Nielsen O S, Bentzen S M, Sandberg E, Gadeberg C C, Timothy A R
Department of Oncology, Aarhus University Hospital, Denmark.
Radiother Oncol. 1998 Jun;47(3):233-40. doi: 10.1016/s0167-8140(98)00011-5.
Data in the literature suggest that for painful bone metastases a single dose is as effective as fractionated radiotherapy. In the present multicentre prospective trial, the effects of 8 Gy x1 and 5 Gy x4 were compared.
A total of 241 patients were randomized to 8 Gy (122 patients) or 20 Gy (119 patients). The primary tumour was in the breast in 39% of patients, in the prostate in 34% of patients, in the lung in 13% of patients and in other locations in 14% of patients. Outcome measures were pain relief as measured by VAS and in half of the patients also by a five-point categorical pain scale, global quality of life (QoL) and analgesic consumption. Evaluation was performed before and 4, 8, 12 and 20 weeks after treatment.
A total of 239 patients were evaluable for response. The two groups did not differ with respect to age, sex, primary tumour, metastasis localization, analgesic consumption (type and dose), performance status, prior systemic treatment, degree of pain and QoL. The treatment was completed as planned in 98% of patients. The degree of pain relief did not differ between the two treatment groups. At 4 weeks the difference in pain relief was 6% (95% CI 7, 20%) and at 8 weeks the difference was 13% (95% CI 3, 28%). Neither was there any significant difference in the duration of pain relief, the number of new painful sites and the need for reirradiation and toxicity was minor.
The present randomized study showed that a single fraction of 8 Gy was as effective as 5 Gy x4 in relieving pain from bone metastasis.
文献数据表明，对于疼痛性骨转移，单次剂量放疗与分次放疗效果相同。在本多中心前瞻性试验中，比较了8 Gy×1和5 Gy×4的疗效。
共241例患者被随机分为8 Gy组（122例患者）和20 Gy组（119例患者）。39%的患者原发肿瘤位于乳腺，34%的患者位于前列腺，13%的患者位于肺，14%的患者位于其他部位。观察指标包括采用视觉模拟评分法（VAS）测量的疼痛缓解情况，半数患者还采用五点分类疼痛量表进行评估，同时评估总体生活质量（QoL）和镇痛药消耗量。在治疗前以及治疗后4、8、12和20周进行评估。
共有239例患者可评估疗效。两组在年龄、性别、原发肿瘤、转移部位、镇痛药消耗量（类型和剂量）、体能状态、既往全身治疗、疼痛程度和生活质量方面无差异。98%的患者按计划完成了治疗。两个治疗组的疼痛缓解程度无差异。4周时疼痛缓解差异为6%（95%可信区间7, 20%），8周时差异为13%（95%可信区间3, 28%）。疼痛缓解持续时间、新疼痛部位数量以及再次放疗需求方面也均无显著差异，且毒性较小。
本随机研究表明，8 Gy单次分割放疗在缓解骨转移疼痛方面与5 Gy×4分次放疗效果相同。
