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[沃博·穆戈斯蛋白水解酶疗法对乳腺癌患者化疗所致毒性的影响——一项初步研究的结果]

[Effects of proteolytic enzyme therapy with Wobe Mugos against chemotherapy-induced toxicity in breast cancer patients - results of a pilot study].

作者信息

Petru Edgar, Stranz Bettina, Petru Claudia

机构信息

Klinische Abteilung für Gynäkologie, Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz, Österreich.

出版信息

Wien Med Wochenschr. 2010 Nov;160(19-20):513-6. doi: 10.1007/s10354-010-0835-9. Epub 2010 Oct 26.

DOI:10.1007/s10354-010-0835-9
PMID:20972712
Abstract

BACKGROUND

Wobe Mugos(®) is an enzyme preparation containing the proteases trypsin and papain from the pancreatic calf and commonly used in complementary medicine. From non-randomized studies, its multiple favorable effects including the reduction of adverse events from radiotherapy and chemotherapy in oncology patients have been reported.

METHODS

Patients with invasive breast cancer receiving adjuvant or palliative chemotherapy between 2005 and 2006 and who were scheduled for at least two further cycles of this specific chemotherapy were included in this pilot study. A specific toxicity of at least grade 2 using the NCI common toxicity criteria which occurred during the preceeding cycle and was relevant to the patient was recorded. This specific toxicity, e.g. grade 2 emesis, was again evaluated after two analogously administered further chemotherapy cycles in which Wobe Mugos(®) had been coadministered. The hypothesis was that specific toxicites of individual patients will be reduced by this enzyme therapy. The majority of the 57 consecutive patients received palliative chemotherapy. Peroral enzyme therapy was coadministered with two uncracked coated tablets three times daily on all days of a chemotherapy cycle except on the day of chemotherapy administration.

RESULTS

Tolerability was good. Positive and neutral effects on toxicity parameters were observed in 11 and 42 patients, respectively, and a negative influence in 4 women.

CONCLUSION

We observed only a marginal influence of Wobe Mugos(®) in patients with breast cancer who had experienced at least a grade 2 toxicity in the preceding cycle and who received two further identical cycles of this chemotherapy in conjunction with the enzyme preparation. Randomized studies on homogenous patient populations are necessary.

摘要

背景

沃贝·穆戈斯(®)是一种酶制剂,含有来自小牛胰腺的蛋白酶胰蛋白酶和木瓜蛋白酶,常用于辅助医学。从非随机研究中可知,其具有多种有益作用,包括减少肿瘤患者放疗和化疗的不良事件。

方法

本试点研究纳入了2005年至2006年间接受辅助或姑息化疗且计划至少再进行两个周期这种特定化疗的浸润性乳腺癌患者。记录在前一周期中出现的、使用美国国立癌症研究所通用毒性标准确定的至少2级且与患者相关的特定毒性。在又进行了两个类似的化疗周期(同时给予沃贝·穆戈斯(®))后,再次评估这种特定毒性,例如2级呕吐。假设是这种酶疗法将降低个体患者的特定毒性。57例连续患者中的大多数接受了姑息化疗。口服酶疗法在化疗周期的所有日子里,除了化疗给药当天,每天三次与两片未裂解的包衣片一起服用。

结果

耐受性良好。分别在11例和42例患者中观察到对毒性参数有积极和中性影响,4例女性有负面影响。

结论

我们观察到,对于在前一周期中至少经历过2级毒性且在接受另外两个相同周期化疗并同时使用该酶制剂的乳腺癌患者,沃贝·穆戈斯(®)仅有轻微影响。有必要对同质患者群体进行随机研究。

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1
[Effects of proteolytic enzyme therapy with Wobe Mugos against chemotherapy-induced toxicity in breast cancer patients - results of a pilot study].[沃博·穆戈斯蛋白水解酶疗法对乳腺癌患者化疗所致毒性的影响——一项初步研究的结果]
Wien Med Wochenschr. 2010 Nov;160(19-20):513-6. doi: 10.1007/s10354-010-0835-9. Epub 2010 Oct 26.
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Strahlenther Onkol. 2007 Mar;183(3):121-7. doi: 10.1007/s00066-007-1634-0.
4
[Modification of liver parameters by adjuvant administration of proteolytic enzymes following chemotherapy in patients with ovarian carcinoma].
Wien Med Wochenschr. 1995;145(24):663-8.
5
[Wobe-Mugos: a proteolytic enzyme combination for tumor therapy. Documentation No. 7].[沃博-穆戈斯:一种用于肿瘤治疗的蛋白水解酶组合。文献编号7]
Schweiz Rundsch Med Prax. 1987 Dec 15;76(51):1430-2.
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8
Double-blind pilot-study on the efficacy of enzyme therapy in advanced colorectal cancer.
Przegl Lek. 2000;57 Suppl 5:142.
9
[The efficacy of the multienzyme preparation Wobe-Mugos E in lymphoproliferative diseases].
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Impact of complementary oral enzyme application on the postoperative treatment results of breast cancer patients--results of an epidemiological multicentre retrolective cohort study.辅助口服酶应用对乳腺癌患者术后治疗结果的影响——一项流行病学多中心回顾性队列研究的结果
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AGO Recommendations for Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer. Update 2011.AGO原发性和转移性乳腺癌患者诊断与治疗建议。2011年更新版
Breast Care (Basel). 2011;6(4):299-313. doi: 10.1159/000331459. Epub 2011 Aug 30.

本文引用的文献

1
Impact of complementary oral enzyme application on the postoperative treatment results of breast cancer patients--results of an epidemiological multicentre retrolective cohort study.辅助口服酶应用对乳腺癌患者术后治疗结果的影响——一项流行病学多中心回顾性队列研究的结果
Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S45-54. doi: 10.1007/s002800170009.
2
Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma.口服酶制剂辅助治疗多发性骨髓瘤患者的回顾性队列研究。
Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S38-44. doi: 10.1007/s002800170008.
3
Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects.
子宫颈放射治疗中与水解酶联合用药:减轻急性副作用的证据
Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S29-34. doi: 10.1007/s002800170006.
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Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers.水解酶在预防头颈部癌症患者放射治疗引起的副作用方面的疗效。
Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S23-8. doi: 10.1007/s002800170005.
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[Modification of liver parameters by adjuvant administration of proteolytic enzymes following chemotherapy in patients with ovarian carcinoma].
Wien Med Wochenschr. 1995;145(24):663-8.