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预防性硫糖铝混悬液对癌症化疗所致口腔炎的影响。一项随机、双盲交叉研究。

Effect of prophylactic sucralfate suspension on stomatitis induced by cancer chemotherapy. A randomized, double-blind cross-over study.

作者信息

Pfeiffer P, Madsen E L, Hansen O, May O

机构信息

Department of Oncology, Odense University Hospital, Denmark.

出版信息

Acta Oncol. 1990;29(2):171-3. doi: 10.3109/02841869009126540.

DOI:10.3109/02841869009126540
PMID:1692228
Abstract

We have studied whether mouth-swishing with sucralfate, a well-known gastric mucosal protective agent, may be used as prophylaxis against chemotherapy-induced stomatitis. Using radioactively labelled sucralfate we found that 20-30% was still bound to the oral mucosal lining 2 1/2 h after mouth-swishing. Forty patients receiving cisplatin and continuous infusion with 5-fluorouracil (5-FU) for 5 days entered a double-blind placebo-controlled cross-over study. Among 23 evaluable patients a significant reduction (p = 0.04) in an objective score of edema, erythema, erosion and ulcerations was seen during treatment with sucralfate. Patient preference favored sucralfate, but this preference failed to reach statistical significance (p = 0.06). Seven patients were inevaluable for reasons not associated with the study treatment. However, ten patients did not complete the study since the swishing procedure aggravated chemotherapy-induced nausea. An equal rate of non-compliance was seen with sucralfate and placebo. To overcome this problem, the oral medication should have a neutral taste, the solution should not be swallowed after the swishing, which should not be started until the nausea had ceased.

摘要

我们研究了使用知名的胃黏膜保护剂硫糖铝进行口腔含漱是否可用于预防化疗引起的口腔炎。通过使用放射性标记的硫糖铝,我们发现口腔含漱2个半小时后,仍有20% - 30%的硫糖铝与口腔黏膜结合。40名接受顺铂治疗并连续5天输注5-氟尿嘧啶(5-FU)的患者进入了一项双盲安慰剂对照交叉研究。在23名可评估的患者中,使用硫糖铝治疗期间,水肿、红斑、糜烂和溃疡的客观评分显著降低(p = 0.04)。患者更倾向于硫糖铝,但这种倾向未达到统计学意义(p = 0.06)。7名患者因与研究治疗无关的原因无法评估。然而,10名患者未完成研究,因为含漱程序加重了化疗引起的恶心。硫糖铝组和安慰剂组的不依从率相同。为克服这个问题,口服药物应无味,含漱后不应吞咽溶液,且应在恶心停止后再开始含漱。

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