和 6938 人年。在这三个队列中，暴露于 1-30g、31-60g、61-100g 和 101-200g 细辛的所有风险比均显示出细辛暴露与 HCC 发展之间呈负相关。此外，三个队列均表明，摄入低于 200g 的细辛是安全的。
结论
上市后监测表明，在摄入低于 200g 的情况下，细辛与 HCC 的发生没有关系。该研究有助于进一步了解细辛的最大允许用量。
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