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槲寄生提取物可减轻癌症患者手术对自然杀伤细胞活性的抑制作用。一项随机III期试验。

Mistletoe extract reduces the surgical suppression of natural killer cell activity in cancer patients. a randomized phase III trial.

作者信息

Schink Michael, Tröger Wilfried, Dabidian Ali, Goyert Andreas, Scheuerecker Heinz, Meyer Johannes, Fischer Imma U, Glaser Florian

机构信息

Forschungsabteilung, Verein Filderklinik e.V., Filderstadt, Germany.

出版信息

Forsch Komplementmed. 2007 Feb;14(1):9-17. doi: 10.1159/000098135. Epub 2007 Mar 6.

DOI:10.1159/000098135
PMID:17341882
Abstract

BACKGROUND

Major surgery suppresses natural killer (NK) cell cytotoxic activity which is potentially harmful for cancer patients by favouring haematogenic tumour cell dissemination. The influence of a perioperative infusion of a standardized mistletoe extract (Iscador) on immune functions was tested in a prospective, sequential, randomized clinical trial.

PATIENTS AND METHODS

Colorectal cancer patients undergoing open tumour resection were randomly assigned to either mistletoe infusion or no additional therapy. We hypothesized that mistletoe infusion improves NK cell activity and increases expression of MHC class II antigen HLA-DR on monocytes 24 h and 7 days after surgery, respectively. For statistical analysis we used a sequential study design. The decision boundaries for the two triangular tests were calculated for altogether 62 patients.

RESULTS

The sequential study design allowed stopping the recruitment prematurely. NK cell activity differed significantly between the therapy groups 24 h after surgery (p = 0.027). The absolute number of HLA-DR molecules on monocytes did not differ 7 days after surgery. NK cell activity of patients treated with mistletoe extract did not change significantly during the course of the study (-7.9% 24 h after surgery), whereas HLA-DR expression changed significantly (-38.5% at day 7 after surgery). For control patients both parameters decreased significantly after surgery (NK cell activity: -44.4% at 24 h; HLA-DR expression: -32.9% at day 7 after surgery).

CONCLUSION

Perioperative infusion of mistletoe extracts can prevent a suppression of NK cell activity in cancer patients. The impact of this therapy on relapse and survival should be tested in further studies.

摘要

背景

大手术会抑制自然杀伤(NK)细胞的细胞毒性活性,这可能会因有利于血源性肿瘤细胞的播散而对癌症患者产生潜在危害。在一项前瞻性、序贯、随机临床试验中,测试了围手术期输注标准化槲寄生提取物(Iscador)对免疫功能的影响。

患者与方法

接受开放性肿瘤切除术的结直肠癌患者被随机分配接受槲寄生输注或不接受额外治疗。我们假设槲寄生输注分别在术后24小时和7天改善NK细胞活性并增加单核细胞上MHC II类抗原HLA-DR的表达。为进行统计分析,我们采用了序贯研究设计。为总共62名患者计算了两个三角检验的决策边界。

结果

序贯研究设计允许提前停止招募。术后24小时,治疗组之间的NK细胞活性存在显著差异(p = 0.027)。术后7天,单核细胞上HLA-DR分子的绝对数量没有差异。在研究过程中,接受槲寄生提取物治疗的患者的NK细胞活性没有显著变化(术后24小时为-7.9%),而HLA-DR表达有显著变化(术后第7天为-38.5%)。对于对照组患者,术后这两个参数均显著下降(NK细胞活性:术后24小时为-44.4%;HLA-DR表达:术后第7天为-32.9%)。

结论

围手术期输注槲寄生提取物可预防癌症患者NK细胞活性的抑制。这种治疗对复发和生存的影响应在进一步研究中进行测试。

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