Grigsby P W, Pilepich M V, Parsons C L
Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO 63110.
Am J Clin Oncol. 1990 Feb;13(1):28-31. doi: 10.1097/00000421-199002000-00008.
This is a report of a phase I/II study of 13 patients treated with sodium pentosanpolysulfate (PPS) for chronic radiation-induced proctitis. A complete response was obtained in 82%, a partial response occurred in 9%, and 9% failed to respond to therapy. No significant toxicity was observed. It is concluded that PPS is an effective treatment for chronic radiation-induced proctitis and a phase III randomized, double-blind study of PPS versus placebo is planned.
这是一项关于13例慢性放射性直肠炎患者接受戊聚糖多硫酸钠(PPS)治疗的I/II期研究报告。82%的患者获得完全缓解,9%的患者部分缓解,9%的患者对治疗无反应。未观察到明显毒性。结论是PPS是慢性放射性直肠炎的有效治疗方法,计划开展一项PPS与安慰剂对比的III期随机双盲研究。