Stengel B, Jones E
INSERM U 170, Villejuif.
Nephrologie. 1998;19(1):15-20.
In May 1994 in Toulouse, there were two cases of end-stage renal failure (ESRF) related to Chinese herbs similar to those incriminated in the case series reported in Belgium in 1992-93, they led to an epidemiologic investigation aimed at evaluating the risk linked to these plants in France. Studies carried out by the Pharmacy Inspection showed that powders labelled Stephania Tetrandra, but consisting instead of Aristolochia Fangji and containing aristolochic acid, were sold in France between 1989 and May 1994. A systematic attempt to ascertain cases of ESRF associated with ingesting Chinese herbs was carried out by analysing data from the ERA-EDTA Registry of ESRF as well as from the French adverse drug reaction monitoring system. Registry data showed no significant increase over previous years in the number of new ESRF cases caused by tubulo-interstitial nephritis (TIN) between 1990 and 1993. In eight regions of France, the files of 85 ESRF cases were examined, and all patients whose nephropathy began after 1989 were interviewed using a very detailed questionnaire. No association with Chinese herb use was found in any of these cases. In 1996, two new ESRF cases were reported in Nice; the regional adverse drug reaction monitoring center considered the relationship with Aristolochia Fangji to be as possible (I2) for one case and dubious (I1) for the other. Despite a lack of sensitivity of the methods used to detect cases, it seems clear that no phenomenon as extensive as that observed in Belgium occurred in France, although the same drugs prescribed at the same doses have been widely distributed in our country. A possible explantation for the difference in the number of cases in Belgium and France is that of an unrecognised factor, promoting the toxicity of aristolochic acid or peculiar to the Belgian clinic and causative. The precautionary principle led the authorities to ban Stephania Tetrandra and Aristolochia Fangji from the market permanently.
1994年5月在图卢兹,出现了两例终末期肾衰竭(ESRF)病例,病因与1992 - 1993年比利时报告的病例系列中涉及的中草药相似,这引发了一项流行病学调查,旨在评估法国境内与这些植物相关的风险。药品检查部门开展的研究表明,1989年至1994年5月期间,法国市场上出售的标有“防己”字样的粉末,实际成分却是广防己且含有马兜铃酸。通过分析欧洲肾脏替代治疗协作组(ERA - EDTA)的终末期肾衰竭登记数据以及法国药品不良反应监测系统的数据,对与服用中草药相关的终末期肾衰竭病例进行了系统排查。登记数据显示,1990年至1993年期间,由肾小管间质性肾炎(TIN)导致的新终末期肾衰竭病例数量与前几年相比没有显著增加。在法国的八个地区,对85例终末期肾衰竭病例的档案进行了审查,并使用一份非常详细的问卷对所有肾病始于1989年之后的患者进行了访谈。在这些病例中均未发现与使用中草药有关联。1996年,尼斯报告了两例新的终末期肾衰竭病例;地区药品不良反应监测中心认为,其中一例与广防己的关系为“有可能(I2)”,另一例为“可疑(I1)”。尽管用于检测病例的方法缺乏敏感性,但很明显,法国并未出现像比利时那样广泛的现象,尽管相同剂量的相同药物在我国已广泛流通。比利时和法国病例数量存在差异的一个可能解释是存在一个未被识别的因素,该因素会增强马兜铃酸的毒性,或者是比利时诊所特有的致病因素。基于预防原则,当局永久禁止防己和广防己进入市场。