Berberine-induced Haemolysis Revisited: Safety of Rhizoma coptidis and Cortex phellodendri in Chronic Haematological Diseases

Berberine-induced Haemolysis Revisited: Safety of Rhizoma coptidis and Cortex phellodendri in Chronic Haematological Diseases
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DOI:
10.1002/ptr.3617
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发表时间:
2012-05-01
影响因子:
7.2
通讯作者:
Ng, Han-seong
Ng, Han-seong
中科院分区:
医学2区
文献类型:
--
作者:
Linn, Yeh-ching;Lu, Jiahui;Ng, Han-seong

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在过去的30年里,两种常用的含黄连素的中草药黄连(RC)和黄柏(CP)在新加坡被禁止使用,因为黄连素在加重葡萄糖-6-磷酸脱氢酶缺乏症新生儿黄疸和核黄连方面的作用。在这里,我们对慢性细胞减少性血液病患者进行了一项单臂、I/II期中药临床研究,并分析了20名同时患有RC、CP或两者兼有的患者。我们在这20例患者中没有发现器官毒性或电解质失衡,其中RC治疗1055个病例日,CP治疗1252个病例日。在三名中间地中海贫血患者中,观察到血清胆红素水平一过性升高,但这与贫血或肝功能障碍的任何加重无关。对文献的回顾发现,不同程度的相互矛盾的证据支持或驳斥了由黄连素引起的新生儿黄疸和核黄斑病变的指控。然而,有关口服中药制剂中RC或CP引起的不良反应的临床报道很少。结论:根据传统剂量和适应证,RC和CP在口腔制剂中的应用是安全的。版权所有(C)2011 John Wiley&Sons,Ltd.
Two commonly used berberine-containing Chinese herbs, Rhizoma coptidis (RC) and Cortex phellodendri (CP), have been banned in Singapore for the past three decades due to implication of berberine in aggravating jaundice and kernicterus in neonates with glucose-6-phosphate dehydrogenase deficiency. Here we conducted a single arm, phase I/II clinical study on Chinese herbal medicine for patients with chronic cytopenic haematological conditions and we analysed a subset of 20 patients who also had RC, CP or both in their herbal concoction. We found no organ toxicity or electrolyte imbalance in these 20 patients where RC was administered for 1055 patient-days and CP for 1252 patient-days. In three patients with thalassemia intermedia, transient elevation in serum bilirubin level was observed but this was not associated with any aggravation of anaemia or liver dysfunction. A review of the literature found conflicting evidence of varying levels either supporting or refuting the allegation of neonatal jaundice and kernicterus caused by berberine. There were, however, very few clinical reports of adverse reaction attributable to RC or CP in oral TCM concoction. We conclude that based on traditional dosage and indication, the use of RC and CP in oral concoction is safe. Copyright (c) 2011 John Wiley & Sons, Ltd.