Fushimi R, Amino N
Central Laboratory for Clinical Investigation, Osaka University Hospital, Suita.
Rinsho Byori. 1995 Jan;43(1):34-40.
Immunoreactive digoxin-like activity was found in the Chinese medicine, KYUSHIN tablet, taken popularly in Japan without prescription. The antibodies used in the assays of digoxin reacted with Ch'an-su, the major effective component of KYUSHIN, which contained cardiotonic steroids with a chemical structure similar to that of digoxin. One tablet of KYUSHIN had digoxin-like immunoreactivity equivalent to 1.9 micrograms. (TDx analyzer), 1.5 micrograms (Du Pont aca analyzer) and 72 micrograms digoxin (Enzymun-Test, Boehringer). These different equivalencies may be attributed to differences in cross-reactivity of the antibody used in the immunoassays. Two healthy volunteers took two KYUSHIN tablets three times a day, a typical dose, and digoxin-like immunoreactivity reached almost 0.4 microgram/l in 0.5 day. Recently, a competitive digoxin chemiluminescent immunoassay has been developed by Ciba Corning ACS 180. The assay utilizes an acridinium-ester labelled mouse monoclonal digoxin antibody as the tracer. In the extracted solution of KYUSHIN and serum after administration of two tablets, the digoxin-like immunoreactivity value on the Ciba Corning ACS 180 digoxin assay was < 0.10 microgram/l (off-range low). Therapeutic drug monitoring should be interpreted carefully in patients taking Chinese medicines, many of which contain the Ch'an-su component.
在日本无需处方即可普遍服用的中药救心丹中发现了免疫反应性地高辛样活性。用于地高辛检测的抗体与救心丹的主要有效成分蟾酥发生反应，蟾酥含有化学结构与地高辛相似的强心甾体。一片救心丹的地高辛样免疫反应性相当于1.9微克（TDx分析仪）、1.5微克（杜邦aca分析仪）和72微克地高辛（酶免疫试验，勃林格公司）。这些不同的等效值可能归因于免疫测定中所用抗体交叉反应性的差异。两名健康志愿者每天服用两片救心丹，这是典型剂量，在0.5天内地高辛样免疫反应性几乎达到0.4微克/升。最近，汽巴康宁ACS 180开发了一种竞争性地高辛化学发光免疫测定法。该测定法使用吖啶酯标记的小鼠单克隆地高辛抗体作为示踪剂。在服用两片救心丹后的救心丹提取液和血清中，汽巴康宁ACS 180地高辛测定法的地高辛样免疫反应性值<0.10微克/升（超出范围下限）。对于服用中药的患者，治疗药物监测应谨慎解读，因为许多中药都含有蟾酥成分。
