Hovdenak N, Sørbye H, Dahl O
Division of Gastroenterology, Section of Oncology, Haukeland University Hospital, University of Bergen, Bergen, Norway.
Clin Oncol (R Coll Radiol). 2005 Sep;17(6):485-91. doi: 10.1016/j.clon.2005.04.011.
During pelvic radiotherapy, many patients develop radiation-induced gastrointestinal symptoms, which may interfere with treatment. Prophylaxis during radiotherapy should ideally prevent acute reaction and the development of delayed injury. Sucralfate, an aluminium sucrose octasulphate, has been used for acute and delayed radiation side-effects. However, conflicting results have been published. We report here a prospective, randomised, placebo-controlled study of prophylactic sucralfate during pelvic radiotherapy. In addition, a meta-analysis of available data from the literature has been carried out.
Fifty-one patients with localised pelvic tumours scheduled for curative conformal pelvic radiotherapy (total dose 64-70 Gy over 6.5-7 weeks in 2 Gy daily fractions) were included. Peroral sucralfate 2 g three times daily, or identically appearing placebo tablets, was given during the course of radiotherapy. Symptom registration, endoscopy and biopsies were carried out immediately before radiotherapy, 2 weeks and 6 weeks into the treatment course, and 2 weeks after completing radiotherapy. Mucosal cup forceps biopsies were obtained through a rigid proctoscope. Graded endoscopic appearance and quantitative histology were registered.
On the basis of previously published negative reports, an unplanned interim analysis of 44 evaluable patients showed significantly increased diarrhoea in the sucralfate group and the trial was stopped. No difference was seen in other symptoms, endoscopic appearance or histology. A meta-analysis comprising five published studies showed no statistically significant beneficial effect of sucralfate on acute symptoms.
Sucralfate cannot be recommended for prophylaxis of acute radiation proctopathy and may even worsen the symptoms.
在盆腔放疗期间，许多患者会出现放射性胃肠道症状，这可能会干扰治疗。放疗期间进行预防措施理想情况下应能预防急性反应和延迟性损伤的发生。硫糖铝，一种八硫酸蔗糖铝，已被用于治疗急性和延迟性放疗副作用。然而，已发表的结果相互矛盾。我们在此报告一项关于盆腔放疗期间预防性使用硫糖铝的前瞻性、随机、安慰剂对照研究。此外，还对文献中的现有数据进行了荟萃分析。
纳入51例计划进行根治性适形盆腔放疗（总剂量64 - 70 Gy，分6.5 - 7周，每日2 Gy分次照射）的局限性盆腔肿瘤患者。在放疗过程中，给予口服硫糖铝2 g，每日3次，或外观相同的安慰剂片。在放疗前、治疗过程的第2周和第6周以及放疗结束后2周进行症状记录、内镜检查和活检。通过硬式直肠镜获取黏膜钳活检组织。记录内镜分级表现和定量组织学情况。
基于之前发表的阴性报告，对44例可评估患者进行的一项非计划中期分析显示，硫糖铝组腹泻明显增加，试验因此停止。在其他症状、内镜表现或组织学方面未发现差异。一项包含五项已发表研究的荟萃分析显示，硫糖铝对急性症状无统计学显著的有益作用。
不推荐使用硫糖铝预防急性放射性直肠病，甚至可能会使症状恶化。
