Long-term treatment with sulindac in familial adenomatous polyposis: A prospective cohort study

Long-term treatment with sulindac in familial adenomatous polyposis: A prospective cohort study
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DOI:
10.1053/gast.2002.31890
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发表时间:
2002-03-01
期刊:
影响因子:
29.4
通讯作者:
Giardiello, FM
Giardiello, FM
中科院分区:
医学1区
文献类型:
--
作者:
Cruz-Correa, M;Hylind, LM;Giardiello, FM

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背景和目标。家族性腺瘤性息肉病(FAP)患者的治疗包括结肠切除加回肠直肠吻合术(伊拉)。舒林酸是一种非甾体类抗炎药,可使FAP患者保留直肠段的结直肠腺瘤消退,但长期使用该疗法尚未进行研究。我们评估了舒林酸在试图维持保留的直肠段无腺瘤的长期有效性和毒性。12例FAP患者(5例女性),平均年龄37.1岁,伊拉接受舒林酸(平均剂量,158 mg/天)治疗,平均时间为63.4 ± 31.3个月(范围,14-98个月)。每4个月评估一次息肉的数量、大小和组织学分级、副作用和药物依从性。结果:12例患者中有7例(58%)留在研究中(其中6例无息肉),平均时间为76.9 ± 27.5个月。其中5例:12例患者(42%)在平均随访44 28个月(范围,14-89个月)后退出试验。在12个月(P = 0.039)和平均63.4 +/- 31.3个月(P = 0.006)时,在所有患者中观察到息肉数量显著回归。还观察到较高级别腺瘤(管状绒毛状腺瘤、绒毛状腺瘤)的复发预防(P = 0.004)。在35个月随访时,1例患者在直肠残端发生III期癌症。最常见的副作用为直肠黏膜糜烂6例。结论:长期使用舒林酸似乎可以有效减少大多数FAP患者保留直肠段的息肉数量和预防高级别腺瘤复发。伊拉部位的糜烂可能妨碍充分的剂量维持。
Background & Aims. Management of patients with familial adenomatous polyposis (FAP) can consist of colectomy with ileorectal anastomosis (IRA). Sulindac, a nonsteroidal anti-inflammatory drug, causes regression of colorectal adenomas in the retained rectal segment of FAP patients, although long-term use of this therapy has not been studied. We evaluated the long-term effectiveness and toxicity of sulindac in attempting to maintain retained rectal segments free of adenomas, Methods. Twelve FAP patients (5 women), mean age 37.1 years, with IRA received sulindac (mean dosage, 158 mg/day) for a mean period of 63.4 +/- 31.3 months (range, 14-98 months). Number, size, and histologic grade of polyps, side effects, and medication compliance were assessed every 4 months. Results: Seven of 12 patients (58%) remained in the study (6 of these polyp-free) for a mean of 76.9 +/- 27.5 months. Five of :12 patients (42%) withdrew from the trial after a mean follow-up period of 44 28 months (range, 14-89 months). A significant regression of polyp number was observed in all patients at 12 months (P = 0.039) and at a mean of 63.4 +/- 31.3 months (P = 0.006). Prevention of recurrence of higher-grade adenomas (tubulovillous, villous adenomas) was also observed (P = 0.004). At 35 months of follow-up, 1 patient developed stage III cancer in the rectal stump. The most common side effect was rectal mucosal erosions in 6 patients. Conclusions: Long-term use of sulindac seems to be effective in reducing polyp number and preventing recurrence of higher-grade adenomas in the retained rectal segment of most FAP patients. Erosions at the IRA site can preclude adequate dose maintenance.