Steuer-Vogt M K, Bonkowsky V, Scholz M, Fauser C, Licht K, Ambrosch P
Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Klinikum rechts der Isar--Technische Universität München.
HNO. 2006 Apr;54(4):277-86. doi: 10.1007/s00106-005-1318-y.
ML-1 standardized mistletoe extracts have been recommended for increasing the health-related quality of life in cancer patients.
The EORTC questionnaire QLQ-C30((V2)) was given to a randomly chosen subgroup of 399 patients of a prospective, randomized, open, multi-center trial. A total of 200 patients from this trial were randomized for ML-1 treatment (1 ng/kg body weight ML-1 was injected subcutaneously twice weekly over a 60-week period. Treatment cycles of 12 weeks were followed by a break of 4 weeks (between weeks 12-16, 28-32, and 44-48)). The remaining 199 patients formed the control group.
Patients completed questionnaires before the start of their treatments at week 0 and continued until week 156. The compliance rate was high: 3611 questionnaires were available, which equals a median of nine longitudinal measurements per patient between weeks 0 and 156. Analysis did not indicate any improvement in the quality of life for either group. A significant decrease in quality of life, however, was seen in patients undergoing radiotherapy. In these patients, the global state of health was reduced and four symptom scales were significantly worse.
Our results demonstrated no improvement in the quality of life in head and neck cancer patients when treated with ML-1 extract.
ML-1标准化槲寄生提取物已被推荐用于提高癌症患者与健康相关的生活质量。
在一项前瞻性、随机、开放、多中心试验中，将EORTC问卷QLQ-C30（第2版）发放给随机选择的399名患者亚组。该试验中共有200名患者被随机分配接受ML-1治疗（每周两次皮下注射1 ng/kg体重的ML-1，共60周。12周的治疗周期后休息4周（在第12 - 16周、28 - 32周和44 - 48周之间））。其余199名患者组成对照组。
患者在第0周治疗开始前完成问卷，并持续到第156周。依从率很高：共获得3611份问卷，这相当于每位患者在第0周和第156周之间平均有9次纵向测量。分析表明两组患者的生活质量均未得到改善。然而，接受放疗的患者生活质量出现显著下降。在这些患者中，整体健康状况下降，四个症状量表明显变差。
我们的结果表明，ML-1提取物治疗对头颈部癌症患者的生活质量没有改善。
