Medical Physics, San Raffaele Scientific Institute, Milan, Italy.
Department of Radiotherapy, Ospedale S. Maria della Misericordia, Udine, Italy.
Int J Radiat Oncol Biol Phys. 2014 Jul 1;89(3):518-24. doi: 10.1016/j.ijrobp.2014.03.018. Epub 2014 May 3.
To evaluate the efficacy of sodium butyrate enemas (NABUREN) in prostate cancer radiation therapy (RT) in reducing the incidence, severity, and duration of acute RT-induced proctitis.
166 patients, randomly allocated to 1 of 4 groups (rectal sodium butyrate 1 g, 2 g, or 4 g daily or placebo), were treated with NABUREN during and 2 weeks after RT. The grade of proctitis was registered in a daily diary. The correlation between NABUREN and proctitis was investigated through χ(2) statistics. The toxicity endpoints considered were as follows: total number of days with grade ≥1 proctitis (≥G1); total number of days with grade ≥2 proctitis (≥G2); ≥G1 and ≥G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 (≥G1+3d, ≥G2+3d); damaging effects of RT on rectal mucosa as measured by endoscopy. The relationship between endpoints and pretreatment morbidities, hormonal therapy, presence of diabetes or hypertension, abdominal surgery, or hemorrhoids was investigated by univariate analysis.
The patients were randomly allocated to the 4 arms. No difference in the distribution of comorbidities among the arms was observed (P>.09). The mean ≥G1 and ≥G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group, respectively. No favorable trend in reduction of incidence, severity, and duration of ≥G1 and ≥G2 proctitis was observed with NABUREN use. In univariate analysis, ≥G1+3d toxicity was found to be related to hemorrhoids (P=.008), and a slight correlation was found between ≥G2 proctitis and hormonal therapy (P=.06). The RT effects on rectal mucosa as based on endoscopic assessment were mainly related to diabetes (P<.01). Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms. The other investigated endpoints were not correlated with any of the clinical risk factors analyzed.
There was no evidence of efficacy of NABUREN in reducing the incidence, severity, and duration of acute radiation proctitis. There was a correlation between some endpoints and clinical risk factors.
评估丁酸钠灌肠（NABUREN）在前列腺癌放射治疗（RT）中减少急性 RT 诱导的直肠炎的发生率、严重程度和持续时间的疗效。
166 名患者随机分为 4 组（直肠内给予丁酸钠 1 克、2 克或 4 克/天或安慰剂），在 RT 期间和 RT 后 2 周内使用 NABUREN。每天记录直肠炎的严重程度。通过 χ(2)统计分析 NABUREN 与直肠炎的相关性。考虑的毒性终点如下：每天有≥1 级直肠炎的天数（≥G1）；每天有≥2 级直肠炎的天数（≥G2）；从第 4 周开始至少连续 3 天和 5 天有≥G1 和≥G2 直肠炎（≥G1+3d、≥G2+3d）；内镜检查评估 RT 对直肠黏膜的损伤效应。通过单变量分析研究终点与预处理合并症、激素治疗、糖尿病或高血压、腹部手术或痔疮的关系。
患者被随机分配到 4 个臂。各组之间的合并症分布无差异（P＞.09）。安慰剂组的平均≥G1 和≥G2 直肠炎分别为 7.8 和 4.9，NABUREN 组分别为 8.9 和 4.7。使用 NABUREN 并不能减少≥G1 和≥G2 直肠炎的发生率、严重程度和持续时间。单变量分析发现，≥G1+3d 毒性与痔疮有关（P=.008），而≥G2 直肠炎与激素治疗有轻微相关性（P=.06）。基于内镜评估的直肠黏膜 RT 效应主要与糖尿病有关（P＜.01）。6 周时的内镜数据显示，安慰剂组和丁酸钠组之间无显著差异。其他研究终点与分析的任何临床危险因素均无相关性。
NABUREN 不能降低急性放射性直肠炎的发生率、严重程度和持续时间。一些终点与临床危险因素有关。
