Dohmen W, Breier M, Mengs U
Academical Practice of General Medicine, Medical Faculty, RWTH Aachen, Thomashofstrasse 3, D-52070 Aachen, Germany.
Anticancer Res. 2004 Mar-Apr;24(2C):1231-7.
Non-selected tumor patients (n=12) with various solid carcinomas were treated continuously twice weekly over 48 weeks with the aqueous mistletoe extract PS76A2, standardized to active mistletoe lectin. The preparation was applied subcutaneously at a concentration of 15 ng mistletoe lectin per 0.5 ml. Cellular immune response and safety were determined at various times during and after the therapy. In the course of treatment, virtually all the investigated immunoparameters were raised compared to the baseline values at the start of treatment. The statistically significant rises in the cell count of total lymphocytes, monocytes and natural killer (NK) cells was noteworthy. The differences in comparison with the baseline values at the various measuring times during treatment were up to 35%. In the first weeks of treatment at least, the raised cell count of NK cells correlated with the significantly increased cytotoxic activity versus tumor cells ex vivo. The NK factor (product of NK cells and ex vivo activity) was determined to assess the total NK activity more accurately, which rose up to 50% compared to the baseline value. Other lymphatic subpopulations, for instance CD3+, CD8+, CD3+CD4+ and CD3+CD8+ cells, also revealed distinct rises in cell count in the course of treatment. Within 6 weeks after completion of treatment, the overall values dropped again; but for a series of immunoparameters--in particular for the NK cells--they were still raised in comparison to the baseline values. The extensive laboratory diagnostics (haematology, clinical chemistry) showed that treatment with the standardized mistletoe extract PS76A2 was well tolerated by all patients. In single cases, local reactions at the injection sites were of a minor nature and reversible within two days. Summarizing, it can be stated that the standardized mistletoe extract PS76A2 significantly improved the immune status of tumor patients and was administered safely over a long period.
12例患有各种实体癌的未选择肿瘤患者，连续48周每周接受两次欧洲槲寄生水提取物PS76A2治疗，该提取物以活性欧洲槲寄生凝集素进行标准化。制剂以每0.5 ml含15 ng欧洲槲寄生凝集素的浓度皮下注射。在治疗期间及治疗后的不同时间点测定细胞免疫反应和安全性。在治疗过程中，与治疗开始时的基线值相比，几乎所有研究的免疫参数均升高。总淋巴细胞、单核细胞和自然杀伤（NK）细胞计数的统计学显著升高值得注意。与治疗期间不同测量时间的基线值相比，差异高达35%。至少在治疗的最初几周，NK细胞计数的升高与体外对肿瘤细胞的细胞毒性活性显著增加相关。为了更准确地评估总NK活性，测定了NK因子（NK细胞与体外活性的乘积），与基线值相比升高了50%。其他淋巴细胞亚群，例如CD3 +、CD8 +、CD3 + CD4 +和CD3 + CD8 +细胞，在治疗过程中细胞计数也有明显升高。治疗完成后6周内，总体值再次下降；但对于一系列免疫参数，特别是NK细胞，与基线值相比仍有所升高。广泛的实验室诊断（血液学、临床化学）表明，所有患者对标准化欧洲槲寄生提取物PS76A2的治疗耐受性良好。个别情况下，注射部位的局部反应轻微，两天内可恢复。总之，可以说标准化欧洲槲寄生提取物PS76A2显著改善了肿瘤患者的免疫状态，并且长期给药安全。
