Hyperbaric oxygen treatment of chronic refractory radiation proctitis: A randomized and controlled double-blind crossover trial with long-term follow-up
Hyperbaric oxygen treatment of chronic refractory radiation proctitis: A randomized and controlled double-blind crossover trial with long-term follow-up
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DOI：
10.1016/j.ijrobp.2007.12.048
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发表时间：
2008-09-01
影响因子：
7
通讯作者：
Walker, Margaret B.
中科院分区：
文献类型：
--
作者：
Clarke, Richard E.;Tenorio, L. M. Catalina;Walker, Margaret B.
目的：接受放射治疗的癌症患者仍处于放射性损伤正常组织的终身风险中。我们进行了一项随机，对照，双盲交叉试验，长期随访，以评估高压氧对难治性放射性直肠炎的有效性。方法和材料：难治性放射性直肠炎患者随机高压氧在2.0绝对大气压（组1）或空气在1.1绝对大气压（组2）。随后将假手术患者交叉至第1组。所有患者均由不知道治疗分配的研究者在第3个月和第6个月以及第1-5年进行重新评价。主要结局指标为晚期效应正常组织-主观、客观、管理、分析（SOMA-LENT）评分和标准化临床评估。次要结果是生活质量的变化。结果：226例患者评估，150人进入研究，120人可评价。初始分配后，两组的平均SOMA-LENT评分均有所改善。对于第1组，平均值较低（p = 0.0150），改善量几乎是第1组的两倍（5.00 vs. 2.61，p = 0.0019）。同样，根据临床评估，第1组的应答者比例高于第2组（分别为88.9%和62.5%; p = 0.0009）。当从意向治疗角度分析数据时，显著性提高（p = 0.0006）。在生活质量肠道困扰子量表中，I组的结果更好。这些差异被取消后cross.Conclusion：高压氧治疗显着提高了难治性放射性直肠炎患者的愈合反应，产生的绝对风险降低32%（需要治疗的3）组之间的初始分配后。其他医疗管理要求已停止，基本上避免了先进的干预措施。由此提高了肠道特异性生活质量。(C)2008年爱思唯尔公司
Purpose: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis.Methods and Materials: Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life.Results: Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p = 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61,p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p = 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group I had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover.Conclusion: Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted. (C) 2008 Elsevier Inc.