Prokein Benjamin, Holtmann Henrik, Hautmann Matthias G, Rösler Hans-Peter, Graeber Stefan, Dzierma Yvonne, Ruebe Christian, Fleckenstein Jochen, Niewald Marcus
Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany.
Department of Oral and Maxillofacial Surgery, University Hospital of Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
Strahlenther Onkol. 2017 Jun;193(6):483-490. doi: 10.1007/s00066-017-1116-y. Epub 2017 Feb 27.
In this randomized multicenter trial, we compared the effect of a lower single dose of 0.5 Gy vs. a standard single dose of 1 Gy concerning pain relief and quality of life, while maintaining a uniform total dose of 6 Gy. On the basis of laboratory observations, the lower single dose would be expected to be more effective.
A total of 127 patients suffering from painful heel spur were randomized: Patients in the standard group were treated with single fractions of 6 × 1 Gy twice a week, while the experimental group was treated with single fractions of 12 × 0.5 Gy three times a week. Patients who did not show satisfactory pain relief after 12 weeks were offered re-irradiation with the standard dose. The study's primary endpoints were pain relief and quality of life. Therapy results were evaluated and compared based on follow-up examinations after 12 and 48 weeks.
The data of 117 patients could be evaluated. There was no significant difference between the groups concerning the results of a visual analogue scale (VAS), Calcaneodynia Score (CS), and the somatic scale of the 12-Item Short-Form Health Survey(SF-12). Patients undergoing re-irradiation showed a significant benefit concerning pain relief. Their total outcome was comparable to patients showing a good response from the beginning. No relevant acute or chronic side effects were recorded.
Both patient groups showed good results concerning pain relief. A fractionation schedule of 12 × 0.5 Gy was not superior to the current standard dose of 6 × 1 Gy. Further trials are necessary to explore the best fractionation schedule.
在这项随机多中心试验中，我们比较了较低单剂量0.5 Gy与标准单剂量1 Gy在缓解疼痛和生活质量方面的效果，同时保持总剂量统一为6 Gy。基于实验室观察，预期较低单剂量会更有效。
总共127例患有疼痛性足跟骨刺的患者被随机分组：标准组患者每周接受两次6×1 Gy的单次分割治疗，而试验组患者每周接受三次12×0.5 Gy的单次分割治疗。12周后疼痛缓解不令人满意的患者接受标准剂量的再次照射。该研究的主要终点是疼痛缓解和生活质量。根据12周和48周后的随访检查对治疗结果进行评估和比较。
117例患者的数据可进行评估。在视觉模拟量表（VAS）、跟骨疼痛评分（CS）以及12项简短健康调查问卷（SF - 12）的躯体量表结果方面，两组之间无显著差异。接受再次照射的患者在疼痛缓解方面显示出显著益处。他们的总体结果与从一开始就有良好反应的患者相当。未记录到相关的急性或慢性副作用。
两组患者在疼痛缓解方面均显示出良好结果。12×0.5 Gy的分割方案并不优于当前标准剂量6×1 Gy。有必要进行进一步试验以探索最佳分割方案。
