Delaney G, Fisher R, Hook C, Barton M
Department of Radiation Oncology, Liverpool Hospital, New South Wales, Australia.
Australas Radiol. 1997 Aug;41(3):270-5. doi: 10.1111/j.1440-1673.1997.tb00672.x.
Randomized trials have shown that sucralfate is effective in the management of acute radiation reactions such as oesophagitis, mucositis and proctitis. However, at the time of commencement of the present trial, it had never been used in the management of moist desquamation of the skin. The purpose of the present study was to assess the value of sucralfate cream in the management of moist desquamation during radiotherapy. Patients who developed moist desquamation during radiation were eligible. Patients were stratified by site of radiotherapy into three groups: (i) the head and neck; (ii) the breast; and (iii) other sites. Patients were randomized to receive 10% sucralfate in sorbolene cream or sorbolene alone. Patients' pain and skin healing were assessed by using linear analogue self-assessment (LASA) scales and by serial measurement of the desquamated area. Due to poor patient accrual, the trial was terminated after 2 years and 39 patients. No statistically significant difference was found between the two arms in either time from randomization to healing or improvement in pain score. Twenty patients in the sucralfate arm took a geometric mean of 14.8 days to heal whereas 19 patients receiving sorbolene alone took a geometric mean of 14.2 days. The ratio of mean times of healing, 1.043, is not statistically different from 1 (P = 0.86; 95% CI = 0.65, 1.67). A total of 75% of the patients reported pain relief on application of either cream. Mean LASA scores for pain for each day after randomization were compared by treatment arm and there was no statistically significant difference (P = 0.32). The present trial was unable to show a difference in terms of time to healing or pain relief in the treatment of moist desquamation. The small number of patients in the trial gave a wide confidence interval for treatment difference, implying that an important effect of sucralfate has not been excluded. Given the poor accrual in the present, single-institution study, future studies may need to be multi-institutional and we encourage other centres to perform randomized trials in the management of moist desquamation.
随机试验表明，硫糖铝对治疗急性放射反应如食管炎、粘膜炎和直肠炎有效。然而，在本试验开始时，硫糖铝从未用于治疗皮肤湿性脱屑。本研究的目的是评估硫糖铝乳膏在放射治疗期间治疗皮肤湿性脱屑的价值。在放疗期间出现皮肤湿性脱屑的患者符合条件。患者按放疗部位分为三组：（i）头颈部；（ii）乳房；（iii）其他部位。患者被随机分配接受含10%硫糖铝的索布二醇乳膏或单纯索布二醇乳膏。通过使用线性模拟自评（LASA）量表和对脱屑面积进行连续测量来评估患者的疼痛和皮肤愈合情况。由于患者入组情况不佳，该试验在2年纳入39例患者后终止。在从随机分组到愈合的时间或疼痛评分改善方面，两组之间未发现统计学上的显著差异。硫糖铝组的20例患者愈合的几何平均时间为14.8天，而仅接受索布二醇乳膏的19例患者愈合的几何平均时间为14.2天。愈合平均时间的比值为1.043，与1无统计学差异（P = 0.86；95%置信区间 = 0.65，1.67）。共有75%的患者报告使用任一乳膏后疼痛缓解。按治疗组比较随机分组后每天的疼痛平均LASA评分，无统计学显著差异（P = 0.32）。本试验未能显示在治疗皮肤湿性脱屑的愈合时间或疼痛缓解方面存在差异。试验中的患者数量较少，治疗差异的置信区间较宽，这意味着硫糖铝的重要作用尚未被排除。鉴于本单机构研究的入组情况不佳，未来的研究可能需要多机构进行，我们鼓励其他中心开展关于皮肤湿性脱屑治疗的随机试验。
