van Wely M, Stoss M, Gorter R W
Institute for Oncological and Immunological Research, Berlin, Germany.
Am J Ther. 1999 Jan;6(1):37-43. doi: 10.1097/00045391-199901000-00006.
Iscador is being used by many patients as unconventional anticancer and immunomodulating therapy. To determine the toxicity profile and biochemical effects of Iscador Qu Spezial (Weleda AG Schwäbisch Gmünd, Germany) in human immunodeficiency virus (HIV)-positive patients and healthy controls, we performed a phase I/II study. Escalating doses of Iscador Qu Spezial, standardized for its lectin and viscotoxin content, were administered to 16 HIV-positive patients and 8 healthy subjects during a period of 6 to 8 months. Iscador Qu Spezial preparations were administered twice per week subcutaneously in increasing doses (ie, 0.01 mg, 0.1 mg, 1.0 mg, 2.0 mg, 5.0 mg, and 0.1 mg/kg for 2-6 weeks per dose). Drug-related adverse effects were flulike symptoms, gingivitis, fever, local erythema, and eosinophilia. These side effects were never severe. The incidence of systemic adverse events was highest in HIV-positive patients. Furthermore, increased urea levels and slightly decreased total protein caused by a minor decrease in albumin were observed. None of the HIV-positive patients progressed in disease stage. Iscador Qu Spezial can be administered safely to immunocompromised patients.
许多患者将伊斯卡多(Iscador)用作非常规抗癌和免疫调节疗法。为了确定德国施瓦本格明德市 Weleda AG 公司生产的伊斯卡多特殊制剂(Iscador Qu Spezial)对人类免疫缺陷病毒(HIV)阳性患者和健康对照者的毒性特征及生化影响,我们开展了一项 I/II 期研究。在 6 至 8 个月的时间里,对 16 名 HIV 阳性患者和 8 名健康受试者给予按其凝集素和毒蓖麻蛋白含量标准化的递增剂量伊斯卡多特殊制剂。伊斯卡多特殊制剂每周皮下注射两次,剂量递增(即每剂分别为 0.01 毫克、0.1 毫克、1.0 毫克、2.0 毫克、5.0 毫克以及 0.1 毫克/千克,每剂量持续 2 - 6 周)。与药物相关的不良反应为流感样症状、牙龈炎、发热、局部红斑和嗜酸性粒细胞增多。这些副作用均不严重。全身不良事件的发生率在 HIV 阳性患者中最高。此外,还观察到尿素水平升高以及由于白蛋白略有下降导致总蛋白略有降低。没有一名 HIV 阳性患者疾病阶段进展。伊斯卡多特殊制剂可安全地用于免疫功能低下的患者。