硫酸铝与美沙拉嗪及氢化可的松在前列腺癌适形放疗期间预防急性放射性直肠炎中的比较：一项随机研究
Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study.
作者信息
Sanguineti Giuseppe, Franzone Paola, Marcenaro Michela, Foppiano Franca, Vitale Vito
机构信息
Department of Radiation Oncology, National Institute for Cancer Research, Genova, Italy.
出版信息
Strahlenther Onkol. 2003 Jul;179(7):464-70. doi: 10.1007/s00066-003-1082-4.
PURPOSE
To assess whether the topical use of steroids or 5-aminosalicylic acid (5-ASA) is superior to sucralfate in preventing acute rectal toxicity during three-dimensional conformal radiotherapy (3DCRT) to 76 Gy.
PATIENTS AND METHODS
Patients undergoing 3DCRT for prostate carcinoma at our institution were offered to be randomized to sucralfate 3 g in 15 ml suspension enema (Antepsin, mesalazine 4 g gel enema (Enterasyn, or hydrocortisone 100 mg foam enema (Colifoam. Randomization was blind to the treating physician but not to the patient. Sucralfate was chosen as control arm. Topical treatment had to be performed once daily, starting on day 1 of 3DCRT. Acute rectal toxicity was scored weekly according to RTOG criteria. Time to occurrence of grade 2+ acute rectal toxicity was taken as endpoint.
RESULTS
The trial was opened in August 1999, and after the first 24 patients had been treated, arm 2 was discontinued because of eight patients receiving mesalazine, seven actually developed acute rectal toxicity (five patients grade 3 and two patients grade 2). Until May 2001, 134 consecutive patients were randomly assigned to sucralfate (63 patients), mesalazine (eight patients) or hydrocortisone (63 patients). The cumulative incidence of acute rectal toxicity at the end of treatment by arm is 61.9 +/- 6.1%, 87.5 +/- 11.7%, and 52.4 +/- 6.2% for arms 1, 2, and 3, respectively. The difference between the mesalazine group and the sucralfate group is highly significant (hazard ratio [HR] 2.5, 95% confidence interval [CI] 1.1-5.7; p = 0.03). At both uni- and multivariate analysis taking into account several patients and treatment covariates, the difference between hydrocortisone and sucralfate is not significant (HR 0.7, 95% CI 0.5-1.2; p = 0.2).
CONCLUSION
Topical mesalazine is contraindicated during radiotherapy. Hydrocortisone enema is not superior to sucralfate in preventing acute rectal toxicity.
目的
评估在三维适形放疗（3DCRT）至76 Gy剂量时，局部使用类固醇或5-氨基水杨酸（5-ASA）预防急性直肠毒性是否优于硫糖铝。
患者与方法
在我们机构接受前列腺癌3DCRT治疗的患者被随机分为三组，分别接受15 ml悬浮液灌肠的3 g硫糖铝（安特胃仙）、4 g美沙拉嗪凝胶灌肠（肠炎宁）或100 mg氢化可的松泡沫灌肠（可立福）。随机分组对治疗医生保密，但对患者不保密。选择硫糖铝组作为对照组。局部治疗必须在3DCRT第1天开始，每天进行一次。根据RTOG标准每周对急性直肠毒性进行评分。将发生2级及以上急性直肠毒性的时间作为终点。
结果
该试验于1999年8月开始，在前24例患者接受治疗后，第二组（美沙拉嗪组）因8例接受美沙拉嗪治疗的患者中有7例实际发生急性直肠毒性（5例3级，2例2级）而停止。到2001年5月，134例连续患者被随机分配至硫糖铝组（63例）、美沙拉嗪组（8例）或氢化可的松组（63例）。治疗结束时，三组急性直肠毒性的累积发生率分别为61.9±6.1%、87.5±11.7%和52.4±6.2%。美沙拉嗪组与硫糖铝组之间的差异具有高度显著性（风险比[HR]2.5，95%置信区间[CI]1.1 - 5.7；p = 0.03）。在单因素和多因素分析中，考虑了多个患者和治疗协变量后，氢化可的松组与硫糖铝组之间的差异不显著（HR 0.7，95% CI 0.5 - 1.2；p = 0.2）。
结论
放疗期间局部使用美沙拉嗪是禁忌的。氢化可的松灌肠在预防急性直肠毒性方面并不优于硫糖铝。
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