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一项关于洗必泰漱口水缓解放射性口腔黏膜炎的随机试验。

Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis.

作者信息

Foote R L, Loprinzi C L, Frank A R, O'Fallon J R, Gulavita S, Tewfik H H, Ryan M A, Earle J M, Novotny P

机构信息

Mayo Clinic, Rochester, MN 55905.

出版信息

J Clin Oncol. 1994 Dec;12(12):2630-3. doi: 10.1200/JCO.1994.12.12.2630.

Abstract

PURPOSE

To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis.

PATIENTS AND METHODS

Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratification, they were randomized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash. Both groups were then similarly evaluated for mucositis and mouthwash toxicity.

RESULTS

Twenty-five patients were randomized to receive the chlorhexidine mouthwash, while 27 received the placebo mouthwash. Treatment arms were well balanced. There was a trend for more mucositis and there was substantially more toxicity (eg, mouthwash-induced discomfort, taste alteration, and teeth staining) on the chlorhexidine arm.

CONCLUSION

In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation.

摘要

目的

确定洗必泰漱口水是否能减轻放射性口腔黏膜炎。

患者与方法

选择计划接受放射治疗且口腔黏膜受照面积超过三分之一的患者进行研究。分层后,他们以双盲方式随机接受洗必泰漱口水或安慰剂漱口水。然后对两组患者的黏膜炎和漱口水毒性进行类似评估。

结果

25例患者随机接受洗必泰漱口水,27例接受安慰剂漱口水。治疗组间均衡性良好。洗必泰组有更多黏膜炎的趋势,且毒性(如漱口水引起的不适、味觉改变和牙齿染色)明显更多。

结论

与研究前的假设(洗必泰漱口水可能对接受口腔黏膜放射治疗的患者有益)相反,本研究提供了有力证据表明,在这种临床情况下洗必泰漱口水有害。

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