Violon C
Association Pharmaceutique Belge, Service du Contrôle des Médicaments, Bruxelles.
J Pharm Belg. 1997 Jan-Feb;52(1):7-27.
During the last years several patients with renal failure were admitted in Brussels hospitals. The progressive interstitial fibrosis with tubular atrophy seen in these patients has been ascribed to the slimming therapy preceding the pathology. The nephropathy was remarkable with regard to its extensive fibrotic process and the rapidity of its evolution. The ingestion of Aristolochia fangchi instead of the prescribed Stephania tetrandra, one of the components of the slimming therapy, was put forward as hypothesis for the etiology of the nephropathies in the literature. Questions however remain unanswered: Why have certain persons, among thousands similarly treated including ingestion of Aristolochic acids, not withstood the treatment? Why is there no correlation between the length of treatment and the occurrence nor the degree of illness? Last but not least: Is it in the actual conditions possible to be confident again in slimming treatments as the concerned one? We made an overview of the pharmacological action and possible (nephro) toxicity of the known components of the concerned therapy. Concerning the Chinese plants we have described and commented on the procedures for quality control actually at disposal and the difficulties in differentiation between resembling species and possible substitute herbs. We have described largely the traditional and medicinal use of the involved Chinese plants as to evaluate their implication in the nephrotoxicity. The elements of the therapy possibly relevant in the etiology of the disease are mentioned. The overview shows that different elements of the therapy are hazardous. Attention is caught to the danger of the use of (Chinese) herbs of unknown origin when nor the indications nor the form of preparation--in this case decoctions--are respected and when the quality cannot be assured, due to lack of (official) operating procedures. Medicinal plants as those implied contain secondary metabolites (bis)-benzylisoquinoline-alkaloids, dihydroxy-diallyl-biphenyls, aristolochic acids) with strong pharmacological (and possibly toxic) actions. Attention is caught to the danger of alternative therapies as mesotherapy. Products are injected which are not proved safe for this administration way. The administration during long periods of cocktails with anorectics (fenfluramine and diethylpropion) in association with a diuretic, a tranquilizer, plants with laxative and atropinergic action are alike to be at the origin of susceptibility in the excretion system. Under these circumstances exposure to any toxic product might cause renal failure. Several years have passed after the scientific reports of the first nephropathy cases in Belgium. We are afraid that prohibiting (temporarily) three Chinese herbs (Stephania tetrandra, Aristolochia fangchi and Magnolia officinalis) does not provide enough safety in order to assume responsibilities for common health care. Keeping in mind that these treatments were not meant to cure any disease but only for slimming, we ask Belgian authorities to regulate strictly the use of (Chinese) herbal medicines, the products and practices in alternative practices as mesotherapy and cocktail-treatments.
在过去几年里,布鲁塞尔的几家医院收治了数名肾衰竭患者。这些患者出现的进行性间质纤维化伴肾小管萎缩被归因于发病前的减肥疗法。就其广泛的纤维化过程及其演变速度而言,这种肾病非常显著。文献中提出,服用广防己而非规定的防己(减肥疗法的成分之一)是这些肾病病因的一种假设。然而,问题仍然没有答案:在数千名接受类似治疗(包括摄入马兜铃酸)的人中,为什么有些人无法耐受这种治疗?为什么治疗时间长短与疾病的发生及严重程度之间没有关联?最后但同样重要的是:在实际情况下,还能否像之前那样对相关的减肥治疗有信心?我们对相关疗法中已知成分的药理作用及可能的(肾)毒性进行了综述。关于这些中国植物,我们描述并评论了现有的质量控制程序以及区分相似物种和可能替代草药的困难。我们还详细描述了所涉中国植物的传统药用用途,以评估它们在肾毒性中的作用。文中提到了该疗法中可能与疾病病因相关的因素。综述表明,该疗法的不同成分都有危害。当不遵守适应证和制剂形式(在这种情况下是煎剂),且由于缺乏(官方)操作程序而无法保证质量时,要注意使用来源不明的(中国)草药的危险。像所涉的这些药用植物含有具有强大药理(可能还有毒性)作用的次生代谢物(双)苄基异喹啉生物碱、二羟基二烯丙基联苯、马兜铃酸)。还要注意中胚层疗法等替代疗法的危险。所注射的产品并未被证明对这种给药方式是安全的。长期将鸡尾酒疗法与食欲抑制剂(芬氟拉明和二乙丙胺)、利尿剂、镇静剂、具有泻药和阿托品能作用的植物联合使用,可能是排泄系统易感性的根源。在这种情况下,接触任何有毒产品都可能导致肾衰竭。自比利时首例肾病病例的科学报告发布以来,已经过去了数年。我们担心,仅仅暂时禁止三种中国草药(防己、广防己和厚朴)并不能为公共医疗保健承担责任提供足够的安全保障。鉴于这些治疗并非旨在治愈任何疾病,而只是用于减肥,我们要求比利时当局严格监管(中国)草药、中胚层疗法和鸡尾酒疗法等替代疗法中的产品及做法的使用。